HISA Anti-Doping and Medication Control Rule, 5070-5201 [2023-00957]

Agencies

• FEDERAL TRADE COMMISSION

[Federal Register Volume 88, Number 17 (Thursday, January 26, 2023)]
[Notices]
[Pages 5070-5201]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-00957]



[[Page 5069]]

Vol. 88

Thursday,

No. 17

January 26, 2023

Part II





Federal Trade Commission





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HISA Anti-Doping and Medication Control Rule; Notice

Federal Register / Vol. 88, No. 17 / Thursday, January 26, 2023 / 
Notices

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FEDERAL TRADE COMMISSION

[Matter No. P222100]


HISA Anti-Doping and Medication Control Rule

AGENCY: Federal Trade Commission.

ACTION: Notice of Horseracing Integrity and Safety Authority (HISA) 
proposed rule; request for public comment.

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SUMMARY: The Horseracing Integrity and Safety Act of 2020 recognizes a 
self-regulatory nonprofit organization, the Horseracing Integrity and 
Safety Authority, which is charged with developing proposed rules on a 
variety of subjects. Those proposed rules and later proposed rule 
modifications take effect only if approved by the Federal Trade 
Commission. The proposed rules and rule modifications must be published 
in the Federal Register for public comment. Thereafter, the Commission 
has 60 days from the date of publication to approve or disapprove the 
proposed rule or rule modification. The Authority submitted to the 
Commission a proposed rule on Anti-Doping and Medication Control on 
December 30, 2022. The Office of the Secretary of the Commission 
determined that the proposal complied with the Commission's rule 
governing such submissions. This document publicizes the Authority's 
proposed rule's text and explanation, and it seeks public comment on 
whether the Commission should approve or disapprove the proposed rule. 
This document is substantially similar to the document published on 
October 28, 2022, as corrected on November 4, 2022, and the Commission 
will consider all comments filed in response to that document as well 
as all comments filed in response to this document.

DATES: If approved, the HISA proposed rule would take effect 
immediately, and the Commission must approve or disapprove the rule by 
March 27, 2023. Comments must be received on or before February 9, 
2023.

ADDRESSES: Interested parties may file a comment online or on paper by 
following the instructions in the Comment Submissions part of the 
SUPPLEMENTARY INFORMATION section below. Write ``HISA Anti-Doping and 
Medication Control'' on your comment and file your comment online at 
https://www.regulations.gov under docket number FTC-2023-0009. If you 
prefer to file your comment on paper, mail your comment to the 
following address: Federal Trade Commission, Office of the Secretary, 
600 Pennsylvania Avenue NW, Suite CC-5610 (Annex B), Washington, DC 
20580.

FOR FURTHER INFORMATION CONTACT: Austin King (202-326-3166), Associate 
General Counsel for Rulemaking, Office of the General Counsel, Federal 
Trade Commission, 600 Pennsylvania Avenue NW, Washington, DC 20580.

SUPPLEMENTARY INFORMATION: 

Table of Contents

I. Self-Regulatory Organization's Statement of the Background, 
Purpose of, and Statutory Basis for, the Proposed Rule
    a. Background and Purpose
    b. Statutory Basis
II. Self-Regulatory Organization's Statement of the Terms of 
Substance of the Proposed Rule and Discussion of Alternatives
III. Self-Regulatory Organization's Summary of Comments Received 
Pre-Submission and Its Responses to Those Comments
IV. Legal Authority
V. Effective Date
VI. Request for Comments
VII. Comment and Submissions
VIII. Communications by Outside Parities to the Commissioners or 
Their Advisors
IX. Self-Regulatory Organization's Proposed Rule Language

Background

    The Horseracing Integrity and Safety Act of 2020 \1\ recognizes a 
self-regulatory nonprofit organization, the Horseracing Integrity and 
Safety Authority, which is charged with developing proposed rules on a 
variety of subjects. Those proposed rules and later proposed rule 
modifications take effect only if approved by the Federal Trade 
Commission.\2\ The proposed rules and rule modifications must be 
published in the Federal Register for public comment.\3\ Thereafter, 
the Commission has 60 days from the date of publication to approve or 
disapprove the proposed rule or rule modification.\4\
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    \1\ 15 U.S.C. 3051 through 3060.
    \2\ 15 U.S.C. 3053(b)(2).
    \3\ 15 U.S.C. 3053(b)(1).
    \4\ 15 U.S.C. 3053(c)(1).
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    Pursuant to Section 3053(a) of the Horseracing Integrity and Safety 
Act of 2020 and Commission Rule Sec.  1.142, notice is hereby given 
that, on December 30, 2022, the Horseracing Integrity and Safety 
Authority (``HISA'' or the ``Authority'') filed with the Federal Trade 
Commission a proposed Anti-Doping and Medication Control rule and 
supporting documentation as described in Items I, II, III, IV, and IX 
below, which Items have been prepared by HISA. The Office of the 
Secretary of the Commission determined that the filing complied with 
the Commission's rule governing such submissions.\5\ The Commission 
publishes this Notice to solicit comments on the proposed rule from 
interested persons. This document is substantially similar to the 
document published on October 28, 2022, 87 FR 65292, as corrected on 
November 4, 2022, 87 FR 66705, and the Commission will consider all 
comments filed in response to that document as well as all comments 
filed in response to this document.
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    \5\ 16 CFR 1.140 through 1.144; see also Fed. Trade Comm'n, 
Procedures for Submission of Rules Under the Horseracing Integrity 
and Safety Act, 86 FR 54819 (Oct. 5, 2021).
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I. Self-Regulatory Organization's Statement of the Background, Purpose 
of, and Statutory Basis for, the Proposed Rule

a. Background and Purpose

    The Act recognizes that the establishment of a national set of 
uniform standards for racetrack safety and medication control will 
enhance the safety and integrity of horseracing. As part of this 
endeavor, section 3053(a) of the Act directs the Authority to develop 
proposed rules relating to ``(2) a list of permitted and prohibited 
medications, substances, and methods, including allowable limits of 
permitted medications, substances, and methods; (3) laboratory 
standards for accreditation and protocols; [. . .] (8) a description of 
safety, performance, and anti-doping and medication control rule 
violations applicable to covered horses and covered persons; (9) a 
schedule of civil sanctions for violations; and (10) a process or 
procedures for disciplinary hearings.'' \6\
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    \6\ 15 U.S.C. 3053(a)(2)-(3), (8)-(10).
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    With the review, input, and ultimate approval of the Anti-Doping 
and Medication Control Standing Committee (``ADMC'') and the 
Authority's Board of Directors, the proposed rules: (1) set forth a 
list of anti-doping and controlled medication rules; (2) set forth a 
list of prohibited substances and methods; (3) set forth a framework 
for the testing of covered horses and the investigation of possible 
rule violations by the Horseracing Integrity and Welfare Unit (the 
``Agency''); (4) set forth a framework by which laboratories will be 
accredited and will analyze samples for prohibited substances and 
markers of prohibited methods; (5) specify the civil sanctions that 
apply to anti-doping and controlled medication violations; (6) create 
procedures for disciplinary hearings, tailored to the nature of the 
charge. The Agency participated in the development of the proposed rule 
and approves of the rules as filed.

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    In compliance with 16 CFR 1.142(a), the Authority states that the 
reason for adopting the Protocol is that the Horseracing Integrity and 
Safety Act of 2020 (``Act'') mandates and empowers the Horseracing 
Integrity and Safety Authority (the ``Authority'') to establish a 
uniform anti-doping and controlled medication program to improve the 
integrity and safety of horseracing in the United States (``Program''). 
The Equine Anti-Doping and Controlled Medication Protocol 
(``Protocol'') has been developed and issued by the Authority as part 
of that mandate. It contains or incorporates by reference rules, 
standards, and procedures to improve and protect the integrity and 
safety of horseracing in the United States by deterring and penalizing 
the improper administration or application of Prohibited Substances and 
Prohibited Methods to Covered Horses. The Protocol is split into five 
chapters: (1) the purpose, scope, and organization of the Protocol; (2) 
the Prohibited List, rules of proof, and testing and investigations; 
(3) the Equine Anti-Doping Rules; (4) the Equine Controlled Medication 
Rules; and (5) other violations and general procedure/administration.
    The Protocol has intentionally divided the regulation of Anti-
Doping Rule Violations and Controlled Medication Rule Violations into 
separate chapters to reflect the Authority's view that the treatment of 
such violations should be separate and distinct from each other. Anti-
Doping Rule Violations involve Banned Substances or Banned Methods, 
which are substances/methods that should never be in a horse's system 
or used on a horse as they serve no legitimate treatment purpose. 
Conversely, Controlled Medication Rule Violations involve Controlled 
Medication Substances or Controlled Medication Methods, which are 
substances/methods that have been determined to have appropriate and 
therapeutic purposes, and so may be used outside the Race Period, 
except if specified otherwise.
    The Protocol and related rules are intended to address the need for 
uniformity in horseracing, to protect the welfare of Covered Horses, to 
safeguard the integrity of horseracing, and to ensure the confidence of 
stakeholders (including the betting public) in the sport. Prior to the 
implementation of the Authority, horseracing has been regulated in the 
United States by the States. By its nature, this results in a lack of 
uniformity in the rules of horseracing, including in many vital areas 
of equine safety and the proper regulation of the use of prohibited 
substances. Congress acted to impose a comprehensive program that would 
effectively regulate horseracing with a common set of rules. The 
Protocol was developed in collaboration with industry experts and 
stakeholders who brought to the endeavor an unparalleled depth of 
equine safety, anti-doping, veterinary medicine, sports integrity, and 
compliance experience. The Protocol will provide one standard set of 
rules that apply to doping and medication control, laboratory drug 
testing methods and techniques, sample collection procedures, 
investigatory procedures, and hearing and adjudication procedures that 
will enhance the effective regulation of horse safety and medication 
issues.
    In considering reasonable alternatives to the proposed rule or 
modification that may accomplish the stated objective, it is important 
to underline that the Authority and the development of the Protocol is 
unprecedented. As a consequence, there are of course countless 
``alternatives'' on various issues, but the Authority has sought to 
combine the best practice elements from various sources, including 
rules and practices developed by the global anti-doping community, 
horseracing authorities (national and international), and other equine 
sport organizations.
    The Protocol will affect Covered Persons, Covered Horses, and 
Covered Horseraces by ensuring that horseracing is conducted in a 
manner that is consistent with the highest standards of integrity and 
that prioritizes the safety of Covered Horses and Covered Persons. The 
welfare of Covered Horses is secured by rules that strictly ban and 
penalize the use of doping substances and methods, and that sanction 
the misuse of therapeutic medications. All Covered Persons are required 
to comply with the Protocol and related rules, and to cooperate with 
the Authority and the Agency in relation to all aspects of doping and 
medication control, including sample collection, testing, and 
investigation procedures. The manner in which the Protocol implements 
these requirements is outlined in detail in Item II of this Notice.
    In developing the Protocol and related rules in a manner that is 
consistent with the Act and the rules and regulations applicable to the 
Authority, the Authority took the following principles and mandates 
into consideration, as directed by section 3055(b) of the Act:
    (1) Covered Horses should compete only when they are free from the 
influence of medications, other foreign substances, and methods that 
affect their performance. The entire Protocol is dedicated to this 
principle, and the elaborate anti-doping and controlled medication 
rules work toward the objective of ensuring that Covered Horses compete 
in a manner that is free of the influence of doping substances, 
medications, and methods that affect their performance. The Prohibited 
List and related Technical Document prescribe the substances and 
methods that are prohibited and permitted under certain circumstances. 
The Standards (Rules 5000 and 6000 Series) set out comprehensive 
investigatory and sample collection provisions and an accreditation 
system that ensures accurate laboratory testing, and the Arbitration 
Procedures establish a set of disciplinary procedures to deal fairly 
but firmly with violations of the rules.
    (2) Covered Horses that are injured or unsound should not train or 
participate in covered races, and the use of medications, other foreign 
substances, and treatment methods that mask or deaden pain in order to 
allow injured or unsound horses to train or race should be prohibited. 
In the Protocol, Rule 3111 operates together with the Prohibited List 
to ban substances and methods for which there exists medical, 
veterinary, or other scientific evidence or experience to a support 
their actual or potential masking properties (``Banned Substances'' and 
``Banned Methods'') and to restrict the use of medications during the 
Race Period (``Controlled Medication Substances'' and ``Controlled 
Medication Methods''). Certain Controlled Medication Substances are 
also prohibited during workouts, as set out in the Prohibited List. The 
Protocol also operates in conjunction with the Rule 2000 Racetrack 
Safety Program, which sets forth stringent rules for placing Covered 
Horses on the Veterinarians' List and requires the Regulatory 
Veterinarian to oversee removal from the list. These processes help to 
ensure that injured and unsound horses do not train or participate in 
Covered Horseraces. It should also be noted that Rule 2271 in the 
Racetrack Safety Program prohibits the ``[u]se of physical or 
veterinary procedures to mask the effects or signs of injury so as to 
allow training or racing to the detriment of the Horse's health and 
welfare.''
    (3) Rules, standards, procedures, and protocols regulating 
medication and treatment methods for Covered Horses and Covered 
Horseraces should be uniform and uniformly administered nationally. The 
Protocol preempts state laws and provides instead a uniform set of 
comprehensive rules that embrace all of the areas previously addressed 
in state anti-doping and medication

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control regulation schemes. The entire scheme will be administered 
nationally by the Authority and the Agency to ensure uniform and 
consistent application of the law. The Protocol and related rules will 
create a comprehensive program that is unprecedented in horseracing as 
previously conducted and regulated in the United States.
    (4) Consideration should be given to international anti-doping and 
medication control standards of the International Federation of 
Horseracing Authorities (``IFHA'') and the Principles of Veterinary 
Medical Ethics of the American Veterinary Medical Association. As 
directed by the Act, the ADMC has scrutinized the IFHA standards and 
rules very closely and also considered the Principles of Veterinary 
Medical Ethics of the American Veterinary Medical Association in 
preparing the Protocol. The World Anti-Doping Code also provided much 
of the inspiration for the Protocol, adapted as necessary for 
horseracing, taking into account national and international horseracing 
rules and Equine Anti-Doping and Controlled Medication Regulations of 
the International Equestrian Federation (i.e., the global governing 
body for equestrian sport).
    (5) The administration of medications and treatment methods to 
Covered Horses should be based upon an examination and diagnosis that 
identifies an issue requiring treatment for which the medication or 
method represents an appropriate component of treatment. The Protocol 
addresses the requirement for a sound diagnosis as a prerequisite for 
treatment and the need for such treatment not to be administered in a 
manner contrary to horse welfare. Specifically, Rule 3040(b)(3) states 
that it is the personal responsibility of each Responsible Person to 
ensure that treatments and medications administered to his or her 
Covered Horses (i) are administered only on the advice of a 
Veterinarian or (if a prescription is not required) following 
sufficient due diligence regarding the treatment or medication; (ii) 
are not administered in a manner detrimental or contrary to horse 
welfare; (iii) are the minimum necessary to address the diagnosed 
health concerns identified during the veterinary examination and 
diagnostic process; (iv) do not contain a Banned Substance or involve a 
Banned Method; and (v) do not otherwise violate the Protocol. Further, 
Rule 3314 penalizes use of a Controlled Medication Substance or Method 
in a manner that is contrary to horse welfare. In particular, Rule 
3314(a) specifically mandates that any use of a Controlled Medication 
Substance or a Controlled Medication Method on a Covered Horse must 
``(i) be justified by the Covered Horse's medical condition(s) as 
diagnosed by a Veterinarian, (ii) have been recommended by a 
Veterinarian in the context of a valid veterinarian-patient-client 
relationship, (iii) go no further than the minimum necessary to address 
the diagnosed health concerns, and (iv) be in the best interests of the 
Covered Horse's health and welfare.'' Rule 3314(b) also states that it 
is ``the personal and non-delegable duty of the Responsible Person'' to 
ensure the above requirements in Rule 3314(a) are complied with. The 
Protocol also establishes in Rules 3227 and 3327 that an aggravating 
circumstance that may be taken into account in assessing sanctions for 
a rule violation may include ``administration of a Controlled 
Medication Substance that is detrimental to the health and welfare of 
the horse or is designed to deceive the betting public.'' It should 
also be noted that Rule 2221 (of the previously approved Racetrack 
Safety Rule) also establishes examination and diagnoses requirements in 
the context of the veterinarian-client-patient relationship.
    (6) The amount of therapeutic medication that a Covered Horse 
receives should be the minimum necessary to address the diagnosed 
health concerns identified during the examination and diagnostic 
process. As noted above, Rule 3040(b)(3) and Rule 3314 specifically 
address the requirement that any use of a Controlled Medication 
Substance or a Controlled Medication Method on a Covered Horse must go 
no further than ``the minimum necessary to address the diagnosed health 
concerns.''
    (7) The welfare of Covered Horses, the integrity of the sport, and 
the confidence of the betting public require full disclosure to 
regulatory authorities regarding the administration of medications and 
treatments to Covered Horses. The Protocol addresses this issue in 
several ways. It requires all Covered Persons to cooperate promptly and 
completely with the Authority and the Agency in the exercise of their 
respective powers under the Act and the Protocol and related rules 
(Rule 3040(a)). Each Responsible Persons is required to maintain 
accurate, complete, and up-to-date treatment records of his or her 
Covered Horses in a form specified by the Agency, and to provide the 
records on request to the Agency (Rule 3040(b)(8)). Responsible Persons 
must declare to the Agency any use of Banned Substances or Banned 
Methods on a horse prior to it becoming a Covered Horse (Rule 
3040(b)(9)). To facilitate out-of-competition testing, Responsible 
Persons must file whereabouts information if their Covered Horses are 
moved to a private facility (Rule 3040(b)(10)). Attending Veterinarians 
must keep updated treatment records in an electronic database 
designated by the Agency or in any other form designated by the Agency 
and must provide access on request to copies of these records (Rule 
3040(d)). Refusal or failure to cooperate with the Authority or the 
Agency, or the commission of a Whereabouts Failure, constitutes a 
violation of the Protocol under Rule 3510. Several provisions in the 
Rule 2000 Series complement the Protocol's disclosure requirements. 
Rule 2551, for example, requires every Veterinarian who examines or 
treats a Covered Horse to submit to the Authority, within 24 hours of 
such examination or treatment medications, treatment records with 
details as prescribed in the Rule.
    In further compliance with the Act, the Protocol establishes a 
comprehensive set of violations and hearing procedures to prohibit 
certain conduct, to provide a process for determining the existence of 
a violation; of charging a Covered Person with a violation; and with 
resolving the matter in a full and fair hearing process. The Protocol 
authorizes the imposition of sanctions that comport with the severity 
of the violation. Consistent with 15 U.S.C. 3057(d)(2), the violation 
and sanction system is tailored to the unique aspects of horseracing in 
that it has the power to declare a Covered Person or Covered Horse 
ineligible to race for a specified time, imposes substantial fines upon 
Covered Persons, and establishes a points system to implement a system 
of penalties for multiple violations of the Protocol. These penalties 
are common in the adjudication and sanction of violations in the world 
of horseracing. The sanctions also include forfeiture of purse, 
disqualification of horses, and changes to the order of finish in horse 
races. The elaborate hearing procedures and penalty rules ensure that 
violations are consistently and fairly penalized, which in turn deters 
future violations, and maintains the integrity and conduct of fair and 
transparent horseraces. Effective sample collection and testing 
techniques, as set forth in Rule Series 5000 and 6000 also serve to 
enhance successful prosecution of violations, which deter future 
violations. The goal of transparency is also served by operation of the 
public disclosure rules in the Protocol, which

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mandate that the public be informed of information concerning specific 
cases as the cases are adjudicated or otherwise resolved.
    The components of the Protocol and related rules comport with the 
baseline standards in 15 U.S.C. 3055(g)(2)(a), which include: (1) the 
lists of permitted and prohibited substances (including drugs, 
medications, and naturally occurring substances and synthetically 
occurring substances) in effect for the International Federation of 
Horseracing Authorities, including the International Federation of 
Horseracing Authorities International Screening Limits for urine, dated 
May 2019, and the International Federation of Horseracing Authorities 
International Screening Limits for plasma, dated May 2019; (2) the 
World Anti-Doping Agency International Standard for Laboratories 
(version 10.0), dated November 12, 2019; (3) the Association of Racing 
Commissioners International out-of-competition testing standards, Model 
Rules of Racing (version 9.2); and (4) the Association of Racing 
Commissioners International penalty and multiple medication violation 
rules, Model Rules of Racing (version 6.2). Any deviations from the 
baseline standards have been approved by the Authority and the Agency 
following detailed consideration and adoption of an approach that is 
either stricter or more consistent with horseracing.

b. Statutory Basis

    The Horseracing Integrity and Safety Act of 2020, 15 U.S.C. 3051 
through 3060.

II. Self-Regulatory Organization's Statement of the Terms of Substance 
of the Registration Proposed Rule and Discussion of Alternatives

a. Existing Standards

    Anti-doping and controlled medication rules currently vary from 
State to State, but the overall structure of the rules governing 
horseracing is generally consistent among the States. In particular, 
the rules of horseracing center around a number of common subject 
areas, including the licensing of racing associations and of individual 
participants in horseracing, medication control rules, pari-mutuel 
wagering rules, the operation of various incentive funds, rules 
concerning the running of the race, and rules establishing disciplinary 
measures and hearing procedures. The basic precepts of many of the 
rules pertaining to violations, sanctions, hearing procedures, and 
investigatory powers have been in force in racing states for many 
years, and the Authority has reviewed and considered key provisions 
from numerous states in developing these rules.
    The Association of Racing Commissioners International (``ARCI'') 
sets forth standards and protocols in its Model Rules of Racing (``ARCI 
Rules''). Relying upon the collective expertise of regulatory personnel 
in member jurisdictions in consultation with regulated entities, 
industry stakeholders, and individuals, ARCI committees regularly 
consider ways to improve and enhance the regulation of racing. The 
Authority considered the ARCI Model Rules of Racing when developing the 
Protocol and related rules. Likewise, the Authority considered rules 
from other racing jurisdictions such as the British Horseracing 
Authority's Rules of Racing.
    The Authority also considered and relied heavily on international 
anti-doping standards, including the World Anti-Doping Code (applicable 
to human athletes) and the International Equestrian Federation 
(``FEI'') Equine Anti-Doping and Controlled Medication Regulations 
(applicable at the international level to various equestrian 
disciplines). Those regulations provide a robust anti-doping framework 
that has been tested before arbitration tribunals for many years, and 
that has generated a well-developed body of precedent and guidance for 
interpreting the provisions in those frameworks.
    The Authority, in consultation with the ADMC and the Agency, 
reviewed these existing standards and tailored them to the Authority's 
regulatory structure and goals, and to the specificities of 
horseracing.
    The provisions of these Series were made publicly available on the 
Authority website at www.hisaus.org/regulations on June 1, 2022. A 
number of stakeholder comments were received, which are addressed 
further in Item III below. Additionally, the Authority consulted 
directly with a number of industry officials and participants in 
obtaining feedback on the proposed rules. The Authority is submitting 
those comments along with this Notice of Filing as Exhibit A, which is 
available for public inspection at the corresponding docket at https://www.regulations.gov. Furthermore, all the important source materials on 
which the Authority relied in developing its proposed rule are also 
collected at that docket as Exhibit B.

b. Terms of Substance: Rule Series 3000--Equine Anti-Doping and 
Controlled Medication Protocol

1. Purpose, Scope, and Organization--Rules 3010-3090
    Chapter I of the Protocol has been developed taking account of the 
requirements of the Act, including, in particular, those set out at 
sections 3054 and 3055 of the Act.
    The Protocol will go into effect if and when the Commission 
approves the proposed rule. The Protocol contains or incorporates by 
reference rules, standards, and procedures to improve and protect the 
integrity and safety of horseracing in the United States by deterring 
and penalizing the improper administration or application of Prohibited 
Substances and Prohibited Methods to Covered Horses. The Protocol is 
divided into five substantive chapters: (1) the purpose, scope, and 
organization of the Protocol; (2) the Prohibited List, rules of proof, 
and testing and investigations; (3) the Equine Anti-Doping Rules; (4) 
the Equine Controlled Medication Rules; and (5) other violations and 
general procedure/administration.
    The Protocol has intentionally divided the regulation of Anti-
Doping Rule Violations and Controlled Medication Rule Violations into 
separate chapters to reflect the Authority's view that the treatment of 
such violations should be separate and distinct from each other. Anti-
Doping Rule Violations involve Banned Substances or Banned Methods, 
which are substances/methods that should never be in a horse's system 
or used on a horse as they serve no legitimate treatment purpose. 
Conversely, Controlled Medication Rule Violations involve Controlled 
Medication Substances or Controlled Medication Methods, which are 
substances/methods that have been determined to have appropriate and 
therapeutic purposes, and so may be used outside the Race Period, 
except if specified otherwise. This division accords with international 
best practices. However, the two distinct processes share many common 
features and rules, and therefore the Protocol is streamlined to make 
the processes consistent with each other wherever possible.
    The Protocol will be implemented and enforced on behalf of the 
Authority by the Agency, which has created an entity designated as the 
Horseracing Integrity and Welfare Unit (``Agency''). In addition, and 
only where so agreed, State Racing Commissions acting under the 
delegated authority of the Authority

[[Page 5074]]

or the Agency (Rule 3010(e)) may also assist in implementation.
    In accordance with section 3055(a)(1) of the Act, the Protocol 
applies to all Covered Horses, Covered Persons, and Covered Horseraces 
(Rule 3020). Pursuant to section 3054 of the Act, Covered Persons must 
register with the Authority.
    In developing the Protocol, the Authority reviewed and considered 
various anti-doping and controlled medication rules, including:

Exhibit B.2. ARCI Model Rules of Racing, including, in particular, the 
penalty provisions and rules on multiple medication violation.
Exhibit B.3. FEI Equine Anti-Doping & Controlled Medication 
Regulations.
Exhibit B.4. FEI Atypical Findings Policy.
Exhibit B.5. World Anti-Doping Code.
Exhibit B.6. British Horseracing Authority Equine Anti-Doping Rules.
2. Prohibited List, Rules of Proof, and Testing and Investigations--
Rules 3110-3140
    The Protocol incorporates the Prohibited List, which identifies the 
Banned Substances and Banned Methods that are prohibited at all times 
on the basis of the Agency's determination that medical, veterinary, or 
other scientific evidence or experience supports their actual or 
potential (i) ability to enhance the performance in Covered Horses, 
(ii) masking properties, or (iii) detrimental impact on horse welfare. 
The Prohibited List also identifies Controlled Medication Substances 
and Controlled Medication Methods, which are prohibited for Use on or 
Administration to a Covered Horse during the Race Period and must not 
be present in a Post-Race Sample or Post-Work Sample, except as 
specified otherwise. In other words, the phrase ``Prohibited Substances 
and Prohibited Methods'' refers to Banned Substances and Banned Methods 
as well as Controlled Substances and Controlled Medication Methods that 
are only restricted during the Race Period. The Prohibited List will be 
published at least annually (Rule 3112).
    The Prohibited List is supplemented by the ``Technical Document--
Prohibited Substances,'' which enumerates the Prohibited Substances 
that fall into the general categories listed in the Prohibited List and 
sets forth detection times, screening limits, and thresholds for those 
Prohibited Substances. The Technical document also designates certain 
Prohibited Substances as Specified Substances, which are those that 
pose a higher risk of being the result of contamination and that are, 
therefore, subject to more flexible sanctions.
    In disciplinary cases brought under the Protocol, the Agency will 
have the burden of establishing that a violation of the Protocol has 
occurred to the comfortable satisfaction of the hearing panel, bearing 
in mind the seriousness of the allegation made (Rule 3121), and facts 
may be established by any reliable means (Rule 3122). The ``comfortable 
satisfaction'' standard of proof is greater than a mere balance of 
probability (i.e., a preponderance of the evidence) but less than clear 
and convincing evidence or proof beyond a reasonable doubt (Rule 3121).
    Only the Agency (and those authorized by the Agency) may initiate 
and direct testing on any Covered Horse. The Agency will have broad 
authority to conduct testing both in and out of competition (Rule 
3132), and samples collected will be owned by the Authority (Rule 
3135). Samples obtained from Covered Horses will be analyzed primarily 
to detect the presence of Prohibited Substances (Rule 3137).
    State Racing Commissions, Racetracks, Race Organizers, and Training 
Facilities shall not initiate or direct any Testing of Covered Horses. 
However, they may request that the Agency initiate and direct enhanced 
or additional Testing (e.g., in relation to a particular Covered 
Horserace). The Agency may accept or decline such request at its 
absolute discretion. Where the Agency accepts the request, the costs of 
Sample collection and analysis shall be borne by the entity requesting 
the additional or enhanced Testing. The Agency may conduct the Testing 
itself or delegate the Testing to the relevant State Racing Commission. 
(Rule 3132).
3. Equine Anti-Doping Rules--Rules 3210-3260
    The Equine Anti-Doping Rules set out in Chapter III of the Protocol 
apply to conduct involving Banned Substances or Banned Methods, i.e., 
substances and methods prohibited at all times. The violations set out 
in this Chapter are included as directed by section 3057(a)(2) of the 
Act, and are also substantively modelled on World Anti-Doping Code 
violations. The violations prohibit use, possession, trafficking, and 
administration to a Covered Horse of Banned Substances or Banned 
Methods (Rules 3213 and 3214). It is a violation to evade, refuse or 
fail to submit a Covered Horse to sample collection (Rule 3215), and 
the presence of a Banned Substance in a sample collected from a Covered 
Horse is also a violation (Rule 3212). In accordance with section 
3057(a)(2) of the Act, presence and use violations are strict liability 
offenses for the Responsible Person, although other Covered Persons may 
also be liable to the same extent if they are complicit in the 
violation. Other prohibited conduct includes tampering with doping 
control, complicity with another person's violation, associating with a 
person who is banned, and improper retaliation against actual or 
potential whistle-blowers or intimidation of witnesses (Rule 3216). 
Attempts to commit Anti-Doping Rule Violations are also sanctionable.
    As directed by the Act, the Authority has developed a list of civil 
sanctions for Anti-Doping Rule Violations. The Protocol and Prohibited 
List establish uniform rules imposing civil sanctions against Covered 
Persons and Covered Horses for Anti-Doping Rule Violations (and also 
for Controlled Medication Rule Violations, addressed under chapter IV 
of the Protocol), as directed by section 3057(d) of the Act. The range 
of civil sanctions (a) take into account the unique aspects of 
horseracing; (b) are designed to ensure fair and transparent Covered 
Horseraces; and (c) are intended to deter violations. The severity of 
the sanctions depends on the nature of the violation, and allows an 
opportunity for adjustment in penalty depending on the violation and 
facts involved.
    A mandatory part of each sanction will include Public Disclosure of 
relevant information, including the Covered Person's name, the 
violation, and consequences imposed (Rules 3231 and 3620).
    If the violation arises from a Post-Race Sample or occurs during 
the Race Period, the Covered Horse's results at that Covered Horserace 
will automatically be disqualified, because the horse competed with a 
Banned Substance in its system, irrespective of the reason why the 
Banned Substance was there or any degree of fault on the part of the 
Covered Person (Rule 3221(a)). Subsequent results may also be 
disqualified (Rule 3221(b)) and in any case of disqualification, all 
purses and other compensation, prizes, trophies, points, and rankings 
are forfeited and must be repaid or surrendered to the race organizer, 
and the results of the other Covered Horses in the race in question 
must be adjusted accordingly (Rule 3221(c)).
    The Protocol now also specifies what happens to the race 
classification pending the outcome of the disciplinary proceedings 
(Rules 3221 and 3321). Further, Rule 3221(a) allows for the Agency, the 
Responsible Person, and the

[[Page 5075]]

Owner of the Covered Horse in question to agree (or to ask the 
Arbitral) to apply Rule 3221 immediately, i.e., prior to adjudication 
of any other issue.
    In presence or use cases, the Covered Horse will be subject to a 
period of ineligibility, the length of which depends on the particular 
Banned Substance(s) detected, as set out in the Prohibited List. During 
any period of ineligibility, the Covered Horse shall not participate in 
any Workout or Covered Horserace, but will remain subject to testing 
(Rule 3229).
    The Covered Person will be sanctioned with a period of 
ineligibility commensurate to his or her level of fault, in accordance 
with a detailed sanctioning framework. The starting point for presence, 
use, possession, or administration violations is a period of 
ineligibility of two years, subject to elimination or reduction if the 
Covered Person can demonstrate that he or she bears no or no 
significant fault or negligence, or subject to increase if aggravating 
circumstances are present (Rules 3223(b), 3224, and 3225). For other 
violations, the rules specify other starting points or ranges for the 
applicable period of ineligibility that reflect the seriousness of the 
violation (Rule 3223(b)). The rules also provide the Authority with the 
ability to eliminate or reduce an applicable period of ineligibility in 
circumstances where a Covered Person provides Substantial Assistance or 
admits the violation early or in the absence of other evidence (Rule 
3226). There are also increased sanctions for repeat offenders (Rule 
3228). During any period of ineligibility, the Covered Person shall not 
participate in any capacity in any activity involving Covered Horses or 
in any other activity (other than authorized anti-doping education or 
rehabilitation programs) taking place at a Racetrack or Training 
Facility; nor shall he or she permit anyone to participate in any 
capacity on his or her behalf in any such activities (Rule 3229(a)). 
The Covered Horse(s) of an Owner or Trainer subject to a Provisional 
Suspension or period of Ineligibility shall also be subject to 
restrictions (Rule 3229(b)).
    The Covered Person may also be required to pay a fine, depending on 
the violation, and some or all of the Agency's legal costs (Rule 
3223(b)).
    Where a Covered Person is found based on the same facts to have 
committed a violation involving both (i) one or more Banned 
Substance(s) or Banned Method(s), and (ii) one or more Controlled 
Medication Substance(s) or Controlled Medication Method(s), the Covered 
Person shall be considered to have committed one Anti-Doping Rule 
Violation and the sanction imposed shall be based on the Banned 
Substance or Banned Method that carries the most severe sanction. Rule 
3227 (Aggravating Circumstances) may also be applied to increase the 
sanction imposed (Rule 3228(d)).
    The Equine Anti-Doping Rules provide a framework for the results 
management of potential anti-doping rule violations, as directed by the 
Act. Different types of Samples may be collected from Covered Horses, 
including urine, blood, and hair. Unless specified otherwise in the 
rules, at the time of collection, the Sample will be divided into an 
``A'' and a ``B'' Sample. Review of ``A Sample'' adverse analytical 
findings or other evidence leads to an initial notification by the 
Agency to the Covered Person that he or she may have committed an anti-
doping rule violation (Rule 3245). In some cases, the Covered Person 
will be provisionally suspended pending determination of the matter 
(Rule 3247), and the ``B Sample'' may be tested (Rule 3246). The 
Covered Person is entitled to respond to the Agency's initial 
notification, and if he or she does, the Agency will take any comments 
and additional information into account before deciding whether to 
formally charge the Covered Person with an anti-doping rule violation 
and request a more formal response (Rule 3248)).
    The Covered Person is entitled to have the charge determined by the 
Arbitral Body (the panel hearing will consist of either one or three 
impartial arbitrators) in accordance with the Arbitration Procedures 
(Series 7000). The final decision of the Arbitral Body is subject to 
review in accordance with the Act (Rule 3264). The rules also provide 
for the Agency and Covered Person to agree to a resolution to the 
charge without a hearing (Rule 3249).
4. Equine Controlled Medication Rules--Rules 3310-3360
    The Equine Controlled Medication Rules set out in Chapter IV of the 
Protocol apply to conduct involving Controlled Medication Substances or 
Controlled Medication Methods (i.e., substances prohibited for use on 
or administration to a Covered Horse during the Race Period and 
prohibited to be present in a Post-Race Sample or Post-Work Sample, 
except as otherwise specified in the Prohibited List). The violations 
set out in this Chapter are drawn from similar provisions to those 
relating to Anti-Doping Rule Violations, modified to reflect the 
differing approaches to the use of Controlled Medication Substances and 
Controlled Medication Methods, as opposed to Banned Substances and 
Banned Methods. The violations include the use, possession, or 
administration to a Covered Horse of Controlled Medication Substances 
or Controlled Medication Methods during the Race Period (Rules 3313 and 
3315). Other violations include use of a Controlled Medication 
Substance that is not justified by the horse's medical condition or 
does not meet other criteria (Rule 3314), tampering with medication 
control (Rule 3316), and the presence of a Controlled Medication 
Substance in a sample collected from a Covered Horse (Rule 3312). In 
accordance with section 3057(a)(2) of the Act, presence and use 
violations are considered strict liability offenses. Attempts to commit 
Controlled Medication Rule Violations are also sanctionable.
    As directed by the Act, the Authority has developed a list of civil 
sanctions for Controlled Medication Rule Violations. The Protocol and 
Prohibited List establish uniform rules imposing civil sanctions 
against Covered Persons and Covered Horses for Controlled Medication 
Rule Violations, as directed by section 3057(d) of the Act. The range 
of civil sanctions (a) take into account the unique aspects of 
horseracing; (b) are designed to ensure fair and transparent Covered 
Horseraces; and (c) are intended to deter violations. The severity of 
the sanctions depends on the nature of the violation, and allows an 
opportunity for adjustment depending on the violation and facts 
involved.
    A mandatory part of each sanction will include Public Disclosure of 
relevant information, including the Covered Person's name, the 
violation, and consequences imposed (Rules 3331 and 3620).
    If the violation arises from a Post-Race Sample or occurs during 
the Race Period, the Covered Horse's results at that Covered Horserace 
will automatically be disqualified, with all resulting consequences, 
because the horse competed with a Controlled Medication Substance in 
its system. The results will be automatically disqualified irrespective 
of the reason why the Controlled Medication Substance was detected or 
of any degree of fault on the part of the Covered Person (Rule 
3321(a)). Subsequent results will not be disqualified (Rule 3321(b)).
    The Covered Horse will not be subject to a period of ineligibility 
if the violation involves a Controlled Medication Substance, but may be 
subject to a period of ineligibility if the violation involves a 
Controlled Medication Method as specified in the Prohibited List (Rule 
3322).

[[Page 5076]]

    Covered Persons shall be sanctioned for any Controlled Medication 
Rule Violations in accordance with Rule 3323(b), depending on the 
category or class of the violation, and the number of violations 
committed within that same category/class in the previous two-year 
period. Presence, use, and administration violations are divided into 
three different classes (Class A, Class B, Class C) with Class A 
carrying the more severe sanctions. The sanctions for Controlled 
Medication Rule Violations are subject to elimination (Rule 3324), 
reduction (Rules 3325 and 3326), or increase (Rule 3327), depending on 
the violation in issue and the specific circumstances of the case.
    The Protocol also establishes a multiple medication violation 
penalty points system for repeat offenders which takes account of 
violations committed in different categories/classes (Rule 3328). As 
directed by section 3055(g) of the Act, the Authority used the 
Association of Racing Commissioners International penalty and multiple 
medication violation rules, Model Rules of Racing, as a baseline for 
the multiple violations penalty points system. All adjustments and 
modifications to the baseline rules were approved by the Authority in 
consultation with the ADMC and the Agency in accordance with section 
3055(g)(3) of the Act.
    The penalty points system is not a substitute for the consequences 
that apply to the underlying Controlled Medication Rule Violations. 
Rather, the penalty points system is intended to apply additional 
uniform Consequences where the Covered Person is a repeat offender and 
exceeds the permissible number of points. Where the relevant cumulative 
point threshold is exceeded, the Covered Person shall receive an 
automatic additional period of ineligibility as specified in Rule 
3328(c). Penalty points are assigned automatically depending on the 
category/class of violation in issue, save where specified otherwise in 
Rule 3328. Penalty points and the additional period of Ineligibility 
shall be applied automatically at the conclusion of the proceeding on 
the underlying violation, without any additional hearing or right of 
review. Penalty points shall be applied retroactively to start on the 
date on which the Controlled Medication Rule Violation occurred and 
shall expire after 2 years (Rule 3328(d)).
    During any period of Ineligibility or Provisional Suspension, 
Covered Persons shall be prohibited from the same activities as anyone 
banned for an Anti-Doping Rule Violation. As for Anti-Doping Rule 
Violations, the Covered Horses of a suspended Trainer or Owner may not 
participate in any Timed and Reported Workout or Covered Horserace, but 
in contrast to Anti-Doping Rule Violations, they may participate in a 
Covered Horserace if they were entered in the race before the Trainer 
was notified of the Provisional Suspension or the period of 
Ineligibility was imposed (whichever is earlier) (Rule 3320(b)). 
Further, in contrast to Anti-Doping Rule Violations, the Covered Horses 
of a suspended Trainer must only be transferred to another Covered 
Person if the period of ineligibility imposed on the Trainer is more 
than 30 days (Rule 3329(b)).
    The Covered Person may also be required to pay a fine depending on 
the category of the violation, and some or all of the Agency's legal 
costs (Rule 3323(b)).
    The Equine Controlled Medication Rules provide a framework for the 
results management of potential controlled medication rule violations 
as directed by the Act, from review of ``A Sample'' adverse analytical 
findings or other evidence leading to an initial notification by the 
Agency to the Covered Person that he or she may have committed a 
controlled medication rule violation (Rule 3345). The Covered Person 
will not be provisionally suspended pending determination of the matter 
unless he or she voluntarily accepts a provisional suspension (Rule 
3347), and the B Sample may be tested (Rule 3346). The Covered Person 
is entitled to respond to the Agency's initial notification, and if he 
or she does, the Agency will take any comments and additional 
information into account before deciding whether to formally charge the 
Covered Person with a controlled medication rule violation and request 
a more formal response (Rule 3348).
    The Covered Person is entitled to request a hearing before the 
Internal Adjudication Panel. The hearing will ordinarily be conducted 
before a single member of the Internal Adjudication Panel, though three 
members may be assigned to hear the case where appropriate. The 
Internal Adjudication Panel may decide in its sole discretion to 
determine the matter on the written submissions alone without a hearing 
if the Internal Adjudication Panel considers itself sufficiently well-
informed to render a decision on the written submissions alone. The 
Internal Adjudication Panel will issue a final decision, subject to 
review in accordance with the Act (Rules 3361-3364).
    The rules also provide for the Agency and Covered Person to agree 
to a resolution to the charge without a hearing (Rule 3349).
5. Other Violations and General Procedure/Administration--Rules 3500-
3800
    Chapter V sets out additional disciplinary offenses that do not 
fall within the chapters on Equine Anti-Doping Rules or Equine 
Controlled Medication Rules (Rule 3510), and also prescribes sanctions 
(periods of ineligibility and fines) for those violations (Rule 3520). 
Those violations include engaging in disruptive or offensive conduct 
towards doping control personnel, refusing/failing to cooperate in full 
with the Authority or Agency in the discharge of his or her respective 
responsibilities under this Protocol, and committing a whereabouts 
failure (in effect, failing to provide the necessary information to 
enable a Covered Horse to be located for testing). Alleged violations 
will be determined by the Internal Adjudication Panel (Rule 3361).
    In accordance with section 3057(c)(2) of the Act, the rules provide 
guidelines for confidentiality and public reporting of decisions (Rules 
3610-3630). Rule 3710 also provides for the recognition of decisions by 
recognized, official third parties, for example, national horseracing 
authorities in other countries applying substantially similar rules 
(Rule 3700).

c. Terms of Substance: Rule Series 1000--General Provisions

    The Protocol and other Series are supported by the general rules of 
interpretation (Rule 1010) and a list of defined terms (Rule 1020) to 
assist with clarity of meaning.

d. Terms of Substance: Rule Series 4000--Prohibited List

    As directed by sections 3053 and 3055 of the Act, the Authority has 
developed a list of permitted and prohibited medications, substances, 
and methods, including allowable limits of permitted medications, 
substances, and methods, using as a baseline the lists of permitted and 
prohibited substances (including drugs, medications, and naturally 
occurring substances and synthetically occurring substances) in effect 
for the International Federation of Horseracing Authorities (``IFHA''), 
including the IFHA International Screening Limits for urine and the 
IFHA International Screening Limits for plasma. All adjustments and 
modifications to the baseline rules were approved by the Authority in 
consultation with the

[[Page 5077]]

ADMC and the Agency in accordance with section 3055(g)(3) of the Act.
    The Prohibited List identifies Prohibited Substances and Prohibited 
Methods that are: (a) prohibited at all times (``Banned Substances'' 
and ``Banned Methods'') on the basis of the Agency's determination that 
medical, veterinary, or other scientific evidence or experience 
supports their actual or potential (i) ability to enhance the 
performance in Covered Horses, (ii) masking properties, or (iii) 
detrimental impact on horse welfare; or (b) prohibited for Use on or 
Administration to a Covered Horse during the Race Period and prohibited 
to be present in a Post-Race Sample (which includes samples collected 
following a Covered Horserace or Vets' List Workout) or Post-Work 
Sample (which includes samples collected following a Timed and Reported 
Workout), except as otherwise specified in the Prohibited List 
(``Controlled Medication Substances'' and ``Controlled Medication 
Methods''). Prohibited Substances and Prohibited Methods may be 
included in the Prohibited List by general category (e.g., anabolic 
steroids) or by specific reference to a particular substance or method.
    The Prohibited List is supplemented by the ``Technical Document--
Prohibited Substances,'' which enumerates the Prohibited Substances 
that fall into the general categories listed in the Prohibited List and 
sets forth detection times, screening limits, and thresholds for those 
Prohibited Substances. The Technical Document also designates certain 
Prohibited Substances as Specified Substances, which are those that 
pose a higher risk of being the result of contamination and that are 
therefore subject to more flexible sanctions.
    In accordance with section 3055(d) of the Act, the use or 
administration of Controlled Medication Substances and Controlled 
Medication Methods is prohibited during the ``Race Period'' (i.e., 48 
hours prior to post-time) except where expressly provided otherwise in 
the Prohibited List or Protocol. Responsible Persons are strictly 
liable for any substance found to be present in a Post-Race Sample or 
Post-Work Sample, even if such substance was used or administered 
before the Race Period. As specified in section 3055(e) and (f) of the 
Act, certain exemptions apply to furosemide (i.e., Lasix/Salix), which 
are set out in the Prohibited List.
    The Prohibited List and supporting Technical Document were prepared 
in consultation with the ADMC and the Agency, and approved by the 
Authority, as directed by section 3055(c)(5) of the Act. In preparing 
the Prohibited List and the ``Technical Document--Prohibited 
Substances,'' the Authority considered lists of prohibited substances 
and methods published by other organizations, including the ARCI, World 
Anti-Doping Agency (``WADA''), the FEI, and the British Horseracing 
Association. Documents considered in preparing the Prohibited List are 
exhibited below:

Exhibit B.7. IFHA International Screening Limits for urine.
Exhibit B.8. IFHA International Screening Limits for plasma.
Exhibit B.9. ARCI Uniform Classification Guidelines for Foreign 
Substances and Recommended Penalties Model Rule.
Exhibit B.10. WADA 2022 Prohibited List.
Exhibit B.11. 2022 FEI Equine Prohibited Substances List.
Exhibit B.12. British Horseracing Association Equine Prohibited List 
Code (2022).
Exhibit B.13. British Horseracing Association Published Detection Times 
(June 2019).
Exhibit B.14. Hong Kong Jockey Club Medication and Prohibited 
Substances.

    The ADMC also considered a number of scientific papers when 
developing the Prohibited List and supporting Technical Document:

Exhibit B.15. AAS 16 Detection of Some Designer Steroids in Horse 
Urine: Identifies the integrity risks associated with the use of 
anabolic steroids in racehorses.
Exhibit B.16. AAS 29 Anabolic Effects of [beta]2-agonists, formoterol 
and salbutamol on cancellous bone of ovariectomized (OVX) rat: With the 
banning of anabolic steroids, those seeking an anabolic effect turned 
to [beta]2-agonists. Their misuse has been well-documented in horses 
engaged in racing and training.
Exhibit B.17. ACA 01 Effects of intravenous aminocaproic acid on 
exercise-induced pulmonary haemorrhage (EIPH): Although this drug has 
extensive anecdotal support for effect in mitigating EIPH, this article 
demonstrates no effect on the condition. While not regulated in human 
sport, the illicit use of this substance, particularly in races where 
furosemide is prohibited, represents an integrity threat.
Exhibit B.18. AU 04 Disposition of the anti-ulcer medications 
ranitidine, cimetidine, and omeprazole following administration of 
multiple doses to exercised Thoroughbred horses. The results of 
multiple RMTC administration studies supporting the use of anti-ulcer 
medications up to 24 hours prior to a horse's race.
Exhibit B.19. Bicarb 08 Sodium Bicarbonate as an Ergogenic Aid: 
Supports the use of alkalinizing agents as a Prohibited Method.
Exhibit B.20. BP Gen 04 Bisphosphonate Therapy in Equine Sports 
Medicine: While having legitimate use in human medicine, the documented 
pharmacologic effect of this class of drug (blocking remodeling) on 
bone represents a significant increased risk for fracture development 
in the racehorse.
Exhibit B.21. Cobalt 01 The Disparate Roles of Cobalt in 
Erythropoiesis, and Doping Relevance: Establishes the relevance of the 
administration of cobalt salts as a doping threat and justifies the 
controls established in the Prohibited List.
Exhibit B.22. Comp 18 The Disparate Roles of Cobalt in Erythropoiesis, 
and Doping Relevance: Published by the American Veterinary Medical 
Association, this document clarifies what constitutes legal compounding 
of drugs as the ethical use of compounded medications is important to 
maintaining equine health. However, the compounding or administration 
of illicitly compounded substances to circumvent Food and Drug 
Administration (``FDA'') oversight represents a substantial risk to 
horse health and racing integrity.
Exhibit B.23. EIPH 33 Exercise-induced pulmonary hemorrhage (EIPH): 
mechanistic bases and therapeutic interventions: Describes this 
condition (rarely, but occasionally, experienced by human athletes) 
that affects virtually every race horse at some point(s) in its racing 
and training career.
Exhibit B.24. Furos 15 Efficacy of furosemide in the treatment of 
exercise-induced pulmonary hemorrhage in Thoroughbred racehorses: The 
seminal study that demonstrated the efficacy of furosemide in 
mitigating or preventing episodes of EIPH in the racing Thoroughbred. 
While not submitted as a justification for the continued use of 
furosemide, this study did establish furosemide as the only medication 
having efficacy for controlling EIPH and why the WADA total ban on 
furosemide cannot be, at this time, applied to horseracing. This 
article also then justifies the Prohibited List's exclusion for the use 
of furosemide in training exercise.
Exhibit B.25. PAG 13 Intra-Articular Polyacrylamide Hydrogel Injections

[[Page 5078]]

Are Not Innocent: While the use of polyacrylamide hydrogels have a 
history of use in human joint disease, their introduction into the 
equine market as medical devices, is relatively recent, and the lack of 
documented method of action causes reservations about its use in that 
it may have the potential to mask pain and allow the progression of 
orthopedic disease to the overall detriment of the horse.
Exhibit B.26. PBZ 05 Effectiveness of administration of phenylbutazone 
alone or concurrent administration of phenylbutazone and flunixin 
meglumine to alleviate lameness in horses: Establishes justification 
for the prohibition on ``stacking'' of NSAIDs--medications that are not 
controlled in human sport, but require control in equine sport for 
safety reasons and ethical considerations.
Exhibit B.27. Ract 04 Effects of Ractopamine HCl on Physical and 
Reproductive Parameters in the Horse: This anabolic agent is not 
addressed in human sport but has been detected in post-race and out of 
competition samples derived from racehorses. Its presence has been both 
the result of contamination of commercial feed at the processing site 
as well as deliberate administration.
Exhibit B.28. Thyro 07 A randomised, controlled trial to determine the 
effect of levothyroxine on Standardbred racehorses: This prescription 
medication had widespread use for the (scientifically unsupported) 
treatment of a multitude of conditions--other than hypothyroidism which 
is exceedingly rare in the horse. This article elucidates the health 
risk in its use and justifies the ban as established in the Prohibited 
List.
Exhibit B.29. Tryp 03 Effects of a commercial dose of L-tryptophan on 
plasma tryptophan concentrations and behaviour in horses: An example of 
unregulated, over the counter oral nutraceuticals that have the 
potential to impact a horse's health, behavior, or mental state--thus 
exerting a drug-like effect while evading regulation by the FDA. It is 
for this reason that the Prohibited List is not permissive of the use 
of these substances during the race period, to be consistent with FDA-
approved drugs having similar effects.
1. Banned Substances and Banned Methods--Rule Series 4100
    Banned Substances and Banned Methods are set out in categories, 
including anabolic agents, peptide hormones and growth factors, beta-2 
agonists, hormone and metabolic modulators, and diuretics and masking 
agents (Rule 4110). Banned Methods include blood manipulation, chemical 
castration or immunocastration, and gene and cell doping (Rule 4120).
2. Controlled Medication Substances and Controlled Medication Methods 
and Exceptions--Rule Series 4200
    Subject to exceptions specified in the Prohibited List (Rule 4212), 
only feed, hay, and water are permitted during the Race Period (Rule 
4211(a)). Accordingly, subject to Rule 4212, any substance administered 
during the Race Period or present in a Post-Race Sample (including any 
metabolite(s), artifact(s), and isomer(s) of such substance(s)) that 
does not otherwise qualify as a Banned Substance shall constitute a 
prohibited Controlled Medication Substance. In addition, certain 
Controlled Medication Substances are prohibited from presence in a 
Post-Work Sample (Rule 4211(b)). Exceptions are provided in Rule 4212 
for emergency veterinary care, for certain substances that are 
permitted up to 24 hours prior to Post-Time (e.g., anti-ulcer 
medications), electrolyte solutions consumed by the horse by free 
choice, furosemide (i.e., Lasix/Salix), and for supplements or feed 
additives that do not have an action or effect on listed mammalian body 
systems.
    Controlled Medication Methods include alkalinization, intra-
articular injections, and use of a nasogastric tube within specified 
time periods (Rule 4220).
3. Ineligibility Periods for Covered Horses--Rule Series 4300
    Consistent with section 3057(d) of the Act, Rule 4300 establishes 
uniform rules setting out the periods of ineligibility that apply to 
Covered Horses implicated in Anti-Doping Rule Violations or Controlled 
Medication Rule Violations. The Ineligibility period ranges from zero 
months to lifetime bans, depending on the category of the substance or 
method.
    Violations involving Controlled Medication Substances will not 
result in a period of Ineligibility for the Covered Horse. However, the 
Covered Horse shall be placed on the Veterinarians' List and a Vets' 
List Workout must be scheduled (at which the horse may be subject to 
Sample collection). Violations involving Controlled Medication Methods 
may result in a period of Ineligibility for the Covered Horse where 
specified in the Prohibited List at Rule 4320.
    Covered Horses are not subject to increased Ineligibility periods 
if they are involved in multiple violations.
4. Rule Series 4000 Appendix: Technical Document--Prohibited Substances
    The ``Technical Document--Prohibited Substances'' supplements the 
Prohibited List (Rule Series 4000) and sets out additional detail 
concerning Prohibited Substances. The ``Technical Document--Prohibited 
Substances,'' enumerates specific Prohibited Substances that fall into 
the general categories listed in the Prohibited List and sets forth 
detection times, screening limits, and thresholds for those Prohibited 
Substances. The Technical Document also designates certain Prohibited 
Substances as Specified Substances, which are those that pose a higher 
risk of being the result of contamination and that are therefore 
subject to more flexible sanctions. The following paragraphs describe 
the rules and specifications applicable to certain categories of 
medications that vary from the baseline standards enumerated in 15 
U.S.C. 3055(g).
i. Anti-Ulcer Medications (Cimetidine, Omeprazole, Ranitidine)
    The IFHA has published a restricted administration period that 
prohibits administration of anti-ulcer medications within 48 hours of 
the post time for the race in which the horse is entered. HISA in the 
Protocol recommends a 24-hour restricted administration period.
    The basis for this deviation is two-fold: (1) Withdrawal intervals 
of greater than 24 hours have been identified as an equine welfare 
issue. Published research demonstrates a rebound effect when anti-ulcer 
medications are withdrawn for more than 24 hours with resultant ulcers 
more severe than those originally treated. (2) The IFHA's Advisory 
Council on Prohibited Substances and Practices will be revisiting the 
control of these substances, and it is anticipated that the 
international community will adopt a withdrawal interval strategy 
similar to the one proposed by HISA.
ii. Non-Steroidal Anti-Inflammatory Drugs (``NSAIDs'') (Flunixin, 
Ketoprofen, Phenylbutazone)
    The IFHA has published a 48-hour Detection Time (DT) for a single 
NSAID--meclofenamic acid. There is no FDA-approved product containing 
meclofenamic acid commercially available in the United States. (It is 
important to note that a Detection Time is the foundation for 
determining a withdrawal interval, but under no circumstances should 
the Detection Time be equated with withdrawal guidance. The withdrawal 
interval is decided by the veterinarian in

[[Page 5079]]

consultation with the responsible person for the horse in consideration 
of their level of risk aversion and their knowledge of the specific 
horse's health, management, other medications or foreign substances co-
administered, and other relevant factors. The withdrawal interval 
should always be longer than the Detection Time, and in most cases this 
means adding 24 hours (at a minimum) to the Detection Time.)
    The HISA Protocol establishes Screening Limits corresponding to a 
48-hour Detection Time for 3 commercially available NSAIDs having FDA-
approval for use in the horse. The Protocol allows the veterinarian to 
select one NSAID that can be administered using a withdrawal interval 
based on the 48-hourr Detection Time. All other NSAIDs are then 
controlled applying IFHA Detection Times and Screening Limits, and the 
detection of more than one NSAID in a horse's sample is a violation. 
This is philosophically consistent with the IFHA and represents a far 
more restrictive approach to the use of NSAIDs than currently exists in 
the United States.
iii. Methocarbamol/Glycopyrrolate
    The IFHA is silent on these substances. However, the Asian Racing 
Federation (a signatory to the IFHA's International Agreement on 
Breeding, Racing, and Wagering (IABRW)) has published a Screening Limit 
for methocarbamol. So there is precedent for establishing Screening 
Limits in addition to those provided by the IFHA. Further, the IFHA's 
IABRW references the adoption of Screening Limits and advises that a 
regulatory authority may elect to publish Detection Times.
    The Screening Limits and Detection Times for methocarbamol and 
glycopyrrolate were derived after reviewing the Racing Medication and 
Testing Consortium's administration study pharmacokinetic data. The 
elected Screening Limits and corresponding Detection Times ensure 
withdrawal intervals of sufficient length to prevent the substances 
from having any potential to impact a horse's racing performance.
iv. Ciclesonide/Lidocaine
    The Protocol adheres to IFHA Screening Limits, but, consistent with 
the requirements of IABRW Article 6, HISA has elected to adopt 
Detection Times that vary from those of the IFHA. In the case of 
ciclesonide, the Detection Time is consistent with that used by Racing 
Australia (also an IFHA member). For lidocaine, HISA elected to use a 
lower dose in determining a Detection Time, as it believed that IFHA's 
dosing is too permissive and potentially allows illicit low-dose use on 
Race Day, which may be undetectable by laboratory testing.
v. Procaine Penicillin
    The European Horseracing Scientific Liaison Committee (EHSLC) has 
established a detection time of 240 hours (10 days) for procaine 
penicillin. (The EHSLC is the scientific body that the IFHA consults 
when developing medication control policy.) HISA has determined that 
the 240-hour detection time could negatively impact horse welfare, 
through the withholding of appropriate medical treatment. HISA has 
elected instead to adopt the current ARCI controls, which allow for the 
use of this safe and effective antibiotic up to 48 hours prior to a 
race, while still effectively controlling against the illicit use of 
procaine as a local anesthetic.

e. Terms of Substance: Rule Series 5000--Equine Standards for Testing 
and Investigation

    In accordance with section 3055 of the Act, the Authority has 
developed Equine Standards for Testing and Investigations to manage 
test distribution planning (including intelligence-based testing), the 
sample collection process, and in-competition and out-of-competition 
testing. The Authority considered the Association of Racing 
Commissioners International out-of-competition testing standards as a 
baseline, but also relied in large part on the WADA International 
Standard for Testing and Investigations, given the comprehensive nature 
of that standard. All adjustments and modifications to the baseline 
rules were approved by the Authority in consultation with the ADMC and 
the Agency in accordance with section 3055(g)(3) of the Act.
    In preparing the standards, the Authority consulted with the 
Agency, the ADMC, and experts in the field to tailor the standards to 
horseracing. The Authority considered and relied significantly on the 
following rules:

Exhibit B.2. The ARCI out-of-competition testing standards, Model Rules 
of Racing (version 11.0). The Authority notes that the Act refers to 
version 9.2, but the model rules have since been updated. The most 
recent versions of the ARCI documents are available at https://www.arci.com/model-rules-standards/.
Exhibit B.30. WADA International Standard for Testing and 
Investigations dated January 1, 2021. The most recent versions of the 
WADA documents are available at https://www.wada-ama.org/en/resources/.
1. Testing--Rules 5100-5500 and 5800
    The Testing and Investigations Standards sets out how the Agency 
will plan effective testing by using risk assessments and prioritizing 
between Covered Horses and types of testing (Rule 5100). As directed by 
section 3055(c)(4)(C) of the Act, Sample Collection Personnel will 
notify the Responsible Person or Nominated Person without advance 
notice that his or her Covered Horse has been selected for testing 
(Rule 5200), following--as applicable--the procedure set out at Rule 
5220 depending on when the sample is collected.
    Sample Collection Sessions will be conducted by suitably qualified 
personnel (Rule 5450), using suitable equipment (Rule 5320), in a 
suitable ``test barn'' environment (Rule 5310). Samples will be 
collected in accordance with Rule 5400, in particular to ensure that 
the sample is of suitable quality and quantity, is clearly and 
accurately identified, is sealed in a tamper evident kit, and has not 
been manipulated or tampered with. Further specific procedures and 
requirements apply to the collection of urine samples (Rule 5420), 
blood samples (Rule 5430), and hair samples (Rule 5440).
    Once collected, Samples will be stored and transported by Sample 
Collection Personnel in a manner that protects the integrity, identity, 
and security of the Samples (Rules 5510 and 5520).
2. Investigations--Rule 5600-5700
    As directed by the Act, the Agency will put in place internal 
processes and procedures to ensure it is able to gather, analyze, and 
process anti-doping and medication control intelligence from all 
available sources in order to help deter and detect doping and 
medication abuse, to inform effective, intelligent, and proportionate 
test distribution planning, to plan intelligence-based Target Testing, 
and to conduct investigations (Rule 5600).
    Further, the Agency will conduct efficient and effective 
investigations into (among other things) atypical findings and other 
sample abnormalities, and other analytical or non-analytical 
information or intelligence. The purpose of such investigations is to 
either rule out or develop evidence that supports an anti-doping or 
controlled medication rule violation or other violation of the Protocol 
(Rule 5710). The Agency will make use of all investigative resources 
available to it, which may include obtaining information from law 
enforcement authorities and other

[[Page 5080]]

regulators (Rule 5730). The Agency may also exercise the investigative 
powers conferred under applicable rules, including powers of 
inspection, examination, seizure, production of documents, request to 
the Authority for the issuance of subpoenas, and the conduct of 
interviews). All Covered Persons are required to cooperate with the 
Agency's investigations in the manner set forth in the rules, and 
failure to cooperate may result in the imposition of sanctions (Rule 
5720(f)).

f. Terms of Substance: Rule Series 6000--Equine Standards for 
Laboratories and Accreditation

    As directed by sections 3053, 3055, and 3057 of the Act, the 
Authority has developed the Equine Standards for Laboratories and 
Accreditation (``Laboratory Standards'') using the WADA International 
Standard for Laboratories as a baseline. All adjustments and 
modifications to the baseline rules were approved by the Authority in 
consultation with the ADMC and the Agency in accordance with section 
3055(g)(3) of the Act.
    Exhibit B.31. WADA International Standard for Laboratories dated 
January 1, 2021. The Authority notes that the Act refers to the WADA 
International Standard for Laboratories (version 10.0) dated November 
12, 2019, but that version has since been updated by WADA. The most 
recent versions of the WADA documents are available at: www.wada-ama.org/en/resources/.
    As directed by the Act at section 3057(b), the Laboratory Standards 
establish standards of accreditation for laboratories involved in 
testing samples from Covered Horses; the process for achieving and 
maintaining accreditation; and the standards and protocols for testing 
of such samples. The Laboratory Standards will be supported by 
technical documents, letters, notes, and laboratory guidelines, as 
appropriate.
    The Laboratory Standards also cross refer in a number of places to 
the ISO/IEC 17025 standard. Laboratories must obtain ISO/IEC 17025 
accreditation before receiving HISA Equine Analytical Laboratory 
(``HEAL'') accreditation.
    Exhibit B.32. ISO/IEC 17025:2017. The Authority consulted with 
laboratory experts in order to tailor the Laboratory Standards to 
horseracing laboratories and to reflect the specificities of equine 
sport. As part of its review, the Authority considered the ILAC-G7:04/
2021 Accreditation Requirements and Operating Criteria for Horseracing 
Laboratories, which may inform subsequent Technical Documents.
    Exhibit B.33. ILAC-G7:04/2021 Accreditation Requirements and 
Operating Criteria for Horseracing Laboratories. The most recent 
versions of the International Laboratory Accreditation Cooperation 
(``ILAC'') standards are available at: https://ilac.org/publications-and-resources/ilac-guidance-series/.
1. Laboratory Accreditation--Rule Series 6100 and 6500
    In accordance with sections 3055(c) and 3057(b) of the Act, the 
Laboratory Standards establish the requirements for obtaining HISA 
Equine Analytical Laboratory (``HEAL'') accreditation, and the 
requirements and standards for maintenance of HEAL accreditation. The 
rules set out a procedure by which laboratories may achieve HEAL 
accreditation, starting with an application and the granting of 
``candidate laboratory'' status. The candidate laboratory must provide 
specified information to the Agency, perform pre-probationary testing 
to identify prohibited substances in samples, and complete an on-site 
assessment. The Agency will assess the outcomes of those processes and 
any non-conformities identified, and the candidate laboratory will have 
a specified period of time to remedy those non-conformities with 
corrective actions (Rule 6110).
    If a candidate laboratory is granted probationary accreditation 
status, it will be accredited by the Agency, with a probationary period 
of two years or until analysis of 2,500 samples has been performed, 
whichever occurs first. If the probationary period is successfully 
completed and the laboratory successfully completes a final 
accreditation test, the Agency will grant accreditation to the 
laboratory (Rule 6120).
    The rules impose continuing obligations on each laboratory that 
must be satisfied in order to maintain HEAL accreditation (Rule 6130), 
including maintenance of ISO/IEC 17025 accreditation, satisfactory 
participation in the Agency External Quality Assessment Scheme 
(``EQAS'') whereby laboratories are sent samples to be analyzed (blind 
or for specified substances), compliance with the code of ethics (which 
is set out in full at Rule 6600), and continued research and 
development activities and sharing of knowledge.
    The Agency will regularly monitor and review the compliance of each 
laboratory with its ongoing accreditation obligations (Rule 6140). A 
laboratory's HEAL accreditation may be suspended or revoked, or 
subjected to specified analytical testing restrictions if (among other 
things) the laboratory fails to comply with the Laboratory Standards or 
other Agency requirements (Rules 6510 and 6520). The rules set out the 
effects of such decisions on Agency-related laboratory activity and the 
transfer of samples to other laboratories pending resolution of the 
matter (Rule 6560), and provide for reinstatement of the laboratory if 
it has remedied the non-compliance that resulted in the Agency's 
decision.
2. Laboratory Quality Monitoring--Rule Series 6200, 6400, and 6600
    The Agency will regularly distribute External Quality Assessment 
Scheme (EQAS) samples in order to monitor the capabilities of 
laboratories and probationary laboratories, evaluate their proficiency, 
and improve test result uniformity between laboratories (Rule 6210). 
Some of these samples are blind (the laboratory will know it is an EQAS 
sample but will not know its contents), some are double-blind (the 
laboratory will not know it is an EQAS sample or know its contents), 
and some are educational (the laboratory will know it is an EQAS sample 
and will know its contents) (Rule 6220). EQAS samples should be 
analyzed in a manner substantially similar to that applied to routine 
samples, unless otherwise specified by the Agency, and results reported 
to the Agency (Rules 6250 and 6260).
    The Agency will evaluate laboratory EQAS results and, as necessary 
and appropriate, inform the laboratory of any technical, 
methodological, or clerical errors that should be remedied. If such 
errors are remedied, no penalty will be imposed (Rule 6410). The Agency 
may request corrective action reports that detail actions taken to 
correct any non-conformity or other issue (Rule 6420). The annual EQAS 
evaluation will be a factor in assessment of HEAL accreditation and 
maintenance of HEAL accreditation.
3. Analysis of Samples--Rule Series 6300
    The Laboratory Standards set out a process for the withdrawal of 
accreditation if the relevant requirements and standards are not met. 
The Laboratory Standards also ensure that laboratories report valid 
test results based on reliable evidentiary data and facilitate 
harmonization in analytical testing of Samples by laboratories.
    The rules also contain detailed standards for the analysis of 
samples (section 6300). When analyzing a sample, the laboratory will 
prepare an aliquot, select the analytical testing

[[Page 5081]]

procedure, and conduct the initial testing procedure, with the 
objective of obtaining information about the potential presence of 
prohibited substances in the sample (Rule 6308). The laboratory will 
then conduct the confirmation procedure to obtain a result that either 
supports or does not support the reporting of an adverse analytical 
finding or atypical finding, in particular, by identifying and 
sometimes quantifying--for example in the case of a threshold 
substance--a prohibited substance in the sample (Rules 6309 and 6311). 
The laboratory must conduct a detailed review of the analysis (Rule 
6315) and report all results to the Agency (Rule 6316).
    An important amendment to the baseline rules is that any B sample 
analysis will be conducted by a different laboratory than the one that 
performed the A sample analysis, unless the Agency considers that is 
not possible due to due to (i) reasonable concerns over Sample 
integrity or unstable analytes; or (ii) because no other Laboratory is 
available to perform the B Sample procedure within a reasonable period 
of time (Rule 6312).
    If the laboratory reports an adverse analytical finding for the A 
sample, and the Covered Person requests or the Agency orders that the B 
sample be analyzed, the laboratory will promptly transfer the B sample 
to the laboratory specified by the Agency, and that (second) laboratory 
will perform the B sample procedure and analysis (Rule 6312). The 
samples will be stored and may be subject to further analysis if 
directed by the Agency (Rules 6313 and 6319).

e. Terms of Substance: Rule Series 7000--Arbitration Procedures

    In accordance with sections 3053(a)(10) and 3057(c) of the Act, the 
Arbitration Procedures set out a disciplinary process for the hearing 
and adjudication of Anti-Doping Rule Violations, Controlled Medication 
Rule Violations, and other related offenses. As directed by section 
3057(c)(3), the procedures were developed to provide for adequate due 
process, including impartial hearing panels commensurate with the 
seriousness of the alleged violation. Different procedures apply to 
Anti-Doping Rule Violations (heard by the Arbitral Body) as compared to 
Controlled Medication Rule Violations (heard by the Internal 
Adjudication Panel, which may adjudicate the matter on written 
submissions alone.
1. Dispute Resolution Frameworks--Rules 7010-7050
    The arbitrators on the Arbitral Body will be appointed by the 
Agency for four-year terms (Rule 7030). Members of the Internal 
Adjudication Panel will be appointed by the Agency for four-year terms 
(Rule 7040). Members of the Arbitral Body and Internal Adjudication 
Panel will receive mandatory annual training and education on issues 
relating to the proper handling of cases (Rule 7050).
2. Initiating Proceedings--Rules 7060-7160
    If a Covered Person is charged with an Anti-Doping Rule Violation 
or Controlled Medication Rule Violation, proceedings will be initiated 
with the appropriate adjudicator by the Agency. The adjudicator will be 
appointed by the arbitral body or by the coordinator of the Internal 
Adjudication Panel, as applicable (Rule 7130), and the rules establish 
a process by which parties may challenge the adjudicator's appointment 
in appropriate circumstances. The adjudicator has broad powers to 
manage the proceedings, including the power to issue orders for 
expedited procedures, rule on their own jurisdiction, and consolidate 
proceedings.
3. Hearings and Evidence--Rules 7170-7330
    In cases involving Anti-Doping Rule Violations or related 
violations, the rules set out a procedure for the exchange of written 
submissions and evidence (Rule 7170), and for the conduct of hearings 
(Rule 7250). The Arbitral Body has broad discretion to determine the 
admissibility, relevance and materiality of evidence offered, and may, 
if necessary and appropriate, order production (Rule 7260 and 7270) or 
interim measures (Rule 7280) or resolve challenges to provisional 
suspensions at a provisional hearing (Rule 7290).
    In cases involving Controlled Medication Rule Violations and 
related violations, and other violations of the Protocol, a more 
streamlined and flexible process applies (Rule 7180).
4. Decisions--Rules 7240-7450
    In all cases, a final decision will be issued and the adjudicator 
may grant any remedy or relief authorized by the Protocol (Rule 7340-
7350). Final decisions issued by the Arbitral Body or Internal 
Adjudication Panel are subject to review as specified in section 3058 
of the Act (Rule 7400).

III. Self-Regulatory Organization's Summary of Comments Received Pre-
Submission and Its Responses to Those Comments

    As encouraged by the Commission's procedural rule, the Authority, 
before finalizing this submission to the Commission, made a draft of 
the Anti-Doping and Medication Control proposed rule available to the 
public for review and comment on the HISA website, https://www.hisausregs.org/, beginning on June 1, 2022. Comments on the Anti-
Doping and Medication Control proposed rule were received from various 
individuals and groups in the horseracing industry.
    The stakeholder feedback received was constructive and well-
considered. All submitted comments were carefully reviewed by the 
Authority as well as by the ADMC and the Agency. Those collected 
comments are available as Exhibit A on the docket at https://www.regulations.gov. The Authority also engaged with a number of 
stakeholders through follow-up conference calls to further analyze 
their comments and discuss any questions raised. The stakeholder 
comments informed a number of adjustments and modifications to the 
proposed rules, as explained in more detail below. The open 
consultation process and stakeholder engagement is an important process 
and one that is intended to build consensus where possible within the 
industry.
    The following is a summary of the substance of the comments 
received. The following also summarizes the Authority's response to the 
significant issues raised in the comments, and the manner in which the 
Authority has addressed those comments in developing the proposed rules 
submitted to the Commission. In a few instances the Authority declined 
to make a suggested change, though the Authority will consider the 
suggestions made in the course of future rulemaking.
1000 Series--General Provisions
    The Authority revised the definition of ``Race Day'' based on 
comments received, amending it so that the period will end one hour 
after the end of the Official Workout or Covered Horserace or at the 
end of any Sample collection process, whichever is later, instead of 
ending at 23:59 (11:59pm) on the day of the Official Workout/Covered 
Horserace as previously stated. This revision was made to take account 
of horse welfare, recognizing in particular that once a horse has been 
subject to sample collection, or it has been decided that a

[[Page 5082]]

horse will not be selected for sample collection, the horse should not 
be prohibited from receiving any necessary therapeutic treatments post-
race that are permitted outside the Race Period. The end of the ``Race 
Day'' now also coincides with the end of the ``Race Period.''
    The definition of ``Tampering'' was adjusted to make clear that it 
does not include the actions of bona fide veterinary personnel 
involving a Controlled Medication Substance or Controlled Medication 
Method used for genuine and legal therapeutic purposes or other 
acceptable justification. This addition mirrors the wording used in the 
definition of ``Administration,'' which includes the same important 
carve-out.
3000 Series--Equine Anti-Doping and Controlled Medication Protocol
    Some commenters expressed the strong opinion that there is a 
material difference between the use of doping substances to unfairly 
affect the performance of horses, as opposed to errors in the 
administration of recognized therapeutic substances. The Authority 
agrees that this is a vital distinction, and the Protocol recognizes 
the distinction in the penalty structure and other provisions 
throughout the Protocol.
    Further detail on the meaning of ``Owner'' has been provided to 
take account of the varied and sometimes complex ownership structures 
in horseracing (Rule 3020(c)).
    The term ``Responsible Person'' defined in Rule 3030 has been 
simplified to make clear that the trainer of a Covered Horse is the 
Responsible Person for that horse. In circumstances where the horse 
does not have a Trainer, the Owner is the Responsible Person. The 
Responsible Person is personally liable for his or her Covered 
Horse(s). However, other Covered Persons (including veterinarians, 
among others) who made a relevant decision about the Covered Horse may 
be found to be complicit in a violation and may be liable to the same 
extent as the Responsible Person.
    In response to comments received, the Authority removed the 
disciplinary provisions concerning hypodermic needles, because 
equivalent provisions are included in the Rule 2000 Series (Racetrack 
Safety Program).
    Some commenters proposed increasing the sanctions applicable to 
repeat medication violation offenders and lengthening the period of 
time that such violations would remain on their ``official record.'' 
The limitation period and roll-off period for Controlled Medication 
Rule Violations has been increased from one to two years, and a 
multiple violation penalty points system, modelled on the ARCI system, 
has been added. As a consequence, in addition to any sanction received 
for the underlying Controlled Medication Rule Violation, a Covered 
Person will also receive a certain number of penalty points which 
accumulate over a two-year period. When the points thresholds are 
exceeded, additional sanctions will be imposed (in a manner similar to 
the points system in the driver's licensing violation system).
    A number of commenters requested that Controlled Medication 
Substances be stratified into different classes, with individual 
screening limits prescribed for each category. The Authority has done 
so by classifying Controlled Medication Substances into Classes A to C 
in the Technical Document-Prohibited Substances, which supplements the 
Prohibited List. The sanctions in the Protocol in turn depend on the 
class of substance in issue.
    Commenters requested clarification of the requirement that a 
Responsible Person make a Covered Horse available for testing ``at any 
time and place.'' The Protocol was clarified to specify that the 
Covered Horse must be available for testing at any time and place where 
the horse is located (e.g., Racetrack, Training Facility, private 
facility). The Protocol was also clarified to specify that Responsible 
Persons shall ensure that the Covered Horse is produced for Sample 
collection immediately upon notification by a duly authorized Person, 
or, if the horse is not available at the location for Testing, within 6 
hours of notification by a duly authorized Person (or if the Agency 
agrees to extend that time period due to extenuating circumstances, 
then within such extended time period). Failure to produce a Covered 
Horse for Sample collection within six hours (or any extended period 
agreed by the Agency) shall constitute a violation of Rule 3215 
(evasion, or refusal or failure to submit to Sample collection). Sample 
collection shall ordinarily be conducted where the Covered Horse is 
located (e.g., Racetrack, Training Facility, or private facility), 
unless the Agency agrees that the Covered Horse may be transported to 
another agreed location (e.g., a nearby Racetrack).
    In response to comments received, the Authority extended the period 
of inactivity of a Covered Horse from 12 to 18 months, after which the 
horse may be retired by the Authority, subject to an objection by the 
Owner of the horse. This change was based on the rationale that horses 
may suffer injuries that require a 12-month recovery period (such as 
tendon injuries).
    The Protocol was modified to clarify that where a horse's Sample 
reveals the presence of more than one Controlled Medication Substance 
above the applicable thresholds (if any), each substance may be treated 
as a separate presence violation.
    The Protocol was revised to clarify that Covered Persons may 
request clearance testing to be conducted on their Covered Horses by a 
Laboratory, but only if such request is authorized by the Authority in 
advance and paid for by the Covered Person, and provided that such 
samples will be treated in the same way as official Post-Race Samples, 
such that any violation detected may be pursued by the Agency.
    Some concerns were expressed regarding how cases involving 
environmental contamination would be handled and publicized. The 
Authority has incorporated an ``Atypical Findings Policy'' as Appendix 
1 to the Rule 3000 Series. The Policy allows for certain substances to 
be investigated first as Atypical Findings before being pursued as 
Adverse Analytical Findings. If further to such investigation it is 
determined that the positive test was the result of environmental 
contamination, the matter will not be pursued as an Adverse Analytical 
Finding, and the Atypical Finding will not be publicly disclosed.
    The Authority has added provisions to the Protocol to clarify the 
provisions on claimed horses. Some commenters expressed the concern 
that testing every horse in a claiming race would be excessive. In 
particular, Rule 3060 provides that a claimed horse may be subject to 
Sample collection at a claiming race if elected (and paid for) by the 
claimant. If the analysis of such Sample(s) results in an Anti-Doping 
Rule Violation or Controlled Medication Rule Violation, the claim may 
be voided at the option of the claimant and the claimant shall be 
entitled to return of all sums paid for the claimed horse and of all 
expenses incurred after the date of the claim.
    Commenters also expressed the opinion that use of Lasix should not 
be prohibited during training. The Protocol does not prohibit the use 
of Lasix during training (see Rule 4212(d)).
4000 Series--Prohibited List
    The key change made based on comments received was the development 
of the ``Technical Document--Prohibited Substances,'' which supplements 
the Prohibited List. The Technical Document provides additional detail 
concerning the

[[Page 5083]]

Prohibited Substances that fall into the general categories established 
in the Prohibited List, and sets forth detection times, screening 
limits, and thresholds for those Prohibited Substances. The Technical 
Document also designates certain Prohibited Substances as Specified 
Substances. Specified Substances are those substances that pose a 
higher risk of being the result of contamination, and that are 
therefore subject to more flexible sanctions.
    Comments were also received urging that anti-ulcer medications 
should be permitted within 24 hours prior to a race. The ADMC 
considered that proposition further, including the scientific paper 
referenced below, which shows that the pH of gastric fluids returns to 
baseline 24 hours after treatment with Omeprazole (an anti-ulcer 
medication). Given that pH directly affects the development of ulcers, 
the paper supports the use of anti-ulcer medications up to 24 hours 
prior to Post-Time. To require a longer withdrawal interval means that 
the stomach lining of a horse could be vulnerable to the recrudescence 
of gastric ulceration.
    Exhibit B.34. Jessica Wise et al., Pharmacokinetic and 
pharmacodynamic effects of 2 registered omeprazole preparations and 
varying dose rates in horses, J. Veterinary Internal Medicine (Nov. 
2020), https://doi.org/10.1111/jvim.15971.
5000 Series--Equine Testing and Investigations Standards
    In addition to a number of minor revisions based on the comments 
received, the Authority added a section to address procedures for total 
carbon dioxide (``TCO2'') testing, i.e., testing blood samples for 
total carbon dioxide as evidence of use or administration of the 
Controlled Medication Method M4 (alkalinization or use/administration 
of an alkalinizing agent) (see Rule 5430).
6000 Series--Equine Standards for Laboratories and Accreditation
    A number of minor revisions were made based on the detailed 
comments received and further consultation with laboratory experts. 
Some duplication with ISO/IEC 17025 was also removed, in particular in 
section 6300.
7000 Series--Arbitration Procedures
    Some commenters expressed confusion concerning the role of racing 
stewards in the adjudication body previously designated as the 
``National Stewards Panel.'' The body is now designated as the 
``Internal Adjudication Panel,'' with individual members referred to as 
Internal Adjudication Panel (``IAP'') members instead of ``stewards.''
    The procedure for Controlled Medication Rule Violations was 
developed partly in response to requests by commenters to provide for a 
simplified hearing process for Covered Persons charged with a 
violation. The procedures allow the IAP members adjudicating the case 
to dispense with written filings and permit the Covered Person to make 
an oral presentation in a hearing context. This procedure allows the 
adjudication process to dispense where appropriate with certain of the 
more formal and costly aspects of legal proceedings.
    The Arbitration Procedures were also clarified to specify that 
hearings regarding alleged breaches of the Protocol will not be open to 
the media or the public, and to specify the Owners who may attend 
hearings involving Covered Horses when the horse is owned by multiple 
persons or entities.
    The Arbitration Procedures were also clarified to specify that 
while document production requests may be permitted, discovery or other 
wide-ranging document requests are not permitted.
Minor Corrections Made to October 2022 Proposed Rule
    Based on stakeholder comments and further review, the Authority has 
made a few minor corrections to the proposed rule previously filed with 
the Commission. Minor corrections were made to the Technical Document, 
including (i) correcting certain references to thresholds throughout 
the Technical Document, to ensure consistency with the approach taken 
by the IFHA; (ii) correcting a typographical error regarding the 
threshold for ketoprofen, which is 2ng/ml, as approved by the ADMC, as 
noted in a correction published November 4, 2022, 87 FR 66705; (iii) 
adding a comment about pemoline that was mistakenly deleted from the 
previous version; (iv) correcting certain minor typographical errors in 
the spelling of substance names; (v) capitalizing defined terms; and 
(vi) other minor amendments to ensure consistency across the document, 
including deletion of duplicate entries.
    Certain other minor corrections were made to the proposed rule, 
including (i) clarifying, in the definition of ``Aggravating 
Circumstances,'' that one or both of an additional period of 
ineligibility or fine may be imposed; (ii) correcting Rule 3346(a) to 
clarify that the Responsible Person and Owner and one representative 
each may attend the Laboratory to witness the opening and 
identification of the B sample; (iii) adding ``to the extent possible'' 
in Rule 5220(b)(iv)(B) for consistency with other similar provisions; 
(iv) specifying in Rule 5320 that sample collection equipment must be 
able to withstand -20[deg]C rather than -80[deg]C, consistent with 
industry standard; (v) removing the requirement for a signature in Rule 
5410(i)(1) because the personnel tagging the horse at the end of the 
race will not accompany the horse to the Test Barn and the signing of 
the doping control documentation will occur at a later stage in the 
sample collection process (see Rule 5410(i)(10)); (vi) minor 
corrections to Rules 5420(j) and 5430(e) by striking ``within the 
kit,'' as it was not consistent with collection kits available in the 
industry; (vii) amending references to the ``BCO or DCO'' in Rule 
5430(e) to ``relevant Sample Collection Personnel'' for consistency 
with other similar provisions; (viii) amending Rules 5420(n) and 
5430(k) to clarify that copies of doping control documentation will be 
sent to the Responsible Person subsequently and not instantaneously; 
and (ix) adding a reference to ``or refrigerator'' in Rule 5510(b)(1) 
because, if urine samples are not shipped on the day of collection, 
they will be refrigerated rather than frozen.
    Minor typographical errors, such as extra spaces, spelling errors, 
and punctuation, were corrected as well.

IV. Legal Authority

    This rule is proposed by the Authority for approval or disapproval 
by the Commission under 15 U.S.C. 3053(c)(1).

V. Effective Date

    This rule would take effect upon approval by the Commission, and 
the Commission must approve or disapprove the rule by March 27, 2023.

VI. Request for Comments

    Members of the public are invited to comment on the Authority's 
proposed rule. The Commission requests that factual data on which the 
comments are based be submitted with the comments. The supporting 
documentation referred to in the Authority's filing, as well as the 
written comments it received before submitting the proposed rule to the 
Commission, are available for public inspection at https://www.regulations.gov under docket number FTC-2023-0009.
    The Commission seeks comments that address the decisional criteria 
provided by the Act. The Act gives the Commission two criteria against 
which to measure proposed rules and rule modifications: ``The 
Commission shall approve a proposed rule or modification if the 
Commission finds that the

[[Page 5084]]

proposed rule or modification is consistent with--(A) this chapter; and 
(B) applicable rules approved by the Commission.'' \7\ In other words, 
the Commission will evaluate the proposed rule for its consistency with 
the specific requirements, factors, standards, or considerations in the 
text of the Act as well as the Commission's procedural rule.
---------------------------------------------------------------------------

    \7\ 15 U.S.C. 3053(c)(2).
---------------------------------------------------------------------------

    Although the Commission evaluates the Authority's proposed rule for 
its consistency with the Act and the Commission's procedural rule, the 
Commission may consider broader questions--about the health and safety 
of horses and jockeys, the integrity of horseraces and wagering on 
horseraces, and the administration of the Authority itself--in another 
context: ``The Commission . . . may abrogate, add to, or modify the 
rules of the Authority promulgated in accordance with this Act as the 
Commission finds necessary or appropriate to ensure the fair 
administration of the Authority, to conform the rules of the Authority 
to requirements of this Act and applicable rules approved by the 
Commission, or otherwise in furtherance of the purposes of this Act.'' 
\8\ The Commission may exercise this rulemaking power on its own 
initiative or in response to a petition from a member from the public. 
If members of the public wish to provide comments to the Commission 
about its use of the rulemaking power, they are encouraged to submit a 
petition requesting that the Commission issue a rule addressing the 
subject of interest. The petition must meet all the criteria 
established in the Rules of Practice (part 1, subpart D); \9\ if it 
does, the petition will be published in the Federal Register for public 
comment. In particular, the petition for a rulemaking must ``identify 
the problem the requested action is intended to address and explain why 
the requested action is necessary to address the problem.'' \10\
---------------------------------------------------------------------------

    \8\ 15 U.S.C. 3053(e) (as amended by the Consolidated 
Appropriations Act, 2023, H.R. 2617, 117th Cong., Division O, Title 
VII (2022)).
    \9\ 16 CFR 1.31; see Fed. Trade Comm'n, Procedures for 
Responding to Petitions for Rulemaking, 86 FR 59851 (Oct. 29, 2021).
    \10\ 16 CFR 1.31(b)(3).
---------------------------------------------------------------------------

VII. Comment Submissions

    You can file a comment online or on paper. For the Commission to 
consider your comment, we must receive it on or before February 9, 
2023. Write ``HISA Anti-Doping and Medication Control'' on your 
comment. Your comment--including your name and your State--will be 
placed on the public record of this proceeding, including, to the 
extent practicable, on the website https://www.regulations.gov.
    Because of public health measures and the Commission's heightened 
security screening, postal mail addressed to the Commission will be 
subject to delay. We strongly encourage you to submit your comments 
online through the https://www.regulations.gov website. To ensure that 
the Commission considers your online comment, please follow the 
instructions on the web-based form.
    If you file your comment on paper, write ``HISA Anti-Doping and 
Medication Control'' on your comment and on the envelope, and mail your 
comment to the following address: Federal Trade Commission, Office of 
the Secretary, 600 Pennsylvania Avenue NW, Suite CC-5610 (Annex B), 
Washington, DC 20580.
    Because your comment will be placed on the public record, you are 
solely responsible for making sure that your comment does not include 
any sensitive or confidential information. In particular, your comment 
should not contain sensitive personal information, such as your or 
anyone else's Social Security number; date of birth; driver's license 
number or other State identification number or foreign country 
equivalent; passport number; financial account number; or credit or 
debit card number. You are also solely responsible for making sure your 
comment does not include any sensitive health information, such as 
medical records or other individually identifiable health information. 
In addition, your comment should not include any ``[t]rade secret or 
any commercial or financial information which * * * is privileged or 
confidential''--as provided in Section 6(f) of the FTC Act, 15 U.S.C. 
46(f), and FTC Rule Sec.  4.10(a)(2), 16 CFR 4.10(a)(2)--including in 
particular competitively sensitive information such as costs, sales 
statistics, inventories, formulas, patterns, devices, manufacturing 
processes, or customer names.
    Comments containing material for which confidential treatment is 
requested must be filed in paper form, must be clearly labeled 
``Confidential,'' and must comply with FTC Rule Sec.  4.9(c), 16 CFR 
4.9(c). In particular, the written request for confidential treatment 
that accompanies the comment must include the factual and legal basis 
for the request and must identify the specific portions of the comment 
to be withheld from the public record. See FTC Rule Sec.  4.9(c). Your 
comment will be kept confidential only if the General Counsel grants 
your request in accordance with the law and the public interest. Once 
your comment has been posted publicly at https://www.regulations.gov--
as legally required by FTC Rule Sec.  4.9(b), 16 CFR 4.9(b)--we cannot 
redact or remove your comment, unless you submit a confidentiality 
request that meets the requirements for such treatment under FTC Rule 
Sec.  4.9(c), and the General Counsel grants that request.
    Visit the FTC website to read this document and the news release 
describing it. The FTC Act and other laws that the Commission 
administers permit the collection of public comments to consider and 
use in this proceeding as appropriate. The Commission will consider all 
timely and responsive public comments it receives on or before February 
9, 2023. For information on the Commission's privacy policy, including 
routine uses permitted by the Privacy Act, see https://www.ftc.gov/siteinformation/privacypolicy.

VIII. Communications by Outside Parties to the Commissioners or Their 
Advisors

    Written communications and summaries or transcripts of oral 
communications respecting the merits of this proceeding, from any 
outside party to any Commissioner or Commissioner's advisor, will be 
placed on the public record. See 16 CFR 1.26(b)(5).

IX. Self-Regulatory Organization's Proposed Rule Language

1000. General Provisions

Rule 1010. Rules of Interpretation
    Unless specified otherwise:
    (a) words in the singular include the plural, and words in the 
plural include the singular;
    (b) references to any ``Rule'' or ``Rule Series'' are references to 
the rules or rule series approved by the Commission pursuant to section 
3053 of the Act;
    (c) any Appendices to a Rule Series form an integral part of such 
Rule Series;
    (d) any reference to a provision in rules, protocols, policies, 
standards, guidelines, or similar includes any modifications or 
successor provisions made or issued from time to time;
    (e) any reference to legislation includes any modification or re-
enactment of legislation enacted in substitution of that legislation, 
and any regulation or other instrument from time to time issued or made 
under that legislation;
    (f) any term defined in this Rule 1000 Series shall supersede the 
definition of that term in the Rule 2000 Series;

[[Page 5085]]

    (g) a reference to ``writing,'' ``write,'' or ``written'' includes 
communications transmitted by email;
    (h) a reference to ``may'' means ``in the sole and absolute 
discretion of such person or body'';
    (i) a reference to a ``day'' means any day of the week and is not 
limited to working days;
    (j) any time limits shall begin from the day after which the 
relevant notification is received (or the day after the relevant 
notification is sent, if sent by email). Official holidays and non-
working days are included in the calculation of time limits. The time 
limits fixed under this Protocol are respected if the communications by 
the parties are sent before midnight (U.S. Eastern time) on the last 
day on which such time limits expire. If the last day of the time limit 
is an official holiday or a non-business day in the state or country 
where the notification has been made, the time limit shall expire at 
the end of the first subsequent business day;
    (k) a reference to a ``person'' (with no initial capital letter) 
means a natural person; and
    (l) any words following the terms ``including,'' ``include,'' ``in 
particular,'' ``such as,'' ``for example,'' or any similar expression, 
are illustrative only, and do not limit the sense of the words, 
description, definition, phrase, or term preceding those terms.
Rule 1020. Definitions
    Act means the Horseracing Integrity and Safety Act of 2020 (15 
U.S.C. 3051-3060), as amended from time to time.
    ADMC means the Anti-Doping and Medication Control Standing 
Committee of the Authority.
    Administration means providing, supplying, supervising, 
facilitating, or otherwise participating in the Use or Attempted Use in 
a Covered Horse of a Prohibited Substance or Prohibited Method. 
However, this definition shall not include the actions of bona fide 
veterinary personnel involving a Controlled Medication Substance or 
Controlled Medication Method used for genuine and legal therapeutic 
purposes or other acceptable justification.
    Adverse Analytical Finding (``AAF'') means a report from a 
Laboratory that, consistent with the Laboratory Standards, establishes 
in a Sample the presence of a Prohibited Substance or its Metabolites 
or Markers or evidence of the Use of a Prohibited Method.
    Agency means the anti-doping and controlled medication enforcement 
agency known as the Horseracing Integrity and Welfare Unit.
    Aggravating Circumstances means circumstances involving, or actions 
by, a Covered Person that may justify the imposition of one or both of 
a period of Ineligibility or fine greater than the otherwise applicable 
standard sanction. Such circumstances and actions include those set 
forth in Rule 3227 or Rule 3327 (as applicable).
    Aliquot means a portion of the Sample obtained from the Covered 
Horse.
    Analyte means a substance, compound, or measurand that is analyzed 
or determined in a biological matrix using an Analytical Testing 
Procedure performed under controlled analytical and laboratory 
conditions. For anti-doping and controlled medication purposes, an 
Analyte may be a Prohibited Substance, a Metabolite of a Prohibited 
Substance, or a Marker of the Use of a Prohibited Substance or 
Prohibited Method.
    Analytical Method has the same meaning as Analytical Testing 
Procedure.
    Analytical Testing means the parts of the Doping Control or 
Medication Control process performed at the Laboratory, which includes 
Sample handling, analysis, and the reporting of results.
    Analytical Testing Procedure means a Fit-for-Purpose procedure, as 
demonstrated through method validation, that is used to detect, 
identify or quantify Analytes in a Sample in accordance with the 
Laboratory Standards and relevant Technical Document(s), Technical 
Letter(s), Technical Note(s), or Laboratory Guidelines. Unless the 
context otherwise requires, Analytical Testing Procedure is also 
referred to or known as an Analytical Method or Test Method.
    Analytical Testing Restriction (``ATR'') means a restriction on a 
Laboratory's application of specified Analytical Testing Procedure(s) 
or on the analysis of a particular class(es) of Prohibited Substances 
or Prohibited Methods to Samples, as determined by the Agency.
    Anti-Doping Rule Violation (``ADRV'') means an anti-doping rule 
violation under the Protocol.
    Arbitral Body has the meaning given to it in the Rule 7000 Series.
    Arbitration Procedures means the arbitration procedures set forth 
in the Rule 7000 Series.
    Assistant Trainer means a person engaged in the training of Covered 
Horses, under the direct or indirect supervision of a Trainer.
    Association Veterinarian means a Veterinarian employed by a 
Racetrack.
    Attempt means purposely engaging in conduct that constitutes a 
substantial step in a course of conduct planned to culminate in the 
commission of an Anti-Doping Rule Violation or Controlled Medication 
Rule Violation; provided, however, that there shall be no Anti-Doping 
Rule Violation or Controlled Medication Rule Violation based solely on 
an Attempt to commit a violation if the Covered Person renounces the 
Attempt prior to it being discovered by a third party not involved in 
the Attempt.
    Attending Veterinarian means a Veterinarian providing treatment or 
services to Covered Horses hired or otherwise authorized by the Trainer 
or Owner or his or her respective designee.
    Atypical Finding means a report from a Laboratory that requires 
further investigation in accordance with the Atypical Findings Policy 
set out at Appendix 1 to the Protocol, prior to the determination of 
whether it is an Adverse Analytical Finding.
    Atypical Findings Policy means the policy set out at Appendix 1 to 
the Protocol.
    Authority means the Horseracing Integrity and Safety Authority 
designated by section 3052(a) of the Act.
    Banned Method has the meaning given to it in Rule 3111.
    Banned Substance has the meaning given to it in Rule 3111.
    Batch means a set of Samples processed as a group.
    Bias means deviation of a measured result from the expected or 
reference value when using the complete measurement procedure.
    Billing Standards means the standards governing compensation for 
arbitrators and stewards under the Arbitration Procedures.
    Blood Collection Officer (``BCO'') means a Veterinarian or a 
veterinary technician who has been authorized by the Agency (or its 
delegate) to collect blood Samples from a Covered Horse.
    Breeder means a Person who is in the business of breeding Covered 
Horses.
    Certified Reference Material (``CRM'') means Reference Material 
characterized by a metrologically valid procedure for one or more 
specified properties, which is accompanied by a certificate that 
provides the value of the specified property, its associated 
uncertainty, and a statement of metrological traceability.
    Certifying Scientists means personnel appointed by a Laboratory to 
review all pertinent analytical data, Analytical Method validation 
results, quality control results, Laboratory Documentation Packages, 
and to attest to the validity of the Laboratory's test results.
    Chain of Custody means the sequence of individuals or organizations 
who

[[Page 5086]]

have responsibility for the custody of a Sample from the provision of 
the Sample until the Sample has been delivered to the Laboratory for 
analysis.
    Chaperone means a person authorized by the Agency (or its delegate) 
to carry out the responsibilities given to Chaperones in the Testing 
and Investigations Standards or by the DCO.
    Charge Letter has the meaning given to it in (as the context 
requires) Rule 3248 or Rule 3348.
    Claim means, in the context of a Claiming Race, the purchase of a 
Covered Horse for a designated amount.
    Claiming Race means a Covered Horserace in which a Covered Horse 
after leaving the starting gate may be claimed in accordance with the 
rules and regulations of the applicable State Racing Commission.
    Code of Ethics means the Code of Ethics for Laboratories set forth 
at Rule 6610.
    Commission means the Federal Trade Commission.
    Confirmation Procedure (``CP'') means an Analytical Testing 
Procedure that has the purpose of confirming the presence in a Sample--
or, when applicable, confirming the concentration, ratio, or score, or 
establishing the origin (exogenous or endogenous)--of one or more 
specific Prohibited Substances, Metabolite(s) of a Prohibited 
Substance, or Marker(s) of the Use of a Prohibited Substance or 
Prohibited Method.
    Consequences means the penalties resulting from the occurrence of 
one or more violations of the Protocol, as set forth in the Rule 3000 
Series. The Consequences for an Anti-Doping Rule Violation or a 
Controlled Medication Rule Violation may include one or more of the 
following:
    (1) Disqualification;
    (2) Ineligibility;
    (3) Provisional Suspension;
    (4) financial penalties; and
    (5) Public Disclosure.
    Contaminated Product means a product other than feed, hay, or 
water, that contains a Prohibited Substance that (i) is not disclosed 
on the product label, and (ii) a Veterinarian or Trainer would not 
otherwise reasonably be aware might be included in the product.
    Controlled Medication Method means any method so described on the 
Prohibited List.
    Controlled Medication Rule Violation has the meaning given to it in 
Rule 3311(a).
    Controlled Medication Substance means any substance so described on 
the Prohibited List or the Technical Document-Prohibited Substances.
    Corrective Action Report (``CAR'') means a report describing the 
Root Cause Analysis of a nonconformity and the corrective actions 
implemented to rectify it. If appropriate, it shall also describe the 
improvements adopted to minimize the risk of recurrence of the 
nonconformity.
    Covered Horse means any Thoroughbred horse, or any other horse made 
subject to the Act by election of the applicable State Racing 
Commission or the breed governing organization for such horse under 
section 3054(l), during the period: (A) beginning on the date of the 
horse's first Timed and Reported Workout at a Racetrack that 
participates in Covered Horseraces or at a training facility; and (B) 
ending on the date on which the horse is deemed retired pursuant to 
Rule 3050(b).
    Covered Horserace means any horserace involving Covered Horses that 
has a substantial relation to interstate commerce, including any 
Thoroughbred horserace that is the subject of interstate off-track or 
advance deposit wagers.
    Covered Person means all Trainers, Owners, Breeders, Jockeys, 
Racetracks, Veterinarians, Persons licensed by a State Racing 
Commission, and the agents, assigns, and employees of such Persons; any 
other Persons required to be registered with the Authority; and any 
other horse support personnel who are engaged in the care, treatment, 
training, or racing of Covered Horses.
    Decision Limit means the value of the result for a Threshold 
Substance in a Sample, above which an Adverse Analytical Finding shall 
be reported.
    Designated Owner has the meaning given to it in Rule 3020(c).
    Detection Time means the interval after a medication is 
administered during which it is detectable in a specific matrix (serum, 
plasma, urine, or hair) from any member(s) of a group of test horses. 
Detection times are determined from analysis of samples collected at 
specific time points following an administration of a medication to 
group of, potentially as few as 2, test horses. A detection time is not 
the same as a withdrawal time. The withdrawal time for a medication 
must be decided upon by a Veterinarian (in consultation with the 
Responsible Person) and is likely to be based on the Detection Time and 
an added safety margin. This margin should be determined using 
professional judgment and discretion to take into account the 
variability that could be expected to normally occur in a larger 
population by considering individual differences between horses, such 
as size, metabolism, fitness, health, or recent illness or disease. The 
withdrawal interval used for a medication should always be longer than 
its Detection Time.
    Disqualification means the results of a Covered Horse in a 
particular Covered Horserace are invalidated, with all resulting 
consequences, including forfeiture of any purses and other 
compensation, prizes, trophies, points, and rankings associated with 
such Covered Horserace.
    Doping Control means all steps and processes from test distribution 
planning through to ultimate disposition of any adjudication and review 
process pursuant to the Protocol and the Act involving an Anti-Doping 
Rule Violation and the enforcement of Consequences, including all steps 
and processes in between, including Testing, investigations, 
whereabouts program, Sample collection and handling, Laboratory 
analysis, Results Management, hearings and reviews, and investigations 
and proceedings relating to Anti-Doping Rule Violations not arising 
from or related to Testing or violations of Rule 3229.
    Doping Control Officer (``DCO'') means an official who has been 
authorized by the Agency (or its delegate) to carry out the 
responsibilities given to DCOs in the Testing and Investigations 
Standards and any related Agency procedures.
    EAD Notice has the meaning given to it in Rule 3245.
    EAD Violations means Anti-Doping Rule Violations arising out of the 
Rule 3000 Series and violations of Rule 3229.
    ECM Notice has the meaning given to it in Rule 3345.
    ECM or Other Violations means Controlled Medication Rule Violations 
arising out of the Rule 3000 Series, violations of Rule 3329, or 
violations of Rule 3510.
    Equibase means the official database for Thoroughbred horseracing.
    Equine Constituencies means, collectively, Owners, Breeders, 
Trainers, Racetracks, Veterinarians, State Racing Commissions, and 
Jockeys who are engaged in the care, training, or racing of Covered 
Horses.
    Equine Industry Representative means an organization regularly and 
significantly engaged in the equine industry, including organizations 
that represent the interests of, and whose membership consists of, 
Owners, Breeders, Trainers, Racetracks, Veterinarians, State Racing 
Commissions, or Jockeys.
    Expanded Measurement Uncertainty means the multiplication of the 
coverage factor (q.v.) by the Measurement Uncertainty (q.v.).
    External Quality Assessment Scheme (``EQAS'') means a program for 
quality

[[Page 5087]]

assessment of Laboratory performance, which includes the periodic 
distribution of urine, blood, hair, or other samples to Laboratories 
and probationary laboratories by the Agency, to be analyzed for the 
presence or absence of Prohibited Substances or their Metabolite(s), or 
Marker(s) of Use of Prohibited Substances or Prohibited Methods. EQAS 
samples may be open (i.e., educational; in such cases the content may 
be indicated), blind or double-blind (in such cases the content is 
unknown to the Laboratories).
    Fault means any breach of duty or any lack of care appropriate to a 
particular situation. Factors to be taken into consideration in 
assessing a Covered Person's degree of Fault include (but are not 
limited to) the Covered Person's experience and special considerations 
such as impairment, the degree of risk that should have been perceived 
by the Covered Person, and the level of care and investigation 
exercised by the Covered Person in relation to what should have been 
the perceived level of risk. With respect to supervision, factors to be 
taken into consideration are the degree to which the Covered Person 
conducted appropriate due diligence, educated, supervised, and 
monitored Covered Persons (including Veterinarians), employees, 
personnel, agents, and other Persons involved in any way with the care, 
treatment, training, or racing of his or her Covered Horses, and 
created and maintained systems to ensure compliance with the Protocol. 
In assessing the Covered Person's degree of Fault, the circumstances 
considered must be specific and relevant to explain the Covered 
Person's departure from the expected standard of behavior. Thus, for 
example, the fact that the Covered Person would lose the opportunity to 
earn large sums of money during a period of Ineligibility, or the fact 
that the Covered Person or Covered Horse only has a short time left in 
a career, or the timing of the horseracing calendar, would not be 
relevant factors to be considered in reducing the period of 
Ineligibility based on degree of Fault.
    Fit(ness)-for-Purpose means suitable for the intended purpose and 
in conformity with the ISO/IEC 17025, ILAC-G7, the Laboratory 
Standards, and relevant Technical Document(s) and Technical Letter(s).
    Further Analysis means additional analysis conducted by a 
Laboratory on an A Sample or a B Sample after it has reported an 
analytical result for that A Sample or that B Sample, save that it 
excludes (and, therefore, there is no limitation on a Laboratory's 
authority to conduct) repeat or confirmation analysis, and analysis 
with additional or different Analytical Methods.
    IAP member means a member of the Internal Adjudication Panel.
    Immediate Family Member means a spouse, domestic partner, mother, 
father, aunt, uncle, sibling, or child.
    Ineligibility means the Covered Horse or Covered Person is barred 
for a specified period of time from participating in specified 
activities, as further particularized in the provisions of the Protocol 
relating to Ineligibility.
    Initial Testing Procedure (``ITP'') means an Analytical Testing 
Procedure whose purpose is to identify those Samples that may contain a 
Prohibited Substance, Metabolite(s) of a Prohibited Substance, or 
Marker(s) of the Use of a Prohibited Substance or Prohibited Method or 
an elevated quantity of a Prohibited Substance, Metabolite(s) of a 
Prohibited Substance, or Marker(s) of the Use of a Prohibited Substance 
or Prohibited Method.
    Interested Party means the Authority, the Owner of the Covered 
Horse, the Trainer of the Covered Horse, and the relevant State Racing 
Commission (provided that such State Racing Commission has entered into 
an agreement incorporating required confidentiality provisions).
    Intermediate Precision (sw) means variation in results observed 
when one or more factors, such as time, equipment, or operator, are 
varied within a Laboratory, and may also be referred to as inter-batch 
or inter-run precision.
    Internal Adjudication Panel has the meaning given to it in the Rule 
7000 Series. The Internal Adjudication Panel shall have the same 
meaning as the National Stewards Panel in any other rules approved by 
the Commission.
    Jockey means a rider or driver of a Covered Horse in Covered 
Horseraces.
    Laboratory means a laboratory approved by the Agency, applying Test 
Methods and processes to provide evidentiary data for the detection or 
identification of Prohibited Substances, Metabolites, Markers, or 
Prohibited Methods, and, if applicable, quantification of a Threshold 
Substance in Samples of urine, blood, hair, and other biological 
matrices in the context of Doping Control or Medication Control 
activities.
    Laboratory Director means a person appointed by a Laboratory to be 
responsible for overseeing the professional, organizational, 
educational, operational, and administrative responsibilities of the 
Laboratory's operations in accordance with the Laboratory Standards.
    Laboratory Documentation Package (``LDP'') means the physical or 
electronic material produced by a Laboratory upon reporting of an 
Adverse Analytical Finding or as requested by the Agency to support an 
analytical result such as an Adverse Analytical Finding or an Atypical 
Finding.
    Laboratory Expert Group (``LabEG'') means the group of laboratory 
experts responsible for providing advice, recommendations, and guidance 
to the Agency with respect to the overall management of Laboratory 
accreditation, disciplinary action, re-accreditation, approval 
processes, and monitoring activities.
    Laboratory Guidelines (``LGs'') means recommendations of Laboratory 
best practices that may be provided by the Agency to address specific 
Laboratory operations or to provide technical requirements and guidance 
on interpretation and reporting of results for the analysis of specific 
Prohibited Substance(s), Metabolites, or Markers, or Prohibited 
Method(s), or on the application of specific Laboratory procedures.
    Laboratory Internal Chain of Custody means documentation maintained 
within the Laboratory to record the chronological traceability of 
custody and actions performed on the Sample and any Aliquot of the 
Sample taken for Analytical Testing. Laboratory Internal Chain of 
Custody is generally documented by a written or electronic record of 
the date, location, action taken, and the person performing an action 
with a Sample or Aliquot.
    Laboratory Standards means the Equine Standards for Laboratories 
and Accreditation set forth in the Rule 6000 Series.
    Laboratory Supervisory Personnel means personnel appointed by a 
Laboratory to serve as Laboratory supervisors.
    Limit of Detection (``LOD'') means the analytical parameters of 
assay technical performance. Lowest concentration of an Analyte in a 
Sample that can be routinely detected, but not necessarily identified 
or quantified, under the stated Test Method conditions used.
    Limit of Identification (``LOI'') means analytical parameter of 
technical performance for chromatographic-mass spectrometric 
Confirmation Procedures. The LOI is estimated during method validation 
to evaluate the rate of false negative results at a certain 
concentration level. The LOI of a Test Method, at 5% false negative 
rate, for an Analyte (for which a Reference Material is available) 
shall be less than the MRPL. Since the LOI is an estimation of

[[Page 5088]]

the false negative rate, Laboratories may report findings below the 
estimated LOI as Adverse Analytical Findings or Atypical Findings, as 
applicable, when the Analyte is identified in the Sample according to 
the criteria established in a Technical Document.
    Limit of Quantification (``LOQ'') means the analytical parameter of 
assay technical performance. Lowest concentration of an Analyte in a 
Sample that can be quantitatively determined with acceptable precision 
and accuracy (i.e., acceptable Measurement Uncertainty) under the 
stated Test Method conditions.
    Management System refers to the Laboratory's quality system to deal 
with control of management system documents and records and with 
actions to address risk, test improvements, corrective actions, and 
ongoing management reviews.
    Managing Owner has the meaning given to it in Rule 3020(c).
    Marker means a compound, group of compounds, or biological 
variable(s) that indicates the Use of a Prohibited Substance or 
Prohibited Method.
    Measurement Uncertainty (``MU'') means the parameter associated 
with a measurement result that characterizes the dispersion of quantity 
values attributed to the measure and provides confidence in the 
validity of the measured result.
    Medication Control means all steps and processes from test 
distribution planning through to ultimate disposition of any 
adjudication and review process pursuant to the Protocol and the Act 
involving a Controlled Medication Rule Violation and to enforcement of 
Consequences, including all steps and processes in between, including 
Testing, investigations, whereabouts program, Sample collection and 
handling, Laboratory analysis, Results Management, hearings and 
reviews, and investigations and proceedings relating to Controlled 
Medication Rule Violations not arising from or related to Testing or 
violations of Rule 3329.
    Metabolite means any substance produced from a Prohibited Substance 
by a biotransformation process.
    Minimum Reporting Level means the estimated concentration of a 
Prohibited Substance or its Metabolite(s) or Marker(s) in a Sample 
below which Laboratories will not report that Sample as an Adverse 
Analytical Finding.
    Minimum Required Performance Level (``MRPL'') means minimum 
analytical criterion of Laboratory technical performance established by 
the Agency, including the minimum concentration at which a Laboratory 
is expected to consistently detect and confirm a Prohibited Substance, 
Metabolite of a Prohibited Substance, or Marker of a Prohibited 
Substance or Prohibited Method in the routine daily operation of the 
Laboratory.
    Minor means a natural person who has not reached the age of 18 
years.
    National Stewards Panel means the Internal Adjudication Panel.
    Negative Finding means a test result from a Laboratory that, in 
accordance with the Laboratory Standards and any relevant Technical 
Document(s) and Technical Letter(s), concludes that no Prohibited 
Substance(s) or its Metabolite(s) or Marker(s) or evidence of the Use 
of a Prohibited Method(s), included in the requested Analytical Testing 
menu, were found in a Sample based on the applied Initial Testing 
Procedure(s) or Confirmation Procedure(s).
    No Fault or Negligence means the Covered Person establishing that 
he or she did not know or suspect, and could not reasonably have known 
or suspected, even with the exercise of utmost caution, that he or she 
had administered to the Covered Horse (or that the Covered Horse's 
system otherwise contained) a Banned Substance or a Controlled 
Medication Substance, or that he or she had Used on the Covered Horse a 
Banned Method or a Controlled Medication Method, or otherwise committed 
an Anti-Doping Rule Violation or Controlled Medication Rule Violation. 
For any violation of Rule 3212 or Rule 3312, the Covered Person must 
also establish how the Prohibited Substance entered the Covered Horse's 
system in order to establish No Fault or Negligence.
    No Significant Fault or Negligence means the Covered Person 
establishing that his or her fault or negligence, when viewed in the 
totality of the circumstances and taking into account the criteria for 
No Fault or Negligence, was not significant in relationship to the 
Anti-Doping Rule Violation or Controlled Medication Rule Violation in 
question. For any violation of Rule 3212 or 3312, the Covered Person 
must also establish how the Prohibited Substance entered the Covered 
Horse's system in order to establish No Significant Fault or 
Negligence.
    Nominated Person means a person nominated by a Responsible Person 
at the time of notification or through a whereabouts filing to assist, 
consent to, and witness Sample collection from a Covered Horse. If the 
Responsible Person is not present to nominate a person, or the 
designated Nominated Person is not present or willing to assist with 
Sample collection, anyone employed by the Responsible Person or Owner 
at the stable where the Covered Horse is located shall be the Nominated 
Person for that Sample collection. If no Nominated Person is promptly 
identified as described above, the person who has custody or control of 
the Covered Horse or granted the DCO, BCO, or Chaperone access to the 
Covered Horse shall be the Nominated Person for that Sample collection. 
In each case, the Nominated Person shall be 18 years or older.
    Non-Threshold Substance means a Prohibited Substance for which the 
identification, in compliance with any applicable Technical 
Document(s), constitutes an Adverse Analytical Finding.
    Owner means a person who holds an ownership interest in one or more 
Covered Horses.
    Person means a natural person or an organization or other entity.
    Possession means actual, physical possession, or constructive 
possession (which shall be found only if the Covered Person has 
exclusive control or intends to exercise exclusive control over the 
Prohibited Substance or Prohibited Method or the premises in which a 
Prohibited Substance or Prohibited Method exists). If the Covered 
Person does not have exclusive control over the Prohibited Substance or 
Prohibited Method or the premises in which a Prohibited Substance or 
Prohibited Method exists, constructive Possession shall only be found 
if the Covered Person knew about the presence of the Prohibited 
Substance or Prohibited Method and intended to exercise control over 
it. There shall be no Anti-Doping or Controlled Medication Rule 
violation based solely on Possession if, prior to receiving 
notification of any kind of any violation, the Covered Person has taken 
concrete action demonstrating that the Covered Person never intended to 
have possession and has renounced possession by explicitly declaring it 
to the Agency. Notwithstanding anything to the contrary in this 
definition, the act of purchasing (including by any electronic or other 
means) a Banned Substance or Banned Method constitutes Possession by 
the Covered Person who makes the purchase, whether or not the Banned 
Substance or Banned Method purchased is ever delivered to the Covered 
Person.
    Post-Race Sample means a Sample collected by or on behalf of the 
Agency from a Covered Horse where notification of such Sample 
collection takes place no more than 1 hour after the end of a Covered 
Horserace in which a Covered Horse participates or is entered, or the

[[Page 5089]]

end of a Vets' List Workout in which a Covered Horse participates. All 
Banned Substances and all Controlled Medication Substances are 
prohibited from being present in a Post-Race Sample.
    Post-Time means the start time of a Covered Horserace in which a 
Covered Horse participates or is entered, or the start time of a Vets' 
List Workout in which a Covered Horse participates.
    Post-Work Sample means a Sample collected by or on behalf of the 
Agency from a Covered Horse where notification of such Sample 
collection takes place no more than 1 hour after the end of a Timed and 
Reported Workout. All Banned Substances and any Controlled Medication 
Substances specifically identified on the Prohibited List as prohibited 
during Timed and Reported Workouts are prohibited from being present in 
a Post-Work Sample.
    Presumptive Adverse Analytical Finding (``PAAF'') means the status 
of a Sample test result from the Initial Testing Procedure which 
represents a suspicious finding, but for which a Confirmation Procedure 
to render a conclusive test result has not yet been performed.
    Program means the anti-doping and medication control program 
established under section 3055(a) of the Act.
    Program Effective Date means the date on which the Commission 
approves the proposed rule.
    Prohibited List means the list identifying Prohibited Substances 
and Prohibited Methods set forth in the Rule 4000 Series.
    Prohibited Method means any method so described on the Prohibited 
List.
    Prohibited Substance means any substance or class of substances so 
described on the Prohibited List or the Technical Document-Prohibited 
Substances.
    Protocol means the Rule 3000 Series (Equine Anti-Doping and 
Controlled Medication Protocol), as amended from time to time.
    Provisional Hearing means an expedited abbreviated hearing to 
resolve a challenge to a Provisional Suspension, occurring prior to the 
adjudication of the violation in issue.
    Provisional Suspension means the Covered Horse or Covered Person is 
barred temporarily from participating in any Timed and Reported Workout 
or Covered Horserace in accordance with Rules 3229 or 3329 (as 
applicable).
    Public Disclosure means the dissemination or distribution of 
information by the Authority or the Agency to the general public.
    Quality Manager means the staff member appointed by a Laboratory to 
perform that role in accordance with the Laboratory Standards.
    Race Day means the period commencing at 12:01 a.m. on the day of a 
Vets' List Workout or Covered Horserace and ending (i) 1 hour after the 
end of such Vets' List Workout or Covered Horserace or (ii) at the end 
of any Sample Collection Session conducted at that Vets' List Workout 
or Covered Horserace when the Covered Horse is released from the Test 
Barn, whichever is later.
    Race Organizer means any Person that arranges, organizes, and has 
administrative responsibility for a Covered Horserace.
    Race Period means the period:
    (a) commencing 48 hours prior to the Post-Time of either (i) any 
Vets' List Workout in which the Covered Horse participates or (ii) any 
Covered Horserace that the Covered Horse has been entered in, whether 
or not the Covered Horse actually starts; and
    (b) ending (i) 1 hour after the end of such Vets' List Workout or 
Covered Horserace or (ii) at the end of any Sample collection process 
conducted at that Vets' List Workout or Covered Horserace when the 
Covered Horse is released from the Test Barn, whichever is later.
    However, the Prohibited List may specify a Race Period that is 
shorter or longer in duration than the above period for certain 
Controlled Medication Substances or Controlled Medication Methods.
    Racetrack means an organization licensed by a State Racing 
Commission to conduct Covered Horseraces.
    Racetrack Safety Program means the program set forth in Rule 2000 
Series, established pursuant to section 3056(a) of the Act.
    Reference Collection (``RC'') means a collection of samples or 
isolates of known origin that may be used in the determination of the 
identity of an unknown substance. For example, a well-characterized 
sample obtained from a controlled administration or from in vitro 
studies in which the presence of the substance of interest has been 
established.
    Reference Material (``RM'') means a Reference Substance or 
Reference Standard that is sufficiently characterized, homogeneous, and 
stable with respect to one or more specified properties and that has 
been established to be fit for its intended use in an Analytical 
Testing Procedure.
    Regulatory Veterinarian means a Veterinarian who is employed, 
contracted, or appointed by a State Racing Commission, Racetrack, the 
Authority, or the Agency to monitor the health and welfare of Covered 
Horses, in addition to any other duties assigned to him or her by the 
Authority or the Agency.
    Repeatability (sr) means variability of results obtained within a 
laboratory using the same method, over a short time, using a single 
operator, item of equipment, etc. It is also referred to as intra-
batch/intra-run precision.
    Reproducibility (sR) means variability of results obtained when 
different laboratories analyze Aliquots of the same Sample. 
Reproducibility is a property of the results obtained and represents a 
measurable agreement of analytical results between different 
laboratories.
    Responsible Person has the meaning given to it in Rule 3030.
    Results Management means the process encompassing the timeframe 
from provision of an EAD Notice or ECM Notice through the charge until 
the final resolution of the matter, including the end of any 
adjudication and review process pursuant to the Protocol and the Act.
    Revocation means the permanent withdrawal of a Laboratory's Equine 
Analytical Laboratory accreditation by the Agency.
    Risk Assessment means the assessment of risk of doping and 
controlled medication misuse conducted by the Agency and used to 
effectively conduct test distribution planning or Target Testing.
    RMTC has the meaning given to it in Rule 6070(a).
    Root Cause Analysis (``RCA'') means an investigation to identify 
one or more fundamental causes of a nonconformity based on the 
collection of objective evidence from an assessment of the likely 
factors that led to the nonconformity. The removal of a root cause 
factor prevents the recurrence of the nonconformity; in contrast, 
removing a causal factor can improve the outcome, but it does not 
prevent the recurrence of the problem with certainty.
    Sample means any biological material collected for the purposes of 
Doping Control or Medication Control, including urine, blood, and hair.
    Sample Collection Equipment means A and B bottles, kits, 
containers, collection vessels, tubes, or other apparatus used to 
collect, hold, or store a Sample at any time during or after a Sample 
Collection Session.
    Sample Collection Personnel means all qualified officials 
authorized by the Agency to carry out or assist with duties during 
Doping Control or Medication Control, including, but not limited to, 
Blood Collection Officers, Doping

[[Page 5090]]

Control Officers, and Chaperones. An individual may be authorized by 
the Agency to carry out one or more roles during Doping Control or 
Medication Control.
    Sample Collection Session means all of the sequential activities 
that directly involve the collection of a Sample from a Covered Horse 
from the point that initial contact is made with the Responsible Person 
or Nominated Person until the Covered Horse provides a Sample and is 
discharged from Sample collection obligations.
    Screening Limit means a concentration to be used by Laboratories 
when screening for certain Non-Threshold Substances during the Initial 
Testing Procedure, below which a Laboratory will not pursue the 
possible presence of a Prohibited Substance. When the concentration of 
an Analyte subject to a Screening Limit exceeds the Screening Limit as 
determined by the Initial Testing Procedure, qualitative confirmatory 
analysis by mass spectrometry Confirmation Procedure is required to 
confirm the presence or absence of the Prohibited Substance. 
Quantification is not required. A Screening Limit is not a Limit of 
Detection, a Limit of Identification, or a Limit of Quantification.
    Selectivity means the ability of the Analytical Testing Procedure 
to detect or identify (as applicable) the substance of interest in the 
Sample.
    Specified Substance has the meaning given to it in Rule 3111(c).
    Stacking Violation has the meaning given to it in Rule 3312(e).
    Stakes Race means any race so designated by the Racetrack at which 
such race is run, including, without limitation, the races the 
Breeders' Cup World Championships comprises and the races designated as 
graded stakes by the American Graded Stakes Committee of the 
Thoroughbred Owners and Breeders Association.
    Standard Operating Procedure means a document setting out 
prescribed methods or procedures to be followed when performing certain 
routine operations.
    Standards means the Testing and Investigations Standards and the 
Laboratory Standards. Compliance with a Standard (as opposed to another 
alternative standard, practice, or procedure) shall be sufficient to 
conclude that the procedures addressed by the Standard were performed 
properly. Standards shall include any Technical Documents issued 
pursuant to the Standards.
    State Racing Commission means an entity designated by State law or 
regulation that has jurisdiction over the conduct of horseracing within 
the applicable state.
    Substantial Assistance means, for purposes of Rule 3226(a) and Rule 
3326(a), a Covered Person providing the following assistance:
    (1) fully disclosing in a signed written statement or recorded 
interview all information the Covered Person possesses in relation to 
violations of the Protocol; and
    (2) fully cooperating with the investigation and adjudication of 
any case or matter related to that information, including, for example, 
by providing an affidavit and presenting testimony at a hearing if 
requested to do so by the Agency or adjudication body.
    Further, the information provided must be credible and must 
comprise an important part of any case or proceeding which is initiated 
or, if no case or proceeding is initiated, must have provided a 
sufficient basis on which a case or proceeding could have been brought.
    Tamper Evident means to have one or more indicators or barriers to 
entry included with or incorporated into the Sample Collection 
Equipment, which, if breached, missing, or otherwise compromised, can 
provide visible evidence that Tampering or Attempted Tampering of 
Sample Collection Equipment has occurred.
    Tampering means intentional conduct that subverts the Doping 
Control or Medication Control process, but that would not otherwise be 
included in the definition of Prohibited Methods. Tampering includes 
offering or accepting a bribe to perform or fail to perform an act, 
preventing the collection of a Sample, affecting or making impossible 
the analysis of a Sample, falsifying documents submitted to the Agency 
(or a committee or adjudication body), procuring false testimony from 
witnesses, committing any other fraudulent act upon the Agency (or 
committee or adjudication body) to affect Results Management or the 
imposition of Consequences, and any other similar interference or 
attempted interference with any aspect of Doping Control or Medication 
Control. However, this definition shall not include the actions of bona 
fide veterinary personnel involving a Controlled Medication Substance 
or Controlled Medication Method used for genuine and legal therapeutic 
purposes or other acceptable justification.
    Target Testing means selection of specific Covered Horses for 
Sample collection based on criteria set forth in the Testing and 
Investigations Standards.
    Technical Document (``TD'') means a document adopted and published 
by the Authority from time to time containing requirements or guidance 
on specific anti-doping or medication control topics.
    Technical Letter (``TL'') means a document published containing 
mandatory technical requirements provided by the Agency from time to 
time to address particular issues on the analysis, interpretation, and 
reporting of specific Prohibited Substance(s), Metabolites, Markers, or 
Prohibited Method(s), or on the application of specific Laboratory 
procedures.
    Technical Note (``TN'') means technical guidance provided by the 
Agency to Laboratories on the performance of specific Laboratory 
methods or procedures.
    Test Barn means the location where Sample collection is conducted 
on Race Day.
    Test Barn Veterinarian means a Veterinarian who is employed, 
contracted, or appointed by a State Racing Commission, Racetrack, the 
Authority, or the Agency to monitor the health and welfare of Covered 
Horses subject to Sample collection in the Test Barn.
    Testing means the parts of the Doping Control or Medication Control 
process involving Sample collection, Sample handling, and Sample 
transport to the Laboratory.
    Testing and Investigations Standards means the Equine Testing and 
Investigations Standards set forth in the Rule 5000 Series.
    Test Method has the same meaning as Analytical Testing Procedure.
    Thoroughbred means a horse that is registered in The American Stud 
Book or in a foreign stud book approved by the Jockey Club or the 
International Stud Book Committee.
    Threshold means the maximum permissible level of the concentration, 
ratio, or score for a Threshold Substance in a Sample. The Threshold is 
used to establish the Decision Limit for reporting an Adverse 
Analytical Finding or Atypical Finding for a Threshold Substance. 
Thresholds may only be adopted for (i) substances endogenous to the 
horse or (ii) substances arising from plants traditionally grazed or 
harvested as equine feed.
    Threshold Substance means a Prohibited Substance, or Metabolite or 
Marker of a Prohibited Substance, for which the identification and 
quantitative determination, including, for example, concentration, 
ratio, or score, in excess of a pre-determined Decision Limit, or, when 
applicable, the establishment of an exogenous origin,

[[Page 5091]]

constitutes an Adverse Analytical Finding.
    Timed and Reported Workout means an officially timed and published 
running of a Thoroughbred horse over a predetermined distance that is 
not a horserace, as reported by Equibase or any official supplier of 
racing information and statistics recognized by the Authority. Official 
timed workouts shall have the same meaning as Timed and Reported 
Workouts. Any official timed workout by a Thoroughbred horse in any 
other jurisdiction shall be deemed a Timed and Reported Workout upon 
the earliest to occur of the following: (i) the horse is brought to the 
United States for purposes of participating in any Covered Horserace; 
or (ii) the horse is nominated for a Covered Horserace.
    Trafficking means a Covered Person selling, giving, transporting, 
sending, delivering, or distributing by any means a Banned Substance or 
Banned Method to any other Person, or Possessing a Banned Substance or 
Banned Method for any such purpose; provided, however, that Trafficking 
shall not include the actions of Veterinarians or other licensed 
medical personnel involving a Prohibited Substance used for genuine and 
legal therapeutic purposes or other acceptable justification.
    Trainer means an individual engaged in the training of Covered 
Horses.
    Training Facility means a location that is not a Racetrack licensed 
by a State Racing Commission that operates primarily to house Covered 
Horses and conduct Timed and Reported Workouts.
    Use means the utilization, application, ingestion, injection, or 
consumption by any means whatsoever of any Prohibited Substance or 
Prohibited Method in relation to a Covered Horse.
    Veterinarian means a licensed veterinarian who provides veterinary 
services to Covered Horses.
    Veterinarians' List has the meaning given to it in Rule 2000 Series 
(Racetrack Safety Program).
    Vets' List Workout means an officially timed running of a Covered 
Horse over a predetermined distance that is not a Covered Horserace but 
is overseen by a Regulatory Veterinarian or Racetrack steward.
    Whereabouts Failure means a failure by the Responsible Person to do 
any of the following: (i) provide notice to the Agency that his or her 
Covered Horse has been moved from a Racetrack or Training Facility to a 
private facility (i.e., a facility not under the jurisdiction of the 
Authority/Agency) before such move occurs; (ii) provide whereabouts 
information about his or her Covered Horse(s) upon request by the 
Agency; (iii) provide sufficient information about the Covered Horse's 
whereabouts to enable the Agency to Test the Covered Horse at any time; 
or (iv) update any whereabouts information provided to the Agency if it 
changes.
    Without Prejudice Agreement means a written agreement between the 
Agency and a Covered Person that allows the Covered Person to provide 
information to the Agency in a defined time-limited setting with the 
understanding that, if an agreement for Substantial Assistance or a 
case resolution agreement is not finalized, the information provided by 
either party may not be used by the other party in any Results 
Management proceeding under this Protocol. Such an agreement shall not 
preclude the parties from using any information or evidence gathered 
from any source.
    Workout means a timed running of a horse over a predetermined 
distance not associated with a race or its first qualifying race, if 
such race is made subject to the Act by election under section 3054(l) 
of the Act of the horse's breed governing organization or the 
applicable State Racing Commission.

3000. Equine Anti-Doping and Controlled Medication Protocol

3000. General Provisions

Rule 3010. Introduction
    (a) The Horseracing Integrity and Safety Act of 2020 (``Act'') 
mandates and empowers the Horseracing Integrity and Safety Authority 
(``Authority'') to establish a uniform anti-doping and controlled 
medication program to improve the integrity and safety of horseracing 
in the United States (``Program'').
    (b) This Equine Anti-Doping and Controlled Medication Protocol 
(``Protocol'') has been developed and issued by the Authority as part 
of that mandate. It contains or incorporates by reference rules, 
standards, and procedures to improve and protect the integrity and 
safety of horseracing in the United States by deterring and penalizing 
the improper administration or application of Prohibited Substances and 
Prohibited Methods to Covered Horses. The Protocol is split into five 
chapters:
    (1) the purpose, scope, and organization of the Protocol;
    (2) the Prohibited List, rules of proof, and testing and 
investigations;
    (3) the Equine Anti-Doping Rules;
    (4) the Equine Controlled Medication Rules; and
    (5) other violations and general procedure/administration.
    (c) The Protocol has intentionally divided the regulation of Anti-
Doping Rule Violations and Controlled Medication Rule Violations into 
separate chapters to reflect the Authority's view that the treatment of 
such violations should be separate and distinct from each other. Anti-
Doping Rule Violations involve Banned Substances or Banned Methods, 
which are substances/methods that should never be in a horse's system 
or used on a horse as they serve no legitimate treatment purpose. 
Conversely, Controlled Medication Rule Violations involve Controlled 
Medication Substances or Controlled Medication Methods, which are 
substances/methods that have been determined to have appropriate and 
therapeutic purposes, and so may be used outside the Race Period, 
except as otherwise provided in the Prohibited List. For the avoidance 
of doubt, the Protocol does not regulate the use of drugs or 
medications by human participants in Covered Horseraces.
    (d) The Protocol reflects and implements the following principles 
set out in section 3055(b) of the Act that:
    (1) Covered Horses should compete only when they are free from the 
influence of medications, other foreign substances, and treatment 
methods that affect their performance;
    (2) Covered Horses that are injured or unsound should not train or 
participate in Covered Horseraces, and that medications, other foreign 
substances, and treatment methods that mask or deaden pain in order to 
allow injured or unsound horses to train or race should be prohibited;
    (3) rules, standards, procedures, and protocols regulating 
medication and treatment methods for Covered Horses and Covered 
Horseraces should be uniform and uniformly administered throughout the 
United States;
    (4) to the extent consistent with the Act, consideration should be 
given to international anti-doping and medication control standards of 
the International Federation of Horseracing Authorities and the 
Principles of Veterinary Medical Ethics of the American Veterinary 
Medical Association;
    (5) the administration of medications and treatment methods to 
Covered Horses should be based upon a veterinary examination and 
diagnosis that identifies an issue requiring treatment for which the 
medication or method represents an appropriate component of treatment;
    (6) the amount of therapeutic medication that a Covered Horse 
receives should be the minimum necessary to address the diagnosed

[[Page 5092]]

health concerns identified during the veterinary examination and 
diagnostic process; and
    (7) the welfare of Covered Horses, the integrity of the sport of 
horseracing, and the confidence of its stakeholders (including the 
betting public) require full disclosure to regulatory authorities 
regarding the administration of medications and treatments to Covered 
Horses.
    (e) The Protocol will be implemented and enforced on behalf of the 
Authority by:
    (1) an anti-doping and controlled medication enforcement agency 
known as the Horseracing Integrity and Welfare Unit (``Agency''); and
    (2) where agreed in accordance with 3060 of the Act, by State 
Racing Commissions acting under the delegated authority of the 
Authority or the Agency (and references to the Authority or the Agency 
in the Protocol will be deemed to encompass such commissions as the 
context requires, subject to and consistent with the scope of their 
delegated authority).
    (f) In accordance with section 3054(b) of the Act, the rules of the 
Authority promulgated in accordance with the Act shall preempt any 
provision of State law or regulation with respect to matters within the 
jurisdiction of the Authority under the Act. Among other things, the 
Protocol:
    (1) identifies the conduct that will constitute an Anti-Doping Rule 
Violation (Rules 3211 to 3216), a Controlled Medication Rule Violation 
(Rules 3311 to 3315), or a related violation (Rules 3229, 3329, and 
3510);
    (2) establishes evidentiary and other rules for proving violations 
of the Protocol (Rules 3121 to 3122);
    (3) provides for the creation, maintenance, and updating of a 
Prohibited List and related Technical Document that identify Prohibited 
Substances and Prohibited Methods (Rules 3111 to 3113);
    (4) empowers the Agency to perform and manage test distribution 
planning and Testing of Covered Horses both in and out of competition, 
in accordance with the Testing and Investigations Standards (Rule 
3133);
    (5) empowers the Agency to gather intelligence and investigate 
potential violations of the Protocol, in accordance with the Testing 
and Investigations Standards, which incorporate uniform rules and 
procedures in accordance with section 3054(c) of the Act (Rule 3133);
    (6) empowers the Agency to accredit testing laboratories in 
accordance with the Laboratory Standards and to monitor, test, and 
audit approved Laboratories to ensure continuing compliance with the 
Laboratory Standards; and provides for all samples collected pursuant 
to the Protocol to be analyzed at approved Laboratories in accordance 
with the Laboratory Standards or by other laboratories, such as 
international laboratories accredited by the International Federation 
of Horseracing Authorities, in accordance with Rule 3136(d) (Rule 
3136);
    (7) sets out uniform rules and procedures for the Agency's 
management of the results of testing and investigations, and for its 
prosecution of any charges that Covered Persons have violated the 
Protocol, including incorporating the Arbitration Procedures to ensure 
the fair adjudication of those charges;
    (8) sets out the sanctions that may be applied in case of 
violations of the Protocol, including, but not limited to, 
Disqualification of results, forfeiture of prizes and purses, fines, 
payment of costs, periods of Ineligibility for Covered Horses or 
Covered Persons (including additional periods of Ineligibility for 
repeat offenders), and Public Disclosure (sections 3220 and 3320); and 
requires the Authority, Racetracks, Race Organizers, Training 
Facilities, all Covered Persons, and all other relevant Persons to 
recognize, respect, enforce, and give full force and effect to final 
decisions issued under the Protocol within their respective spheres of 
authority (Rule 3710);
    (9) regulates the public reporting and disclosure of cases, and 
permits and facilitates statistical reporting to the Authority and to 
the U.S. Congress, the Commission, State Racing Commissions, and other 
Federal or State governmental bodies or agencies having jurisdiction 
over the sport of horseracing in the United States (section 3600); and
    (10) empowers the Agency to undertake and commission education and 
research activities designed to advance the integrity and safety of 
horseracing in the United States (Rule 3810).
    (g) The Protocol comes into force on the Program Effective Date and 
will apply in full as from that date. In accordance with section 
3054(k)(1) of the Act, the Protocol only has prospective effect, i.e., 
it does not apply to, and does not give the Authority or Agency 
authority to investigate, prosecute, adjudicate, or penalize conduct 
that occurred before the Program Effective Date (Rule 3080).
    (h) The Protocol incorporates by reference the supporting rules and 
documents approved by the Commission and issued by the Authority, 
including Rule 1000 Series (General Provisions), Rule 2000 Series 
(Racetrack Safety Program), Rule 4000 Series (Prohibited List), Rule 
5000 Series (Testing and Investigations Standards), Rule 6000 Series 
(Laboratory Standards), Rule 7000 Series (Arbitration Procedures), Rule 
8000 Series (Enforcement Rule), Rule 8500 Series (Methodology for 
Determining Assessments), and Rule 9000 Series (Registration of Covered 
Persons and Covered Horses).
    (i) In accordance with section 3055(c)(4) of the Act, the Agency 
may develop further rules, protocols, policies, and guidelines for 
approval by the Authority to support the implementation of the 
Protocol. These materials will be developed in consultation with the 
Anti-Doping and Medication Control Standing Committee (ADMC) of the 
Authority and will be consistent with international best practices.
    (j) Nothing in the Protocol or in any of its associated rules, 
protocols, policies, and guidelines:
    (1) is intended to constrain or limit in any way the powers of the 
Authority or the Agency under the Act; or
    (2) shall be interpreted or applied in a manner that has the effect 
of constraining or limiting those powers in any way.
    (k) Unless specified otherwise, words and terms in the Protocol 
that are capitalized are defined terms that have the meaning given to 
them in Rule 1020.
    (l) The rules of interpretation included at Rule 1010 and Rule 3070 
shall be used as an aid to interpretation of the Protocol.
Rule 3020. Application
    (a) The Protocol applies to and is binding on:
    (1) any horserace involving Covered Horses that has a substantial 
relation to interstate commerce, including any Thoroughbred horserace 
that is the subject of interstate off-track or advance deposit wagers 
(each, a Covered Horserace);
    (2) any Thoroughbred horse, or any other horse made subject to the 
Act by election of the applicable State Racing Commission or the breed 
governing organization for such horse under section 3054(l), during the 
period: (A) beginning on the date of the horse's first Timed and 
Reported Workout at a racetrack that participates in Covered Horseraces 
or at a Training Facility; and (B) ending on the date on which the 
horse is deemed retired pursuant to Rule 3050(b) (each, a Covered 
Horse); and
    (3) the following persons (each, a Covered Person): all Trainers, 
Owners,

[[Page 5093]]

Breeders, Jockeys, Racetracks, Veterinarians, Persons licensed by a 
State Racing Commission, and the agents, assigns, and employees of such 
Persons; any other Persons required to be registered with the 
Authority; and any other horse support personnel who are engaged in the 
care, treatment, training, or racing of Covered Horses.
    (b) Pursuant to section 3054 of the Act, Covered Persons must 
register with the Authority. However, they are bound by the Protocol by 
undertaking the activity (or activities) that make(s) them a Covered 
Person, whether or not they register with the Authority.
    (c) Owners. Covered Horses may be owned by a sole individual, 
multiple individuals, or one or more entities. As a consequence of the 
various ownership structures and property interests of Covered Horses, 
it is necessary to identify which Person shall be responsible as the 
Owner for purposes of registration, communication, personal liability, 
and other requirements under the Protocol and related rules. 
Accordingly:
    (1) For purposes of mandatory registration with the Authority, any 
Covered Person who owns a 5% or greater ownership or property interest 
in a Covered Horse shall register with the Authority as an Owner.
    (2) The following person shall be responsible as the Owner for any 
communication, notification, and reporting requirements under the 
Protocol:
    (i) if the Covered Horse is owned by one individual, that 
individual; or
    (ii) if the Covered Horse is owned by more than one individual or 
by a partnership, corporation, limited liability company, syndicate, or 
other association or entity, the individual designated in the 
Authority's database as the representative for the other owners of the 
Covered Horse authorized to receive communications or notifications and 
fulfill any reporting requirements on their behalf in respect of the 
Covered Horse (Designated Owner).
    (3) If Rule 3030 makes the Owner the Responsible Person for a 
Covered Horse, that shall mean that the following person is personally 
liable for violations involving that Covered Horse:
    (i) if the Covered Horse is owned by one individual, that 
individual; or
    (ii) if the Covered Horse is owned by more than one individual or 
by a partnership, corporation, limited liability company, syndicate, or 
other association or entity, the individual who manages the Covered 
Horse as a matter of fact (Managing Owner). If an individual owns more 
than a 50% stake in a Covered Horse or where the entity that owns the 
Covered Horse has designated an individual with an ownership interest 
in the Covered Horse as the individual who will be personally liable 
under the Protocol as the Owner of the Covered Horse, that individual 
will be presumed to be the Managing Owner. If an individual with an 
ownership or property interest in the Covered Horse who is not the 
Managing Owner makes a relevant decision about the Covered Horse that 
leads to a violation of the Protocol, that person shall be jointly and 
severally liable with the Managing Owner for such decision as an Owner 
of the Covered Horse.
    (4) Only the following persons may attend hearings under the 
Protocol as the Owner of the Covered Horse, unless otherwise agreed by 
the hearing panel:
    (i) if the Covered Horse is owned by one individual, that 
individual; or
    (ii) if the Covered Horse is owned by more than one individual or 
by a partnership, corporation, limited liability company, syndicate, or 
other association or entity, the Designated Owner or Managing Owner.
    (5) Unless the context requires otherwise, the individual owner or 
Managing Owner of the Covered Horse (as applicable) shall be 
responsible for discharging any other requirements imposed on an Owner 
under the Protocol or related rules.
Rule 3030. Responsible Persons
    (a) ``Responsible Person'' means the Trainer of the Covered Horse. 
If the Covered Horse does not have a Trainer, the Responsible Person 
shall be the Owner of the Covered Horse. The Responsible Person shall 
be personally liable for his or her Covered Horse(s) as set out under 
the Protocol. Other Covered Persons who make a relevant decision about 
the Covered Horse may also be liable depending on the facts and 
circumstances.
    (b) If a Covered Horse is claimed in a Claiming Race, the person 
designated as the Responsible Person prior to that Claiming Race shall 
be liable for any violation resulting from a Sample collected on Race 
Day. The person who claims the Covered Horse in the Claiming Race shall 
not be liable for such violation, unless he or she was complicit in the 
violation.
    (c) The Responsible Person shall register their designation as the 
Responsible Person for a Covered Horse with the Authority and shall 
keep such designation and registration up-to-date. Any transfer of the 
Responsible Person designation to another Covered Person shall be done 
with the Authority in accordance with its procedures prior to the 
effective date of the transfer, except that if a Covered Horse is 
claimed in a Claiming Race, the transfer shall be done on the day of 
the Claiming Race.
    (d) The Responsible Person for a Covered Horse shall be the sole 
representative for the interests of that Covered Horse in any matter 
arising under the Protocol. The Owner (if not the Responsible Person) 
may attend any hearing concerning a violation of the Protocol involving 
his or her Covered Horse(s) in accordance with the Arbitration 
Procedures.
Rule 3040. Core Responsibilities of Covered Persons
(a) Responsibilities of All Covered Persons
    It is the personal responsibility of each Covered Person:
    (1) to be knowledgeable of and to comply with the Protocol and 
related rules at all times. All Covered Persons shall be bound by the 
Protocol and related rules, and any revisions thereto, from the date 
they go into effect, without further formality. It is the 
responsibility of all Covered Persons to familiarize themselves with 
the most up-to-date version of the Protocol and related rules and all 
revisions thereto;
    (2) to cooperate promptly and completely with the Authority and the 
Agency in the exercise of their respective powers under the Act and the 
Protocol and related rules, including:
    (i) in relation to the Testing program and in relation to the 
investigation of potential violations of the Protocol;
    (ii) by providing complete and accurate information to the 
Authority and the Agency in all interactions and filings; and
    (iii) on request by the Agency:
    (A) making available for inspection any facility, office, stall, or 
equipment or other relevant location that is used in the care, 
treatment, training, or racing of Covered Horses, or any feed, 
medicine, or other item given to Covered Horses;
    (B) submitting to under-oath transcribed interviews about his or 
her dealings with or in relation to Covered Horses;
    (C) providing immediate and unfettered access to any and all data, 
documents, and records used in the care, treatment, training or racing 
of any Covered Horse (including, but not limited to, data, documents 
and records existing in electronic form, e.g., on computers, mobile 
phones, or other devices); and
    (D) permitting the Agency to review or make and take away copies of 
any such data, documents, or records for analysis, investigation, and 
potential

[[Page 5094]]

use as evidence of a violation of the Protocol by a Covered Person;

Failure to cooperate promptly and completely with the Agency may 
constitute a violation pursuant to Rule 3510(b); and
    (3) not to engage in offensive conduct towards any Sample 
Collection Personnel or any representative of the Agency or the 
Authority (including engaging in improper, insulting, or obstructive 
conduct, or recording any Sample Collection Session contrary to Rule 
5410). Failure to comply may constitute a violation pursuant to Rule 
3510(a) or Tampering or Attempted Tampering, depending on the 
circumstances of the case.
(b) Additional Responsibilities of Responsible Persons
    In addition to the duties under Rule 3040(a), it is the personal 
responsibility of each Responsible Person:
    (1) to ensure that Covered Horses for which he or she is the 
Responsible Person are made available for Sample collection at any time 
and any place where they are located (e.g., Racetrack, Training 
Facility, private facility) upon request by the Agency (or its 
delegate). In particular, without limiting the generality of the 
foregoing:
    (i) The Responsible Person shall ensure that the Covered Horse is 
produced for Sample collection immediately upon notification by a duly 
authorized person in accordance with the Agency's procedures if the 
Covered Horse is present at the location where notification is 
attempted. If the Covered Horse is present at the location where 
notification is attempted, failure to produce a Covered Horse 
immediately upon valid notification shall constitute an Anti-Doping 
Rule Violation under Rule 3215.
    (ii) If the Covered Horse is not present at the location where 
notification is attempted (including due to a Whereabouts Failure), the 
Responsible Person shall ensure that the Covered Horse is produced for 
Sample collection within 6 hours of notification by a duly authorized 
Person in accordance with the Agency's procedures, except that the 
Agency may extend the 6-hour period if it determines that extenuating 
circumstances justify doing so. If the Covered Horse is not present at 
the location where notification is attempted or if a Covered Horse 
cannot be located by the Agency, failure to produce a Covered Horse for 
Sample collection within 6 hours (or any extended period agreed by the 
Agency) of valid notification period shall constitute an Anti-Doping 
Rule Violation under Rule 3215.
    (2) to either be present during a Sample collection involving his 
or her Covered Horse and comply with all Sample collection procedure 
requirements, or (if not present) to ensure that a Nominated Person who 
is 18 years or older is present to represent him or her and complies 
with all Sample collection procedure requirements;
    (3) to ensure that treatments and medications administered to his 
or her Covered Horses:
    (i) are administered only on the advice of a Veterinarian or (if a 
prescription is not required) following sufficient due diligence 
regarding the treatment or medication;
    (ii) are not administered in a manner detrimental or contrary to 
horse welfare;
    (iii) are the minimum necessary to address the diagnosed health 
concerns identified during the veterinary examination and diagnostic 
process;
    (iv) do not contain a Banned Substance or involve a Banned Method; 
and
    (v) do not otherwise violate the Protocol;
    (4) to inform all Covered Persons (including Veterinarians), 
employees, personnel, agents, and other Persons involved in any way 
with the care, treatment, training, or racing of his or her Covered 
Horses of their respective obligations under the Protocol (including, 
in particular, those specified in Rule 3040(a));
    (5) to adequately supervise all Covered Persons (including 
Veterinarians), employees, personnel, agents, and other Persons 
involved in any way with the care, treatment, training, or racing of 
his or her Covered Horses, including by (without limitation):
    (i) conducting appropriate due diligence in the hiring process 
before engaging their services;
    (ii) clearly communicating to such Persons that compliance with the 
Protocol is a condition of employment or continuing engagement in the 
care, treatment, training, or racing of his or her Covered Horses;
    (iii) creating and maintaining systems to ensure that those Persons 
comply with the Protocol; and
    (iv) adequately monitoring and overseeing the services provided by 
those Persons in relation to the care, treatment, training, or racing 
of his or her Covered Horses;
    (6) to bear strict liability for any violations of the Protocol by 
such Covered Persons (including Veterinarians), employees, personnel, 
agents, and other Persons involved in the care, treatment, training, or 
racing of his or her Covered Horses;
    (7) to file and update as necessary with the Authority information 
identifying what Covered Horses he or she is the Responsible Person 
for;
    (8) to maintain accurate, complete, and up-to-date treatment 
records (including, without limitation, records of medical, 
therapeutic, and surgical treatments and procedures, including 
diagnostics) of his or her Covered Horses in an electronic or other 
form specified by the Agency, and to provide the Agency with access to 
those records upon request and without delay so that it may inspect and 
make and retain copies of them for purposes of monitoring and ensuring 
compliance with the requirements of the Protocol. The records must 
include the details required under Rule 2251(b). The Responsible Person 
must retain copies of such treatment records for a period of no less 
than 3 years, although the Responsible Person is advised to retain them 
for the duration of the limitation periods under Rule 3090;
    (9) at the time of registering a horse with the Authority and prior 
to such horse competing in any Timed and Reported Workout or Covered 
Horserace, the Responsible Person shall declare in writing to the 
Agency all administrations of Banned Substances and Banned Methods to 
the horse since the Responsible Person first owned the horse (or, if 
not the Owner, since the Owner at the time of registration first owned 
the horse) or since the Program Effective date, whichever is earlier. 
On request by the Agency, the Responsible Person shall provide any 
related treatment records for the horse during that period. If a Banned 
Substance or Banned Method has been administered in that period, the 
Agency may impose a stand down period for the horse of up to the period 
of Ineligibility that would be applicable for the relevant Banned 
Substance or Banned Method and require that (at the Responsible 
Person's cost) the Covered Horse provide one or more negative Samples 
before subsequently being eligible to participate in a Timed and 
Reported Workout or a Covered Horserace. Failure by a Responsible 
Person to comply with this Rule 3040(b)(9) may constitute a violation 
of Rule 3510(b);
    (10) if any Covered Horse is moved from a Racetrack or Training 
Facility to a private facility (i.e., a facility not under the 
jurisdiction of the Authority or the Agency), the Responsible Person 
shall provide sufficient information about the Covered Horse's 
whereabouts so that the Agency remains able to collect Samples from the 
Covered Horse

[[Page 5095]]

at any time. The Responsible Person shall also provide any further 
information about the whereabouts of a Covered Horse that is 
specifically requested by the Agency. Failure to do so may constitute a 
violation of Rule 3510(d);
    (11) to notify the Authority in writing within 7 days of becoming 
aware that any of his or her Covered Horses:
    (i) is pregnant;
    (ii) was pregnant but has foaled or is no longer pregnant;
    (iii) has been castrated or hemicastrated (including chemical 
castration or immunocastration); or
    (iv) has suffered a fatal condition.

In each case, the Responsible Person shall state the name of the 
Covered Horse, the date of the event triggering the notice, and (for 
paragraph (iv) above) a summary explanation regarding the cause of the 
fatal condition.
(c) Additional Responsibilities of Owners
    In addition to the duties under Rule 3040(a):
    (1) each person with a 5% percent or greater ownership or property 
interest in a Covered Horse shall register with the Authority as an 
Owner of the Covered Horse, and ensure that any transfer of ownership 
is registered with the Authority in accordance with its procedures; and
    (2) if a Covered Horse is owned by multiple Owners, they shall 
ensure that the Agency is notified in writing of one Designated Owner 
authorized to receive communications and notifications and fulfil any 
reporting requirements on their behalf.
(d) Additional Responsibilities of Attending Veterinarians
    In addition to the duties under Rule 3040(a), and the further 
duties and requirements imposed under the Rule 2000 Series (Racetrack 
Safety Program), it is the personal responsibility of each Attending 
Veterinarian to act in strict compliance with the Protocol and keep 
updated treatment records (including, without limitation, records of 
medical, therapeutic, and surgical treatments and procedures, including 
diagnostics) in an electronic database designated by the Agency or in 
any other form designated by the Agency and provide access to the 
Agency upon request and without delay to or copies of such treatment 
records. The records must include the details required under Rule 
2251(b) and must be submitted in an electronic format designated by the 
Authority within the deadline specified in that same provision. 
Attending Veterinarians must retain copies of such treatment records 
for a period of no less than 3 years, or for the retention period 
required by the relevant state veterinary practice act, whichever is 
longer.
Rule 3050. Retirement and Equine Fatalities
    (a) Covered Persons.
    (1) Each Responsible Person who wishes to no longer be bound by the 
Protocol shall give written notice to the Authority of his or her 
retirement from the position that made him or her a Responsible Person. 
In each case, the Responsible Person shall be deemed to have retired 
(and to be no longer subject to the Protocol) on the later of (i) the 
date given in the written notice of retirement and (ii) the date the 
notice is received.
    (2) Any other Covered Person will continue to be bound by and 
required to comply with the Protocol and related rules unless and until 
he or she unregisters with the Authority.
    (3) If a Covered Person ceases to be subject to the Protocol while 
the Agency is conducting a Results Management process in respect of 
that person, the Agency retains jurisdiction to complete its Results 
Management process. If a Covered Person retires or ceases to be subject 
to the Protocol before any Results Management process has begun, and 
the Agency had jurisdiction over the Covered Person at the time the 
Anti-Doping Rule Violation or Controlled Medication Rule Violation was 
committed, the Agency retains jurisdiction to conduct Results 
Management in respect of that violation.
    (4) If a Covered Person retires while subject to a period of 
Ineligibility, he or she must give written notice of such retirement to 
the Authority. The Covered Person may not return to the sport (i.e., 
carry out any of the activities prohibited during the period of 
Ineligibility pursuant to Rules 3229 and 3329) unless the Covered 
Person has given 4 months' prior written notice (or notice equivalent 
to the period of Ineligibility remaining as of the date the Covered 
Person retired, if that period was longer than 4 months) to the 
Authority of his or her intent to return to the sport.
    (5) The Agency may forward notifications of retirement of Covered 
Persons to Interested Parties or other Persons with a need to know.
    (b) Covered Horses.
    (1) If an Owner wishes to retire a Covered Horse such that it is no 
longer made available for Testing, the Owner must provide written 
notice of such retirement to the Agency, in accordance with its 
procedures.
    (2) A Covered Horse that has been retired in accordance with the 
previous clause may not participate in a Timed and Reported Workout or 
be entered in a Covered Horserace until the Covered Horse has been made 
available for Testing at least 4 months prior to notice being given to 
the Agency (in accordance with its procedures) of the intention to 
unretire the Covered Horse.
    (3) If a Covered Horse is retired from horseracing or suffers a 
fatal condition while the Agency is conducting a Results Management 
process in respect of it, the Agency retains jurisdiction to complete 
its Results Management process. If a Covered Horse is retired or 
suffers a fatal condition before any Results Management process has 
begun, and the Agency had jurisdiction over the Covered Horse at the 
time the Anti-Doping Rule Violation or Controlled Medication Rule 
Violation was committed, the Agency retains jurisdiction to conduct 
Results Management in respect of that violation. If a Covered Horse 
suffers a fatal condition, the Agency retains Testing authority over 
that horse in accordance with Rule 3132(d).
    (4) If a Covered Horse is retired from horseracing while subject to 
a period of Ineligibility, the Owner must notify the Agency in writing 
of such retirement. If the Owner wishes that horse to return to 
participation in Covered Horseraces or Timed and Reported Workouts, the 
Owner must first provide the Agency with written notice and make the 
Covered Horse available for Testing for at least 4 months prior to such 
participation or for the remainder of the Covered Horse's period of 
Ineligibility, whichever is longer.
    (5) In order to manage the number of Covered Horses registered with 
the Authority, the Agency may retire a Covered Horse based on 
inactivity (i.e., where the Covered Horse does not participate in a 
Timed and Reported Workout or Covered Horserace for 18 months or more, 
excluding periods of inactivity due to a Provisional Suspension or 
period of Ineligibility) by sending written notice thereof to the 
Authority and the Owner in accordance with the Agency's procedures. If 
the Owner disputes that retirement, while the dispute is pending the 
Covered Horse may not participate in any Timed and Reported Workout or 
Covered Horserace but must be made available for Testing. Upon 
resolution of the dispute, the Authority will notify the Agency whether 
the horse is retired and, therefore, no longer subject to Testing. If 
the Owner wishes to return the Covered Horse to participation in Timed 
and Reported Workouts or Covered

[[Page 5096]]

Horseraces, the Owner must first provide the Agency with written notice 
and make the Covered Horse available for Testing for at least 4 months 
prior to such participation.
    (6) The Agency may reduce the 4-month notice period in Rule 3050(b) 
to 2 months where the Owner of the Covered Horse submits an application 
establishing good cause to do so, and where the Agency approves such 
application based on a review conducted in accordance with the 
objectives of the Protocol.
    (7) The Agency may forward notifications of retirement of Covered 
Horses to Interested Parties or other Persons with a need to know.
Rule 3060. Claiming Races and Voidable Claims
    (a) Subject to Rule 3132(b), a claimed horse may be subject to 
Sample collection at a Claiming Race if requested (and paid for) by the 
claimant as part of the claiming procedure on the day of the Claim. If 
a Sample collected from the claimed horse results in an Anti-Doping 
Rule Violation or Controlled Medication Rule Violation, the Claim may 
be voided at the option of the claimant, and the claimant shall be 
entitled to the return from the seller of all sums paid for the claimed 
horse and of all reasonable expenses incurred after the date of the 
Claim. While awaiting test results, a claimant shall: (i) exercise due 
care in maintaining and boarding a claimed horse; and (ii) not 
materially alter a claimed horse.
    (b) Any voided claim shall be recorded in Equibase.
Rule 3070. Amendment and Interpretation of the Protocol
    (a) The Authority may amend the Protocol from time to time, as 
necessary to ensure that it remains fit for purpose, in accordance with 
section 3057(e) of the Act. Unless provided otherwise, any amendments 
will come into force on the date specified or (if no date is specified) 
on the date the amendment is approved by the Commission.
    (b) Subject to Rule 3070(d), the Protocol shall be interpreted as 
an independent and autonomous text and not by reference to existing law 
or statutes.
    (c) The Protocol has been adopted pursuant to the Act and shall be 
interpreted, where applicable, in a manner that is consistent with 
applicable provisions of the Act and the other rules in Rule 1000-9000 
Series. In the event of any conflict between the Act and the Protocol, 
the Act shall prevail. In the event of any conflict between the 
Protocol and any other rules in Rule 1000-9000 Series, the Protocol 
shall prevail.
    (d) The World Anti-Doping Code and related International Standards, 
procedures, documents, and practices (WADA Code Program), the comments 
annotating provisions of the WADA Code Program, and any case law 
interpreting or applying any provisions, comments, or other aspects of 
the WADA Code Program, may be considered when adjudicating cases 
relating to the Protocol, where appropriate.
Rule 3080. Transitional Provisions
    (a) The Protocol shall not apply retroactively to matters pending 
before the Program Effective Date.
    (b) A presence violation under Rule 3212 or Rule 3312 that occurs 
after the Program Effective Date as a result of Use or Administration 
prior to the Program Effective Date shall not constitute a violation of 
the Protocol.
    (c) The relevant State Racing Commission retains authority 
(including results management) in relation to any anti-doping or 
controlled medication matters taking place prior to the Program 
Effective Date.
    (d) Changes to substances or methods covered by the Prohibited List 
or related Technical Document--Prohibited Substances shall not, unless 
they specifically provide otherwise, be applied retroactively. However, 
a Responsible Person or other Covered Person who is serving a period of 
Ineligibility on account of a Prohibited Substance or Prohibited Method 
that is later subject to a change in status (either because it is no 
longer prohibited or subject to lesser sanctions) may apply to the 
Agency for consideration of a reduction in the period of Ineligibility 
in light of that change in status. The Responsible Person may also 
apply to the Agency for consideration of a reduction in the period of 
Ineligibility applicable to his or her Covered Horse(s).
Rule 3090. Statute of Limitations
    (a) No charge may be brought against a Covered Person or in 
relation to a Covered Horse in respect of an Anti-Doping Rule Violation 
unless the Covered Person or Responsible Person for the Covered Horse 
has been given notice, or notification has been reasonably attempted, 
within 10 years of the date the Anti-Doping Rule Violation is asserted 
to have occurred. Any violation of Rule 3229 is also subject to a 10-
year limitation period.
    (b) No charge may be brought against a Covered Person or in 
relation to a Covered Horse in respect of a Controlled Medication Rule 
Violation unless the Covered Person or Responsible Person for the 
Covered Horse has been given notice, or notification has been 
reasonably attempted, within 2 years of the date the Controlled 
Medication Rule Violation is asserted to have occurred. Any violation 
of Rule 3329 is also subject to a 2-year limitation period.
    (c) Any violation of Rule 3510 is subject to a 4-year limitation 
period.

3110. The Prohibited List

Rule 3111. Prohibited Substances and Prohibited Methods
    (a) The Prohibited List identifies Prohibited Substances and 
Prohibited Methods that are:
    (1) prohibited at all times (Banned Substances and Banned Methods) 
on the basis of the Agency's determination that medical, veterinary, or 
other scientific evidence or experience supports their actual or 
potential (i) ability to enhance the performance of Covered Horses, 
(ii) masking properties, or (iii) detrimental impact on horse welfare; 
or
    (2) prohibited for Use or Administration in relation to a Covered 
Horse during the Race Period and prohibited to be present in a Post-
Race Sample or Post-Work Sample, except as otherwise specified in the 
Prohibited List (Controlled Medication Substances and Controlled 
Medication Methods).
    (b) Prohibited Substances and Prohibited Methods may be included in 
the Prohibited List by general category (e.g., anabolic steroids) or by 
specific reference to a particular substance or method.
    (c) The Prohibited List is supplemented by the ``Technical 
Document--Prohibited Substances,'' which provides guidance on the 
Prohibited Substances that fall into the general categories listed in 
the Prohibited List and on Screening Limits, Thresholds, or Detection 
Times for those Prohibited Substances (as applicable), and also 
designates certain Prohibited Substances as Specified Substances, which 
are those that pose a higher risk of being the result of contamination 
and, therefore, are subject to more flexible sanctions.
    (d) Certain Prohibited Substances may first be reported as Atypical 
Findings requiring further investigation before being declared as 
Adverse Analytical Findings, in accordance with the Atypical Findings 
Policy set out at Appendix 1 to the Protocol.
Rule 3112. Review and Publication of the Prohibited List and Related 
Technical Documents
    The Agency will publish the Prohibited List on its website at least

[[Page 5097]]

annually, following an opportunity for stakeholder comment. The Agency 
will review and consider such stakeholder comment and will provide 
recommended revisions to the Authority. Each new version of the 
Prohibited List will also be sent to the State Racing Commissions.
    The Authority (on recommendation of the ADMC, in consultation with 
the Agency) may revise the Prohibited List from time to time, subject 
to approval by the Commission. Revisions to the Prohibited List will go 
into effect on the date specified in the revised Prohibited List (which 
will not be any earlier than 90 days following its publication). The 
Agency will also publish any Technical Documents supplementing the 
Prohibited List (including the Technical Document--Prohibited 
Substances) on its website at least annually, following an opportunity 
for public comment. Any revisions to such Technical Documents will go 
into effect on the date specified in the revised Technical Document.
    All Covered Persons shall be bound by the Prohibited List and 
related Technical Documents (including the Technical Document--
Prohibited Substances), and any revisions thereto, from the date they 
go into effect, without further formality. It is the responsibility of 
all Covered Persons to familiarize themselves with the most up-to-date 
version of the Prohibited List and related Technical Documents 
(including the Technical Document--Prohibited Substances) and all 
revisions thereto.
Rule 3113. Validity of the Prohibited List and Related Technical 
Documents
    The following decisions are final and shall not be subject to any 
challenge by any Covered Person or other Person on any basis, including 
any challenge based on an argument that the substance or method is not 
a masking agent or does not have the potential to enhance the 
performance of Covered Horses or have a detrimental impact on horse 
welfare:
    (a) the Authority's determination of the Prohibited Substances and 
Prohibited Methods included on the Prohibited List or Technical 
Document--Prohibited Substances;
    (b) the approval of the Prohibited List or Technical Document--
Prohibited Substances by the Commission or the Authority;
    (c) the classification of substances and methods into categories or 
classes on the Prohibited List or Technical Document--Prohibited 
Substances;
    (d) the classification of a substance or method as a Banned 
Substance or Banned Method as opposed to a Controlled Medication 
Substance or Controlled Medication Method;
    (e) the periods during which Prohibited Substances or Prohibited 
Methods are prohibited; and
    (f) the classification of Prohibited Substances as either Specified 
Substances or non-Specified Substances.
Rule 3114. Monitoring Program
    The Agency may approve a monitoring program regarding substances 
that are not on the Prohibited List or Technical Document--Prohibited 
Substances, if the Agency wishes to research or monitor such 
substances, including to identify potential patterns of misuse in 
horseracing. Laboratories will report the instances of reported Use or 
detected presence of monitored substances to the Agency, but the 
results of any such analyses shall not constitute an Anti-Doping Rule 
Violation or Controlled Medication Rule Violation. Nothing in this Rule 
3114 or elsewhere in the Protocol prevents a Laboratory from sharing 
information with the Agency for any anti-doping or controlled 
medication purpose or other purpose authorized by the Act. The list of 
substances in the monitoring program will be reviewed annually by the 
Agency.

3120. Proof of Violations

Rule 3121. Burden and Standard of Proof
    (a) The Agency shall have the burden of establishing that a 
violation of the Protocol has occurred to the comfortable satisfaction 
of the hearing panel, bearing in mind the seriousness of the allegation 
that is made. This standard of proof in all cases is greater than a 
mere balance of probability (i.e., a preponderance of the evidence) but 
less than clear and convincing evidence or proof beyond a reasonable 
doubt.
    (b) Where the Protocol places the burden of proof on a Covered 
Person to rebut a presumption or to establish specified facts or 
circumstances, the standard of proof shall be by a balance of 
probability (i.e., a preponderance of the evidence), except as provided 
in Rules 3122(c) and 3122(d).
Rule 3122. Methods of Establishing Facts and Presumptions
    Facts related to violations may be established by any reliable 
means, including admissions. The following rules of proof shall apply:
    (a) Analytical methods, Minimum Reporting Levels, Thresholds, 
Screening Limits, Decision Limits, and any other Laboratory reporting 
requirements approved by the Commission are presumed to be 
scientifically valid.
    (b) Compliance with the Standards (as opposed to an alternative 
standard, practice, or procedure) will be sufficient to conclude that 
the procedures addressed by those Standards were performed properly.
    (c) Laboratories are presumed to have conducted Sample analysis and 
custodial procedures in accordance with the Laboratory Standards. A 
Covered Person who is alleged to have committed a violation may rebut 
this presumption by establishing that a departure from the Laboratory 
Standards occurred that could reasonably have caused the Adverse 
Analytical Finding or other factual basis for any other violation 
asserted. Where the presumption is rebutted, the Agency shall have the 
burden of establishing that such departure did not cause the Adverse 
Analytical Finding or other factual basis for the violation asserted.
    (d) Departures from any other Standards or any provisions of the 
Protocol shall not invalidate analytical results or other evidence of a 
violation, and shall not constitute a defense to a charge of such 
violation; provided, however, that if the Covered Person establishes 
that a departure from any other Standards or any provisions of the 
Protocol could reasonably have caused the Adverse Analytical Finding or 
other factual basis for the violation charged, the Agency shall have 
the burden to establish that such departure did not cause the Adverse 
Analytical Finding or other factual basis for the violation.
    (e) Non-appealable and final factual findings of a court, arbitral 
tribunal, professional disciplinary body, or administrative body of 
competent jurisdiction shall be irrebuttable evidence against the 
Covered Person to whom the decision pertained of those facts, unless 
the Covered Person establishes that the decision did not respect due 
process.
    (f) A hearing panel may draw an inference adverse to a Covered 
Person who is asserted to have committed a violation of the Protocol 
based on the Covered Person's refusal to cooperate with the Agency, 
including any refusal to respond to questions put to him or her as part 
of an investigation or to appear at the hearing (either in person or 
remotely) and to answer questions put by the Agency or the hearing 
panel.

[[Page 5098]]

3130. Testing and Investigations

Rule 3131. Purpose of Testing and Investigations
    Testing and investigations may be undertaken to assist in the 
effective policing and enforcement of the Protocol, including to obtain 
evidence regarding potential violations of the Protocol.
Rule 3132. Authority To Test
    (a) Only the Agency (and those authorized by the Agency) may 
initiate and direct Testing on Covered Horses. The Agency has authority 
to conduct Testing both in and out of competition.
    (b) No other entity (including State Racing Commissions, 
Racetracks, Race Organizers, and Training Facilities) may initiate or 
direct any Testing on Covered Horses. However, a State Racing 
Commission, Racetrack, Race Organizer, or other third party may request 
that the Agency initiate and direct enhanced or additional Testing 
(e.g., in relation to a particular Covered Horserace). The Agency may 
accept or decline such request at its absolute discretion. Where the 
Agency accepts the request, the costs of Sample collection and analysis 
shall be borne by the entity requesting the additional or enhanced 
Testing. The Agency may conduct the Testing itself or delegate Testing 
(or aspects thereof) to the relevant State Racing Commission, subject 
to the applicable State Racing Commission electing to enter into an 
agreement with the Agency.
    (c) Covered Horses may be subject to Testing at any time and any 
place where they are located by or on behalf of the Agency.
    (d) A Covered Horse that is subject to a Provisional Suspension or 
period of Ineligibility, or that sustains a fatal condition, remains 
subject to Testing.
    (e) In accordance with the Racetrack Safety Program, a Covered 
Horse may be required to submit to Sample collection (at the Owner's 
cost) following a Vets' List Workout in order to be released from the 
Veterinarians' List. Any Sample collected following a Vets' List 
Workout constitutes a Post-Race Sample, and, as a result, is subject to 
all of the same requirements that apply to Sample collection at Covered 
Horseraces. To schedule a Vets' List Workout, the Responsible Person or 
the Owner of the Covered Horse shall make a request to a Regulatory 
Veterinarian who shall, in turn, notify the Agency in order to make any 
necessary arrangements. The Agency must be given a minimum of 48 hours' 
notice of any Vets' List Workout.
Rule 3133. Requirements
    (a) Testing. The Agency shall conduct test distribution planning 
and Testing in accordance with the Testing and Investigations 
Standards. The Agency may delegate authority to third parties, 
including State Racing Commissions (see Rule 3132), to conduct Testing 
(or aspects thereof) in accordance with the Testing and Investigations 
Standards under its supervision.
    (b) Investigations and intelligence gathering. The Agency shall 
gather intelligence and conduct investigations, or delegate to third 
parties to do so under its supervision, in accordance with the Testing 
and Investigations Standards, which incorporate uniform rules and 
procedures in accordance with section 3054 of the Act providing for:
    (1) access for the Agency to books, records, offices, racetrack 
facilities, and other places of business of Covered Persons that are 
used in the care, treatment, training, or racing of Covered Horses;
    (2) the issuance and enforcement of subpoenas and subpoenas duces 
tecum by the Authority at the request of the Agency;
    (3) the exercise of other investigatory powers similar in nature 
and scope to those exercised by State Racing Commissions before the 
Program Effective Date; and
    (4) the coordination and sharing of intelligence and information 
with the Authority, law enforcement (authorized by any government, 
including Federal, State, or international), State Racing Commissions, 
Racetracks, Race Organizers, Training Facilities, Laboratories, anti-
doping organizations, equine regulatory bodies, or other relevant 
regulatory or disciplinary authorities.
Rule 3134. Sample Analysis
    Samples shall be analyzed in accordance with the principles set 
forth in Rules 3135 through 3139.
Rule 3135. Ownership of Samples
    Samples collected under the Protocol are the property of the 
Authority, and the Authority is entitled (subject to Rule 3138(b)) to 
determine all matters regarding access to and the analysis and disposal 
of such Samples.
Rule 3136. Use of Approved Laboratories and Other Laboratories
    (a) The Agency will publish a list of approved Laboratories, which 
may be revised from time to time.
    (b) Subject to paragraph (d) below, Samples collected by or on 
behalf of the Agency pursuant to the Protocol will be analyzed by 
approved Laboratories. Only approved Laboratories may declare an 
Adverse Analytical Finding.
    (c) Selection of Laboratories
    (1) Subject to paragraph (2) below, a State Racing Commission may 
select a Laboratory to analyze A Samples or TCO2 Samples collected in 
its State. If a State Racing Commission does not select a Laboratory, 
the selection of the Laboratory to analyze such Samples shall be 
determined exclusively by the Agency.
    (2) The Agency shall have the authority to require specific Samples 
to be directed to and analyzed by Laboratories having special expertise 
in the required analysis.
    (3) The selection of the Laboratory for any B Sample analysis shall 
be determined exclusively by the Agency. The B Sample analysis (if 
applicable) will be performed in a different Laboratory from the A 
Sample analysis, except if provided otherwise in the Laboratory 
Standards.
    (d) In accordance with Rule 3122, facts related to violations of 
the Protocol may be established by any reliable means. This would 
include, for example, laboratory analysis or other forensic testing 
conducted reliably outside of Agency-approved laboratories.
Rule 3137. Purpose of Sample Analysis
    (a) General. Samples, related analytical data, Doping Control 
information, and Medication Control information shall be analyzed (1) 
to detect the presence of Prohibited Substances and Prohibited Methods 
identified on the Prohibited List (or Technical Document--Prohibited 
Substances) and other substances as may be directed pursuant to Rule 
3114, (2) to assist the Agency in profiling relevant parameters in a 
Covered Horse's urine, blood, hair, or other matrix, including for DNA 
or genomic profiling, or (3) for any other legitimate purpose.
    (b) Research on Samples and Data. Samples, related analytical data, 
Doping Control information, and Medication Control information may be 
used for anti-doping or medication control research purposes. However, 
the results of any analyses performed for such research purposes may 
not be used as the basis for pursuing an Anti-Doping Rule Violation or 
Controlled Medication Rule Violation.
Rule 3138. Standards for Sample Analysis and Reporting
    (a) General. Laboratories may not accept or analyze any Samples 
from Covered Horses that were not collected

[[Page 5099]]

by or on behalf of the Agency or otherwise authorized by the Agency. 
Laboratories shall analyze Samples and report results in accordance 
with the Laboratory Standards. The results of all Sample analyses must 
be sent exclusively to the Agency via secure transmission in a form 
designated by the Agency. All communications must be conducted in such 
a way that the results of the Sample analyses are kept confidential.
    (b) Further Analysis of a Sample prior to or during Results 
Management. Further Analyses may be conducted, without limitation, on a 
Sample prior to the time that it is reported as negative or prior to 
the time that the Agency notifies a Covered Person that the Sample is 
the basis for an Anti-Doping Rule Violation or Controlled Medication 
Rule Violation. If the Agency notifies a Covered Person that the Sample 
is the basis for an Anti-Doping Rule Violation or Controlled Medication 
Rule Violation, and the Agency wishes to conduct Further Analyses on 
that Sample after such notification, it may do so only with the consent 
of the Covered Person or the approval of the hearing panel adjudicating 
the case against the Covered Person.
    (c) Further Analysis of a Sample after it has been reported as 
negative or has otherwise not resulted in an Anti-Doping Rule Violation 
or Controlled Medication Rule Violation. A Sample that has been 
reported as negative or has otherwise not resulted in a charge may be 
stored and subjected to Further Analyses for the purpose described in 
Rule 3137 at any time exclusively at the direction of the Agency. Any 
Sample storage and Further Analysis initiated by the Agency shall be at 
the Agency's expense. Further Analysis of Samples shall be conducted in 
accordance with the Laboratory Standards.
    (d) Split of A or B Sample. Where, in exceptional circumstances, 
the Laboratory (on instruction from the Agency) is required to further 
split an A or B Sample for the purpose of using the first part of the 
resulting split Sample for an A Sample analysis and the second part of 
the resulting split Sample for B confirmation, the procedures and 
analysis shall be conducted in accordance with the Laboratory 
Standards.
Rule 3139. The Agency's Right To Take Possession of Samples and Related 
Data
    The Agency may at any time, with or without prior notice, take 
physical possession of any Sample collected by or on behalf of the 
Agency and any related analytical data or information in the possession 
of a Laboratory. Upon request by the Agency, the Laboratory in 
possession of the Sample or related data shall grant access to and 
enable the Agency to take physical possession of the Sample or data as 
soon as possible.
Rule 3140. Clearance Testing
    Clearance testing for a Covered Horse at the request of a Covered 
Person (i.e., testing to determine if Controlled Medications Substances 
have cleared the horse's system) may be performed by a Laboratory only 
if in advance of such testing (1) the Agency approves such request 
(which approval may be subject to conditions determined by the Agency), 
and (2) the Covered Person pays for all of the costs of Sample 
collection and analysis. The Agency may pursue any violation of the 
Protocol that is evidenced by the results of the clearance testing.

3210. Anti-Doping Rule Violations

Rule 3211. Definition of Anti-Doping Rule Violation and Responsibility 
for Violations
    (a) Doping cases will be initiated based on the assertion that one 
or more of Rules 3212 through 3216 has been violated (each, an Anti-
Doping Rule Violation).
    (b) The Anti-Doping Rule Violations described below may only be 
committed by Covered Persons, but the Consequences for Anti-Doping Rule 
Violations may apply to both the Covered Person(s) who commit(s) the 
violation and any Covered Horse(s) implicated by the violation.
    (c) All Covered Persons are responsible for knowing what 
constitutes an Anti-Doping Rule Violation and what Banned Substances 
and what Banned Methods are included on the Prohibited List and 
Technical Document--Prohibited Substances.
Rule 3212. Presence of a Banned Substance
    (a) It is the personal and non-delegable duty of the Responsible 
Person to ensure that no Banned Substance is present in the body of his 
or her Covered Horse(s). The Responsible Person is therefore strictly 
liable for any Banned Substance or its Metabolites or Markers found to 
be present in a Sample collected from his or her Covered Horse(s). 
Accordingly, it is not necessary to demonstrate intent, Fault, 
negligence, or knowing Use on the part of the Responsible Person in 
order to establish that the Responsible Person has committed a Rule 
3212 Anti-Doping Rule Violation.
    (b) Sufficient proof of a Rule 3212 Anti-Doping Rule Violation is 
established by any of the following:
    (1) the presence of a Banned Substance or its Metabolites or 
Markers in the Covered Horse's A Sample where the Responsible Person 
waives analysis of the B Sample and the B Sample is not analyzed;
    (2) the Covered Horse's B Sample is analyzed and the analysis of 
the B Sample confirms the presence of the Banned Substance or its 
Metabolites or Markers found in the A Sample; or
    (3) where, in exceptional circumstances, the Laboratory (on 
instruction from the Agency) further splits the A or B Sample into two 
parts in accordance with the Laboratory Standards, the analysis of the 
second part of the resulting split Sample confirms the presence of the 
same Banned Substance or its Metabolites or Markers as were found in 
the first part of the split Sample, or the Responsible Person waives 
analysis of the second part of the split Sample.
    (c) The general rule is that the presence of any amount of a Banned 
Substance or its Metabolites or Markers in a Sample collected from a 
Covered Horse constitutes an Anti-Doping Rule Violation by the 
Responsible Person of that Covered Horse.
    (d) As an exception to the general rule of Rule 3212(c), the 
Prohibited List, Standards, or Technical Documents may establish 
special criteria for the reporting or the evaluation of certain Banned 
Substances, including a Minimum Reporting Level, Screening Limit, 
Threshold, or Decision Limit.
Rule 3213. Use or Attempted Use of a Banned Substance or a Banned 
Method
    (a) Subject to Rule 3213(c), the Use or Attempted Use of a Banned 
Substance or Banned Method in relation to a Covered Horse constitutes 
an Anti-Doping Rule Violation. The success or failure of that Use or 
Attempted Use is not material. For a Rule 3213 violation to be 
committed, it is sufficient that the Banned Substance or Banned Method 
was Used or Attempted to be Used.
    (b) It is the personal and non-delegable duty of the Responsible 
Person to ensure that no Banned Substance or Banned Method is Used in 
relation to his or her Covered Horse. The Responsible Person is 
therefore strictly liable for any Use of a Banned Substance or Banned 
Method in relation to his or her Covered Horse(s). Accordingly, it is 
not necessary to demonstrate intent, Fault, negligence, or knowing Use 
on the part of the Responsible Person in order to establish that the 
Responsible Person has committed a Rule 3213 Anti-Doping Rule Violation 
of Use. However, in accordance with the definition of

[[Page 5100]]

Attempt, it is necessary to show intent on the part of the Responsible 
Person in order to establish that the Responsible Person has committed 
a Rule 3213 Anti-Doping Rule Violation of Attempted Use.
    (c) The presence of a Prohibited Substance or of evidence of Use of 
a Prohibited Method in the Covered Horse's Sample or other evidence of 
Use of such Prohibited Substance or Prohibited Method shall not be 
considered an Anti-Doping Rule Violation if it is determined to have 
resulted from Use of the Banned Substance or Banned Method prior to the 
horse becoming a Covered Horse. However, any such Use is subject to 
Rule 3040(b)(9) and may be reported to the relevant State Racing 
Commission.
Rule 3214. Other Anti-Doping Rule Violations Involving Banned 
Substances or Banned Methods
    The following acts and omissions constitute Anti-Doping Rule 
Violations by the Covered Person(s) in question:
    (a) Possession of a Banned Substance or a Banned Method, unless 
there is compelling justification for such Possession.
    (b) Trafficking or Attempted Trafficking in any Banned Substance or 
Banned Method.
    (c) Administration or Attempted Administration to a Covered Horse 
of any Banned Substance or any Banned Method.
Rule 3215. Evading Collection of a Sample From a Covered Horse; 
Refusing or Failing Without Compelling Justification To Submit a 
Covered Horse to Sample Collection; or Refusing or Failing To Comply 
With All Sample Collection Procedure Requirements
    (a) Except as provided in Rule 3215(d), each of the following 
constitutes an Anti-Doping Rule Violation: (1) evading collection of a 
Sample from a Covered Horse, (2) refusing or failing without compelling 
justification to submit a Covered Horse to Sample collection after 
notification by a duly authorized person, or (3) refusing or failing to 
comply with all Sample collection procedure requirements.
    (b) Responsible Persons are responsible for ensuring compliance 
with Rules 3040(b)(1) and 3040(b)(2). A Responsible Person may delegate 
the submission and supervision of the Covered Horse to a third party, 
but the Responsible Person remains responsible for the Covered Horse 
throughout the Sample collection process and for the acts and omissions 
of his or her delegate. Therefore, the Responsible Person shall be 
deemed liable for any evasion by his or her delegate of Sample 
collection, any refusal or failure by his or her delegate without 
compelling justification to submit the Covered Horse to Sample 
collection, or any refusal or failure by his or her delegate to comply 
with all Sample collection procedure requirements.
    (c) Sample collection shall ordinarily be conducted where the 
Covered Horse is located (e.g., Racetrack, Training Facility, or 
private facility), unless the Agency agrees that the Covered Horse may 
be transported to another agreed location (e.g., a nearby Racetrack).
    (d) No violation occurs where a Covered Horse is made available for 
Sample collection, but a Sample is not collected because the Covered 
Horse is intractable.
Rule 3216. Other Anti-Doping Rule Violations
    The following acts and omissions constitute Anti-Doping Rule 
Violations by the Covered Person(s) in question:
    (a) Tampering or Attempted Tampering by a Covered Person with any 
part of Doping Control or Medication Control;
    (b) a Covered Person assisting, encouraging, aiding, abetting, 
conspiring, covering up, or engaging in any other type of intentional 
complicity or Attempted complicity involving (1) an Anti-Doping Rule 
Violation or Attempted Anti-Doping Rule Violation, or (2) a violation 
of Rule 3229 by another Covered Person.
    (c) Prohibited Association:
    (1) Association by a Covered Person in a professional or sport-
related capacity with any Person who:
    (i) is serving a period of Ineligibility imposed pursuant to the 
Protocol or is serving a period of ineligibility imposed pursuant to 
anti-doping rules administered by any other equine regulatory body or 
anti-doping organization; or
    (ii) has been found in a criminal, disciplinary, or professional 
proceeding to have engaged in conduct that would have constituted a 
violation of the Protocol if it had been applicable to such Person at 
the relevant time. The disqualifying status of such Person shall last 
for the longer of:
    (A) 6 years from the criminal, professional, or disciplinary 
decision; and (B) the duration of the criminal, disciplinary, or 
professional sanction imposed; or
    (iii) is serving as a front or intermediary for an individual 
falling within paragraph (i) or (ii) above.
    (2) To establish a violation of Rule 3216(c), the Agency must 
establish that the Covered Person knew at the relevant time of the 
Person's disqualifying status. It is presumed that any association with 
the Person described in Rules 3216(c)(1)(i) and (ii) is in a 
professional or sport-related capacity, and the burden shall be on the 
Covered Person to rebut that presumption.
    (3) It shall be a defense to a charge of violation of Rule 3216 if 
the Covered Person establishes that the association with the Person 
could not have been reasonably avoided.
    (d) Acts by a Covered Person to discourage or retaliate against 
reporting to authorities.
    (1) Where such conduct does not otherwise constitute a violation 
under Rule 3216(a) (Tampering or Attempted Tampering), each of the 
following constitutes an Anti-Doping Rule Violation under this Rule 
3216(d):
    (i) any act that threatens or seeks to intimidate another Person 
with the intent of discouraging that Person from the good faith 
reporting of information that relates to an alleged Anti-Doping Rule 
Violation or other alleged non-compliance with the Protocol to the 
Agency or other appropriate Person; and
    (ii) retaliation against a Person who, in good faith, has provided 
evidence or information that relates to an alleged Anti-Doping Rule 
Violation or other alleged non-compliance with the Protocol to the 
Agency or other appropriate entity or Person.
    (2) For purposes of Rule 3216(d), threatening or seeking to 
intimidate a Person, and retaliation against a Person, include an act 
taken against such Person that lacks a good faith basis or is a 
disproportionate response.

3220. Sanctions

Rule 3221. Disqualification of the Covered Horse's Results
    (a) Automatic Disqualification of results.
    (1) An Anti-Doping Rule Violation that arises from a Post-Race 
Sample, or that occurs during the Race Period, automatically leads to 
Disqualification of the results of the Covered Horse obtained on the 
Race Day(s) that fall(s) within the Race Period, even if any other 
sanction for the violation is eliminated or reduced under Rules 3224, 
3325, or 3226.
    (2) In circumstances where an EAD Notice has been sent as required 
under Rule 3245, and the B Sample analysis confirms the A Sample 
analysis, or the right to request the analysis of the B Sample is 
waived, the Agency, the Responsible Person, and the Owner of the 
Covered Horse in question may agree to apply Rule 3221 immediately,

[[Page 5101]]

i.e., prior to adjudication of any other issue, or (in the absence of 
such agreement) any one of them may request that the Arbitral Body 
apply Rule 3221 immediately.
    (b) Disqualification of subsequent results.
    (1) Subject to paragraph (2), in addition to the automatic 
Disqualification of results under Rule 3221(a), any other results that 
the Covered Horse obtained from the date the Anti-Doping Rule Violation 
first occurred, as well as during any period of retroactive 
Ineligibility, shall be Disqualified, unless it is established by the 
Responsible Person that fairness requires otherwise.
    (2) If the Anti-Doping Rule Violation occurs in relation to a 
Claiming Race in which the Covered Horse is claimed, Rule 3221(b)(1) 
shall not apply to any results obtained by the Covered Horse under the 
new ownership.
    (c) Consequence of Disqualification of results:
    (1) If a Covered Horse has results Disqualified under the Protocol, 
all purses and other compensation, prizes, trophies, points, and 
rankings are forfeited and must be repaid or surrendered (as 
applicable) to the Race Organizer, and the results of the other Covered 
Horses in the race(s) in question must be adjusted accordingly and the 
purses, prizes, and trophies redistributed. Purses, prizes, trophies, 
and other compensation shall (where possible) be withheld for the 
Covered Horse in issue pending resolution of the relevant charge.
    (2) The Covered Horses that participated in a Covered Horserace 
involving an alleged Anti-Doping Rule Violation are often entered in 
other Covered Horseraces prior to the final adjudication of the 
violation. The ultimate Disqualification of a Covered Horse in 
connection with final adjudication of a violation shall only impact 
that horse's conditions for eligibility. By way of example, a maiden 
that is Disqualified after finishing first in a maiden race shall 
remain a maiden until it has won another race, but the runner-up in the 
disputed Covered Horserace shall not be considered the winner for 
purposes of its future condition eligibility. The adjustment to the 
Disqualified horse's condition eligibility shall only occur once the 
violation has been finally adjudicated.
Rule 3222. Ineligibility for Covered Horses
    (a) For a violation of Rule 3212 (presence), 3213 (Use or Attempted 
Use), or Rule 3214(c) (Administration or Attempted Administration), the 
Covered Horse involved shall be Ineligible for the period designated in 
the Prohibited List for the Banned Substance or Banned Method in issue.
    (b) For a violation of Rule 3215 involving evasion of Sample 
collection, the Covered Horse shall be Ineligible for 18 months. For a 
violation of Rule 3215 involving refusal or failure to submit to Sample 
collection, or refusal or failure to comply with all Sample collection 
procedure requirements, the Covered Horse shall be Ineligible for 18 
months, unless it is established by the Responsible Person that 
fairness requires otherwise, in which case the period of Ineligibility 
may be reduced, depending on the specific circumstances of the case and 
considerations of horse welfare.
    (c) Rule 3228 on increased periods of Ineligibility for repeat 
offenders does not apply to Covered Horses.
    (d) The period of Ineligibility for a Covered Horse shall be deemed 
to commence on the date that the violation occurred (which, in the case 
of a Rule 3212 violation, shall be the date that the positive Sample 
was collected, even if the Covered Horse has participated in Timed and 
Reported Workouts or Covered Races after that date).
Rule 3223. Ineligibility and Financial Penalties for Covered Persons
    (a) General.
    (1) The periods of Ineligibility and financial penalties set out in 
this Rule 3223 apply to the Covered Person's first doping offense. 
Where an offense is not the Covered Person's first doping offense, Rule 
3228 applies.
    (2) Unless specified otherwise, the periods of Ineligibility set 
out in this Rule 3223 are subject to potential elimination, reduction, 
or suspension pursuant to Rules 3224 to 3226 or potential increase 
pursuant to Rule 3227.
    (3) In accordance with Rule 3247(i), any period of Provisional 
Suspension served by the Covered Person shall be credited against the 
period of Ineligibility ultimately imposed on that Covered Person for 
the violation in question.
    (b) Consequences.
    Subject to Rule 3223(a), and in addition to any other Consequences 
that apply under the Protocol (including Disqualification), the periods 
of Ineligibility and financial penalties specified below shall apply to 
a Covered Person for his or her first Anti-Doping Rule Violation:

------------------------------------------------------------------------
   Anti-doping rule violation
    (first offense in 10-year          Period of           Financial
             period)                 ineligibility         penalties
------------------------------------------------------------------------
Presence (Rule 3212); Use or      2 years             Fine of up to
 Attempted Use (Rule 3213);                            $25,000 or 25% of
 Possession (Rule 3214(a)); or                         the total purse
 Administration or Attempted                           (whichever is
 Administration (Rule 3214(c)).                        greater); and
                                                       Payment of some
                                                       or all of the
                                                       adjudication
                                                       costs and the
                                                       Agency's legal
                                                       costs.
Trafficking or Attempted          Minimum of 4 years  Fine of up to
 Trafficking (Rule 3214(b)).       up to lifetime      $50,000 or 50% of
                                   Ineligibility,      the total purse
                                   depending on the    (whichever is
                                   seriousness of      greater); and
                                   the violation.     Payment of some or
                                  A violation          all of the
                                   involving a Minor   adjudication
                                   shall be            costs and the
                                   considered a        Agency's legal
                                   particularly        costs.
                                   serious violation
                                   and shall result
                                   in lifetime
                                   Ineligibility for
                                   the Covered
                                   Person who
                                   commits it..
                                  A violation that
                                   may also violate
                                   non-sporting laws
                                   and regulations
                                   shall be reported
                                   to the competent
                                   administrative,
                                   professional, or
                                   judicial
                                   authorities..

[[Page 5102]]

 
Evading collection of a Sample    4 years, except:    Fine up to $50,000
 from a Covered Horse; refusing   in the case of       or 50% of the
 or failing without compelling     failing to submit   total purse
 justification to submit a         to Sample           (whichever is
 Covered Horse to Sample           collection, if      greater); and
 collection; or refusing or        the Covered        Payment of some or
 failing to comply with all        Person can          all of the
 Sample collection procedure       establish that      adjudication
 requirements (Rule 3215); or      the failure was     costs and the
 Tampering or Attempted            not intentional,    Agency's legal
 Tampering (Rule 3216(a)).         the period of       costs.
                                   Ineligibility
                                   shall be in a
                                   range between 3
                                   months to 2
                                   years, depending
                                   on his or her
                                   degree of Fault;.
                                  and, in all other
                                   cases, if the
                                   Covered Person
                                   can establish
                                   exceptional
                                   circumstances
                                   that justify a
                                   reduction of the
                                   period of
                                   Ineligibility,
                                   the period of
                                   Ineligibility
                                   shall be in a
                                   range from 3
                                   months to 4
                                   years, depending
                                   on his or her
                                   degree of Fault..
                                 ---------------------------------------
Complicity or Attempted           Same Consequences that apply to the
 complicity (Rule 3216(b)).        principal actor, absent mitigating or
                                   aggravating circumstances.
                                 ---------------------------------------
Prohibited Association (Rule      2 years, subject    Fine up to $25,000
 3216(c)).                         to a reduction      or 25% of the
                                   down to a minimum   total purse
                                   of 1 year,          (whichever is
                                   depending on the    greater); and
                                   Covered Person's   Payment of some or
                                   degree of Fault     all of the
                                   and other           adjudication
                                   circumstances of    costs and the
                                   the case.           Agency's legal
                                                       costs.
Acts to discourage or retaliate   2 years up to       Fine of up to
 against reporting (Rule           lifetime            $50,000 or 50% of
 3216(d)).                         Ineligibility,      the total purse
                                   depending on the    (whichever is
                                   seriousness of      greater); and
                                   the violation.     Payment of some or
                                                       all of the
                                                       adjudication
                                                       costs and the
                                                       Agency's legal
                                                       costs.
------------------------------------------------------------------------

    (c) Commencement of the period of Ineligibility for a Covered 
Person.
    (1) Except as otherwise provided in this Rule 3223, the period of 
Ineligibility imposed on any Covered Person shall start on the date the 
period of Ineligibility is accepted or otherwise imposed in accordance 
with the Protocol.
    (2) Where a Covered Person is already serving a period of 
Ineligibility for another violation of the Protocol, any new period of 
Ineligibility shall start to run the day after the original period of 
Ineligibility ends.
    (3) Where there have been substantial delays in the adjudication 
process or other aspects of Doping Control that go well beyond the 
standard timeframes for Laboratory analyses and Results Management, and 
the Covered Person can establish that such delays are not attributable 
to him or her, the start date of the period of Ineligibility may be 
deemed back-dated to reflect such delays, but in no event may it be 
deemed back-dated to a date before the Anti-Doping Rule Violation last 
occurred. All competitive results achieved during the period of 
Ineligibility by the Covered Person or Covered Horse in issue, 
including retroactive Ineligibility, shall be Disqualified, unless it 
is established by the Covered Person that fairness requires otherwise.
Rule 3224. Elimination of the Period of Ineligibility Where There Is No 
Fault or Negligence
    (a) If a Covered Person establishes in an individual case that he 
or she bears No Fault or Negligence for the Anti-Doping Rule 
Violation(s) charged, the otherwise applicable period of Ineligibility 
and other Consequences for such Covered Person shall be eliminated 
(except for those set out in Rule 3221(a) and Rule 3620). When the 
violation is of Rule 3212 (presence of a Banned Substance), the Covered 
Person must also establish how the Banned Substance entered the Covered 
Horse's system as a pre-condition to application of this Rule 3224(a). 
In the event the period of Ineligibility otherwise applicable is 
eliminated pursuant to this Rule 3224, the Anti-Doping Rule Violation 
shall not be considered a prior violation for the purpose of Rule 3228.
    (b) Rule 3224 only applies in exceptional circumstances. In 
particular, it will not apply where the Banned Substance found to be 
present in a Sample: (1) came from a mislabeled or contaminated 
supplement; or (2) was administered to the Covered Horse by veterinary 
or other support personnel without the knowledge of the Responsible 
Person.
    (c) A finding that the Covered Person bears No Fault or Negligence 
for an Anti-Doping Rule Violation shall not affect the Consequences of 
that violation that apply to the Covered Horse (i.e., Ineligibility in 
accordance with Rule 3222(a) and Disqualification of results in 
accordance with Rule 3221).
Rule 3225. Reduction of the Period of Ineligibility Where There Is No 
Significant Fault or Negligence
    Reductions under this Rule 3225 are mutually exclusive and not 
cumulative, i.e., no more than one of them may be applied in a 
particular case.
    (a) General rule.
    Where the Covered Person establishes that he or she bears No 
Significant Fault or Negligence for the Anti-Doping Rule Violation in 
question, then (unless Rule 3225(b) or 3225(c) applies) the period of 
Ineligibility shall be fixed between 3 months and 2 years, depending on 
the Covered Person's degree of Fault.
    (b) Specified Substances.
    Where the Covered Person establishes that he or she bears No 
Significant Fault or Negligence for the Anti-Doping Rule Violation in 
question, and the violation involves only a Specified Substance, the 
period of Ineligibility shall be, at a minimum, a reprimand and no 
period of Ineligibility, and, at a maximum, 2 years of Ineligibility, 
depending on the Covered Person's degree of Fault.
    (c) Contaminated Products or other contamination.
    Where the Covered Person establishes that he or she bears No 
Significant Fault or Negligence for the Anti-Doping Rule Violation in 
question and that the Banned Substance in question came from a 
Contaminated Product or from another form of contamination, the period 
of Ineligibility shall be, at a minimum, a reprimand and no period of

[[Page 5103]]

Ineligibility, and, at a maximum, 2 years of Ineligibility, depending 
on the Covered Person's degree of Fault.
Rule 3226. Elimination, Reduction, or Suspension of Period of 
Ineligibility or Other Consequences for Reasons Unrelated to Degree of 
Fault
    (a) Substantial Assistance. The Agency may suspend all or part of 
the Consequences imposed on a Covered Person in an individual doping 
case--other than Disqualification of results pursuant to Rule 3221--
based on the following:
    (1) The Covered Person provides Substantial Assistance to the 
Agency, the Authority, or a State Racing Commission, a criminal 
authority, or a professional disciplinary body that results in:
    (i) the Agency discovering or bringing forward an Anti-Doping Rule 
Violation or a Controlled Medication Rule Violation by another Covered 
Person; or
    (ii) a criminal or disciplinary body discovering or bringing 
forward a sport-related criminal offense or the breach of professional 
or sports rules by another Person, including offenses arising out of a 
sport integrity violation or sport safety violation, or the violation 
of any rule or requirement in the Act, and the information provided by 
the Covered Person providing Substantial Assistance is also made 
available to the Agency.
    (2) The extent to which the otherwise applicable period of 
Ineligibility may be suspended shall be based on the seriousness of the 
Anti-Doping Rule Violation committed by the Covered Person and the 
degree to which the Substantial Assistance provided by the Covered 
Person assists the effort to promote doping-free racing, compliance 
with the Protocol, or the integrity of racing. In any event, no more 
than three-quarters of the otherwise applicable period of Ineligibility 
may be suspended. If the otherwise applicable period of Ineligibility 
is a lifetime, the non-suspended period under this section must be no 
less than 8 years. For purposes of this Rule 3226, the otherwise 
applicable period of Ineligibility shall not include any period of 
Ineligibility that could be added under Rule 3228(c)(2).
    (3) If so requested, the Agency shall allow the Covered Person who 
seeks to provide Substantial Assistance to provide the information to 
the Agency subject to a Without Prejudice Agreement.
    (4) If the Covered Person fails to continue to cooperate or fails 
to provide the complete, accurate, and credible Substantial Assistance 
promised, the Agency shall reinstate the original Consequences. That 
decision is not subject to review.
    (b) Voluntary Admission of an Anti-Doping Rule Violation in the 
absence of other evidence. If (1) the Covered Person voluntarily admits 
the commission of an Anti-Doping Rule Violation before receiving the 
EAD Notice or (in the case of a Rule 3212 violation) before having 
received notice of a Sample collection that could establish the Anti-
Doping Rule Violation, and (2) that admission is the only reliable 
evidence of the violation at the time the admission is made, the 
otherwise applicable period of Ineligibility may be reduced by up to 
one-half.
    (c) Application of multiple grounds for reduction of a sanction. If 
the Covered Person establishes entitlement to a reduction or suspension 
of the period of Ineligibility under 2 or more of Rules 3224, 3225, or 
3226, the otherwise applicable period of Ineligibility shall be 
determined in accordance with Rules 3223, 3224, and 3225 before 
applying any reduction or suspension under Rule 3226. If the Covered 
Person establishes entitlement to a reduction or suspension of the 
period of Ineligibility under Rule 3226, up to three-quarters of the 
otherwise applicable period of Ineligibility may be reduced or 
suspended.
    (d) Reductions for certain Anti-Doping Rule Violations based on 
early admission and acceptance of sanction.
    (1) If the Agency notifies a Covered Person of a potential Anti-
Doping Rule Violation that carries an asserted period of Ineligibility 
of 4 or more years (including any period of Ineligibility asserted 
under Rule 3227), if the Covered Person admits the violation and 
accepts the asserted period of Ineligibility no more than 7 days after 
receiving the Charge Letter, the period of Ineligibility to be served 
will be automatically reduced by 1 year (but no further reduction shall 
be allowed under any other Rule).
    (2) If the Agency notifies a Covered Person of a potential Anti-
Doping Rule Violation that carries an asserted period of Ineligibility 
of 2 years or more years, but less than 4 years (including any period 
of Ineligibility asserted under Rule 3227), if the Covered Person 
admits the violation and accepts the asserted period of Ineligibility 
no more than 7 days after receiving the Charge Letter, the period of 
Ineligibility to be served will be automatically reduced by 6 months 
(but no further reduction shall be allowed under any other Rule).
Rule 3227. Aggravating Circumstances
    (a) In an individual case involving an Anti-Doping Rule Violation 
that is not a Rule 3214(b) violation (Trafficking or Attempted 
Trafficking) or a Rule 3216(d) violation (acts to discourage or 
retaliate against reporting), if the Agency establishes that 
Aggravating Circumstances are present, the period of Ineligibility 
otherwise applicable shall be increased by up to 2 years, depending on 
the seriousness of the Aggravating Circumstances, unless the Covered 
Person establishes that he or she did not knowingly commit the Anti-
Doping Rule Violation. Where the period of Ineligibility is increased 
pursuant to this Rule, an additional fine of up to $10,000 or an 
additional 10% of the total purse (whichever is greater) may also be 
imposed.
    (b) Actions and circumstances constituting Aggravating 
Circumstances include:
    (1) Administration of a Banned Substance or Use of a Banned Method 
that is detrimental to the health and welfare of the horse or is 
designed to deceive the betting public;
    (2) the presence in the Covered Horse's Sample of a combination of 
Banned Substance(s) and Controlled Medication Substance(s);
    (3) prior violations under the Protocol; or
    (4) the Covered Person engaged in deceptive or obstructive conduct 
to avoid the detection or adjudication of an Anti-Doping Rule Violation 
or a Controlled Medication Rule Violation, for which the Covered Person 
has not been separately sanctioned for Tampering.
    (c) For the avoidance of doubt, the examples set out in Rule 
3227(b) are not exhaustive and other similar circumstances or conduct 
may also be deemed to amount to Aggravating Circumstances that justify 
the imposition of a longer period of Ineligibility.
Rule 3228. Increased Sanctions for Repeat Offenders
    (a) For purposes of this Rule 3228, the following prior Anti-Doping 
Rule Violations shall be disregarded: (1) violations that occurred more 
than 10 years prior to the violation now being sanctioned; and (2) 
violations for which the Covered Person was found to bear No Fault or 
Negligence.
    (b) Subject to Rule 3228(a), and in addition to any other 
Consequences that apply under the Protocol (including 
Disqualification), the periods of Ineligibility and financial penalties 
specified below shall apply to any Covered Person who commits a second 
or subsequent Anti-Doping Rule Violation:

[[Page 5104]]



------------------------------------------------------------------------
   Number of anti-doping rule          Period of           Financial
 violations (in 10-year period)      ineligibility         penalties
------------------------------------------------------------------------
Second Anti-Doping Rule           The period of       Fine of up to
 Violation.                        Ineligibility       $50,000 or 50% of
                                   shall be the        the total purse
                                   greater of:         (whichever is
                                  (a) a 6-month        greater); and
                                   period of          Payment of some or
                                   Ineligibility; or.  all of the
                                  (b) a period of      adjudication
                                   Ineligibility in    costs and the
                                   the following       Agency's legal
                                   range, taking       costs.
                                   into account the
                                   entirety of the
                                   circumstances and
                                   the Covered
                                   Person's degree
                                   of Fault with
                                   respect to the
                                   second violation:.
                                  (i) the sum of the
                                   period of
                                   Ineligibility
                                   imposed for the
                                   first Anti-Doping
                                   Rule Violation,
                                   plus the period
                                   of Ineligibility
                                   otherwise
                                   applicable to the
                                   second Anti-
                                   Doping Rule
                                   Violation treated
                                   as if it were a
                                   first violation;
                                   and
                                  (ii) twice the
                                   period of
                                   Ineligibility
                                   otherwise
                                   applicable to the
                                   second Anti-
                                   Doping Rule
                                   Violation treated
                                   as if it were a
                                   first violation.
Third (or subsequent) Anti-       Lifetime            Fine of up to
 Doping Rule Violation.            Ineligibility,      $100,000 or 100%
                                   except if the       of the total
                                   third violation     purse (whichever
                                   satisfies the       is greater); and
                                   conditions for     Payment of some or
                                   elimination or      all of the
                                   reduction of the    adjudication
                                   period of           costs and the
                                   Ineligibility       Agency's legal
                                   under Rule 3224     costs.
                                   or Rule 3225, in
                                   which case the
                                   period of
                                   Ineligibility
                                   shall be from 8
                                   years to lifetime
                                   Ineligibility.
                                  If the above
                                   exception
                                   applies, the same
                                   rule shall apply
                                   to any subsequent
                                   violation.
------------------------------------------------------------------------

    (c) Additional rules for certain multiple violations.
    (1) Multiple violations for the same Banned Substance/Method 
incurred by a Covered Person in relation to the same Covered Horse 
prior to delivery of an EAD Notice may (at the Agency's discretion) be 
treated together as a single Anti-Doping Rule Violation, unless the 
facts demonstrate that there was more than one administration. Multiple 
violations for the same Banned Substance/Method incurred by a Covered 
Person in relation to different Covered Horses prior to delivery of an 
EAD Notice may (at the Agency's discretion) each be treated as a first 
Anti-Doping Rule Violation. Where multiple Banned Substances are 
detected in a single Post-Race Sample or Post-Work Sample, each Banned 
Substance may (at the Agency's discretion) be treated as a separate 
violation.
    (2) If the Agency establishes that, prior to receiving an EAD 
Notice in respect of one Anti-Doping Rule Violation, the Covered Person 
committed an additional Anti-Doping Rule Violation that occurred 12 
months or more before or after the violation asserted in that EAD 
Notice, the period of Ineligibility for the additional violation shall 
be calculated as if the additional violation were a stand-alone first 
violation, and that period of Ineligibility will run consecutively to 
(rather than concurrently with) the period of Ineligibility imposed for 
the first-notified violation. Where this Rule applies, the violations 
taken together will constitute a single violation for purposes of Rule 
3228.
    (3) If a Doping Control process results in the assertion of an 
Anti-Doping Rule Violation, and the Agency establishes that the Covered 
Person committed an independent violation of Rule 3216(a) (Tampering) 
in connection with that Doping Control process, the Rule 3216(a) 
(Tampering) violation shall be treated as a stand-alone violation and 
the period of Ineligibility for such violation shall be served 
consecutively to, rather than concurrently with, the period of 
Ineligibility imposed for the other Anti-Doping Rule Violation. Where 
this Rule 3228(c)(3) is applied, the violations taken together shall 
constitute a single violation for purposes of Rule 3228.
    (4) If the Agency establishes that the Covered Person has committed 
a further violation of the Protocol during a period of Ineligibility, 
any new period of Ineligibility shall start to run the day after the 
original period of Ineligibility ends.
    (d) Violations involving both a Banned Substance or Method and a 
Controlled Medication Substance or Method.
    Where a Covered Person is found, based on a common set of facts, to 
have committed a (1) violation involving one or more Banned 
Substance(s) or Banned Method(s), and (2) a violation involving one or 
more Controlled Medication Substance(s) or Controlled Medication 
Method(s), they shall be treated as separate violations, but shall be 
adjudicated together in consolidated proceedings pursuant to the 
procedure that applies to Anti-Doping Rule Violations under the 
Arbitration Procedures.
Rule 3229. Status During Provisional Suspension or Ineligibility
    (a) While serving a Provisional Suspension or period of 
Ineligibility for an Anti-Doping Rule Violation:
    (1) a Covered Horse may not participate in any Timed and Reported 
Workout or Covered Horserace, but shall remain subject to Testing;
    (2) a Covered Person may not participate in any capacity in any 
activity involving Covered Horses, or in any other activity (other than 
authorized anti-doping education or rehabilitation programs) taking 
place at a Racetrack or Training Facility; nor shall he or she permit 
anyone to participate in any capacity on his or her behalf in any such 
activities, except to the extent that the Covered Person is an Owner 
and the activity is necessary to ensure the safekeeping and wellbeing 
of the horse during the period of such Owner's Provisional Suspension 
or Ineligibility.
    (b) The Covered Horse(s) of an Owner or Trainer who is subject to a 
Provisional Suspension or period of Ineligibility shall be subject to 
the following restrictions:
    (1) The Covered Horse(s) of a Trainer who is subject to a 
Provisional Suspension or period of Ineligibility may not participate 
in any Timed and Reported Workout or Covered Horserace unless and until 
they have been transferred to another Covered Person. For the 
``transfer'' to be valid, (i) the transfer must be registered with the 
Authority in accordance with its procedures, and (ii) the Covered 
Horses must also be physically relocated to facilities under the care 
or control of a Covered Person who is not affiliated

[[Page 5105]]

with the suspended Trainer (and failure to comply may constitute an 
Anti-Doping Rule Violation under Rule 3216(c), i.e., Prohibited 
Association).
    (2) The Covered Horse(s) of an Owner who is subject to a 
Provisional Suspension or period of Ineligibility may not participate 
in any Timed and Reported Workout or Covered Horserace unless and until 
they have been transferred in a bona fide transaction to a different 
Owner. If an Immediate Family Member has any ownership or property 
interest in the Covered Horse(s) following such transfer, the transfer 
shall not constitute a bona fide transaction to a different Owner.
Rule 3230. Consequences for Violation of the Prohibition on 
Participation During Ineligibility or Provisional Suspension Under Rule 
3229
    (a) Consequences for violation of the prohibition on participation 
during Ineligibility.
    (1) If a Covered Person violates the prohibition against 
participation during Ineligibility described in Rule 3229, any results 
obtained from such participation shall be Disqualified and a new period 
of Ineligibility equal in length to the original period of 
Ineligibility shall be added to the end of the Covered Person's 
original period of Ineligibility.
    (2) If a Covered Horse participates in any Timed and Reported 
Workout or Covered Horserace in violation of the prohibition against 
participation during Ineligibility described in Rule 3229, any results 
obtained from such participation shall be Disqualified and the 
Responsible Person for that Covered Horse shall receive the following 
period of Ineligibility:
    (i) if the Responsible Person was subject to an original period of 
Ineligibility, a new period of Ineligibility equal in length to the 
original period of Ineligibility shall be added to the end of the 
original period of Ineligibility. If the original period of 
Ineligibility has already expired, the new period of Ineligibility 
shall start on the date that it is accepted or imposed; or
    (ii) if the Responsible Person was not subject to an original 
period of Ineligibility, the period of Ineligibility for violating Rule 
3229 shall be from a reprimand to 1 year, depending on the Covered 
Person's degree of Fault.
    (b) Consequences for violation of the prohibition on participation 
during Provisional Suspension.
    (1) A Covered Person who violates the prohibition against 
participation during a Provisional Suspension shall receive no credit 
for any period of Provisional Suspension served and the results of such 
participation shall be Disqualified.
    (2) If a Covered Horse participates in any Timed and Reported 
Workout or Covered Horserace in violation of the prohibition against 
participation during a Provisional Suspension described in Rule 3229, 
the Responsible Person for that Covered Horse and the Covered Horse 
shall receive no credit for any period of Provisional Suspension served 
and the results of such participation shall be Disqualified.
    (c) The consequence of Disqualification under this Rule 3230 shall 
be the same as set out in Rule 3221(c).
    (d) The Arbitral Body (or the Agency, if the Covered Person admits 
the violation and accepts the consequences) shall determine whether 
there has been a violation of the prohibition against participation 
during Provisional Suspension or Ineligibility and apply the 
appropriate consequences pursuant to Rule 3261.
Rule 3231. Automatic Public Disclosure
    A mandatory part of each sanction shall include automatic Public 
Disclosure in accordance with Rule 3620.
Rule 3232. Conditions Precedent to Reinstatement for Covered Persons
    (a) To be reinstated after commission of an Anti-Doping Rule 
Violation, the Covered Person must have respected his or her period of 
Ineligibility (Rule 3229); and repaid or surrendered any purses and 
other compensation, prizes, trophies, points, and rankings forfeited 
pursuant to Rule 3221, and paid any fines and reimbursed any costs 
imposed or accepted to the Agency, unless an installment plan was 
established pursuant to Rule 3232(b), in which case the Covered Person 
must have made all payments due under that plan. If any installment(s) 
subsequently become(s) overdue under that plan (i.e., after 
reinstatement), the Covered Person and the Covered Horses under his or 
her ownership or training may not participate in any Timed and Reported 
Workout or Covered Horserace until such overdue installment(s) is/are 
paid in full.
    (b) Where fairness requires, the Agency or the Arbitral Body may 
establish an installment plan for repayment of amounts due to be paid 
or reimbursed under the Protocol. The payment schedule may extend 
beyond any period of Ineligibility imposed upon the Covered Person.
Rule 3233. Conditions Precedent to Reinstatement for Covered Horses
    (a) A Covered Horse shall be reinstated once its period of 
Ineligibility ends, provided that (1) the Ineligibility has been 
respected in full throughout that period in accordance with Rule 3229, 
(2) the Covered Horse has been made available for Testing during that 
period in accordance with Rule 3132(d), and (3) the Covered Horse has 
completed any Vets' List Workout(s) required by the Racetrack Safety 
Program or the Agency (for the avoidance of doubt, such workouts may be 
scheduled prior to the expiry of the period of Ineligibility and will 
not constitute a violation of Rule 3229).
    (b) Any reinstatement pursuant to this Rule 3233 is without 
prejudice to any rest or stand down period that may be imposed on the 
Covered Horse (e.g., due to injuries), and any requirements for release 
from the Veterinarians' List, pursuant to the Racetrack Safety Program.

3240. Results Management

Rule 3241. General
    Where there is evidence of a potential Anti-Doping Rule 
Violation(s), the Agency will conduct Results Management in accordance 
with this section 3240 and the Testing and Investigations Standards.
Rule 3242. Review of Adverse Analytical Findings
    (a) Upon receipt of an Adverse Analytical Finding in relation to an 
A Sample, the Agency will conduct a review of the Laboratory 
certificate of analysis supporting the Adverse Analytical Finding and 
the relevant Sample collection documentation and Testing documents to 
determine whether the Adverse Analytical Finding was caused by any 
apparent departure from the Testing and Investigations Standards, the 
Laboratory Standards, or any provision of the Protocol. Subject to Rule 
3242(b), the Agency may, but does not have to, communicate with the 
Responsible Person and Owner during such review.
    (b) If the review under Rule 3242(a) reveals an apparent departure 
that caused the Adverse Analytical Finding, the entire test shall be 
considered negative, and the Agency shall promptly inform the 
Responsible Person and each Interested Party of that fact.
    (c) If the initial review of an Adverse Analytical Finding under 
Rule 3242(a) does not reveal an apparent departure that caused the 
Adverse Analytical Finding, the Agency shall promptly send an EAD 
Notice to the Responsible

[[Page 5106]]

Person and each Interested Party in accordance with Rule 3245.
Rule 3243. Review of Atypical Findings Relating to Banned Substances
    (a) In certain circumstances, Laboratories may report the presence 
of certain Banned Substances as ``Atypical Findings'' in accordance 
with the Atypical Findings Policy set out at Appendix 1. Upon receipt 
of an A Sample Atypical Finding, the Agency will conduct a review to 
determine whether the Atypical Finding was caused by a departure from 
the Testing and Investigations Standards, the Laboratory Standards, or 
any provision of the Protocol. If that review does not reveal any 
departure that caused the Atypical Finding, the Agency will conduct an 
investigation (including directing any Further Analysis) or take any 
other steps required to decide whether the Atypical Finding should be 
brought forward as an Adverse Analytical Finding, in accordance with 
the Atypical Findings Policy.
    (b) The Agency may, but does not have to, provide notice of an 
Atypical Finding to anyone until it has made that decision unless one 
of the following circumstances exists:
    (1) if the Agency determines that the B Sample should be analyzed 
prior to the conclusion of its investigation, the Agency may conduct 
the B Sample analysis after notifying the Responsible Person and the 
Owner, with such notice to include a description of the Atypical 
Finding and the information described in Rule 3245; or
    (2) if the Atypical Finding is likely connected to a serious 
pathology that requires urgent veterinary attention.
    (c) If the Agency ultimately decides not to pursue the Atypical 
Finding as an Adverse Analytical Finding, the Agency may, but does not 
have to, communicate that fact to the Responsible Person and Owner 
unless he or she has previously received notice of the Analytical 
Finding pursuant to Rule 3243(b).
    (d) If the Agency decides to move forward with the matter as an 
Adverse Analytical Finding, the Agency shall promptly send an EAD 
Notice to the Responsible Person and each Interested Party.
Rule 3244. Review of Other Evidence of a Potential Anti-Doping Rule 
Violation
    The Agency shall conduct any follow-up investigation required into 
any potential Anti-Doping Rule Violation not covered by Rules 3242 or 
3243. At such time as the Agency is satisfied that it has sufficient 
evidence to establish that an Anti-Doping Rule Violation occurred, it 
shall promptly send an EAD Notice to the relevant Covered Person and 
each Interested Party.
Rule 3245. EAD Notice
    (a) Where it is determined that a Covered Person may have committed 
one or more Anti-Doping Rule Violations, the Agency will promptly 
notify the Covered Person and each Interested Party in writing of the 
following (the EAD Notice):
    (1) the alleged Anti-Doping Rule Violation and the Consequences if 
it is agreed or determined to have been committed;
    (2) the Adverse Analytical Finding (with a copy of the Laboratory 
certificate of analysis in a form designated by the Agency) or a brief 
summary of the facts relied on by the Agency to assert the alleged 
violation (including, where applicable, the name of the Covered Horse 
implicated in the alleged violation, whether the alleged violation was 
in connection with a particular Covered Horserace, and the date of 
Sample collection or of the other relevant facts said to give rise to 
the violation);
    (3) if applicable, the right of the Responsible Person and the 
Owner to receive copies of the A Sample Laboratory Documentation 
Package after the B Sample analysis has been completed or after such 
analysis is waived;
    (4) if applicable, the following details regarding the B Sample 
analysis:
    (i) that the B Sample has been (or will be) analyzed because the 
Agency has authorized immediate analysis to preserve the scientific 
integrity of the Sample;
    (ii) if the B Sample has not been analyzed, the Responsible 
Person's and Owner's right to promptly request the analysis of the B 
Sample within no more than 5 days or (failing such request) that the B 
sample analysis shall be deemed to be waived;
    (iii) an explanation that, where the Responsible Person or Owner 
requests the B Sample analysis within the applicable deadline, or where 
the Agency decides to proceed with the B Sample analysis, the Agency 
will notify the Responsible Person and Owner of the date, time, and 
place where the B Sample will be analyzed and (where the analysis is 
requested by the Responsible Person or Owner) the amount that the 
Responsible Person or Owner must pay to have the B Sample tested and B 
Sample Laboratory Documentation Package prepared, and the date by which 
such payment must be received, failing which the B Sample analysis 
shall be deemed to have been waived; and
    (5) the opportunity for the Covered Person to provide an 
explanation within a short deadline set by the Agency;
    (6) the opportunity to provide Substantial Assistance, to admit the 
Anti-Doping Rule Violation, or to seek to resolve the matter without a 
hearing under Rule 3249;
    (7) all relevant details relating to any Provisional Suspension 
(including, if applicable, the possibility to accept a voluntary 
Provisional Suspension) in accordance with Rule 3247; and
    (8) if applicable, the ability for the automatic Disqualification 
of results to be applied immediately in accordance with Rule 
3221(a)(2).
    (b) Before sending an EAD Notice, for purposes of Rule 3228, the 
Agency shall seek to determine whether the Covered Person in question 
has committed any prior violations under the Protocol.
    (c) Any defect in the EAD Notice (including a failure to identify 
the Covered Horseraces implicated in the alleged violation, if any) may 
be corrected by the Agency and shall not in any event invalidate the 
EAD Notice or affect the due application of the provisions of the 
Protocol (including the Disqualification provisions) in relation to 
that violation.
Rule 3246. B Sample Analysis
    (a) Arrangements shall be made for analysis of the B Sample without 
undue delay, in accordance with the Protocol and the Laboratory 
Standards. Subject to Rule 3246(b), the Responsible Person or Owner 
must pay the costs of the B Sample analysis in advance, but, if the B 
Sample analysis does not confirm the A Sample analysis, they will be 
reimbursed that cost by the Agency. The Responsible Person and Owner or 
one representative each may attend the Laboratory to witness the 
opening and identification of the B Sample. They do not have any right 
to witness the analysis of the B Sample.
    (b) The Responsible Person and Owner may (if they both agree) waive 
analysis of the B Sample (in which case they shall be deemed to accept 
the A Sample analytical results). If waived, the Agency may nonetheless 
elect to proceed with the B Sample analysis at its own expense.
    (c) If the B Sample proves negative, the entire Test shall be 
considered negative, and the Responsible Person and Owner shall be so 
informed. In such circumstances, unless the Agency asserts an Anti-
Doping Rule Violation under Rule 3213 (Use), the EAD Notice will be 
withdrawn, any Provisional Suspensions imposed shall be deemed 
automatically vacated with immediate effect (without the need for any 
order

[[Page 5107]]

from the Arbitral Body), and no further disciplinary action will be 
taken against the Responsible Person, other Covered Person, or Covered 
Horse by the Agency in relation to the original Adverse Analytical 
Finding (provided, however, that the Agency may investigate why the B 
Sample did not match the A Sample). If the Agency asserts that a Rule 
3213 (Use) violation has occurred, it shall send a Charge Letter to the 
Responsible Person and other Covered Person(s), with a copy to each 
Interested Party.
    (d) If the presence of a Banned Substance or the Use of a Banned 
Method is confirmed by the B Sample analysis, or the B Sample analysis 
is waived, the Agency shall send a Charge Letter to the Responsible 
Person and any other relevant Covered Person(s), with a copy to each 
Interested Party, asserting that a Rule 3212 (presence) violation or a 
Rule 3213 (Use) violation (as applicable) has occurred.
Rule 3247. Provisional Suspensions
    (a) Provisional Suspensions shall be imposed as follows:
    (1) For each alleged violation of Rule 3212 (presence), 3213 (Use), 
or 3214(c) (Administration or Attempted Administration) that involves a 
Banned Substance that is not a Specified Substance, the Agency shall 
impose a Provisional Suspension, effective from the date specified by 
the Agency in the EAD Notice or in further correspondence up to and 
including the Charge Letter, on (i) the Covered Horse, (ii) the 
Responsible Person, and (iii) any other Covered Person charged with the 
violation.
    (2) For each alleged violation of Rule 3215 (evading Sample 
collection; refusing or failing to submit to Sample collection; or 
refusing or failing to comply with all Sample collection procedure 
requirements), the Agency may impose a Provisional Suspension, 
effective from the date specified by the Agency in the EAD Notice or in 
further correspondence up to and including the Charge Letter, on (i) 
the Covered Horse, (ii) the Responsible Person, or (iii) any other 
Covered Person charged with the violation.
    (3) For all other alleged Anti-Doping Rule Violations, the Agency 
may impose a Provisional Suspension, effective from the date specified 
by the Agency in the EAD Notice or in further correspondence up to and 
including the Charge Letter, on the Responsible Person, or any other 
Covered Person alleged to be implicated in the violation, but not on 
the Covered Horse.
    (b) Where a Provisional Suspension is imposed pursuant to Rule 
3247(a), the Responsible Person (on his or her own behalf and on behalf 
of the Covered Horse) and any other Covered Person made subject to the 
Provisional Suspension shall be given:
    (1) an opportunity for a Provisional Hearing before imposition of 
the Provisional Suspension;
    (2) an opportunity for a Provisional Hearing on a timely basis 
after imposition of the Provisional Suspension; or
    (3) an opportunity for an expedited final adjudication in 
accordance with Rule 3262 on a timely basis after imposition of the 
Provisional Suspension.
    (c) Provisional Hearings shall be conducted by the Arbitral Body 
and heard via telephone or video conference call within the time frame 
specified in accordance with the Arbitration Procedures. The sole issue 
to be determined by the Arbitral Body will be whether the Agency's 
decision to impose a Provisional Suspension shall be maintained. The 
Agency's decision to impose a Provisional Suspension shall be 
maintained unless the Responsible Person/Covered Person requesting the 
lifting of the Provisional Suspension establishes that:
    (1) the allegation that an Anti-Doping Rule Violation has been 
committed has no reasonable prospect of being upheld, e.g., because of 
a material defect in the evidence on which the allegation is based;
    (2) the Responsible Person/Covered Person charged bears No Fault or 
Negligence for the Anti-Doping Rule Violation that is alleged to have 
been committed, so that any period of Ineligibility that might 
otherwise be imposed for such offense would be completely eliminated by 
application of Rule 3224. (This ground does not apply in respect of any 
Provisional Suspension imposed on a Covered Horse);
    (3) Rule 3225 applies and the Responsible Person/Covered Person 
bears No Significant Fault or Negligence and he or she will likely be 
given a period of Ineligibility that is not longer than the period for 
which he or she has already been provisionally suspended (this ground 
does not apply in respect of any Provisional Suspension imposed on a 
Covered Horse); or
    (4) exceptional circumstances exist that make it clearly unfair, 
taking into account all of the circumstances of the case, to impose a 
Provisional Suspension prior to the final hearing on the merits. This 
ground is to be construed narrowly and applied only in truly 
exceptional circumstances. For example, the fact that the Provisional 
Suspension would prevent the Responsible Person, Covered Person, or 
Covered Horse from participating in a particular Timed and Reported 
Workout, Covered Horserace, or other activity shall not qualify as 
exceptional circumstances for these purposes.
    (d) If the application is made before the Provisional Suspension 
comes into effect, the Provisional Suspension will not come into effect 
pending the decision on the application. If the application is made 
after the Provisional Suspension has come into effect, the Provisional 
Suspension will remain in place pending the decision on the 
application.
    (e) If it considers it appropriate to do so on the specific facts 
of the case, the Agency may lift the Provisional Suspension.
    (f) If the application to have a Provisional Suspension not 
imposed/lifted is not granted, a further application may not be made to 
lift the Provisional Suspension unless: (i) it is based on new and 
material evidence that the Responsible Person or other Covered Person 
was not aware of and could not reasonably have been aware of at the 
time he or she made the original application; or (ii) there has been 
some other significant and material change in circumstances since the 
original application was decided. If the Responsible Person or other 
Covered Person makes a further application that does not meet either of 
these requirements, costs may be awarded against him or her.
    (g) Voluntary Provisional Suspension.
    (1) In all cases where a Responsible Person/Covered Person has been 
notified of or charged with an Anti-Doping Rule Violation, but no 
Provisional Suspension has been imposed on him or her or on the Covered 
Horse, that person may (on his or her own behalf and, if the 
Responsible Person, on behalf of the Covered Horse) voluntarily accept 
a Provisional Suspension at any time by written notice to the Agency. A 
copy of the voluntary Provisional Suspension shall promptly be provided 
to each Interested Party.
    (2) A Provisional Suspension that is voluntarily accepted will have 
effect (in the same manner as if the Provisional Suspension had been 
imposed under Rule 3247(a)) from the date that written notice of its 
acceptance is received by the Agency.
    (h) No admission will be inferred, or other adverse inference 
drawn, from the decision of a Covered Person: (1) not to make an 
application to lift a Provisional Suspension; or (2) to accept a 
voluntary Provisional Suspension.

[[Page 5108]]

    (i) If a Provisional Suspension is imposed or voluntarily accepted, 
and that Provisional Suspension is respected, then the Responsible 
Person/Covered Person and Covered Horse in question shall receive a 
credit for such period of Provisional Suspension against any period of 
Ineligibility that may ultimately be imposed. If the Responsible 
Person/Covered Person or Covered Horse does not respect a Provisional 
Suspension, the Responsible Person/Covered Person or Covered Horse 
shall receive no credit for any period of Provisional Suspension 
served. If a period of Ineligibility is served pursuant to a decision 
that is subsequently subject to review, the Responsible Person/Covered 
Person or Covered Horse shall receive a credit for such period of 
Ineligibility served against any period of Ineligibility that may 
ultimately be imposed on review.
    (j) Notwithstanding any other provision in this Rule 3247 or 
elsewhere in the Protocol, any Provisional Suspension imposed on a 
Covered Horse will be automatically lifted (without the need for any 
hearing) if it has been in place for a period equal to the period of 
Ineligibility specified in the Protocol or Prohibited List.
Rule 3248. Charge Letter
    If, after receipt of the Covered Person's explanation, or expiry of 
the deadline to provide such explanation, the Agency remains satisfied 
that the Covered Person has committed an Anti-Doping Rule Violation(s), 
the Agency shall promptly charge the Covered Person with the asserted 
Anti-Doping Rule Violation(s). In this letter of charge (Charge 
Letter), which will be copied to each Interested Party, the Agency 
shall:
    (a) set out the Anti-Doping Rule Violation(s) that the Covered 
Person is charged with having committed;
    (b) provide a summary of the relevant facts upon which the charge 
is based, enclosing a copy of the A Sample Laboratory Documentation 
Package and (if applicable and if requested) the B Sample Laboratory 
Documentation Package;
    (c) specify the Consequences that will apply if the charge is 
upheld;
    (d) grant a deadline of not more than 7 days from receipt of the 
Charge Letter (unless otherwise agreed by the Agency) for the Covered 
Person to either:
    (1) admit the Anti-Doping Rule Violation(s) charged and:
    (i) accept the Consequences proposed by the Agency, in which case 
the Agency will issue a decision under Rule 3249(b);
    (ii) seek to agree to mitigated Consequences with the Agency 
pursuant to Rule 3249, failing which the Consequences may still be 
disputed at a hearing; or
    (iii) dispute or seek to mitigate the proposed Consequences at a 
hearing in accordance with Rule 3261 and the Arbitration Procedures; or
    (2) deny the Anti-Doping Rule Violation charged and dispute the 
proposed Consequences at a hearing in accordance with Rule 3261 and 
Arbitration Procedures;
    (e) indicate that, if the Covered Person does not challenge the 
Agency's assertion of an Anti-Doping Rule Violation or the proposed 
Consequences within the prescribed deadline, the Covered Person shall 
be deemed to have waived his or her right to a hearing, admitted the 
Anti-Doping Rule Violation(s) charged, and accepted the Consequences 
specified by the Agency in the Charge Letter (without any mitigation of 
those Consequences);
    (f) give the opportunity to provide Substantial Assistance in 
accordance with Rule 3226(a); and
    (g) provide all relevant details relating to any Provisional 
Suspensions (including, if applicable, the possibility to accept a 
voluntary Provisional Suspension) in accordance with Rule 3247.
Rule 3249. Case Resolution Without a Hearing
    (a) At any time prior to a final decision under the Arbitration 
Procedures: (1) the Agency may withdraw a Charge Letter for good cause, 
in which case any Provisional Suspension will be automatically lifted 
and (absent the emergence of new information) no further steps will be 
taken in relation to the violations alleged in the Charge Letter; or 
(2) the Covered Person may agree to admit the Anti-Doping Rule 
Violation(s) charged (or any other violation of the Protocol) and 
accede to specified Consequences consistent with the Protocol. In any 
such case, an adjudication under the Arbitration Procedures will not be 
required.
    (b) In the event that the Covered Person admits the Anti-Doping 
Rule Violation(s) charged and accedes to Consequences specified by the 
Agency (or is deemed to have done so in accordance with Rule 
3248(a)(5)), the Agency will (1) promptly issue a final decision 
confirming the commission of the Anti-Doping Rule Violation(s) and 
setting out the factual basis for the decision and all of the 
Consequences to be imposed (including a brief summary of the reasons 
for any period of Ineligibility imposed, unless doing so could 
compromise an ongoing investigation or proceeding), and (2) send notice 
of the decision to each Interested Party. The Agency will also Publicly 
Disclose the decision (or a summary thereof, at the discretion of the 
Agency) in accordance with Rule 3620.
    (c) In the event that the Agency withdraws the Charge Letter, it 
will (1) promptly issue a summary decision confirming the withdrawal of 
the Charge Letter, (2) send notice of the decision to the Covered 
Person concerned, with a copy to each Interested Party, and (3) 
Publicly Disclose the decision (or a summary thereof, at the discretion 
of the Agency) in accordance with Rule 3620.
Rule 3250. Notification Requirements
    (a) Notification of Anti-Doping Rule Violations will take place as 
set out in Rule 3245 and Rule 3248. If at any point after an EAD Notice 
has been provided the Agency decides not to move forward with the 
charge, it will notify the Covered Person(s) concerned and each 
Interested Party of that decision.
    (b) Notification to a Covered Person by the Agency, for all 
purposes of the Protocol, may be accomplished either through actual or 
constructive notice. Actual notice may be accomplished by any means. 
Constructive notice shall be deemed to have been given when the 
information in question is delivered by third-party courier or U.S. 
postal mail to the Covered Person's most recent mailing address on file 
with the Authority or by email or text message to the Covered Person's 
most recent email address or mobile telephone number on file with the 
Authority.

3260. Hearings and Review of Final Decisions

Rule 3261. Hearing Before the Arbitral Body
    Where a Covered Person is alleged to have committed an Anti-Doping 
Rule Violation or to have violated Rule 3229, the Covered Person shall 
be entitled to a hearing before the Arbitral Body in accordance with 
the Arbitration Procedures. A copy of the final decision of the 
Arbitral Body shall be sent to the Covered Person(s) concerned, with a 
copy to the Agency and each Interested Party. The decision (or a 
summary thereof, at the discretion of the Agency) shall be Publicly 
Disclosed as provided in Rule 3620. If an individual case involves 
allegations that both an Anti-Doping Rule Violation and a Controlled 
Medication Rule Violation have been committed, the matter shall be 
referred to and adjudicated by the Arbitral Body in accordance with the 
Arbitration Procedures.

[[Page 5109]]

    The Arbitral Body may also adjudicate any other matter referred to 
it under the Protocol, and any other matter that might arise from time 
to time under the Protocol that the Agency considers should be 
determined by the Arbitral Body.
Rule 3262. Expedited Hearing
    In Anti-Doping Rule Violation cases where the Covered Horse or 
Covered Person in question is not Provisionally Suspended and is likely 
to participate in a Covered Horserace within 45 days, the Agency may 
(if it sees fit) address the case on an expedited basis and shorten any 
deadlines in the Protocol or Arbitration Procedures proportionately to 
ensure resolution of the matter prior to the Covered Horserace.
Rule 3263. Finality
    Subject to Rule 3264, decisions rendered by the Arbitral Body under 
the Protocol shall be final and binding.
Rule 3264. Review of Final Decisions
    Any final decision by the Agency or the Arbitral Body is subject to 
review in accordance with section 3058 of the Act. Any final decision 
under review shall remain in effect pending resolution of the review 
unless ordered otherwise.

3310. Controlled Medication Rule Violations

Rule 3311. Definition of Controlled Medication Rule Violation and 
Responsibility for Violations
    (a) Controlled medication cases will be initiated based on the 
assertion that one or more of Rules 3312 through 3315 has been violated 
(each, a Controlled Medication Rule Violation).
    (b) The Controlled Medication Rule Violations described below may 
only be committed by Covered Persons, but the Consequences for 
Controlled Medication Rule Violations may apply to both the Covered 
Person(s) who commit(s) the violation and any Covered Horse(s) 
implicated by the violation.
    (c) All Covered Persons are responsible for knowing what 
constitutes a Controlled Medication Rule Violation and what Controlled 
Medication Substances and what Controlled Medication Methods are 
included on the Prohibited List and Technical Document-Prohibited 
Substances.
Rule 3312. Presence of a Controlled Medication Substance
    (a) It is the personal and non-delegable duty of the Responsible 
Person to ensure that no Controlled Medication Substance is present in 
the Post-Race Sample of his or her Covered Horse(s), and that no 
Controlled Medication Substance specifically identified on the 
Prohibited List as prohibited during Timed and Reported Workouts is 
present in the Post-Work Sample of his or her Covered Horse(s). The 
Responsible Person is therefore strictly liable for any Controlled 
Medication Substance or its Metabolites or Markers found to be present 
in a Post-Race Sample collected from his or her Covered Horse(s), and 
for any specifically prohibited Controlled Medication Substance or its 
Metabolites or Markers found to be present in a Post-Work Sample 
collected from his or her Covered Horse(s). Accordingly, it is not 
necessary to demonstrate intent, Fault, negligence, or knowing Use on 
the part of the Responsible Person in order to establish that the 
Responsible Person has committed a Rule 3312 Controlled Medication Rule 
Violation.
    (b) Sufficient proof of a Rule 3312 Controlled Medication Rule 
Violation is established by any of the following:
    (1) the presence of a Controlled Medication Substance or its 
Metabolites or Markers in the Covered Horse's A Sample where the 
Responsible Person waives analysis of the B Sample and the B Sample is 
not analyzed;
    (2) the Covered Horse's B Sample is analyzed and the analysis of 
the B Sample confirms the presence of the Controlled Medication 
Substance or its Metabolites or Markers found in the A Sample; or
    (3) where, in exceptional circumstances, the Laboratory (on 
instruction from the Agency) further splits the A or B Sample into two 
parts in accordance with the Laboratory Standards, the analysis of the 
second part of the resulting split Sample confirms the presence of the 
same Controlled Medication Substance or its Metabolites or Markers as 
were found in the first part of the split Sample, or the Responsible 
Person waives analysis of the second part of the split Sample.
    (c) The general rule is that the presence of any amount of a 
Controlled Medication Substance or its Metabolites or Markers in a 
Post-Race Sample or Post-Work Sample collected from a Covered Horse 
constitutes a Controlled Medication Rule Violation by the Responsible 
Person of that Covered Horse.
    (d) As an exception to the general rule of Rule 3312(c), the 
Prohibited List, Standards, or Technical Documents may establish 
special criteria for the reporting or the evaluation of certain 
Controlled Medication Substances, including a Minimum Reporting Level, 
Screening Limit, Threshold, or Decision Limit.
    (e) Nonsteroidal Anti-Inflammatory Drugs (NSAIDs) and 
corticosteroids, which are Controlled Medication Substances prohibited 
during Timed and Reported Workouts and during the Race Period, are 
subject to Screening Limits.
    (1) If one NSAID or one corticosteroid is detected in the Post-Race 
Sample or Post-Work Sample of a Covered Horse above the applicable 
Screening Limit, it constitutes a presence violation under Rule 3312.
    (2) If more than one NSAID or more than one corticosteroid is 
detected in the Post-Race Sample or Post-Work Sample of a Covered 
Horse, each NSAID and each corticosteroid above the applicable 
Screening Limit constitutes a separate presence violation of Rule 3312.
    (3) If more than one NSAID or more than one corticosteroid is 
detected in the Post-Race Sample or Post-Work Sample of a Covered 
Horse, but each are below the applicable Screening Limits (and so 
individually would not constitute a presence violation), they will 
together constitute a single presence violation under Rule 3312 
(Stacking Violation).
Rule 3313. Use or Attempted Use of a Controlled Medication Substance or 
a Controlled Medication Method During the Race Period
    (a) Subject to Rule 3313(c), the Use or Attempted Use of a 
Controlled Medication Substance or Controlled Medication Method in 
relation to a Covered Horse during the Race Period constitutes a 
Controlled Medication Rule Violation. The success or failure of that 
Use or Attempted Use is not material. For a Rule 3313 violation to be 
committed, it is sufficient that the Controlled Medication Substance or 
Controlled Medication Method was Used or Attempted to be Used on a 
Covered Horse during the Race Period.
    (b) It is the personal and non-delegable duty of the Responsible 
Person to ensure that no Controlled Medication Substance or Controlled 
Medication Method is Used in relation to his or her Covered Horse 
during the Race Period. The Responsible Person is therefore strictly 
liable for any Use of a Controlled Medication Substance or Controlled 
Medication Method in relation to his or her Covered Horse(s). 
Accordingly, it is not necessary to demonstrate intent, Fault, 
negligence, or knowing Use on the part of the Responsible Person in 
order to establish that the Responsible Person has committed a Rule 
3313 Controlled

[[Page 5110]]

Medication Rule Violation of Use. However, in accordance with the 
definition of Attempt, it is necessary to show intent on the part of 
the Responsible Person in order to establish that the Responsible 
Person has committed a Rule 3313 Controlled Medication Rule Violation 
of Attempted Use.
    (c) Use of a Controlled Medication Substance or a Controlled 
Medication Method outside the Race Period is not a Rule 3313 violation. 
However, if a Controlled Medication Substance or any of its Metabolites 
or Markers is still present in a Post-Race Sample or Post-Work Sample, 
that constitutes a Rule 3312 (presence) violation.
Rule 3314. Use of a Controlled Medication Substance or a Controlled 
Medication Method in a Manner Contrary to Horse Welfare
    (a) Any Use of a Controlled Medication Substance or a Controlled 
Medication Method in relation to a Covered Horse must (1) be justified 
by the Covered Horse's health condition(s), (2) have been recommended 
by a Veterinarian in the context of a valid veterinarian-patient-client 
relationship or (if a prescription is not required) following 
sufficient due diligence regarding the substance or method, (3) go no 
further than the minimum necessary to address the health concerns, and 
(4) be in the best interests of the Covered Horse's health and welfare.
    (b) It is the personal and non-delegable duty of the Responsible 
Person to ensure that no Controlled Medication Substance or Controlled 
Medication Method is Used on his or her Covered Horse in breach of the 
requirements set out in Rule 3314(a). The Responsible Person is 
therefore strictly liable for a violation of this Rule 3314. 
Accordingly, it is not necessary to demonstrate intent, Fault, 
negligence, or knowing Use on the part of the Responsible Person in 
order to establish that the Responsible Person has committed a Rule 
3314 Controlled Medication Rule Violation.
Rule 3315. Other Controlled Medication Rule Violations Involving 
Controlled Medication Substances or Controlled Medication Methods
    The following acts and omissions constitute Controlled Medication 
Rule Violations by the Covered Person(s) in question:
    (a) The Administration or Attempted Administration of a Controlled 
Medication Substance or Controlled Medication Method by a Covered 
Person to a Covered Horse during the Race Period.
    (b) The Possession of a Controlled Medication Substance or 
Controlled Medication Method by any Covered Person that is not in 
compliance with applicable State or Federal law.
    (c) A Covered Person assisting, encouraging, aiding, abetting, 
conspiring, covering up, or engaging in any other type of intentional 
complicity or Attempted complicity involving (1) a Controlled 
Medication Rule Violation or Attempted Controlled Medication Rule 
Violation, or (2) a violation of Rule 3329 by another Covered Person.
Rule 3316. Tampering or Attempted Tampering With Medication Control
    If the Agency establishes that a Covered Person committed a 
violation of Tampering or Attempted Tampering in connection with a 
Medication Control process, that will constitute an Anti-Doping Rule 
Violation under Rule 3216(a), and the matter will be dealt with in 
accordance with the procedures and Consequences applicable to Anti-
Doping Rule Violations.

3320. Sanctions

Rule 3321. Disqualification of the Covered Horse's Results
    (a) Automatic Disqualification of results.
    (1) A Controlled Medication Rule Violation that arises from a Post-
Race Sample, or that occurs during the Race Period, automatically leads 
to Disqualification of the results of the Covered Horse obtained on the 
Race Day(s) that fall(s) within the Race Period, even if any other 
sanction for the violation is eliminated or reduced under Rules 3324, 
3325, or 3326.
    (2) In circumstances where an ECM Notice has been sent as required 
under Rule 3345, and the B Sample analysis confirms the A Sample 
analysis, or the right to request the analysis of the B Sample is 
waived, the Agency, the Responsible Person, and the Owner of the 
Covered Horse in question may agree to apply Rule 3321 immediately, 
i.e., prior to adjudication of any other issue, or (in the absence of 
such agreement) any one of them may request that the Internal 
Adjudication Panel apply Rule 3321 immediately.
    (b) No Disqualification of subsequent results.
    Subsequent results obtained by the Covered Horse from the date a 
Controlled Medication Rule Violation first occurred through the 
commencement of any Provisional Suspension or Ineligibility period for 
the Covered Horse shall not be Disqualified.
    (c) Consequence of Disqualification of results.
    (1) If a Covered Horse has results Disqualified under the Protocol, 
all purses and other compensation, prizes, trophies, points, and 
rankings are forfeited and must be repaid or surrendered (as 
applicable) to the Race Organizer, and the results of the other Covered 
Horses in the race(s) in question must be adjusted accordingly and the 
purses, prizes, and trophies redistributed. Purses, prizes, trophies, 
and other compensation shall (where possible) be withheld for the 
Covered Horse in issue pending resolution of the relevant charge.
    (2) The Covered Horses that participated in a Covered Horserace 
involving an alleged Controlled Medication Rule Violation are often 
entered in other Covered Horseraces prior to the final adjudication of 
the violation. The ultimate Disqualification of a Covered Horse in 
connection with final adjudication of a violation shall only impact 
that horse's conditions for eligibility. By way of example, a maiden 
that is Disqualified after finishing first in a maiden race shall 
remain a maiden until it has won another race, but the runner-up in the 
disputed Covered Horserace shall not be considered the winner for 
purposes of its future condition eligibility. The adjustment to the 
Disqualified horse's condition eligibility shall only occur once the 
violation has been finally adjudicated.
Rule 3322. Ineligibility for Covered Horses
    (a) There shall be no period of Ineligibility for Covered Horses 
implicated in violations involving only Controlled Medication 
Substances.
    (b) There may be a period of Ineligibility for Covered Horses 
implicated in violations involving Controlled Medication Methods. Where 
the Prohibited List specifies a period of Ineligibility, it shall be 
applied only prospectively (i.e., going forward from the date that it 
is imposed), with no Disqualification of any results obtained by the 
Covered Horse before the date that the period of Ineligibility starts 
to run, other than as provided under Rule 3321(a)(1).
Rule 3323. Ineligibility and Financial Penalties for Covered Persons
    (a) General.
    (1) The periods of Ineligibility and financial penalties set out in 
this Rule 3323 apply to any Controlled Medication Rule Violation 
committed by a Covered Person. However:
    (i) When determining if a Covered Person has committed multiple

[[Page 5111]]

violations, the following prior Controlled Medication Rule Violations 
shall be disregarded: (A) violations that occurred more than 2 years 
prior to the violation now being sanctioned; and (B) violations for 
which the Covered Person was found to bear No Fault or Negligence.
    (ii) A Controlled Medication Rule Violation will be considered a 
second or subsequent violation only if the Covered Person committed an 
offense in the same category/class in the previous 2 years. Violations 
in different categories will be taken into account when assigning 
penalty points under Rule 3328.
    (iii) Unless specified otherwise, the periods of Ineligibility set 
out in this Rule 3323 are subject to potential elimination, reduction, 
or suspension pursuant to Rules 3324-3326, or increase pursuant to Rule 
3327.
    (2) In accordance with Rule 3347(j), any period of Provisional 
Suspension served by the Covered Person shall be credited against the 
period of Ineligibility ultimately imposed on that Covered Person for 
the violation in question.
    (3) If a presence violation involves a Controlled Medication 
Substance that has not been assigned a Class A-C, the Agency shall 
determine the class of the substance. Any supplements or feed additives 
used in contravention of Rule 4211(a) of the Prohibited List that have 
not been assigned a class shall be designated as Class C substances, 
unless the Agency decides otherwise.
    (4) If two or more Controlled Medication Rule Violations in the 
same category/class are adjudicated separately, the first violation 
adjudicated shall constitute the ``first violation'' for sanctioning 
purposes, the second violation adjudicated shall constitute the 
``second violation,'' and so on, regardless of the chronological order 
in which those violations occurred.
    (b) Consequences.
    Subject to Rule 3323(a), and in addition to any other Consequences 
that apply under the Protocol, the periods of Ineligibility, fines, and 
Disqualification of results specified below shall apply to any Covered 
Person who commits multiple Controlled Medication Rule Violations. The 
Covered Person may also be required to pay some or all of the 
adjudication costs and the Agency's legal costs.

----------------------------------------------------------------------------------------------------------------
                                                                                           Third or subsequent
 Controlled medication rule violation  First violation (within      Second violation       violation (within 2-
                                            2-year period)       (within 2-year period)        year period)
----------------------------------------------------------------------------------------------------------------
Presence, Use or Attempted Use, or
 Administration or Attempted
 Administration of a Controlled
 Medication Substance (Rules 3312,
 3313, and 3315(a)):
    Class A..........................  60 days................  90 days................  120 days.
                                       Fine of up to $5,000 or  Fine of up to $10,000    Fine of up to $25,000
                                        5% of the total purse    or 10% of the total      or 25% of the total
                                        (whichever is greater).  purse (whichever is      purse (whichever is
                                                                 greater).                greater).
                                       Automatic                Automatic                Automatic
                                        Disqualification of      Disqualification of      Disqualification of
                                        Race Day results (Rule   Race Day results (Rule   Race Day results (Rule
                                        3321).                   3321).                   3321).
    Class B..........................  15 days................  30 days................  60 days.
                                       Fine up to $1,000......  Fine up to $2,500......  Fine up to $5,000.
                                       Automatic                Automatic                Automatic
                                        Disqualification of      Disqualification of      Disqualification of
                                        Race Day results (Rule   Race Day results (Rule   Race Day results (Rule
                                        3321).                   3321).                   3321).
    Class C..........................  .......................  15 days................  30 days.
                                       Fine up to $500........  Fine up to $1,000......  Fine up to $2,500.
                                       Automatic                Automatic                Automatic
                                        Disqualification of      Disqualification of      Disqualification of
                                        Race Day results (Rule   Race Day results (Rule   Race Day results (Rule
                                        3321).                   3321).                   3321).
----------------------------------------------------------------------------------------------------------------
             Note: Sanctions apply for each Controlled Medication Substance detected in the Sample.
           A Stacking Violation shall be treated as a single violation for the purposes of sanctions.
----------------------------------------------------------------------------------------------------------------
Use or Attempted Use or                60 days................  90 days................  120 days.
 Administration or Attempted           Fine of up to $5,000 or  Fine of up to $10,000    Fine of up to $25,000
 Administration of a Controlled         5% of the total purse    or 10% of the total      or 25% of the total
 Medication Method (Rule 3313).         (whichever is greater).  purse (whichever is      purse (whichever is
                                       Automatic                 greater).                greater).
                                        Disqualification of     Automatic                Automatic
                                        Race Day results (Rule   Disqualification of      Disqualification of
                                        3321).                   Race Day results (Rule   Race Day results (Rule
                                                                 3321).                   3321).
Use of a Controlled Medication         60 days................  90 days................  120 days.
 Substance or a Controlled Medication  Fine of up to $5,000 or  Fine of up to $10,000    Fine of up to $25,000
 Method in a manner contrary to horse   5% of the total purse    or 10% of the total      or 25% of the total
 welfare (Rule 3314).                   (whichever is greater).  purse (whichever is      purse (whichever is
                                                                 greater).                greater).
Possession of a Controlled Medication  .......................  15 days................  30 days.
 Substance/Method that is not in       Fine up to $500........  Fine up to $1,000......  Fine up to $2,500.
 compliance with applicable State or   Referral to the          Referral to the          Referral to the
 Federal law (Rule 3315(b)).            relevant State or        relevant State or        relevant State or
                                        Federal authority.       Federal authority.       Federal authority.
Complicity or Attempted complicity     Same Consequences that   Same Consequences that   Same Consequences that
 (Rule 3315(c)).                        apply to the principal   apply to the principal   apply to the principal
                                        actor, absent            actor, absent            actor, absent
                                        mitigating or            mitigating or            mitigating or
                                        aggravating              aggravating              aggravating
                                        circumstances.           circumstances.           circumstances.
----------------------------------------------------------------------------------------------------------------

    (c) Commencement of the period of Ineligibility for a Covered 
Person.
    (1) Except as otherwise provided in this Rule 3323, the period of 
Ineligibility imposed on any Covered Person shall start on the date the 
period

[[Page 5112]]

of Ineligibility is accepted or otherwise imposed in accordance with 
the Protocol.
    (2) Where a Covered Person is already serving a period of 
Ineligibility for another violation of the Protocol, any new period of 
Ineligibility shall start to run the day after the original period of 
Ineligibility ends.
    (3) Where there have been substantial delays in the adjudication 
process or other aspects of Medication Control that go well beyond the 
standard timeframes for Laboratory analyses and Results Management, and 
the Covered Person can establish that such delays are not attributable 
to him or her, the start date of the period of Ineligibility may be 
deemed back-dated to reflect such delays, but in no event may it be 
deemed back-dated to a date before the Controlled Medication Rule 
Violation last occurred.
    (d) Additional rules for certain multiple violations.
    (1) Multiple violations for the same Controlled Medication 
Substance/Method incurred by a Covered Person in relation to the same 
Covered Horse prior to delivery of an ECM Notice may (at the Agency's 
discretion) be treated together as a single Controlled Medication Rule 
Violation, unless the facts demonstrate that there was more than one 
administration. Multiple violations for the same Controlled Medication 
Substance/Method incurred by a Covered Person in relation to different 
Covered Horses prior to delivery of an ECM Notice may each be treated 
as a first Controlled Medication Rule Violation within the relevant 
category/class. Where multiple Controlled Medication Substances are 
detected in a single Post-Race Sample or Post-Work Sample, each 
Controlled Medication Substance may be treated as a separate violation 
and assigned separate penalty points.
    (2) If the Agency establishes that prior to receiving an ECM Notice 
in respect of one Controlled Medication Rule Violation the Covered 
Person committed an additional Controlled Medication Rule Violation 
that occurred 12 months or more before or after the violation asserted 
in that ECM Notice, the period of Ineligibility for the additional 
violation shall be calculated as if the additional violation were a 
stand-alone first violation, and that period of Ineligibility will run 
consecutively to (rather than concurrently with) the period of 
Ineligibility imposed for the first-notified violation. Where this Rule 
applies, the violations taken together will constitute a single 
violation for purposes of Rule 3323(b).
    (3) If the Agency establishes that the Covered Person has committed 
a further violation of the Protocol during a period of Ineligibility, 
any new period of Ineligibility shall start to run the day after the 
original period of Ineligibility ends.
    (e) Violations involving both a Banned Substance or Method and a 
Controlled Medication Substance or Method.
    Where a Covered Person is found, based on a common set of facts, to 
have committed a (1) violation involving one or more Banned 
Substance(s) or Banned Method(s), and (2) a violation involving one or 
more Controlled Medication Substance(s) or Controlled Medication 
Method(s), they shall be treated as separate violations, but shall be 
adjudicated together in consolidated proceedings pursuant to the 
procedure that applies to Anti-Doping Rule Violations under the 
Arbitration Procedures.
Rule 3324. Elimination of the Period of Ineligibility Where There Is No 
Fault or Negligence
    (a) If a Covered Person establishes in an individual case that he 
or she bears No Fault or Negligence for the Controlled Medication Rule 
Violation(s) charged, the otherwise applicable period of Ineligibility 
and other Consequences for such Covered Person shall be eliminated 
(except for those set out in Rule 3321 and Rule 3620). When the 
violation is of Rule 3312 (presence of a Controlled Medication 
Substance), the Covered Person must also establish how the Controlled 
Medication Substance entered the Covered Horse's system as a pre-
condition to application of this Rule 3324. In the event the period of 
Ineligibility otherwise applicable is eliminated pursuant to this Rule 
3324, the Controlled Medication Rule Violation shall not be considered 
a prior violation for the purpose of Rule 3323(b).
    (b) Rule 3324 only applies in exceptional circumstances. In 
particular, it will not apply where the Controlled Medication Substance 
found to be present in a Sample: (1) came from a mislabeled or 
contaminated supplement; or (2) was administered to the Covered Horse 
by veterinary or other support personnel without the knowledge of the 
Responsible Person.
    (c) A finding that the Covered Person bears No Fault or Negligence 
for a Controlled Medication Rule Violation shall not affect the 
Consequences of that violation that apply to the Covered Horse (i.e., 
Ineligibility in accordance with Rule 3322(b) and Disqualification of 
results in accordance with Rule 3321).
Rule 3325. Reduction of the Period of Ineligibility Where There Is No 
Significant Fault or Negligence (Limited to Class A/B or Equivalent)
    This Rule applies only to Controlled Medication Rule Violations 
involving Class A or Class B substances or a category of violation with 
sanctions equivalent to Class A or Class B substances. Reductions under 
this Rule 3325 are mutually exclusive and not cumulative, i.e., no more 
than one of them may be applied in a particular case.
    (a) General rule.
    Where the Covered Person establishes that he or she bears No 
Significant Fault or Negligence for the Controlled Medication Rule 
Violation in question, then (unless Rule 3325(b) or 3325(c) applies) 
the period of Ineligibility may be reduced, depending on the Covered 
Person's degree of Fault, but the reduced period of Ineligibility may 
not be less than one-half of the otherwise applicable period of 
Ineligibility.
    (b) Specified Substances.
    Where the Covered Person establishes that he or she bears No 
Significant Fault or Negligence for the Controlled Medication Rule 
Violation in question, and the violation involves only a Specified 
Substance, the period of Ineligibility shall be, at a minimum, a 
reprimand and no period of Ineligibility, and, at a maximum, the 
otherwise applicable period of Ineligibility, depending on the Covered 
Person's degree of Fault.
    (c) Contaminated Products or other contamination.
    Where the Covered Person establishes that he or she bears No 
Significant Fault or Negligence for the Controlled Medication Rule 
Violation in question and that the Controlled Medication Substance in 
question came from a Contaminated Product or from another form of 
contamination, the period of Ineligibility shall be, at a minimum, a 
reprimand and no period of Ineligibility, and, at a maximum, the 
otherwise applicable period of Ineligibility, depending on the Covered 
Person's degree of Fault.
Rule 3326. Elimination, Reduction, or Suspension of Period of 
Ineligibility or Other Consequences for Reasons Unrelated to Degree of 
Fault
    (a) Substantial Assistance. The Agency may suspend all or part of 
the Consequences imposed on a Covered Person in an individual 
Controlled Medication Rule Violation case--other

[[Page 5113]]

than Disqualification of results pursuant to Rule 3321--based on the 
following:
    (1) The Covered Person provides Substantial Assistance to the 
Agency, the Authority, or a State Racing Commission, a criminal 
authority, or a professional disciplinary body that results in:
    (i) the Agency discovering or bringing forward an Anti-Doping Rule 
Violation or a Controlled Medication Rule Violation by another Covered 
Person; or
    (ii) a criminal or disciplinary body discovering or bringing 
forward a sport-related criminal offense or the breach of professional 
or sports rules by another Person, including offenses arising out of a 
sport integrity violation or sport safety violation, or the violation 
of any rule or requirement in the Act, and the information provided by 
the Covered Person providing Substantial Assistance is also made 
available to the Agency.
    (2) The extent to which the otherwise applicable period of 
Ineligibility may be suspended shall be based on the seriousness of the 
Controlled Medication Rule Violation committed by the Covered Person 
and the degree to which the Substantial Assistance provided by the 
Covered Person assists the effort to promote doping-free racing, 
compliance with the Protocol, or the integrity of racing. In any event, 
no more than three-quarters of the otherwise applicable period of 
Ineligibility may be suspended. For purposes of this Rule 3326, the 
otherwise applicable period of Ineligibility shall not include any 
period of Ineligibility that could be added under Rule 3323(d)(2).
    (3) If so requested, the Agency shall allow the Covered Person who 
seeks to provide Substantial Assistance to provide the information to 
the Agency subject to a Without Prejudice Agreement.
    (4) If the Covered Person fails to continue to cooperate or fails 
to provide the complete, accurate, and credible Substantial Assistance 
promised, the Agency shall reinstate the original Consequences. That 
decision is not subject to review.
    (b) Voluntary Admission of a Controlled Medication Rule Violation 
in the absence of other evidence. If (1) the Covered Person voluntarily 
admits the commission of a Controlled Medication Rule Violation before 
receiving the ECM Notice or (in the case of a Rule 3312 violation) 
before having received notice of a Sample collection that could 
establish the Controlled Medication Rule Violation, and (2) that 
admission is the only reliable evidence of the violation at the time 
the admission is made, the otherwise applicable period of Ineligibility 
may be reduced by up to one-half.
    (c) Application of multiple grounds for reduction of a sanction. If 
the Covered Person establishes entitlement to a reduction or suspension 
of the period of Ineligibility under 2 or more of Rules 3324, 3325, or 
3326, the otherwise applicable period of Ineligibility shall be 
determined in accordance with Rules 3323, 3324, and 3325 before 
applying any reduction or suspension under Rule 3326. If the Covered 
Person establishes entitlement to a reduction or suspension of the 
period of Ineligibility under Rule 3326, up to three-quarters of the 
otherwise applicable period of Ineligibility may be reduced or 
suspended.
    (d) Reductions for certain Controlled Medication Rule Violations 
based on early admission and acceptance of sanction. If the Covered 
Person admits the violation and accepts the asserted period of 
Ineligibility no more than 7 days after receiving the Charge Letter, 
the period of Ineligibility to be served will be automatically reduced 
by one-half (but no further reduction shall be allowed under any other 
Rule).
Rule 3327. Aggravating Circumstances
    (a) If the Agency establishes in an individual Controlled 
Medication Rule Violation case that Aggravating Circumstances are 
present, the period of Ineligibility otherwise applicable shall be 
increased by up to 6 months depending on the seriousness of the 
Aggravating Circumstances, unless the Covered Person establishes that 
he or she did not knowingly commit the Controlled Medication Rule 
Violation. Where the period of Ineligibility is increased pursuant to 
this Rule, an additional fine of up to $5,000 or an additional 5% of 
the total purse (whichever is greater) may also be imposed.
    (b) Actions and circumstances constituting Aggravating 
Circumstances include:
    (1) Administration of a Controlled Medication Substance or Use of a 
Controlled Medication Method that is detrimental to the health and 
welfare of the horse or is designed to deceive the betting public;
    (2) prior violations under the Protocol; or
    (3) the Covered Person engaged in deceptive or obstructive conduct 
to avoid the detection or adjudication of a Controlled Medication Rule 
Violation, for which the Covered Person has not been separately 
sanctioned for Tampering.
    (c) For the avoidance of doubt, the examples set out in Rule 
3327(b) are not exhaustive and other similar circumstances or conduct 
may also be deemed to amount to Aggravating Circumstances that justify 
the imposition of a longer period of Ineligibility.
Rule 3328. Penalty Points System for Multiple Controlled Medication 
Rule Violations
    (a) The penalty points system established in this Rule 3328 does 
not replace or lessen in any way the Consequences that apply to the 
underlying Controlled Medication Rule Violation. Rather, the penalty 
points system is intended to apply additional uniform Consequences 
where the Covered Person is a repeat offender and exceeds the 
permissible number of points.
    (b) Covered Persons shall be assigned penalty points as set out in 
the table below for each Controlled Medication Rule Violation that they 
commit. The imposition of the specified penalty points is automatic, 
without any consideration of mitigating or aggravating circumstances, 
except that:
    (1) no points shall be assigned for any violations (i) where the 
Covered Person was found to bear No Fault or Negligence, or (ii) 
resulting from environmental contamination;
    (2) fewer or no points may be assigned where the Covered Person 
provides Substantial Assistance in accordance with Rule 3326; and
    (3) the penalty points for a complicity or Attempted complicity 
violation may be adjusted if there are mitigating or aggravating 
circumstances.

------------------------------------------------------------------------
   Controlled medication rule violation            Penalty points
------------------------------------------------------------------------
Presence, Use or Attempted Use, or
 Administration or Attempted
 Administration of a Controlled Medication
 Substance:
    Class A...............................  3.
    Class B...............................  2.
    Class C...............................  1\1/2\.
------------------------------------------------------------------------

[[Page 5114]]

 
   Note: Points are assigned for each Controlled Medication Substance
   detected in the Sample. A Stacking Violation shall be treated as a
                            single violation.
------------------------------------------------------------------------
Use of a Controlled Medication Substance    3.
 or a Controlled Medication Method in a
 manner contrary to horse welfare.
Use or Attempted Use or Administration or   3.
 Attempted Administration of a Controlled
 Medication Method.
Possession of a Controlled Medication       1.
 Substance or Controlled Medication Method
 that is not in compliance with applicable
 State or Federal law.
Complicity or Attempted complicity in a     Same number of points that
 Controlled Medication Rule Violation        apply to the Responsible
 committed by another Person.                Person, absent mitigating
                                             or aggravating
                                             circumstances.
Violation of Rule 3329....................  Same number of points as
                                             were assigned for the
                                             underlying violation.
------------------------------------------------------------------------

    (c) In addition to the Consequences applicable to the underlying 
Controlled Medication Rule Violation, the following Consequences shall 
be imposed based on the cumulative points contained in the Covered 
Person's official record:

------------------------------------------------------------------------
                                                       Additional period
              Cumulative penalty points                of ineligibility
                                                            (days)
------------------------------------------------------------------------
6-7.................................................                  30
7.5-9...............................................                  60
9.5-12..............................................                  90
12.5 or more........................................                 180
------------------------------------------------------------------------

    (d) Penalty points and the additional period of Ineligibility shall 
be applied automatically at the conclusion of the proceeding on the 
underlying violation, without any additional hearing or right of 
review. Penalty points shall be applied retroactively to start on the 
date on which the Controlled Medication Rule Violation occurred and 
shall expire after 2 years.
    (e) The additional period of Ineligibility imposed based on penalty 
points shall run consecutive to any period of Ineligibility imposed for 
the underlying Controlled Medication Rule Violation.
    (f) A Covered Person's official record of cumulative penalty points 
shall be maintained by the Agency.
Rule 3329. Status During Provisional Suspension or Ineligibility
    (a) While serving a Provisional Suspension or period of 
Ineligibility for a Controlled Medication Rule Violation:
    (1) a Covered Horse may not participate in any Timed and Reported 
Workout or Covered Horserace, but shall remain subject to Testing;
    (2) a Covered Person may not participate in any capacity in any 
activity involving Covered Horses, or in any other activity (other than 
authorized anti-doping education or rehabilitation programs) taking 
place at a Racetrack or Training Facility, nor shall he or she permit 
anyone to participate in any capacity on his or her behalf in any such 
activities, except to the extent that the Covered Person is an Owner 
and the activity is necessary to ensure the safekeeping and wellbeing 
of the horse during the period of such Owner's Provisional Suspension 
or Ineligibility.
    (b) The Covered Horse(s) of an Owner or Trainer who is subject to a 
Provisional Suspension or period of Ineligibility shall be subject to 
the following restrictions:
    (1) The Covered Horse(s) of a Trainer who is subject to a 
Provisional Suspension or period of Ineligibility may not participate 
in any Timed and Reported Workout or Covered Horserace unless and until 
they have been transferred to another Covered Person, except that such 
Covered Horses may participate in a Covered Horserace if they were 
entered in the race before the Trainer was notified of the Provisional 
Suspension or the period of Ineligibility was imposed or accepted 
(whichever is earlier). For the ``transfer'' to be valid, (i) the 
transfer must be registered with the Authority in accordance with its 
procedures, and (ii) if the Trainer is subject to a period of 
Ineligibility of more than 30 days, the Covered Horses must also be 
physically relocated to facilities under the care or control of a 
Covered Person who is not affiliated with the suspended Trainer (and 
failure to comply may constitute an Anti-Doping Rule Violation under 
Rule 3216(c), i.e., Prohibited Association).
    (2) The Covered Horse(s) of an Owner who is subject to a 
Provisional Suspension or period of Ineligibility may not participate 
in any Timed and Reported Workout or Covered Horserace unless and until 
they have been transferred in a bona fide transaction to a different 
Owner. If an Immediate Family Member has any ownership or property 
interest in the Covered Horse(s) following such transfer, the transfer 
shall not constitute a bona fide transaction to a different Owner.
Rule 3330. Consequences for Violation of the Prohibition on 
Participation During Ineligibility or Provisional Suspension Under Rule 
3329
    (a) Consequences for violation of the prohibition on participation 
during Ineligibility.
    (1) If a Covered Person violates the prohibition against 
participation during Ineligibility described in Rule 3329, any results 
obtained from such participation shall be Disqualified and a new period 
of Ineligibility equal in length to the original period of 
Ineligibility shall be added to the end of the Covered Person's 
original period of Ineligibility.
    (2) If a Covered Horse participates in any Timed and Reported 
Workout or Covered Horserace in violation of the prohibition against 
participation during Ineligibility described in Rule 3329, any results 
obtained from such participation shall be Disqualified, and the 
Responsible Person for that Covered Horse shall receive the following 
period of Ineligibility:
    (i) if the Responsible Person was subject to an original period of 
Ineligibility, a new period of Ineligibility equal in length to the 
original period of Ineligibility shall be added to the end of the 
original period of Ineligibility. If the original period of 
Ineligibility has already expired, the new period of Ineligibility 
shall start on the date that it is accepted or imposed; or
    (ii) if the Responsible Person was not subject to an original 
period of Ineligibility, the period of Ineligibility for violating Rule 
3329 shall be from a reprimand to 1 year, depending on the Covered 
Person's degree of Fault.
    (b) Consequences for violation of the prohibition on participation 
during Provisional Suspension.
    (1) A Covered Person who violates the prohibition against 
participation during a Provisional Suspension shall receive no credit 
for any period of Provisional

[[Page 5115]]

Suspension served and the results of such participation shall be 
Disqualified.
    (2) If a Covered Horse participates in any Timed and Reported 
Workout or Covered Horserace in violation of the prohibition against 
participation during a Provisional Suspension described in Rule 3329, 
the Responsible Person for that Covered Horse and the Covered Horse 
shall receive no credit for any period of Provisional Suspension served 
and the results of such participation shall be Disqualified.
    (c) The consequence of Disqualification under this Rule 3330 shall 
be the same as set out in Rule 3321(c).
    (d) The Internal Adjudication Panel (or the Agency, if the Covered 
Person admits the violation and accepts the consequences) shall 
determine whether there has been a violation of the prohibition against 
participation during Provisional Suspension or Ineligibility and apply 
the appropriate consequences pursuant to Rule 3361.
Rule 3331. Automatic Public Disclosure
    A mandatory part of each sanction shall include automatic Public 
Disclosure in accordance with Rule 3620.
Rule 3332. Conditions Precedent to Reinstatement for Covered Persons
    (a) To be reinstated after commission of a Controlled Medication 
Rule Violation, the Covered Person must have respected his or her 
period of Ineligibility (Rule 3329); and repaid or surrendered any 
purses and other compensation, prizes, trophies, points, and rankings 
forfeited pursuant to Rule 3321, and paid any fines and reimbursed any 
costs imposed or accepted to the Agency, unless an installment plan was 
established pursuant to Rule 3332(b), in which case the Covered Person 
must have made all payments due under that plan. If any installment(s) 
subsequently become(s) overdue under that plan (i.e., after 
reinstatement), the Covered Person and the Covered Horses under his or 
her ownership or training may not participate in any Timed and Reported 
Workout or Covered Horserace until such overdue installment(s) is/are 
paid in full.
    (b) Where fairness requires, the Agency or the Internal 
Adjudication Panel may establish an installment plan for repayment of 
amounts due to be paid or reimbursed under the Protocol. The payment 
schedule may extend beyond any period of Ineligibility imposed upon the 
Covered Person.
Rule 3333. Conditions Precedent to Reinstatement for Covered Horses
    (a) A Covered Horse shall be reinstated once its period of 
Ineligibility ends, provided that (1) the Ineligibility has been 
respected in full throughout that period in accordance with Rule 3329, 
(2) the Covered Horse has been made available for Testing during that 
period in accordance with Rule 3132(d), and (3) the Covered Horse has 
completed any Vets' List Workout(s) required by the Racetrack Safety 
Program or the Agency (for the avoidance of doubt, such workouts may be 
scheduled prior to the expiry of the period of Ineligibility and will 
not constitute a violation of Rule 3329).
    (b) Any reinstatement pursuant to this Rule 3333 is without 
prejudice to any rest or stand down period that may be imposed on the 
Covered Horse (e.g., due to injuries), and any requirements for release 
from the Veterinarians' List, pursuant to the Racetrack Safety Program.

3340. Results Management

Rule 3341. General
    Where there is evidence of a potential Controlled Medication Rule 
Violation(s), the Agency will conduct Results Management in accordance 
with this section 3340 and the Testing and Investigations Standards.
Rule 3342. Review of Adverse Analytical Findings
    (a) Upon receipt of an Adverse Analytical Finding in relation to an 
A Sample, the Agency will conduct a review of the Laboratory 
certificate of analysis supporting the Adverse Analytical Finding and 
the relevant Sample collection documentation and Testing documents to 
determine whether the Adverse Analytical Finding was caused by any 
apparent departure from the Testing and Investigations Standards, the 
Laboratory Standards, or any provision of the Protocol. Subject to Rule 
3342(b), the Agency may, but does not have to, communicate with the 
Responsible Person and Owner during such review.
    (b) If the review under Rule 3342(a) reveals an apparent departure 
that caused the Adverse Analytical Finding, the entire test shall be 
considered negative, and the Agency shall promptly inform the 
Responsible Person and each Interested Party of that fact.
    (c) If the initial review of an Adverse Analytical Finding under 
Rule 3342(a) does not reveal an apparent departure that caused the 
Adverse Analytical Finding, the Agency shall promptly send an ECM 
Notice to the Responsible Person and each Interested Party in 
accordance with Rule 3345.
Rule 3343. Review of Atypical Findings Relating to Controlled 
Medication Substances
    (a) In certain circumstances, Laboratories may report the presence 
of certain Controlled Medication Substances as ``Atypical Findings'' in 
accordance with the Atypical Findings Policy set out at Appendix 1. 
Upon receipt of an A Sample Atypical Finding, the Agency will conduct a 
review to determine whether the Atypical Finding was caused by a 
departure from the Testing and Investigations Standards, the Laboratory 
Standards, or any provision of the Protocol. If that review does not 
reveal any departure that caused the Atypical Finding, the Agency will 
conduct an investigation (including directing any Further Analysis) or 
take any other steps required to decide whether the Atypical Finding 
should be brought forward as an Adverse Analytical Finding, in 
accordance with the Atypical Findings Policy.
    (b) The Agency may, but does not have to, provide notice of an 
Atypical Finding to anyone until it has made that decision unless one 
of the following circumstances exists:
    (1) if the Agency determines that the B Sample should be analyzed 
prior to the conclusion of its investigation, the Agency may conduct 
the B Sample analysis after notifying the Responsible Person and the 
Owner, with such notice to include a description of the Atypical 
Finding and the information described in Rule 3345; or
    (2) if the Atypical Finding is likely connected to a serious 
pathology that requires urgent veterinary attention.
    (c) If the Agency ultimately decides not to pursue the Atypical 
Finding as an Adverse Analytical Finding, the Agency may, but does not 
have to, communicate that fact to the Responsible Person and Owner 
unless he or she has previously received notice of the Analytical 
Finding pursuant to Rule 3343(b).
    (d) If the Agency decides to move forward with the matter as an 
Adverse Analytical Finding, the Agency shall promptly send an ECM 
Notice to the Responsible Person and each Interested Party.
Rule 3344. Review of Other Evidence of a Potential Controlled 
Medication Rule Violation
    The Agency shall conduct any follow-up investigation required into 
any potential Controlled Medication Rule Violation not covered by Rules 
3342 or 3343. At such time as the Agency is

[[Page 5116]]

satisfied that it has sufficient evidence to establish that a 
Controlled Medication Rule Violation occurred, it shall promptly send 
an ECM Notice to the relevant Covered Person and each Interested Party.
Rule 3345. ECM Notice
    (a) Where it is determined that a Covered Person may have committed 
one or more Controlled Medication Rule Violations, the Agency will 
promptly notify the Covered Person and each Interested Party in writing 
of the following (the ECM Notice):
    (1) the alleged Controlled Medication Rule Violation and the 
Consequences if it is agreed or determined to have been committed;
    (2) the Adverse Analytical Finding (with a copy of the Laboratory 
certificate of analysis in a form designated by the Agency) or a brief 
summary of the facts relied on by the Agency to assert the alleged 
violation (including, where applicable, the name of the Covered Horse 
implicated in the alleged violation, whether the alleged violation was 
in connection with a particular Covered Horserace, and the date of 
Sample collection or of the other relevant facts said to give rise to 
the violation);
    (3) if applicable, the right of the Responsible Person and the 
Owner to receive copies of the A Sample Laboratory Documentation 
Package after the B Sample analysis has been completed or after such 
analysis is waived;
    (4) if applicable, the following details regarding the B Sample 
analysis:
    (i) that the B Sample has been (or will be) analyzed because the 
Agency has authorized immediate analysis to preserve the scientific 
integrity of the Sample;
    (ii) if the B Sample has not been analyzed, the Responsible 
Person's and Owner's right to promptly request the analysis of the B 
Sample within no more than 5 days or (failing such request) that the B 
sample analysis shall be deemed to be waived;
    (iii) an explanation that where the Responsible Person or Owner 
requests the B Sample analysis within the applicable deadline, or where 
the Agency decides to proceed with the B Sample analysis, the Agency 
will notify the Responsible Person and Owner of the date, time, and 
place where the B Sample will be analyzed and (where the analysis is 
requested by the Responsible Person or Owner) the amount that the 
Responsible Person or Owner must pay to have the B Sample tested and B 
Sample Laboratory Documentation Package prepared, and the date by which 
such payment must be received, failing which the B Sample analysis 
shall be deemed to have been waived; and
    (5) the opportunity for the Covered Person to provide an 
explanation within a short deadline set by the Agency;
    (6) the opportunity to provide Substantial Assistance, to admit the 
Anti-Doping Rule Violation, or to seek to resolve the matter without a 
hearing under Rule 3349;
    (7) all relevant details relating to any Provisional Suspension 
(including, if applicable, the possibility to accept a voluntary 
Provisional Suspension) in accordance with Rule 3347; and
    (8) if applicable, the ability for the automatic Disqualification 
of results to be applied immediately in accordance with Rule 
3321(a)(2).
    (b) Before sending an ECM Notice, for purposes of Rule 3323, the 
Agency shall seek to determine whether the Covered Person in question 
has committed any prior violations under the Protocol.
    (c) Any defect in the ECM Notice (including a failure to identify 
the Covered Horseraces implicated in the alleged violation, if any) may 
be corrected by the Agency and shall not in any event invalidate the 
ECM Notice or affect the due application of the provisions of the 
Protocol (including the Disqualification provisions) in relation to 
that violation.
Rule 3346. B Sample Analysis
    (a) Arrangements shall be made for analysis of the B Sample without 
undue delay, in accordance with the Protocol and the Laboratory 
Standards. Subject to Rule 3346(b), the Responsible Person or Owner 
must pay the costs of the B Sample analysis in advance, but, if the B 
Sample analysis does not confirm the A Sample analysis, they will be 
reimbursed that cost by the Agency. The Responsible Person and Owner 
and one representative each may attend the Laboratory to witness the 
opening and identification of the B Sample. They do not have any right 
to witness the analysis of the B Sample.
    (b) The Responsible Person and Owner may (if they both agree) waive 
analysis of the B Sample (in which case they shall be deemed to accept 
the A Sample analytical results). If waived, the Agency may nonetheless 
elect to proceed with the B Sample analysis at its own expense.
    (c) If the B Sample proves negative, the entire Test shall be 
considered negative, and the Responsible Person and Owner shall be so 
informed. In such circumstances, unless the Agency asserts a Controlled 
Medication Rule Violation under Rules 3313 or 3314 (Use), the ECM 
Notice will be withdrawn, any Provisional Suspensions imposed shall be 
deemed automatically vacated with immediate effect (without the need 
for any order from the Internal Adjudication Panel), and no further 
disciplinary action will be taken against the Responsible Person, other 
Covered Person, or Covered Horse by the Agency in relation to the 
original Adverse Analytical Finding (provided, however, that the Agency 
may investigate why the B Sample did not match the A Sample). If the 
Agency asserts that a Rule 3313 or 3314 (Use) violation has occurred, 
it shall send a Charge Letter to the Responsible Person and other 
Covered Person(s), with a copy to each Interested Party.
    (d) If the presence of a Controlled Medication Substance or the Use 
of a Controlled Medication Method is confirmed by the B Sample 
analysis, or the B Sample analysis is waived, the Agency shall send a 
Charge Letter to the Responsible Person and any other relevant Covered 
Person(s), with a copy to each Interested Party, asserting that a Rule 
3312 (presence) violation or a Rule 3313 (Use) violation (as 
applicable) has occurred.
Rule 3347. Provisional Suspensions
    (a) The Agency shall not impose a Provisional Suspension on a 
Covered Horse for a Controlled Medication Rule Violation, unless the 
violation involves a Controlled Medication Method for which the 
Prohibited List specifies a period of Ineligibility.
    (b) The Agency may impose a Provisional Suspension on a Covered 
Person for a Controlled Medication Rule Violation where it considers it 
appropriate to do so in the circumstances of the case, including where 
(1) the Covered Person admits the Controlled Medication Rule Violation 
and is likely to be subject to a period of Ineligibility, (2) there is 
an Adverse Analytical Finding for more than one Controlled Medication 
Substance and those substances are not Specified Substances, (3) the 
Covered Person has a pending Anti-Doping Rule Violation or Controlled 
Medication Rule Violation or prior violation that is likely to result 
in an increased period of Ineligibility, or (4) the individual 
represents a threat to the health, safety, or welfare of horses or the 
integrity of the sport of horseracing.
    (c) Where a Provisional Suspension is imposed pursuant to Rule 
3347(a) or (b), the Responsible Person (on his or her own behalf and on 
behalf of the Covered Horse) and any other Covered Person made subject 
to the Provisional Suspension shall be given:

[[Page 5117]]

    (1) an opportunity for a Provisional Hearing before imposition of 
the Provisional Suspension;
    (2) an opportunity for a Provisional Hearing on a timely basis 
after imposition of the Provisional Suspension; or
    (3) an opportunity for an expedited final adjudication in 
accordance with Rule 3362 on a timely basis after imposition of the 
Provisional Suspension.
    (d) Provisional Hearings shall be conducted by the Internal 
Adjudication Panel and heard via telephone or video conference call 
within the time frame specified in accordance with the Arbitration 
Procedures, except where the Internal Adjudication Panel decides to 
determine the matter based solely on the written submissions without a 
hearing. The sole issue to be determined by the Internal Adjudication 
Panel will be whether the Agency's decision to impose a Provisional 
Suspension shall be maintained. The Agency's decision to impose a 
Provisional Suspension shall be maintained unless the Responsible 
Person/Covered Person requesting the lifting of the Provisional 
Suspension establishes that:
    (1) the allegation that a Controlled Medication Rule Violation has 
been committed has no reasonable prospect of being upheld, e.g., 
because of a material defect in the evidence on which the allegation is 
based;
    (2) the Responsible Person/Covered Person charged bears No Fault or 
Negligence for the Controlled Medication Rule Violation that is alleged 
to have been committed, so that any period of Ineligibility that might 
otherwise be imposed for such offense would be completely eliminated by 
application of Rule 3324. (This ground does not apply in respect of any 
Provisional Suspension imposed on a Covered Horse);
    (3) Rule 3325 applies and the Responsible Person/Covered Person 
bears No Significant Fault or Negligence and he or she will likely be 
given a period of Ineligibility that is not longer than the period for 
which he or she has already been provisionally suspended. (This ground 
does not apply in respect of any Provisional Suspension imposed on a 
Covered Horse); or
    (4) exceptional circumstances exist that make it clearly unfair, 
taking into account all of the circumstances of the case, to impose a 
Provisional Suspension prior to the final hearing on the merits. This 
ground is to be construed narrowly and applied only in truly 
exceptional circumstances. For example, the fact that the Provisional 
Suspension would prevent the Responsible Person, Covered Person, or 
Covered Horse from participating in a particular Timed and Reported 
Workout, Covered Horserace, or other activity shall not qualify as 
exceptional circumstances for these purposes.
    (e) If the application is made before the Provisional Suspension 
comes into effect, the Provisional Suspension will not come into effect 
pending the decision on the application. If the application is made 
after the Provisional Suspension has come into effect, the Provisional 
Suspension will remain in place pending the decision on the 
application.
    (f) If it considers it appropriate to do so on the specific facts 
of the case, the Agency may lift the Provisional Suspension.
    (g) If the application to have a Provisional Suspension not 
imposed/lifted is not granted, a further application may not be made to 
lift the Provisional Suspension unless: (1) it is based on new and 
material evidence that the Responsible Person or other Covered Person 
was not aware of and could not reasonably have been aware of at the 
time he or she made the original application; or (2) there has been 
some other significant and material change in circumstances since the 
original application was decided. If the Responsible Person or other 
Covered Person makes a further application that does not meet either of 
these requirements, costs may be awarded against him or her.
    (h) Voluntary Provisional Suspension.
    (1) In all cases where a Responsible Person/Covered Person has been 
notified of or charged with a Controlled Medication Rule Violation, but 
no Provisional Suspension has been imposed on him or her or on the 
Covered Horse, that person may (on his or her own behalf and, if the 
Responsible Person, on behalf of the Covered Horse where it might be 
subject to a period of Ineligibility), voluntarily accept a Provisional 
Suspension at any time by written notice to the Agency. A copy of the 
voluntary Provisional Suspension shall promptly be provided to each 
Interested Party.
    (2) A Provisional Suspension that is voluntarily accepted will have 
effect (in the same manner as if the Provisional Suspension had been 
imposed under Rule 3347(a)) from the date that written notice of its 
acceptance is received by the Agency.
    (i) No admission will be inferred, or other adverse inference 
drawn, from the decision of a Covered Person: (1) not to make an 
application to lift a Provisional Suspension; or (2) to accept a 
voluntary Provisional Suspension.
    (j) If a Provisional Suspension is imposed or voluntarily accepted, 
and that Provisional Suspension is respected, then the Responsible 
Person/Covered Person and Covered Horse in question shall receive a 
credit for such period of Provisional Suspension against any period of 
Ineligibility that may ultimately be imposed. If the Responsible 
Person/Covered Person or Covered Horse does not respect a Provisional 
Suspension, the Responsible Person/Covered Person or Covered Horse 
shall receive no credit for any period of Provisional Suspension 
served. If a period of Ineligibility is served pursuant to a decision 
that is subsequently subject to review, the Responsible Person/Covered 
Person or Covered Horse shall receive a credit for such period of 
Ineligibility served against any period of Ineligibility that may 
ultimately be imposed on review.
    (k) Notwithstanding any other provision in this Rule 3347 or 
elsewhere in the Protocol, any Provisional Suspension imposed on a 
Covered Horse will be automatically lifted (without the need for any 
hearing) if it has been in place for a period equal to the period of 
Ineligibility specified in the Protocol or Prohibited List.
Rule 3348. Charge Letter
    If, after receipt of the Covered Person's explanation, or expiry of 
the deadline to provide such explanation, the Agency remains satisfied 
that the Covered Person has committed a Controlled Medication Rule 
Violation(s), the Agency shall promptly charge the Covered Person with 
the asserted Controlled Medication Rule Violation(s). In this letter of 
charge (Charge Letter), which will be copied to each Interested Party, 
the Agency shall:
    (a) set out the Controlled Medication Rule Violation(s) that the 
Covered Person is charged with having committed;
    (b) provide a summary of the relevant facts upon which the charge 
is based, enclosing a copy of the A Sample Laboratory Documentation 
Package and (if applicable and if requested) the B Sample Laboratory 
Documentation Package;
    (c) specify the Consequences that will apply if the charge is 
upheld;
    (d) grant a deadline of not more than 7 days from receipt of the 
Charge Letter (unless otherwise agreed by the Agency) for the Covered 
Person to either:
    (1) admit the Controlled Medication Rule Violation(s) charged and:
    (i) accept the Consequences proposed by the Agency, in which case 
the Agency will issue a decision under Rule 3349,

[[Page 5118]]

    (ii) seek to agree mitigated Consequences with the Agency pursuant 
to Rule 3349 failing which the Consequences may still be disputed at a 
hearing; or
    (iii) dispute or seek to mitigate the proposed Consequences at a 
hearing in accordance with Rule 3361 and the Arbitration Procedures; or
    (2) deny the Controlled Medication Rule Violation charged and 
dispute the proposed Consequences at a hearing in accordance with Rule 
3361 and Arbitration Procedures;
    (e) indicate that if the Covered Person does not challenge the 
Agency's assertion of a Controlled Medication Rule Violation or the 
proposed Consequences within the prescribed deadline, the Covered 
Person shall be deemed to have waived his or her right to a hearing, 
admitted the Controlled Medication Rule Violation(s) charged, and 
accepted the Consequences specified by the Agency in the Charge Letter 
(without any mitigation of those Consequences);
    (f) give the opportunity to provide Substantial Assistance in 
accordance with Rule 3326(a); and
    (g) provide all relevant details relating to any Provisional 
Suspensions (including, if applicable, the possibility to accept a 
voluntary Provisional Suspension) in accordance with Rule 3347.
Rule 3349. Case Resolution Without a Hearing
    (a) At any time prior to a final decision under the Arbitration 
Procedures: (1) the Agency may withdraw a Charge Letter for good cause, 
in which case any Provisional Suspension will be automatically lifted 
and (absent the emergence of new information) no further steps will be 
taken in relation to the violations alleged in the Charge Letter; or 
(2) the Covered Person may agree to admit the Controlled Medication 
Rule Violation(s) charged (or any other violation of the Protocol) and 
accede to specified Consequences consistent with the Protocol. In any 
such case, an adjudication under the Arbitration Procedures will not be 
required.
    (b) In the event that the Covered Person admits the Controlled 
Medication Rule Violation(s) charged and accedes to Consequences 
specified by the Agency (or is deemed to have done so in accordance 
with Rule 3348(a)(5)), the Agency will (1) promptly issue a final 
decision confirming the commission of the Controlled Medication Rule 
Violation(s) and setting out the factual basis for the decision and all 
of the Consequences to be imposed (including a brief summary of the 
reasons for any period of Ineligibility imposed, unless doing so could 
compromise an ongoing investigation or proceeding), and (2) send notice 
of the decision to each Interested Party. The Agency will also Publicly 
Disclose the decision (or a summary thereof, at the discretion of the 
Agency) in accordance with Rule 3620.
    (c) In the event that the Agency withdraws the Charge Letter, it 
will (1) promptly issue a summary decision confirming the withdrawal of 
the Charge Letter, (2) send notice of the decision to the Covered 
Person concerned, with a copy to each Interested Party, and (3) 
Publicly Disclose the decision (or a summary thereof, at the discretion 
of the Agency) in accordance with Rule 3620.
Rule 3350. Notification Requirements
    (a) Notification of Controlled Medication Rule Violations will take 
place as set out in Rule 3345 and Rule 3348. If at any point after an 
ECM Notice has been provided the Agency decides not to move forward 
with the charge, it will notify the Covered Person(s) concerned and 
each Interested Party of that decision.
    (b) Notification to a Covered Person by the Agency, for all 
purposes of the Protocol, may be accomplished either through actual or 
constructive notice. Actual notice may be accomplished by any means. 
Constructive notice shall be deemed to have been given when the 
information in question is delivered by third-party courier or U.S. 
postal mail to the Covered Person's most recent mailing address on file 
with the Authority or by email or text message to the Covered Person's 
most recent email address or mobile telephone number on file with the 
Authority.

3360. Hearings and Review of Final Decisions

Rule 3361. Procedure Before the Internal Adjudication Panel
    Where a Covered Person is alleged to have committed a Controlled 
Medication Rule Violation, a violation of Rule 3329, or any violation 
of Rule 3510, the Covered Person shall be entitled to request a hearing 
before the Internal Adjudication Panel in accordance with the 
Arbitration Procedures. However, the Internal Adjudication Panel may 
decide, in its sole discretion, to determine the matter based solely on 
the written submissions without a hearing if the Internal Adjudication 
Panel considers itself sufficiently well-informed to render a decision 
on the written submissions alone. A copy of the final decision of the 
Internal Adjudication Panel shall be sent to the Agency and the Covered 
Person(s) concerned. Where the Agency considers it necessary or 
appropriate to do so, a copy of the decision may be sent to any 
Interested Party. The decision (or a summary thereof, at the discretion 
of the Agency) shall be Publicly Disclosed as provided in Rule 3620. 
The Internal Adjudication Panel may also adjudicate any other matter 
referred to it under the Protocol, and any other matter that might 
arise from time to time under the Protocol that the Agency considers 
should be determined by the Internal Adjudication Panel.
Rule 3362. Expedited Hearing
    In Controlled Medication Rule Violation cases where the Covered 
Horse or Covered Person in question is not Provisionally Suspended and 
is likely to participate in a Covered Horserace within 45 days, the 
Agency may (if it sees fit) address the case on an expedited basis and 
shorten any deadlines in the Protocol or Arbitration Procedures 
proportionately to ensure resolution of the matter prior to the Covered 
Horserace.
Rule 3363. Finality
    Subject to Rule 3364, decisions rendered by the Internal 
Adjudication Panel under the Protocol shall be final and binding.
Rule 3364. Review of Final Decisions
    Any final decision by the Agency or the Internal Adjudication Panel 
is subject to review in accordance with section 3058 of the Act. Any 
final decision under review shall remain in effect pending resolution 
of the review unless ordered otherwise.

3500. Other Violations

Rule 3510. Other Violations Under the Protocol
    Where a Covered Person:
    (a) engages in disruptive or offensive conduct towards a Doping 
Control official or other Person involved in Doping Control that does 
not rise to the level of Tampering;
    (b) refuses or fails to cooperate promptly and completely with the 
Authority or the Agency in the exercise of their respective powers 
under the Act and the Protocol and related rules, including any refusal 
or failure to comply with Rule 3040(a)(2);
    (c) commits a Whereabouts Failure; or
    (d) refuses or fails without compelling justification to comply 
with any other provision of the Protocol (where such refusal or failure 
does not constitute an Anti-Doping Rule Violation);


[[Page 5119]]


the Covered Person will not be deemed to have committed an Anti-Doping 
Rule Violation or Controlled Medication Rule Violation. However, 
disciplinary proceedings may be brought against him or her before the 
Internal Adjudication Panel in accordance with the Arbitration 
Procedures or resolved without a hearing applying the rules of proof 
set out in Rule 3120 and following the procedures set out in section 
3360 (in each case, mutatis mutandis, i.e., amended as required to 
reflect the different context). The Agency will send the Covered Person 
at issue a notice of the alleged violation, setting out a summary of 
the relevant facts upon which the charge is based, and giving the 
Covered Person the opportunity to provide an explanation within a short 
deadline. If the Internal Adjudication Panel finds the violation 
alleged to be proven, or if the Covered Person admits the violation 
alleged and does not request a hearing to determine the consequences, 
the Internal Adjudication Panel or the Agency (as applicable) may 
impose sanctions on Covered Persons as set out in Rule 3520.
Rule 3520. Sanctions for Other Violations Under the Protocol
    (a) For a violation of Rule 3510(a) (disruptive or offensive 
conduct), the Covered Person shall be subject to, at a minimum, a 
reprimand and no period of Ineligibility, and, at a maximum, 30 days of 
Ineligibility, depending on the seriousness of the violation. A fine of 
up to $5,000 may also be imposed.
    (b) For a violation of Rule 3510(b) (refusal or failure to 
cooperate), the Covered Person shall be subject to, at a minimum, a 
reprimand and no period of Ineligibility, and, at a maximum, a period 
of Ineligibility of up to 2 years, depending on the seriousness of the 
violation. A fine of up to $15,000 may also be imposed. A failure to 
comply with Rule 3040(b)(7) will be considered a particularly serious 
violation that will ordinarily warrant the imposition of the maximum 
sanction.
    (c) For a violation of Rule 3510(c) (Whereabouts Failures), the 
Covered Person shall not be subject to any penalty for the first 
Whereabouts Failure, but shall be subject to a fine of $250 for the 
second Whereabouts Failure, and a fine of $500 for the third 
Whereabouts Failure. For any subsequent Whereabouts Failures, the fine 
will increase by $500 each time (i.e., $1,000 for the fourth failure, 
$1,500 for the fifth failure, etc.).
    (d) For a first violation of Rule 3510(d) (refusal or failure to 
comply with any other provision of the Protocol), the Covered Person 
shall be subject to, at a minimum, a reprimand and no period of 
Ineligibility, and, at a maximum, 30 days of Ineligibility, as well as 
a fine of up to $2,500, depending on the seriousness of the violation.
    (e) For any second or subsequent Rule 3510 violation, the maximum 
potential Ineligibility and potential fine will be double what the 
maximum potential Ineligibility and potential fine was for the previous 
violation.
    (f) Where a violation of Rule 3510 is alleged and the Covered 
Person represents a threat to the health, safety, or welfare of horses 
or the integrity of the sport of horseracing, the Agency may impose a 
Provisional Suspension on the Covered Person concerned pending 
resolution of the charge. The Covered Person may challenge the 
Provisional Suspension in accordance with Rule 3347 (which shall apply 
mutatis mutandis, i.e., amended as required to reflect the different 
context).

3600. Confidentiality and Reporting

Rule 3610. Notice of Violations and Confidentiality
    (a) Notice.
    (1) Notice of Anti-Doping Rule Violation or Controlled Medication 
Rule Violations shall be sent to the Covered Persons concerned, with a 
copy to each Interested Party, as set out in Rules 3245/3248 and 3345/
3348.
    (2) Notice of other violations shall be sent to the Covered Persons 
concerned. The Agency may send a copy to any Interested Party where it 
considers it necessary or appropriate to do so in the circumstances.
    (3) State Racing Commissions shall only be entitled to receive 
notice of violations of the Protocol as Interested Parties if they 
first enter into an agreement with the Agency incorporating 
confidentiality provisions required by the Agency pursuant to the Act 
or the Protocol. The Agency may, in its sole discretion, delay notice 
to the State Racing Commission for case- or investigation-related 
reasons.
    (b) Confidentiality and public reporting.
    (1) Subject to the other provisions of this paragraph (b), the 
Agency will use its reasonable endeavors to ensure that Persons under 
its control do not publicly identify Covered Horses or Covered Persons 
who are alleged to have committed a violation under the Protocol, 
unless and until (i) in presence cases, the B Sample confirms the 
results of the A Sample analysis, or the B Sample analysis is waived, 
(ii) a Provisional Suspension has been imposed or voluntarily accepted, 
(iii) a charge has been brought, or (iv) a violation has been admitted, 
whichever is earlier.
    (2) In such circumstances, subject to paragraph (3) below, the 
Agency shall publicly report:
    (i) the identity of any Covered Person who is the subject of the 
alleged violation;
    (ii) the identity of any relevant Covered Horse(s); and
    (iii) the rule violated and, where appropriate, the basis of the 
asserted violation.
    (3) The Agency shall not be required to publicly report a matter 
under this paragraph (b) if it would risk compromising an ongoing 
investigation or proceeding. When the Agency determines that an ongoing 
investigation or proceeding will no longer be compromised by public 
reporting, the Agency shall at such time make any public reporting 
required under this Rule.
    (4) The mandatory public reporting under Rule 3610(b) shall not be 
required where the Covered Person who is alleged to have committed a 
violation is a Minor. Any optional public reporting in a case involving 
a Minor shall be proportionate to the facts and circumstances of the 
case.
    (5) If at any time information pertaining to an alleged violation 
is publicly reported by a Person not affiliated with the Authority or 
the Agency, the Agency may respond to such public comment as it 
considers necessary.
    (6) The Agency may publicly report any relevant information at any 
time, including prior to delivery of notice of a violation, if the 
Agency determines that such disclosure:
    (i) concerns a violation or circumstance that poses a serious and 
imminent risk of harm to any Covered Person(s), Covered Horse(s), State 
Racing Commission(s), Racetrack(s), Race Organizer(s), Training 
Facilities, or the public; or
    (ii) is otherwise in the best interest of horseracing conducted at 
Covered Horseraces.
    (7) The Agency may at any time disclose to other Persons such 
information as the Agency considers necessary or appropriate to 
facilitate administration or enforcement of the Protocol (including 
Interested Parties and other Persons with a need to know), provided 
that each Person provides assurance satisfactory to the Agency that the 
organization will maintain all such information in confidence.
    (8) Interested Parties and other Persons may not publicly report 
any information about an alleged violation unless the information has 
been

[[Page 5120]]

publicly reported by the Agency or the Covered Person(s) concerned, or 
the Agency gives written authorization for him or her to publicly 
report the information.
Rule 3620. Public Disclosure
    (a) The Agency shall Publicly Disclose the resolution of an alleged 
violation of the Protocol no later than 20 calendar days after:
    (1) the final decision;
    (2) a resolution between the Agency and the Covered Person; or
    (3) the withdrawal of a charge or a final decision finding of no 
violation.
    (b) Public Disclosure shall include:
    (1) the name of the Covered Person who committed the violation(s) 
and any Covered Horse(s) implicated by the violation;
    (2) the Rule(s) violated;
    (3) the Prohibited Substance(s) or Prohibited Method(s) involved, 
if any;
    (4) the Consequences imposed;
    (5) any final decision or a summary thereof, unless publishing that 
decision could compromise an ongoing investigation or proceeding, and 
excluding decisions made by the Agency with respect to Atypical 
Findings pursuant to Appendix 1; and
    (6) any review rights available in respect of the decision.
    (c) The mandatory Public Disclosure required by this 3620 shall not 
be required where the Covered Person who has been found to have 
committed a violation is a Minor. Any optional Public Disclosure in a 
case involving a Minor shall be proportionate to the facts and 
circumstances of the case.
    (d) Publication shall be accomplished by, at a minimum, placing the 
required information on the Agency's website.
Rule 3630. General Reporting
    The Agency may publish general statistical reports of its Doping 
Control and Medication Control activities and may report as necessary 
on its activities to the U.S. Congress, the Commission, the Authority, 
the State Racing Commissions, and other federal or state governmental 
bodies or agencies having jurisdiction over the sport of horseracing in 
the United States. The Agency may also publish reports showing the 
names of any Covered Horses Tested and the date of each Sample 
collection.
Rule 3640. Data Privacy
    The Agency may collect, store, process, or disclose personal 
information relating to Covered Persons, Covered Horses, or other 
Persons and horses where necessary and appropriate to discharge its 
responsibilities under the Protocol, but shall take appropriate steps 
to maintain that information and its confidentiality in compliance with 
applicable law.

3700. Implementation of Decisions

Rule 3710. Application and Recognition of Decisions
    (a) Any final decision issued pursuant to the Protocol that a 
violation of the Protocol has taken place and imposing Consequences or 
other sanctions for that violation shall be automatically and 
immediately recognized, respected, enforced and given full force and 
effect by the Authority, Racetracks, Race Organizers, Training 
Facilities, all Covered Persons, and all other relevant Persons within 
their respective spheres of authority.
    (b) Where a third party with its own jurisdiction over Covered 
Persons or Covered Horses imposes consequences on them for violation of 
anti-doping or controlled medication rules that are consistent with the 
Protocol or the World Anti-Doping Code, that decision, upon review and 
acceptance by the Authority and the Agency, shall be immediately 
recognized, respected, enforced and given full force and effect by the 
Agency, the Authority, Racetracks, Race Organizers, all Covered 
Persons, and all other relevant Persons within their respective spheres 
of authority.

3800. Education

Rule 3810. Education Programs
    The Agency shall plan, implement, evaluate, and monitor education 
programs for responsible medication use and doping-free horseracing.

Rule Series 3000 Appendix 1: Atypical Finding Policy

Overview
    1. Atypical Findings occur when the Laboratory provides the results 
of its analysis of a Sample to the Agency and more investigation or 
review is needed to determine whether or not it should be treated as an 
Adverse Analytical Finding. This Atypical Findings Policy (Atypical 
Findings Policy) sets out the process by which the Agency will decide 
whether or not Atypical Findings will be pursued as Adverse Analytical 
Findings.
Prohibited Substances To Be Treated as Atypical Findings
    2. If detected in the Sample of a Covered Horse, the following 
Prohibited Substances shall be investigated or reviewed as Atypical 
Findings:
    (a) Specified Substances;
    (b) endogenous substances;
    (c) ractopamine; and
    (d) zilpaterol.
    3. The Laboratory may also report other Atypical Findings in 
relation to substances that are not specifically listed in the 
Prohibited List or Technical Document-Prohibited Substances.
Decisions Regarding Atypical Findings
    4. The Agency is responsible for issuing a decision regarding 
whether or not an Atypical Finding will be pursued as an Adverse 
Analytical Finding.
    5. Subject to the notification requirements set out below, the 
deliberations of the Agency shall be confidential.
Preliminary Steps
    6. Initial review.
    The Agency will first conduct a review to determine whether there 
is any apparent departure from any Standards or any provisions of the 
Protocol that caused the Atypical Finding. If that review does not 
reveal any departure that caused the Atypical Finding, the Agency will 
conduct the required investigation in accordance with this Atypical 
Findings Policy. The precise nature of the investigation will depend on 
basis for the Atypical Finding, including the Prohibited Substance(s) 
associated with the Atypical Finding (if applicable), and the level of 
cooperation of the Responsible Person.
    7. Notification.
    The Agency will promptly inform the Responsible Person and 
Interested Parties in writing of the Atypical Finding and any relevant 
information, such as the Covered Horserace to which the Atypical 
Finding relates, and the Responsible Person will have the opportunity 
to provide any information that he or she believes might assist the 
Agency in deciding whether or not to pursue the Atypical Finding as an 
Adverse Analytical Finding, as set forth in the criteria below. Such 
information must be provided to the Agency by the deadlines set by the 
Agency in order for it to be considered by the Agency.
    8. Additional information.
    The Agency may request such additional information or explanations 
from the Responsible Person as it considers necessary to evaluate the 
Atypical Finding, and the Responsible Person must comply fully and 
promptly with any such requests.
Criteria
    In deciding whether or not an Atypical Finding should be pursued as 
an Adverse Analytical Finding, the Agency will consider the following 
criteria:

[[Page 5121]]

    9. Proving source of the Prohibited Substance(s) as a precondition.
    (a) The Responsible Person has the burden of proving how the 
Prohibited Substance(s) entered the body of the Covered Horse. If the 
Responsible Person is unable to discharge that burden, the Atypical 
Finding must be pursued as an Adverse Analytical Finding. If the 
Responsible Person proves the source, the Agency will determine whether 
or not the Analytical Finding should be pursued as an Adverse 
Analytical Finding.
    (b) The Agency will take a number of factors into account when 
considering whether or not the source of the Atypical Finding has been 
established including, but not limited to:
    (i) if there were Atypical Findings for the same Prohibited 
Substance(s) arising from other Samples collected at the relevant 
Covered Horserace;
    (ii) if there were Atypical Findings for the same Prohibited 
Substance(s) arising from other Samples collected at previous Covered 
Horseraces held at the same Racetrack or in the same region;
    (iii) if Samples taken from feed or bedding at the relevant Covered 
Horserace (if such samples are available) test positive for the 
Prohibited Substance(s) in question;
    (iv) if there were other (non-Atypical Finding) Prohibited 
Substance(s) in the Sample; and
    (v) the concentration level of the particular Prohibited 
Substance(s) in the Sample.
    (c) In addition, the Agency may, in accordance with Rules 3246 and 
3346 of the Protocol, request the B Sample analysis.
    (d) If the Atypical Finding concerns a Prohibited Substance(s) that 
is an endogenous substance, the Agency will request that the 
Responsible Person provide any veterinary information that would assist 
in establishing if the result is due to a physiological or pathological 
condition, and such information shall be taken into account by the 
Agency.
    (e) When trying to establish the source of the Prohibited 
Substance(s) in question, the Agency may consult, as necessary, with 
one or more experts to obtain further information on the Prohibited 
Substance(s) in order to assess whether or not: (i) the explanations 
provided by the Responsible Person (if any) are plausible; or (ii) the 
presence of the Prohibited Substance(s) in the Sample is likely to be 
due to contamination.
    (f) The Agency will consider any measures the Responsible Person 
has in place to prevent Prohibited Substances entering the body of his 
or her Covered Horse(s), including:
    (i) whether or not the Responsible Person keeps up-to-date 
treatment records;
    (ii) whether or not the Responsible Person keeps a record of the 
feed and supplements given to his or her Covered Horses, and whether 
samples of such feed or supplements have been stored for potential 
analysis;
    (iii) the security measures put in place by the Responsible Person 
at his or her stables and when travelling to or attending Covered 
Horseraces; and
    (iv) other measures taken by the Responsible Person to prevent 
Prohibited Substances inadvertently entering the body of his or her 
Covered Horses.
    10. Other factors.
    The Agency may also have regard to other factors that it considers 
necessary or relevant, including, but not limited to:
    (a) the security measures in place at the relevant Covered 
Horserace;
    (b) the report(s) of the Veterinarians or stewards at the relevant 
Covered Horserace;
    (c) the prevalence of the use of the Prohibited Substance(s); and
    (d) whether or not the Responsible Person has any prior Anti-Doping 
Rule Violation(s) or Controlled Medication Rule Violation(s) (excluding 
any violations where the Responsible Person was found to bear No Fault 
or Negligence).
Conclusion of the Investigation and Notification
    11. Following the Agency's investigation of the Atypical Finding in 
accordance with the criteria above, the Agency shall decide whether or 
not the Atypical Finding should be pursued as an Adverse Analytical 
Finding. The Agency shall issue a written decision, with a short 
summary of the basis for that decision. The decision of the Agency is 
final and is not subject to review. The Agency will send a copy of its 
decision to the Responsible Person.
    12. If the Agency determines that the Atypical Finding should not 
be pursued as an Adverse Analytical Finding, no further action will be 
taken, and no case will be opened against the Responsible Person.
    13. If the Agency determines that the Atypical Finding should be 
pursued as an Adverse Analytical Finding, the Agency will follow the 
notification procedure set out in Rules 3250 and 3350 and will refer 
the matter for adjudication in accordance with the Arbitration 
Procedures (unless the matter is resolved by agreement without a 
hearing as permitted under the Protocol). The Agency may rely on any 
information submitted or obtained when investigating the Atypical 
Finding in the subsequent Adverse Analytical Finding case.
Publication of Atypical Findings
    14. At the end of each year, the Agency may publish a report 
setting out the following information, on an anonymised basis:
    (a) how many Atypical Findings were reported by Laboratories that 
year;
    (b) how many Atypical Findings were pursued as Adverse Analytical 
Findings, and the Prohibited Substances in question;
    (c) how many Atypical Findings were not pursued as Adverse 
Analytical Findings, and the Prohibited Substances in question; and
    (d) how many Atypical Findings remain under investigation.
Public Comment
    15. Unless there are compelling reasons (as determined by the 
Agency), no Person may make any public comment on the specific details 
of an Atypical Finding while the investigation is ongoing. If such a 
disclosure is made by a Person not affiliated with the Authority or the 
Agency, the Authority or the Agency may respond to such public comment 
as it considers necessary.
    16. If an Atypical Finding is not pursued as an Adverse Analytical 
Finding, no Person may make any public comment on the details of that 
Atypical Finding without the prior consent of the Responsible Person. 
If such a disclosure is made by a Person not affiliated with the 
Authority or the Agency, the Authority or the Agency may respond to 
such public comment as it considers necessary.

4000. Prohibited List

4010. Purpose
    In accordance with Rule 3111, the Prohibited List identifies 
substances and methods that are prohibited at all times (Banned 
Substances and Banned Methods) and those that are prohibited for Use or 
Administration in relation to a Covered Horse during the Race Period 
and prohibited to be present in a Post-Race Sample or Post-Work Sample, 
except as otherwise specified in the Prohibited List (Controlled 
Medication Substances and Controlled Medication Methods). In accordance 
with the definition of ``Race Period'' (see Rule 1020), the Prohibited 
List may specify that, for certain specified Controlled Medication 
Substances and Controlled Medication Methods, the Race Period shall be 
shorter or longer in duration.

[[Page 5122]]

Prohibited Substances and Prohibited Methods may be included in the 
Prohibited List by general category (e.g., anabolic steroids) or by 
specific reference to a particular substance or method. The Prohibited 
List is supplemented by the ``Technical Document--Prohibited 
Substances,'' which provides guidance on the Prohibited Substances that 
fall into the general categories listed in the Prohibited List and on 
the Screening Limits, Thresholds, or Detection Times for those 
Prohibited Substances (as applicable), and also designates certain 
Prohibited Substances as Specified Substances, which are those that 
pose a higher risk of being the result of contamination and, therefore, 
are subject to more flexible sanctions. Certain Prohibited Substances 
might also first be reported as Atypical Findings requiring further 
investigation before being declared as Adverse Analytical Findings, in 
accordance with the Atypical Findings Policy set out as Appendix 1 to 
the Protocol. The Prohibited List also sets out the periods of 
Ineligibility applicable to Covered Horses for Anti-Doping Rule 
Violations and Controlled Medication Rule Violations (see Rule 4300).

4100. Banned Substances and Banned Methods

4110. Banned Substances
Rule 4111. S0 Non-Approved Substances
    Any pharmacological substance that (i) is not addressed by Rules 
4112 through 4117, (ii) has no current approval by any governmental 
regulatory health authority for veterinary or human use, and (iii) is 
not universally recognized by veterinary regulatory authorities as a 
valid veterinary use, is prohibited at all times. For the avoidance of 
doubt, compounded products compliant with the Animal Medicinal Drug Use 
Clarification Act (AMDUCA) and the FDA Guidance for Industry (GFI) #256 
(also known as Compounding Animal Drugs from Bulk Drug Substances) are 
not prohibited under this section S0.
Rule 4112. S1 Anabolic Agents
    The following substances, and other substances with similar 
chemical structure or similar biological effect(s), are prohibited at 
all times:
    (a) anabolic androgenic steroids when administered exogenously;
    (b) other anabolic agents, including, but not limited to:
    (1) Selective Androgen Receptor Modulators (SARMs);
    (2) Zeranol;
    (3) Zilpaterol; and
    (4) Ractopamine.
Rule 4113. S2 Peptide Hormones, Growth Factors, Related Substances, and 
Mimetics
    The following substances, and other substances with similar 
chemical structure or similar biological effect(s), are prohibited at 
all times:
    (a) Erythropoietins (EPO) and agents affecting erythropoiesis, 
including, but not limited to:
    (1) erythropoietin-receptor agonists;
    (2) Hypoxia-Inducible Factor (HIF) activating agents;
    (3) GATA (Erythroid Transcription Factor) inhibitors;
    (4) Transforming Growth Factor-beta (TGF-[beta]) signaling 
inhibitors; and
    (5) innate repair receptor agonists.
    (b) Peptide Hormones and their releasing factors, including, but 
not limited to:
    (1) Chorionic Gonadotrophin (CG) and Luteinizing Hormone (LH) and 
their releasing factors in stallions, ridglings, and geldings;
    (2) corticotrophins and their releasing factors (excluding ACTH if 
administered outside the Race Period);
    (3) Growth Hormone (GH) and its analogues and fragments; and
    (4) Growth Hormone (GH) releasing factors.
    (c) Growth factors and growth factor modulators affecting muscle, 
tendon, or ligament protein synthesis/degradation, vascularization, 
energy utilization, regenerative capacity, or fiber type switching.
Rule 4114. S3 Beta-2 Agonists
    The following substances, and other substances with similar 
chemical structure or similar biological effect(s), are prohibited at 
all times: all selective and non-selective beta-2 agonists, including 
all optical isomers. Notwithstanding the above, the following are not 
prohibited under this section S3:
    (a) inhaled beta-2 agonists (e.g., albuterol, salbutamol) when 
prescribed by a Veterinarian (in the context of a valid veterinarian-
patient-client relationship) as a bronchodilator; and
    (b) clenbuterol when prescribed by a Veterinarian (in the context 
of a valid veterinarian-patient-client relationship) for a duration not 
to exceed 30 days in a 6-month period and provided that, following 
administration of clenbuterol, the Covered Horse shall be placed on the 
Veterinarians' List and shall not be eligible to participate in any 
Timed and Reported Workout or Covered Horserace until a urine and a 
blood Sample have been collected from it by or on behalf of the Agency, 
and analysis by a Laboratory of those Samples does not detect the 
presence of clenbuterol or its Metabolites or Markers.
Rule 4115. S4 Hormone and Metabolic Modulators
    The following substances, and other substances with similar 
chemical structure or similar biological effect(s), are prohibited at 
all times:
    (a) aromatase inhibitors;
    (b) anti-estrogenic substances, anti-estrogens, and selective 
estrogen receptor modulators (SERMS);
    (c) agents preventing activin receptor IIB activation, including, 
but not limited to, myostatin inhibitors;
    (d) metabolic modulators, including, but not limited to:
    (1) insulins and insulin-mimetics;
    (2) meldonium; and
    (3) trimetazidine; and
    (e) thyroid hormone and thyroid hormone modulators.
Rule 4116. S5 Diuretics and Masking Agents
    (a) Diuretics and masking agents, and other substances with a 
similar chemical structure or similar biological effect(s), are 
prohibited at all times.
    (b) Notwithstanding the above, the following are not prohibited 
under this section S5:
    (1) drospirenone, pamabrom, and topical ophthalmic administration 
of carbonic anhydrase inhibitors (e.g., dorzolamide, brinzolamide);
    (2) trichlormethiazide for treatment of edema;
    (3) plasma expanders for life-saving procedures; and
    (4) furosemide (also known as Lasix/Salix), subject to the 
limitations set out in Rule 4212(d).
Rule 4117. S6 Miscellaneous Substances
    The following substances, and other substances with similar 
chemical structure or similar biological effect(s), are prohibited at 
all times:
    (a) bisphosphonates (except that bisphosphonates may be 
administered for the purpose of diagnostic imaging, i.e., gamma 
scintigraphy);
    (b) toxins (e.g., botulinum toxin, botox);
    (c) venoms of any species, their synthetic analogs, or derivatives 
thereof;
    (d) altrenogest in stallions, ridglings, or geldings;
    (e) pitcher plant extract (Sarapin); and
    (f) perfluorocarbons.

4120. Banned Methods

Rule 4121. M1 Manipulation of Blood and Blood Components
    The following are prohibited at all times:

[[Page 5123]]

    (a) The Administration or reintroduction of any quantity of 
autologous, allogenic (homologous), or heterologous blood or red blood 
cell products of any origin into the circulatory system.
    (b) Artificially enhancing the uptake, transport, or delivery of 
oxygen, including, but not limited to: perfluorochemicals; efaproxiral 
(RSR13); and modified haemoglobin products, e.g., haemoglobin-based 
blood substitutes and microencapsulated haemoglobin products; excluding 
supplemental oxygen by inhalation.
    (c) Any form of intravascular manipulation of the blood or blood 
components by physical or chemical means.
    (d) Withdrawal of blood for any purpose other than for diagnostic/
Laboratory Testing procedures.
    (e) Notwithstanding the above, manipulation of blood or blood 
components is not prohibited under this section M1:
    (1) procedures performed for life-saving purposes; and
    (2) use of veterinary regenerative therapies (i.e., autologous 
conditioned serum or platelet-rich plasma) for the treatment of 
musculoskeletal injury or disease.
Rule 4122. M2 Chemical Castration or Immunocastration
    In case of chemical castration or immunocastration, the Covered 
Horse shall remain designated as an intact male. Designating a Covered 
Horse that has had chemical castration or immunocastration as a gelding 
constitutes Use of a Prohibited Method.
Rule 4123. M3 Gene and Cell Doping
    The following, which have the potential to enhance performance or 
modify the heritable genome, are prohibited at all times:
    (a) the use of nucleic acids or nucleic acid analogues that might 
alter genome sequences or alter gene expression by any mechanism. This 
includes, but is not limited to, gene editing, gene silencing, and gene 
transfer technologies;
    (b) the use of normal or genetically modified cells; and
    (c) modification of the heritable genome.

4200. Controlled Medication Substances and Controlled Medication 
Methods

4210. Controlled Medication Substances
Rule 4211. S7 Controlled Medication Substances
    (a) Subject to Rule 4212, only feed, hay, and water are permitted 
during the Race Period. Accordingly, subject to Rule 4212, any 
substance administered during the Race Period or present in a Post-Race 
Sample (including any metabolite(s), artifact(s), and isomer(s) of such 
substance(s)) that does not otherwise qualify as a Banned Substance 
shall constitute a prohibited Controlled Medication Substance.
    (b) The following Controlled Medication Substances are prohibited 
from presence in a Post-Work Sample:
    (1) analgesics;
    (2) Nonsteroidal Anti-Inflammatory Drugs (NSAIDs);
    (3) local anesthetics; and
    (4) corticosteroids.
    (c) S7 Controlled Medication Substances exclude those substances 
that fall under section S0, which are Banned Substances.
Rule 4212. Exceptions to Rule 4211
    (a) Medications administered or authorized by a Regulatory 
Veterinarian or Test Barn Veterinarian to provide medical care to a 
Covered Horse as a result of an injury sustained, or other adverse 
health event, during the Race Period are not prohibited.
    (b) The following may be administered up to 24 hours prior to Post-
Time:
    (1) orally administered vitamins;
    (2) licensed vaccines against infectious agents;
    (3) anti-ulcer medications (e.g., Cimetidine, Omeprazole, and 
Ranitidine);
    (4) unsupplemented isotonic electrolyte solutions by oral or 
intravenous administration;
    (5) altrenogest in female horses;
    (6) antimicrobials (antibiotics) and other anti-infective agents, 
excluding procaine penicillin or other antimicrobial/anti-infective 
agents containing or metabolizing to Prohibited Substances; and
    (7) antiparasitic/anthelmintics approved and registered for use in 
horses, excluding levamisole or other antiparasitic/anthelmintics 
metabolizing to or containing other Prohibited Substances.
    (c) Unsupplemented isotonic electrolyte solutions may be consumed 
by the horse's free choice at any time (but may not be administered 
except as provided in paragraph (b) above).
    (d) Furosemide (also known as Lasix or Salix):
    (1) is permitted during Timed and Reported Workouts and Vets' List 
Workouts; and
    (2) may be administered during the Race Period in accordance with 
specific provisions of the Act and any guidance or exceptions approved 
by the Authority, but shall not be administered within the 4 hours 
prior to Post-Time.
    (e) The Use or Administration of supplements or feed additives 
during the Race Period shall not be prohibited if the Responsible 
Person or Covered Person establishes, or the Agency expressly accepts, 
that such substances are not capable at any time of causing an action 
or effect, or both an action and effect, within one or more of the 
following mammalian body systems:
    (1) the blood system;
    (2) the urinary system;
    (3) the cardiovascular system;
    (4) the digestive system;
    (5) the endocrine system;
    (6) the immune system;
    (7) the musculoskeletal system;
    (8) the nervous system;
    (9) the reproductive system; or
    (10) the respiratory system.
4220. Controlled Medication Method(s)
    In addition to any prohibited practices set forth in the Rule 2000 
Series (Racetrack Safety Program):
Rule 4221. M4 Alkalinization or Use/Administration of an Alkalinizing 
Agent
    Alkalinization or Use/Administration of an alkalinizing agent is 
prohibited on Race Day. A threshold concentration of total carbon 
dioxide (TCO2) in the blood in excess of 37 mmol constitutes prima 
facie evidence of alkalinization or Use/Administration of an 
alkalinizing agent.
Rule 4222. M5 Intra-Articular Injections
    Intra-articular injections are prohibited on Race Day; within 14 
days prior to Post-Time; and within 7 days prior to any Timed and 
Reported Workout.
Rule 4223. M6 Nasogastric Tube
    The use of a nasogastric tube for any purpose is prohibited within 
24 hours prior to Post-Time.
Rule 4224. M7 Intra-Articular Injections of Polyacrylamide Hydrogels
    Intra-articular injections of polyacrylamide hydrogels are 
prohibited within 180 days prior to Post-Time.
Rule 4225. Modification of Race Period
    The start of the ``Race Period'' shall be modified for each of the 
Controlled Medication Methods above (i.e., each of M4-M7) based on the 
restricted administration time period specified for such method (e.g., 
the Race Period for M7 shall start180 days prior to Post-Time).

[[Page 5124]]

4300. Ineligibility Periods for Covered Horse

4310. Violations Involving Prohibited Substances
    The period of Ineligibility of a Covered Horse resulting from a 
violation involving a Prohibited Substance shall be as set forth in 
Table 1 below:

                                 Table 1
------------------------------------------------------------------------
               Violation                       Ineligibility period
------------------------------------------------------------------------
S0 BANNED Substances-non-approved        Up to 14 months
 substances.
S1 BANNED Substances-anabolic agents...  14 months
S2 BANNED Substances-peptide hormones..  6 months
S3 BANNED Substances-beta-2 agonists...  14 months
S4 BANNED Substances-hormone and         3 months
 metabolic modulators.
S5 BANNED Substances-diuretics and       0 months
 masking agents.
S6 BANNED Substances-miscellaneous
 substances:
    (1) Bisphosphonates................  Life
    (2) All other S6 miscellaneous       0 months.
     substances.
S7 CONTROLLED Medication Substances....  0 months.
                                         The Covered Horse may be placed
                                          on the Veterinarians' List,
                                          and if so, a subsequent Vets'
                                          List Workout must be
                                          scheduled. A post-Vets' List
                                          Workout Sample may be required
------------------------------------------------------------------------

4320. Violations Involving Prohibited Methods
    The period of Ineligibility of a Covered Horse resulting from a 
violation involving a Prohibited Method shall be as set forth in Table 
2 below:

                                 Table 2
------------------------------------------------------------------------
               Violation                       Ineligibility period
------------------------------------------------------------------------
M1 Manipulation of blood and blood       6 months.
 components.
M2 Chemical castration or                0 months.
 immunocastration.
M3 Gene and cell doping................  Life.
M4 Alkalinization......................  0 months.
M5 Intra-articular injection...........  1 month.
M6 Nasogastric tube....................  0 months.
M7 Intra-articular injection of          12 months.
 polyacrylamide hydrogel.
------------------------------------------------------------------------

4330. Other Violations Leading to a Period of Ineligibility for the 
Covered Horse
    The period of Ineligibility of a Covered Horse resulting from a 
violation of Rule 3215 shall be as set forth in Table 3 below:

                                 Table 3
------------------------------------------------------------------------
               Violation                       Ineligibility period
------------------------------------------------------------------------
Evading collection of a Sample from a    Evasion: 18 months.
 Covered Horse; refusing or failing      Refusal or failure: 18 months,
 without compelling justification to      unless it is established by
 submit a Covered Horse to Sample         the Responsible Person that
 collection; or refusing or failing to    fairness requires otherwise,
 comply with all Sample collection        in which case the period of
 procedure requirements (Rule 3215).      Ineligibility may be reduced,
                                          depending on the specific
                                          circumstances of the case and
                                          considerations of horse
                                          welfare.
------------------------------------------------------------------------

Appendix 1 to Rule Series 4000: Technical Document--Prohibited 
Substances

[[Page 5125]]



--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                Penalty
                                           subclassification                                           Commercial
                                  HISA         (specified                                               name(s)                          Screening limit
        HISA listed as           status      substances are        Substance          Action         (developmental    Detection time           *
                                            designated with                                              names)
                                                  `x')
--------------------------------------------------------------------------------------------------------------------------------------------------------
BANNED........................  S1        ...................  [Delta]-1-        Anabolic........  Lacks FDA
                                                                androstene-3,                       approval. DEA
                                                                17diol.                             Schedule III.
BANNED........................  S1        ...................  [Delta]-1-        Anabolic........  Lacks FDA
                                                                androstene-3,                       approval. DEA
                                                                17dione.                            Schedule III.
BANNED........................  S1        ...................  [Delta]-1-        Anabolic........  Lacks FDA
                                                                dihydrotestoste                     approval. DEA
                                                                rone.                               Schedule III.
BANNED........................  S1        ...................  19-               Anabolic........  Lacks FDA
                                                                Norandrostenedi                     approval. DEA
                                                                ol.                                 Schedule III.
BANNED........................  S1        ...................  19-               Anabolic........  Lacks FDA
                                                                Norandrostenedi                     approval. DEA
                                                                one.                                Schedule III.
BANNED........................  S1        ...................  19-               Anabolic........  Lacks FDA
                                                                Noretiocholanol                     approval.
                                                                one.
BANNED........................  S1        ...................  1-androstenediol  Anabolic........  Lacks FDA
                                                                (5[alpha]                           approval. DEA
                                                                androst-1-ene-                      Schedule III.
                                                                3[beta],
                                                                17[beta]diol).
BANNED........................  S1        ...................  1-                Anabolic........  Lacks FDA
                                                                androstenedione                     approval. DEA
                                                                (5[alpha]andros                     Schedule III.
                                                                t-1-ene-3,
                                                                17dione).
BANNED........................  S1        ...................  1-testosterone    Anabolic........  Lacks FDA
                                                                (17[beta]hydrox                     approval. DEA
                                                                y-5[alpha]-                         Schedule III.
                                                                androst-1en-3-
                                                                one).
BANNED........................  S0        ...................  2-Aminoheptane    Sympathomimetic/  Lacks FDA
                                                                (Tuaminoheptane   Vasoconstrictor.  approval.
                                                                ).
BANNED........................  S4        ...................  2-                Pheromone/        Lacks FDA
                                                                androstenol(5[a   Reproductive      approval.
                                                                lpha]-            Hormone.
                                                                androstane-2-en-
                                                                17-ol).
BANNED........................  S4        ...................  2-androstenone    Pheromone/        Lacks FDA
                                                                (5[alpha]-        Reproductive      approval.
                                                                androst-2-en-17-  Hormone.
                                                                one).
BANNED........................  S0        ...................  3,4-              Stimulant.......  Lacks FDA
                                                                methylenedioxyp                     approval.
                                                                yrovalerone
                                                                (MDVP).
BANNED........................  S4        ...................  3-androstenol     Pheromone/        Lacks FDA
                                                                (5[alpha]-        Reproductive      approval.
                                                                androst-3-en-17-  Hormone.
                                                                ol).
BANNED........................  S4        ...................  3-androstenone    Pheromone/        Lacks FDA
                                                                (5[alpha]-        Reproductive      approval.
                                                                androst-3-en-17-  Hormone.
                                                                one).
BANNED........................  S4        ...................  4-androstenediol  Anabolic........  Lacks FDA
                                                                (androst-4-ene-                     approval. DEA
                                                                3[beta],17[beta                     Schedule III.
                                                                ]diol).
BANNED........................  S4        ...................  4-                Anabolic........  Lacks FDA
                                                                chloromethatand                     approval. DEA
                                                                ienone.                             Schedule III.
BANNED........................  S1        ...................  4-                Anabolic........  Lacks FDA
                                                                Hydroxytestoste                     approval. DEA
                                                                rone.                               Schedule III.
BANNED........................  S4        ...................  5-                Anabolic........  Lacks FDA
                                                                androstenedione                     approval. DEA
                                                                (androst-5- ene-                    Schedule III.
                                                                 3,17dione).
BANNED........................  S1        ...................  5[alpha]-Andros-  Anabolic........  Lacks FDA
                                                                2-ene-17one.                        approval. DEA
                                                                                                    Schedule III.
BANNED........................  S1        ...................  5[alpha]-         Anabolic........  Lacks FDA
                                                                Androstane-                         approval. DEA
                                                                3[alpha], 17                        Schedule III.
                                                                [alpha]-diol.
BANNED........................  S1        ...................  5[alpha]-         Anabolic........  Lacks FDA
                                                                Androstane-                         approval. DEA
                                                                3[alpha], 17                        Schedule III.
                                                                [beta]-diol.
BANNED........................  S1        ...................  5[alpha]-         Anabolic........  Lacks FDA
                                                                Androstane-                         approval. DEA
                                                                3[beta],                            Schedule III.
                                                                17[alpha] -diol.
BANNED........................  S1        ...................  5[alpha]-         Anabolic........  Lacks FDA
                                                                Androstane-                         approval. DEA
                                                                3[beta],                            Schedule III.
                                                                17[beta] -diol.
BANNED........................  S1        ...................  5[beta]-          Anabolic........  Lacks FDA
                                                                androstane-3                        approval. DEA
                                                                [alpha],                            Schedule III.
                                                                17[beta]diol,
                                                                androst-4-
                                                                ene3[alpha],17[
                                                                alpha]-diol.
BANNED........................  S1        ...................  7-keto-dhea.....  Anabolic........
BANNED........................  S1        ...................  7[alpha]-hydroxy- Anabolic........
                                                                dhea.
BANNED........................  S1        ...................  7[beta]-hydroxy-  Anabolic........
                                                                dhea.
BANNED........................  S5        ...................  Acebutolol......  Antihypertensive  Generic..........
BANNED........................  S0        ...................  Acecarbromal....  Sedative/         Lacks FDA
                                                                                  Hypnotic.         approval.
BANNED........................  S0        ...................  Acefylline......  Bronchodilator..  Lacks FDA
                                                                                                    approval.
BANNED........................  S0        ...................  Acemetacin......  NSAID...........  Lacks FDA
                                                                                                    approval.
BANNED........................  S0        ...................  Acenocoumarol...  Anticoagulant...  Lacks FDA
                                                                                                    approval.

[[Page 5126]]

 
CONTROLLED....................  S7        B                    Acepromazine....  Sedative........  PromAce,           Detection Time:   10 ng/mL as 2-(1-
                                                                                                    Aceproject.        72 hrs 0.15 mg/    hydroxyethyl)
                                                                                                                       kg single oral    promazine
                                                                                                                       dose (6           sulfoxide
                                                                                                                       horses).          (HEPS) in
                                                                                                                       Detection Time:   urine; 0.02 ng/
                                                                                                                       48 hrs 0.05 mg/   mL in serum or
                                                                                                                       kg single IV      plasma.
                                                                                                                       dose (20
                                                                                                                       horses).
CONTROLLED....................  S7        C                    Acetaminophen     NSAID...........  Tylenol..........
                                                                (Paracetamol).
BANNED........................  S0        ...................  Acetanilide.....  NSAID...........  Lacks FDA
                                                                                                    approval.
BANNED........................  S5        ...................  Acetazolamide...  Carbonic          Generic..........
                                                                                  Anhydrase
                                                                                  Inhibitor.
BANNED........................  S0        ...................  Acetohexamide...  Insulin           Discontinued, no
                                                                                  secretion.        FDA-approved
                                                                                                    product
                                                                                                    commercially
                                                                                                    available.
BANNED........................  S0        ...................  Acetophenazine..  Antipsychotic...  Discontinued, no
                                                                                                    FDA-approved
                                                                                                    product
                                                                                                    commercially
                                                                                                    available.
BANNED........................  S0        ...................  Acetophenetidin   NSAID...........  Lacks FDA
                                                                (Phenacetin).                       approval.
CONTROLLED....................  S7        C                    Acetylcysteine..  Mucolytic.......  Mucomyst,
                                                                                                    Parvolex.
BANNED........................  S0        ...................  Acetylmorphine..  Opioid Analgesic  Lacks FDA
                                                                                                    approval.
CONTROLLED....................  S7        C                    Acetylsalicylic   NSAID...........  Generic..........
                                                                acid (Aspirin).
BANNED........................  S0        ...................  Aclidinium        Bronchodilator..  Tudorza Pressair;
                                                                bromide.                            Dualkir Pressair
                                                                                                    (with
                                                                                                    formoterol).
BANNED........................  S0        ...................  Adinazolam......  Sedative/         Lacks FDA
                                                                                  Anxiolytic.       approval.
BANNED........................  S0        ...................  Adiphenine......  Antispasmodic...  Lacks FDA
                                                                                                    approval.
BANNED........................  S0        ...................  Adrafinil.......  Stimulant.......  Lacks FDA
                                                                                                    approval.
BANNED........................  S4        ...................  AICAR (5-         Metabolic         Lacks FDA
                                                                Aminoimidazole-   modulator.        approval.
                                                                4-carboxamide
                                                                ribonucleotide).
CONTROLLED....................  S7        B                    Albuterol         Bronchodilator..  FDA-approved       Detection Time:   SL: 0.5 ng/mL in
                                                                (Salbutamol).                       equine product     72 hours at 5 x   urine.
                                                                                                    Torpex no longer   100 [mu]g
                                                                                                    commercially       actuations per
                                                                                                    available.         dose for 2 days
                                                                                                    Available as FDA-  dosed every 4
                                                                                                    approved for       hours.
                                                                                                    human use via     Note: Albuterol
                                                                                                    inhalation as      administered by
                                                                                                    Proair HFA,        any route other
                                                                                                    Ventolin HFA,      than inhalation
                                                                                                    and generic        is a Banned
                                                                                                    formulations.      Substance.
                                                                                                                       Evidence that
                                                                                                                       albuterol was
                                                                                                                       administered by
                                                                                                                       a route other
                                                                                                                       than
                                                                                                                       inhalation,
                                                                                                                       regardless of
                                                                                                                       the albuterol
                                                                                                                       concentration
                                                                                                                       in a urine
                                                                                                                       sample,
                                                                                                                       constitutes a
                                                                                                                       Doping
                                                                                                                       Violation.
BANNED........................  S0        ...................  Alclofenac......  NSAID...........  Lacks FDA
                                                                                                    approval.
CONTROLLED....................  S7        C                    Alclometasone...  Corticosteroid..  Generic..........
BANNED........................  S0        ...................  Alcuronium......  Muscle relaxant.  Lacks FDA
                                                                                                    approval.
BANNED........................  S5        ...................  Aldosterone.....  Diuretic........  Lacks FDA
                                                                                                    approval.
BANNED........................  S6        ...................  Alendronate.....  Bisphosphonate..  Fosamax, Binosto.
BANNED........................  S2        ...................  Alexamorelin....  Growth Hormone..  Lacks FDA
                                                                                                    approval.
CONTROLLED....................  S7        A                    Alfentanil......  Opioid Analgesic  Alfenta. DEA
                                                                                                    Schedule II.
CONTROLLED....................  S7        B                    Allopurinol.....  Xanthine oxidase  Lopurin,
                                                                                  inhibitor.        Zyloprim,
                                                                                                    Aloprim.
BANNED........................  S0        ...................  Almotriptan.....  Selective         Generic..........
                                                                                  Serotonin
                                                                                  Receptor
                                                                                  Agonist.
BANNED........................  S0        ...................  Alpha-            Stimulant/        Lacks FDA
                                                                pyrrolidinovale   Hallucinogen.     approval. DEA
                                                                rophenone                           Schedule I.
                                                                (Alpha PVP and
                                                                ``Bath Salts'').
BANNED........................  S2        ...................  Alpha-casozepine  Sedative........  Lacks FDA
                                                                                                    approval.
BANNED........................  S0        ...................  Alphadolone       Anesthetic......  Lacks FDA
                                                                (Alfadolone)                        approval.
                                                                acetate.
BANNED........................  S0        ...................  Alphaprodine....  Opioid Analgesic  Lacks FDA
                                                                                                    approval. DEA
                                                                                                    Schedule II.
BANNED........................  S0        ...................  Alphenal........  Barbiturate/      Lacks FDA
                                                                                  Anticonvulsant.   approval.

[[Page 5127]]

 
BANNED........................  S0        ...................  Alpidem.........  Anxiolytic......  Lacks FDA
                                                                                                    approval.
CONTROLLED....................  S7        A                    Alprazolam......  Sedative/         Xanax. DEA
                                                                                  Anxiolytic.       Schedule IV.
BANNED........................  S0        ...................  Alprenolol......  Antihypertensive  Generic..........
BANNED........................  S0        ...................  Althesin........  Anesthetic......  Lacks FDA
                                                                                                    approval.
BANNED........................  S5        ...................  Althiazide......  Diuretic........  Lacks FDA
                                                                                                    approval.
CONTROLLED--fillies and mares.  S7        C                    Altrenogest.....  Progestogen/      Regumate.........
                                                                                  Estrus
                                                                                  Suppression.
BANNED--Intact males,           S6        ...................  Altrenogest.....  Progestogen/      Regumate.........
 geldings, spayed females.                                                        Estrus
                                                                                  Suppression.
BANNED........................  S0        ...................  Alverine........  Antispasmodic...  Lacks FDA
                                                                                                    approval.
BANNED........................  S0        ...................  Amantadine......  Dopamine agonist  Gocovri, Osmolex
                                                                                                    ER.
BANNED........................  S0        ...................  Ambenonium......  Cholinesterase    Discontinued, no
                                                                                  Inhibitor.        FDA-approved
                                                                                                    product
                                                                                                    commercially
                                                                                                    available.
BANNED........................  S0        ...................  Ambroxol........  Mucolytic.......  Lacks FDA
                                                                                                    approval.
BANNED........................  S0        ...................  Ambucetamide....  Antispasmodic...  Lacks FDA
                                                                                                    approval.
CONTROLLED....................  S7        C                    Amcinonide......  Corticosteroid..  Generic..........
BANNED........................  S0        ...................  Amfepramone.....  Antidepressant..  Lacks FDA
                                                                                                    approval.
BANNED........................  S0        ...................  Amfetaminil.....  Stimulant.......  Lacks FDA
                                                                                                    approval.
BANNED........................  S0        ...................  Amidephrine.....  Stimulant.......  Lacks FDA
                                                                                                    approval.
BANNED........................  S5        ...................  Amiloride.......  Diuretic........  Midamor..........
BANNED........................  S0        ...................  Amineptine......  Antidepressant..  Lacks FDA
                                                                                                    approval.
CONTROLLED....................  S7        C                    Aminocaproic      Anti-             Amicar...........
                                                                acid.             fibrinolytic.
BANNED........................  S4        ...................  Aminoglutethimid  Aromatase         Discontinued, no
                                                                e.                inhibitor.        FDA-approved
                                                                                                    product
                                                                                                    commercially
                                                                                                    available.
BANNED........................  S0        ...................  Aminomethylbenzo  Anti-             Lacks FDA
                                                                ic acid.          fibrinolytic.     approval.
BANNED........................  S0        ...................  Aminometradine..  Diuretic........  Lacks FDA
                                                                                                    approval.
CONTROLLED....................  S7        B                    Aminophylline...  Bronchodilator..  Generic..........
BANNED........................  S0        ...................  Aminopterin.....  Anti-neoplastic/  Lacks FDA
                                                                                  Immunosuppressi   approval.
                                                                                  ve.
BANNED........................  S0        ...................  Aminopyrine       Analgesic.......  Lacks FDA
                                                                (Pyramidon).                        approval.
BANNED........................  S0        (x)                  Aminorex........  Stimulant.......  Lacks FDA
                                                                                                    approval. DEA
                                                                                                    Schedule I.
CONTROLLED....................  S7        B                    Amiodarone......  Antiarrhythmic..  Nexterone,
                                                                                                    Pacerone.
BANNED........................  S0        ...................  Amiphenazole....  Respiratory       Lacks FDA
                                                                                  Stimulant.        approval.
BANNED........................  S5        ...................  Amisometradine..  Diuretic........  Lacks FDA
                                                                                                    approval.
BANNED........................  S0        ...................  Amisulpride.....  Antipsychotic...  Barhemsys........
CONTROLLED....................  S7        A                    Amitraz.........  Stimulant.......  Mitaban..........
CONTROLLED....................  S7        A                    Amitriptyline...  Antidepressant..  Elavil...........
BANNED........................  S5        ...................  Amlodipine......  Antihypertensive  Norvasc..........
BANNED........................  S0        ...................  Ammonium          Chemical          Generic..........
                                                                Chloride.         neurectomy.
BANNED........................  S0        ...................  Ammonium          Chemical          Lacks FDA
                                                                Sulphate.         neurectomy.       approval.
BANNED........................  S0        ...................  Ammonium          Chemical          Lacks FDA
                                                                Sulphide.         neurectomy.       approval.
BANNED........................  S0        ...................  Amobarbital.....  Bartiburate/      Lacks FDA
                                                                                  Anticonvulsant.   approval. DEA
                                                                                                    Schedule III.
BANNED........................  S0        ...................  Amoxapine.......  Antidepressant..  Generic..........
BANNED........................  S0        ...................  Amperozide......  Antipsychotic...  Lacks FDA
                                                                                                    approval.
BANNED........................  S0        ...................  Amphetamine.....  Stimulant.......  Adzenys XR-ODT,
                                                                                                    Dyanavel XR,
                                                                                                    Evekeo. DEA
                                                                                                    Schedule III.
BANNED........................  S0        ...................  Amphetaminil....  Stimulant.......  Lacks FDA
                                                                                                    approval.
BANNED........................  S0        ...................  Ampyrone........  NSAID...........  Lacks FDA
                                                                                                    approval.
CONTROLLED....................  S7        B                    Amrinone          Vasodilator.....  Amicor,
                                                                (inamrinone).                       Cardiotone.
BANNED........................  S0        ...................  Amyl nitrite....  Antihypertensive/ Lacks FDA
                                                                                  CNS Depressant.   approval.
BANNED........................  S0        ...................  Amylocaine......  Local anesthetic  Lacks FDA
                                                                                                    approval.
BANNED........................  S2        ...................  Anamorelin......  Growth Hormone..  New Drug
                                                                                                    Application
                                                                                                    submitted;
                                                                                                    currently lacks
                                                                                                    FDA approval.
BANNED........................  S4        ...................  Anastrozole.....  Anti-estrogen...  Arimidex.........
BANNED........................  S1        ...................  Andarine........  Selective         Lacks FDA
                                                                                  Androgen          approval.
                                                                                  Receptor
                                                                                  Modulator
                                                                                  (SARM).
BANNED........................  S1        ...................  Androst-4-ene-    Anabolic........  DEA Schedule III.
                                                                3[alpha],17[bet
                                                                a] diol.
BANNED........................  S1        ...................  Androst-4-ene-    Anabolic........  DEA Schedule III.
                                                                3[beta],17[alph
                                                                a] diol.
BANNED........................  S1        ...................  Androst-5-ene-    Anabolic........  DEA Schedule III.
                                                                3[alpha],17[alp
                                                                ha] diol.
BANNED........................  S1        ...................  Androst-5-ene-    Anabolic........  DEA Schedule III.
                                                                3[alpha],17[bet
                                                                a] diol.
BANNED........................  S1        ...................  Androst-5-ene-    Anabolic........  DEA Schedule III.
                                                                3[beta],17[alph
                                                                a] diol.

[[Page 5128]]

 
BANNED........................  S4        ...................  Androstatrienedi  Anabolic........  DEA Schedule III.
                                                                one (Androsta-
                                                                1,4,6-triene-
                                                                3,17-ddione).
BANNED........................  S4        ...................  Androstenediol    Anabolic........  DEA Schedule III.
                                                                (androst-5-ene-
                                                                3[beta],
                                                                17[beta]diol).
BANNED........................  S4        ...................  Androstenedione   Anabolic........  DEA Schedule III.
                                                                (androst-4-ene-
                                                                3, 17dione).
BANNED........................  S4        ...................  Androsterone (3   Anabolic........  DEA Schedule III.
                                                                [beta]hydroxy-5
                                                                [alpha]-
                                                                androstan-17-
                                                                one).
BANNED........................  S0        ...................  Anileridine.....  Opioid Analgesic  Discontinued, no
                                                                                                    FDA-approved
                                                                                                    product
                                                                                                    commercially
                                                                                                    available. DEA
                                                                                                    Schedule II.
BANNED........................  S0        ...................  Anilopam........  Opioid Analgesic  Lacks FDA
                                                                                                    approval.
BANNED........................  S0        ...................  Anisindione.....  Anticoagulant...  Discontinued, no
                                                                                                    FDA-approved
                                                                                                    product
                                                                                                    commercially
                                                                                                    available.
BANNED........................  S0        ...................  Anisotropine      Anticholinergic.  Discontinued, no
                                                                (Octatropine                        FDA-approved
                                                                methylbromide).                     product
                                                                                                    commercially
                                                                                                    available.
CONTROLLED....................  S7        B                    Antazoline......  Antihistamine     Discontinued, no
                                                                                  (ophthalmic).     FDA-approved
                                                                                                    product
                                                                                                    commercially
                                                                                                    available.
BANNED........................  S0        ...................  Antipyrine......  NSAID...........  Lacks FDA
                                                                                                    approval.
BANNED........................  S0        ...................  Apazone           NSAID...........  Lacks FDA
                                                                (Azapropazone).                     approval.
BANNED........................  S0        ...................  Apocodeine......  Dopamine agonist  Lacks FDA
                                                                                                    approval.
BANNED........................  S0        ...................  Apomorphine.....  Opioid Analgesic  Kynmobi, Apokyn..
BANNED........................  S0        ...................  Aprindine.......  Antiarrhythmic..  Lacks FDA
                                                                                                    approval.
BANNED........................  S0        ...................  Aprobarbital....  Barbiturate.....  Lacks FDA
                                                                                                    approval. DEA
                                                                                                    Schedule III.
BANNED........................  S0        ...................  Apronalide......  Sedative/         Lacks FDA
                                                                                  Hypnotic.         approval.
BANNED........................  S2        ...................  ARA-290.........  Erythropoiesis..  FDA Orphan Drug
                                                                                                    status.
BANNED........................  S0        ...................  Arecoline.......  Stimulant.......  Lacks FDA
                                                                                                    approval.
BANNED........................  S3        ...................  Arformoterol....  Beta-2 agonist-   Brovana..........
                                                                                  bronchodilator.
BANNED........................  S2        ...................  Argon...........  Hypoxia
                                                                                  Inducible
                                                                                  Factor
                                                                                  activating.
BANNED........................  S4        ...................  Arimistane        Anabolic........  Lacks FDA
                                                                (Anrosta-3,5-                       approval.
                                                                diene-7,17-
                                                                dione).
CONTROLLED....................  S7        A                    Aripiprazole....  Antipsychotic...  Abilify..........
CONTROLLED....................  S7        B (x)                Arsenic.........  Stimulant.......  Environmental      ................  0.3 mcg/mL total
                                                                                                    substance.                           (free and
                                                                                                                                         conjugated) in
                                                                                                                                         urine.
CONTROLLED....................  S7        B                    Articaine.......  Local anesthetic  Orabloc,
                                                                                                    Septocaine.
BANNED........................  S2        ...................  Asialo EPO......  Erythropoiesis..
BANNED........................  S0        ...................  Atenolol........  Antihypertensive  Tenormin.........
CONTROLLED....................  S7        A                    Atipamezole.....  Alpha adrenergic  Antisedan,
                                                                                  antagonist.       Revertidine.
BANNED........................  S0        ...................  Atomoxetine.....  Stimulant.......  Strattera........
CONTROLLED....................  S7        A                    Atracurium......  Muscle relaxant.  Generic..........
CONTROLLED....................  S7        B (x)                Atropine........  Anticholinergic.  Atropen..........  ................  60 ng/mL total
                                                                                                                                         (free and
                                                                                                                                         conjugated) in
                                                                                                                                         urine.
BANNED........................  S0        ...................  Azacylonol        CNS depressant..  Lacks FDA
                                                                ([gamma]-                           approval.
                                                                pipradrol).
BANNED........................  S0        ...................  Azaperone.......  Sedative........  Stresnil.........
BANNED........................  S0        ...................  Azapetine.......  Vasodilator.....  Lacks FDA
                                                                                                    approval.
BANNED........................  S0        ...................  Azapropazone....  NSAID...........  Lacks FDA
                                                                                                    approval.
BANNED........................  S0        ...................  Azathioprine....  Immunosuppressor  Imuran...........
BANNED........................  S0        ...................  Azatidine         Antihistamine...  Discontinued, no
                                                                (Azatadine).                        FDA-approved
                                                                                                    product
                                                                                                    commercially
                                                                                                    available.
BANNED........................  S5        ...................  Azosemide.......  Diuretic........  Lacks FDA
                                                                                                    approval.
CONTROLLED....................  S7        B                    Baclofen........  Muscle relaxant.  Lyvispah,
                                                                                                    Gablofen,
                                                                                                    Lioresal,
                                                                                                    Ozobax, Fleqsuvy.
BANNED........................  S0        ...................  Bambuterol......  Beta-2 agonist-   Lacks FDA
                                                                                  bronchodilator.   approval.
BANNED........................  S0        ...................  Bamifylline.....  Bronchodilator..  Lacks FDA
                                                                                                    approval.
BANNED........................  S0        ...................  Barbital          Sedative/         Lacks FDA
                                                                (barbitone).      Hypnotic.         approval. DEA
                                                                                                    Schedule IV.

[[Page 5129]]

 
BANNED........................  S4        ...................  Bazedoxifene....  Selective         FDA-approved in
                                                                                  Estrogen          combination with
                                                                                  Receptor          Premarin as
                                                                                  Modulator         Duavee.
                                                                                  (SERM).
BANNED........................  S0        ...................  Beclamide.......  Anticonvulsant..  Lacks FDA
                                                                                                    approval.
CONTROLLED....................  S7        C                    Beclomethasone..  Corticosteroid..  Qvar, Qnasl,
                                                                                                    Beclovent.
BANNED........................  S0        ...................  Bemegride.......  Stimulant.......  Lacks FDA
                                                                                                    approval.
BANNED........................  S0        ...................  Benactyzine.....  Anticholinergic.  Lacks FDA
                                                                                                    approval.
BANNED........................  S0        ...................  Benapryzine.....  Anticholinergic.  Lacks FDA
                                                                                                    approval.
BANNED........................  S0        ...................  Benazepril......  Antihypertensive  Lotensin, Lotrel
                                                                                                    (with
                                                                                                    amlodipine).
BANNED........................  S5        ...................  Bendroflumethiaz  Diuretic........  Naturetin,
                                                                ide.                                Corzide.
BANNED........................  S0        ...................  Benorilate......  NSAID...........  Lacks FDA
                                                                                                    approval.
BANNED........................  S0        ...................  Benoxaprofen....  NSAID...........  Lacks FDA
                                                                                                    approval.
CONTROLLED....................  S7        C                    Benoxinate(Oxybu  Local anesthetic  Altafluor Benox
                                                                caine,                              [with
                                                                Oxybuprocaine).                     fluorescein
                                                                                                    stain].
BANNED........................  S0        ...................  Benperidol......  Antipsychotic...  Lacks FDA
                                                                                                    approval.
BANNED........................  S0        ...................  Bentazepam......  Anxiolytic......  Lacks FDA
                                                                                                    approval.
CONTROLLED....................  S7        B                    Benzocaine......  Local anesthetic  Orajel, Anbesol,
                                                                                                    Lanacane.
BANNED........................  S0        ...................  Benzoctamine....  Sedative/         Lacks FDA
                                                                                  Anxiolytic.       approval.
BANNED........................  S0        ...................  Benzonatate.....  Antitussive.....  Tessalon.........
BANNED........................  S0        ...................  Benzphetamine...  Stimulant.......  Generic. DEA
                                                                                                    Schedule III.
BANNED........................  S0        ...................  Benzquinamide...  Antipsychotic/    Discontinued, no
                                                                                  Anti-emetic.      FDA-approved
                                                                                                    product
                                                                                                    commercially
                                                                                                    available.
BANNED........................  S0        ...................  Benzthiazide....  Diuretic........  Discontinued, no
                                                                                                    FDA-approved
                                                                                                    product
                                                                                                    commercially
                                                                                                    available.
CONTROLLED....................  S7        A                    Benztropine.....  Anticholinergic.  Generic..........
BANNED........................  S0        ...................  Benzydamine.....  NSAID...........  Lacks FDA
                                                                                                    approval.
BANNED........................  S0        ...................  Benzylpiperazine  Stimulant.......  Lacks FDA
                                                                (BZP).                              approval.
BANNED........................  S0        ...................  Bepridil........  Antihypertensive  Lacks FDA
                                                                                                    approval.
CONTROLLED....................  S7        C                    Betamethasone...  Corticosteroid..  Betavet,           ................  0.2 ng/mL in
                                                                                                    Celestone.                           urine.
BANNED........................  S0        ...................  Betaprodine.....  Opioid Analgesic  Lacks FDA
                                                                                                    approval. DEA
                                                                                                    Schedule I.
BANNED........................  S0        ...................  Betaxolol.......  Antihypertensive  Betoptic.........
CONTROLLED....................  S7        C                    Bethanechol.....  Cholinergic.....  Duovoid..........
BANNED........................  S0        ...................  Bethanidine       Antihypertensive  Discontinued, no
                                                                (Betanidine).                       FDA-approved
                                                                                                    product
                                                                                                    commercially
                                                                                                    available.
BANNED........................  S4        ...................  Bimagrumab......  Anabolic........  Lacks FDA
                                                                                                    approval (Orphan
                                                                                                    drug designation
                                                                                                    withdrawn).
BANNED........................  S0        ...................  Biperiden.......  Anticholinergic.  Discontinued, no
                                                                                                    FDA-approved
                                                                                                    product
                                                                                                    commercially
                                                                                                    available.
BANNED........................  S0        ...................  Biphenamine.....  Local anesthetic  Lacks FDA
                                                                                                    approval.
BANNED........................  S0        ...................  Biprsoprolol....  Antihypertensive  Ziac [with
                                                                                                    hydrochlorothiaz
                                                                                                    ide].
BANNED........................  S0        ...................  Biriperone        Antipsychotic...  Lacks FDA
                                                                (Centbutindole).                    approval.
BANNED........................  S0        ...................  Bitolterol......  Beta-2 agonist-   Discontinued, no
                                                                                  bronchodilator.   FDA-approved
                                                                                                    product
                                                                                                    commercially
                                                                                                    available.
BANNED........................  S1        ...................  Bolandiol (estr-  Anabolic........  Lacks FDA
                                                                4-ene3[beta],                       approval.
                                                                17[beta]-diol).
BANNED........................  S1        ...................  Bolasterone       Anabolic........  Lacks FDA
                                                                (7[alpha],                          approval. DEA
                                                                17[alpha]-                          Schedule III.
                                                                dimethyltestost
                                                                erone).
BANNED........................  S1        ...................  Boldenone.......  Anabolic........  Equipoise. DEA     ................  Threshold: 0.015
                                                                                                    Schedule III.                        mcg free and
                                                                                                                                         conjugated
                                                                                                                                         boldenone per
                                                                                                                                         mL in urine in
                                                                                                                                         male horses
                                                                                                                                         (other than
                                                                                                                                         geldings).
BANNED........................  S1        ...................  Boldione........  Anabolic........  Lacks FDA
                                                                                                    approval. DEA
                                                                                                    Schedule III.
BANNED........................  S6        ...................  Botulinum toxin.  Neurotoxin......  Botox, Dysport,
                                                                                                    Jeuveau.
BANNED........................  S0        ...................  Brallobarbital..  Barbiturate.....  Lacks FDA
                                                                                                    approval.
CONTROLLED....................  S7        B                    Bretylium.......  Antiarrhythmic..  Generic..........
BANNED........................  S0        ...................  Brimonidine.....  Antihypertensive  Alphagan P,
                                                                                                    Qoliana, Lumify.
CONTROLLED....................  S7        B                    Brinzolamide....  Carbonic          Simbrinza, Azopt.
                                                                                  Anhydrase
                                                                                  Inhibitor.
BANNED........................  S0        ...................  Bromantan.......  Psychostimulant.  Lacks FDA
                                                                                                    approval.
BANNED........................  S0        ...................  Bromazepam......  Anxiolytic......  Lacks FDA
                                                                                                    approval. DEA
                                                                                                    Schedule IV.
CONTROLLED....................  S7        A                    Bromfenac.......  NSAID...........  Prolensa,
                                                                                                    Bromsite.
BANNED........................  S0        ...................  Bromhexine......  Mucolytic.......  Lacks FDA
                                                                                                    approval.
BANNED........................  S0        ...................  Bromisovalum....  Sedative/         Lacks FDA
                                                                                  Hypnotic.         approval.
BANNED........................  S0        ...................  Bromocriptine...  Anticholinergic.  Parlodel,
                                                                                                    Cycloset.

[[Page 5130]]

 
CONTROLLED....................  S7        B                    Bromodiphenhydra  Antihistamine...  Ambodryl,
                                                                mine.                               Ambrodil.
BANNED........................  S0        ...................  Bromophenethylam  Psychedelic.....  Lacks FDA
                                                                ine.                                approval.
BANNED........................  S0        ...................  Bromperidol.....  Antipsychotic...  Lacks FDA
                                                                                                    approval.
CONTROLLED....................  S7        B                    Brompheniramine.  Antihistamine...  Dimetapp.........
BANNED........................  S0        ...................  Brotizolam......  Sedative/         Lacks FDA
                                                                                  Hypnotic.         approval.
BANNED........................  S0        ...................  Bucetin.........  NSAID...........  Lacks FDA
                                                                                                    approval.
BANNED........................  S0        ...................  Buclizine.......  Antihistamine/    Discontinued, no
                                                                                  Anti-emetic.      FDA-approved
                                                                                                    product
                                                                                                    commercially
                                                                                                    available.
CONTROLLED....................  S7        C                    Budesonide......  Corticosteroid..  Uceris, Entocort,
                                                                                                    Tarpeyo,
                                                                                                    Ortikos,
                                                                                                    Pulmicor
                                                                                                    Flexhaler,
                                                                                                    Symbicort (with
                                                                                                    formoterol),
                                                                                                    Rhinocort
                                                                                                    Allergy.
BANNED........................  S0        ...................  Bufexamac.......  NSAID...........  Lacks FDA
                                                                                                    approval.
BANNED........................  S0        ...................  Buflomedil......  Vasodilator.....  Lacks FDA
                                                                                                    approval.
BANNED........................  S0        (x)                  Bufotenine......  Hallucinogen....  Lacks FDA          ................  10 mcg/mL Total
                                                                                                    approval. DEA                        (free and
                                                                                                    Schedule I.                          conjugated) in
                                                                                                                                         urine,
BANNED........................  S5        ...................  Bumetanide......  Diuretic........  Bumex............
BANNED........................  S0        ...................  Bunitrolol......  Vasodilator.....  Lacks FDA
                                                                                                    approval.
BANNED........................  S0        ...................  Bunolol.........  Anti-             Betagan..........
                                                                                  hypertensive.
BANNED........................  S0        ...................  Buphenine         Vasodilator.....  Lacks FDA
                                                                (nylidrin).                         approval.
CONTROLLED....................  S7        B                    Bupivacaine.....  Local anesthetic  Marcaine,
                                                                                                    Sensorcaine,
                                                                                                    Exparel.
BANNED........................  S0        ...................  Bupranolol......  Antihypertensive  Lacks FDA
                                                                                                    approval.
CONTROLLED....................  S7        A                    Buprenorphine...  Analgesic.......  Simbadol,
                                                                                                    Zorbium,
                                                                                                    Butrans,
                                                                                                    Sublocade,
                                                                                                    Belbuca,
                                                                                                    Buprenex,
                                                                                                    Zubsolv. DEA
                                                                                                    Schedule III.
BANNED........................  S0        ...................  Bupropion.......  Antidepressant..  Wellbutrin, Zyban
BANNED........................  S4        ...................  Buserelin.......  Gonadotropin      Lacks FDA
                                                                                  Releasing         approval.
                                                                                  Hormone.
CONTROLLED....................  S7        A                    Buspirone.......  Anxiolytic......  Generic..........
BANNED........................  S0        ...................  Butabarbital      Barbiturate.....  Discontinued, no
                                                                (Secbutobarbito                     FDA-approved
                                                                ne).                                product
                                                                                                    commercially
                                                                                                    available. DEA
                                                                                                    Schedule III.
BANNED........................  S0        ...................  Butacaine.......  Local anesthetic  Lacks FDA
                                                                                                    approval.
BANNED........................  S0        ...................  Butalbital        Barbiturate.....  Esgic, Fioricet.
                                                                (Talbutal).                         DEA Schedule III.
CONTROLLED....................  S7        C                    Butamben (butyl   Local anesthetic  Cetacaine........
                                                                aminobenzoate).
BANNED........................  S0        ...................  Butanilicaine...  Local anesthetic  Lacks FDA
                                                                                                    approval.
BANNED........................  S0        ...................  Butaperazine....  Antipsychotic...  Lacks FDA
                                                                                                    approval.
BANNED........................  S0        ...................  Butoctamide.....  Serotonin         Lacks FDA
                                                                                  release.          approval.
BANNED........................  S0        ...................  Butofilolol.....  Antihypertensive  Lacks FDA
                                                                                                    approval.
CONTROLLED....................  S7        B                    Butorphanol.....  Sedative........  Torbugesic,        Detection Time:   1 ng/mL in
                                                                                                    Tobutrol,          72 hrs. 0.1 mg/   hydrolyzed
                                                                                                    Stadol, Dolorex.   kg single IV      urine or 0.01
                                                                                                    DEA Schedule IV.   dose (6 horses).  ng/mL plasma or
                                                                                                                                         serum.
BANNED........................  S0        ...................  Butoxycaine.....  Local anesthetic  Lacks FDA
                                                                                                    approval.
BANNED........................  S0        ...................  Cafedrine.......  Cardiac           Lacks FDA
                                                                                  Stimulant.        approval.
CONTROLLED....................  S7        B (x)                Caffeine........  Stimulant.......  Cafcit, Migergot   ................  50 ng/mL (free
                                                                                                    (with                                and conjugated)
                                                                                                    ergotamine),                         in urine.
                                                                                                    combined with
                                                                                                    NSAIDs in OTC
                                                                                                    formulations.
                                                                                                    Recognized by
                                                                                                    IFHA as Feed
                                                                                                    Contaminant.
BANNED........................  S0        ...................  Calcium           Vasoprotective..  Lacks FDA
                                                                dobesilate.                         approval.
BANNED........................  S1        ...................  Calusterone       Anabolic........  Lacks FDA
                                                                (Methosarb,                         approval. (NSC-
                                                                Riedemil, NSC-                      88536, U-22550)
                                                                88536, U-22550).                    DEA Schedule III.
BANNED........................  S0        ...................  Camazepam.......  Anxiolytic......  Lacks FDA
                                                                                                    approval. DEA
                                                                                                    Schedule IV.
CONTROLLED....................  S7        C                    Camphor.........  Local anesthetic  Vicks VapoRub....
BANNED........................  S0        ...................  Candesartan.....  Antihypertensive  Atacand..........
CONTROLLED....................  S7        B                    Cannabidiol       Analgesic/anti-   Epidiolex........
                                                                (CBD).            inflammatory.

[[Page 5131]]

 
BANNED........................  S0        (x)                  Cannabinoids      Psychotropic....  Lack FDA approval
                                                                (natural,
                                                                synthetic and
                                                                other
                                                                cannabimimetics
                                                                ).
BANNED........................  S5        ...................  Canrenone.......  Diuretic........  Lacks FDA
                                                                                                    approval.
BANNED........................  S1        ...................  Capromorelin....  Anabolic........  Entyce, Elura....
CONTROLLED....................  S7        B                    Capsaicin.......  Topical           Zostrix, Salonpas
                                                                                  analgesic/        Hot.
                                                                                  irritant.
BANNED........................  S0        ...................  Captodiame        Antihistamine...  Lacks FDA
                                                                (captodiamine).                     approval.
BANNED........................  S0        ...................  Captopril.......  Antihypertensive  Generic..........
BANNED........................  S0        ...................  Caramiphen......  Anticholinergic.  Lacks FDA
                                                                                                    approval.
BANNED........................  S0        ...................  Carazolol.......  Antihypertensive  Lacks FDA
                                                                                                    approval.
CONTROLLED....................  S7        B                    Carbachol.......  Cholinergic.....  Miostat..........
CONTROLLED....................  S7        B                    Carbamazepine...  Anticonvulsant..  Tegretol,
                                                                                                    Carbatrol,
                                                                                                    Equetro, Teril.
BANNED........................  S2        ...................  Carbamylated EPO  Erythropoiesi...
                                                                (CEPO).
BANNED........................  S0        ...................  Carbazochrome     Hemostatic......  Lacks FDA
                                                                (Adrenochrome                       approval.
                                                                monosemicarbazo
                                                                ne).
BANNED........................  S0        ...................  Carbetapentane    Antitussive.....  Lacks FDA
                                                                (pentoxyverine).                    approval.
BANNED........................  S0        ...................  Carbidopa.......  Decarboxylase     Lodosyn; Stalevo,
                                                                                  Inhibitor.        Rytary, Duopa,
                                                                                                    Dhivy, Sinemet
                                                                                                    (all with
                                                                                                    levodopa).
BANNED........................  S0        ...................  Carbimazole.....  Anti-             Lacks FDA
                                                                                  hyperthyroidism.  approval.
CONTROLLED....................  S7        B                    Carbinoxamine...  Antihistamine...  Karbinal ER......
BANNED........................  S0        ...................  Carbocysteine...  Mucolytic.......  Lacks FDA
                                                                                                    approval.
BANNED........................  S0        ...................  Carbromal.......  Sedative/         Lacks FDA
                                                                                  Hypnotic.         approval.
BANNED........................  S0        ...................  Carbuterol......  Beta-2 agonist-   Lacks FDA
                                                                                  bronchodilator.   approval.
BANNED........................  S1        ...................  Cardarine (GW-    Selective         Lacks FDA
                                                                501, GW516, GSK-  Androgen          approval.
                                                                516).             Receptor
                                                                                  Modulator
                                                                                  (SARM).
BANNED........................  S0        ...................  Carfentanil.....  Opioid Analgesic  Lacks FDA
                                                                                                    approval. DEA
                                                                                                    Schedule II.
CONTROLLED....................  S7        B                    Carisoprodol....  Muscle relaxant.  Soma. DEA
                                                                                                    Schedule IV.
BANNED........................  S0        ...................  Carphedon.......  Psychostimulant.  Lacks FDA
                                                                                                    approval.
BANNED........................  S0        ...................  Carphenazine....  Antipsychotic...  Discontinued, no
                                                                                                    FDA-approved
                                                                                                    product
                                                                                                    commercially
                                                                                                    available.
BANNED........................  S0        ...................  Carpipramine....  Antipsychotic...  Lacks FDA
                                                                                                    approval.
CONTROLLED....................  S7        B                    Carprofen.......  NSAID...........  Rimadyl..........
BANNED........................  S3        ...................  Carteolol.......  Antihypertensive  Generic..........
CONTROLLED....................  S7        B                    Carticaine (see   Local anesthetic  Septocaine,
                                                                Articaine).                         Orbloc.
BANNED........................  S0        ...................  Carvedilol......  Antihypertensive  Coreg............
BANNED........................  S0        ...................  Cathinone.......  Stimulant.......  Lacks FDA
                                                                                                    approval. DEA
                                                                                                    Schedule I.
CONTROLLED....................  S7        B                    Celecoxib.......  NSAID...........  Celebrex.........
BANNED........................  S0        ...................  Celiprolol......  Anti-             Lacks FDA
                                                                                  hypertensive.     approval.
BANNED........................  S0        ...................  Cephaeline......  Emetic, plant     Lacks FDA
                                                                                  alkaloid.         approval.
CONTROLLED....................  S7        C                    Cetirizine......  Antihistamine...  Quzyttir,          Detection Time:   3 ng/mL in serum
                                                                                                    Zerviate, Zyrtec.  48 hours. 0.4     or plasma.
                                                                                                                       mg/kg twice
                                                                                                                       daily for 5
                                                                                                                       doses. (9
                                                                                                                       horses).
BANNED........................  S0        ...................  Chlomethiazole..  Anticonvulsant..  Lacks FDA
                                                                                                    approval.
BANNED........................  S0        ...................  Chloral (cloral)  Sedative/         Lacks FDA
                                                                betaine.          Hypnotic.         approval. DEA
                                                                                                    Schedule IV.
BANNED........................  S0        ...................  Chloral hydrate.  Sedative........  Lacks FDA
                                                                                                    approval. DEA
                                                                                                    Schedule IV.
BANNED........................  S0        ...................  Chloralose        Anxiolytic......  Lacks FDA
                                                                (AlphaChloralos                     approval.
                                                                e).
BANNED........................  S0        ...................  Chlorcyclizine..  Antihistamine...  Lacks FDA
                                                                                                    approval.
BANNED........................  S0        ...................  Chlordiazepoxide  Anxiolytic......  Librium; Librax
                                                                                                    (with
                                                                                                    chlordiazepoxide
                                                                                                    hydrochloride).
                                                                                                    DEA Schedule IV.
BANNED........................  S0        ...................  Chlormadinone     Reproductive      Lacks FDA
                                                                acetate.          hormone.          approval.
BANNED........................  S0        ...................  Chlormerodrin...  Diuretic........  Discontinued, no
                                                                                                    FDA-approved
                                                                                                    product
                                                                                                    commercially
                                                                                                    available.
BANNED........................  S0        ...................  Chlormezanone...  Muscle relaxant.  Discontinued, no
                                                                                                    FDA-approved
                                                                                                    product
                                                                                                    commercially
                                                                                                    available.
BANNED........................  S0        ...................  Chloroform......  Anesthetic......  Lacks FDA
                                                                                                    approval.
BANNED........................  S0        ...................  Chlorophenylpipe  Psychoactive....  Lacks FDA
                                                                razine.                             approval.
CONTROLLED....................  S7        A                    Chloroprocaine..  Local anesthetic  Nesacaine........
BANNED........................  S0        ...................  Chloropyramine..  Antihistamine...  Lacks FDA
                                                                                                    approval.
BANNED........................  S5        ...................  Chlorothiazide..  Diuretic........  Diuril...........
BANNED........................  S0        ...................  Chlorphenesin...  Muscle relaxant.  Discontinued, no
                                                                                                    FDA-approved
                                                                                                    product
                                                                                                    commercially
                                                                                                    available.

[[Page 5132]]

 
CONTROLLED....................  S7        B                    Chlorpheniramine  Antihistamine...  ChlorTrimeton....
BANNED........................  S0        ...................  Chlorphenoxamine  Antihistamine...  Lacks FDA
                                                                                                    approval.
BANNED........................  S0        ...................  Chlorphentermine  Stimulant.......  Discontinued, no
                                                                                                    FDA-approved
                                                                                                    product
                                                                                                    commercially
                                                                                                    available.
BANNED........................  S0        ...................  Chlorproethazine  Muscle relaxant.  Lacks FDA
                                                                                                    approval.
BANNED........................  S0        ...................  Chlorpromazine..  Sedative........  Generic..........
BANNED........................  S0        ...................  Chlorpropamide..  Hypoglycemic....  Discontinued, no
                                                                                                    FDA-approved
                                                                                                    product
                                                                                                    commercially
                                                                                                    available.
BANNED........................  S0        ...................  Chlorprothixene.  Antipsychotic...  Discontinued, no
                                                                                                    FDA-approved
                                                                                                    product
                                                                                                    commercially
                                                                                                    available.
BANNED........................  S5        ...................  Chlorthalidone..  Diuretic........  Thalitone........
BANNED........................  S0        ...................  Chlorthenoxazine  NSAID...........  Lacks FDA
                                                                                                    approval.
BANNED........................  S5        ...................  Chlorthiazide     Diuretic........  Diuril...........
                                                                (Chlorothiazide
                                                                ).
CONTROLLED....................  S7        B                    Chlorzoxazone...  Muscle relaxant.  Generic..........
CONTROLLED--fillies and mares.  S7        B                    Chorionic         Reproductive      Pregnyl--biologic
                                                                Gonadotropin      hormone.          , does not
                                                                (CG).                               require FDA
                                                                                                    approval.
BANNED--intact males and        S2        ...................  Chorionic         Reproductive      Pregnyl..........
 geldings.                                                      Gonadotropin      hormone.
                                                                (CG).
CONTROLLED....................  S7        C                    Ciclesonide.....  Corticosteroid..  Aservo EquiHaler,  Detection Time:   ................
                                                                                                    Alvesco.           48 hours. 5.5
                                                                                                                       mg/day x 5
                                                                                                                       days, then 4.1
                                                                                                                       mg/day x 5 days
                                                                                                                       via inhalation
                                                                                                                       (Aservo
                                                                                                                       Equihaler). (6
                                                                                                                       horses).
BANNED........................  S0        ...................  Cicloprofen.....  NSAID...........  Lacks FDA
                                                                                                    approval.
BANNED........................  S0        ...................  Cilazapril......  Anti-             Lacks FDA
                                                                                  hypertensive.     approval.
CONTROLLED....................  S7        B                    Cilostazol......  Vasodilator.....  Pletal...........
BANNED........................  S0        ...................  Cimaterol.......  Beta-2 agonist-   Lacks FDA
                                                                                  bronchodilator.   approval.
BANNED........................  S3        ...................  Cimbuterol......  Beta-2 agonist-   Lacks FDA
                                                                                  bronchodilator.   approval.
CONTROLLED....................  S7        C                    Cimetidine......  Anti-ulcer......  Tagamet..........  Restricted        400 ng/mL in
                                                                                                                       administration    serum or
                                                                                                                       time: 24 hours.   plasma.
                                                                                                                       20 mg/kg orally
                                                                                                                       twice daily for
                                                                                                                       a total of 7
                                                                                                                       doses (9
                                                                                                                       horses).
BANNED........................  S0        ...................  Cinchocaine.....  Local anesthetic  Lacks FDA
                                                                                                    approval.
BANNED........................  S0        ...................  Cinchophen......  NSAID...........  Lacks FDA
                                                                                                    approval.
BANNED........................  S0        ...................  Cinnarizine.....  Antihistamine...  Lacks FDA
                                                                                                    approval.
BANNED........................  S0        ...................  Citalopram......  Antidepressant..  Celexa...........
BANNED........................  S0        ...................  Clanobutin......  Cholerectic.....  Lacks FDA
                                                                                                    approval.
CONTROLLED....................  S7        B                    Clemastine......  Antihistamine...  Tavist, Dayhist..
BANNED........................  S0        ...................  Clemizole.......  Antihistamine...  Lacks FDA
                                                                                                    approval.
CONTROLLED....................  S7        B                    Clenbuterol.....  Beta-2 agonist-   Ventipulmin......  Treated horse
                                                                                  bronchodilator.                      Vet Listed for
                                                                                                                       minimum 21 days
                                                                                                                       after last
                                                                                                                       treatment.
                                                                                                                       Official
                                                                                                                       Workout and
                                                                                                                       Clearance
                                                                                                                       Testing (blood
                                                                                                                       and urine)
                                                                                                                       required to re-
                                                                                                                       establish
                                                                                                                       eligibility to
                                                                                                                       race. Dosing
                                                                                                                       specification:
                                                                                                                       0.8 mcg/kg
                                                                                                                       orally twice
                                                                                                                       daily for up to
                                                                                                                       30 days total
                                                                                                                       in a 6 month
                                                                                                                       period.
BANNED........................  S3        ...................  Clenpenterol....  Beta-2 agonist-   Lacks FDA
                                                                                  bronchodilator.   approval.
BANNED........................  S0        ...................  Clibucaine......  Local anesthetic  Lacks FDA
                                                                                                    approval.
BANNED........................  S0        ...................  Clidinium.......  Anticholinergic.  No FDA-approved
                                                                                                    produc.
BANNED........................  S0        ...................  Clobazam........  Anxiolytic......  Sympazan, Onfi.
                                                                                                    DEA Schedule IV.
BANNED........................  S0        ...................  Clobenzorex.....  Stimulant.......  Lacks FDA
                                                                                                    approval.

[[Page 5133]]

 
CONTROLLED....................  S7        C                    Clobetasol......  Corticosteroid..  Olux, Cormax,
                                                                                                    Embeline,
                                                                                                    Impoyz, Clobex,
                                                                                                    Impeklo.
CONTROLLED....................  S7        C                    Clocortolone....  Corticosteroid..  Cloderm..........
BANNED........................  S6        ...................  Clodronate        Bisphosphonate..  OsPhos...........
                                                                (Clodronic
                                                                acid).
BANNED........................  S5        ...................  Clofenamid......  Carbonic          Lacks FDA
                                                                                  Anhydrase         approval.
                                                                                  Inhibitor.
BANNED........................  S0        ...................  Clomethiazole     Sedative/         Lacks FDA
                                                                (Chlormethiazol   Hypnotic.         approval.
                                                                e).
BANNED........................  S4        ...................  Clomifene.......  Induce ovulation  Generic..........
BANNED........................  S0        ...................  Clomipramine....  Antidepressant..  Clomicalm........
BANNED........................  S0        ...................  Clonazepam......  Anxiolytic......  Klonopin. DEA
                                                                                                    Schedule IV.
CONTROLLED....................  S7        A                    Clonidine.......  Antihypertensive/ Catapres-TTS.....
                                                                                  Analgesic.
BANNED........................  S0        ...................  Clonixin........  NSAID...........  Lacks FDA
                                                                                                    approval.
BANNED........................  S5        ...................  Clopamide.......  Diuretic........  Lacks FDA
                                                                                                    approval.
BANNED........................  S0        ...................  Cloranolol......  Antihypertensive  Lacks FDA
                                                                                                    approval.
BANNED........................  S0        ...................  Clorazepate.....  Anxiolytic......  Lacks FDA
                                                                                                    approval. DEA
                                                                                                    Schedule IV.
BANNED........................  S0        ...................  Clormecaine.....  Local anesthetic  Lacks FDA
                                                                                                    approval.
BANNED........................  S0        ...................  Clorprenaline...  Bronchodilator..  Lacks FDA
                                                                                                    approval.
BANNED........................  S1        ...................  Clostebol.......  Anabolic........  Lacks FDA
                                                                                                    approval. DEA
                                                                                                    Schedule III.
BANNED........................  S0        ...................  Clotiapine......  Antipsychotic...  Lacks FDA
                                                                                                    approval.
BANNED........................  S0        ...................  Clotiazepam.....  Anxiolytic......  Lacks FDA
                                                                                                    approval.
BANNED........................  S0        ...................  Cloxazolam......  Anxiolytic......  Lacks FDA
                                                                                                    approval. DEA
                                                                                                    Schedule IV.
BANNED........................  S0        ...................  Clozapine.......  Antipsychotic...  Clozaril,
                                                                                                    Versacloz.
BANNED........................  S2        ...................  CNTO 530........  Erythropoiesis..  Lacks FDA
                                                                                                    approval.
BANNED........................  S2        ...................  Cobalt Salts      Erythropoiesi...  .................  ................  Threshold: 0.1
                                                                (e.g., CoCl2).                                                           mcg/mL total
                                                                                                                                         Cobalt in urine
                                                                                                                                         OR 0.025 mcg/mL
                                                                                                                                         total (free and
                                                                                                                                         protein bound)/
                                                                                                                                         mL in serum or
                                                                                                                                         plasma.
BANNED........................  S6        ...................  Cobratoxin,       Neurotoxin......  Lacks FDA
                                                                alpha.                              approval.
BANNED........................  S0        ...................  Cocaine           Stimulant.......  Goprelto,
                                                                (metabolite:                        Numbrino. DEA
                                                                benzoylecgonine                     Schedule II.
                                                                ).
BANNED........................  S0        ...................  Codeine.........  Opioid Analgesic  Generic (DEA
                                                                                                    Schedule II or
                                                                                                    in combination
                                                                                                    with NSAIDs,
                                                                                                    caffeine and
                                                                                                    other drugs (DEA
                                                                                                    Schedule III).
CONTROLLED....................  S7        B (x)                Colchicine......  Anti-gout.......  Colcrys, Mitigare
BANNED........................  S0        ...................  Conorphone......  Opioid Analgesic  Lacks FDA
                                                                                                    approval.
BANNED........................  S2        ...................  Corticorelin....  Corticosteroid    Approved Oprhan
                                                                                  stimulation.      Drug.
CONTROLLED....................  S7        B                    Corticotrophin..  Corticosteroid    ACTH-80, Acthar
                                                                                  stimulation.      Gel.
BANNED........................  S0        ...................  Cortivazol......  Glucocorticoid..  Lacks FDA
                                                                                                    approval.
BANNED........................  S0        ...................  Cotinine          Psychoactive/     Lacks FDA
                                                                (Cotinine is a    Anxiolytic.       approval.
                                                                metabolite of
                                                                nicotine. If
                                                                there is
                                                                credible
                                                                evidence that
                                                                the presence of
                                                                cotinine in a
                                                                horse's sample
                                                                is a
                                                                consequence of
                                                                nicotine
                                                                exposure, the
                                                                classification
                                                                of cotinine may
                                                                be revised to
                                                                S7(A).).
CONTROLLED....................  S7        C                    Cromolyn          Mast Cell         Gastrocrom.......
                                                                (Cromoglycate).   Stabilizer.
BANNED........................  S0        ...................  Cropropamide....  Respiratory       Lacks FDA
                                                                                  Stimulant.        approval.
BANNED........................  S0        ...................  Crotethamide....  Respiratory       Lacks FDA
                                                                                  Stimulant.        approval.
BANNED........................  S0        ...................  Cyamemazine.....  Antipsychotic...  Lacks FDA
                                                                                                    approval.
BANNED........................  S0        ...................  Cyclandelate....  Vasodilator.....  Lacks FDA
                                                                                                    approval.
BANNED........................  S0        ...................  Cyclizine.......  Antihistamine...  Discontinued, no
                                                                                                    FDA-approved
                                                                                                    product
                                                                                                    commercially
                                                                                                    available.
BANNED........................  S0        ...................  Cyclobarbital...  Barbiturate.....  Lacks FDA
                                                                                                    approval.
CONTROLLED....................  S7        B                    Cyclobenzaprine.  Muscle relaxant.  Flexeril, Amrix..
BANNED........................  S4        ...................  Cyclofenil......  Selective         Lacks FDA
                                                                                  Estrogen          approval.
                                                                                  Receptor
                                                                                  Modulator
                                                                                  (SERM).
BANNED........................  S0        ...................  Cycloguanil.....  Antimalarial....  Lacks FDA
                                                                                                    approval.
BANNED........................  S0        ...................  Cyclomethycaine.  Local anesthetic  Lacks FDA
                                                                                                    approval.
BANNED........................  S0        ...................  Cyclopentamine..  Vasoconstrictor.  Lacks FDA
                                                                                                    approval.

[[Page 5134]]

 
CONTROLLED....................  S7        ...................  Cyclopentolate..  Mydriatic.......  Akpentolate,
                                                                                                    Cyclogyl,
                                                                                                    Pentolair,
                                                                                                    Cyclomydril.
BANNED........................  S0        ...................  Cyclophenil.....  Selective         Lacks FDA
                                                                                  Estrogen          approval.
                                                                                  Receptor
                                                                                  Modulator
                                                                                  (SERM).
BANNED........................  S0        ...................  Cyclothiazide...  Diuretic........  Discontinued, no
                                                                                                    FDA-approved
                                                                                                    product
                                                                                                    commercially
                                                                                                    available.
BANNED........................  S0        ...................  Cycrimine.......  Anticholinergic.  Discontinued, no
                                                                                                    FDA-approved
                                                                                                    product
                                                                                                    commercially
                                                                                                    available.
CONTROLLED....................  S7        B                    Cyproheptadine..  Antihistamine...  Periactin........
BANNED........................  S4        ...................  Dalantercept      Anti-neoplastic.  Lacks FDA
                                                                (ACE-041).                          approval.
BANNED........................  S1        ...................  Danazol.........  Anabolic........  Generic..........
CONTROLLED....................  S7        C                    Dantrolene......  Muscle relaxant.  Dantrium.........  Detection Time:   3 ng/mL of 5-
                                                                                                                       48 hrs. 500 mg    hydroxydantrole
                                                                                                                       orally once       ne in urine;
                                                                                                                       daily for 3       0.1 ng/mL in
                                                                                                                       days. (12         serum or plasma
                                                                                                                       horses).          as 3'-
                                                                                                                                         hydroxydantrole
                                                                                                                                         ne.
BANNED........................  S2        ...................  Darbepoetin       Erythropoiesis..  Aranesp..........
                                                                (dEPO).
BANNED........................  S0        ...................  Decamethonium...  Muscle relaxant.  Discontinued, no
                                                                                                    FDA-approved
                                                                                                    product
                                                                                                    commercially
                                                                                                    available.
BANNED........................  S1        ...................  Dehydrochloromet  Anabolic........  Turinabol. DEA
                                                                hyltestos-                          Schedule III.
                                                               terone..........
BANNED........................  S0        ...................  Delmadinone       Reproductive      Lacks FDA
                                                                acetate.          hormone.          approval.
BANNED........................  S0        ...................  Delorazepam.....  Anxiolytic......  Lacks FDA
                                                                                                    approval. DEA
                                                                                                    Schedule IV.
BANNED........................  S0        ...................  Dembroxol         Mucolytic.......  Lacks FDA
                                                                (Dembrexine).                       approval.
BANNED........................  S0        (x)                  Demecolcine.....  Anti-neoplastic/  Lacks FDA
                                                                                  Immunomodulator.  approval.
BANNED........................  S0        ...................  Demoxepam.......  Anxiolytic......  Lacks FDA
                                                                                                    approval.
BANNED........................  S0        ...................  Deoxycorticoster  Minerlocorticoid  Lacks FDA
                                                                one.                                approval.
BANNED........................  S0        ...................  Deptropine......  Antihistamine...  Lacks FDA
                                                                                                    approval.
CONTROLLED....................  S7        B                    Deracoxib.......  NSAID...........  Deramaxx.........
BANNED........................  S6        ...................  Dermorphin......  Opioid Receptor   Lacks FDA
                                                                                  Agonist.          approval.
BANNED........................  S0        ...................  Deserpidine.....  Antihypertensive  Discontinued, no
                                                                                                    FDA-approved
                                                                                                    product
                                                                                                    commercially
                                                                                                    available.
BANNED........................  S0        ...................  Desipramine.....  Antidepressant..  Norpramin........
CONTROLLED--fillies and Mares.  S7        B                    Deslorelin......  Induce ovulation  Ovuplant,
                                                                                                    SucroMate,
                                                                                                    Suprelorin.
BANNED--intact males and        S4        ...................  Deslorelin......  Reproductive      Ovuplant,
 geldings.                                                                        hormone.          SucroMate,
                                                                                                    Suprelorin.
BANNED........................  S5        ...................  Desmopressin....  Anti-diuretic...  DDAVP, Nocdurna..
CONTROLLED....................  S7        C                    Desonide........  Corticosteroid..  Verdeso, Desowen.
CONTROLLED....................  S7        C                    Desoximethasone   Corticosteroid..  Topicor..........
                                                                (desoxymethason
                                                                e,
                                                                desoximetasone).
BANNED........................  S1        ...................  Desoxymethyltest  Anabolic........  Lacks FDA
                                                                osterone.                           approval. DEA
                                                                                                    Schedule III.
BANNED........................  S1        ...................  Desoxyvinyl-      Anabolic........  Lacks FDA
                                                                testosterone.                       approval.
CONTROLLED....................  S7        B                    Detomidine......  Sedative/         Dormosedan.......  Detection Time:   2 ng/mL 3-
                                                                                  Analgesic.                           48 hrs. 0.02 mg/  carboxydetomidi
                                                                                                                       kg single IV      ne in urine;
                                                                                                                       dose (10          0.02 ng/mL in
                                                                                                                       horses).          serum or
                                                                                                                                         plasma.
CONTROLLED....................  S7        C                    Dexamethasone...  Corticosteroid..  Azium, Dexasone..  Detection Time:   0.2 ng/mL in
                                                                                                                       72 hours.         urine.
                                                                                                                       Single 20 mg
                                                                                                                       oral dose (20
                                                                                                                       horses).
CONTROLLED....................  S7        C                    Dexamethasone     Corticosteroid..  Generic..........  Detection Time:
                                                                Sodium                                                 72 hours. 0.06
                                                                phosphate.                                             mg/kg single IV
                                                                                                                       dose (6 horses).
CONTROLLED....................  S7        B                    Dextromethorphan  Antitussive.....  Delsym,
                                                                                                    Robitussin.

[[Page 5135]]

 
BANNED........................  S0        ...................  Dextromoramide..  Opioid Analgesic  Lacks FDA
                                                                                                    approval. DEA
                                                                                                    Schedule I.
BANNED........................  S0        ...................  Dextropropoxyphe  Opioid Analgesic  Discontinued, no
                                                                ne.                                 FDA-approved
                                                                                                    product
                                                                                                    commercially
                                                                                                    available. DEA
                                                                                                    Schedule IV.
BANNED........................  S0        ...................  Dextrorphan       Psychoactive/     Lacks FDA
                                                                (Dextrorphan      Antitussive.      approval.
                                                                may be present
                                                                as a metabolite
                                                                of
                                                                dextromethorpha
                                                                n. If there is
                                                                credible
                                                                evidence that
                                                                the presence of
                                                                dextrorphan in
                                                                the horse's
                                                                sample is the
                                                                consequence of
                                                                dextromethorpha
                                                                n
                                                                administration,
                                                                the
                                                                classification
                                                                of dextrorphan
                                                                may be revised
                                                                to S7(A).).
BANNED........................  S0        ...................  Dezocine........  Opioid Analgesic  Discontinued, no
                                                                                                    FDA-approved
                                                                                                    product
                                                                                                    commercially
                                                                                                    available.
BANNED........................  S0        ...................  Diacerein.......  Anti-             Lacks FDA
                                                                                  osteoarthritic.   approval.
BANNED........................  S0        ...................  Diamorphine       Opioid Analgesic  Lacks FDA
                                                                (diacetylmorphi                     approval. DEA
                                                                ne).                                Schedule I.
CONTROLLED....................  S7        B                    Diazepam........  Anxiolytic......  Valium. DEA
                                                                                                    Schedule IV.
BANNED........................  S0        ...................  Diazoxide.......  Antihypertensive/ Proglycem........
                                                                                  Hyperglycemic.
BANNED........................  S0        ...................  Dibenzepin......  Antidepressant..  Lacks FDA
                                                                                                    approval.
BANNED........................  S0        ...................  Dibucaine.......  Local anesthetic  Discontinued, no
                                                                                                    FDA-approved
                                                                                                    product
                                                                                                    commercially
                                                                                                    available.
BANNED........................  S0        ...................  Dichlorisone....  Corticosteroid..  Lacks FDA
                                                                                                    approval.
BANNED........................  S0        ...................  Dichloroacetate.  Anti-neoplastic.  Lacks FDA
                                                                                                    approval.
CONTROLLED....................  S7        C                    Dichlorphenamide  Carbonic          Keveyis..........
                                                                                  Anhydrase
                                                                                  Inhibitor.
CONTROLLED....................  S7        C                    Diclofenac......  NSAID...........  Surpass, Voltaren  ................  50 ng/mL in
                                                                                                                                         urine.
BANNED........................  S0        ...................  Dicumarol.......  Anticoagulant...  Discontinued, no
                                                                                                    FDA-approved
                                                                                                    product
                                                                                                    commercially
                                                                                                    available.
BANNED........................  S0        ...................  Diethylpropion..  Stimulant.......  Lacks FDA
                                                                                                    approval. DEA
                                                                                                    Schedule IV.
BANNED........................  S0        ...................  Diethylthiambute  Opioid Analgesic  Lacks FDA
                                                                ne.                                 approval. DEA
                                                                                                    Schedule I.
BANNED........................  S0        ...................  Diethyltryptamin  Hallucinogen....  Lacks FDA
                                                                e (DET).                            approval.
CONTROLLED....................  S7        C                    Diflorasone.....  Corticosteroid..  Florone..........
BANNED........................  S0        ...................  Diflucortolone..  Corticosteroid..  Lacks FDA
                                                                                                    approval.
BANNED........................  S0        ...................  Diflunisal......  NSAID...........  Generic..........
BANNED........................  S0        ...................  Digitoxin.......  Antiarrhythmic..  Discontinued, no
                                                                                                    FDA-approved
                                                                                                    product
                                                                                                    commercially
                                                                                                    available.
CONTROLLED....................  S7        B                    Digoxin.........  Antiarrhythmic..  Lanoxin..........
BANNED........................  S0        ...................  Dihydrocodeine..  Opioid Analgesic  Trezix (with
                                                                                                    acetaminophen
                                                                                                    and caffeine)
                                                                                                    DEA Schedule III.
BANNED........................  S0        ...................  Dihydrocodeinone  Opioid Analgesic  Lacks FDA
                                                                                                    approval.
CONTROLLED....................  S7        B                    Dihydroergotamin  Ergot alkaloid..  Migranal,
                                                                e mesylate.                         Trudhesa.
BANNED........................  S0        ...................  Dihydromorphine.  Opioid Analgesic  Lacks FDA
                                                                                                    approval. DEA
                                                                                                    Schedule I.
BANNED........................  S1        ...................  Dihydrotestoster  Anabolic........  Anabolex,
                                                                one (17[beta]-                      Andractimm,
                                                                hydroxy-5a                          Pesomax,
                                                                androstan-3-                        Stanolone. DEA
                                                                one,                                Schedule III.
                                                                Androstanolone).
BANNED........................  S0        ...................  Diisopropylamine  Vasodilator.....  Lacks FDA
                                                                                                    approval.
BANNED........................  S0        ...................  Diltiazem.......  Antihypertensive  Cardizem CD,
                                                                                                    Taztia XT,
                                                                                                    Tiazac.
BANNED........................  S0        ...................  Dimefline.......  Respiratory       Lacks FDA
                                                                                  Stimulant.        approval.
BANNED........................  S0        ...................  Dimethindene....  Antihistamine...  Lacks FDA
                                                                                                    approval.
BANNED........................  S0        ...................  Dimethisoquin     Local anesthetic  Lacks FDA
                                                                (quinocaine).                       approval.
BANNED........................  S0        ...................  Dimethylamphetam  Stimulant.......  Lacks FDA
                                                                ine.                                approval.
BANNED........................  S0        ...................  Dimethylphenidat  Stimulant.......  Lacks FDA
                                                                e.                                  approval.

[[Page 5136]]

 
CONTROLLED....................  S7        C                    Dimethylsulfoxid  NSAID...........  Domoso...........  Detection Time:   15 mcg/mL in
                                                                e (DMSO).                                              48 hrs. 70 mL     urine or 1,000
                                                                                                                       90% DMSO in 500   ng/mL in serum
                                                                                                                       mL LRS IV         or plasma.
                                                                                                                       single            Note: The
                                                                                                                       administration    detection of
                                                                                                                       (30 horses).      more than one
                                                                                                                                         NSAID in a
                                                                                                                                         horse's post-
                                                                                                                                         Race or Post-
                                                                                                                                         Official
                                                                                                                                         Workout blood
                                                                                                                                         sample
                                                                                                                                         constitutes a
                                                                                                                                         Stacking
                                                                                                                                         Violation.
BANNED........................  S0        (x)                  Dimethyltryptami  Hallucinogen....  Lacks FDA          ................  10 mcg/mL total
                                                                ne (DMT).                           approval. DEA                        (free and
                                                                                                    Schedule I.                          conjugated) in
                                                                                                                                         urine.
BANNED........................  S0        ...................  Diphenadione....  Anticoagulant...  No FDA-approved
                                                                                                    product.
                                                                                                    Rodenticide.
CONTROLLED....................  S7        B                    Diphenhydramine.  Antihistamine...  Benadryl.........
CONTROLLED....................  S7        B                    Diphenoxylate...  Anti-diarrheal..  DEA Schedule II.
                                                                                                    Lomotil (with
                                                                                                    atropine), DEA
                                                                                                    Schedule II.
BANNED........................  S0        ...................  Diphenylpyraline  Antihistamine...  Discontinued, no
                                                                                                    FDA-approved
                                                                                                    product
                                                                                                    commercially
                                                                                                    available.
BANNED........................  S0        ...................  Dipipanone......  Opioid Analgesic  Lacks FDA
                                                                                                    approval. DEA
                                                                                                    Schedule I.
BANNED........................  S0        ...................  Diprenorphine...  Narcotic          M50-50...........
                                                                                  antagonist.
BANNED........................  S0        ...................  Diprophylline...  Bronchodilator..  Lacks FDA
                                                                                                    approval.
CONTROLLED....................  S7        B                    Dipyridamole....  Platelet          Persantine.......
                                                                                  inhibitor.
CONTROLLED....................  S7        C                    Dipyrone........  NSAID/Anti-       Zimeta...........  Detection Time:   1,000 ng/mL of 4-
                                                                                  pyretic.                             72 hrs. 30 mg/    methylaminoanti
                                                                                                                       kg single IV      pyrine in
                                                                                                                       dose (10          urine. Note:
                                                                                                                       horses).          The detection
                                                                                                                                         of more than
                                                                                                                                         one NSAID in a
                                                                                                                                         horse's post-
                                                                                                                                         Race or Post-
                                                                                                                                         Official
                                                                                                                                         Workout blood
                                                                                                                                         sample
                                                                                                                                         constitutes a
                                                                                                                                         Stacking
                                                                                                                                         Violation.
CONTROLLED....................  S7        B                    Disopyramide....  Antiarrhythmic..  Norpace,
                                                                                                    Rythmodan.
BANNED........................  S0        ...................  Disulfiram......  Alcohol           Generic..........
                                                                                  antagonist.
BANNED........................  S0        ...................  Divalproex......  Anticonvulsant..  Depakote.........
BANNED........................  S0        ...................  Dixyrazine......  Antipsychotic...  Lacks FDA
                                                                                                    approval.
CONTROLLED....................  S7        B                    Dobutamine......  Beta-1 agonist..  Generic..........
BANNED........................  S4        ...................  Domagrozumab....  Anabolic........  Lacks FDA
                                                                                                    approval.
BANNED........................  S0        ...................  Donepezil.......  Behavior and      Adilarity, Aricep
                                                                                  Cognitive
                                                                                  Modifier.
CONTROLLED....................  S7        A                    Dopamine........  Neurotransmitter  Generic..........
BANNED........................  S0        ...................  Dopexamine......  Vasodilator.....  Lacks FDA
                                                                                                    approval.
CONTROLLED....................  S7        B                    Dorzolamide.....  Carbonic          Cosop............
                                                                                  Anhydrase
                                                                                  Inhibitor.
BANNED........................  S0        ...................  Dothiepin.......  Antidepressant..  Lacks FDA
                                                                                                    approval.
BANNED........................  S0        ...................  Doxacurium......  Muscle relaxant.  Discontinued, no
                                                                                                    FDA-approved
                                                                                                    product
                                                                                                    commercially
                                                                                                    available.
CONTROLLED....................  S7        A                    Doxapram........  Respiratory       Dopram, Respiram.
                                                                                  Stimulant.
BANNED........................  S0        ...................  Doxazosin.......  Antihypertensive  Cardura..........
BANNED........................  S0        ...................  Doxefazepam.....  Anxiolytic......  Lacks FDA
                                                                                                    approval.
CONTROLLED....................  S7        A                    Doxepin.........  Antidepressant..  Generic..........
CONTROLLED....................  S7        B                    Doxylamine......  Antihistamine...  Unisom...........
BANNED........................  S1        ...................  Dromostanolone    Anabolic........  Lacks FDA
                                                                (drostanolone).                     approval.
BANNED........................  S0        ...................  Droperidol......  Antipsychotic...  Inapsine.........
BANNED........................  S0        ...................  Drospirenone....  Reproductive      Slynd,
                                                                                  hormone.          Nextstellis,
                                                                                                    Angeliq, Lo-
                                                                                                    Zumandimine,
                                                                                                    Loryna, elamisa,
                                                                                                    Nikki, Yaz.
BANNED........................  S0        ...................  Duloxetine......  Antidepressant..  Cymbalta,
                                                                                                    Drizalma.
CONTROLLED....................  S7        C                    Dyclonine.......  Topical           Dyclopro.........
                                                                                  anesthetic.
BANNED........................  S0        ...................  Dyphylline        Antipsychotic/    Discontinued, no
                                                                (Diphylline).     Anti-emetic.      FDA-approved
                                                                                                    product
                                                                                                    commercially
                                                                                                    available.

[[Page 5137]]

 
BANNED........................  S0        ...................  Edrophonium.....  Muscle            Discontinued, no
                                                                                  strengthener.     FDA-approved
                                                                                                    product
                                                                                                    commercially
                                                                                                    available.
BANNED........................  S2        ...................  Efaproxiral       Hemoglobin        FDA orphan drug..
                                                                (RSR13).          modifier.
BANNED........................  S0        ...................  Eletriptan......  Selective         Relpax...........
                                                                                  Serotonin
                                                                                  Receptor
                                                                                  Agonist.
BANNED........................  S0        ...................  Eltenac.........  NSAID...........  Lacks FDA
                                                                                                    approval.
BANNED........................  S0        ...................  Embramine.......  Antihistamine...  Lacks FDA
                                                                                                    approval.
BANNED........................  S0        ...................  Embutramide.....  Opioid Analgesic  Lacks FDA
                                                                                                    approval. DEA
                                                                                                    Schedule III.
BANNED........................  S0        ...................  Emepronium......  Antispasmodic...  Lacks FDA
                                                                                                    approval.
BANNED........................  S0        ...................  Emidonol........  Anti-             Lacks FDA
                                                                                  inflammatory.     approval.
BANNED........................  S0        ...................  Enalapril         Angiotensin-      Vasotec..........
                                                                (metabolite       converting
                                                                enaloprilat).     enzyme
                                                                                  inhibitor.
BANNED........................  S0        ...................  Enciprazine.....  Anxiolytic/       Lacks FDA
                                                                                  Antipsychotic.    approval.
CONTROLLED....................  S7        A                    Ephedrine.......  Stimulant.......  Akovaz,
                                                                                                    Corphedra,
                                                                                                    Emerphed.
BANNED........................  S6        ...................  Epibatidine.....  Analgesic.......  Lacks FDA
                                                                                                    approval.
BANNED........................  S1        ...................  Epi-              Anabolic........  Lacks FDA
                                                                dihydrotestoste                     approval. DEA
                                                                rone.                               Schedule III.
CONTROLLED....................  S7        A                    Epinephrine.....  Stimulant.......  Adrenalin,
                                                                                                    Epipen,
                                                                                                    Adrenaclick,
                                                                                                    Auvi-Q, Symjepi,
                                                                                                    Primatene Mist.
BANNED........................  S1        ...................  Epitestosterone.  Anabolic........  Lacks FDA
                                                                                                    approval. DEA
                                                                                                    Schedule III.
BANNED........................  S0        ...................  Eplerenone......  Antihypertensive  Inspra...........
BANNED........................  S2        ...................  EPO-based         Erythropoiesis..  Lacks FDA
                                                                constructs                          approval.
                                                                (e.g. EPO-Fc).
BANNED........................  S2        ...................  EPO-mimetic       Erythropoiesis..  .................
                                                                agents (e.g.
                                                                CNTO-530,
                                                                peginesatide).
BANNED........................  S0        ...................  Ergonovine......  Ergot alkaloid..  Lacks FDA
                                                                                                    approval.
BANNED........................  S0        (x)                  Ergotamine......  Ergot alkaloid..  Ergomar, Migergot
                                                                                                    (with caffeine).
BANNED........................  S0        ...................  Erythritol        Vasodilator.....  Lacks FDA
                                                                tetranitrate.                       approval.
BANNED........................  S2        ...................  Erythropoietin    Erythropoiesis..
                                                                (EPO).
BANNED........................  S0        ...................  Esmolol.........  Antihypertensive  Brevibloc........
CONTROLLED....................  S7        C                    Esomeprazole....  Anti-ulcer......  Nexium...........
BANNED........................  S0        ...................  Estazolam.......  Sedative/         Prosom. DE
                                                                                  Anticonvulsant.   Schedule IV.
CONTROLLED--in male horses      S7        B                    Estranediol.....  Estroge.........  .................  ................  Threshold: 0.045
 (other than geldings).                                                                                                                  mcg/mL total
                                                                                                                                         (free and
                                                                                                                                         conjugated)
                                                                                                                                         5[alpha]-
                                                                                                                                         estrane-
                                                                                                                                         3[beta],
                                                                                                                                         17[alpha]-diol
                                                                                                                                         per millilitre
                                                                                                                                         in urine when,
                                                                                                                                         at screening,
                                                                                                                                         the total
                                                                                                                                         5[alpha]-
                                                                                                                                         estrane-
                                                                                                                                         3[beta],
                                                                                                                                         17[alpha]-diol
                                                                                                                                         exceeds the
                                                                                                                                         total 5,10
                                                                                                                                         estrene-
                                                                                                                                         3[beta],17[alph
                                                                                                                                         a]-diol in
                                                                                                                                         urine.
BANNED........................  S0        ...................  Eszopiclone.....  Hypnotic........  Lunesta..........
BANNED........................  S0        ...................  Etafedrine......  Bronchodilator..  Lacks FDA
                                                                                                    approval.
BANNED........................  S0        ...................  Etamiphylline...  Respiratory       Lacks FDA
                                                                                  Stimulant.        approval.
BANNED........................  S0        ...................  Etamivan          Respiratory       Lacks FDA
                                                                (Ethamivan).      Stimulant.        approval.
CONTROLLED....................  S7        B                    Etanercept......  NSAID...........  Enbrel...........
BANNED........................  S5        ...................  Ethacrynic acid   Diuretic........  Edecrin..........
                                                                (Etacrynic
                                                                acid).
BANNED........................  S0        ...................  Ethamivan.......  Respiratory       Lacks FDA
                                                                                  Stimulant.        approval.
BANNED........................  S0        ...................  Ethamsylate.....  Antihemorrhagic.  Lacks FDA
                                                                                                    approval.
BANNED........................  S0        ...................  Ethanol.........  Depressant......  Grain alcohol,
                                                                                                    Everclear.
BANNED........................  S0        ...................  Ethaverine......  Vasodilator.....  Lacks FDA
                                                                                                    approval.
BANNED........................  S0        ...................  Ethchlorvynol...  Sedative/         Discontinued, no
                                                                                  Hypnotic.         FDA-approved
                                                                                                    product
                                                                                                    commercially
                                                                                                    available. DEA
                                                                                                    Schedule IV.
BANNED........................  S0        ...................  Ethiazide.......  Diuretic........  Lacks FDA
                                                                                                    approval.
BANNED........................  S0        ...................  Ethinamate......  Sedative/         Discontinued, no
                                                                                  Hypnotic.         FDA-approved
                                                                                                    product
                                                                                                    commercially
                                                                                                    available. DEA
                                                                                                    Schedule IV.
BANNED........................  S0        ...................  Ethinylestradiol  Reproductive      Lacks FDA
                                                                                  hormone.          approval.
BANNED........................  S0        ...................  Ethoheptazine...  Analgesic.......  Lacks FDA
                                                                                                    approval.
BANNED........................  S0        ...................  Ethopropazine...  Anticholinergic.  Discontinued, no
                                                                                                    FDA-approved
                                                                                                    product
                                                                                                    commercially
                                                                                                    available.
BANNED........................  S0        ...................  Ethosuximide....  Anticonvulsant..  Zarontin.........

[[Page 5138]]

 
BANNED........................  S0        ...................  Ethotoin........  Anticonvulsant..  Discontinued, no
                                                                                                    FDA-approved
                                                                                                    product
                                                                                                    commercially
                                                                                                    available.
BANNED........................  S0        ...................  Ethoxzolamide...  Carbonic          Discontinued, no
                                                                                  Anhydrase         FDA-approved
                                                                                  Inhibitor.        product
                                                                                                    commercially
                                                                                                    available.
BANNED........................  S0        ...................  Ethyl             Sedative........  Lacks FDA
                                                                isobutrazine.                       approval.
BANNED........................  S0        ...................  Ethyl             Sedative          Discontinued, no
                                                                Loflazepate.      Anxiolytic.       FDA-approved
                                                                                                    product
                                                                                                    commercially
                                                                                                    available. DEA
                                                                                                    Schedule IV.
CONTROLLED....................  S7        C                    Ethylaminobenzoa  Local anesthetic  Orajel...........
                                                                te (Benzocaine).
BANNED........................  S0        ...................  Ethylamphetamine  Stimulant.......  Lacks FDA
                                                                                                    approval.
BANNED........................  S1        ...................  Ethylestrenol...  Anabolic........  Discontinued, no
                                                                                                    FDA-approved
                                                                                                    product
                                                                                                    commercially
                                                                                                    available. DEA
                                                                                                    Schedule III.
BANNED........................  S0        ...................  Ethylmorphine...  Opioid Analgesic  Lacks FDA
                                                                                                    approval. DEA
                                                                                                    Schedule II.
BANNED........................  S0        ...................  Ethylnorepinephr  Stimulant.......  Lacks FDA
                                                                ine.                                approval.
BANNED........................  S0        ...................  Ethylphenidate..  Stimulant.......  Lacks FDA
                                                                                                    approval.
BANNED........................  S0        ...................  Etidocaine......  Local anesthetic  Discontinued, no
                                                                                                    FDA-approved
                                                                                                    product
                                                                                                    commercially
                                                                                                    available.
BANNED........................  S0        ...................  Etifoxine         Anticonvulsant..  Lacks FDA
                                                                (etafenoxine).                      approval.
BANNED........................  S0        ...................  Etilefrine......  Stimulant.......  Lacks FDA
                                                                                                    approval.
BANNED........................  S0        ...................  Etiocholanolone.  Anabolic........  Lacks FDA
                                                                                                    approval.
BANNED........................  S0        ...................  Etizolam........  Anxiolytic......  Lacks FDA
                                                                                                    approval.
CONTROLLED....................  S7        B                    Etodolac........  NSAID...........  Generic..........
BANNED........................  S0        ...................  Etodroxizine....  Antihistamine...  Lacks FDA
                                                                                                    approval.
BANNED........................  S0        ...................  Etofenamate.....  NSAID...........  Lacks FDA
                                                                                                    approval.
BANNED........................  S0        ...................  Etomidate.......  Anesthetic......  Amidate..........
BANNED........................  S0        ...................  Etoricoxib......  NSAID...........  Lacks FDA
                                                                                                    approval.
BANNED........................  S0        ...................  Etorphine HCl...  Opioid analgesic  M99. DEA Schedule
                                                                                                    I.
BANNED........................  S2        ...................  Examorelin        Growth Hormone..  Lacks FDA
                                                                (hexarelin).                        approval.
BANNED........................  S4        ...................  Exemestane......  Aromatase         Aromasin.........
                                                                                  inhibitor.
CONTROLLED....................  S7        C                    Famotidine......  Anti-ulcer......  Duexis, Pepcid...
BANNED........................  S0        ...................  Famprofazone....  NSAID...........  Lacks FDA
                                                                                                    approval.
BANNED........................  S0        ...................  Febarbamate.....  Anxiolytic......  Lacks FDA
                                                                                                    approval.
BANNED........................  S0        ...................  Felbamate.......  Anticonvulsant..  Trezix, Tuxari,
                                                                                                    Triacin-C.
BANNED........................  S0        ...................  Felbinac........  NSAID...........  Lacks FDA
                                                                                                    approval.
BANNED........................  S0        ...................  Felodipine......  Antihypertensive  Generic..........
BANNED........................  S0        ...................  Fenbufen........  NSAID...........  Felbatol.........
BANNED........................  S0        ...................  Fenbutrazate....  Psychostimulant.  Lacks FDA
                                                                                                    approval.
BANNED........................  S0        ...................  Fencamfamine....  Stimulant.......  Lacks FDA
                                                                                                    approval. DEA
                                                                                                    Schedule IV.
BANNED........................  S0        ...................  Fencamine.......  Psychostimulant.  Lacks FDA
                                                                                                    approval.
BANNED........................  S0        ...................  Fenclofenac.....  NSAID...........  Lacks FDA
                                                                                                    approval.
BANNED........................  S0        ...................  Fenclozic acid..  NSAID...........  Lacks FDA
                                                                                                    approval.
BANNED........................  S0        ...................  Fenetylline       Psychostimulant.  Lacks FDA
                                                                (fenetylline,                       approval.
                                                                phenethylline,
                                                                phenetylline).
BANNED........................  S0        ...................  Fenfluramine....  Stimulant.......  Fintepla. DEA
                                                                                                    Schedule IV.
CONTROLLED....................  S7        B                    Fenoldopam......  Vasodilator.....  Corlopam.........
CONTROLLED....................  S7        B                    Fenoprofen......  NSAID...........  Nalfon...........
BANNED........................  S3        ...................  Fenoterol.......  Beta-2 agonist-   Lacks FDA
                                                                                  bronchodilator.   approval.
BANNED........................  S0        ...................  Fenozolone......  Psychostimulant.  Lacks FDA
                                                                                                    approval.
BANNED........................  S0        ...................  Fenpiprane......  Antispasmodic...  Lacks FDA
                                                                                                    approval.
BANNED........................  S0        ...................  Fenproporex.....  Stimulant.......  Lacks FDA
                                                                                                    approval. DEA
                                                                                                    Schedule IV.
BANNED........................  S0        ...................  Fenspiride......  Bronchodilator..  Lacks FDA
                                                                                                    approval.
CONTROLLED....................  S7        A                    Fentanyl          Opioid Analgesic  Actiq, Fentora,
                                                                (fentanil).                         Lazanda,
                                                                                                    Sublimaze,
                                                                                                    Subsys. DEA
                                                                                                    Schedule II.

[[Page 5139]]

 
BANNED........................  S0        ...................  Fentiazac.......  NSAID...........  Lacks FDA
                                                                                                    approval.
BANNED........................  S0        ...................  Feprazone.......  NSAID...........  Lacks FDA
                                                                                                    approval.
CONTROLLED....................  S7        C                    Fexofenadine....  Antihistamine...  Allegra..........
BANNED........................  S2        ...................  Fibroblast        Growth Hormone..  .................
                                                                Growth Factors
                                                                (FGFs).
CONTROLLED....................  S7        C                    Firocoxib.......  NSAID...........  Equioxx, Previcox  Detection Time:   2 ng/mL in serum
                                                                                                                       360 hrs. 100      or plasma.
                                                                                                                       mcg/kg orally
                                                                                                                       once daily for
                                                                                                                       total of 7
                                                                                                                       doses. (20
                                                                                                                       horses).
BANNED........................  S0        ...................  Flavoxate.......  Anticholinergic.  Generic..........
CONTROLLED....................  S7        B                    Flecainide......  Antiarrhythmic..  Generic..........
BANNED........................  S0        ...................  Floctafenine....  NSAID...........  Lacks FDA
                                                                                                    approval.
BANNED........................  S0        ...................  Fluanisone......  Antipsychotic...  Lacks FDA
                                                                                                    approval.
BANNED........................  S0        ...................  Fludiazepam.....  Anxiolytic......  Lacks FDA
                                                                                                    approval. DEA
                                                                                                    Schedule IV.
BANNED........................  S0        ...................  Fludrocortisone.  Corticosteroid..  Generic..........
BANNED........................  S0        ...................  Flufenamic acid.  NSAID...........  Lacks FDA
                                                                                                    approval.
CONTROLLED....................  S7        C                    Flumethasone      Corticosteroid..  Flucort, Anaprime
                                                                (flumetasone).
BANNED........................  S5        ...................  Flumethiazide...  Diuretic........  Discontinued, no
                                                                                                    FDA-approved
                                                                                                    product
                                                                                                    commercially
                                                                                                    available.
BANNED........................  S0        ...................  Flunarizine.....  Calcium channel   Lacks FDA
                                                                                  blocker.          approval.
BANNED........................  S0        ...................  Flunisolide.....  Corticosteroid..  Generic..........
BANNED........................  S0        ...................  Flunitrazepam...  Sedative/         Lacks FDA
                                                                                  Anxiolytic.       approval. DEA
                                                                                                    Schedule IV.
CONTROLLED....................  S7        C                    Flunixin........  NSAID (3 NSAIDs   Banamine,          Detection Time:   4 ng/mL in serum
                                                                                  (Flunixin,        Flunixamine,       48 hrs. 1.1 mg/   or plasma.
                                                                                  Ketoprofen,       Equileve,          kg single IV      Note: The
                                                                                  Phenylbutazone)   Meflosyl.          dose (16          detection of
                                                                                  are associated                       horses); 500 mg   more than one
                                                                                  with a                               single IV dose    NSAID in a
                                                                                  Detection Time                       (12 horses).      horse's post-
                                                                                  of 48 hours.                                           Race or Post-
                                                                                  Only one of the                                        Official
                                                                                  three may be                                           Workout blood
                                                                                  administered                                           sample
                                                                                  using a                                                constitutes a
                                                                                  Withdrawal                                             Stacking
                                                                                  Interval based                                         Violation.
                                                                                  on the 48 hour
                                                                                  Detection Time.
                                                                                  To avoid a
                                                                                  stacking
                                                                                  violation
                                                                                  (detection of
                                                                                  more than 1
                                                                                  NSAID in a
                                                                                  blood sample)
                                                                                  the following
                                                                                  secondary
                                                                                  Detection Times
                                                                                  should be
                                                                                  applied for the
                                                                                  following 3
                                                                                  NSAIDs:
                                                                                  Flunixin: 144
                                                                                  hours;
                                                                                  Ketoprofen 96
                                                                                  hours;
                                                                                  Phenylbutazone:
                                                                                  168 hours.).
CONTROLLED....................  S7        C                    Fluocinolone      Corticosteroid..  Flucort-N........
                                                                acetonide.
CONTROLLED....................  S7        C                    Fluocinonide....  Corticosteroid..  Fluonex, Lidex,
                                                                                                    Lonide, Lyderm.
BANNED........................  S0        ...................  Fluocortolone...  Corticosteroid..  Lacks FDA
                                                                                                    approval.
BANNED........................  S0        ...................  Fluopromazine     Antipsychotic...  Lacks FDA
                                                                (Triflupromazin                     approval.
                                                                e).
BANNED........................  S0        ...................  Fluoresone......  Anticonvulsant..  Lacks FDA
                                                                                                    approval.
BANNED........................  S0        ...................  Fluorocortisone.  Corticosteroid..  Lacks FDA
                                                                                                    approval.
CONTROLLED....................  S7        C                    Fluorometholone.  Corticosteroid..  FML Forte........
BANNED........................  S0        ...................  Fluorophenethyla  Stimulant.......  Lacks FDA
                                                                mine.                               approval.
BANNED........................  S0        ...................  Fluoroprednisolo  Corticosteroid..  Discontinued, no
                                                                ne.                                 FDA-approved
                                                                                                    product
                                                                                                    commercially
                                                                                                    available.
BANNED........................  S0        ...................  Fluoxetine......  Antidepressant..  Prozac...........
BANNED........................  S1        ...................  Fluoxymesterone.  Anabolic........  Discontinued, no
                                                                                                    FDA-approved
                                                                                                    product
                                                                                                    commercially
                                                                                                    available. DEA
                                                                                                    Schedule III.
BANNED........................  S0        ...................  Flupenthixol      Antipsychotic...  Lacks FDA
                                                                (flupentixol).                      approval.
CONTROLLED....................  S7        B                    Fluphenazine....  Antipsychotic...  Generic..........
BANNED........................  S0        ...................  Flupirtine......  Analgesic.......  Lacks FDA
                                                                                                    approval.
BANNED........................  S0        ...................  Fluprednisolone.  Corticosteroid..  Discontinued, no
                                                                                                    FDA-approved
                                                                                                    product
                                                                                                    commercially
                                                                                                    available.
CONTROLLED....................  S7        C                    Flurandrenolide   Corticosteroid..  Cordran..........
                                                                (Flurandrenolon
                                                                e,
                                                                Fludroxycortide
                                                                ).
BANNED........................  S0        ...................  Flurazepam......  Sedative/         Generic. DEA
                                                                                  Anxiolytic.       Schedule IV.
CONTROLLED....................  S7        B                    Flurbiprofen....  NSAID...........  Ansaid, Ocufen,
                                                                                                    Strepfen.
BANNED........................  S0        ...................  Fluspirilene....  Antipsychotic...  Lacks FDA
                                                                                                    approval.

[[Page 5140]]

 
CONTROLLED....................  S7        C                    Fluticasone.....  Corticosteroid..  Flovent, Flonase.
BANNED........................  S0        ...................  Flutoprazepam...  Sedative/         Lacks FDA
                                                                                  Anxiolytic.       approval.
BANNED........................  S0        ...................  Fluvoxamine.....  Antidepressant..  Luvox............
BANNED........................  S4        ...................  Follistatin.....  Myostatin
                                                                                  inhibitor.
BANNED........................  S1        ...................  Formebolone.....  Anabolic........  Lacks FDA
                                                                                                    approval. DEA
                                                                                                    Schedule III.
BANNED........................  S4        ...................  Formestane......  Aromatase         Lacks FDA
                                                                                  inhibitor.        approval.
BANNED........................  S3        ...................  Formoterol        Beta-2 agonist-   Brovana; Breyna
                                                                (Aformoterol).    bronchodilator.   (with
                                                                                                    budesonide);
                                                                                                    Duaklir Pressair
                                                                                                    (with
                                                                                                    aclidinium).
BANNED........................  S0        ...................  Fosinopril......  Antihypertensive  Generic..........
BANNED........................  S0        ...................  Fosphenytoin....  Anticonvulsant..  Cerebyx..........
BANNED........................  S4        ...................  Fulvestrant.....  Estrogen          Falsodex.........
                                                                                  antagonist.
BANNED........................  S1        ...................  Furazabol.......  Anabolic........  Lacks FDA
                                                                                                    approval. DEA
                                                                                                    Schedule III.
BANNED........................  S0        ...................  Furazadrol......  Anabolic........  Lacks FDA
                                                                                                    approval.
BANNED........................  S0        ...................  Furfenorex......  Stimulant.......  Lacks FDA
                                                                                                    approval.
CONTROLLED-(Permitted at all    S7        C                    Furosemide......  Diuretic........  Lasix, Salix.....  Restricted        50 ng/mL in
 times during Workouts,                                                                                                Administration:   urine or 0.1 ng/
 Official Workouts, and other                                                                                          48 hrs. 1 mg/kg   mL in serum or
 training exercise).                                                                                                   single IV dose    plasma.
                                                                                                                       (6 horses).
CONTROLLED-where permitted on   S7        C                    Furosemide        Diuretic........  Lasix, Salix.....  Shall not be      100 ng/mL in
 race day.                                                      (where                                                 administered      serum or plasma
                                                                permitted by                                           within 4 hours    AND urine S.G.
                                                                exemption).                                            prior to Post-    < 1.010.
                                                                                                                       Time.
CONTROLLED....................  S7        B                    Gabapentin......  Anticonvulsant..  Horizant,
                                                                                                    Gralise,
                                                                                                    Neurontin.
BANNED........................  S0        ...................  Galantamine.....  Acetylcholineste  Razadyne.........
                                                                                  rase inhibitor.
BANNED........................  S0        ...................  Gallamine.......  Muscle relaxant.  Discontinued, no
                                                                                                    FDA-approved
                                                                                                    product
                                                                                                    commercially
                                                                                                    available.
BANNED........................  S0        ...................  Gamma             Neurotransmitter  Endogenous
                                                                Aminobutyric                        substance.
                                                                Acid (GABA).
BANNED........................  S0        ...................  Gamma-            Neurohormone....  Lacks FDA
                                                                butyrolactone                       approval.
                                                                (GBL).
BANNED........................  S0        ...................  Gamma-            CNS depressant..  Lacks FDA
                                                                hydroxybutyrate                     approval.
                                                                (GHB).
BANNED........................  S0        ...................  Gepirone........  Antidepressant..  Lacks FDA
                                                                                                    approval.
BANNED........................  S1        ...................  Gestrinone......  Anabolic........  Lacks FDA
                                                                                                    approval. DEA
                                                                                                    Schedule III.
BANNED........................  S1        ...................  GH-Releasing      Growth Hormone..
                                                                Peptides
                                                                (ghrps), e.g.,
                                                                alexamorelin,
                                                                GHRP-6,
                                                                hexarelin and
                                                                pralmorelin
                                                                (GHRP-2).
BANNED........................  S0        (x)                  Glaucine........  Antitussive.....  Lacks FDA          ................  0.5 ng/mL in
                                                                                                    approval..                           serum or
                                                                                                                                         plasma.
BANNED........................  S0        ...................  Glutethimide      Sedative........  Discontinued, no
                                                                (chlorhexidol).                     FDA-approved
                                                                                                    product
                                                                                                    commercially
                                                                                                    available. DEA
                                                                                                    Schedule II.
CONTROLLED....................  S7        C                    Glycopyrrolate..  Anticholinergic.  Robinul..........  Detection Time:   0.003 ng/mL in
                                                                                                                       48 hours. 1 mg    serum or
                                                                                                                       single dose IV.   plasma.
                                                                                                                       (20 horses).
CONTROLLED--fillies and mares.  S7        B                    Gonadorelin.....  Induce ovulation  Cystorelin,
                                                                                                    Factrel,
                                                                                                    Fertelin,
                                                                                                    OvaCyst,
                                                                                                    Fertagyl,
                                                                                                    Gonabree.
BANNED--intact males and        S4        ...................  Gonadorelin.....  Reproductive      Cystorelin,
 geldings.                                                                        hormone           Factrel,
                                                                                  modulator.        Fertelin,
                                                                                                    OvaCyst,
                                                                                                    Fertagyl,
                                                                                                    Gonabreed.
BANNED........................  S2        ...................  Goserelin.......  Reproductive      Zoladex..........
                                                                                  hormone
                                                                                  modulator.
BANNED........................  S1        ...................  Growth Hormone    Anabolic........
                                                                Releasing
                                                                Hormone (GHRH).

[[Page 5141]]

 
CONTROLLED....................  S7        C                    Guaifenesin       Expectorant.....  Mucinex..........  Detection Time:   1 ng/mL in serum
                                                                (glycerol                                              48 hrs. 2 grams   or plasma.
                                                                guiacolate).                                           total body
                                                                                                                       dose, orally
                                                                                                                       twice daily for
                                                                                                                       5 doses. (9
                                                                                                                       horses).
BANNED........................  S         ...................  ................  Antihypertensive  Generic..........
BANNED........................  S0        ...................  Guanadrel.......  Antihypertensive  Discontinued, no
                                                                                                    FDA-approved
                                                                                                    product
                                                                                                    commercially
                                                                                                    available.
BANNED........................  S0        ...................  Guanethidine....  Antihypertensive  Discontinued, no
                                                                                                    FDA-approved
                                                                                                    product
                                                                                                    commercially
                                                                                                    available.
BANNED........................  S0        ...................  Guanoclor.......  Antihypertensive  Lacks FDA
                                                                                                    approval.
BANNED........................  S0        ...................  Halazepam.......  Sedative/         Discontinued, no
                                                                                  Anxiolytic.       FDA-approved
                                                                                                    product
                                                                                                    commercially
                                                                                                    available. DEA
                                                                                                    Schedule IV.
CONTROLLED....................  S7        C                    Halcinonide.....  Corticosteroid..  Halog............
BANNED........................  S0        ...................  Haldrol.........  Anabolic........  Lacks FDA
                                                                                                    approval.
CONTROLLED....................  S7        C                    Halobetasol.....  Corticosteroid..  Lexette, Bryhali,
                                                                                                    Ultravate.
BANNED........................  S0        ...................  Haloperidol.....  Antipsychotic...  Haldol...........
BANNED........................  S0        ...................  Haloxazolam.....  Sedative/         Lacks FDA
                                                                                  Anxiolytic.       approval.
BANNED........................  S0        ...................  Harmaline.......  Psychoactive....  Lacks FDA
                                                                                                    approval.
CONTROLLED....................  S7        B                    Harpagoside       Anti-             Glycoside of
                                                                (Devil's Claw).   inflammatory.     plangt origin.
                                                                                                    No FDA-approved
                                                                                                    products
                                                                                                    commercially
                                                                                                    available.
                                                                                                    Constituent of
                                                                                                    multiple,
                                                                                                    unregulated OTC
                                                                                                    herbal remedies.
BANNED........................  S2        ...................  Hepatocyte        Growth Hormone..
                                                                Growth Factor
                                                                (HGF).
BANNED........................  S0        ...................  Heptaminol......  Cardiac
                                                                                  stimulant.
BANNED........................  S0        ...................  Hexafluorenium..  Muscle relaxant.  Discontinued, no
                                                                                                    FDA-approved
                                                                                                    product
                                                                                                    commercially
                                                                                                    available.
BANNED........................  S0        ...................  Hexobarbital....  Sedative........  Lacks FDA
                                                                                                    approval.
BANNED........................  S0        ...................  Hexocyclium.....  Anticholinergic.  Discontinued, no
                                                                                                    FDA-approved
                                                                                                    product
                                                                                                    commercially
                                                                                                    available.
BANNED........................  S0        ...................  Hexylcaine......  Local anesthetic  Discontinued, no
                                                                                                    FDA-approved
                                                                                                    product
                                                                                                    commercially
                                                                                                    available.
BANNED........................  S3        ...................  Higenamine        Bronchodilator..  Constituent of
                                                                (norclaurine,                       numerous OTC
                                                                demethylcoclaur                     dietary
                                                                ine).                               supplements
                                                                                                    marketed for
                                                                                                    weight loss or
                                                                                                    as sports/energy
                                                                                                    supplements.
                                                                                                    Lacks FDA
                                                                                                    approval.
BANNED........................  S0        ...................  Histapyrrodine..  Antihistamine...  Lacks FDA
                                                                                                    approval.
BANNED........................  S4        ...................  Histrelin.......  GnRH agonist....  Supprelin LA,
                                                                                                    Vantas.
CONTROLLED....................  S7        B                    Homatropine.....  Anticholinergic.  Hycodan [with
                                                                                                    hydrocodone].
BANNED........................  S0        ...................  Homophenazine...  Antipsychotic...  Lacks FDA
                                                                                                    approval.
CONTROLLED....................  S7        A (x)                Hordenine.......  Stimulant.......  Plant alkaloid     ................  80 mcg/mL total
                                                                                                    (e.g. barley).                       (free and
                                                                                                    Constituent of                       conjugated) in
                                                                                                    numerous OTC                         urine.
                                                                                                    dietary
                                                                                                    supplements
                                                                                                    marketed for
                                                                                                    weight loss.
                                                                                                    Lacks FDA
                                                                                                    approval..
CONTROLLED....................  S7        B                    Hydralazine.....  Vasodilator.....  Hydra-Zide, Bidi.
BANNED........................  S5        ...................  Hydrochlorthiazi  Diuretic........  Lotensin (with
                                                                de.                                 bisoprolol);
                                                                                                    Vaseretic (with
                                                                                                    enalapril);
                                                                                                    Avilide (with
                                                                                                    irbesartan);
                                                                                                    Zestoretic (with
                                                                                                    lisinopril);
                                                                                                    Lopressor (with
                                                                                                    metoprolol);
                                                                                                    Micardis (with
                                                                                                    telmisartan);
                                                                                                    and other.
BANNED........................  S0        ...................  Hydrocodone       Opioid Analgesic  Hysingla; Apadaz,
                                                                (dihydrocodieno                     Anexsia (with
                                                                ne).                                acetaminophen);
                                                                                                    Hycodan (with
                                                                                                    homatropine) DEA
                                                                                                    Schedule II.
CONTROLLED....................  S7        C                    Hydrocortisone..  Corticosteroid..  Cortef. Note:      ................  Threshold: 1 mcg/
                                                                                                    hydrocortisone                       mL in urine.
                                                                                                    is a component
                                                                                                    of numerous
                                                                                                    products,
                                                                                                    particularly
                                                                                                    those for
                                                                                                    topical,
                                                                                                    ophthalmic, and
                                                                                                    otic
                                                                                                    applications.
                                                                                                    The Responsible
                                                                                                    Person is
                                                                                                    advised to read
                                                                                                    all medication
                                                                                                    labels prior to
                                                                                                    authorizing
                                                                                                    administration.

[[Page 5142]]

 
BANNED........................  S5        ...................  Hydroflumethiazi  Diuretic........  Discontinued, no
                                                                de.                                 FDA-approved
                                                                                                    product
                                                                                                    commercially
                                                                                                    available.
BANNED........................  S0        ...................  Hydromorphinol..  Opioid Analgesic  Lacks FDA
                                                                                                    approval.
BANNED........................  S0        ...................  Hydromorphone...  Opioid Analgesic  Dilaudid. DEA
                                                                                                    Schedule II.
BANNED........................  S0        ...................  Hydroxyamphetami  Stimulant.......  Paremyd (with
                                                                ne.                                 tropicamide).
BANNED........................  S0        ...................  Hydroxy-gamma     Neurohormone....  Lacks FDA
                                                                amino butyric                       approval.
                                                                acid.
BANNED........................  S0        ...................  Hydroxytestoster  Anabolic........  Lacks FDA
                                                                one.                                approval.
CONTROLLED....................  S7        C                    Hydroxyzine.....  Antihistamine...  Atarax...........  Detection time:   ................
                                                                                                                       96 hours.
                                                                                                                       Hydroxyzine:
                                                                                                                       190 mg twice
                                                                                                                       daily for a
                                                                                                                       total of 9
                                                                                                                       doses (2
                                                                                                                       horses)..
BANNED........................  S6        ...................  Ibandronate.....  Bisphosphonate..  Generic..........
BANNED........................  S0        ...................  Ibogaine........  Psychoactive....  Lacks FDA
                                                                                                    approval. DEA
                                                                                                    Schedule I.
CONTROLLED....................  S7        C                    Ibuprofen.......  NSAID...........  Advil, Motrin....
BANNED........................  S2        ...................  Ibutamoren......  Growth Hormone..  Investigational
                                                                                                    New Drug (in
                                                                                                    clinical trials).
CONTROLLED....................  S7        B                    Ibutilide.......  Antiarrhythmic..  Corvert..........
BANNED........................  S0        ...................  Iloprost........  Vasodilator.....  Ventavis.........
CONTROLLED....................  S7        A                    Imipramine......  Antidepressant..  Tofranil.........
BANNED........................  S3        ...................  Indacaterol.....  Beta-2 agonist-   Discontinued, no
                                                                                  bronchodilator.   FDA-approved
                                                                                                    product
                                                                                                    commercially
                                                                                                    available.
BANNED........................  S5        ...................  Indapamide......  Diuretic........  Generic..........
CONTROLLED....................  S7        B                    Indomethacin....  NSAID...........  Indocin..........
BANNED........................  S0        ...................  Indoprofen......  NSAID...........  Lacks FDA
                                                                                                    approval.
BANNED........................  S0        ...................  Indoramin.......  Antihypertensive  Lacks FDA
                                                                                                    approval.
CONTROLLED....................  S7        B                    Infliximab......  Immunosuppressor  Remicade.........
BANNED........................  S2        ...................  Insulin- like     Peptide hormone.
                                                                Growth Factor-1
                                                                (IGF-1) and its
                                                                analogues.
BANNED........................  S2        ...................  Insulins........  Anti-
                                                                                  hyperglycemics.
BANNED........................  S2        ...................  IOX-2...........  Erythropoiesis..  Lacks FDA
                                                                                                    approval.
BANNED........................  S2        ...................  Ipamorelin......  Growth Hormone..  Lacks FDA
                                                                                                    approval.
CONTROLLED....................  S7        B                    Ipratropium.....  Bronchodilator..  Atrovent.........  Detection Time:   0.25 ng/mL in
                                                                                                                       120 hrs. 5.5      urine.
                                                                                                                       mcg/kg once
                                                                                                                       daily via
                                                                                                                       nebulization
                                                                                                                       for 3 total
                                                                                                                       doses (6
                                                                                                                       horses).
CONTROLLED....................  S7        B                    Ipratropium       Bronchodilator..  Atrovent;
                                                                bromide.                            Combivent (with
                                                                                                    albuterol).
BANNED........................  S0        ...................  Iprindole.......  Antidepressant..  Lacks FDA
                                                                                                    approval.
BANNED........................  S0        ...................  Iproniazid......  Antidepressant..  Lacks FDA
                                                                                                    approval.
BANNED........................  S0        ...................  Ipsapirone......  Antidepressant..  Lacks FDA
                                                                                                    approval.
BANNED........................  S5        ...................  Irbesartan......  Antihypertensive  Avalide, Avapro..
BANNED........................  S0        ...................  Isoaminile......  Antitussive.....  Lacks FDA
                                                                                                    approval.
BANNED........................  S0        ...................  Isocarboxazid...  Antidepressant..  Marplan..........
BANNED........................  S0        ...................  Isoetharine.....  Bronchodilator..  Discontinued, no
                                                                                                    FDA-approved
                                                                                                    product
                                                                                                    commercially
                                                                                                    available.
CONTROLLED....................  S7        C                    Isoflupredone...  Corticosteroid..  Predef 2x........  14 day stand      ................
                                                                                                                       down for all
                                                                                                                       intra-articular
                                                                                                                       injections.
                                                                                                                       Serum
                                                                                                                       concentrations
                                                                                                                       associated with
                                                                                                                       an experimental
                                                                                                                       dose of 8 mg IA
                                                                                                                       single joint (6
                                                                                                                       horses) were
                                                                                                                       all below Limit
                                                                                                                       of Detection by
                                                                                                                       14 days..
BANNED........................  S0        ...................  Isomethadone      Synthetic opioid  Lacks FDA
                                                                (isoamidone).     analgesic.        approval. DEA
                                                                                                    Schedule I.
BANNED........................  S0        ...................  Isometheptene...  Sympathomimetic.  Lacks FDA
                                                                                                    approval.

[[Page 5143]]

 
BANNED........................  S0        ...................  Isopropamide....  Anticholinergic.  Discontinued, no
                                                                                                    FDA-approved
                                                                                                    product
                                                                                                    commercially
                                                                                                    available.
BANNED........................  S3        ...................  Isoproterenol...  Beta-2 agonist..  Generic..........
BANNED........................  S0        ...................  Isopyrin          NSAID...........  Lacks FDA
                                                                (Raminfenazone).                    approval.
CONTROLLED....................  S7        B                    Isosorbide        Vasodilator.....  Isordil..........
                                                                dinitrate.
BANNED........................  S0        ...................  Isothipendyl....  Antihistamine...  Lacks FDA
                                                                                                    approval.
BANNED........................  S0        ...................  Isoxicam........  NSAID...........  Lacks FDA
                                                                                                    approval.
BANNED........................  S0        ...................  Isradipine......  Antihypertensive  Generic..........
BANNED........................  S0        ...................  Isoxsuprine.....  Vasodilator.....  Lacks FDA
                                                                                                    approval.
BANNED........................  S0        ...................  Kebuzone........  NSAID...........  Lacks FDA
                                                                                                    approval.
CONTROLLED....................  S7        B                    Ketamine/         Anesthetic......  Ketaset, Vetalar.
                                                                norketamine.                        DEA Schedule III.
BANNED........................  S0        ...................  Ketazolam.......  Sedative/         Lacks FDA
                                                                                  Anxiolytic.       approval. DEA
                                                                                                    Schedule IV.
CONTROLLED....................  S7        C                    Ketoprofen......  NSAID...........  Ketofen..........  Detection Time:   2 ng/mL in serum
                                                                                                                       48 hrs. 2.2 mg/   or plasma.
                                                                                                                       kg single IV      Note: The
                                                                                                                       dose. (24         detection of
                                                                                                                       horses).          more than one
                                                                                                                                         NSAID in a
                                                                                                                                         horse's post-
                                                                                                                                         Race or Post-
                                                                                                                                         Official
                                                                                                                                         Workout blood
                                                                                                                                         sample
                                                                                                                                         constitutes a
                                                                                                                                         Stacking
                                                                                                                                         Violation. 3
                                                                                                                                         NSAIDs
                                                                                                                                         (Flunixin,
                                                                                                                                         Ketoprofen,
                                                                                                                                         Phenylbutazone)
                                                                                                                                         are associated
                                                                                                                                         with a
                                                                                                                                         Detection Time
                                                                                                                                         of 48 hours.
                                                                                                                                         Only one of the
                                                                                                                                         three may be
                                                                                                                                         administered
                                                                                                                                         using a
                                                                                                                                         Withdrawal
                                                                                                                                         Interval based
                                                                                                                                         on the 48 hour
                                                                                                                                         Detection Time.
                                                                                                                                         To avoid a
                                                                                                                                         stacking
                                                                                                                                         violation
                                                                                                                                         (detection of
                                                                                                                                         more than 1
                                                                                                                                         NSAID in a
                                                                                                                                         blood sample)
                                                                                                                                         the following
                                                                                                                                         secondary
                                                                                                                                         Detection Times
                                                                                                                                         should be
                                                                                                                                         applied for the
                                                                                                                                         following
                                                                                                                                         NSAIDs:
                                                                                                                                         Flunixin: 144
                                                                                                                                         hours;
                                                                                                                                         Ketoprofen 96
                                                                                                                                         hours;
                                                                                                                                         Phenylbutazone:
                                                                                                                                         168 hours.
CONTROLLED....................  S7        A                    Ketorolac.......  NSAID...........  Acular, Acuvail,
                                                                                                    Sprix, Omidria.
CONTROLLED....................  S7        B                    Ketotifen.......  Antihistamine...  Alaway, Zaditor..
BANNED........................  S2        ...................  Krypton.........  Hypoxia           .................
                                                                                  Inducible
                                                                                  Factor
                                                                                  activating.
BANNED........................  S0        ...................  Labetalol.......  Antihypertensive  Trandate.........
CONTROLLED....................  S7        A                    Lamotrigine.....  Anticonvulsant..  Lamictal.........
BANNED........................  S4        ...................  Landogrozumab...  Myostatin         Lacks FDA
                                                                                  inhibitor.        approval.
CONTROLLED....................  S7        C                    Lansoprazole....  Anti-ulcer......  Prevacid.........
BANNED........................  S2        ...................  Lenomorelin       Growth Hormone..  Lacks FDA
                                                                (ghrelin).                          approval.
BANNED........................  S0        ...................  Lenperone.......  Antipsychotic...  Lacks FDA
                                                                                                    approval.
BANNED........................  S0        ...................  Leptazole         Stimulant.......  Lacks FDA
                                                                (Pentylenetetra                     approval.
                                                                zole).
BANNED........................  S0        ...................  Letosteine......  Mucolytic.......  Lacks FDA
                                                                                                    approval.
BANNED........................  S2        ...................  Letrozole.......  Aromatase         Femara...........
                                                                                  inhibitor.
BANNED........................  S2        ...................  Leuprorelin       Reproductive      Eligard Kit,
                                                                (leuprolide).     hormone           Fensolvi Kit,
                                                                                  modulator.        Camcevi Kit.
BANNED........................  S0        ...................  Levallorphan....  Opioid            Discontinued, no
                                                                                  Antagonist.       FDA-approved
                                                                                                    product
                                                                                                    commercially
                                                                                                    available.
CONTROLLED....................  S7        B                    Levamisole......  Anthelmintic/     Ripercol,
                                                                                  Immunostimulant.  Tramisol,
                                                                                                    Levasole,
                                                                                                    Prohibit,
                                                                                                    LevaMed.
BANNED........................  S0        ...................  Levobunolol.....  Antihypertensive  Betagan..........
BANNED........................  S0        ...................  Levocabastine...  Antihistamine...  Discontinued, no
                                                                                                    FDA-approved
                                                                                                    product
                                                                                                    commercially
                                                                                                    available.

[[Page 5144]]

 
BANNED........................  S0        ...................  Levodopa........  Decarboxylase     Inbrija; Stalevo,
                                                                                  Inhibitor.        Rytary, Duopa,
                                                                                                    Dhivy, Sinemet
                                                                                                    (all with
                                                                                                    carbidopa).
BANNED........................  S0        ...................  Levomethadone...  Opioid Analgesic  Lacks FDA
                                                                                                    approval.
BANNED........................  S0        ...................  Levomethorphan..  Opioid Analgesic  Lacks FDA
                                                                                                    approval. DEA
                                                                                                    Schedule II.
BANNED........................  S0        ...................  Levophacetoperan  Psychostimulant.  Lacks FDA
                                                                e.                                  approval.
BANNED........................  S0        ...................  Levorphanol.....  Opioid Analgesic  Generic. DEA
                                                                                                    Schedule I.
BANNED........................  S3        ...................  Levosalbutamol    Beta-2 agonist-   Xopenex..........
                                                                (levalbuterol).   bronchodilator.
BANNED........................  S4        ...................  Levothyroxine...  Metabolic         Thyro-Tabs,
                                                                                  hormone.          ThyroKare,
                                                                                                    Tirosint,
                                                                                                    Ermeza,
                                                                                                    Euthyrox,
                                                                                                    Levolet,
                                                                                                    Synthroid,
                                                                                                    Levoxyl,
                                                                                                    Unithroid.
CONTROLLED....................  S7        B                    Lidocaine.......  Local anesthetic  Xylocaine [with    Detection Time:   10 ng/mL as 3-
                                                                                                    epinephrine],      48 hours. 200     hydroxylidocain
                                                                                                    Lignospan,         mg of lidocaine   e in urine;
                                                                                                    Ztlido, Akten.     as its            0.02 ng/mL as 3-
                                                                                                                       hydrochloride     hydroxylidocain
                                                                                                                       salt              e in serum or
                                                                                                                       administered      plasma.
                                                                                                                       subcutaneously
                                                                                                                       (6 horses).
BANNED........................  S0        ...................  Lidoflazine.....  Vasodilator.....  Lacks FDA
                                                                                                    approval.
BANNED........................  S4        ...................  Ligandrol (LGD-   Selective         Lacks FDA
                                                                4033).            Androgen          approval.
                                                                                  Receptor
                                                                                  Modulator
                                                                                  (SARM).
BANNED........................  S0        ...................  Lisinopril......  Antihypertensive  Zestoretic,
                                                                                                    Qbrelis.
BANNED........................  S0        ...................  Lithium.........  Mood Stabilizer.  Lithobid.........
BANNED........................  S0        (x)                  Lobeline........  Respiratory       Plant alkaloid     ................  2 ng/mL in serum
                                                                                  Stimulant.        (Lobelia, Indian                     or plasma.
                                                                                                    Tobacco)
                                                                                                    Environmental
                                                                                                    substance. Lacks
                                                                                                    FDA approval..
BANNED........................  S0        ...................  Lofentanil......  Opioid Analgesic  Lacks FDA
                                                                                                    approval.
BANNED........................  S0        ...................  Lofepramine.....  Antidepressant..  Lacks FDA
                                                                                                    approval.
BANNED........................  S0        ...................  Loflazepate,      Anxiolytic......  Lacks FDA
                                                                Ethyl.                              approval.
BANNED........................  S2        ...................  Lonapegsomatropi  Growth Hormone..  FDA Orphan Drug..
                                                                n.
CONTROLLED....................  S7        B                    Loperamide......  Anti-diarrheal..  Imodium..........
BANNED........................  S0        ...................  Loprazolam......  Anxiolytic......  Lacks FDA
                                                                                                    approval. DEA
                                                                                                    Schedule IV.
CONTROLLED....................  S7        C                    Loratidine......  Antihistamine...  Claritin.........
BANNED........................  S0        ...................  Lorazepam.......  Anxiolytic......  Ativan. DEA
                                                                                                    Schedule IV.
BANNED........................  S0        ...................  Lormetazepam....  Sedative/         Lacks FDA
                                                                                  Anxiolytic.       approval.
BANNED........................  S0        ...................  Lornoxicam......  NSAID...........  Lacks FDA
                                                                                                    approval. DEA
                                                                                                    Schedule IV.
BANNED........................  S0        ...................  Losartan........  Antihypertensive  Cozaar, Hyzaar
                                                                                                    [with
                                                                                                    hydrochlorothiaz
                                                                                                    ide].
BANNED........................  S0        ...................  Loxapine........  Antipsychotic...  Adasuve..........
BANNED........................  S3        ...................  Lubabegron......  Beta adrenergic   Experior.........
                                                                                  modulator.
BANNED........................  S0        ...................  Lumiracoxib.....  NSAID...........  Lacks FDA
                                                                                                    approval.
BANNED........................  S2        ...................  Luspatercept....  Erythropoiesis..  FDA Orphan Drug..
CONTROLLED--fillies and mares.  S7        B                    Luteinizing       Reproductive
                                                                Hormone (LH).     hormone
                                                                                  modulator.
BANNED--intact males and        S2        ...................  Luteinizing       Reproductive
 geldings.                                                      Hormone (LH).     hormone
                                                                                  modulator.
BANNED........................  S3        ...................  Mabuterol.......  Beta-2 agonist-   Lacks FDA
                                                                                  bronchodilator.   approval.
BANNED........................  S2        ...................  Macimorelin.....  Growth Hormone..  Macrilen.........
CONTROLLED....................  S7        B                    Magnesium         Sedative/         Generic..........
                                                                sulfate.          Laxative.
BANNED........................  S0        ...................  Maprotiline.....  Antidepressant..  Discontinued, no
                                                                                                    FDA-approved
                                                                                                    product
                                                                                                    commercially
                                                                                                    available.
BANNED........................  S0        ...................  Mazindol........  Stimulant.......  Discontinued, no
                                                                                                    FDA-approved
                                                                                                    product
                                                                                                    commercially
                                                                                                    available. DEA
                                                                                                    Schedule IV.
BANNED........................  S0        ...................  Mebanazine......  Antidepressant..  Lacks FDA
                                                                                                    approval.
BANNED........................  S0        ...................  Mebeverine......  Antispasmodic...  Lacks FDA
                                                                                                    approval.
BANNED........................  S0        ...................  Mebhyroline       Antihistamine...  Lacks FDA
                                                                (Mebhydrolin).                      approval.

[[Page 5145]]

 
BANNED........................  S0        ...................  Mebutamate......  Sedative/         Discontinued, no
                                                                                  Anxiolytic.       FDA-approved
                                                                                                    product
                                                                                                    commercially
                                                                                                    available. DEA
                                                                                                    Schedule IV.
BANNED........................  S0        ...................  Mecamylamine....  Vasodilator.....  Generic..........
BANNED........................  S2        ...................  Mechano Growth    Growth Hormone..
                                                                Factors (MGFs).
BANNED........................  S0        ...................  Meclizine.......  Antihistamine...  Antivert.........
CONTROLLED....................  S7        B                    Meclofenamic      NSAID...........  Discontinued, no
                                                                acid.                               FDA-approved
                                                                                                    product
                                                                                                    commercially
                                                                                                    available.
                                                                                                    Routinely
                                                                                                    compounded.
BANNED........................  S1        ...................  Meclofenoxate...  Cholinergic       Lacks FDA
                                                                                  nootropic.        approval.
BANNED........................  S0        (x)                  Meconine........  Opioid..........  Lacks FDA
                                                                                                    approval.
BANNED........................  S0        ...................  Medazepam.......  Sedative/         Lacks FDA
                                                                                  Anxiolytic.       approval. DEA
                                                                                                    Schedule IV.
CONTROLLED....................  S7        B                    Medetomidine....  Sedative/         Domitor,           ................  5 ng/mL as 3-
                                                                                  Analgesic.        Placadine.                           hydroxymedetomi
                                                                                                                                         dine in urine.
CONTROLLED....................  S7        B                    Medroxyprogester  Reproductive      Depo-Provera.....
                                                                one.              hormone.
BANNED........................  S0        ...................  Medrylamine.....  Antihistamine...  Lacks FDA
                                                                                                    approval.
BANNED........................  S0        ...................  Medrysone.......  Corticosteroid..  Discontinued, no
                                                                                                    FDA-approved
                                                                                                    product
                                                                                                    commercially
                                                                                                    available.
BANNED........................  S0        ...................  Mefenamic acid..  NSAID...........  Ponstel..........
BANNED........................  S0        ...................  Mefenorex.......  Stimulant.......  Lacks FDA
                                                                                                    approval. DEA
                                                                                                    Schedule IV.
BANNED........................  S0        ...................  Mefexamide......  Stimulant.......  Lacks FDA
                                                                                                    approval.
BANNED........................  S0        ...................  Mefruside.......  Diuretic........  Lacks FDA
                                                                                                    approval.
BANNED........................  S2        ...................  Meldonium.......  Anti-ischemic...  Lacks FDA
                                                                                                    approval.
CONTROLLED....................  S7        B                    Meloxicam.......  NSAID...........  Metacam..........
BANNED........................  S0        ...................  Melperone.......  Antipsychotic...  Lacks FDA
                                                                                                    approval.
BANNED........................  S0        ...................  Memantine.......  Alzheimer's       Namenda; Namzaric
                                                                                  treatment.        (with donepezil).
BANNED........................  S0        ...................  Meparfynol        Sedative........  Lacks FDA
                                                                (methylpentynol                     approval.
                                                                ).
BANNED........................  S0        ...................  Mepazine........  Antipsychotic...  Lacks FDA
                                                                                                    approval.
BANNED........................  S0        ...................  Mepednisone.....  Corticosteroid..  Lacks FDA
                                                                                                    approval.
BANNED........................  S0        ...................  Mepenzolate.....  Anti-ulcer......  Discontinued, no
                                                                                                    FDA-approved
                                                                                                    product
                                                                                                    commercially
                                                                                                    available.
BANNED........................  S0        ...................  Meperidine......  Opioid analgesic  Demerol. DEA
                                                                                                    Schedule II.
BANNED........................  S0        ...................  Mephenesin......  Muscle relaxant.  Lacks FDA
                                                                                                    approval.
BANNED........................  S0        ...................  Mephenoxalone...  Muscle relaxant.  Lacks FDA
                                                                                                    approval.
BANNED........................  S0        ...................  Mephentermine...  Cardiac           Discontinued, no
                                                                                  stimulant.        FDA-approved
                                                                                                    product
                                                                                                    commercially
                                                                                                    available.
BANNED........................  S0        ...................  Mephenytoin.....  Anticonvulsant..  Discontinued, no
                                                                                                    FDA-approved
                                                                                                    product
                                                                                                    commercially
                                                                                                    available.
BANNED........................  S0        ...................  Mephobarbital     Sedative/         Lacks FDA
                                                                (Methylphenobar   Anxiolytic.       approval.
                                                                bital).
BANNED........................  S0        ...................  Mepindolol......  Beta blocker....  Lacks FDA
                                                                                                    approval.
CONTROLLED....................  S7        B                    Mepivacaine.....  Local anesthetic  Carbocaine,        Detection Time:   10 ng/mL as 3-
                                                                                                    Polocaine,         72 hrs. 40 mg     hydroxymepivaca
                                                                                                    Scandonest.        (2 ml) single     ine in urine;
                                                                                                                       dose SQ distal    0.05 ng/mL in
                                                                                                                       limb (6 horses).  serum or
                                                                                                                                         plasma.
BANNED........................  S0        ...................  Meprobamate       Anxiolytic......  Generic. DEA
                                                                (Meprobamate is                     Schedule IV.
                                                                a metabolite of
                                                                carisoprodol.
                                                                If there is
                                                                credible
                                                                evidence that
                                                                the presence of
                                                                meprobamate in
                                                                a horse's
                                                                sample is the
                                                                consequence of
                                                                carisoprodol
                                                                administration,
                                                                the
                                                                classification
                                                                of meprobamate
                                                                may be revised
                                                                to S7(A).).
BANNED........................  S0        ...................  Meprylcaine.....  Local anesthetic  Lacks FDA
                                                                                                    approval.
BANNED........................  S0        ...................  Meptazinol......  Narcotic........  Lacks FDA
                                                                                                    approval.
BANNED........................  S5        ...................  Meralluride.....  Diuretic........  Lacks FDA
                                                                                                    approval.
BANNED........................  S5        ...................  Merbaphen.......  Diuretic........  Lacks FDA
                                                                                                    approval.
BANNED........................  S5        ...................  Mercaptomerin...  Diuretic........  Lacks FDA
                                                                                                    approval.
BANNED........................  S0        ...................  Mersalyl........  Diuretic........  Discontinued, no
                                                                                                    FDA-approved
                                                                                                    product
                                                                                                    commercially
                                                                                                    available.

[[Page 5146]]

 
CONTROLLED....................  S7        C                    Mesalamine        Anti-             Delzicol,
                                                                (mesalazine).     inflammatory.     Pentasa,
                                                                                                    Sfrowasa,
                                                                                                    Canasa, Lialda.
BANNED........................  S0        ...................  Mesocarb........  Stimulant.......  Lacks FDA
                                                                                                    approval.
BANNED........................  S0        ...................  Mesoridazine....  Antipsychotic...  Discontinued, no
                                                                                                    FDA-approved
                                                                                                    product
                                                                                                    commercially
                                                                                                    available.
BANNED........................  S1        ...................  Mestanolone.....  Anabolic........  Lacks FDA
                                                                                                    approval. DEA
                                                                                                    Schedule III.
BANNED........................  S1        ...................  Mesterolone.....  Anabolic........  Lacks FDA
                                                                                                    approval. DEA
                                                                                                    Schedule III.
BANNED........................  S0        ...................  Metaclazepam....  Anxiolytic......  Lacks FDA
                                                                                                    approval.
BANNED........................  S1        ...................  Metandienone....  Anabolic........  Lacks FDA
                                                                                                    approval.
BANNED........................  S3        ...................  Metaproterenol    Beta-2 agonist-   Generic..........
                                                                (Orciprenaline).  bronchodilator.
BANNED........................  S0        ...................  Metaraminol.....  Antihypotensive.  Generic..........
BANNED........................  S0        ...................  Metaxalone......  Muscle relaxant.  Skelaxin.........
BANNED........................  S0        ...................  Metazocine......  Opioid analgesic  Lacks FDA
                                                                                                    approval. DEA
                                                                                                    Schedule II.
BANNED........................  S1        ...................  Metenolone......  Anabolic........  Lacks FDA
                                                                                                    approval. DEA
                                                                                                    Schedule III.
BANNED........................  S0        ...................  Metformin.......  Anti-             Fortamet,
                                                                                  hyperglycemic.    Glumetza,
                                                                                                    Glucophage.
BANNED........................  S0        ...................  Methacholine....  Bronchoconstrict  Provocholine.....
                                                                                  or.
BANNED........................  S0        ...................  Methadone.......  Synthetic opioid  Methadose. DEA
                                                                                  agonist.          Schedule II.
BANNED........................  S0        ...................  Methallenestril.  Synthetic         Lacks FDA
                                                                                  estrogen.         approval.
BANNED........................  S0        ...................  Methamphetamine.  Stimulant.......  Desoxyn. DEA
                                                                                                    Schedule II.
BANNED........................  S1        ...................  Methandienone...  Anabolic........  Lacks FDA
                                                                                                    approval. DEA
                                                                                                    Schedule III.
BANNED........................  S1        ...................  Methandriol       Anabolic........  Lacks FDA
                                                                (Methylandroste                     approval. DEA
                                                                nediol).                            Schedule III.
BANNED........................  S1        ...................  Methandrostenolo  Anabolic........  Lacks FDA
                                                                ne.                                 approval.
BANNED........................  S0        ...................  Methantheline...  Anticholinergic.  Discontinued, no
                                                                                                    FDA-approved
                                                                                                    product
                                                                                                    commercially
                                                                                                    available.
BANNED........................  S0        ...................  Methapyrilene...  Antihistamine...  Lacks FDA
                                                                                                    approval.
BANNED........................  S0        ...................  Methaqualone....  Sedative........  Lacks FDA
                                                                                                    approval. DEA
                                                                                                    Schedule I.
BANNED........................  S0        ...................  Metharbital.....  Sedative........  Discontinued, no
                                                                                                    FDA-approved
                                                                                                    product
                                                                                                    commercially
                                                                                                    available.
BANNED........................  S1        ...................  Methasterone....  Anabolic........  Lacks FDA
                                                                                                    approval. DEA
                                                                                                    Schedule III.
BANNED........................  S0        ...................  Methazolamide...  Carbonic          Generic..........
                                                                                  Anhydrase
                                                                                  Inhibitor.
BANNED........................  S0        ...................  Methcathinone...  Stimulant.......  Lacks FDA
                                                                                                    approval. DEA
                                                                                                    Schedule I.
BANNED........................  S0        ...................  Methdilazine....  Antihistamine...  Discontinued, no
                                                                                                    FDA-approved
                                                                                                    product
                                                                                                    commercially
                                                                                                    available.
BANNED........................  S1        ...................  Methenolone.....  Anabolic........  Lacks FDA
                                                                                                    approval. DEA
                                                                                                    Schedule III.
BANNED........................  S0        ...................  Methimazole.....  Anti-thyroid....  Generic..........
BANNED........................  S0        ...................  Methixene.......  Anticholinergic.  Discontinued, no
                                                                                                    FDA-approved
                                                                                                    product
                                                                                                    commercially
                                                                                                    available.
CONTROLLED....................  S7        C                    Methocarbamol...  Muscle relaxant.  Robaxin..........  Detection Time:   1 ng/mL in serum
                                                                                                                       48 hours. 15 mg/  or plasma.
                                                                                                                       kg single IV
                                                                                                                       dose. (20
                                                                                                                       horses).
BANNED........................  S0        ...................  Methohexital....  Sedative........  Brevital.........
CONTROLLED....................  S7        B                    Methotrexate....  Immunomodulator.  Otrexup, Rasuvo,
                                                                                                    Reditrex,
                                                                                                    Trexall.
BANNED........................  S0        ...................  Methotrimeprazin  Antipsychotic...  Lacks FDA
                                                                e.                                  approval.
BANNED........................  S0        ...................  Methoxamine.....  Stimulant.......  Discontinued, no
                                                                                                    FDA-approved
                                                                                                    product
                                                                                                    commercially
                                                                                                    available.
BANNED........................  S3        ...................  Methoxyphenamine  Bronchodilator..  Lacks FDA
                                                                                                    approval.
BANNED........................  S2        ...................  Methoxypolyethyl  Erythropoiesis..  Micera...........
                                                                ene glycol-
                                                                epoetin beta
                                                                (CERA).

[[Page 5147]]

 
BANNED........................  S0        ...................  Methoxytyramine   Neuromodulator..  Endogenous         ................  Threshold: 4 mcg/
                                                                (3-).                               substance.                           mL total (free
                                                                                                                                         and conjugated)
                                                                                                                                         3-
                                                                                                                                         methoxytyramine
                                                                                                                                         per mL in
                                                                                                                                         urine.
BANNED........................  S0        ...................  Methscopolamine   Anticholinergic.  Generic..........
                                                                (Methyl
                                                                scopolamine).
BANNED........................  S0        ...................  Methsuximide....  Anticonvulsant..  Celontin.........
BANNED........................  S1        ...................  Methyl-1-         Anabolic........  Android 25. DEA
                                                                testosterone.                       Schedule III.
BANNED........................  S0        ...................  Methylaminorex..  Stimulant.......  Lacks FDA
                                                                                                    approval. DEA
                                                                                                    schedule I.
BANNED........................  S0        ...................  Methylatropine..  Anticholinergic.  Lacks FDA
                                                                                                    approval.
BANNED........................  S0        ...................  Methylchlorthiaz  Diuretic........  Lacks FDA
                                                                ide                                 approval.
                                                                (Methylclothiaz
                                                                ide).
BANNED........................  S1        ...................  Methylclostebol.  Anabolic........  Lacks FDA
                                                                                                    approval. DEA
                                                                                                    Schedule III.
BANNED........................  S5        ...................  Methylclothiazid  Diuretic........  Discontinued, no
                                                                e.                                  FDA-approved
                                                                                                    product
                                                                                                    commercially
                                                                                                    available.
BANNED........................  S1        ...................  Methyldienolone.  Anabolic........  Lacks FDA
                                                                                                    approval. DEA
                                                                                                    Schedule III.
BANNED........................  S0        ...................  Methyldopa......  Antihypertensive  Generic..........
BANNED........................  S0        ...................  Methylenedioxyam  Stimulant.......  Lacks FDA
                                                                phetamine (MDA).                    approval. DEA
                                                                                                    Schedule I.
BANNED........................  S0        ...................  Methylenedioxyet  Stimulant.......  Lacks FDA
                                                                hylamphetamine                      approval. DEA
                                                                (MDEA).                             Schedule I.
BANNED........................  S0        ...................  Methylenedioxyme  Stimulant.......  Lacks FDA
                                                                thamphetamine                       approval. DEA
                                                                (MDMA).                             Schedule I.
BANNED........................  S0        ...................  Methylephedrine.  Stimulant.......  Lacks FDA
                                                                                                    approval.
CONTROLLED....................  S7        C                    Methylergonovine  Ergot alkaloid..  Methergine.......
BANNED........................  S0        ...................  Methylhexanamine  Stimulant.......  Lacks FDA
                                                                (Methylhexaneam                     approval.
                                                                ine).
BANNED........................  S0        ...................  Methylmethcathin  Stimulant.......  Lacks FDA
                                                                one.                                approval.
BANNED........................  S1        ...................  Methylnortestost  Anabolic........  Lacks FDA
                                                                erone                               approval. DEA
                                                                (Trestolone).                       Schedule III.
BANNED........................  S0        ...................  Methylphenidate.  Stimulant.......  Ritalin. DEA
                                                                                                    Schedule II.
CONTROLLED....................  S7        C                    Methylprednisolo  Corticosteroid..  Depo-Medrol......
                                                                ne.
BANNED........................  S0        ...................  Methylprylone     Sedative........  Lacks FDA
                                                                (methprylon).                       approval.
BANNED........................  S0        ...................  Methylpseudoephe  Stimulant.......  Lacks FDA
                                                                drine.                              approval.
CONTROLLED....................  S7        C                    Methylsalicylate  NSAID...........  Salonpas (with
                                                                                                    menthol).
CONTROLLED....................  S7        C                    Methylsulfonylme  Anti-             Feed contaminant   ................  1200 mcg/mL in
                                                                thane (MSM).      inflammatory.     per IFHA.                            urine.
BANNED........................  S1        ...................  Methyltestostero  Anabolic........  Android 25. DEA
                                                                ne.                                 Schedule III.
BANNED........................  S1        ...................  Methyltrienolone  Anabolic........  Lacks FDA
                                                                (metribolone).                      approval. DEA
                                                                                                    Schedule III.F89.
BANNED........................  S0        ...................  Methyprylon.....  Sedative........  Discontinued, no
                                                                                                    FDA-approved
                                                                                                    product
                                                                                                    commercially
                                                                                                    available. DEA
                                                                                                    Schedule III.
BANNED........................  S0        ...................  Methysergide....  Ergot alkaloid..  Discontinued, no
                                                                                                    FDA-approved
                                                                                                    product
                                                                                                    commercially
                                                                                                    availabl.
BANNED........................  S0        ...................  Metiamide.......  Antihistamine...  Lacks FDA
                                                                                                    approval.
BANNED........................  S5        ...................  Meticrane.......  Diuretic........  Lacks FDA
                                                                                                    approval.
BANNED........................  S0        ...................  Metipranolol....  Antihypertensive  Lacks FDA
                                                                                                    approval.
CONTROLLED....................  S7        C                    Metoclopramide..  Anti-emetic/      Gimoti, Reglan...
                                                                                  Prokinetic.
BANNED........................  S0        ...................  Metocurine......  Muscle relaxant.  Discontinued, no
                                                                                                    FDA-approved
                                                                                                    product
                                                                                                    commercially
                                                                                                    available.
BANNED........................  S5        ...................  Metolazone......  Diuretic........  Generic..........
BANNED........................  S0        ...................  Metomidate......  Sedative/         Lacks FDA
                                                                                  Hypnotic.         approval.
BANNED........................  S0        ...................  Metopon           Opioid analgesic  Lacks FDA
                                                                (methydihydromo                     approval. DEA
                                                                rphinone).                          Schedule II.
BANNED........................  S0        ...................  Metoprolol......  Antihypertensive  Lopressor........
BANNED........................  S0        ...................  Metrenperone....  Myositis          Lacks FDA
                                                                                  preventative.     approval.
BANNED........................  S1        ...................  Metribolone.....  Anabolic........  Lacks FDA
                                                                                                    approval. DEA
                                                                                                    Schedule III.
BANNED........................  S0        ...................  Metyrapone......  Hydrocortisone    Metopirone.......
                                                                                  synthesis
                                                                                  inhibitor.
BANNED........................  S0        ...................  Mexazolam.......  Anxiolytic......  Lacks FDA
                                                                                                    approval.
CONTROLLED....................  S7        B                    Mexiletine......  Antiarrhythmic..  Generic..........
BANNED........................  S0        ...................  Mianserin.......  Antidepressant..  Lacks FDA
                                                                                                    approval.

[[Page 5148]]

 
BANNED........................  S0        ...................  Mibefradil......  Antihypertensive  Lacks FDA
                                                                                                    approval.
BANNED........................  S1        ...................  Mibolerone......  Anabolic........  Cheque Drops. DEA
                                                                                                    Schedule III.
CONTROLLED....................  S7        B                    Midazolam.......  Anticonvulsant..  Seizalam. DEA
                                                                                                    Schedule IV.
BANNED........................  S0        ...................  Midodrine.......  Antihypotensive.  Orvaten..........
CONTROLLED....................  S7        B                    Milrinone.......  Vasodilator.....  Generic..........
BANNED........................  S0        ...................  Minoxidil.......  Antihypertensive  Rogaine..........
BANNED........................  S0        ...................  Mirtazapine.....  Antidepressant..  Remeron..........
CONTROLLED....................  S7        C                    Misoprostol.....  Prostaglandin     Cytotec..........  Detection Time:   ................
                                                                                  analog.                              48 hrs. 5 mcg/
                                                                                                                       kg orally twice
                                                                                                                       daily for 14
                                                                                                                       days. (6
                                                                                                                       horses).
BANNED........................  S0        ...................  Mitragynine.....  Stimulant.......  Lacks FDA
                                                                                                    approval.
BANNED........................  S0        ...................  Mivacurium......  Muscle relaxant.  Generic..........
BANNED........................  S0        ...................  Modafinil.......  Stimulant.......  Provigil. DEA
                                                                                                    Schedule IV.
BANNED........................  S0        ...................  Moexipril         Antihypertensive  Generic..........
                                                                (metabolite,
                                                                moexiprilat).
BANNED........................  S0        ...................  Mofebutazone....  NSAID...........  Lacks FDA
                                                                                                    approval.
BANNED........................  S2        ...................  Molidustat (BAY   Erythropoiesis..  Lacks FDA
                                                                85-3934).                           approval.
BANNED........................  S0        ...................  Molindone.......  Antipsychotic...  Generic..........
CONTROLLED....................  S7        C                    Mometasone......  Corticosteroid..  Asmanex, Sinuva,
                                                                                                    Elocon,
                                                                                                    Ryaltris,
                                                                                                    Nasonex.
CONTROLLED....................  S7        C                    Montelukast.....  Leukotriene       Singulair........
                                                                                  receptor
                                                                                  antagonist.
BANNED........................  S0        ...................  Moperone........  Antipsychotic...  Lacks FDA
                                                                                                    approval.
BANNED........................  S0        ...................  Moprolol........  Antihypertensive  Lacks FDA
                                                                                                    approval.
BANNED........................  S0        ...................  Morpheridine....  Analgesic.......  Lacks FDA
                                                                                                    approval.
CONTROLLED....................  S7        A (x)                Morphine........  Opioid Analgesic  Duramorph,         ................  30 ng/mL total
                                                                                                    Infumorph,                           (free and
                                                                                                    Mitigo, MS                           conjugated) in
                                                                                                    Contin. DEA                          urine.
                                                                                                    Schedule II;
                                                                                                    Dietary
                                                                                                    substance per
                                                                                                    IFHA.
BANNED........................  S0        ...................  Mosapramine.....  Antipsychotic...  Lacks FDA
                                                                                                    approval.
BANNED........................  S0        ...................  Moxaverine......  Vasodilator.....  Lacks FDA
                                                                                                    approval.
BANNED........................  S0        (x)                  Muscarine.......  Cholinergic.....  Plant alkaloid...
BANNED........................  S0        ...................  Myo-inositol      Oxygen transfer.  Lacks FDA
                                                                trispyrophospha                     approval.
                                                                te (ITPP,
                                                                OXY111A).
CONTROLLED....................  S7        B                    Nabumetone......  NSAID...........  Generic..........
BANNED........................  S0        ...................  Nadolol.........  Antihypertensive  Corgard..........
BANNED........................  S0        ...................  Nadoxolol.......  Antihypertensive  Lacks FDA
                                                                                                    approval.
BANNED........................  S0        ...................  Naepaine........  Local anesthetic  Lacks FDA
                                                                                                    approval.
BANNED........................  S2        ...................  Nafarelin.......  Reproductive      Synarel..........
                                                                                  hormone
                                                                                  modulator.
BANNED........................  S0        ...................  Naftidrofuryl...  Vasodilator.....  Lacks FDA
                                                                                                    approval.
BANNED........................  S0        ...................  Nalbuphine......  Opioid receptor   Generic..........
                                                                                  agonist and
                                                                                  antagonist.
CONTROLLED....................  S7        A                    Nalmefene.......  Opioid            Revex............
                                                                                  antagonist.
BANNED........................  S0        ...................  Nalorphine......  Opioid receptor   Nalline. DEA
                                                                                  agonist and       Schedule III.F94.
                                                                                  antagonist.
CONTROLLED....................  S7        B                    Naloxone........  Opioid            Narcan, Zimhi,
                                                                                  antagonist.       Suboxone (with
                                                                                                    buprenorphine
                                                                                                    hydrochloride),
                                                                                                    Zubsolv (with
                                                                                                    buprenorphine
                                                                                                    hydrochloride).
CONTROLLED....................  S7        A                    Naltrexone......  Opioid            Trexonil.........
                                                                                  antagonist.
BANNED--fillies, mares and      S1        ...................  Nandrolone (19-   Anabolic........  Discontinued, no
 geldings.                                                      nortestosterone                     FDA-approved
                                                                ).                                  product
                                                                                                    commercially
                                                                                                    available. DEA
                                                                                                    schedule III.
CONTROLLED....................  S7        B                    Naphazoline.....  Sympathomimetic.  Naphcon-A (with
                                                                                                    pheniramine
                                                                                                    maleate), Opcon-
                                                                                                    A (with
                                                                                                    pheniramine
                                                                                                    maleate), Visine
                                                                                                    (with
                                                                                                    pheniramine
                                                                                                    maleate).
CONTROLLED....................  S7        C                    Naproxen........  NSAID...........  Aleve, Naprosyn,
                                                                                                    Anaprox.

[[Page 5149]]

 
BANNED........................  S0        ...................  Naratriptan.....  Selective         Amerge...........
                                                                                  Serotonin
                                                                                  Receptor
                                                                                  Agonist.
CONTROLLED....................  S7        C                    N-                Anticholinergic.  Buscopan.........  Detection Time:   25 ng/mL in
                                                                Butylscopolammo                                        48 hrs. 0.3 mg/   urine.
                                                                nium.                                                  kg single IV
                                                                                                                       dose (6 horses).
BANNED........................  S0        ...................  Nebivolol.......  Antihypertensive  Bystolic.........
CONTROLLED....................  S7        C                    Nedocromil......  Mast Cell         Alocril..........
                                                                                  Stabilizer.
BANNED........................  S0        ...................  Nefazodone......  Antidepressant..  Generic..........
BANNED........................  S0        ...................  Nefopam.........  Analgesic.......  Lacks FDA
                                                                                                    approval.
CONTROLLED....................  S7        B                    Neostigmine.....  Anticholinestera  Bloxiverz........
                                                                                  se.
BANNED........................  S6        ...................  Neridronate.....  Bisphosphonate..  Lacks FDA
                                                                                                    approval.
BANNED........................  S0        ...................  Nialamide.......  Antidepressant..  Lacks FDA
                                                                                                    approval.
BANNED........................  S0        ...................  Nicardipine.....  Antihypertensive  Generic..........
BANNED........................  S0        ...................  Nicoumalone.....  Anticoagulant...  Lacks FDA
                                                                                                    approval.
BANNED........................  S0        ...................  Nifedipine......  Antihypertensive  Procardia........
BANNED........................  S0        ...................  Nifenalol.......  Antihypertensive/ Lacks FDA
                                                                                  Antiarrhythmic.   approval.
BANNED........................  S0        ...................  Niflumic acid...  NSAID...........  Lacks FDA
                                                                                                    approval.
BANNED........................  S0        ...................  Nikethamide.....  Stimulant.......  Lacks FDA
                                                                                                    approval.
BANNED........................  S0        ...................  Nimesulide......  NSAID...........  Lacks FDA
                                                                                                    approval.
BANNED........................  S0        ...................  Nimetazepam.....  Hypnotic........  Lacks FDA
                                                                                                    approval. DEA
                                                                                                    Schedule IV.
BANNED........................  S0        ...................  Nimodipine......  Calcium channel   Generic..........
                                                                                  blocker.
BANNED........................  S0        ...................  Nitrazepam......  Sedative/         Lacks FDA
                                                                                  Anxiolytic.       approval. DEA
                                                                                                    Schedule IV.
BANNED........................  S0        ...................  Nitroglycerin...  Vasodilator.....  Nitromist, Nitro-
                                                                                                    Dur, Nitrostat.
CONTROLLED....................  S7        C                    Nizatidine......  Anti-ulcer......  Axid.............
BANNED........................  S0        ...................  Nomifensine.....  Antidepressant..  Lacks FDA
                                                                                                    approval.
BANNED........................  S1        ...................  Norandrostenedio  Anabolic........  Lacks FDA
                                                                l.                                  approval.
BANNED........................  S1        ...................  Norandrostenedio  Anabolic........  Lacks FDA
                                                                ne.                                 approval.
BANNED........................  S1        ...................  Norandrosterone.  Anabolic........  Lacks FDA
                                                                                                    approval. DEA
                                                                                                    Schedule III.
BANNED........................  S1        ...................  Norbolethone/     Anabolic........  Lacks FDA
                                                                Norboletone.                        approval. DEA
                                                                                                    Schedule III.
BANNED........................  S1        ...................  Norclostebol....  Anabolic........  Lacks FDA
                                                                                                    approval. DEA
                                                                                                    Schedule III.
BANNED........................  S0        ...................  Nordiazepam/      Sedative/         Lacks FDA
                                                                Nordazepam        Anxiolytic.       approval. DEA
                                                                (Nordiazepam is                     Schedule IV.
                                                                a metabolite of
                                                                diazepam. If
                                                                there is
                                                                credible
                                                                evidence that
                                                                the presence of
                                                                nordiazepam in
                                                                a horse's
                                                                sample is the
                                                                consequence of
                                                                exposure to
                                                                diazepam, the
                                                                classification
                                                                of nordiazepam
                                                                may be revised
                                                                to S7(A).).
CONTROLLED....................  S7        A                    Norepinephrine..  Stimulant.......  Levophed.........
BANNED........................  S1        ...................  Norethandrolone.  Anabolic........  Lacks FDA
                                                                                                    approval. DEA
                                                                                                    Schedule III.
BANNED........................  S1        ...................  Norethisterone    Anabolic........  Combipatch,
                                                                (norethindrone).                    Activella,
                                                                                                    Amabelz,
                                                                                                    Nortrel,
                                                                                                    Alyacen,
                                                                                                    Aranelle and
                                                                                                    multiple others
                                                                                                    (with estradiol).
BANNED........................  S0        ...................  Norfenefrine....  Antihypotensive.  Lacks FDA
                                                                                                    approval.
BANNED........................  S0        ...................  Norfenfluramine.  Stimulant.......  Lacks FDA
                                                                                                    approval.
BANNED........................  S0        ...................  Norfluoxetine     Antidepressant..  Lacks FDA
                                                                (Seproxetine).                      approval.
BANNED........................  S0        ...................  Norpseudoephedri  Stimulant.......  Lacks FDA
                                                                ne (cathine).                       approval. DEA
                                                                                                    Schedule IV.
BANNED........................  S0        ...................  Nortriptyline...  Antidepressant..  Pamelor..........
BANNED........................  S0        ...................  Noscapine.......  Antitussive.....  Lacks FDA
                                                                                                    approval.
BANNED........................  S0        ...................  Nylidrin          Vasodilator.....  Lacks FDA
                                                                (buphenine).                        approval.

[[Page 5150]]

 
BANNED........................  S0        ...................  Octopamine        Stimulant.......  Lacks FDC
                                                                (Octopamine is                      approval.
                                                                a metabolite of
                                                                ephedrine. If
                                                                there is
                                                                credible
                                                                evidence that
                                                                the presence of
                                                                octopamine is a
                                                                consequence of
                                                                exposure to
                                                                ephedrine, the
                                                                classification
                                                                of octopamine
                                                                may be revised
                                                                to S7(A).).
BANNED........................  S0        ...................  Olanzapine......  Antipsychotic...  Zyprexa..........
BANNED........................  S0        ...................  Oliceridine.....  Opioid agonist..  Olinvk. DEA
                                                                                                    Schedule I.
BANNED........................  S0        ...................  Olmesartan......  Antihypertensive  Benicar (with
                                                                                                    medoxomil).
BANNED........................  S3        ...................  Olodaterol......  Beta-2 agonist-   Striverdi
                                                                                  bronchodilator.   Respimat,
                                                                                                    Stiolto Respimat
                                                                                                    (with tiotropium
                                                                                                    bromide).
BANNED........................  S6        ...................  Olpadronate.....  Bisphosphonate..  Lacks FDA
                                                                                                    approval.
CONTROLLED....................  S7        C                    Olsalazine......  Anti-             Diipentum........
                                                                                  inflammatory.
CONTROLLED....................  S7        C                    Omeprazole......  Anti-ulcer......  Gastrogard.......  Restricted        10 ng/mL in
                                                                                                                       administration    serum or plasma
                                                                                                                       time: 24 hours.   as omeprazole
                                                                                                                       2.2 g orally      sulfide.
                                                                                                                       once daily for
                                                                                                                       4 doses (9
                                                                                                                       horses).
BANNED........................  S0        ...................  Opipramol.......  Antidepressant..  Lacks FDA
                                                                                                    approval.
BANNED........................  S3        ...................  Orciprenaline     Beta-2 agonist-   Generic..........
                                                                (Metaproterenol   bronchodilator.
                                                                ).
BANNED........................  S0        (x)                  Oripavine.......  Opioid..........  Plant alkaloid.
                                                                                                    DEA schedule I.
BANNED........................  S0        ...................  Orphenadrine....  Muscle relaxant.  Generic..........
BANNED........................  S4        ...................  Ospemifene......  Selective         Osphena..........
                                                                                  Estrogen
                                                                                  Receptor
                                                                                  Modulator
                                                                                  (SERM).
BANNED........................  S1        ...................  Ostarine          Selective         Lacks FDA
                                                                (enobosarm).      Androgen          approval.
                                                                                  Receptor
                                                                                  Modulator
                                                                                  (SARM).
BANNED........................  S1        ...................  Oxabolone.......  Anabolic........  Lacks FDA
                                                                                                    approval.
BANNED........................  S0        ...................  Oxaflumazine....  Psychosedative..  Lacks FDA
                                                                                                    approval.
BANNED........................  S1        ...................  Oxandrolone.....  Anabolic........  Generic. DEA
                                                                                                    Schedule III.
BANNED........................  S0        ...................  Oxaprozin.......  NSAID...........  Daypro...........
BANNED........................  S0        ...................  Oxazepam          Anxiolytic......  Generic. DEA
                                                                (Oxazepam is a                      Schedule IV.
                                                                metabolite of
                                                                diazepam. If
                                                                there is
                                                                credible
                                                                evidence that
                                                                the presence of
                                                                oxazepam in a
                                                                horse's sample
                                                                is the
                                                                consequence of
                                                                exposure to
                                                                diazepam, the
                                                                classification
                                                                of oxazepam may
                                                                be revised to
                                                                S7(A).).
BANNED........................  S0        ...................  Oxazolam........  Sedative/         Lacks FDA
                                                                                  Anxiolytic.       approval. DEA
                                                                                                    Schedule IV.
BANNED........................  S0        ...................  Oxcarbazepine...  Anticonvulsant..  Generic..........
BANNED........................  S0        ...................  Oxethazaine       Local anesthetic  Lacks FDA
                                                                (Oxetacaine).                       approval.
BANNED........................  S0        ...................  Oxilofrine        Stimulant.......  Lacks FDA
                                                                (hydroxyephedri                     approval.
                                                                ne).
BANNED........................  S0        ...................  Oxolamine.......  Antitussive.....  Lacks FDA
                                                                                                    approval.
BANNED........................  S0        ...................  Oxprenolol......  Antihypertensive  Lacks FDA
                                                                                                    approval.
CONTROLLED....................  S7        C                    Oxybuprocaine     Local anesthetic  Atafluor Benox...
                                                                (Benoxinate,
                                                                oxybucaine).
BANNED........................  S0        ...................  Oxycodone.......  Opioid Analgesic  Oxycontin,
                                                                                                    Roxybond,
                                                                                                    Roxicodone,
                                                                                                    Oxaydo, Xtampza;
                                                                                                    Percocet,
                                                                                                    Percodan, Oxycet
                                                                                                    (with NSAID).
                                                                                                    DEA Schedule II.
BANNED........................  S1        ...................  Oxyguno.........  Anabolic........  Lacks FDA
                                                                                                    approval.
BANNED........................  S1        ...................  Oxymesterone....  Anabolic........  Lacks FDA
                                                                                                    approval. DEA
                                                                                                    Schedule III.
CONTROLLED....................  S7        B                    Oxymetazoline...  Nasal             Rhofade, Upneq,
                                                                                  decongestant.     Visine.

[[Page 5151]]

 
BANNED........................  S1        ...................  Oxymetholone....  Anabolic........  Discontinued, no
                                                                                                    FDA-approved
                                                                                                    product
                                                                                                    commercially
                                                                                                    available. DEA
                                                                                                    Schedule III.
BANNED........................  S0        ...................  Oxymorphone.....  Opioid analgesic  Generic. DEA
                                                                                                    Schedule II.
BANNED........................  S0        ...................  Oxypertine......  Antipsychotic...  Lacks FDA
                                                                                                    approval.
BANNED........................  S0        ...................  Oxyphencyclimine  Anticholinergic.  Discontinued, no
                                                                                                    FDA-approved
                                                                                                    product
                                                                                                    commercially
                                                                                                    available.
BANNED........................  S0        ...................  Oxyphenonium....  Anticholinergic.  Discontinued, no
                                                                                                    FDA-approved
                                                                                                    product
                                                                                                    commercially
                                                                                                    available.
CONTROLLED....................  S7        B                    Oxytocin........  Uterine           Pitocin..........
                                                                                  contraction.
BANNED........................  S0        ...................  Paliperidone....  Antipsychotic...  Invega...........
BANNED........................  S0        ...................  Palmitoylethanol  Anti-             Lacks FDA
                                                                amid.             inflammatory.     approval.
BANNED........................  S6        ...................  Pamidronate.....  Bisphosphonate..  Generic..........
CONTROLLED....................  S7        A                    Pancuronium.....  Muscle relaxant.  Generic..........
CONTROLLED....................  S7        C                    Pantoprazole....  Anti-ulcer......  Protonix.........
BANNED........................  S0        (x)                  Papaverine......  Vasodilator.....  Plant alkaloid...
BANNED........................  S0        ...................  Paraldehyde.....  Anticonvulsant..  Lacks FDA
                                                                                                    approval. DEA
                                                                                                    Schedule IV.
BANNED........................  S0        ...................  Paramethadione..  Anticonvulsant..  Discontinued, no
                                                                                                    FDA-approved
                                                                                                    product
                                                                                                    commercially
                                                                                                    available.
BANNED........................  S0        ...................  Paramethasone...  Corticosteroid..  Discontinued, no
                                                                                                    FDA-approved
                                                                                                    product
                                                                                                    commercially
                                                                                                    available.
BANNED........................  S0        (x)                  Paraxanthine      Stimulant.......  Lacks FDA
                                                                (Paraxanthine                       approval.
                                                                is a metabolite
                                                                of caffeine. If
                                                                there is
                                                                credible
                                                                evidence that
                                                                the presence of
                                                                paraxanthine in
                                                                a horse's
                                                                sample is the
                                                                consequence of
                                                                exposure to
                                                                caffeine, the
                                                                classification
                                                                of paraxanthine
                                                                may be revised
                                                                to S7(B).).
BANNED........................  S0        ...................  Parecoxib.......  NSAID...........  Lacks FDA
                                                                                                    approval.
BANNED........................  S0        ...................  Pargyline.......  Antihypertensive  Discontinued, no
                                                                                                    FDA-approved
                                                                                                    product
                                                                                                    commercially
                                                                                                    available.
BANNED........................  S0        ...................  Paroxetine......  Antidepressant..  Paxil............
BANNED........................  S2        ...................  Pegepoietin.....  Erythropoiesis..  Micera...........
BANNED........................  S2        ...................  Peginesatide....  Erythropoiesis..  Discontinued, no
                                                                                                    FDA-approved
                                                                                                    product
                                                                                                    commercially
                                                                                                    available.
BANNED........................  S0        ...................  Pemoline          Stimulant.......  Discontinued, no
                                                                (Pemoline is a                      FDA-approved
                                                                metabolite of                       product
                                                                aminorex, which                     commercially
                                                                is a metabolite                     available. DEA
                                                                of levamisole.                      Schedule IV.
                                                                If there is
                                                                credible
                                                                evidence that
                                                                the detection
                                                                of pemoline in
                                                                a horse's
                                                                sample is the
                                                                consequence of
                                                                exposure to
                                                                levamisole, the
                                                                classification
                                                                of pemoline may
                                                                be revised to
                                                                S7(B).).
BANNED........................  S0        ...................  Pempidine.......  Ganglion blocker/ Lacks FDA
                                                                                  antihypertensiv   approval.
                                                                                  e.
BANNED........................  S0        ...................  Penbutolol......  Antihypertensive  Discontinued, no
                                                                                                    FDA-approved
                                                                                                    product
                                                                                                    commercially
                                                                                                    available.
BANNED........................  S0        ...................  Penfluridol.....  Antipsychotic...  Lacks FDA
                                                                                                    approval.
BANNED........................  S0        ...................  Pentaerythritol   Vasodilator.....  Lacks FDA
                                                                tetranitrate.                       approval.
CONTROLLED....................  S7        B                    Pentazocine.....  Opioid analgesic  Generic (with
                                                                                                    naloxone
                                                                                                    hydrochloride).
                                                                                                    DEA Schedule IV.
BANNED........................  S0        ...................  Pentetrazol.....  Stimulant.......  Lacks FDA
                                                                                                    approval.
BANNED........................  S0        ...................  Pentifylline....  Vasodilator.....  Lacks FDA
                                                                                                    approval.
CONTROLLED....................  S7        A                    Pentobarbital...  Barbiturate.....  Nembutal. DEA
                                                                                                    Schedule II.
CONTROLLED....................  S7        C                    Pentoxyfylline..  Vasodilator.....  Discontinued, no
                                                                                                    FDA-approved
                                                                                                    product
                                                                                                    commercially
                                                                                                    available.
BANNED........................  S0        ...................  Pentylenetetrazo  Stimulant.......  Lacks FDA
                                                                l.                                  approval.
BANNED........................  S2        ...................  Perfluorodecahyd  Oxygen transfer.  Lacks FDA
                                                                ronophthalene.                      approval.
BANNED........................  S0        ...................  Perfluorodecalin  Oxygen transport  Lacks FDA
                                                                (Octadecafluoro                     approval.
                                                                naphthalene).

[[Page 5152]]

 
BANNED........................  S2        ...................  Perfluorooctyl    Oxygen transfer.  Discontinued, no
                                                                bromide.                            FDA-approved
                                                                                                    product
                                                                                                    commercially
                                                                                                    available.
BANNED........................  S2        ...................  Perfluorotriprop  Oxygen transfer.  Discontinued, no
                                                                ylamine.                            FDA-approved
                                                                                                    product
                                                                                                    commercially
                                                                                                    available.
CONTROLLED....................  S7        B                    Pergolide.......  Dopamine agonist  Prascend.........
BANNED........................  S0        ...................  Periciazine.....  Antipsychotic...  Lacks FDA
                                                                                                    approval.
BANNED........................  S0        ...................  Perindopril.....  Antihypertensive  Generic,
                                                                                                    Prestalia (with
                                                                                                    amlodipine
                                                                                                    besylate).
BANNED........................  S0        ...................  Perlapine.......  Sedative/         Lacks FDA
                                                                                  Hypnotic.         approval.
BANNED........................  S0        ...................  Perphenazine....  Antipsychotic...  Generic..........
BANNED........................  S0        ...................  Phenacemide.....  Anticonvulsant..  Discontinued, no
                                                                                                    FDA-approved
                                                                                                    product
                                                                                                    commercially
                                                                                                    available.
BANNED........................  S0        ...................  Phenaglycodol...  Sedative/         Lacks FDA
                                                                                  Anxiolytic.       approval.
BANNED........................  S0        ...................  Phenazocine.....  Opioid analgesic  Lacks FDA
                                                                                                    approval. DEA
                                                                                                    Schedule II.
BANNED........................  S0        ...................  Phenazone.......  NSAID...........  Lacks FDA
                                                                                                    approval.
CONTROLLED....................  S7        A                    Phenazopyridine.  Local anesthetic  Discontinued, no
                                                                                                    FDA-approved
                                                                                                    product
                                                                                                    commercially
                                                                                                    available.
BANNED........................  S0        ...................  Phencyclidine     Dissociative      Lacks FDA
                                                                (PCP).            hallucinogen.     approval. DEA
                                                                                                    Schedule I.
BANNED........................  S0        ...................  Phendimetrazine.  Stimulant.......  Bontril. DEA
                                                                                                    Schedule II.
BANNED........................  S0        ...................  Phenelzine......  Antidepressant..  Nardil...........
BANNED........................  S0        ...................  Phenibut........  Anxiolytic......  Lacks FDA
                                                                                                    approval.
BANNED........................  S0        ...................  Phenindamine....  Antihistamine...  Lacks FDA
                                                                                                    approval.
BANNED........................  S0        ...................  Phenindione.....  Anticoagulant...  Discontinued, no
                                                                                                    FDA-approved
                                                                                                    product
                                                                                                    commercially
                                                                                                    available.
BANNED........................  S0        ...................  Pheniramine.....  Antihistamine...  Bromfed-DM (with
                                                                                                    dextromethorphan
                                                                                                    and
                                                                                                    pseudoephedrine).
BANNED........................  S0        ...................  Phenmetrazine...  Stimulant.......  Discontinued, no
                                                                                                    FDA-approved
                                                                                                    product
                                                                                                    commercially
                                                                                                    available.
CONTROLLED....................  S7        A                    Phenobarbital...  Barbiturate.....  predates FDA,
                                                                                                    grandfathered.
                                                                                                    DEA schedule IV.
BANNED........................  S0        ...................  Phenoxybenzamine  Antihypertensive  Dibenzyline......
BANNED........................  S0        ...................  Phenprocoumon...  Anticoagulant...  Discontinued, no
                                                                                                    FDA-approved
                                                                                                    product
                                                                                                    commercially
                                                                                                    available.
BANNED........................  S0        ...................  Phenpromethamine  Stimulant.......  Lacks FDA
                                                                                                    approval.
BANNED........................  S0        ...................  Phensuximide....  Anticonvulsant..  Discontinued, no
                                                                                                    FDA-approved
                                                                                                    product
                                                                                                    commercially
                                                                                                    available.
BANNED........................  S0        ...................  Phentermine.....  Stimulant.......  Adipex-P,
                                                                                                    Lomaira, Qsymia.
                                                                                                    DEA Schedule IV.
CONTROLLED....................  S7        B                    Phentolamine....  Vasodilator.....  Oraverse.........
CONTROLLED....................  S7        C                    Phenylbutazone..  NSAID (3 NSAIDs   Butazolidin,       Detection Time:   0.2 mcg/mL in
                                                                                  (Flunixin,        Butatron,          48 hours. 4.4     serum or
                                                                                  Ketoprofen,       EquiBute, Phen     mg/kg single IV   plasma. Note:
                                                                                  Phenylbutazone)   Buta Vet,          dose. (17         The detection
                                                                                  are associated    Bizolin,           horses).          of more than
                                                                                  with a            Butequine,                           one NSAID in a
                                                                                  Detection Time    Superiorbute,                        horse's post-
                                                                                  of 48 hours.      Pributazone.                         Race or post-
                                                                                  Only one of the                                        Official
                                                                                  three may be                                           Workout blood
                                                                                  administered                                           and sample
                                                                                  using a                                                constitutes a
                                                                                  Withdrawal                                             Stacking
                                                                                  Interval based                                         Violation.
                                                                                  on the 48 hour
                                                                                  Detection Time.
                                                                                  To avoid a
                                                                                  stacking
                                                                                  violation
                                                                                  (detection of
                                                                                  more than 1
                                                                                  NSAID in a
                                                                                  blood sample)
                                                                                  the following
                                                                                  secondary
                                                                                  Detection Times
                                                                                  should be
                                                                                  applied for the
                                                                                  following
                                                                                  NSAIDs:
                                                                                  Flunixin: 144
                                                                                  hours;
                                                                                  Ketoprofen: 96
                                                                                  hours;
                                                                                  Phenylbutazone:
                                                                                  168 hours.).
CONTROLLED....................  S7        B                    Phenylephrine...  Stimulant.......  Biorphen.........

[[Page 5153]]

 
BANNED........................  S0        ...................  Phenylpiracetam   Stimulant.......  Lacks FDA
                                                                (Carphedon).                        approval.
BANNED........................  S0        ...................  Phenylpropanolam  Stimulant.......  Proin............
                                                                ine.
BANNED........................  S0        ...................  Phenyltoloxamine  Antihistamine...  Lacks FDA
                                                                                                    approval.
CONTROLLED....................  S7        B                    Phenytoin.......  Anticonvulsant..  Dilantin,
                                                                                                    Phenytek.
BANNED........................  S0        ...................  Pholcodine......  Opioid            Lacks FDA
                                                                                  antitussive.      approval; DEA
                                                                                                    Schedule I.
BANNED........................  S0        ...................  Pholedrine......  Stimulant.......  Lacks FDA
                                                                                                    approval.
CONTROLLED....................  S7        A                    Physostigmine...  Acetylcholineste  Antilirium.......
                                                                                  rase inhibitor.
BANNED........................  S0        ...................  Picrotoxin......  Stimulant.......  Lacks FDA
                                                                                                    approval.
BANNED........................  S0        ...................  Piminodine......  Opioid analgesic  Lacks FDA
                                                                                                    approval. DEA
                                                                                                    Schedule II.
BANNED........................  S1        ...................  Pimobendan......  Cardiac           Vetmedin.........
                                                                                  stimulant.
BANNED........................  S0        ...................  Pimozide........  Antipsychotic...  Generic..........
BANNED........................  S0        ...................  Pinazepam.......  Anxiolytic......  Lacks FDA
                                                                                                    approval.DEA
                                                                                                    Schedule IV.
BANNED........................  S0        ...................  Pinazepam.......  Sedative/         Lacks FDA
                                                                                  Anxiolytic.       approval.
BANNED........................  S0        ...................  Pindolol........  Antihypertensive  Generic..........
BANNED........................  S0        ...................  Pipamazine......  Anti-emetic.....  Lacks FDA
                                                                                                    approval.
BANNED........................  S0        ...................  Pipamperone.....  Antipsychotic...  Lacks FDA
                                                                                                    approval.
BANNED........................  S0        ...................  Pipecuronium....  Muscle relaxant.  Discontinued, no
                                                                                                    FDA-approved
                                                                                                    product
                                                                                                    commercially
                                                                                                    available.
BANNED........................  S0        ...................  Pipequaline.....  Anxiolytic......  Lacks FDA
                                                                                                    approval.
BANNED........................  S0        ...................  Piper             Anxiolytic/Anti-  Lacks FDA
                                                                Methysticum       inflammatory.     approval.
                                                                (kava).
BANNED........................  S0        ...................  Piperacetazine..  Antipsychotic...  Lacks FDA
                                                                                                    approval.
BANNED........................  S0        ...................  Piperidione.....  Sedative........  Lacks FDA
                                                                                                    approval.
BANNED........................  S0        ...................  Piperidolate....  Antispasmodic...  Lacks FDA
                                                                                                    approval.
BANNED........................  S0        ...................  Piperocaine.....  Local anesthetic  Lacks FDA
                                                                                                    approval.
BANNED........................  S0        ...................  Piperoxan.......  Antihistamine/    Lacks FDA
                                                                                  Antihypertensiv   approval.
                                                                                  e.
BANNED........................  S0        ...................  Pipotiazine.....  Antipsychotic...  Lacks FDA
                                                                                                    approval.
BANNED........................  S0        ...................  Pipradrol.......  Stimulant.......  Lacks FDA
                                                                                                    approval.
BANNED........................  S0        ...................  Piquindone......  Antipsychotic...  Lacks FDA
                                                                                                    approval.
BANNED........................  S0        ...................  Piracetam.......  Stimulant.......  Lacks FDA
                                                                                                    approval.
BANNED........................  S0        ...................  Pirbuterol......  Beta-2 agonist-   Discontinued, no
                                                                                  bronchodilator.   FDA-approved
                                                                                                    product
                                                                                                    commercially
                                                                                                    available.
BANNED........................  S0        ...................  Pirenzepine.....  Anticholinergic.  Lacks FDA
                                                                                                    approval.
BANNED........................  S5        ...................  Piretanide......  Diuretic........  Lacks FDA
                                                                                                    approval.
BANNED........................  S0        ...................  Piritramide.....  Synthetic opioid  Lacks FDA
                                                                                  analgesic.        approval.
CONTROLLED....................  S7        B                    Piroxicam.......  NSAID...........  Feldene..........
BANNED........................  S0        ...................  Pirprofen.......  NSAID...........  Lacks FDA
                                                                                                    approval.
BANNED........................  S6        ...................  Pitcher Plant     Analgesic.......  Sarapin..........
                                                                Extract.
BANNED........................  S0        ...................  Pizotifen         Antimigraine....  Lacks FDA
                                                                (Pizotylline).                      approval.
BANNED........................  S2        ...................  Platelet-Derived  Growth Hormone..  .................
                                                                Growth Factor
                                                                (PDGF).
BANNED........................  S5        ...................  Polythiazide....  Diuretic........  Discontinued, no
                                                                                                    FDA-approved
                                                                                                    product
                                                                                                    commercially
                                                                                                    available.
CONTROLLED....................  S7        A                    Potassium         Anticonvulsant/   KBroVet-CA1......
                                                                Bromide.          anxiolytic.
BANNED........................  S0        ...................  Practolol.......  Antiarrhythmic..  Lacks FDA
                                                                                                    approval.
BANNED........................  S2        ...................  Pralmorelin.....  Growth Hormone..  Lacks FDA
                                                                                                    approval.
CONTROLLED....................  S7        C                    Pramoxine.......  Topical           Epifoam (with
                                                                                  anesthetic.       hydrocortisone
                                                                                                    acetate),
                                                                                                    Pramosone (with
                                                                                                    hydrocortisone
                                                                                                    acetate).
BANNED........................  S1        ...................  Prasterone        Anabolic........  Intrarosa........
                                                                (dehydroepiandr
                                                                osterone, DHEA,
                                                                3[beta]hydroxya
                                                                ndrost-5-en17-
                                                                one).
BANNED........................  S0        ...................  Prazepam........  Sedative/         Discontinued, no
                                                                                  Anxiolytic.       FDA-approved
                                                                                                    product
                                                                                                    commercially
                                                                                                    available. DEA
                                                                                                    Schedule IV.
BANNED........................  S0        ...................  Prazosin........  Antihypertensive  Minipress........
CONTROLLED....................  S7        C                    Prednisolone....  Corticosteroid..  Endogenous         ................  Threshold: 0.01
                                                                                                    subtance (urine                      mcg/mL free
                                                                                                    only) per IFHA.                      prednisolone in
                                                                                                                                         urine.
CONTROLLED....................  S7        C                    Prednisone......  Corticosteroid..  Rayos............
CONTROLLED....................  S7        A                    Pregabalin......  Anticonvulsant/   Lyrica. DEA
                                                                                  Analgesic.        Schedule V.
BANNED........................  S0        ...................  Prenylamine.....  Vasodilator.....  Lacks FDA
                                                                                                    approval.
BANNED........................  S0        ...................  Pridinol........  Anticholinergic.  Lacks FDA
                                                                                                    approval.

[[Page 5154]]

 
BANNED........................  S0        ...................  Prifinium         Antispasmodic...  Lacks FDA
                                                                Bromide.                            approval.
CONTROLLED....................  S7        B                    Prilocaine......  Local anesthetic  Emla (with
                                                                                                    lidocaine),
                                                                                                    Oraqix (with
                                                                                                    lidocaine),
                                                                                                    Citanest (with
                                                                                                    epinephrine).
CONTROLLED....................  S7        B                    Primidone.......  Anticonvulsant..  Mysoline.........
BANNED........................  S5        ...................  Probenecid......  Anti-gout.......  Probalan.........
CONTROLLED....................  S7        B                    Procainamide....  Antiarrhythmic..  Generic..........
CONTROLLED....................  S7        B                    Procaine........  Local anesthetic  (with Penicillin   17 mg (~17,000    25 ng/mL in
                                                                                                    G).                IU) per kg IM.    serum or
                                                                                                                                         plasma.
BANNED........................  S0        ...................  Procarbazine....  Anti-neoplastic.  Matulane.........
BANNED........................  S3        ...................  Procaterol......  Beta-2 agonist-   Lacks FDA
                                                                                  bronchodilator.   approval.
BANNED........................  S0        ...................  Prochlorperazine  Anti-nausea.....  Compro, Procomp,
                                                                                                    Compazine.
BANNED........................  S0        ...................  Procyclidine....  Anticholinergic.  Discontinued, no
                                                                                                    FDA-approved
                                                                                                    product
                                                                                                    commercially
                                                                                                    available.
BANNED........................  S0        ...................  Proglumide......  Anti-ulcer......  Lacks FDA
                                                                                                    approval.
CONTROLLED....................  S7        B                    Promazine.......  Sedative/         Promazine
                                                                                  Antipsychotic.    Granules.
CONTROLLED....................  S7        B                    Promethazine....  Antihistamine...  Promethegan.
                                                                                                    Note: Component
                                                                                                    of multiple OTC
                                                                                                    cough/cold
                                                                                                    formulations.
BANNED........................  S0        ...................  Pronethalol.....  Antiarrhythmic..  Lacks FDA
                                                                                                    approval.
CONTROLLED....................  S7        B                    Propafenone.....  Antiarrhythmic..  Rythmol..........
BANNED........................  S0        ...................  Propallylonal...  Sedative/         Lacks FDA
                                                                                  Hypnotic.         approval.
BANNED........................  S0        ...................  Propanidid......  Anesthetic......  Lacks FDA
                                                                                                    approval.
BANNED........................  S0        ...................  Propantheline...  Anticholinergic.  Discontinued, no
                                                                                                    FDA-approved
                                                                                                    product
                                                                                                    commercially
                                                                                                    available.
CONTROLLED....................  S7        C                    Proparacaine      Local anesthetic  Alcane...........
                                                                (Proxymetacaine
                                                                ).
BANNED........................  S0        ...................  Propentophylline  Phosphodiesteras  Lacks FDA
                                                                (propentofyllin   e inhibitor.      approval.
                                                                e).
BANNED........................  S0        ...................  Propiomazine....  Antipsychotic...  Discontinued, no
                                                                                                    FDA-approved
                                                                                                    product
                                                                                                    commercially
                                                                                                    available.
BANNED........................  S0        ...................  Propionylpromazi  Sedative........  Lacks FDA
                                                                ne.                                 approval.
BANNED........................  S0        ...................  Propiram........  Opioid analgesic  Lacks FDA
                                                                                                    approval. DEA
                                                                                                    Schedule I.
CONTROLLED....................  S7        A                    Propofol........  Anesthetic......  PropoFlo,
                                                                                                    Rapanofal.
BANNED........................  S0        ...................  Propoxycaine....  Local anesthetic  Discontinued, no
                                                                                                    FDA-approved
                                                                                                    product
                                                                                                    commercially
                                                                                                    available.
BANNED........................  S0        ...................  Propoxyphene....  Opioid analgesic  Discontinued, no
                                                                                                    FDA-approved
                                                                                                    product
                                                                                                    commercially
                                                                                                    available.
CONTROLLED....................  S7        A                    Propranolol.....  Antiarrhythmic/   Inderal,
                                                                                  Antihypertensiv   Hemangeol.
                                                                                  e.
BANNED........................  S0        ...................  Propylhexedrine.  Stimulant.......  Benzedrex........
BANNED........................  S0        ...................  Propyphenazone..  NSAID...........  Lacks FDA
                                                                                                    approval.
BANNED........................  S0        ...................  Proquazone......  NSAID...........  Lacks FDA
                                                                                                    approval.
BANNED........................  S1        ...................  Prostanazol.....  Anabolic........  Lacks FDA
                                                                                                    approval. DEA
                                                                                                    Schedule III.
BANNED........................  S0        ...................  Prothipendyl....  Anxiolytic/       Lacks FDA
                                                                                  Antihistamine.    approval.
BANNED........................  S0        ...................  Protokylol......  Bronchodilator..  Discontinued, no
                                                                                                    FDA-approved
                                                                                                    product
                                                                                                    commercially
                                                                                                    available.
BANNED........................  S0        ...................  Protriptyline...  Antidepressant..  Generic..........
BANNED........................  S0        ...................  Proxibarbital...  Sedative/         Lacks FDA
                                                                                  Anxiolytic.       approval.
BANNED........................  S0        ...................  Proxyphylline...  Bronchodilator..  Lacks FDA
                                                                                                    approval.
CONTROLLED....................  S7        B                    Pseudoephedrine.  Stimulant.......  Sudafed..........
BANNED........................  S0        ...................  Psilocin          Hallucinogen....  Lacks FDA
                                                                (Psilocyn).                         approval; DEA
                                                                                                    Schedule.
CONTROLLED....................  S7        B                    Pyridostigmine..  Cholinesterase    Mestinon, Regonol
                                                                                  Inhibitor.
CONTROLLED....................  S7        B                    Pyrilamine......  Antihistamine...  Histavet-P.......
BANNED........................  S0        ...................  Pyrithyldione...  Sedative/         Lacks FDA
                                                                                  Hypnotic.         approval.
BANNED........................  S0        ...................  Pyrrobutamine...  Antihistamine...  Lacks FDA
                                                                                                    approval.
BANNED........................  S0        ...................  Quazepam........  Sedative........  Doral. DEA
                                                                                                    Schedule IV.
BANNED........................  S0        ...................  Quetiapine......  Antipsychotic...  Lacks FDA
                                                                                                    approval.

[[Page 5155]]

 
BANNED........................  S0        ...................  Quinapril,        Antihypertensive  Accuretic........
                                                                Quinaprilat.
BANNED........................  S1        ...................  Quinbolone......  Anabolic........  Lacks FDA
                                                                                                    approval.
BANNED........................  S5        ...................  Quinethazone....  Diuretic........  Discontinued, no
                                                                                                    FDA-approved
                                                                                                    product
                                                                                                    commercially
                                                                                                    available.
CONTROLLED....................  S7        B                    Quinidine.......  Antiarrhythmic..  Generic..........
BANNED........................  S0        ...................  Quinisocaine....  Local anesthetic  Lacks FDA
                                                                                                    approval.
CONTROLLED....................  S7        C                    Rabeprazole.....  Anti-ulcer......  Aciphex..........
BANNED........................  S0        ...................  Racemethorphan..  Anti-Alzheimer's  Lacks FDA
                                                                                                    approval. DEA
                                                                                                    Schedule II.
BANNED........................  S0        ...................  Racemorphan.....  Opioid agonist..  Lacks FDA
                                                                                                    approval. DEA
                                                                                                    Schedule II.
BANNED........................  S0        ...................  Raclopride......  Antipsychotic...  Lacks FDA
                                                                                                    approval.
BANNED........................  S1        (x)                  Ractopamine.....  Anabolic........  Paylean,
                                                                                                    Optaflexx,
                                                                                                    Topmax.
BANNED........................  S4        ...................  Raloxifene......  Selective         Evista...........
                                                                                  Estrogen
                                                                                  Receptor
                                                                                  Modulator
                                                                                  (SERM).
BANNED........................  S4        ...................  Ramatercept (ACE- Myostatin         Lacks FDA
                                                                031).             inhibitor.        approval.
BANNED........................  S0        ...................  Ramifenazone      NSAID...........  Lacks FDA
                                                                (Isopyrin).                         approval.
BANNED........................  S0        ...................  Ramipril,         Antihypertensive  Altace...........
                                                                metabolite
                                                                Ramiprilat.
CONTROLLED....................  S7        C                    Ranitidine......  Anti-ulcer......  Generic..........  Restricted        40 ng/mL in
                                                                                                                       administration    serum or
                                                                                                                       time: 24 hours.   plasma.
                                                                                                                       8 mg/kg orally
                                                                                                                       twice daily for
                                                                                                                       7 doses. (9
                                                                                                                       horses).
BANNED........................  S0        ...................  Regadenoson.....  Cardiac           Lexiscan.........
                                                                                  stimulant.
BANNED........................  S0        ...................  Remifentanil....  Synthetic opioid  Ultiva. DEA
                                                                                  analgesic.        Schedule II.
BANNED........................  S0        ...................  Remimazolam.....  Anesthetic......  Byfavo. DEA
                                                                                                    schedule IV.
BANNED........................  S0        ...................  Remoxipride.....  Antipsychotic...  Lacks FDA
                                                                                                    approval.
BANNED........................  S3        ...................  Reproterol......  Beta-2 agonist-   Lacks FDA
                                                                                  bronchodilator.   approval.
CONTROLLED....................  S7        A                    Reserpine.......  Antihypertensive/ Serpasil.........
                                                                                  Depressant.
BANNED........................  S0        ...................  Rilmazafone.....  Sedative/         Lacks FDA
                                                                                  Hypnotic.         approval.
BANNED........................  S3        ...................  Rimiterol.......  Beta-2 agonist-   Lacks FDA
                                                                                  bronchodilator.   approval.
BANNED........................  S6        ...................  Risedronate.....  Bisphosphonate..  Actonel..........
BANNED........................  S0        ...................  Risperidone.....  Antipsychotic...  Perseris Kit,
                                                                                                    Risperdal
                                                                                                    Consta,
                                                                                                    Risperdal.
BANNED........................  S0        ...................  Ritanserin......  Antidepressant..  Lacks FDA
                                                                                                    approval.
BANNED........................  S3        ...................  Ritodrine.......  Beta-2 agonist..  Lacks FDA
                                                                                                    approval.
BANNED........................  S0        ...................  Rivastigmine....  Cholinesterase    Exelon...........
                                                                                  Inhibitor.
BANNED........................  S0        ...................  Rizatriptan.....  Selective         Maxalt...........
                                                                                  Serotonin
                                                                                  Receptor
                                                                                  Agonist.
CONTROLLED....................  S7        A                    Rocuronium......  Muscle relaxant.  Generic..........
BANNED........................  S0        ...................  Rofecoxib.......  NSAID...........  Discontinued, no
                                                                                                    FDA-approved
                                                                                                    product
                                                                                                    commercially
                                                                                                    available.
CONTROLLED....................  S7        B                    Romifidine......  Sedative........  Sedivet..........  Detection Time:   1 ng/mL in
                                                                                                                       60 hours. 80      urine.
                                                                                                                       mcg/kg single
                                                                                                                       IV dose (6
                                                                                                                       horses).
CONTROLLED....................  S7        A                    Ropivacaine.....  Local anesthetic  Naropin..........
BANNED........................  S2        ...................  Roxadustat (FG-   Erythropoiesis..  Lacks FDA
                                                                4592).                              approval.
BANNED........................  S0        ...................  Salicylamide....  Analgesic.......  Lacks FDA
                                                                                                    approval.
CONTROLLED....................  S7        C                    Salicylic acid..  NSAID...........  Paser............  ................  Threshold: 750
                                                                                                                                         mcg/mL in urine
                                                                                                                                         or 6.5 mcg/mL
                                                                                                                                         in serum or
                                                                                                                                         plasma.
CONTROLLED--when administered   S7        B                    Salmeterol......  Beta-2 agonist-   Serevent, Advair
 via inhalation.                                                                  bronchodilator.   (with
                                                                                                    fluticasone),
                                                                                                    Airduo (with
                                                                                                    fluticasone),
                                                                                                    Wixela (with
                                                                                                    fluticasone).
BANNED........................  S1        ...................  SARM YK-11......  Anabolic........  Lacks FDA
                                                                                                    approval.
CONTROLLED....................  S7        C (x)                Scopolamine       Anticholinergic.  Transdermal Scop;  ................  60 ng/mL total
                                                                (Hyoscine).                         Dietary                              (free and
                                                                                                    substance per                        conjugated) in
                                                                                                    IFHA.                                urine.
CONTROLLED....................  S7        A                    Secobarbital      Sedative/         Discontinued, no
                                                                (Quinalbarbiton   Hypnotic.         FDA-approved
                                                                e).                                 product
                                                                                                    commercially
                                                                                                    available. DEA
                                                                                                    Schedule II.
BANNED........................  S0        ...................  Selegiline......  Antidepressant..  Emsam, Zelapar...
BANNED........................  S2        ...................  Sermorelin......  Growth Hormone..  Discontinued, no
                                                                                                    FDA-approved
                                                                                                    product
                                                                                                    commercially
                                                                                                    available.
BANNED........................  S0        ...................  Sertraline......  Antidepressant..  Zoloft...........
BANNED........................  S0        ...................  Sibutramine.....  Stimulant.......  Discontinued, no
                                                                                                    FDA-approved
                                                                                                    product
                                                                                                    commercially
                                                                                                    available. DEA
                                                                                                    Schedule IV.

[[Page 5156]]

 
BANNED........................  S0        ...................  Sildenafil......  Phosphodiesteras  Viagra...........
                                                                                  e inhibitor.
BANNED........................  S6        ...................  Snake Venoms....  Neurotoxin......  Lacks FDA
                                                                                                    approval.
BANNED........................  S2        ...................  Somatrem........  Growth Hormone..  Protropin........
BANNED........................  S2        ...................  Somatrogon......  Growth Hormone..  Lacks FDA
                                                                                                    approval.
BANNED........................  S2        ...................  Somatropin......  Growth Hormone..  Lacks FDA
                                                                                                    approval.
CONTROLLED....................  S7        B                    Sotalol.........  Antiarrhythmic..  Betapace, Sorine,
                                                                                                    Sotylize.
BANNED........................  S2        ...................  Sotatercept.....  Growth Hormone..  Lacks FDA
                                                                                                    approval.
BANNED........................  S0        (x)                  Sparteine.......  Antiarrhythmic..  Lacks FDA
                                                                                                    approval.
BANNED........................  S0        ...................  Spiperone.......  Antipsychotic...  Lacks FDA
                                                                                                    approval.
BANNED........................  S0        ...................  Spirapril,        Antihypertensive  Discontinued, no
                                                                metabolite                          FDA-approved
                                                                Spiraprilat.                        product
                                                                                                    commercially
                                                                                                    available.
BANNED........................  S5        ...................  Spironalactone..  Diuretic........  Aldactazide,
                                                                                                    Caarospir,
                                                                                                    Aldactone.
BANNED........................  S4        ...................  Stamulumab (Myo-  Myostatin         Lacks FDA
                                                                29).              inhibitor.        approval.
BANNED........................  S1        ...................  Stanozolol......  Anabolic........  Lacks FDA
                                                                                                    approval. DEA
                                                                                                    Schedule III.
BANNED........................  S1        ...................  Stenbolone......  Anabolic........  Lacks FDA
                                                                                                    approval. DEA
                                                                                                    Schedule III.
BANNED........................  S0        ...................  Strychnine......  CNS stimulant...  Lacks FDA
                                                                                                    approval. (Has
                                                                                                    anetodal use as
                                                                                                    contituent of
                                                                                                    unregulated
                                                                                                    appetite
                                                                                                    stimulants and
                                                                                                    leg paints.
                                                                                                    Extreme caution
                                                                                                    is advised when
                                                                                                    using these
                                                                                                    products.).
BANNED........................  S0        ...................  Styramate.......  Muscle relaxant.  Lacks FDA
                                                                                                    approval.
CONTROLLED....................  S7        A                    Succinylcholine.  Muscle relaxant.  Anectine,
                                                                                                    Quelicin.
BANNED........................  S0        ...................  Sufentanil......  Opioid analgesic  Sufenta, Dsuvia.
                                                                                                    DEA Schedule II.
CONTROLLED....................  S7        C                    Sulfasalazine...  Disease-          Azulfadine.......
                                                                                  modifying anti-
                                                                                  rheumatic.
BANNED........................  S0        ...................  Sulfondiethylmet  Sedative/         Lacks FDA
                                                                hane.             Hypnotic.         approval. DEA
                                                                                                    Schedule III.
BANNED........................  S0        ...................  Sulfonmethane...  Sedative/         Lacks FDA
                                                                                  Hypnotic.         approval. DEA
                                                                                                    Schedule III.
BANNED........................  S0        ...................  Sulforidazine...  Antipsychotic...  Lacks FDA
                                                                                                    approval.
BANNED........................  S0        ...................  Sulindac........  NSAID...........  Generic..........
BANNED........................  S0        ...................  Sulpiride.......  Antipsychotic...  Lacks FDA
                                                                                                    approval.
BANNED........................  S0        ...................  Sultopride......  Antipsychotic...  Lacks FDA
                                                                                                    approval.
BANNED........................  S0        ...................  Sumatriptan.....  Selective         Imitrex, Treximet
                                                                                  Serotonin         [with naproxen].
                                                                                  Receptor
                                                                                  Agonist.
CONTROLLED....................  S7        C                    Suprofen........  NSAID...........  Discontinued, no
                                                                                                    FDA-approved
                                                                                                    product
                                                                                                    commercially
                                                                                                    available.
BANNED........................  S0        ...................  Suxibuzone......  NSAID...........  Lacks FDA
                                                                                                    approval.
BANNED........................  S0        (x)                  Synephrine......  Stimulant.......  Lacks FDA
                                                                                                    approval.
BANNED........................  S4        ...................  T3                Metabolic         Lacks FDA
                                                                (triiodothyroni   hormone.          approval.
                                                                ne).
BANNED........................  S4        ...................  T4                Metabolic         Thyro-Tabs
                                                                (tetraiodothyro   hormone.          Canine,
                                                                nine/thy                            Thyrokare.
                                                                roxine).
BANNED........................  S2        ...................  Tabimorelin.....  Growth Hormone..  Lacks FDA
                                                                                                    approval.
BANNED........................  S0        ...................  Tadalafil.......  Phosphodiesteras  Cialis...........
                                                                                  e inhibitor.
BANNED........................  S0        ...................  Talbutal........  CNS depressant..  Discontinued, no
                                                                                                    FDA-approved
                                                                                                    product
                                                                                                    commercially
                                                                                                    available. DEA
                                                                                                    Schedule III.
BANNED........................  S4        ...................  Tamoxifen.......  Selective         Soltamox.........
                                                                                  Estrogen
                                                                                  Receptor
                                                                                  Modulator
                                                                                  (SERM).
BANNED........................  S0        ...................  Tandospirone....  Anxiolytic......  Lacks FDA
                                                                                                    approval.
BANNED........................  S0        ...................  Tapentadol......  Opioid analgesic  Nucynta. DEA
                                                                                                    Schedule II.
BANNED........................  S0        ...................  Telmisartan.....  Antihypertensive  Micardis.........

[[Page 5157]]

 
CONTROLLED....................  S7        B                    Temazepam         Anxiolytic......  Restoril. DEA
                                                                (Temazepam is a                     Schedule IV.
                                                                major
                                                                metabolite of
                                                                diazepam. If
                                                                there is
                                                                credible
                                                                evidence that
                                                                the presence of
                                                                temazepam in a
                                                                horse's sample
                                                                is the
                                                                consequence of
                                                                exposure to
                                                                diazepam, the
                                                                classification
                                                                of temazepam
                                                                may be revised
                                                                to S7(B).).
BANNED........................  S0        ...................  Tenoxicam.......  NSAID...........  Lacks FDA
                                                                                                    approval.
CONTROLLED....................  S7        B                    Tepoxalin.......  NSAID...........  Zubrin...........
BANNED........................  S0        ...................  Terazosin.......  Antihypertensive  Generic..........
BANNED........................  S3        ...................  Terbutaline.....  Bronchodilator..  Brethine.........
BANNED........................  S0        ...................  Terfenadine.....  Antihistamine...  Lacks FDA
                                                                                                    approval.
BANNED........................  S2        ...................  Tesamorelin.....  Growth Hormone..  Egrifta..........
BANNED........................  S4        ...................  Testolactone....  Aromatase         Teslac. DEA
                                                                                  inhibitor.        Schedule III.
BANNED........................  S2        ...................  Testolone.......  Selective         Lacks FDA
                                                                                  Androgen          approval.
                                                                                  Receptor
                                                                                  Modulator
                                                                                  (SARM).
BANNED--Fillies and Mares       S1        ...................  Testosterone....  Anabolic........  Androderm, Testm,  ................  Threshold: 55 ng/
 (unless in foal).                                                                                  Vogelxo,                             mL total (free
                                                                                                    Testopel, Aveed,                     and conjugated)
                                                                                                    Kyzatrex,                            testosterone in
                                                                                                    Jatenzo,                             urine OR 0.1 n/
                                                                                                    Xyosted. DEA                         mL free
                                                                                                    Schedule III.                        testosterone in
                                                                                                                                         serum or
                                                                                                                                         plasma.
BANNED--Geldings..............  S1        ...................  Testosterone....  Anabolic........  Androderm, Testm,  ................  Threshold: 20 ng/
                                                                                                    Vogelxo,                             mL total (free
                                                                                                    Testopel, Aveed,                     and conjugated)
                                                                                                    Kyzatrex,                            testosterone in
                                                                                                    Jatenzo,                             urine OR 0.1 ng/
                                                                                                    Xyosted. DEA                         mL free
                                                                                                    Schedule III.                        testosterone in
                                                                                                                                         serum or
                                                                                                                                         plasma.
BANNED........................  S0        ...................  Tetrabenazine     Neurotransmitter  Xenazine, Austedo
                                                                (deutetrabenazi   modulator.
                                                                ne).
CONTROLLED....................  S7        B                    Tetracaine......  Local anesthetic  Pliaglis [with
                                                                                                    lidocaine],
                                                                                                    Synera [with
                                                                                                    lidocaine],
                                                                                                    Kovanze [with
                                                                                                    oxymetazoline].
BANNED........................  S1        ...................  Tetrahydrogestri  Anabolic........  Lacks FDA
                                                                none.                               approva. DEA
                                                                                                    Schedule III.
CONTROLLED....................  S7        B                    Tetrahydrozoline  Topical           Visine...........
                                                                                  Decongestant.
BANNED........................  S0        ...................  Tetrazepam......  Anxiolytic......  Lacks FDA
                                                                                                    approval. DEA
                                                                                                    Schedule IV.
BANNED........................  S1        ...................  THC               Psychoactive....  Lacks FDA
                                                                (tetrahydrocann                     approval. DEA
                                                                abinol).                            Schedule I.
BANNED........................  S0        (x)                  Thebaine........  Opioid analgesic  Lacks FDA
                                                                                                    approval. DEA
                                                                                                    Schedule II.
CONTROLLED....................  S7        B (x)                Theobromine.....  Bronchodilator/   Lacks FDA          ................  2 mcg/mL (free
                                                                                  Vasodilator.      approval;                            and conjugated)
                                                                                                    Dietary                              in urine OR 0.3
                                                                                                    substance per                        mcg/mL in serum
                                                                                                    IFHA.                                or plasma.
CONTROLLED....................  S7        B (x)                Theophylline....  Bronchodilator..  Generic; Dietary   ................  250 ng/mL (free
                                                                                                    substance per                        and conjugated)
                                                                                                    IFHA.                                in urine.
BANNED........................  S0        ...................  Thialbarbital...  Sedative/         Lacks FDA
                                                                                  Hypnotic.         approval.
CONTROLLED....................  S7        A                    Thiamylal.......  Sedative/         Surital, Biotal,
                                                                                  Hypnotic.         Anestatal. DEA
                                                                                                    Schedule III.
BANNED........................  S0        ...................  Thiethylperazine  Antipsychotic...  Discontinued, no
                                                                                                    FDA-approved
                                                                                                    product
                                                                                                    commercially
                                                                                                    available.
CONTROLLED....................  S7        A                    Thiopental        Anesthetic......  Combuthal Powder,
                                                                (pentothal).                        Xylamed. DEA
                                                                                                    Schedule III.
BANNED........................  S0        ...................  Thiopropazate...  Antipsychotic...  Lacks FDA
                                                                                                    approval.
BANNED........................  S0        ...................  Thioproperazine.  Antipsychotic...  Lacks FDA
                                                                                                    approval.
BANNED........................  S0        ...................  Thioridazine....  Antipsychotic...  Generc...........
BANNED........................  S0        ...................  Thiothixene.....  Antipsychotic...  Generic..........
BANNED........................  S0        ...................  Thiphenamil       Antispasmodic/    Lacks FDA
                                                                (tifenamil).      Local             approval.
                                                                                  anesthetic.
BANNED........................  S0        ...................  Thonzylamine....  Antihistamine/    Lacks FDA
                                                                                  anticholinergic.  approval.
BANNED........................  S0        ...................  Thozalinone.....  Antidepressant..  Lacks FDA
                                                                                                    approval.
BANNED........................  S2        ...................  Thymosin........  Peptide hormone.  Lacks FDA
                                                                                                    approval.
BANNED........................  S0        ...................  Tiapride........  Antipsychotic...  Lacks FDA
                                                                                                    approval.

[[Page 5158]]

 
BANNED........................  S0        ...................  Tiaprofenic acid  NSAID...........  Lacks FDA
                                                                                                    approval.
BANNED........................  S1        ...................  Tibolone........  Anabolic........  Lacks FDA
                                                                                                    approval.
BANNED........................  S6        ...................  Tildronate        Bisphosphonate..  Tildren..........
                                                                (Tiludronic
                                                                Acid).
CONTROLLED....................  S7        A                    Tiletamine......  Anesthetic......  Telazol [with
                                                                                                    zolazepam]. DEA
                                                                                                    Schedule III.
BANNED........................  S0        ...................  Timiperone......  Antipsychotic...  Lacks FDA
                                                                                                    approval.
BANNED........................  S3        ...................  Timolol.........  Antihypertensive  Istalol, Betimol,
                                                                                                    Timoptic.
CONTROLLED....................  S7        B                    Tiotropium......  Bronchodilator..  Spiriva..........
BANNED........................  S0        ...................  Tocainide.......  Antiarrhythmic..  Discontinued, no
                                                                                                    FDA-approved
                                                                                                    product
                                                                                                    commercially
                                                                                                    available.
BANNED........................  S0        ...................  Tofenacin.......  Antidepressant..  Lacks FDA
                                                                                                    approval.
BANNED........................  S0        ...................  Tofisopam.......  Anxiolytic......  Lacks FDA
                                                                                                    approval.
CONTROLLED....................  S7        A                    Tolazoline......  Vasodilator.....  Discontinued, no
                                                                                                    FDA-approved
                                                                                                    product
                                                                                                    commercially
                                                                                                    available.
BANNED........................  S0        ...................  Tolfenamic Acid.  NSAID...........  Lacks FDA
                                                                                                    approval.
BANNED........................  S0        ...................  Tolmetin........  NSAID...........  Discontinued, no
                                                                                                    FDA-approved
                                                                                                    product
                                                                                                    commercially
                                                                                                    available.
BANNED........................  S5        ...................  Tolvaptan.......  Diuretic........  Jynarque, Samsca.
BANNED........................  S0        ...................  Tolycaine.......  Local anesthetic  Lacks FDA
                                                                                                    approval.
BANNED........................  S0        ...................  Topiramate......  Anticonvulsant..  Topamax, Qsymia
                                                                                                    (with
                                                                                                    phentermine
                                                                                                    hydrochloride).
BANNED........................  S4        ...................  Toremifene......  Selective         Fareston.........
                                                                                  Estrogen
                                                                                  Receptor
                                                                                  Modulator
                                                                                  (SERM).
BANNED........................  S5        ...................  Torsemide         Diuretic........  Soaanz...........
                                                                (Torasemide).
CONTROLLED....................  S7        B                    Tramadol........  Opioid Analgesic  Ultram. DEA
                                                                                                    Schedule IV.
BANNED........................  S0        ...................  Tramazoline.....  Sympathomimetic.  Lacks FDA
                                                                                                    approval.
BANNED........................  S0        ...................  Trandolapril      Antihypertensive  Generic..........
                                                                (and
                                                                metabolite,
                                                                trandolaprilat).
CONTROLLED....................  S7        C                    Tranexamic acid.  Anti-             Cykokapron.......
                                                                                  fibrinolytic.
BANNED........................  S0        ...................  Tranylcypromine.  Antidepressant..  Parnate..........
BANNED........................  S0        ...................  Trazodone.......  Antidepressant..  Generic..........
BANNED........................  S1        ...................  Trenbolone        Anabolic........  Finaplix;
                                                                (trendione).                        Revalor, Synovex
                                                                                                    (with
                                                                                                    Estradiol);
                                                                                                    Component (with
                                                                                                    estradiol and
                                                                                                    tylosin). DEA
                                                                                                    Schedule III.
BANNED........................  S1        ...................  Trendione.......  Anabolic........  Lacks FDA
                                                                                                    approval.
BANNED........................  S0        ...................  Trestolone......  Anabolic........  Lacks FDA
                                                                                                    approval.
BANNED........................  S3        ...................  Tretoquinol       Beta-2 agonist-   Lacks FDA
                                                                (trimetoquinol).  bronchodilator.   approval.
CONTROLLED....................  S7        C                    Triamcinolone...  Corticosteroid..  Vetalog, Kenalog.  ................  0.5 ng/mL in
                                                                                                                                         urine.
BANNED........................  S5        ...................  Triamterene.....  Diuretic........  Dyrenium.........
BANNED........................  S0        ...................  Triazolam.......  CNS depressant..  Halcion. DEA
                                                                                                    Schedule IV.
BANNED........................  S0        ...................  Tribromoethanol.  Anesthetic......  Lacks FDA
                                                                                                    approval.
BANNED........................  S0        ...................  Tricaine          Anesthetic......  Syncaine.........
                                                                methanesulfonat
                                                                e.
CONTROLLED....................  S7        C                    Trichlormethiazi  Diuretic........  Discontinued, no
                                                                de.                                 FDA-approved
                                                                                                    product
                                                                                                    commercially
                                                                                                    available.
BANNED........................  S0        ...................  Trichloroethanol  Sedative/         Lacks FDA
                                                                                  Hypnotic.         approval.
BANNED........................  S0        ...................  Trichloroethylen  Anesthetic......  Lacks FDA
                                                                e.                                  approval.
BANNED........................  S0        ...................  Triclofos.......  Sedative........  Discontinued, no
                                                                                                    FDA-approved
                                                                                                    product
                                                                                                    commercially
                                                                                                    available.
BANNED........................  S0        ...................  Tridihexethyl...  Anticholinergic.  No FDA-approved
                                                                                                    product.
BANNED........................  S0        ...................  Triflumeprazine.  Sedative........  Lacks FDA
                                                                                                    approval.
BANNED........................  S0        ...................  Trifluoperazine.  Antipsychotic...  Generic..........
BANNED........................  S0        ...................  Trifluoromethylp  Stimulant.......  Lacks FDA
                                                                henyl                               approval.
                                                                piperazine.
BANNED........................  S0        ...................  Trifluperidol...  Antipsychotic...  Lacks FDA
                                                                                                    approval.
BANNED........................  S0        ...................  Triflupromazine.  Antipsychotic...  Discontinued, no
                                                                                                    FDA-approved
                                                                                                    product
                                                                                                    commercially
                                                                                                    available.
BANNED........................  S0        ...................  Triflupromazine.  Antipsychotic...  Discontinued, no
                                                                                                    FDA-approved
                                                                                                    product
                                                                                                    commercially
                                                                                                    available.

[[Page 5159]]

 
BANNED........................  S0        ...................  Trihexyphenidyl.  Anticholinergic.  Discontinued, no
                                                                                                    FDA-approved
                                                                                                    product
                                                                                                    commercially
                                                                                                    available.
BANNED........................  S0        ...................  Trimecaine......  Local anesthetic  Lacks FDA
                                                                                                    approval.
BANNED........................  S0        ...................  Trimeprazine      Antihistamine...  Temaril-P [with
                                                                (alimemazine).                      prednisolone].
BANNED........................  S4        ...................  Trimetazidine...  Angina treatment  Lacks FDA
                                                                                                    approval.
BANNED........................  S0        ...................  Trimethadione...  Anticonvulsant..  Discontinued, no
                                                                                                    FDA-approved
                                                                                                    product
                                                                                                    commercially
                                                                                                    available.
BANNED........................  S0        ...................  Trimethaphan....  Antihypertensive/ Discontinued, no
                                                                                  Anesthetic.       FDA-approved
                                                                                                    product
                                                                                                    commercially
                                                                                                    available.
BANNED........................  S0        ...................  Trimipramine....  Antidepressant..  Generic..........
CONTROLLED....................  S7        B                    Tripelennamine..  Antihistamine...  Re-Covr..........
BANNED........................  S0        ...................  Triprolidine....  Antihistamine...  Triacin-C (with
                                                                                                    codeine
                                                                                                    phosphate and
                                                                                                    pseudoephedrine
                                                                                                    hydrochloride).
BANNED........................  S2        ...................  Triptorelin.....  Reproductive      Triptodur,
                                                                                  hormone           Trelstar.
                                                                                  modulator.
BANNED........................  S0        ...................  Trometamol (Tris  Alkalinizing      Discontinued, no
                                                                hydroxymethylam   agent.            FDA-approved
                                                                inomethane                          product is
                                                                [THAM]).                            commercially
                                                                                                    available.
CONTROLLED....................  S7        B                    Tropicamide.....  Ophthalmic        Mydriacyl........
                                                                                  Anticholinergic.
BANNED........................  S0        ...................  Tuaminoheptane..  Stimulant.......  Lacks FDA
                                                                                                    approval.
BANNED........................  S0        ...................  Tubocurarine      Muscle relaxant.  Plant alkaloid.
                                                                (Curare).                           Discontinued, no
                                                                                                    FDA-approved
                                                                                                    product
                                                                                                    commercially
                                                                                                    available.
BANNED........................  S3        ...................  Tulobuterol.....  Beta-2 agonist-   Lacks FDA
                                                                                  bronchodilator.   approval.
BANNED........................  S0        ...................  Tybamate........  Anxiolytic......  Lacks FDA
                                                                                                    approval.
BANNED........................  S0        ...................  Valdecoxib......  NSAID...........  Discontinued, no
                                                                                                    FDA-approved
                                                                                                    product
                                                                                                    commercially
                                                                                                    available.
CONTROLLED....................  S7        A                    Valerenic acid..  Sedative........  Plant derived....
BANNED........................  S0        ...................  Valnoctamide....  Sedative/         Lacks FDA
                                                                                  Hypnotic.         approval.
BANNED........................  S0        ...................  Valproate Sodium  Anticonvulsant..  Discontinued, no
                                                                                                    FDA-approved
                                                                                                    product
                                                                                                    commercially
                                                                                                    available.
BANNED........................  S0        ...................  Valsartan.......  Antihypertensive  Diovan, Entresto
                                                                                                    (with
                                                                                                    sacubitril).
BANNED........................  S0        ...................  Vardenafil......  Phosphodiesteras  Levitra..........
                                                                                  e inhibitor.
BANNED........................  S2        ...................  Vascular-         Growth Hormone..  .................
                                                                Endothelial
                                                                Growth Factor
                                                                (VEGF).
CONTROLLED....................  S7        A                    Vecuronium......  Muscle relaxant.  Generic..........
BANNED........................  S0        ...................  Vedaprofen......  NSAID...........  Lacks FDA
                                                                                                    approval.
BANNED........................  S0        ...................  Venlafaxine.....  Antidepressant..  Pristiq..........
BANNED........................  S0        ...................  Veralipride.....  Antipsychotic...  Lacks FDA
                                                                                                    approval.
BANNED........................  S0        ...................  Verapamil.......  Antihypertensive  Verelan, Calan...
BANNED........................  S3        ...................  Vilanterol......  Beta-2 agonist-   Trelegy, Ellipta.
                                                                                  bronchodilator.
BANNED........................  S0        ...................  Viloxazine......  Antidepressant..  Qelbree..........
BANNED........................  S0        ...................  Vinbarbital.....  Hypnotic........  Lacks FDA
                                                                                                    approval. DEA
                                                                                                    Schedule III.
BANNED........................  S0        ...................  Vinylbital......  Sedative/         Lacks FDA
                                                                                  Hypnotic.         approval.
CONTROLLED....................  S7        C                    Warfarin........  Anticoagulant...  Coumadin,
                                                                                                    Jantoven.
BANNED........................  S2        ...................  Xenon...........  Hypoxia           .................
                                                                                  Inducible
                                                                                  Factor
                                                                                  activating
                                                                                  agent.
BANNED........................  S5        ...................  Xipamide........  Diuretic........  Lacks FDA
                                                                                                    approval.
CONTROLLED....................  S7        B                    Xylazine........  Sedative/         Rompun, Anased...  Detection Time:   SL: 10 ng/mL U
                                                                                  Analgesic.                           72 hours. 200     (as 4-OH
                                                                                                                       mg single IV      xylazine); 0.05
                                                                                                                       dose..            ng/mL B.
BANNED........................  S0        ...................  Xylometazoline..  Stimulant.......  Afrin, Vicks
                                                                                                    Sinex.
CONTROLLED....................  S7        B                    Yohimbine.......  Stimulant.......  Antagonil........
BANNED........................  S0        ...................  Zafirlukast.....  Asthma            Accolate.........
                                                                                  prevention.
BANNED........................  S0        ...................  Zaleplon........  CNS depressant..  Sonata. DEA
                                                                                                    Schedule IV.
BANNED........................  S1        ...................  Zeranol.........  Anabolic........  Ralgro...........
BANNED........................  S6        ...................  Ziconotide......  Neurotoxin......  Prialt...........
BANNED........................  S0        ...................  Zileuton........  Asthma            Zyflo............
                                                                                  prevention.
BANNED........................  S1        (x)                  Zilpaterol        Anabolic........  Zilmax, Heifermax
                                                                hydrochloride.
BANNED........................  S0        ...................  Zimeldine.......  Antidepressant..  Lacks FDA
                                                                                                    approval.
BANNED........................  S0        ...................  Ziprasidone.....  Antipsychotic...  Geodon...........
CONTROLLED....................  S7        A                    Zolazepam.......  Sedative/         Telazol [with
                                                                                  Anxiolytic.       tiletamine].
BANNED........................  S6        ...................  Zoledronic acid.  Bisphosphonate..  Reclast..........

[[Page 5160]]

 
BANNED........................  S0        ...................  Zolmitriptan....  Selective         Zomig............
                                                                                  Serotonin
                                                                                  Receptor
                                                                                  Agonist.
BANNED........................  S0        ...................  Zolpidem........  Sedative/         Ambien. DEA
                                                                                  Hypnotic.         Schedule IV.
BANNED........................  S0        ...................  Zomepirac.......  Anticonvulsant..  Lacks FDA
                                                                                                    approval.
BANNED........................  S0        ...................  Zonisamide......  Anticonvulsant..  Zonegran.........
BANNED........................  S0        ...................  Zopiclone.......  Sedative/         Lunesta. DEA
                                                                                  Hypnotic.         Schedule IV.
BANNED........................  S0        ...................  Zotepine........  Antipsychotic...  Lacks FDA
                                                                                                    approval.
BANNED........................  S0        ...................  Zuclopenthixol..  Antipsychotic...  Lacks FDA
                                                                                                    approval.
--------------------------------------------------------------------------------------------------------------------------------------------------------
* (Unless otherwise designated as a Threshold). Where no value is listed for serum or plasma the substance is controlled by Laboratory Limit of
  Detection. Unless otherwise specified, urine values are in hydrolyzed urine.


[[Page 5161]]

5000. Equine Testing and Investigations Standards

5010. Purpose
    (a) The Equine Testing and Investigations Standards have been 
developed pursuant to the Act and the Protocol.
    (b) The first purpose of the Testing and Investigations Standards 
is to plan for intelligent and effective Testing, both in- and out-of-
competition, and to maintain the integrity and identity of the Samples 
collected from the point of notification of a Covered Horse's selection 
for Sample collection, to the point the Samples are delivered to a 
Laboratory for analysis. To that end, these Testing and Investigations 
Standards establish protocols for test planning, notification of a 
Covered Horse's selection for Sample collection, preparing for and 
conducting Sample collection, security/post-test administration of 
Samples and documentation, and transport of Samples to Laboratories for 
analysis.
    (c) The second purpose of the Testing and Investigations Standards 
is to establish rules for the efficient and effective gathering, 
assessment, and use of anti-doping and medication control intelligence, 
and for efficient and effective investigations into possible anti-
doping and medication control rule violations.
5020. Definitions
    Unless specified otherwise, capitalized terms used in these Testing 
and Investigations Standards have the meanings given to them in Rule 
1020.

5100. Standards for Testing

5110. Planning Effective Testing
    (a) The Agency is required to plan and implement intelligent and 
effective Testing on Covered Horses over which it has authority, and 
that is proportionate to the risk of doping and the misuse of 
medication, and effective to detect and to deter such practices. The 
objective of this Rule is to explain the steps that form part of a Risk 
Assessment to inform Testing plans in a way that best ensures clean 
competition and protects the health and welfare of Covered Horses.
    (b) The Agency shall ensure that Covered Persons with a conflict of 
interest in the outcome of the Testing being contemplated are not 
involved in test planning or in the process of selection of Covered 
Horses for Sample collection.
    (c) The Agency should monitor, evaluate, and update its Risk 
Assessment during the year or cycle in light of changing circumstances 
and in implementing its Testing plans.
5120. Risk Assessment
    The Risk Assessment shall be conducted in good faith, reviewed and 
updated as required (at the discretion of the Agency), and should take 
into account (if available) the following information:
    (a) discipline and individual factors that may result in a higher 
potential for adopting doping behavior or misuse of medication;
    (b) available statistics and research on doping trends and misuse 
of medication, practices, and methods;
    (c) reliable information received and intelligence developed on 
possible doping practices and misuse of medication;
    (d) outcomes of previous test planning cycles, including past 
testing strategies;
    (e) optimal times to apply specific test types (including analysis) 
to maximize opportunities for detecting and deterring doping;
    (f) given the structure of the racing season (including generic 
racing schedules and training patterns), the time during the year a 
horse is most likely to be administered Banned Substances or be 
subjected to Banned Methods (to enhance or impair performance or impact 
welfare or soundness); and
    (g) any Risk Assessment carried out by a State Racing Commission or 
racing authority in another country and provided to the Agency for the 
purposes of enhancing its Risk Assessment.
5130. Prioritizing Between Covered Horses, Types of Testing, and 
Samples
    (a) The Agency should consider various factors in prioritizing the 
allocation of Testing resources. In addition, the Agency will use 
Target Testing to focus Testing resources where they are most needed 
within the overall pool of Covered Horses.
    (b) Factors relevant to determining which Covered Horses should be 
the subject of Target Testing may include, but are not limited to, the 
following:
    (1) Covered Horses serving a period of Ineligibility or a 
Provisional Suspension;
    (2) Covered Horses who were high priority for Testing before 
retirement and are now returning from retirement to active 
participation;
    (3) Covered Horses' testing history, including any abnormal Sample 
data (e.g., an Atypical Finding reported by a Laboratory);
    (4) Covered Persons' prior anti-doping and medication control rule 
violations and testing history, including any abnormal Sample data 
(e.g., an Atypical Finding reported by a Laboratory);
    (5) performance history, performance pattern, or high performance 
(e.g., Trainer strike rate) without a commensurate testing record;
    (6) repeated failure to meet whereabouts requirements;
    (7) suspicious whereabouts filing patterns;
    (8) moving to or training in a remote location;
    (9) suspicious withdrawal or absence from expected Covered 
Horserace(s);
    (10) association with a third party (such as a Trainer, 
Veterinarian, or Owner) with a history of involvement in doping or 
misuse of medication;
    (11) injury;
    (12) age and stage of career;
    (13) financial incentives for improved or degraded performance, 
such as purse size, unusual betting patterns, or upcoming Claiming 
Race; or
    (14) reliable information from a third party, or intelligence 
developed by or shared with the Agency.
    (c) Target Testing is a priority because random Testing, or even 
weighted random Testing, does not ensure that all of the appropriate 
Covered Horses will be sufficiently tested. Covered Horses may be 
tested at any time and at any place where they are located (e.g., 
Racetrack, Training Facility, private facility). The Protocol does not 
impose any reasonable suspicion or probable cause requirement for 
Target Testing or Testing.
    (d) Testing that is not Target Testing should be determined based 
on the Risk Assessment. Testing should be conducted using a documented 
system for such selection, such as weighted testing (where Covered 
Horses are ranked using pre-determined criteria to increase or decrease 
the chances of selection) or random testing (where no pre-determined 
criteria are considered, and Covered Horses are chosen arbitrarily from 
a list or pool of names). Testing that is weighted should be 
prioritized and conducted according to defined criteria which may take 
into account the risk factors to ensure that a greater percentage of at 
risk Covered Horses are selected.
    (e) Based on the Risk Assessment and prioritization process 
described above, the Agency should determine to what extent each of the 
following types of Testing is required to effectively detect and deter 
doping and misuse of medication within the sport:
    (1) TCO2 and Post-Race Sample collection on Race Day;
    (2) Post-Work Sample collection following Timed and Reported 
Workouts;

[[Page 5162]]

    (3) Out-of-competition Sample collection;
    (4) Sample matrices to be considered:
    (i) urine;
    (ii) hair;
    (iii) blood; or
    (iv) other matrices or methodologies, as available.
5140. Sample Analysis, Retention Strategy, and Further Analysis
    (a) Laboratories shall analyze Samples for an Analytical Testing 
menu directed by the Agency. The Agency may also consider undertaking 
more extensive Sample analysis for Prohibited Substances or Prohibited 
Methods based on the assessed risk or any intelligence that the Agency 
may receive (e.g., specific Prohibited Substances, gene doping).
    (b) The Agency should develop a system for retention of Samples and 
related documentation to enable the Further Analysis of such Samples at 
a later date in accordance with Rule 3138. Such a system should comply 
with the requirements of the Laboratory Standards and should take into 
account the purposes of Sample analysis set out in Rule 3137, as well 
as (without limitation) the following elements:
    (1) Laboratory recommendations (when available);
    (2) new relevant detection methods to be introduced in the future;
    (3) collected Samples that meet some or all of the criteria set out 
at Rule 5130; or
    (4) the Agency determining based on available information or random 
selection that long-term storage or Further Analysis of the Samples is 
appropriate.
5150. Coordinating With State Racing Commissions and Other Entities
    (a) In accordance with Rule 3132, the Agency may delegate Testing 
(or aspects thereof) to State Racing Commissions, subject to the 
applicable State Racing Commission electing to enter into an agreement 
with the Agency. For example, the Agency may utilize Sample Collection 
Personnel employed or designated by a State Racing Commission to 
collect Samples. Any state rule, law, or regulation preventing sample 
collection personnel employed or designated by a State Racing 
Commission from contracting with the Agency to collect Samples is pre-
empted by this rule, which expressly permits such arrangements. 
Regardless of who collects a Sample, only the Agency shall receive the 
results of Sample analysis directly from the Laboratory.
    (b) The Agency may delegate Testing (or aspects thereof) to 
qualified third parties, e.g., by contracting a third-party sample 
collection service provider to collect Samples on behalf of the Agency.
    (c) State Racing Commissions, Racetracks, Race Organizers, and 
other third parties may (at their own cost) contract with the Agency to 
collect additional Samples on Covered Horses in a manner that is 
consistent with the Act and the Protocol.

5200. Notification

5210. Requirements Prior to Notification
    (a) Testing without advance notice should be the method for Sample 
collection except in circumstances where advance notice is required to 
facilitate the Testing. If the Responsible Person is with the Covered 
Horse at the time of notification, the Responsible Person should be the 
first Person notified that the Covered Horse has been selected for 
Sample collection. In order to ensure that Testing is conducted on a 
without advance notice basis, the Agency shall ensure Testing selection 
decisions are only disclosed in advance of Testing to those who need to 
know in order for such Testing to be conducted. Any notification to a 
third party shall be conducted in a secure and confidential manner to 
minimize the risk that the Responsible Person or other Covered Person 
will receive any advance notice of a Covered Horse's selection for 
Sample collection.
    (b) The Agency shall appoint DCOs, BCOs, Chaperones, and other 
Sample Collection Personnel sufficient to facilitate Testing without 
advance notice and to ensure continuous observation of the Covered 
Horse and confirmation that the Covered Horse is in a secure location 
(a stall, for example) throughout the Sample collection process. Sample 
Collection Personnel must be trained for their assigned 
responsibilities, must not have a conflict of interest with respect to 
the performance or outcome of the Sample collection, and must be 18 or 
older. See Rule 5450 for more information on Sample Collection 
Personnel requirements.
    (c) Sample Collection Personnel shall have official documentation 
provided by the Agency, evidencing their authority to collect a Sample 
from the Covered Horse.
    (d) Information provided in the Covered Horse's whereabouts filing 
and registration with the Authority, or other equally reliable form of 
identification, shall be used by Sample Collection Personnel to confirm 
the identity of the Covered Horse. Confirmation of the Covered Horse's 
identity by any other method or failure to confirm the identity of the 
Covered Horse shall be documented, including through photographs, and 
reported to the Agency.
    (e) The DCO or BCO shall establish the location of the selected 
Covered Horse and plan the approach and timing of notification, taking 
into consideration the specific circumstances of the location, 
schedule, and the situation in question (e.g., Covered Horserace, Timed 
and Reported Workout, Vets' List Workout).
5220. Requirements for Notification
    (a) Out-of-competition Sample collection.
    (1) The Sample Collection Personnel will seek to locate the Covered 
Horse based on available data regarding Racetracks and Training 
Facilities or based on whereabouts information.
    (2) If the Sample Collection Personnel are able to locate the 
Covered Horse, notification of out-of-competition Sample collection 
shall ordinarily take place in person, but may, if necessary, take 
place by telephone, text message, or email using the contact details 
provided by the Responsible Person upon registration with the 
Authority.
    (3) If the Sample Collection Personnel are not able to locate the 
Covered Horse based on available data or whereabouts information, 
notification of out-of-competition Sample collection shall take place 
by telephone, text message, or email, using the contact details 
provided by the Responsible Person upon registration with the 
Authority.
    (4) In accordance with Rule 3215, the Responsible Person shall 
ensure that the Covered Horse is produced for Sample collection 
immediately upon notification by a duly authorized person in accordance 
with the Agency's procedures if the Covered Horse is present at the 
location where notification is attempted. If the Covered Horse is not 
present at the location where notification is attempted (including due 
to a Whereabouts Failure), the Responsible Person shall ensure that the 
Covered Horse is produced for Sample collection within 6 hours of 
notification by a duly authorized Person in accordance with the 
Agency's procedures, except that the Agency may extend the 6-hour 
period if it considers that extenuating circumstances justify doing so.
    (5) At the time of notification, the Sample Collection Personnel 
shall inform the Responsible Person or Nominated Person:
    (i) that the Covered Horse is required to undergo Sample 
collection;
    (ii) that immediate access to the Covered Horse shall be granted, 
and (if

[[Page 5163]]

that is not possible because the Covered Horse is not present at the 
location), the Responsible Person has 6 hours to produce the Covered 
Horse for Sample collection, failing which significant Consequences may 
apply in accordance with Rule 3215;
    (iii) that the Sample collection process shall start immediately, 
unless there are valid reasons for a delay (as determined by the DCO or 
BCO);
    (iv) that the Sample collection process shall take place in a 
secure location determined suitable by the DCO or BCO (e.g., the 
horse's stall);
    (v) of the responsibilities of the Responsible Person or Nominated 
Person with respect to the Covered Horse, including the requirement to:
    (A) ensure that the Covered Horse remains under continuous 
observation of Sample Collection Personnel at all times until the 
completion of the Sample collection procedure;
    (B) not leave the Covered Horse unattended once the Responsible 
Person or Nominated Person is notified and contact is made with the 
Covered Horse until the completion of the Sample collection procedure;
    (C) produce on request identification for himself or herself and 
the Covered Horse. Identification for the Responsible Person or 
Nominated Person should include his or her Authority registration 
number or (if not available) valid photo identification. The Sample 
Collection Personnel may take photographs of the individual(s) and the 
Covered Horse if identification is not provided;
    (D) comply and cooperate with Sample collection procedures and 
processes (the Responsible Person or Nominated Person should also be 
advised of the possible Consequences of failure to comply, including 
pursuant to Rule 3215 and 3510); and
    (E) ensure that the Covered Horse is not administered any 
medications or supplements from notification of Sample collection until 
completion of Sample collection, unless there is a medical emergency, 
as determined by a Regulatory Veterinarian or (if not available) a 
Veterinarian.
    (6) The Sample Collection Personnel shall have the Responsible 
Person or Nominated Person sign an appropriate form to acknowledge and 
accept the notification of Sample collection. If the Responsible Person 
or Nominated Person refuses to sign the form, or evades notification, 
the Sample Collection Personnel should, if possible, inform the 
Responsible Person or Nominated Person of the Consequences of a failure 
to comply, and the Sample Collection Personnel (if not the DCO) shall 
immediately report all relevant facts to the DCO or BCO. When possible, 
the Sample Collection Personnel shall continue the Sample collection. 
The DCO shall document the facts in a detailed report and report the 
circumstances to the Agency.
    (7) A Nominated Person may be replaced by another Nominated Person 
during the Sample collection process upon reasonable request to the 
Sample Collection Personnel so long as the new Nominated Person (i) 
falls within the scope of the definition of Nominated Person, (ii) 
completes the relevant portions of the Sample collection paperwork, and 
(iii) does not interfere with the Sample collection process. Any 
changes of Nominated Person during the Sample collection process shall 
be documented by the Sample Collection Personnel.
    (b) Post-Race Sample collection.
    (1) Pursuant to Rule 1020, a Post-Race Sample includes any Sample 
collected by or on behalf of the Agency from a Covered Horse where 
notification of such Sample collection takes place no more than 1 hour 
after the end of a Covered Horserace in which a Covered Horse 
participates or is entered, or the end of a Vet's List Workout in which 
a Covered Horse participates.
    (2) A member of the Sample Collection Personnel will tag or 
otherwise identify a Covered Horse selected for Sample collection 
(ordinarily in the unsaddling area) within 1 hour of the end of the 
Covered Horserace or Vets' List Workout and chaperone the Covered 
Horse, to the extent possible, from the point of tagging/notification 
until the end of the Sample Collection Session. Such notification 
should inform the Responsible Person or Nominated Person:
    (i) that the Covered Horse is required to undergo Sample 
collection;
    (ii) that the Covered Horse must report to the Test Barn as soon as 
practicable, unless there are valid reasons for a delay (as determined 
by the DCO or BCO);
    (iii) of the location of the Test Barn;
    (iv) of the responsibilities of the Responsible Person or Nominated 
Person with respect to the Covered Horse, including the requirement to:
    (A) ensure that the Covered Horse remains under observation of 
Sample Collection Personnel, to the extent possible, until the 
completion of the Sample Collection Session;
    (B) not leave the Covered Horse unattended to the extent possible 
once the Responsible Person or Nominated Person is notified and contact 
is made with the Covered Horse until the Sample Collection Session is 
completed;
    (C) produce on request identification for himself or herself (which 
shall include his or her Authority registration number) and the Covered 
Horse. The Sample Collection Personnel may take photographs of the 
individual(s) and the Covered Horse if no identification is provided;
    (D) comply and cooperate with Sample collection procedures and 
processes (the Responsible Person or Nominated Person should be advised 
of the possible Consequences of a failure to comply, including pursuant 
to Rule 3215 and 3510);
    (E) ensure that the Covered Horse is not administered any 
medications or supplements (or similar items) from notification of 
Sample collection until completion of the Sample Collection Session, 
unless there is a medical emergency, as determined by the Test Barn 
Veterinarian or a Regulatory Veterinarian; and
    (F) confirm that the water bucket of the Covered Horse is clean and 
acceptable and ensure that it is only used for that Covered Horse 
during the Sample Collection Session.
    (3) The Sample Collection Personnel shall notify the Responsible 
Person or Nominated Person and document the time and the individual 
notified (e.g., by taking a photograph or by having the Responsible 
Person or Nominated Person sign an appropriate form or through such 
other reasonable and appropriate measure under the circumstances), and 
the Responsible Person or Nominated Person must sign an appropriate 
form to acknowledge and accept the notification no later than once in 
the Test Barn or other secure location. If the Responsible Person or 
Nominated Person refuses to sign the form, or evades the notification, 
the Sample Collection Personnel should, if possible, inform the 
Responsible Person or Nominated Person of the Consequences of a failure 
to comply, and the Sample Collection Personnel (if not the DCO or BCO) 
shall immediately report all relevant facts to the DCO or BCO. When 
possible, the Sample Collection Personnel shall continue the Sample 
collection. The DCO or BCO shall document the facts in a detailed 
report and report the circumstances to the Agency.
    (4) From the time that a Covered Horse is tagged or identified for 
Sample collection until the end of the Sample collection process, the 
Sample Collection Personnel shall keep the Covered Horse under 
observation or ensure the Covered Horse is in a secure location (a 
stall, for example).
    (5) A Nominated Person may be replaced by another Nominated Person

[[Page 5164]]

during the Sample collection process upon reasonable request to the 
Sample Collection Personnel, so long as the new Nominated Person (i) 
falls within the scope of the definition of Nominated Person, (ii) 
completes the relevant portions of the Sample collection paperwork, and 
(iii) does not interfere with the Sample collection process. Any 
changes of Nominated Person during the Sample collection process shall 
be documented by the Sample Collection Personnel.
    (c) Pre-race Sample collection.
    Blood samples may be collected before a Covered Horserace or Vets' 
List Workout for purposes of TCO2 testing in accordance with Rule 5430. 
Sample Collection Personnel shall provide notification of Sample 
collection in accordance with paragraph (a) or (b) above depending on 
the circumstances.
    (d) Post-Work Sample collection.
    Samples may be collected after a Timed and Reported Workout in 
accordance with Rule 5400. All Banned Substances and any Controlled 
Medication Substances specifically identified on the Prohibited List as 
prohibited during Timed and Reported Workouts are prohibited from being 
present in a Post-Work Sample. Sample Collection Personnel shall 
provide notification of Sample collection in accordance with paragraph 
(a) and (b) above depending on the circumstances.
5230. Requests for Delay
    (a) The DCO or BCO may consider any reasonable request from the 
Responsible Person or Nominated Person or third party for permission to 
delay beginning the Sample collection process following acknowledgment 
and acceptance of notification. The DCO or BCO may grant such 
permission only if the Covered Horse can remain under continuous 
observation of Sample Collection Personnel at all times until the 
completion of the Sample collection procedure. The DCO or BCO shall 
otherwise reject a request for delay, unless there is a medical 
emergency (as determined by a Test Barn Veterinarian or Regulatory 
Veterinarian or, if not available for an out-of-competition Sample 
collection, a Veterinarian) or other circumstances so require it (as 
determined by the DCO or BCO).
    (b) For Race Day Sample collection, delayed reporting to the Test 
Barn may be permitted in accordance with paragraph (a) on account of:
    (1) participation in the winner's circle;
    (2) obtaining necessary medical treatment if there is a medical 
emergency, as determined by a Regulatory Veterinarian or Test Barn 
Veterinarian; or
    (3) any other reasonable circumstances, as determined by the DCO or 
BCO, taking into account any instructions of the Agency.
    (c) For out-of-competition Sample collection, delayed reporting for 
Sample collection may be permitted in accordance with paragraph (a) on 
account of:
    (1) completing a training session or a cool down;
    (2) receiving necessary medical treatment if there is a medical 
emergency, as determined by a Regulatory Veterinarian or (if not 
available) a Veterinarian; or
    (3) any other reasonable circumstances, as determined by the DCO or 
BCO, taking into account any instructions of the Agency.
    (d) Sample Collection Personnel shall document any reasons for 
delay in reporting for Sample collection.
    (e) If immediate access to the Covered Horse is not granted, the 
DCO or BCO shall report to the Agency a possible failure to comply. If 
at all possible, the DCO or BCO shall proceed with collecting a Sample.

5300. Preparing for the Sample Collection Session

5310. General Requirements
    (a) The Agency should establish a system for obtaining all of the 
information necessary to ensure that the Sample Collection Session can 
be conducted effectively.
    (b) For Race Day Sample collection, a Test Barn should be used 
that, where possible, is used solely as a Test Barn for the duration of 
all Sample Collection Sessions. Unauthorized persons should not be 
permitted access to the Test Barn. Should the DCO or BCO determine the 
Test Barn is unsuitable, he or she shall seek an alternative location.
    (1) Unless otherwise approved by the Agency, the Test Barn should 
be equipped with:
    (i) an enclosed area for Covered Horses to walk in or adjacent to 
the Test Barn that is large enough to accommodate several horses and 
allow for continuous observation of the Covered Horses;
    (ii) sufficient enclosed stalls for the number of Sample 
collections that permit observation of the collection process and 
provide for the protection of Covered Horses undergoing Sample 
collection and space for Sample Collection Personnel and up to 2 
Covered Persons per Covered Horse;
    (iii) facilities and equipment for the collection, identification, 
and storage of Samples, including one refrigerator or cooler that can 
be locked or otherwise secured, and one freezer that can be locked or 
otherwise secured;
    (iv) an area and appropriate facilities for a Covered Horse to be 
bathed;
    (v) a table or other suitable surface;
    (vi) access to hot and cold running water;
    (vii) clean water buckets for each Covered Horse; and
    (viii) a security officer to ensure no unauthorized person is 
permitted in the Test Barn.
    (2) The Test Barn Veterinarian shall be responsible for managing 
horse welfare in the Test Barn. For example, this includes determining 
when and how to manage congestion in the Test Barn, when to release 
Covered Horses from the Test Barn, and whether (if necessary) to permit 
treatment of a Covered Horse. A Covered Horse in the Test Barn may 
receive medical treatment only with the prior authorization of the Test 
Barn Veterinarian or a Regulatory Veterinarian.
    (c) For out-of-competition Sample collection, the DCO or BCO will 
determine a suitable location to be used for the Sample Collection 
Session. If at a stable, by default the Covered Horse's own stall 
should be used.
5320. Sample Collection Equipment
    (a) General. Sample Collection Personnel should ensure that they 
have and use Sample Collection Equipment provided by or approved by the 
Agency.
    (b) Minimum requirements. Sample Collection Equipment should, at a 
minimum:
    (1) have a unique numbering system for all bottles, containers, 
tubes, security bags, bar code labels, or other items used to seal and 
transport the Samples;
    (2) have a Tamper Evident sealing system;
    (3) not reveal the identities of the Responsible Person and Covered 
Horse on the equipment (i.e., only the unique numbering system shall be 
used on the equipment);
    (4) be clean and sealed prior to use;
    (5) be constructed of a material and sealing system approved by the 
Agency that should:
    (i) be able to withstand the handling conditions and environment in 
which the equipment will be used or subjected to, including, but not 
limited to, transportation, Laboratory analysis, and long-term storage;
    (ii) maintain the integrity (chemical and physical properties) of 
the Sample for Laboratory analysis;
    (iii) if the Sample will be transported or stored frozen, withstand 
temperatures

[[Page 5165]]

of up to -20 [deg]C and a minimum of 3 freeze/thaw cycles;
    (iv) be transparent or translucent so the Sample is visible;
    (v) have a sealing system that allows verification by the 
Responsible Person or Nominated Person and the DCO or BCO that the 
Sample is correctly sealed in the bottles or containers;
    (vi) be designed to prevent leakage during transportation 
(including by air);
    (vii) have been manufactured under the internationally recognized 
ISO 9001 certified process which includes quality control management 
systems; and
    (viii) be able to be resealed after initial opening by a Laboratory 
to maintain the integrity of the Sample and Chain of Custody in 
accordance with the requirements for long-term storage and Further 
Analysis; and
    (6) include a transport device or packaging that is suitable to the 
Sample at issue.
    (c) Additional requirements applicable to urine Samples. In 
addition to the requirements of paragraph (b) of this Rule 5320, Sample 
Collection Equipment used in the collection of urine Samples shall 
include:
    (1) a collection vessel with the capacity to contain a minimum of 
50 mL volume of urine;
    (2) A and B bottles with the capacity to contain a minimum 25 mL 
volume of urine; and
    (3) visual markings on the A and B bottles and the collection 
vessel, indicating the minimum volume of urine required and the maximum 
volume levels that allow for expansion when frozen without compromising 
the bottle, container, or sealing system.
    (d) Specific requirements applicable to blood Samples. In addition 
to the requirements of paragraph (b) of this Rule 5320, Sample 
Collection Equipment used in the collection of blood Samples shall 
include:
    (1) a needle for blood sampling; and
    (2) blood collection tubes, each with a capacity to contain a 
minimum of 8 mL of blood, to ensure a minimum total of 30 mL of blood 
is collected (except for TCO2 testing, where a lesser volume may be 
collected at the discretion of the Agency).
    (e) Specific requirements applicable to Hair Samples and other 
Samples. Sample Collection Personnel should ensure that they have the 
necessary equipment for hair Sample collection and any other approved 
Testing matrices or methodologies, in accordance with any procedures or 
guidance issued by the Agency.

5400. Conducting the Sample Collection Session

5410. Collection of Samples
    (a) The Agency shall be responsible for the overall conduct of the 
Sample Collection Session, with specific responsibilities delegated to 
the DCO or BCO. Sample collection may be performed only by Sample 
Collection Personnel approved by the Agency. The Agency may issue 
supplemental procedures or guidance regarding Sample collection 
procedures as it considers necessary.
    (b) The following Persons may be authorized or required to be 
present during the Sample Collection Session:
    (1) Sample Collection Personnel sufficient to notify, chaperone, 
and collect the required Samples must be present during the Sample 
Collection Session;
    (2) the Responsible Person or Nominated Person should be present 
during the Sample Collection Session. If the Responsible Person or 
Nominated Person is not present, this will be documented by the DCO or 
BCO;
    (3) no more than 2 Covered Persons (including the Responsible 
Person or Nominated Person) may be present during the Sample collection 
for a Covered Horse, except in exceptional circumstances, as determined 
by the DCO or BCO; and
    (4) any Person authorized by the Agency (e.g., a person who is 
involved in the training or supervision of Sample Collection Personnel) 
may be present during the Sample Collection Session.
    (c) The Sample Collection Personnel will coordinate with the Test 
Barn security officer to ensure that no unauthorized person is 
permitted in the Test Barn.
    (d) For Race Day Sample collection, the Covered Horse shall remain 
in the Test Barn through to the end of the Sample collection when the 
Covered Horse is released from the Test Barn by the DCO.
    (e) Samples shall be collected in a manner that ensures:
    (1) the Sample is of a quality and quantity that meets the relevant 
Sample suitability and analytical requirements;
    (2) the Sample has not been contaminated or otherwise tampered with 
in any way at the time of collection;
    (3) the Sample is clearly and accurately identified; and
    (4) the Sample is securely sealed in a Tamper Evident kit.
    (f) The Sample Collection Personnel shall collect the Sample from 
the Covered Horse according to the following protocol(s) for the 
specific type of Sample collection:
    (1) Rule 5420: Collection of urine Samples;
    (2) Rule 5430: Collection of blood Samples; and
    (3) Rule 5440: Collection of hair Samples.
    (g) Except for Samples collected for TCO2 testing (see Rule 5430(p) 
below), each Sample collected shall be split into an A and a B Sample 
at the time of collection.
    (h) In general, the relevant Sample Collection Personnel should 
wear a new pair of disposable gloves when handling the Sample 
collection vessel/tubes and when sealing Samples.
    (i) The following information shall be recorded at a minimum on the 
Sample collection documentation for a Sample Collection Session:
    (1) date and time of notification and name of notifying Sample 
Collection Personnel;
    (2) the arrival time of the Covered Horse to the Test Barn (for 
Race Day Sample collection) or secure location (for out-of-competition 
Sample collection);
    (3) the name of the Responsible Person and Nominated Person;
    (4) any changes in the Nominated Person during the Sample 
Collection Session;
    (5) the contact information of the Responsible Person or Nominated 
Person(s), if requested;
    (6) the name of the Covered Horse;
    (7) the sex of the Covered Horse (intact male, mare, gelding);
    (8) the color of the Covered Horse;
    (9) the means by which the Covered Horse's identity is validated 
(e.g., microchip number, or branding);
    (10) the name and signature of the Sample Collection Personnel 
involved in the Sample collection process for the Covered Horse;
    (11) the name of additional Covered Persons (if any) present during 
the Sample Collection Session;
    (12) the Sample code number(s);
    (13) the date and time of sealing of each Sample collected and date 
and time of completion of entire Sample Collection Session;
    (14) the location at which the Sample Collection Session took 
place;
    (15) the type of the Sample collected (e.g., urine, blood, hair);
    (16) the type of test, e.g., Race Day (TCO2 or Post-Race Sample), 
Post-Work, or out-of-competition;
    (17) whether furosemide was administered to the Covered Horse 
within 48 hours before Post-Time;
    (18) any required Laboratory information on the Sample (e.g., for

[[Page 5166]]

urine or blood Sample, its volume; for hair Sample, mane/tail and 
pulled/cut);
    (19) for a blood Sample, the information to be recorded by the DCO 
or BCO as outlined in Rule 5430;
    (20) any irregularities in procedures (e.g., if advance notice was 
provided, if there were any delays in arriving to the Test Barn or 
secure location, or any anomalous behavior by those present at the 
collection);
    (21) any comments or concerns from the Responsible Person or 
Nominated Person regarding the conduct of the Sample Collection 
Session; and
    (22) acknowledgement by the Responsible Person or Nominated Person 
of the processing of Sample collection data and a description of such 
processing.
    (j) At the conclusion of the Sample Collection Session the 
Responsible Person or Nominated Person and DCO or BCO shall sign 
appropriate documentation to indicate their satisfaction (or otherwise) 
that the documentation accurately reflects the details of the Covered 
Horse's Sample Collection Session. The DCO (or BCO) shall also provide 
the Responsible Person or Nominated Person the opportunity to document 
any concerns he or she may have concerning the manner in which Sample 
Collection Session was conducted.
    (k) The Agency may require the Sample Collection Personnel to 
complete supplemental documentation regarding the Sample Collection 
Session. For example, any anomalous behavior by the Responsible Person, 
Nominated Person, or other Covered Persons or Persons associated with 
the Covered Horse or Responsible Person, or behavior with the potential 
to compromise the Sample collection shall be recorded in detail by the 
Sample Collection Personnel. If the Covered Horse requires any 
emergency medical treatment, that shall be recorded in detail by the 
Sample Collection Personnel.
    (l) Only the DCO or BCO is authorized to end a Sample Collection 
Session and so release a Covered Horse from the Test Barn or Sample 
collection location. Only the DCO or BCO, in consultation with the Test 
Barn Veterinarian for any Race Day Sample collection, is authorized to 
temporarily release a Covered Horse from the Test Barn or Sample 
collection location.
    (m) Subject to Rule 5200, no photography or audio or video 
recording of the Sample Collection Session is permitted. Instead, the 
Sample collection documentation will be the definitive record of the 
Sample Collection Session, and any comments regarding the Sample 
Collection Session must be recorded on the Sample collection 
documentation. If a Covered Person insists on photographing or 
recording the Sample Collection Session (in whole or in part) in 
violation of this Rule, the Sample Collection Session should continue, 
but a case may be brought against the Covered Person under Rule 3510. 
If the conduct of the Covered Person results in the Sample Collection 
Session being discontinued, a case may be brought against the Covered 
Person (on its own or in the alternative) for an Anti-Doping Rule 
Violation under Rule 3215 or Rule 3216. For the avoidance of doubt, any 
conduct by a Nominated Person or other Person or employee, agent, or 
associate of the Responsible Person in relation to a Sample Collection 
Session may in appropriate circumstances be imputed to the Responsible 
Person for these purposes.
    (n) If the Agency collects any Sample(s) from a deceased horse:
    (1) Sample collection shall not interfere with any life-saving 
treatment.
    (2) Sample(s) should ordinarily be collected from the Covered Horse 
before it is removed from the relevant venue where it suffered a fatal 
condition, but otherwise may be collected at the location where the 
Covered Horse is transported to (e.g., veterinary clinic).
    (3) The Agency shall afford the Responsible Person and Nominated 
Person the opportunity to waive attendance at the Sample collection if 
such attendance would cause undue distress.
    (4) The Sample collection shall proceed in accordance with the 
applicable Sample collection procedures, amended as necessary to 
account for the specific circumstances.
5420. Collection of Urine Samples
    (a) Urine Samples may be collected and analyzed for any anti-doping 
analytical matrix or methodology, as determined by the Agency, and in 
accordance with the Prohibited List and related Technical Documents.
    (b) The relevant Sample Collection Personnel will retain control of 
the Sample collection vessel.
    (c) The Responsible Person or Nominated Person will be instructed 
to examine the Sample collection vessel to ensure that it will not 
affect the integrity of the urine Sample.
    (d) The relevant Sample Collection Personnel will then open and use 
the selected Sample collection vessel to collect the urine Sample.
    (e) The relevant Sample Collection Personnel shall ensure as 
unobstructed a view as possible of the Sample leaving the Covered 
Horse's body and shall continue to observe the Sample after provision 
until the Sample is securely sealed.
    (f) When the Covered Horse passes urine, the collection vessel 
should be positioned to collect as much urine as possible.
    (g) The volume of urine required for a full Sample is a minimum of 
25 mL for each of the A Sample and B Sample (minimum of 50 mL in 
total). If during the initial attempt less than 50 mL is obtained, the 
relevant Sample Collection Personnel should try to collect additional 
urine.
    (h) The Test Barn Veterinarian (or a Regulatory Veterinarian), in 
consultation with the DCO, shall determine if a Covered Horse is 
intractable, and (if so) when the urine Sample Collection Session 
should be terminated. If a urine Sample is not collected because the 
Covered Horse is intractable, a blood Sample should be collected (in 
addition to any other Sample, e.g., hair). The Sample Collection 
Personnel should record the reasons for terminating any Sample 
collection on the Sample collection documentation.
    (i) Once the volume of urine provided by the Covered Horse is 
deemed sufficient, the relevant Sample Collection Personnel will bring 
the Sample to the designated processing area.
    (j) The relevant Sample Collection Personnel will select the Sample 
collection kit and will open, inspect, and confirm Sample codes numbers 
match and ask the Responsible Person or Nominated Person to confirm the 
same.
    (k) If the Responsible Person or Nominated Person is not satisfied 
with the chosen Sample Collection Equipment, this shall be recorded by 
the DCO. If the DCO does not agree with the Responsible Person or 
Nominated Person that the equipment is unsatisfactory, the DCO shall 
inform the Responsible Person or Nominated Person that the Sample 
Collection Session is proceeding. If the DCO agrees with the 
Responsible Person or Nominated Person that the equipment is 
unsatisfactory, the DCO shall use other available equipment that the 
DCO determines is satisfactory. If no such equipment is available, the 
DCO shall terminate the Sample Collection Session, and the termination 
and its specific reason shall be recorded by the DCO.
    (l) Once the Sample collection kit has been selected, the relevant 
Sample Collection Personnel will pour and split the urine Sample into A 
and B Sample

[[Page 5167]]

collection bottles within the view of the Responsible Person or 
Nominated Person.
    (m) The relevant Sample Collection Personnel will seal the A and B 
bottles within the view of the Responsible Person or Nominated Person. 
Once closed, the relevant Sample Collection Personnel will check that 
the bottles have been properly sealed.
    (n) The Sample Collection Personnel will complete all the required 
Sample collection documentation, and the Responsible Person will 
subsequently be provided a copy for his or her records.
    (o) Urine should only be discarded when both the A and B bottles or 
containers have been filled to the maximum amount they can hold and 
have been sealed. Any excess urine should be disposed of into a drain 
(ground drain or sink) or into a bin or waste pile, if necessary. The 
Responsible Person or Nominated Person shall be given the option to 
observe the disposal of any residual urine not sent to the Laboratory 
for analysis.
5430. Collection of Blood Samples
    (a) Blood collection shall be conducted by the BCO.
    (b) Blood Samples may be collected and analyzed for any anti-doping 
analytical matrix or methodology, as determined by the Agency, and in 
accordance with the Prohibited List and related Technical Documents.
    (c) The DCO or BCO will select a Sample collection kit containing a 
sufficient number of blood collection tubes (two or three of which will 
be paired together as the A Sample, and the third or fourth of which 
will constitute the B Sample), and the other necessary equipment needed 
to collect a blood Sample.
    (d) If the Responsible Person or Nominated Person is not satisfied 
with the chosen Sample Collection Equipment, this shall be recorded by 
the DCO or BCO. If the DCO or BCO does not agree with the Responsible 
Person or Nominated Person that the equipment is unsatisfactory, the 
DCO or BCO shall inform the Responsible Person or Nominated Person that 
the Sample Collection Session is proceeding. If the DCO or BCO agrees 
with the Responsible Person or Nominated Person that the equipment is 
unsatisfactory, the DCO or BCO shall use other available equipment that 
the DCO or BCO determines is satisfactory. If no such equipment is 
available, the DCO or BCO shall terminate the Sample Collection 
Session, and this termination and its specific reason shall be recorded 
by the DCO or BCO.
    (e) Once the Sample collection kit has been selected, the relevant 
Sample Collection Personnel will open, inspect, and confirm Sample 
codes numbers within the kit match and ask the Responsible Person or 
Nominated Person to confirm the same.
    (f) The BCO will determine the most suitable location of 
venipuncture;
    (g) The BCO shall safely dispose of used blood sampling equipment 
not required to complete the Sample Collection Session.
    (h) Subject to paragraph (l) below, the BCO will collect the amount 
of blood that will adequately satisfy the relevant analytical 
requirements for the Sample analysis to be performed. The minimum total 
volume requirement is 30 mL whole blood, plasma, or serum, with each 
collection tube containing a minimum of 8 mL.
    (i) If the amount of blood that can be removed from the Covered 
Horse at the first attempt is insufficient, the BCO shall repeat as 
necessary and appropriate (taking horse welfare into account) to try to 
obtain the minimum total volume for a blood Sample. If the BCO is 
unable to collect a sufficient amount of blood, the BCO or DCO may 
terminate the blood Sample Collection Session and record the reasons 
for such termination. Other matrices should be considered for 
collection.
    (j) Once a complete blood Sample is obtained, the Sample Collection 
Personnel will properly seal the A and B tubes.
    (k) The Sample Collection Personnel will complete all the required 
Sample collection documentation, and the Responsible Person will 
subsequently be provided a copy for his or her records.
    (l) Total carbon dioxide (TCO2):
    (1) In addition to the collection of a Post-Race Sample, blood 
Sample(s) may also be collected from a Covered Horse prior to a Covered 
Horserace or Vets' List Workout for the purpose of testing for TCO2. 
The Prohibited List specifies the TCO2 levels that will be considered 
prima facie evidence of alkalinization or administration of an 
alkalinizing agent, i.e., a Controlled Medication Method.
    (2) A blood Sample collected for TCO2 analysis may have a total 
volume below 24 mL, at the Agency's discretion. Any volume of blood 
collected for TCO2 analysis will be transported to the Laboratory.
    (3) The Responsible Person or Owner of a Covered Horse selected for 
TCO2 testing may request that a duplicate Sample be taken. Such request 
must be made prior to the collection of the official Sample. The costs 
related to obtaining, handling, shipping, and analyzing the duplicate 
Sample shall be the responsibility of the Responsible Person or Owner 
who requested such Sample.
    (4) The duplicate sample shall not constitute a B Sample. 
Accordingly:
    (i) the provisions in the Protocol addressing the splitting of 
Samples for analysis purposes shall not apply to blood samples 
collected for TCO2 testing.
    (ii) the provisions of Rule 5430 apply to blood Samples collected 
for TCO2 testing, except that any references to A and B Samples or 
tubes shall not apply, as there shall be only one official Sample.
    (5) The official Sample and any duplicate Sample shall be analyzed 
by the same Laboratory. If the Agency, in its discretion, determines 
that the duplicate Sample cannot be analyzed within 5 days after the 
Sample is collected, the findings of the official Sample shall be 
final.
    (6) Blood Samples collected for TCO2 testing may be subject to 
Further Analysis if a Post-Race Sample collected from the same Covered 
Horse returns an Atypical Finding or an Adverse Analytical Finding.
5440. Collection of Hair Samples
    Sample Collection Personnel should collect hair Samples in 
accordance with the following requirements:
    (a) hair should (to the extent possible) be completely dry and free 
of visible dirt, debris, or foreign substances;
    (b) mane hair should be collected unless tail hair is specifically 
requested. If, for a particular reason, a mane Sample cannot be 
obtained (e.g., due to a hogged mane), tail hair may be collected;
    (c) an adequate Sample of hair should be obtained for each of the A 
and B Samples;
    (d) if the mane is less than 10 cm, an additional Sample of hair 
may be required to ensure a suitable volume is obtained for analysis;
    (e) the Sample should be secured tightly with an elastic band, or 
equivalent, and oriented to clearly mark the ends cut or pulled from 
the Covered Horse; and
    (f) hair shafts should remain aligned so that the hair does not 
become knotted.
5450. Sample Collection Personnel Requirements
    (a) Minimum requirements. The Agency shall establish the necessary 
eligibility and qualification requirements for the positions of DCO, 
BCO, and Chaperone. At a minimum:

[[Page 5168]]

    (1) Sample Collection Personnel shall be 18 years or older;
    (2) Sample Collection Personnel shall agree to undergo screening 
required by the Agency (e.g., background checks, conflicts of 
interest); and
    (3) The BCO shall be a Veterinarian or veterinary technician with 
the practical skills and knowledge to perform blood collection from a 
vein on a horse.
    (b) Conflicts.
    (1) The Agency may require all Sample Collection Personnel to sign 
an agreement regarding conflicts of interest, confidentiality, and an 
appropriate code of conduct.
    (2) The Agency shall not assign any Sample Collection Personnel to 
a Sample Collection Session where they have an interest in the 
performance or outcome of the Sample collection process. At a minimum, 
Sample Collection Personnel are deemed to have such an interest if 
they:
    (i) are related to, employed or otherwise engaged by, or otherwise 
affiliated with any Equine Constituencies, excluding State Racing 
Commissions and Racetracks, if the Sample Collection Personnel have met 
the other requirements set forth by the Agency;
    (ii) have a financial interest in or are involved in any way with 
the care or training or ownership of the Covered Horse at issue;
    (iii) are engaged in business with, have a financial interest in, 
or have a personal stake in a Covered Horserace; or
    (iv) appear to have private or personal interests that detract from 
their ability to perform their duties with integrity and in an 
independent and purposeful manner.
    (c) Training.
    (1) The Agency shall establish or approve written training 
materials for Sample Collection Personnel that outline their respective 
responsibilities and that provide adequate training for their roles.
    (2) The Agency shall ensure that DCOs and BCOs have completed the 
necessary training program and are familiar with the requirements 
before issuing them a credential or other authorization documentation.
    (3) The training program for DCOs and BCOs should include, at a 
minimum:
    (i) comprehensive theoretical training in the activities relevant 
to the DCO or BCO position (as applicable);
    (ii) observation of the activities that are the responsibility of 
the DCO or BCO as set out in these Testing and Investigations 
Standards, preferably on-site; and
    (iii) the satisfactory performance of one complete Sample 
Collection Session on-site under observation by a qualified DCO, BCO, 
or similar personnel.
    (4) The training program for Sample Collection Personnel 
responsible for the collection of blood Samples shall also include 
standard precautions in veterinary settings.
    (5) The Agency should ensure that Sample Collection Personnel are 
adequately trained to carry out their responsibilities in a manner 
respectful of any Covered Persons who are of a different race, 
religion, sex, national origin, sexual orientation, age, citizenship, 
disability, gender identity, or Veteran status.
    (d) Credentialing.
    (1) The Agency shall establish a system for credentialing and re-
credentialing DCOs and BCOs. DCOs and BCOs shall have either a 
credential including their name, photograph, and date of expiration, or 
a letter of authority from the Agency and a Federal- or State-issued 
identification. The Agency may determine what information or 
authorization documentation to require for other Sample Collection 
Personnel.
    (2) Only Sample Collection Personnel who have been authorized by 
the Agency are permitted to conduct Doping Control and Medication 
Control activities on behalf of the Agency.
    (3) DCO and BCO credentials shall be valid for a maximum of 2 
years. DCOs and BCOs should be subject to an assessment (theoretical or 
practical) before being re-credentialed.
    (4) The Agency will take steps to develop a system to monitor the 
performance of DCOs and BCOs.
    (5) The Agency will maintain records of conflicts of interest and 
training of all Sample Collection Personnel.

5500. Storage and Transportation

5510. Storage and Custody of Samples Prior to Analysis
    (a) After Sample collection, the DCO or BCO shall store Samples in 
a manner that protects the integrity, identity, and security, prior to 
transport to the Laboratory.
    (b) If a urine or blood Sample is not transported to the Laboratory 
on the day of collection:
    (1) the relevant Sample Collection Personnel shall store the urine 
Sample in a secure freezer or refigerator; and
    (2) the relevant Sample Collection Personnel shall store the blood 
Sample in a secure refrigerator;
    (3) and, in each case, shall document in the Chain of Custody the 
location and time in and time out of the urine or blood Sample.
    (c) The DCO or BCO shall document who has custody of the Samples or 
who is permitted access to the Samples.
    (d) The Agency shall develop a system for recording the Chain of 
Custody of Samples and receiving Sample Collection Session 
documentation to ensure that each Sample is securely handled and the 
documentation for each Sample is completed.

5520. Transport of Samples and Documentation

    (a) Samples should be transported to the Laboratory as soon as 
reasonably practicable after the conclusion of the Sample Collection 
Session. Samples collected on a weekend or over consecutive days may be 
stored and shipped together in batches (e.g., Samples collected on a 
race weekend may be stored and sent to the Laboratory on the next 
Monday), provided that the Samples are stored in accordance with the 
requirements of these Testing and Investigations Standards.
    (b) Samples shall be transported securely via a transportation or 
shipping service authorized by the Agency. The Agency shall authorize a 
transport system that ensures Samples and related documentation are 
transported in a manner that protects their integrity, identity, and 
security, and which minimizes the potential for Sample degradation due 
to factors such as delays and extreme temperature variations. Blood 
samples must be transported in a manner that maintains a cool and 
constant environment.
    (c) State Racing Commissions may select a Laboratory at which the A 
Samples (or official TCO2 Samples) collected in its state shall be 
analyzed. If specific analysis requested by the Agency cannot be 
performed at the selected Laboratory, the Agency may have the Sample 
sent to another Laboratory that can conduct the requested analysis. 
Each year the State Racing Commissions must make their Laboratory 
designation for all Samples collected within its state on or before 
September 30th of the year prior to the designation taking effect. If a 
State Racing Commission fails to select a Laboratory by this deadline, 
the Agency shall select the Laboratory for that particular state. The 
Agency may allow for a State Racing Commission to change its selection 
of Laboratory outside of the time-period set forth above if a 
reasonable request is made (as determined by the Agency).
    (d) A and B Samples (and official and duplicate TCO2 Samples) will 
be shipped together to the Laboratory conducting the A Sample analysis. 
If the

[[Page 5169]]

B sample analysis is requested, the B Sample will be shipped to the B 
Sample Laboratory selected by the Agency.
    (e) The Agency will have the ability to confirm, if necessary, that 
Samples and related documentation arrived at the Laboratory. The 
Laboratory shall report any irregularities to the Agency with respect 
to the condition of Samples upon arrival in accordance with the 
Laboratory Standards.
    (f) The Agency shall develop a system to ensure that, where 
required, instructions for the type of analysis to be conducted are 
provided to the Laboratory that will be conducting the analysis. In 
addition, the Agency shall provide the Laboratory with information as 
required for result reporting and statistical purposes, including 
whether long-term storage is required.
    (g) Documentation identifying the Covered Horse and Responsible 
Person or Nominated Person shall not be included with the Samples or 
documentation sent to the Laboratory that will be analyzing the 
Samples.
    (h) If the Samples or related documentation are not received by the 
Laboratory, or if a Sample's integrity or identity was compromised 
during transport, the Agency will consider whether the Samples should 
be voided. The decision to void a Sample is in the sole discretion of 
the Agency.
5530. Ownership and Retention of Samples and Retention of Documentation
    (a) Samples collected from a Covered Horse are owned by the 
Authority. Samples shall be retained by Laboratories in accordance with 
the requirements of Rule 6319.
    (b) Documentation related to a Sample Collection Session or an 
Anti-Doping Rule Violation or Controlled Medication Rule Violation 
shall be stored by the Agency in accordance with the Agency's record 
retention policy.

5600. Standards for Intelligence Gathering

5610. Purpose
    The Agency shall ensure that it is able to: obtain, assess, and 
process anti-doping and medication control intelligence from all 
available sources to help deter and detect doping and misuse of 
medication and inform effective, intelligent, and proportionate test 
planning; plan Target Testing; and conduct investigations as required 
by the Protocol. The objective of this Rule is to establish standards 
for the efficient and effective gathering, assessment, and processing 
of such intelligence for these purposes.
5620. Gathering Intelligence
    (a) The Agency should make every reasonable effort to ensure that 
it is able to obtain or receive anti-doping and medication control 
intelligence from all available sources, including, but not limited to: 
Covered Persons, including through Substantial Assistance; members of 
the public (e.g., by means of a confidential whistleblower platform); 
Sample Collection Personnel (whether via mission reports, incident 
reports, or otherwise); Laboratories; pharmaceutical companies; the 
Authority; law enforcement (authorized by any government, including 
Federal, State, or international); State Racing Commissions; 
Racetracks; Race Organizers; anti-doping organizations; equine 
regulatory bodies; other relevant regulatory or disciplinary 
authorities; and the media (in all its forms).
    (b) The Agency shall ensure that anti-doping and medication control 
intelligence obtained or received from a confidential source or in a 
non-public fashion is handled securely and confidentially, that sources 
of intelligence are protected, that the risk of leaks or inadvertent 
disclosure is properly addressed, and that intelligence shared with the 
Agency in a matter intended to be confidential is processed, used, and 
disclosed only for any legitimate legal, law enforcement, regulatory, 
anti-doping, medication control, integrity, disciplinary, horse 
welfare, or safety purposes.
    (c) The Agency shall facilitate, encourage, and seek to protect 
whistleblowers.
    (d) The Agency may consult or coordinate with the Authority, law 
enforcement (authorized by any government, including Federal, State, or 
international), State Racing Commissions, Racetracks, Race Organizers, 
Training Facilities, Laboratories, anti-doping organizations, equine 
regulatory bodies, or other relevant regulatory or disciplinary 
authorities in obtaining, developing, or sharing information and 
intelligence that may be useful for the implementation or enforcement 
of the Protocol or the Act or for any legitimate legal, law 
enforcement, regulatory, anti-doping, medication control, integrity, 
disciplinary, horse welfare, or safety purposes (e.g., the Agency may 
share information with other entities investigating the possible 
commission of a crime, regulatory offense, or breach of other rules of 
conduct; in particular, for example, the Agency may share the results 
of Sample analyses with the Authority for purposes of enforcing the 
Racetrack Safety Program).
5630. Assessment and Analysis of Intelligence
    (a) The Agency should ensure that it is able to assess all anti-
doping and medication control intelligence upon receipt for relevance, 
reliability, and accuracy, taking into account the nature of the source 
and the circumstances in which the intelligence has been captured or 
received.
    (b) All relevant anti-doping and medication control intelligence 
obtained or received by the Agency should be collated and analyzed to 
establish patterns, trends, and relationships that may assist the 
Agency in developing an effective anti-doping and medication control 
strategy and in determining (where the intelligence relates to a 
particular case) whether there is reasonable suspicion that an Anti-
Doping Rule Violation or Controlled Medication Rule Violation may have 
been committed, such that further investigation is warranted.
5640. Intelligence Outcomes
    Anti-doping and medication control intelligence may be used for the 
following purposes (without limitation):
    (a) developing, reviewing, and revising test distribution planning;
    (b) determining when to conduct Target Testing; or
    (c) creating targeted intelligence files to be referred for 
investigation.

5700. Standards for Investigations

5710. Purpose
    (a) The objective of this Rule is to establish standards for the 
efficient and effective conduct of investigations under the Protocol, 
including, but not limited to:
    (1) the investigation of Sample abnormalities reported by 
Laboratories;
    (2) the investigation of any other analytical or non-analytical 
information or intelligence where there is reasonable suspicion to 
suspect that an Anti-Doping Rule Violation or Controlled Medication 
Rule Violation may have been committed;
    (3) the investigation of the circumstances surrounding or arising 
from an Adverse Analytical Finding to gain further intelligence 
concerning the Responsible Person or other Covered Persons associated 
with the Covered Horse whose Sample is the subject of the Adverse 
Analytical Finding, including to determine if any other methods are 
involved in doping or medication abuse; and
    (4) where a Covered Person is alleged to have committed an Anti-
Doping Rule Violation or Controlled Medication Rule Violation, the 
investigation into whether

[[Page 5170]]

any other Covered Persons were complicit or otherwise involved in that 
violation.
    (b) In each case, the purpose of the investigation is to achieve 
one of the following:
    (1) to rule out a possible violation or involvement in an Anti-
Doping Rule Violation or Controlled Medication Rule Violation;
    (2) to develop evidence that supports an Anti-Doping Rule Violation 
or Controlled Medication Rule Violation proceeding or the initiation of 
such a proceeding in accordance with the Protocol; or
    (3) to provide evidence of a violation of any other provisions of 
the Protocol or related Rule Series, or applicable law or regulation.
5720. Investigating Possible Violations
    (a) The Agency shall conduct, direct, and manage all investigations 
under the Protocol, unless it specifically delegates an investigation 
(or aspects of an investigation) to a State Racing Commission (subject 
to the applicable State Racing Commission electing to enter into an 
agreement with the Agency).
    (b) The Agency and any State Racing Commission to which the Agency 
delegates investigatory tasks shall ensure that investigations are 
conducted confidentially.
    (c) The Agency will seek to investigate any analytical or non-
analytical information or intelligence that indicates that there is 
reasonable suspicion that an Anti-Doping Rule Violation or Controlled 
Medication Rule Violation may have been committed or that further 
inquiry might lead to the discovery of admissible evidence of such 
violation.
    (d) The Agency should gather and record all relevant information 
and documentation as soon as possible.
    (e) The Agency shall ensure that investigations are conducted 
fairly, objectively, and impartially at all times. The conduct of 
investigations, the evaluation of information and evidence identified 
in the course of that investigation, and the outcome of the 
investigation, should be fully documented.
    (f) Covered Persons are required under the Protocol to cooperate 
with investigations conducted by the Agency (or a State Racing 
Commission, if the investigation is delegated by the Agency). If they 
fail to do so, the Agency may bring proceedings against them for 
failure to cooperate (in accordance with Rule 3510(b)). If their 
conduct amounts to subversion of the investigative process (e.g., by 
providing false, misleading, or incomplete information, or by 
destroying potential evidence), the Agency may also bring proceedings 
against them for the Anti-Doping Rule Violation of Tampering or 
Attempted Tampering.
    (g) It shall not be a defense in a proceeding involving an Anti-
Doping Rule Violation or Controlled Medication Rule Violation that an 
investigation should have been conducted more quickly or that any 
aspect of the Testing and Investigations Standards was not followed by 
the Agency or State Racing Commission, except as provided in Rule 3122.
5730. Obtaining Investigative Information
    (a) General. The Agency should make use of all investigative 
resources reasonably available to it to conduct its investigation. 
These resources may include: obtaining information and assistance from 
other entities pursuant to Rule 5620(d); investigative powers conferred 
under applicable rules (including inspection, examination, and seizure, 
production of documents, subpoenas, and interviews); and the power to 
suspend a period of Ineligibility imposed on a Covered Person in return 
for Substantial Assistance in accordance with the Protocol. Without 
limitation, the Agency may utilize the investigative tools set forth in 
paragraphs (b) through (f) of this Rule in relation to investigations 
and inquiries of possible violations of the Protocol.
    (b) Inspection, examination, and seizure.
    (1) The Agency shall have access to the books, records, offices, 
racetrack facilities, and other places of business of Covered Persons 
that are used in the care, treatment, training, or racing of Covered 
Horses.
    (2) The Agency may seize any medication, drug, substance, or 
paraphernalia in violation or suspected violation of any provision of 
the Act or any rules approved by the Commission pursuant to the Act, 
and any object or device reasonably believed to have been used in 
furtherance of the violation or suspected violation.
    (c) Return of seized property. Upon final resolution of a 
violation, the Agency shall return seized property, including, but not 
limited to, phones, computers and other repositories of electronic 
data, the possession of which is not specifically prohibited by the Act 
or the rules of the Authority.
    (d) Production of documents and information.
    (1) The Agency may require a Covered Person to provide any 
information, documents, or records in such form as the Agency may 
require, which are held by the Covered Person or are within his or her 
power to obtain, and that are used in the care, treatment, training, or 
racing of Covered Horses.
    (2) The Agency may require production of any mobile phones, 
computers, tablets, other electronic devices, books, documents and 
records (including telephone or financial records whether currently in 
the direct possession of a Covered Person or a third person who may be 
directed by the Covered Person to provide the information) that may be 
relevant to any investigation, inquiry, hearing, or proceeding, and 
that are used in the care, treatment, training, or racing of Covered 
Horses.
    (e) Subpoenas. The Agency may request that the Authority issue a 
subpoena to a Person to appear or to answer questions or produce 
evidence related to anti-doping and medication control matters. A 
subpoena may direct the witness to: appear at a specific time and place 
to testify; produce designated evidence by a specific time; or permit 
the Agency to inspect premises at a specific time. A subpoena must be 
issued under the signature of a designated person from the Authority. 
If the Covered Person fails to comply with a subpoena, the Agency or 
Authority may seek enforcement of the subpoena in any of the district 
courts of the United States within the jurisdiction of which such 
inquiry is being conducted. Additionally, the arbitrator(s), IAP 
member(s), administrative law judge, or Commission considering a case 
arising under the Protocol may draw an adverse inference against a 
Covered Person who fails to comply with a valid subpoena, regardless of 
whether a court has been required to enforce the subpoena or has found 
the Covered Person in contempt.
    (1) This issuance of a subpoena and compliance therewith is 
independent of the Agency's powers to inspect and obtain evidence 
without a subpoena and a Covered Persons' duty to cooperate under the 
Protocol. In addition to a rule violation for refusal to cooperate, a 
refusal to cooperate can result in imposition of an adverse inference 
against a Covered Person by the arbitrator(s), IAP member(s), 
administrative law judge, or Commission.
    (2) The following considerations should be taken into account by 
the Agency in determining whether a subpoena should be requested to be 
issued by the Authority:
    (i) the availability of, and success in, using alternative methods 
for obtaining the information in a timely manner;

[[Page 5171]]

    (ii) the indispensability of the information to the success of the 
investigation or establishing a violation; and
    (iii) the need to protect against the destruction of records or 
information that may be necessary to investigate and prosecute 
violations of the Protocol.
    (f) Interviews.
    (1) Covered Persons shall comply with a request to be interviewed 
by the Agency.
    (2) If the Agency requires a Covered Person to submit to an 
interview under oath, the Covered Person may request a delay of the 
interview to seek legal advice. However, such delay shall only 
encompass the time reasonably necessary to contact and retain legal 
counsel and shall in no case exceed 7 days, unless agreed otherwise by 
the Agency.
    (3) An authorized Person may administer an oath or affirmation to a 
Covered Person appearing for an interview under oath.
    (4) The only basis for refusing to answer a question in an 
interview is an assertion of the attorney-client privilege or the Fifth 
Amendment privilege against self-incrimination.
5740. Investigation Outcomes
    (a) The Agency shall determine without undue delay whether 
proceedings should be initiated against a Covered Person for an Anti-
Doping Rule Violation or Controlled Medication Rule Violation.
    (b) If the Agency concludes based on the results of its 
investigation that proceedings should be initiated against a Covered 
Person independently or in relation to a Covered Horse, asserting 
commission of an Anti-Doping Rule Violation or Controlled Medication 
Rule Violation, it shall give notice of that decision in the manner set 
out in the Protocol.
    (c) If the Agency concludes, based on the results of its 
investigation, that proceedings asserting commission of an Anti-Doping 
Rule Violation or Controlled Medication Rule Violation should not be 
initiated against a Covered Person independently or in relation to a 
Covered Horse, the Agency shall consider whether any of the 
intelligence obtained or lessons learned during the investigation 
should be used for test distribution planning, Target Testing, or 
whether it should be shared with any other Person or included in any 
report in accordance with these Testing and Investigations Standards.
    (d) The Agency may include information from its investigations in 
reports made to the Authority, Congress, State Racing Commissions, or 
other appropriate bodies, regardless of whether the information relates 
to one or more rule violations. The fact that information was included 
in such a report shall not be a defense in any proceeding involving a 
potential rule violation.

6000. Equine Standards for Laboratories and Accreditation

Rule 6010. Equine Standards for Laboratories and Accreditation
    (a) The main purpose of these Laboratory Standards is to ensure 
that Laboratories report valid test results based on reliable 
evidentiary data and to facilitate harmonization in Analytical Testing 
of Samples by Laboratories.
    (b) The Laboratory Standards set out the requirements to be 
followed by Laboratories that wish to demonstrate that they are 
technically competent, operate within an effective Management System, 
and can produce forensically valid results. The Laboratory Standards 
include, inter alia, requirements for obtaining and maintaining HISA 
Equine Analytical Laboratory (HEAL) accreditation, operating standards 
for the performance of Laboratories, and a description of the 
accreditation and approval processes. The Laboratory Standards also set 
out requirements and guidance in relation to Sample custody and 
storage, Analytical Testing, and some aspects of Results Management.
    (c) Compliance with the Laboratory Standards in effect at the time 
of Sample analysis (as opposed to another alternative standard, 
practice, or procedure) shall be sufficient to conclude that the 
procedures covered by the Laboratory Standards were performed properly. 
A failure by a Laboratory to follow a requirement in effect at the time 
of Analytical Testing, which has subsequently been eliminated from 
these Laboratory Standards or applicable Technical Document(s) or 
Technical Letter(s) at the time of a hearing, shall not serve as a 
defense to an Anti-Doping Rule Violation.
    (d) Otherwise undefined capitalized terms used in these Laboratory 
Standards have the meanings given to them in Rule 1020.
Rule 6020. Technical Documents
    (a) Technical Documents may be drafted by the Laboratory Expert 
Group or Agency and circulated for stakeholder consultation before 
being finalized. Technical Documents will be approved by the Agency, 
and Authority (where appropriate), and published on the Agency website. 
Once approved, a relevant Technical Document becomes an integral part 
of the Laboratory Standards and supersedes any previous publication on 
a similar topic, including Technical Letter(s) or the Laboratory 
Standards.
    (b) Implementation of the requirements detailed in a Technical 
Document may occur prior to the effective date for implementation 
specified in the Technical Document in accordance with this Rule 6020 
and shall occur no later than the effective date.
    (c) A failure by a Laboratory to implement a Technical Document or 
Technical Letter by the effective date may result in the imposition of 
an Analytical Testing Restriction against the Laboratory for that 
Analytical Testing Procedure, or remediation requirements. In 
exceptional circumstances, a suspension of the Laboratory's HEAL 
accreditation may be warranted, as determined by the Agency.
    (d) If a Laboratory is not able to implement a new Technical 
Document by its effective date, it shall inform the Agency as soon as 
possible. The Laboratory shall send a written request to the Agency for 
an extension beyond the applicable effective date, providing the 
reason(s) for the delayed implementation of the Technical Document, any 
measures taken to ensure that Samples received in the Laboratory will 
be subject to Analytical Testing in compliance with the new Technical 
Document (for example, by subcontracting the analysis to another 
Laboratory as applicable), as well as plans for the implementation of 
the new Technical Document.
    (e) The implementation of the Technical Documents' requirements 
into the Laboratory's Management System is mandatory for obtaining and 
maintaining HEAL accreditation or approval, respectively, and for the 
application of the relevant Analytical Testing Procedure(s) to the 
analysis of Samples.
    (f) In cases when a newly approved version of a Technical Document 
lowers a Threshold for a Threshold Substance, a Minimum Reporting Level 
for a Non-Threshold Substance, or any other limit, as applicable, the 
revised limits specified in the new Technical Document shall not be 
applied to the reporting of analytical results for Samples collected 
before the effective date of the Technical Document.
    (g) Where the above revised limit specification does not apply, 
Laboratories may implement a Technical Document as soon as it is 
approved by the Agency, and Authority (where appropriate), provided 
that the

[[Page 5172]]

requirements of the Technical Document have been implemented and 
documented appropriately by the Laboratory.
    (h) The most recently approved Technical Document shall be applied 
to the Analytical Testing of Samples prior to the effective date if it 
would lead to a result that benefits the Covered Person and Covered 
Horse (e.g., increase of the Threshold for a Threshold Substance or of 
the Minimum Reporting Level for a Non-Threshold Substance, or any other 
limit, establishment of more stringent identification criteria for 
chromatographic-mass spectrometric or other Confirmation Procedures). 
Therefore, in the case where an analytical finding does not meet the 
reporting criteria defined in the new Technical Document, it shall be 
reported as a Negative Finding.
Rule 6030. Technical Letters
    (a) Technical Letters may be issued in letter format on an ad-hoc 
basis to provide direction to the Laboratories on particular issues on 
the analysis, interpretation and reporting of results for specific 
Prohibited Substance(s) or Prohibited Method(s) or on the application 
of specific Laboratory procedures. Technical Letters are modified or 
withdrawn by the Agency, as appropriate.
    (b) Technical Letters will be drafted and approved by the Agency, 
and Authority (where appropriate), in consultation with relevant 
scientific experts, and published on the Agency's website. Technical 
Letters become effective immediately, unless otherwise specified by the 
Agency. Technical Letters may require actions (e.g., validation of new 
Analytes or modifications to Analytical Testing Procedures, the 
procurement of Reference Material(s) or Reference Collection(s)), which 
may justify that its application cannot be immediate. In such cases, 
the Agency shall make a time provision for implementation and specify 
an effective date for the Technical Letter.
    (c) Once approved, a relevant Technical Letter becomes an integral 
part of the Laboratory Standards and supersedes any previous 
publication on a similar topic, including Technical Document(s) or the 
Laboratory Standards.
    (d) The implementation of the requirements of relevant Technical 
Letters into the Laboratory's Management System is mandatory for 
obtaining and maintaining HEAL accreditation or approval, respectively, 
and for the application of the relevant Analytical Testing Procedure(s) 
to the analysis of Samples.
Rule 6040. Laboratory Guidelines
    (a) Laboratory Guidelines may be issued to provide direction to the 
Laboratories on new Analytical Methods or procedures approved by the 
Agency. Laboratory Guidelines will be modified or deleted by the 
Agency, as appropriate.
    (b) Laboratory Guidelines will be approved by the Laboratory Expert 
Group (LabEG). Laboratory Guidelines are provided to Laboratories only 
and are not published on the Agency website.
    (c) Implementation of Laboratory Guidelines is not mandatory. 
However, Laboratories are encouraged to follow, to the fullest extent 
possible, the recommendations of best practice included in relevant 
Laboratory Guidelines.
Rule 6050. Technical Notes
    (a) Technical Notes may be issued to Laboratories to provide 
detailed technical guidance on the performance of specific Analytical 
Methods or procedures.
    (b) Technical Notes will be approved by the LabEG. Technical Notes 
are provided to Laboratories only and are not published on the Agency 
website.
    (c) Implementation of the recommendations detailed in Technical 
Notes is not mandatory. However, Laboratories are encouraged to follow, 
to the fullest extent possible, the technical guidance included in 
Technical Notes.
Rule 6060. Sample Analysis
    (a) Sample analysis is part of the Analytical Testing process and 
involves the detection, identification, and, in some cases, 
demonstration of the presence above a Threshold of Prohibited 
Substance(s) or their Metabolite(s), or Marker(s) of Use of Prohibited 
Substances or Prohibited Methods in an equine Sample.
    (b) Laboratories may accept samples for other forms of analysis, 
subject to the provisions of the Code of Ethics, which are not under 
the scope of HEAL accreditation. Any such analysis shall not be covered 
by the Laboratory's HEAL accreditation and, therefore, shall not be 
subject to the requirements of the Laboratory Standards, Technical 
Documents, or Technical Letters. Test reports or other documentation or 
correspondence from Laboratories shall not declare or represent that 
any such analysis is covered under their HEAL accreditation status.
Rule 6070. Racing Medication and Testing Consortium Accredited 
Laboratories
    (a) These Laboratory Standards will replace current Racing 
Medication and Testing Consortium (RMTC) accreditation, although a 
transition phase which may include RMTC conducting the accreditation 
program may be agreed between the Agency and RMTC.
    (b) Where a laboratory has current RMTC accreditation, any 
information required as part of the HEAL application process that has 
already been provided as part of its RMTC accreditation, and that the 
laboratory checks to confirm it is still current and valid may, with 
the agreement of the parties, be provided to the Agency.

6100. Laboratory Accreditation and Operating Standards

Rule 6110. Process and Requirements for HEAL Laboratory Accreditation
    (a) Applicant laboratory for HEAL accreditation. Only a laboratory 
that satisfies the criteria in this Rule 6110 may apply to become a 
candidate laboratory for HEAL accreditation.
    (1) The applicant laboratory shall submit a completed application 
form, provided by the Agency, duly signed by the laboratory Director 
(or equivalent position) and, if relevant, by the Director (or 
equivalent position) of the host organization (e.g., university or 
public institution).
    (2) Provision of business plan. The Agency shall request the 
applicant laboratory to submit a business plan summary, which shall 
include market considerations (clients, number of Samples, maintenance 
costs, etc.), facility, instrumental, staffing and training needs, and 
shall make a reasonable guarantee of the long-term provision of 
adequate financial and human resources to the laboratory.
    (b) Candidate laboratory for HEAL accreditation. The application 
shall be evaluated by the Agency to determine whether the applicant 
laboratory will be granted candidate laboratory status by the Agency 
and thereby continue within the HEAL accreditation process. Additional 
supporting documentation may be requested by, and at the discretion of, 
the Agency.
    (1) Description of the candidate laboratory. Once approved by the 
Agency, the candidate laboratory shall complete a detailed 
questionnaire and submit it to the Agency. The questionnaire will 
include, but is not limited to, the following:
    (i) Staff list and their qualifications, including description of 
any relevant

[[Page 5173]]

anti-doping experience and a list of relevant scientific publications 
by laboratory staff;
    (ii) Relevant memberships and engagement with professional 
societies, such as the Association of Official Racing Chemists (AORC), 
World Association of Anti-Doping Scientists (WAADS), Society of 
Forensic Toxicologists (SOFT), and The International Association of 
Forensic Toxicologists (TIAFT);
    (iii) Description of the physical laboratory facilities, including 
a description of the security considerations for Samples and records. 
The laboratory facilities shall include ample analytical and 
administrative space to allow separate, restricted and dedicated areas 
for analytical and administrative operations;
    (A) Physical security. Specific measures to maintain secure and 
restricted access to the laboratory facility and a controlled internal 
laboratory environment (e.g., dedicated and restricted Sample storage 
areas, CCTV monitoring);
    (B) IT security. Implementation of firewalls and other cyber 
security measures consistent with best practice and any applicable 
governmental regulations;
    (C) Information Technology (IT) infrastructure. Implementation of a 
data and information management system (e.g., LIMS) and a central 
server/intranet which allows secure data handling.
    (iv) List of actual and proposed instrumental resources and 
equipment, including year of purchase and conditions for technical 
support (e.g., contract/access to instrument manufacturer maintenance 
services);
    (v) List of validated Initial Testing Procedures and Confirmation 
Procedures, including target Analytes and Limits of Detection (LODs), 
Limits of Identification (LOIs) and, where applicable, Limits of 
Quantification (LOQs) and estimates of Measurement Uncertainty (MU);
    (vi) Status of method development and validation, including, at 
minimum, all mandatory Analytical Methods and method validation reports 
(if completed and currently in use);
    (vii) List of available Reference Materials and Reference 
Collections, or plans to acquire Reference Materials or obtain 
Reference Collections;
    (viii) Plans to ensure compliance with laboratory independence and 
impartiality requirements before receiving HEAL accreditation (and if 
this requirement is covered by other accreditation, such as ISO/IEC 
17025, the laboratory may refer to it);
    (ix) Status and scope of ISO/IEC 17025 accreditation; and
    (x) A description of how the principles of the Code of Ethics is 
integrated into the laboratory Management System. A letter of 
compliance with the Code of Ethics signed by the laboratory Director 
shall be provided.
    (xi) The Agency may require an update of this documentation during 
the process of accreditation.
    (2) Payment of initial accreditation fee. Prior to entering the 
probationary period, the candidate laboratory shall pay the Agency a 
one-time non-refundable fee to cover the costs related to the initial 
accreditation process. This fee shall be determined by the Agency and 
disclosed to the laboratory prior to the accreditation process 
commencing. The accreditation process will not commence until the fee 
is agreed upon.
    (3) Compliance with the Code of Ethics. The candidate laboratory 
shall implement and comply with the provision(s) of the Code of Ethics. 
Candidate laboratories shall not accept Samples directly from 
individual Covered Persons or from individuals or organizations acting 
on his or her behalf (unless approved in writing and in advance by the 
Agency and on the condition that Samples will be treated as a Sample 
under the Protocol, and proceedings may be brought against the relevant 
Covered Person(s) if evidence of an Anti-Doping Rule Violation or a 
Controlled Medication Rule Violation emerges).
    (4) Pre-probationary testing and on-site assessment. If this is 
covered by another accreditation, such as ISO/IEC 17025, the laboratory 
may refer to this paragraph (4).
    (i) Prior to entering the probationary accredited period, the 
Agency shall conduct a pre-probationary testing (PPT) and on-site 
assessment of the candidate laboratory at the candidate laboratory's 
expense. The purpose of this assessment is to obtain information about 
different aspects of the laboratory's competence and to clarify any 
issues regarding the accreditation process, which are relevant for the 
HEAL accreditation.
    (ii) As part of the PPT, the candidate laboratory shall be required 
to analyze at least 10 blind EQAS samples arranged by the Agency. The 
general composition and content of the blind EQAS samples and the 
evaluation of laboratory EQAS results are described in the Rule 6200 
and 6400 Series, respectively.
    (iii) The candidate laboratory shall report the results for the PPT 
blind EQAS samples to, and in a form designated by, the Agency (in 
compliance with paragraph (e) of Rule 6260) within 6 weeks, unless 
otherwise requested by the candidate laboratory and agreed to by the 
Agency.
    (A) Upon request, the candidate laboratory shall provide the Agency 
with a Laboratory Documentation Package for selected EQAS samples for 
which there is an Adverse Analytical Finding. Additional data may be 
required upon the Agency's request. This documentation shall be 
submitted within 10 days of the request or as otherwise indicated by 
the Agency.
    (B) For selected EQAS samples with Negative Findings, the Agency 
may request all, or a portion of, the Initial Testing Procedure data.
    (iv) After receiving the PPT EQAS results, the Agency shall inform 
the candidate laboratory of the evaluation of its performance and 
provide guidance for improvement. Corrective actions, if any, shall be 
conducted and reported by the candidate laboratory to the Agency within 
30 days, or as otherwise indicated by the Agency.
    (v) In addition, the Agency shall provide an assessment report 
regarding the outcomes of the on-site assessment, including any 
identified nonconformities, to allow the candidate laboratory to 
implement the necessary improvements. Corrective actions, if requested, 
shall be conducted, and reported by the candidate laboratory to the 
Agency within 30 days, or as otherwise indicated by the Agency.
    (vi) The nonconformities identified in the Agency assessment report 
shall be satisfactorily addressed and the recommendations for 
improvement shall be implemented before the candidate laboratory can be 
accepted as an Agency probationary laboratory. The candidate 
laboratory's performance in the PPT and on-site assessment will be 
considered in the overall review of the candidate laboratory's 
application and may affect the timeliness of the candidate laboratory's 
entry into the probationary phase of accreditation.
    (5) ISO/IEC 17025 accreditation.
    (i) ISO/IEC 17025 accreditation is a critical and mandatory 
precondition for HEAL accreditation.
    (ii) The Agency will consider a candidate laboratory application 
for HEAL accreditation only if the laboratory has obtained (or is in 
the process of obtaining) ISO/IEC 17025 accreditation. ISO/IEC 17025 
accreditation must be conferred prior to an applicant receiving full 
HEAL accreditation.
    (iii) The accreditation body, which may be specified by the Agency, 
shall be an International Laboratory Accreditation Cooperation (ILAC) 
full member that is a signatory to the ILAC

[[Page 5174]]

Mutual Recognition Arrangement (ILAC MRA) for testing activities as 
defined in ISO/IEC 17025.
    (iv) The candidate laboratory shall (in a timely manner) send to 
the Agency a summary of the assessment report and any corrective or 
preventive action documentation addressing nonconformities.
    (6) Analytical Testing Procedures. Before the Agency grants 
accreditation, candidate laboratories shall provide documentation to 
the Agency demonstrating that all mandatory Test Methods have been 
validated and included in the Laboratory's scope of ISO/IEC 17025 
accreditation.
    (7) Laboratory independence and impartiality. Before the Agency 
grants accreditation, probationary laboratories shall provide 
documentation to the Agency demonstrating compliance with the 
requirements of Laboratory independence and impartiality established in 
paragraph (c) of Rule 6130.
    (8) Professional liability insurance coverage. Before the Agency 
grants accreditation, probationary laboratories shall provide 
documentation to the Agency demonstrating that they have adequate 
provisions for self-insuring, or professional liability risk insurance 
coverage has been obtained to cover liability of no less than 
$5,000,000 annually.
Rule 6120. The Agency Accredited Laboratory; Obtaining HEAL 
Accreditation
    (a) The Agency probationary HEAL accreditation.
    (1) Upon satisfactory completion of the candidate laboratory 
requirements (as per Rule 6110), as determined by the LabEG, a 
candidate laboratory can be considered for entry to the probationary 
phase of HEAL accreditation as an Agency probationary laboratory. Once 
the Agency has determined that the laboratory has successfully 
completed the requirements of a candidate laboratory, the Agency can 
grant the laboratory probationary accreditation status.
    (2) A probationary laboratory must comply with the requirements of 
accredited laboratories, including the requirements for maintaining 
accreditation.
    (3) The probationary period is 2 years or following the analysis of 
2,500 Samples, whichever comes later. In circumstances where the 
laboratory was previously accredited by the RMTC, the Agency may 
exercise its discretion to reduce or eliminate the probationary period.
    (b) The Agency pre-final accreditation.
    (1) Once the Agency has determined that the laboratory has 
successfully completed the requirements of the probationary period, the 
laboratory can be granted final accreditation status. At the Agency's 
discretion, as part of the final accreditation process, a Final 
Accreditation Test (FAT) or on-site assessment may be conducted by the 
Agency. Costs associated with the Agency on-site assessment and FAT 
shall be disclosed and agreed to with the probationary laboratory.
    (2) As part of the FAT, the probationary laboratory shall analyze a 
minimum of 15 blind EQAS samples selected from the routine EQAS 
program. The general composition and content of the blind EQAS samples 
and the evaluation of laboratory EQAS results are described in Rules 
6200 and 6400, respectively.
    (3) Compliance with the scope of ISO/IEC 17025 accreditation, the 
Laboratory Standards, and other procedures required by the Agency 
(e.g., Technical Documents, Technical Letters) will be assessed. The 
FAT shall assess both the scientific competence and the capability of 
the probationary laboratory to manage multiple Samples.
    (4) The probationary laboratory shall successfully report the 
results for the blind EQAS samples in the FAT to the Agency in 
accordance with paragraph (e) of Rule 6260 within 6 weeks of receipt 
the samples, unless otherwise specified by the Agency or otherwise 
requested by the laboratory and agreed to by the Agency.
    (5) Upon request, the probationary laboratory shall provide the 
Agency with a Laboratory Documentation Package for selected EQAS 
samples for which there is an Adverse Analytical Finding. Additional 
data may be required upon the Agency's request. This documentation 
shall be submitted within 10 days of the Agency request, or as 
otherwise indicated by the Agency.
    (6) For EQAS samples with Negative Findings, the Agency may request 
all or a portion of the Initial Testing Procedure data.
    (7) After receiving the FAT EQAS results, the Agency shall inform 
the probationary laboratory of the evaluation of its performance. 
Corrective actions, if any, shall be conducted and reported by the 
probationary laboratory to the Agency within 30 days, or as otherwise 
indicated by the Agency.
    (8) The Agency shall provide an assessment report with the outcomes 
of the accreditation assessment, including any identified 
nonconformities, for the probationary laboratory to implement the 
necessary improvements. Corrective actions, if any, shall be conducted 
and reported by the probationary laboratory to the Agency within 30 
days, or as otherwise indicated by the Agency. The nonconformities 
identified in the FAT EQAS and the assessment report shall be 
satisfactorily addressed by the laboratory and the recommendations for 
improvement shall be implemented before accreditation will be granted.
    (c) The Agency recommendation for accreditation.
    (1) Based on the relevant documentation received from the 
probationary laboratory, the assessment report(s) from the Agency and 
from the relevant accreditation body, the Agency shall evaluate the 
probationary laboratory's progress in meeting all the requirements 
outlined in Rules 6110 and 6120.
    (2) Once, as determined by the Agency (in the Agency's sole 
discretion), all accreditation requirements have been satisfactorily 
met by the probationary laboratory, the Agency will grant accreditation 
to the laboratory.
    (3) However, if following the FAT and on-site assessment, and the 
review of any resulting Corrective Action Reports submitted by the 
probationary laboratory, the Agency determines that the probationary 
laboratory shall not be accredited, the laboratory will have a maximum 
of 6 additional months to correct and improve any pending 
nonconformities. The provision of documentation, the analysis of 
additional EQAS samples, or an additional assessment (on-site, 
remotely, or as a documentary audit, as determined by the Agency) may 
be required and, if so, will be conducted at the probationary 
laboratory's expense. A probationary laboratory that fails to provide 
satisfactory improvements after 6 months, as determined by the Agency, 
may be required to renew its candidacy as described in Rule 6110 or to 
restart the probationary phase of accreditation in accordance with 
paragraph (a) of this Rule 6120.
    (d) Issuing and publishing of HEAL accreditation certificate. An 
accreditation certificate signed by a duly authorized representative of 
the Agency shall be issued in recognition of the HEAL accreditation. It 
shall specify probationary or final accreditation status. Such 
accreditation certificate shall specify the name of the Laboratory and 
the period for which the accreditation certificate is valid. 
Accreditation certificates may be issued after the effective date, with 
retroactive effect. A list of HEAL accredited

[[Page 5175]]

laboratories, together with internationally approved laboratories, 
shall be published on the Agency's website.
Rule 6130. Maintaining HEAL Accreditation
    (a) Maintain ISO/IEC 17025 accreditation. The Laboratory shall 
maintain accreditation to ISO/IEC 17025, with primary reference to the 
analysis of Samples, granted by an accreditation body, which may be 
specified by the Agency, and which shall be an International Laboratory 
Accreditation Cooperation (ILAC) full member that is a signatory to the 
ILAC Mutual Recognition Arrangement (ILAC MRA) for testing activities 
as defined in ISO/IEC 17025. Flexible scope of accreditation must be 
included in the Laboratory's scope of accreditation.
    (b) Participation in the Agency EQAS program. Laboratories are 
required to participate in the Agency EQAS on a continuous basis and 
meet the performance requirements of the EQAS as described in the Rule 
6200 Series.
    (c) Laboratory independence and impartiality.
    (1) The Laboratory shall be administratively and operationally 
independent from any organization or person(s) that could exert undue 
pressure on the Laboratory and affect the impartial execution of its 
tasks and operations. Laboratories shall comply with these requirements 
of administrative and operational independence by the program effective 
date, unless otherwise approved by the Agency.
    (2) In order to be operationally independent, the Laboratory shall 
manage its own affairs without hindrance, interference, or direction 
from any Person, except in accordance with the Laboratory Standards. 
The Laboratory shall, without limitation, control: the allocation of 
its budget; the procurement of equipment and other resources; 
Laboratory personnel decisions; the research conducted by the 
Laboratory; and all Sample Analytical Testing and reporting of results. 
The Laboratory shall not accept money from any Covered Person.
    (3) The Laboratory shall have a dedicated budget allowing the 
implementation of an efficient approval process for the timely 
procurement of necessary Reference Materials, reagents, consumables and 
essential equipment, as well as independent Laboratory management 
decisions concerning the recruitment, retention and training of staff, 
participation in scientific meetings and symposia, and other relevant 
scientific decisions. This does not prevent the Laboratory from 
receiving research grants or other financial support from its host 
organization (e.g., university, public institution), anti-doping 
organizations, sport organizations, governments, or other sponsors, 
while following applicable accounting regulations in connection with 
the receipt and management of those funds.
    (d) Document compliance with the Code of Ethics.
    (1) The Laboratory shall comply with the provisions of the Code of 
Ethics.
    (2) The Laboratory shall annually provide to the Agency a letter of 
compliance with the provisions of the Code of Ethics, signed by the 
Laboratory Director. All staff employed at the Laboratory, permanent or 
temporary, shall also read, agree to, and sign documentation to 
indicate their agreement to the Code of Ethics. The Laboratory may be 
asked to provide documentation of compliance with the provisions of the 
Code of Ethics.
    (3) The Laboratory shall establish a system requiring Laboratory 
staff to report any alleged breaches of the Code of Ethics to the 
Laboratory Director, which the Laboratory Director shall promptly 
report to the Agency. However, if Laboratory staff suspect that the 
Laboratory Director may have breached the Code of Ethics, the 
Laboratory staff shall promptly report the alleged breaches of the Code 
of Ethics directly to the Agency. The Laboratory Director or the 
Agency, as applicable, shall immediately and thoroughly investigate any 
alleged breach of the Code of Ethics.
    (4) If the Laboratory's investigation determines that a breach of 
the Code of Ethics occurred, the Laboratory Director shall immediately 
inform the Agency of the results of the investigation and the 
disciplinary actions taken. The Agency may also impose penalties as a 
result of its own investigations. Penalties may range from a personal 
reprimand to the expulsion of the implicated Laboratory staff 
member(s), the reporting of the breach to the pertinent authorities 
(e.g., law enforcement), the suspension or revocation of the 
Laboratory's HEAL accreditation, or any other follow-up measures the 
Agency determines to be appropriate.
    (e) Document implemented research and development activities.
    (1) The Laboratory shall develop and maintain a plan for research 
and development in the field of anti-doping science. The research 
activities can either be conducted by the Laboratory alone or in 
cooperation with other Laboratories or other research organizations.
    (2) The Laboratory shall supply an annual progress report to the 
Agency documenting research and development results in the field of 
anti-doping science. The Laboratory shall also relate research and 
development plans for the following year.
    (3) The annual research summary will be evaluated and scored by the 
LabEG. The Laboratory must, except where otherwise agreed by the 
Agency, achieve the minimum requirement to meet accreditation research 
requirements in Rule 6620.
    (f) Document implemented sharing of knowledge.
    (1) The Laboratory shall demonstrate its willingness and ability to 
share knowledge with other Laboratories. The Laboratory shall 
disseminate the results of its research and development activities to 
other Laboratories. The Laboratory is encouraged to make at least one 
annual contribution to an anti-doping symposium or conference. 
Laboratories are encouraged to: participate in collaborative research 
projects with other Laboratories; exchange experience and protocols 
with other Laboratories; arrange for visits of specialists with other 
Laboratories; and provide training to other Laboratories and 
probationary laboratories in specific areas of Analytical Testing.
    (2) The Laboratory shall supply a report on sharing of knowledge 
with other Laboratories to the Agency, if requested. A description of 
sharing of knowledge is provided in the Code of Ethics.
    (g) Maintain professional liability insurance coverage. 
Laboratories shall provide documentation to the Agency including 
evidence that professional liability risk insurance coverage is 
maintained of no less than $5,000,000 annually (for example, evidence 
of timely payment of applicable fees and premiums).
    (h) Maintain minimum number of Samples.
    (1) To maintain proficiency in Analytical Testing, Laboratories are 
required to analyze a minimum of 2,500 Samples provided annually by the 
Agency. To determine the minimum number of Samples, each urine Sample 
and blood Sample analyzed by the Laboratory (excluding Samples 
submitted for TCO2 analysis only), regardless of whether they are 
collected as a ``paired'' Sample, shall count as an individual Sample. 
The Agency will monitor the number of Samples tested by the Laboratory. 
Except where the Agency fails to send the minimum annual number of 
Samples to the Laboratory, if the number of Samples falls below the 
minimum, the

[[Page 5176]]

Laboratory's HEAL accreditation may be suspended in accordance with 
Rule 6510.
    (2) It is recognized that specific circumstances may affect a 
Laboratory's ability to analyze the minimum Samples annually, such as 
when the Laboratory is not operational for the full calendar year. In 
such cases, the Agency shall require that the Laboratory implement 
measures to maintain proficiency in Analytical Testing, for example, by 
strengthening its internal Quality Assurance Scheme (iQAS) and internal 
audits program. The Agency may also provide additional EQAS samples, 
conduct a documentary audit, or an on-site or remote (online) 
assessment, at its discretion, to assess the status of the Laboratory's 
operations.
    (i) Laboratory Analytical Testing Procedures and services. 
Laboratories shall provide to the Agency an up-to-date list of 
Analytical Testing Procedures and services, to assist the Agency in 
developing test distribution plans. Upon request, Laboratories shall 
cooperate with the Agency by providing other relevant information 
regarding Testing plans (e.g., Laboratory analytical capabilities).
    (j) Participating in the Agency/accreditation body re-assessments 
and continuous assessments during the accreditation cycle.
    (1) The assessment team shall include at least one Laboratory 
Standards-trained assessor selected by the accreditation body for the 
assessment/re-assessment.
    (2) The Laboratory shall (in a timely manner) send to the Agency a 
summary of the assessment report and any corrective or preventive 
action documentation addressing nonconformities.
    (3) The Laboratory shall provide the Agency with an updated copy of 
the ISO/IEC 17025 certificate and scope of ISO/IEC 17025 accreditation 
as soon as it is obtained from the accreditation body.
    (4) The Agency Laboratory assessment. The Agency reserves the right 
to conduct documentary audits, as well as inspect and assess the 
Laboratory, through on-site or remote (online) assessments at any time, 
at the Agency's expense. The notice of the Agency assessment will be 
made in writing to the Laboratory Director. In exceptional 
circumstances, and at the Agency's discretion, the assessment may be 
unannounced.
    (5) As part of an announced or unannounced Laboratory assessment, 
the Agency retains the right to request copies of Laboratory 
documentation or request Further Analysis of selected A or B Samples, 
either on-site or in any Laboratory selected by the Agency.
Rule 6140. The Agency Monitoring of Accreditation Status
    (a) The Agency shall regularly review the compliance of 
Laboratories with the requirements listed in the Laboratory Standards 
and related Technical Documents and Technical Letters. In addition, the 
Agency shall also conduct an annual review of EQAS results and of 
relevant routine Analytical Testing issues to assess the overall 
performance of each Laboratory and to decide its accreditation status.
    (b) Maintenance of HEAL accreditation. Compliance with all the 
requirements established in Rule 6130, including satisfactory 
performance by a Laboratory in the EQAS and in routine Analytical 
Testing, as determined by the Agency, is a critical requirement for the 
maintenance of the Laboratory's HEAL accreditation.
    (c) Issuing and publication of accreditation certificate. On an 
annual basis, when maintenance of accreditation is approved by the 
Agency, the Laboratory shall receive a HEAL accreditation certificate, 
signed by a duly authorized representative of the Agency, which is 
issued in recognition of such accreditation. The accreditation 
certificate shall specify the name of the Laboratory and the period for 
which the accreditation certificate is valid. HEAL accreditation 
certificates may be issued after the effective date, with retroactive 
effect. The list of the HEAL-accredited Laboratories is maintained on 
the Agency's website.

6200. The Agency External Quality Assessment Scheme

Rule 6210. The Agency External Quality Assessment Scheme
    The Agency regularly distributes External Quality Assessment Scheme 
(EQAS) samples to Laboratories and, when applicable, to probationary 
laboratories. The Agency EQAS is designed to continually monitor the 
capabilities of the Laboratories and probationary laboratories, to 
evaluate their proficiency, and to improve test result uniformity 
between Laboratories. EQAS samples are used to assess Laboratory 
routine analytical capacity and performance, reporting turn-around 
times, and overall compliance with the Agency Laboratory standards 
(e.g., Laboratory Standards, Technical Documents and Technical 
Letters), as well as other, non-analytical performance criteria. At the 
same time, the EQAS also represents, via its educational components, a 
source of continuous improvement for the effectiveness of the 
Analytical Testing Procedures.
Rule 6220. Types of EQAS
    (a) Blind EQAS. The Laboratory will be aware that the sample is an 
EQAS sample since it is delivered by the Agency's EQAS sample provider. 
However, the Laboratory will not know the content of the sample.
    (b) Double-blind EQAS. The Laboratory will not be aware that the 
sample is an EQAS sample since it is delivered by the Agency and is 
indistinguishable from routine Samples.
    (c) Educational EQAS.
    (1) Educational EQAS samples may be provided as open (in which case 
the content of the EQAS sample is known), blind or double-blind 
samples. This approach is used for educational purposes or for data 
gathering.
    (2) As part of the educational EQAS, the Agency may provide 
Laboratories with new Reference Materials, Reference Collections, or 
quality control (QC) samples for a prompt implementation of existing or 
new Analytical Testing Procedures.
    (3) The Agency may require the successful participation of 
Laboratories in an educational EQAS for the Agency-specific Analytical 
Testing Procedures for Laboratories to seek an extension of the 
Laboratory's scope of ISO/IEC 17025 accreditation by an accreditation 
body before the subsequent application of the Analytical Testing 
Procedure to the routine analysis of Samples.
Rule 6230. Number of EQAS Samples
    (a) The actual composition and number of EQAS samples supplied to 
different Laboratories may vary; however, within any calendar year, all 
Laboratories participating in the EQAS are expected to have analyzed 
the minimum total number of EQAS samples.
    (b) Each year, the EQAS program will consist of:
    (1) At least 15 blind EQAS samples, distributed by the Agency in 
multiple rounds;
    (2) At least 5 double-blind EQAS samples, distributed by the Agency 
in multiple rounds; and
    (3) At least 3 of the above EQAS samples will contain Threshold 
Substances.
    (c) As part of the Agency's Laboratory monitoring activities, and 
with the main purpose of assisting Laboratories in their continuous 
improvement of performance, the Agency may increase the number of 
annual EQAS samples (mainly for educational purposes) for

[[Page 5177]]

certain Laboratories, according, but not limited, to the following 
criteria:
    (1) Monitoring the effectiveness of corrective action 
implementation after questionable or unsatisfactory performance in the 
Agency EQAS or in routine Analytical Testing;
    (2) Substantiated intelligence information received by the Agency 
indicating questionable or unsatisfactory Laboratory performance;
    (3) Laboratories which do not receive enough Samples (<100 annual 
Samples) for a specific Analytical Testing Procedure, which is not part 
of the Laboratory's routine Analytical Testing menu; and
    (4) As part of the Agency's Laboratory assessments.
Rule 6240. Composition of EQAS Samples
    (a) EQAS samples may or may not contain Prohibited Substance(s) or 
Metabolite(s) of Prohibited Substance(s) or Marker(s) of Prohibited 
Substance(s) or Prohibited Method(s).
    (b) Blank EQAS samples. Blank EQAS samples do not contain 
Prohibited Substance(s) or Metabolite(s) of Prohibited Substance(s) or 
Marker(s) of Prohibited Substance(s) or Prohibited Method(s).
    (c) Adulterated EQAS samples. Adulterated EQAS samples are those 
which have been deliberately adulterated by the spiking of non-
characteristic Metabolite(s) or by the addition of extraneous 
substances designed to dilute or concentrate the sample, or to degrade 
or mask the Analyte prior to or during the analytical determination. 
Adulterated EQAS samples may also be obtained from the controlled 
administration or the addition of non-prohibited substances, which 
share common Metabolite(s) with Prohibited Substance(s).
    (d) EQAS samples containing Prohibited Substance(s), their 
Metabolite(s) or Marker(s), or the Marker(s) of Prohibited Method(s).
    (1) The concentration(s) of selected Analyte(s) are those that may 
be encountered in the urine or blood after Use of Prohibited 
Substance(s) or Prohibited Method(s). For some Analytes, the EQAS 
sample may contain the parent Prohibited Substance or its Metabolite(s) 
or its Marker(s).
    (2) EQAS samples may be spiked with Prohibited Substance(s) or 
their Metabolite(s) or Marker(s) but, where appropriate, may be 
prepared from controlled administration studies. The EQAS sample 
composition shall reflect as closely as possible the expected target 
Analyte Metabolite pattern and concentrations usually found in Samples.
    (3) An EQAS sample may contain more than one Prohibited Substance, 
Metabolite(s), or Marker(s) of a Prohibited Substance or Prohibited 
Method. It may also contain multiple Metabolites or Markers of a single 
Prohibited Substance or Markers of a Prohibited Method, which would 
represent the presence of a single Prohibited Substance or the Use of a 
single Prohibited Method.
    (4) Double-blind EQAS samples shall be representative of Samples. 
Therefore, to the extent possible (in consideration, for example, of 
technical or ethical constraints, availability of the pharmaceutical 
grade substance), double-blind EQAS samples containing Prohibited 
Substance(s) or Metabolite(s) of Prohibited Substance(s) or Marker(s) 
of Prohibited Substance(s) or Prohibited Method(s) shall be prepared 
from controlled administration studies performed in equine subjects. 
However, if this is not possible, then the double-blind EQAS sample(s) 
may be prepared by spiking expected target Analyte(s) in the Sample 
matrix in consideration of the representative metabolic profile(s).
    (5) For Non-Threshold Substances, the concentration in the EQAS 
sample will be guided by, but not limited to, one of the following 
criteria: concentrations of the Prohibited Substance or its 
Metabolite(s) or Marker(s) equal to or greater than (>=) the applicable 
MRPL; concentrations of the Prohibited Substance or its Metabolite(s) 
or Marker(s) between 50% of the MRPL and the MRPL (applicable only to 
Non-Threshold Substances prohibited at all times and with no Minimum 
Reporting Levels); Non-Threshold Substances with Minimum Reporting 
Levels or other limits controlling them (e.g., substances prohibited in 
a Post-Race Sample only), will normally be present in estimated 
concentrations greater than (>) 120% of the applicable Minimum 
Reporting Level; or concentrations of the Prohibited Substance or its 
Metabolite(s) or Marker(s) below (<) 50% of the applicable MRPL (for 
Non-Threshold Substances prohibited at all times with no Minimum 
Reporting Levels, for educational purposes).
    (6) For Threshold Substances, the concentration in the EQAS sample 
will be guided by, but not limited to, one of the following criteria: 
greater than (>) 10% of the Threshold as established in any relevant 
Technical Document(s) or Laboratory Guidelines; or less than (<) 50% of 
the Threshold for those Threshold Substances whose presence shall be 
reported if detected in the presence of diuretics or masking agents.
Rule 6250. Laboratory Analytical Testing Procedures Used in EQAS
    All procedures associated with the Analytical Testing of the EQAS 
samples by the Laboratory are to be conducted in a manner substantially 
similar to that applied to routine Samples, unless otherwise specified 
by the Agency. No effort shall be made to optimize instrument (e.g., 
change multipliers or chromatographic columns) or method performance 
prior to analyzing the EQAS samples, unless it is a scheduled 
maintenance activity. Only validated, Fit-for-Purpose Analytical 
Testing Procedures described in the Laboratory's Standard Operating 
Procedures are to be employed in the analysis of EQAS samples (i.e., 
using the Initial Testing Procedures and Confirmation Procedures 
applied in routine Analytical Testing).
Rule 6260. Reporting of EQAS Results
    (a) The purpose of the EQAS program is to ensure that all 
Laboratories maintain proficiency in the performance of their 
Analytical Testing Procedures and report valid results to the Agency in 
a timely manner.
    (b) In the spirit of the EQAS program, a Laboratory shall not 
communicate with other Laboratories regarding the identity or content 
of substances present in or absent from blind EQAS samples prior to the 
submission of EQAS results to the Agency. This prohibition also applies 
to Laboratory requests for second opinions, which shall not be 
requested for blind EQAS samples.
    (c) Contact between Laboratories regarding any aspect of blind EQAS 
analysis (including the results obtained) prior to reporting by all 
Laboratories to the Agency will be considered an attempt to circumvent 
the quality control assessment.
    (d) For double-blind EQAS samples, which are indistinguishable from 
routine Samples, consultation between Laboratories before reporting 
such EQAS results to the Agency may occur. However, such consultation 
shall not involve identifying the sample as an Agency double-blind EQAS 
sample (in cases when, for any reason, the Laboratory identifies the 
EQAS nature of the sample).
    (e) Reporting blind EQAS results.
    (1) The Laboratory shall report the results of blind EQAS samples 
to the Agency in the same manner as specified for routine Samples (see 
Rule 6316) unless otherwise notified by the Agency. For some blind EQAS 
samples or sample sets, additional information may be requested from 
the Laboratory (e.g., LODs, LOQs, MU estimations).

[[Page 5178]]

    (2) The results of the blind EQAS shall be submitted to the Agency 
on or before the specified reporting date, unless an extension is 
granted by the Agency. Failure to report results of blind EQAS samples 
will be considered a false Negative Finding(s).
    (f) Reporting double-blind EQAS results.
    (1) The Laboratory shall report the results of double-blind EQAS 
samples as per Rule 6316.
    (2) Reporting of double-blind EQAS results shall occur within the 
same timeframe as specified for routine Samples, unless an extension is 
granted by the Agency.
    (3) Failure to report double-blind EQAS results within this 
timeframe or, subject to an extension of this deadline granted by the 
Agency pursuant to subparagraph (2) above, within the agreed or the 
Agency-approved deadline, will be considered a false Negative 
Finding(s).
    (g) Reporting educational EQAS results.
    (1) The Laboratory shall report the results of open or blind 
educational EQAS samples on or before the specified reporting deadline 
and in a format specified by the Agency. Results received after the 
deadline will not be included in the assessment of EQAS results or in 
the subsequent educational EQAS report and will be considered a false 
Negative Finding(s).
    (2) For open educational and blind EQAS samples, the Laboratory 
shall report the LODs of the identified Non-Threshold Substance(s) or 
Metabolite(s) or Marker(s), or of the identified Marker(s) of 
Prohibited Method(s), as estimated during method validation of the 
Initial Testing Procedure.
    (h) Reporting results for EQAS samples containing Non-Threshold 
Substances. Unless otherwise specified by the Agency (for example, for 
an educational EQAS), the report of EQAS results for Non-Threshold 
Substances shall include all the Analytes whose presence in the EQAS 
sample has been confirmed by the Laboratory, including the Prohibited 
Substance(s) (e.g., parent compound(s), if applicable) and all 
identified Metabolite(s) or Marker(s) of the Prohibited Substances or 
Marker(s) of Prohibited Method(s). The Agency may also require that the 
Laboratory report the estimated concentrations of the confirmed 
Analyte(s).
    (i) Reporting results for EQAS samples containing Threshold 
Substances.
    (1) For educational and blind EQAS samples, the report of EQAS 
results for Threshold Substances shall include the values measured for 
each aliquot analyzed, whenever the measured mean value of all 
replicates is greater than or equal to (>=) 50% of the applicable 
Threshold.
    (2) For double-blind EQAS samples, the Laboratory shall report the 
quantitative results to, and in a form designated by, the Agency for 
routine Samples, in accordance with any relevant Technical Document(s), 
Technical Letter(s) or Laboratory Guidelines.

6300. Analysis of Samples

Rule 6301. Application of ISO/IEC 17025 to the Analysis of Samples
    (a) Introduction and scope. This section of the Laboratory 
Standards is intended as an extension of the application of ISO/IEC 
17025 and ILAC-G7 to the field of Doping Control. Any aspect of 
Analytical Testing or management not specifically discussed in this 
document or in any relevant Technical Documents, Technical Letters or 
Laboratory Guidelines shall be governed by ISO/IEC 17025. The 
application focuses on the specific parts of the processes that are 
critical with regard to the quality of the laboratory's performance as 
a Laboratory and are, therefore, significant in the evaluation and 
accreditation process.
    (b) This section introduces the specific performance standards for 
a Laboratory, as applicable. The conduct of Laboratory Analytical 
Testing is considered a process within the definitions of ISO 17000. 
Performance standards are defined according to a process model where 
the Laboratory practice is structured into 3 main categories of 
processes:
    (1) structural and resource requirements;
    (2) process requirements; and
    (3) management requirements.
Rule 6302. Subcontracting Analysis
    (a) A Laboratory may subcontract an analysis to another Laboratory, 
in consultation with, and following written approval from, the Agency. 
The conditions that justify subcontracting include, for example:
    (1) A specific technology or Analyte(s) that are not within the 
Laboratory's scope of ISO/IEC 17025 accreditation;
    (2) An Analytical Testing Restriction decision;
    (3) Other valid explanations, such as a need for higher sensitivity 
or specific equipment or expertise, temporary workload or technical 
incapacity;
    (4) In exceptional circumstances, the Agency may elect to grant 
specific authorization to subcontract analyses using specific methods 
to an ISO/IEC 17025-accredited laboratory approved by the Agency, which 
has the necessary technique within its scope of ISO/IEC 17025 
accreditation (for example, DNA analysis or genomic profiling);
    (5) Other specific investigations, such as, without limitation, 
forensic examinations which need to be performed in the course of the 
Analytical Testing process may also be subcontracted by the Laboratory.
    (b) In all such cases, the Laboratory subcontracting the analysis 
is only responsible for the maintenance of the appropriate Chain of 
Custody up to Sample reception by the subcontracted Laboratory. Such 
arrangements shall be clearly recorded as part of the Sample's 
documentation and included in the Laboratory Documentation Package, if 
applicable.
Rule 6303. Samples With Irregularities
    (a) The Laboratory shall observe and document conditions that exist 
at the time of Sample reception or registration that may adversely 
impact on the integrity of a Sample or on the performance of Analytical 
Testing Procedures. Only unusual conditions shall be recorded.
    (b) Irregularities to be noted by the Laboratory may include, but 
are not limited to:
    (1) Sample transport conditions (e.g., delivery time, temperature), 
which may impact the integrity of the Sample for Analytical Testing, as 
determined by the Laboratory;
    (2) Sample collection information (including Sample identification 
Protocol), which is necessary to conduct the Analytical Testing menu 
requested by the Agency, is not provided (e.g., missing or incomplete 
Sample collection documentation);
    (3) Sample identification is questionable. For example, if the 
number on the Sample container does not match the Sample identification 
number on the Sample collection documentation;
    (4) Covered Person or Covered Horse information is visible on the 
Laboratory copy of the Sample collection documentation or any other 
document transferred to the Laboratory;
    (5) Sample identification numbers are different between the A and 
the B Sample containers of the same Sample;
    (6) Tampering or adulteration of the Sample is evident;
    (7) Sample is not sealed with Tamper Evident device or not sealed 
upon receipt;
    (8) Sample volume does not meet the suitable volume for analysis or 
is otherwise inadequate to perform the

[[Page 5179]]

Analytical Testing menu requested by the Agency;
    (9) The Sample contains foreign objects, such as insects; or
    (10) The Sample condition(s) is unusual (e.g., color, odor, 
presence of turbidity or foam in a urine Sample, color, hemolysis, 
freezing or clotting of a blood Sample, or unusual differences in 
Sample appearance (such as color or turbidity) between the A and the B 
Samples).
    (c) When an analysis on a Sample with documented irregularities is 
performed, the Laboratory shall record the irregularities in the test 
report.
Rule 6304. Sample Splitting Procedure
    (a) In cases when either the A or B Sample is not suitable for the 
performance of the analyses (e.g., there is insufficient Sample volume, 
the Sample container has not been properly sealed or has been broken, 
the Sample's integrity has been compromised in any way, the Sample is 
heavily contaminated, the A or B Sample is missing), the Laboratory 
shall notify and consult with the Agency regarding whether it is 
appropriate to split the other Sample container (A or B, as 
applicable), provided that it is properly sealed. The Agency should 
inform the Laboratory of its decision in writing within 3 days of 
notification by the Laboratory. If the Agency decides not to proceed 
with the Sample splitting procedure, then the Laboratory shall report 
the Sample as ``not analyzed,'' including the noted Sample 
irregularities and the documented reasons if provided by the Agency.
    (b) The first fraction of the split Sample shall be considered as 
the A Sample and shall be used for the Initial Testing Procedure(s), 
unless the Initial Testing Procedure(s) have already been performed, 
and the A Confirmation Procedure(s), if necessary. The second fraction, 
considered as the B Sample, shall be resealed and stored frozen for the 
B Confirmation Procedure(s), if necessary.
    (c) The process of opening and splitting the Sample and resealing 
of the remaining second fraction shall be conducted in accordance with 
Rule 6312 for a customary B Sample opening.
    (d) When the splitting procedure concerns blood Samples, which have 
been collected for Analytical Testing on the blood serum/plasma 
fraction, the sealed, intact (A or B) Sample shall be centrifuged as 
soon as practicable after Laboratory reception to obtain the serum or 
plasma fraction. The centrifuged Sample shall be stored frozen in the 
sealed Sample collection tube according to established protocols until 
the Sample opening/splitting procedure can be conducted. The opening of 
the Sample for the splitting of the serum/plasma fraction and resealing 
of the second fraction shall be carried out as described immediately 
above.
Rule 6305. Initial Storage and Sample Aliquoting for Analysis
    (a) The Aliquot preparation procedure for any Initial Testing 
Procedure or Confirmation Procedure shall minimize the risk of 
contamination of the Sample or Aliquot. The Laboratory shall use new 
material(s) (e.g., new test tubes, disposable pipettes or pipettes with 
disposable, non-reusable tips) to take Aliquots for Confirmation 
Procedures.
    (b) Urine Samples. In order to maintain the stability and integrity 
of the urine Samples, the Laboratory shall implement Sample storage 
procedures that minimize storage time at room and refrigerated 
temperatures, as well as Sample freeze/thaw cycles.
    (1) For urine Samples, the Laboratory shall obtain, following 
proper homogenization of the Sample, an initial Aliquot containing 
enough Sample volume for all analytical procedures (i.e., all Initial 
Testing Procedures or all intended Confirmation Procedures, as 
applicable), by decanting the Aliquot from the urine Sample container 
into a secondary container (e.g., a Falcon tube). Procedure-specific 
Aliquot(s) shall then be taken from the secondary container.
    (2) The Laboratory shall measure the pH and specific gravity of 
urine Samples once, using one Aliquot, during the Initial Testing 
Procedure and the Confirmation Procedure(s) (A and B Samples). Other 
tests that may assist in the evaluation of adulteration or manipulation 
may be performed, if deemed necessary by the Laboratory.
    (3) Urine A Samples shall be frozen after Aliquots are taken for 
the Initial Testing Procedure(s) to minimize risks of Sample microbial 
degradation. Urine B Samples shall be stored frozen after reception 
until analysis, if applicable.
    (c) Blood Samples. The Laboratory shall follow any applicable 
Agency procedures, Technical Document(s), and Technical Letter(s) for 
handling and storing blood Samples.
Rule 6306. Selection and Validation of Analytical Testing Procedures
    (a) The Laboratory shall select, validate, and document Analytical 
Testing Procedures, which are Fit-for-Purpose for the analysis of 
representative target Analytes of Prohibited Substances and Prohibited 
Methods.
    (b) Validation results for Analytical Testing Procedures shall be 
summarized in a validation report and supported by the necessary 
documentation and analytical data. The validation report shall indicate 
whether the Analytical Testing Procedure is Fit-for-Purpose and shall 
be included in a Laboratory scope of accreditation.
    (c) The Laboratory shall define and document the conditions that 
would trigger the revalidation of an Analytical Testing Procedure 
(e.g., change of internal standard, modified extraction procedure or 
chromatographic methodology, change in detection technique) or a 
partial re-assessment of the validation process (e.g., replacement or 
upgrade of instrument, addition of new Analyte to the Analytical 
Method).
    (d) Validation of Analytical Testing Procedures for Non-Threshold 
Substances. The Laboratory shall develop, as part of the method 
validation process, appropriate standard solutions for detection or 
identification and estimation of the concentration of Non-Threshold 
Substances. In the absence of suitable Reference Materials, Reference 
Collections may be used for detection and identification.
    (1) Validation of Initial Testing Procedures for Non-Threshold 
Substances.
    (i) The Laboratory shall validate the Selectivity, carryover, 
reliability of detection at the MRPL and Limit of Detection (LOD) for 
the Initial Testing Procedure from the analysis of an adequate number 
of representative samples prepared in the appropriate matrix of 
analysis. For chromatographic-mass spectrometric Analytical Methods, 
the Initial Testing Procedure shall allow the detection of each Non-
Threshold Substance or its representative Metabolite(s) or Marker(s) at 
50% or less of the Minimum Required Performance Levels (MRPL).
    (ii) For Non-Threshold Substances with Minimum Reporting Levels 
(MRL), the Laboratory shall validate and document the estimated 
concentration levels that will require a Confirmation Procedure.
    (iii) If there is no available Reference Material, an estimate of 
the detection capability of the Initial Testing Procedure (i.e., the 
LOD) for the Non-Threshold Substance or its representative 
Metabolite(s) or Marker(s) may be provided by assessing a 
representative substance from the same class of Prohibited Substances 
with a similar chemical structure.
    (2) Validation of Confirmation Procedures for Non-Threshold 
Substances. Factors to be investigated in the method validation 
procedure to

[[Page 5180]]

demonstrate that a Confirmation Procedure for Non-Threshold Substances 
is Fit-for-Purpose include, but are not limited to:
    (i) Selectivity: The ability of the Confirmation Procedure to 
detect and identify the Analyte of interest, taking into account 
interference(s) from the matrix or from other substance(s) present in 
the Sample. Selectivity shall be determined and documented from the 
analysis of an adequate number of representative samples prepared in 
the matrix of Sample analysis, in compliance with any applicable Agency 
procedures, Technical Document, Technical Letter, or Laboratory 
Guidelines. The Confirmation Procedure shall be able to discriminate 
between Analytes of closely related structures;
    (ii) Limit of Identification (LOI): When the analyses of Non-
Threshold Substances are based on chromatographic-mass spectrometric 
techniques, the Laboratory shall determine the lowest concentration at 
which each Non-Threshold Substance or its representative Metabolite(s) 
or Marker(s), for which a Reference Material is available, is 
identified at no more than 5% false negative rate (in compliance with 
any applicable Agency procedures, Technical Document, Technical Letter, 
or Laboratory Guidelines). The LOI shall be lower than the applicable 
MRPL;
    (iii) Robustness: The Confirmation Procedure shall be demonstrated 
to produce similar results with respect to minor variations in 
analytical conditions, which may affect the results of the analysis. 
Those conditions that are critical to ensuring reproducible results 
shall be considered; and
    (iv) Carryover: The conditions required to eliminate carryover of 
the substance of interest from Sample to Sample during processing or 
instrumental analysis. Elimination of ``injection memory'' effect is 
demonstrated by injecting a blank control sample for the Analyte in 
question, prepared in the Sample matrix, immediately prior to the 
Sample of interest.
    (3) Validation of Analytical Testing Procedures for Threshold 
Substances.
    (i) As part of the validation process for chromatography-mass 
spectrometric Analytical Methods applied to the analysis of Threshold 
Substances, the Laboratory shall develop acceptable standard solutions 
for identification of Threshold Substances. For Confirmation 
Procedures, Certified Reference Materials shall be used for 
quantification, if available.
    (ii) For the application of affinity-binding assays, or other 
methods as applicable, to the analysis of Threshold Substances, the 
Laboratory shall follow any applicable Agency procedures and Technical 
Document, and should follow any relevant Laboratory Guidelines.
    (4) Validation of Initial Testing Procedures for Threshold 
Substances.
    (i) The Laboratory shall validate Initial Testing Procedures that 
are Fit-for-Purpose, in accordance with any applicable Technical 
Document(s), Technical Letter(s), or Laboratory Guidelines.
    (ii) For chromatographic-mass spectrometric Initial Testing 
Procedures, the Laboratory shall validate the Selectivity, LOD and 
dynamic range from the analysis of an adequate number of representative 
samples prepared in the appropriate matrix of analysis, unless 
otherwise specified.
    (iii) Unless otherwise specified, the Laboratory shall validate and 
document the estimated concentration levels which will require 
quantitative Confirmation Procedure(s).
    (iv) In order to account for a possible underestimation of 
concentrations of Threshold Substances during non-quantitative Initial 
Testing Procedures, the Laboratory shall establish and document in the 
Test Method's SOP criteria (e.g., concentration levels) determined, 
during the Initial Testing Procedure method validation, to evaluate 
initial results as Presumptive Adverse Analytical Findings and ensure 
that all potentially positive Samples are subjected to quantitative 
Confirmation Procedures.
    (v) The estimation of Measurement Uncertainty (MU) is not required 
during the validation of Initial Testing Procedures, unless otherwise 
specified.
    (5) Validation of Confirmation Procedures for Threshold Substances. 
Factors to be investigated during the method validation to demonstrate 
that a quantitative Confirmation Procedure for a Threshold Substance is 
Fit-for-Purpose include, but are not limited to:
    (i) Selectivity, LOI, robustness, and carryover;
    (ii) Limit of Quantification (LOQ): The Laboratory shall 
demonstrate that a quantitative Confirmation Procedure has an 
established LOQ of no more than 50% of the Threshold value, in 
accordance with the LOQ values required in relevant Technical 
Document(s) or in consideration of Laboratory Guidelines;
    (iii) Dynamic range: The range of the quantitative Confirmation 
Procedure shall be documented from at least 50% to 200% of the 
Threshold value;
    (iv) Repeatability (sr): The quantitative Confirmation Procedure 
shall allow for the reliable repetition of the results over a short 
time, using a single operator and item of equipment. Repeatability at 
levels close to the Threshold shall be determined;
    (v) Intermediate Precision (sw): The quantitative Confirmation 
Procedure shall allow for the reliable repetition of the results at 
different times and with different operators and instruments, if 
applicable, performing the assay. Intermediate Precision at levels 
close to the Threshold shall be determined;
    (vi) Bias (b): The Bias of the measurement procedure shall be 
evaluated either using Certified Reference Materials or traceable 
Reference Materials, if available, or from comparison with a reference 
method or with the consensus values obtained from an inter-Laboratory 
comparison study or EQAS participation. Bias at the levels close to the 
Threshold shall be determined;
    (vii) Measurement Uncertainty (MU): The MU associated with the 
results obtained with the quantitative Confirmation Procedure shall be 
estimated in accordance with any applicable Agency procedures, 
Technical Document(s), Technical Letter(s), or Laboratory Guidelines. 
At a minimum, MU at levels close to the Threshold shall be addressed 
during the validation of the quantitative Confirmation Procedure.
    (e) Confirmation Procedure method validation data (including the 
estimation of MU) is evaluated during the assessment process for 
inclusion of the quantitative Confirmation Procedure within the 
Laboratory's scope of ISO/IEC 17025 accreditation. Therefore, for those 
Confirmation Procedures that are included within the Laboratory's scope 
of ISO/IEC 17025 accreditation, the Laboratory is not required to 
produce method validation data, SOPs, or other evidence of method 
validation in any legal proceeding.
Rule 6307. Sample Analysis
    (a) Laboratories shall analyze Samples collected by or on behalf of 
the Agency using any Analytical Testing menu directed by the Agency to 
detect the presence of Prohibited Substances or Prohibited Methods only 
(as defined in the Prohibited List).
    (b) Covered Persons and their representatives are not permitted to 
be present for any aspect of Sample analysis or processing described in 
the Laboratory Standards, Technical Documents, Technical Letters, 
Laboratory Guidelines, or Laboratory SOPs. In addition, Covered Persons 
are not permitted to have a Sample transferred to be tested at a 
laboratory.

[[Page 5181]]

    (c) Laboratories may analyze Samples for the following, in which 
case the results of the analysis shall not be reported as an Atypical 
Finding or an Adverse Analytical Finding:
    (1) Non-prohibited substances or methods that are included in the 
Agency monitoring program;
    (2) Non-prohibited substances for results interpretation purposes 
(e.g., non-prohibited substances that share Metabolite(s) or 
degradation products with Prohibited Substances), if applicable;
    (3) Non-prohibited substances or methods requested as part of a 
Results Management process by an adjudicatory body or the Agency;
    (4) Non-prohibited substances or methods requested by the Agency as 
part of its safety Protocol, Protocol of conduct or other regulations; 
or
    (5) Additional analyses for quality assurance/quality improvement/
method development or research purposes, in accordance with the 
requirements indicated in Rule 6320.
    (d) At minimum, all Laboratories are required to implement all 
mandatory Analytical Testing Procedures, as determined by the Agency in 
compliance with any relevant Technical Document(s) and Technical 
Letter(s). Laboratories may implement additional methods for the 
analysis of particular Prohibited Substances or Prohibited Methods.
    (e) Analytical Testing Procedure(s) included in the Laboratory's 
scope of ISO/IEC 17025 accreditation shall be considered as Fit-for-
Purpose, and, therefore, the Laboratory shall not be required to 
provide method validation documentation, SOPs or EQAS performance data 
in support of an Adverse Analytical Finding.
    (f) However, if the Analytical Testing Procedure has not been 
included yet in the Laboratory's scope of ISO/IEC 17025 accreditation, 
the Laboratory shall validate the procedure in compliance with the 
Laboratory Standards and any applicable Agency procedures, Technical 
Document(s), Technical Letter(s), or Laboratory Guidelines prior to its 
application to the analysis of Samples. In such cases, the Laboratory 
may be required to provide method validation documentation or EQAS 
performance data in support of an Adverse Analytical Finding.
    (g) Laboratories may, on their own initiative and prior to 
reporting a test result, apply additional Analytical Testing Procedures 
to analyze Samples for Prohibited Substances or Prohibited Methods not 
included in the standard Analytical Testing menu requested by the 
Agency, provided that the additional work is authorized by the Agency, 
conducted at the Laboratory's expense, and does not significantly 
affect the possibility to submit the Sample to Further Analysis. 
Results from any such analysis shall be reported to, and in a form 
designated by, the Agency and have the same validity and Consequences 
as any other analytical result.
Rule 6308. Application of Initial Testing Procedures
    (a) The objective of the Initial Testing Procedure is to obtain 
information about the potential presence of Prohibited Substance(s) or 
Metabolite(s) of Prohibited Substance(s), or Marker(s) of the Use of a 
Prohibited Substance or Prohibited Method. Results from Initial Testing 
Procedure(s) can be included as part of longitudinal studies (e.g., 
endogenous steroid), provided that the method is Fit-for-Purpose.
    (b) The Initial Testing Procedure(s) shall fulfill the following 
requirements:
    (1) The Initial Testing Procedure shall be Fit-for-Purpose;
    (2) The Initial Testing Procedure shall be performed on Aliquot(s) 
taken from the container identified as the A Sample (and if the A 
Sample cannot be used for the Initial Testing Procedure(s), see Rule 
6304);
    (3) The Initial Testing Procedure shall be recorded, as part of the 
Sample (or Sample batch) record, each time it is conducted;
    (4) All batches undergoing an Initial Testing Procedure shall 
include appropriate negative and positive quality controls prepared in 
the matrix of analysis, unless otherwise specified by the Agency;
    (5) The Initial Testing Procedures for Non-Threshold Substances 
shall include appropriate controls of representative substance(s) at or 
below the MRPL;
    (6) The Initial Testing Procedures for Threshold Substances shall 
include appropriate controls close to the Threshold, unless otherwise 
specified by the Agency;
    (7) Results from Initial Testing Procedures are not required to 
consider the associated MU, unless otherwise specified by the Agency; 
and
    (8) The Laboratory shall establish criteria, based on its method 
validation and in accordance with its SOP, to evaluate results from an 
Initial Testing Procedure as a Presumptive Adverse Analytical Finding, 
which would trigger confirmation analyses.
Rule 6309. Application of Confirmation Procedures
    (a) The objective of the Confirmation Procedure is to obtain a 
result, which supports or does not support the reporting of an Adverse 
Analytical Finding or Atypical Finding.
    (b) A Confirmation Procedure for a Non-Threshold Substance with a 
Minimum Reporting Level or other control limit may also be performed if 
the result estimated from the Initial Testing Procedure is lower than 
the applicable Minimum Reporting Level, as determined by the Laboratory 
in accordance with the method's validation results, or as specifically 
required by the Agency.
    (c) A result obtained in the Initial Testing Procedure for a 
Threshold Substance higher than the Threshold requires a Confirmation 
Procedure. A Confirmation Procedure may also be performed if the result 
obtained in the Initial Testing Procedure is lower than the Threshold, 
as determined by the Laboratory, or as specifically required by the 
Agency.
    (d) Irregularities in the Initial Testing Procedure(s) shall not 
invalidate an Adverse Analytical Finding, which is adequately 
established by a Confirmation Procedure.
    (e) The Confirmation Procedure(s) shall fulfill the following 
requirements:
    (1) The Confirmation Procedure(s) shall be Fit-for-Purpose, 
including the estimation of the MU associated with a quantitative 
Confirmation Procedure;
    (2) The Confirmation Procedure(s) shall be recorded, as part of the 
Sample (or Sample batch) record, each time it is conducted;
    (3) The Confirmation Procedure shall have equal or greater 
Selectivity than the Initial Testing Procedure and shall provide 
accurate quantification results (applicable to Threshold Substances). 
The Confirmation Procedure shall incorporate, when possible and 
adequate, a different Sample extraction protocol or a different 
analytical methodology, unless otherwise specified by the Agency; and
    (4) All batches undergoing a Confirmation Procedure shall include 
appropriate negative and positive quality controls prepared in the 
matrix of analysis.
Rule 6310. Confirmation Procedure Methods
    Mass spectrometry (MS) coupled to chromatographic separation (e.g., 
gas or liquid chromatography) is the analytical technique of choice for 
confirmation of most Prohibited Substances, Metabolite(s) of a 
Prohibited Substance, or Marker(s) of the Use of a Prohibited Substance 
or Prohibited Method. These are acceptable methods for both the Initial 
Testing Procedure and the Confirmation Procedure.

[[Page 5182]]

Rule 6311. A Confirmation Procedure
    (a) Aliquots. The A Confirmation Procedure shall be performed using 
new Aliquot(s) taken from the container identified as the A Sample (and 
if the A Sample cannot be used for the Initial Testing Procedure(s), 
see Rule 6304). At this point, the link between the Sample external 
code, as shown in the Sample container, and the Laboratory internal 
Sample code shall be verified.
    (b) Target Analyte(s). If the presence of more than one Prohibited 
Substance, Metabolite(s) of a Prohibited Substance, or Marker(s) of the 
Use of a Prohibited Substance or Prohibited Method is detected by the 
Initial Testing Procedure(s), the Laboratory shall confirm as many of 
the Presumptive Adverse Analytical Findings as reasonably possible (and 
such decision should consider the volumes available in the A and B 
Samples). The confirmation(s) shall prioritize the identification or 
quantification of the Prohibited Substance(s) or Prohibited Method(s) 
that carry the longest potential period of Ineligibility. The 
prioritization decision shall be made in consultation with the Agency 
and documented by the Laboratory.
    (c) Repetition of the A Confirmation Procedure. The Laboratory may 
repeat the Confirmation Procedure for an A Sample, if appropriate, 
(e.g., quality control failure, chromatographic peak interferences, 
inconclusive A confirmation results). In that case, the previous test 
result shall be nullified. Each repeat confirmation shall be performed 
using a new Aliquot(s) taken from the A Sample container and shall be 
recorded.
    (d) A Confirmation Procedure for Non-Threshold Substances.
    (1) For Non-Threshold Substances without Minimum Reporting Levels, 
Adverse Analytical Finding or Atypical Finding decisions for the A 
Sample shall be based on the identification of the Non-Threshold 
Substance or its characteristic Metabolite(s) or Marker(s), as 
applicable, in compliance with any relevant Technical Document(s) or 
Technical Letter(s) or in consideration of Laboratory Guidelines.
    (2) For Non-Threshold Substances with Minimum Reporting Levels, 
Adverse Analytical Finding decisions for the A Sample shall be based on 
the identification of the Non-Threshold Substance or its characteristic 
Metabolite(s) or Marker(s), in compliance with any applicable Agency 
procedures or Technical Document, at an estimated concentration greater 
than the Minimum Reporting Level, unless there is valid justification 
for reporting the finding at levels below the Minimum Reporting Level 
(e.g., if the analysis forms part of an ongoing investigation).
    (e) A Confirmation Procedure for Threshold Substances.
    (1) For Threshold Substances, Adverse Analytical Finding or 
Atypical Finding decisions for the A Sample shall be based on the 
confirmed identification (in accordance with any applicable Agency 
Procedures or Technical Document) of the Threshold Substance or its 
Metabolite(s) or Marker(s) and their quantitative determination in the 
Sample at a level exceeding the value of the relevant Decision Limit.
    (2) Quantitative Confirmation Procedures for Threshold Substances 
shall be based on the determination of the mean of measured analytical 
values (e.g., concentrations, chromatogram areas) or the ratio/score 
calculated from the mean(s) of the measured analytical values of 2 A 
Sample Aliquots, unless otherwise specified by the Agency. If there is 
not enough Sample volume to analyze 2 Aliquots, the maximum number of 
Aliquots that can be prepared shall be analyzed.
    (3) By determining that the test result exceeds the Decision Limit, 
the quantitative Confirmation Procedure establishes that the Threshold 
Substance or its Metabolite(s) or Marker(s) is present in the Sample at 
a level greater than the Threshold, with a statistical confidence of at 
least 95%.
    (4) For Threshold Substances, Markers of the ``biomarker profile'', 
or any other Prohibited Substance that may be produced endogenously at 
low levels, Adverse Analytical Finding decisions for the A Sample may 
also be based on the application of any Fit-for-Purpose Confirmation 
Procedure that establishes the exogenous origin of the Prohibited 
Substance or its Metabolite(s) or Marker(s). Atypical Findings may 
result from non-conclusive determinations of the origin (i.e., 
endogenous vs. exogenous) of the Prohibited Substance or its 
Metabolite(s) or Marker(s).
Rule 6312. B Sample Procedure
    (a) Testing Laboratory. If the B Sample procedure is to be 
performed, it will be performed in a different Laboratory from the A 
Sample analysis (with the choice of the Laboratory for the B Sample 
analysis determined exclusively by the Agency), except where the Agency 
considers it necessary for the same Laboratory to perform the B Sample 
procedure:
    (1) due to reasonable concerns over Sample integrity or unstable 
analytes; or
    (2) because no other Laboratory is available to perform the B 
Sample procedure within a reasonable period of time.
    (b) Notification and timing of B Sample procedure.
    (1) The B Sample procedure shall only be performed by the 
Laboratory upon request by the Agency.
    (2) The Agency should inform the Laboratory, in writing, within 15 
days following the reporting of an A Sample Adverse Analytical Finding 
by the Laboratory, whether the B Sample procedure shall be conducted. 
This includes situations when the Covered Person does not request the B 
Sample analysis or expressly or implicitly waives his or her right to 
the analysis of the B Sample, but the Agency decides that the B Sample 
procedure shall still be performed.
    (3) If the B Sample procedure is to be performed, whether upon the 
request of the Covered Person in accordance with the Protocol or the 
Agency:
    (i) as soon as reasonably practicable after the Agency so decides 
or the Covered Person so requests, the Agency should notify the 
Laboratory that performed the A Sample analysis, and the Laboratory 
that will perform the B Sample procedure, that the B Sample procedure 
will be performed;
    (ii) within 5 days of receipt of the notice at Rule 6312(b)(3)(i), 
the Laboratory that performed the A Sample analysis should send the B 
Sample to the Laboratory that will perform the B Sample procedure; and
    (iii) the Laboratory that will perform the B Sample procedure 
should perform the B Sample procedure as soon as reasonably practicable 
after receipt of the B Sample.
    (4) The timing of the B Sample procedure may be strictly fixed 
within a very short period of time and without any possible 
postponement, if circumstances so justify it. This can notably and 
without limitation be the case when a postponement of the B Sample 
analysis could significantly increase the risk of Sample degradation or 
inadequately delay the decision-making process in the given 
circumstances (e.g., and without limitation, during or in view of a 
Covered Horserace requiring rapid completion of the Sample analysis).
    (c) Opening, Aliquoting and Resealing of B Sample.
    (1) The B Sample procedure shall be performed using Aliquot(s) 
taken from the container defined as the B Sample (and if the B Sample 
cannot be used, see Rule 6304).
    (2) If the B Sample container was not properly sealed or showed 
signs of

[[Page 5183]]

Tampering, or if the identifying numbers did not match those on the 
Sample collection documentation, the Laboratory shall not proceed with 
the B Sample procedure and will inform the Agency immediately to obtain 
instructions on how to proceed. In such cases, unless the entire case 
is dismissed, the B Sample procedure may have to be re-scheduled.
    (3) The Laboratory shall ensure that the B Sample container is 
opened and Aliquots for the B Sample procedure are taken.
    (4) The Laboratory shall also ensure that, after opening and taking 
Aliquots for the B Sample procedure, the B Sample is properly resealed.
    (5) At a minimum, the Laboratory Director or representative shall 
sign another part of the Laboratory documentation attesting that the B 
Sample opening and aliquoting procedures occurred and that the B Sample 
was properly resealed.
    (d) Target Analyte(s). If more than one Prohibited Substance, 
Metabolite(s) of a Prohibited Substance, or Marker(s) of the Use of a 
Prohibited Substance or Prohibited Method has been confirmed in the A 
Sample procedure, the Laboratory shall confirm as many of the Adverse 
Analytical Findings as possible given the B Sample volume available. 
The decision on the prioritization for the confirmation(s) shall be 
made to prioritize the analysis of the Prohibited Substance(s) or 
Prohibited Method(s) that carry the longest potential period of 
Ineligibility. The prioritization decision shall be made in 
consultation with the Agency and documented.
    (e) Repetition of the B Sample procedure. The Laboratory may repeat 
the B Sample procedure, if appropriate, (e.g., quality control failure, 
chromatographic peak interferences, inconclusive B confirmation 
results). In that case, the previous test result shall be nullified. 
The Laboratory may repeat the B Sample procedure using the remaining 
volume of the same Aliquot initially taken from the B Sample container. 
However, if there is not enough volume left of the initial Aliquot, 
then the Laboratory shall use a new Aliquot(s) taken from the re-sealed 
B Sample container. Each Aliquot used shall be documented.
    (f) B confirmation with negative results. If the final B 
confirmation results are negative, the Analytical Testing result shall 
be considered a Negative Finding. The Laboratory shall notify the 
Agency immediately. If requested by the Agency, one or more 
Laboratories shall conduct an internal investigation of the causes of 
the discrepancy between the A and B Sample results. Target Analytes 
(e.g., parent compound, Metabolite(s), and Marker(s)) used to conclude 
the presence of a given Prohibited Substance or Use of a Prohibited 
Method may differ between the A and B Confirmation Procedures. This 
does not mean that the B confirmation results are negative, as long as 
the Analyte(s) targeted allows the unequivocal and conclusive 
identification of the Prohibited Substance or Prohibited Method in the 
B Sample.
    (g) B Sample procedure for Non-Threshold Substances and exogenous 
Threshold Substances. For Non-Threshold Substances (including those 
with Minimum Reporting Levels) and exogenous Threshold Substances, the 
B Sample results shall only confirm the presence of the Prohibited 
Substance(s) or its Metabolite(s) or Marker(s) identified in the A 
Sample (in compliance with any applicable Agency procedures or 
Technical Document) for the Adverse Analytical Finding to be valid, 
unless otherwise specified by the Agency. No quantification or 
estimation of concentrations of such Prohibited Substance, or its 
Metabolite(s) or Marker(s) is necessary.
    (h) B Sample procedure for Threshold Substances.
    (1) For Threshold Substances, Adverse Analytical Finding decisions 
for the B Sample results shall be based on the confirmed identification 
(in accordance with any applicable Agency procedures or Technical 
Document, applicable to B Sample procedures based on chromatography-
mass spectrometry) of the Threshold Substance or its Metabolite(s) or 
Marker(s) and their quantitative determination in the Sample at a level 
exceeding the value of the relevant Threshold as specified in any 
applicable Agency procedures, Technical Document(s), or Laboratory 
Guidelines. Comparison of the measured value of the B Sample to the 
measured value of the A Sample is not necessary to establish B Sample 
confirmation. The B Sample value is only required to exceed the 
applicable Threshold (plus any Measurement Uncertainty).
    (2) Quantitative B Sample procedures for Threshold Substances shall 
be based on the determination of the mean of measured analytical values 
(e.g., concentrations, chromatogram areas) or the ratio/score 
calculated from the mean(s) of the measured analytical values of 2 B 
Sample Aliquots, unless otherwise specified by the Agency. If there is 
not enough Sample volume to analyze 2 Aliquots, the maximum number of 
Aliquots that can be prepared shall be analyzed.
    (3) For Threshold Substances or any other Prohibited Substance that 
may be produced endogenously at low levels, Adverse Analytical Finding 
decisions for the B Sample results may also be based on the application 
of any Fit-for-Purpose Analytical Testing Procedure that establishes 
the exogenous origin of the Prohibited Substance or its Metabolite(s) 
or Marker(s). Atypical Findings may result from non-conclusive 
determinations of the origin (i.e., endogenous vs. exogenous) of the 
Prohibited Substance or its Metabolite(s) or Marker(s).
Rule 6313. Further Analysis of Stored Samples
    (a) Further Analysis of stored Samples shall, as a matter of 
principle, be aimed at detecting all the Prohibited Substance(s) or 
Metabolite(s) of Prohibited Substance(s), or Marker(s) of the Use of a 
Prohibited Substance or Prohibited Method included in the Prohibited 
List in force at the time of the collection of the Sample(s).
    (b) Selection of Samples and Laboratories for Further Analysis.
    (1) Stored Samples may be selected for Further Analysis at the 
discretion of the Agency or the Authority.
    (2) The choice of which Laboratory will conduct the Further 
Analysis will be made by the Agency. Requests to the Laboratory for 
Further Analysis shall be made in writing and be recorded as part of 
the Sample's documentation.
    (3) When a Sample has been reported as a Negative Finding or 
Atypical Finding, there is no limitation on the Agency to conduct 
Further Analysis on the Sample.
    (4) Further Analysis may also be performed on stored Samples that 
were previously reported as Adverse Analytical Findings. Any Prohibited 
Substance or Prohibited Method detected, which was prohibited at the 
time of Sample collection, shall be reported.
    (5) Previously acquired Initial Testing Procedure data may also be 
re-evaluated for the presence of Prohibited Substances or their 
Metabolite(s) or Marker(s) of Prohibited Substances or Prohibited 
Methods, at the initiative of the Agency or the Laboratory itself. The 
results of such re-evaluation, if suspicious, shall be communicated to 
the Agency, and may lead to Further Analysis.
    (c) Analytical Testing Procedures for Further Analysis of stored 
Samples.
    (1) Further Analysis of stored Samples shall be performed under the 
Laboratory Standards, Technical Documents, and Technical Letters in 
effect at the time the Further Analysis is performed. Any

[[Page 5184]]

Laboratory Guidelines may also be referenced.
    (2) Further Analysis of stored Samples includes, notably, but 
without limitation, the application of newly developed or more 
sensitive Analytical Testing Procedures or the analysis of new target 
Analytes of Prohibited Substance(s) or Prohibited Method(s) (e.g., 
Metabolite(s) or Marker(s)), which were not known or not included in 
the initial Analytical Testing of the Sample.
    (3) Depending on the circumstances, and to ensure an effective and 
targeted use of the available Sample volume, priorities may be set, or 
the scope of the Further Analysis restricted to specific analyses (in 
particular, but without limitation, to analyses based on new or 
improved Analytical Testing Procedures).
    (d) Further Analysis of stored Samples process.
    (1) Use of the A Sample. The Agency may instruct the Laboratory to 
use the A Sample for both the Initial Testing Procedure(s) and the A 
Confirmation Procedure(s), to use it only for the Initial Testing 
Procedure(s), or not to use the A Sample for Further Analysis at all.
    (i) If the Laboratory has been instructed to perform only the 
Initial Testing Procedure(s) on the A Sample, any suspicious analytical 
result obtained from the A Sample shall be considered as a Presumptive 
Adverse Analytical Finding, irrespective of the Analytical Testing 
Procedure applied, and shall be confirmed using the split B Sample.
    (ii) When a Confirmation Procedure is performed on the A Sample and 
an Adverse Analytical Finding is reported on this basis, the B Sample 
procedure shall be applicable (as per Rule 6316).
    (2) Use of the split B Sample. When the A Sample is used only for 
the Initial Testing Procedure(s) or is not used at all during Further 
Analysis, the B Sample shall be split and used for analysis. The B 
Sample shall be split into 2 fractions, in accordance with Rule 6304.
    (i) In the event an Adverse Analytical Finding is notified based on 
the results of a B Sample procedure of the first fraction of the B 
Sample, the second split fraction of the B Sample shall be deemed as 
the B Sample. Since the first split fraction of the B Sample is 
considered as an A Sample, analysis of Aliquots taken from this Sample 
may include the performance of Initial Testing Procedure(s) and A 
Confirmation Procedures or A Confirmation Procedures only (if the 
Initial Testing Procedure(s) was/were already performed using the A 
Sample).
    (ii) If applicable, a B confirmation shall be decided and performed 
in accordance with Rule 6316.
    (e) Alternative biological matrices. Any negative Analytical 
Testing results obtained from hair, hoof, saliva or other biological 
material shall not be used to counter Adverse Analytical Findings or 
Atypical Findings from urine, blood (including whole blood, plasma or 
serum), or hair.
Rule 6314. Ensuring the Validity of Analytical Results
    (a) The Laboratory shall monitor its analytical performance and the 
validity of test results by operating quality control schemes, which 
are appropriate to the type and frequency of Analytical Testing 
performed by the Laboratory. The resulting data shall be recorded in 
such a way that trends are detectable and, where practicable, 
statistical techniques shall be applied to review the results.
    (b) All quality control procedures shall be documented by the 
Laboratory. The range of quality control activities include, but are 
not limited to:
    (1) Use of appropriate quality control samples (QCs).
    (i) Appropriate positive and negative QCs shall be included in 
every analytical run both for the Initial Testing Procedure(s) and B 
Sample procedure(s), unless otherwise specified by the Agency.
    (ii) Appropriate internal standard(s) shall be used for 
chromatographic methods.
    (iii) For Threshold Substances, quality control charts (QC-charts) 
referring to appropriate control limits depending on the Analytical 
Testing Procedure employed (e.g., +/-2SD; +/-3SD; +/-MU95%), shall be 
regularly used to monitor method performance and inter-batch 
variability (when applicable).
    (2) Implementation of an Internal Quality Assurance Scheme (iQAS).
    (i) The Laboratory shall establish a functional and robust iQAS 
program, in accordance with the requirements of ISO/IEC 17025, which 
challenges the entire scope of the Analytical Testing process (i.e., 
from Sample accessioning through result reporting). The Laboratory 
shall implement a procedure that prevents the submission of iQAS 
results to the Agency.
    (ii) The iQAS plan shall include and evaluate as many Laboratory 
procedures as possible, including the submission of a sufficient number 
of test samples on a regular basis (e.g., monthly) and shall 
incorporate as many categories of Prohibited Substances and Prohibited 
Methods as possible.
    (iii) The Laboratory shall have a dedicated SOP for the iQAS 
program which incorporates a detailed procedure for the planning, 
preparation (blind or double-blind), introduction of the iQAS samples, 
and management of the iQAS results (i.e., reviewing and follow-up of 
nonconformities).
    (3) Mandatory participation in the Agency EQAS.
    (4) Implementation of internal audits.
    (i) Internal audits shall be conducted in accordance with the 
requirements of ISO/IEC 17025 and shall have a dedicated SOP 
incorporating a detailed procedure for the planning and performance of 
the audits, the training and selection of internal auditors, and 
specification of their auditing activities, as well as for management 
of the internal audit conclusions (i.e., reviewing and follow-up of 
nonconformities).
    (ii) Internal audit responsibilities may be shared amongst 
personnel provided that any Laboratory staff member does not audit his 
or her own area.
    (iii) Internal audits shall be carried out by qualified Laboratory 
staff members. In addition, qualified members of the Laboratory's host 
organization (e.g., university, institute, company) may also be 
included in the internal auditing teams.
    (5) Implementation of external audits. Laboratories may also 
consider having their procedures and systems audited by other 
Laboratory Directors or external auditors. However, this shall not 
replace the performance of internal audits by the Laboratory.
Rule 6315. Results Management
    (a) Review of results. The Laboratory shall conduct a minimum of 
one independent review of all Initial Testing Procedure raw data and 
results. The review process shall be recorded.
    (b) A minimum of 2 Certifying Scientists shall conduct an 
independent review of all Adverse Analytical Findings and Atypical 
Findings before a test result is reported. Evidence of the review and 
approval of the analytical run/batch shall be recorded.
    (c) Second opinion. The Laboratory may request a second opinion 
from another Laboratory, selected by, and upon approval of, the Agency, 
before reporting an Adverse Analytical Finding or Atypical Finding. 
Such requests for second opinions may be required by specific Technical 
Document(s) or Technical Letter(s), required by the Agency from certain 
Laboratories for all or for specific Analytical Testing Procedures 
under certain conditions (e.g., following the recent obtaining of HEAL 
accreditation or after a period of

[[Page 5185]]

suspension or Analytical Testing Restriction), or requested at the 
discretion of the Laboratory (e.g., for firstly detected Analytes or 
for difficult to interpret findings). In any case, the request for a 
second opinion shall be made in writing, and the second opinion 
received shall be recorded as part of the Sample's documentation. Any 
transfer of data and information necessary for the second opinion shall 
be made securely and respecting the confidentiality of the analytical 
data and any other information. The Laboratory that performed the 
analysis is responsible for the result and for issuing the final test 
report.
    (d) Laboratory review of Adverse Analytical Findings and Atypical 
Findings. At a minimum, the review of Adverse Analytical Findings and 
Atypical Findings shall include:
    (1) Documentation linking the Sample (as specified in the Sample 
collection documentation) to the Laboratory Internal Chain of Custody 
documentation;
    (2) Laboratory Internal Chain of Custody documentation;
    (3) Initial Testing Procedure(s) and Confirmation Procedure(s) 
analytical data and calculations;
    (4) Quality control data;
    (5) Completeness of technical and analytical documentation 
supporting the reported findings;
    (6) Compliance of test data with the Analytical Testing Procedure's 
validation results (e.g., MU); and
    (7) Assessment of the existence of significant data or information 
that would cast doubt on or refute the Laboratory findings.
    (e) When the Confirmation Procedure result(s) are not determined to 
be Adverse Analytical Finding(s) or Atypical Finding(s) based on the 
results review, the reason(s) for the rejection shall be recorded in 
the laboratory test report.
    (f) Traceability of results and documentation. The Laboratory shall 
have documented procedures to ensure that it maintains a record related 
to each Sample analyzed. In the case of an Adverse Analytical Finding 
or Atypical Finding, the record shall include the data necessary to 
support the conclusions reported.
    (1) Each step of Analytical Testing shall be traceable to the staff 
member who performed that step;
    (2) Significant deviation from a written SOP shall be recorded;
    (3) Where instrumental analyses are conducted, the operating 
parameters for each run shall be included as part of the record;
    (4) Requests for information by the Agency to a Laboratory shall be 
made in writing;
    (5) Laboratories are not required to produce a Laboratory 
Documentation Package for a Sample in which no Prohibited Substance or 
Prohibited Method or their Metabolite(s) or Marker(s) was detected, 
unless requested by an adjudication body as part of a Results 
Management process or Laboratory disciplinary proceedings.
    (g) Confidentiality of the Analytical Data and Covered Person or 
Covered Horse's identity.
    (1) The Laboratory shall not make any attempt to identify a Covered 
Person linked to, or the Covered Horse that has provided, a Sample.
    (2) Information sent by a facsimile is acceptable, provided that 
the correct facsimile number is verified prior to transmission and the 
receipt is verified after the facsimile has been transmitted.
    (3) Secure emails or documents shall be used for reporting or 
discussion of Adverse Analytical Findings or Atypical Findings if the 
Covered Person or Covered Horse can be identified or if any information 
regarding the identity of the Covered Person or Covered Horse is 
included.
Rule 6316. Reporting Test Results
    (a) Reporting times (including confirmatory analysis).
    The Laboratory should report all A Sample results to the Agency in 
a form designated by the Agency within 10 business days of receipt by 
the Laboratory of the Sample. The reporting time may be altered by 
agreement between the Laboratory and the Agency. The Agency shall be 
promptly informed of any delay in the reporting of A Sample results.
    (b) Reporting requirements.
    (1) The Laboratory shall record the test result for each individual 
Sample to, and in a form designated by, the Agency.
    (2) The Laboratory shall report test results to the Agency in a 
form designated by the Agency. When reporting test results, the 
Laboratory shall include the following, in addition to the mandatory 
information required by the Agency, in any relevant Technical 
Document(s) or Technical Letter(s), and in the ISO/IEC 17025 standard:
    (i) The specific gravity of the Sample, if applicable (Initial 
Testing Procedure and A and B Confirmation Procedures);
    (ii) Relevant comments, if necessary, for proper interpretation of 
the test result or recommendations to the Agency (for example, for 
Target Testing of the Covered Horse);
    (iii) Specific tests performed, in addition to the Laboratory's 
routine Analytical Testing menu (e.g., EPO, bisphosphonates, hGH); and
    (iv) Any irregularities noted on Samples.
    (c) The Laboratory is not required to provide any additional test 
report, either in hard-copy or digital format, other than the 
submission of test results to, and in a form designated by, the Agency. 
Upon request by the Agency, the Laboratory shall report a summary of 
the results of analyses performed in a format specified by the Agency. 
In addition, the Laboratory shall provide any information requested by 
the Agency in relation to the Monitoring Program (Protocol).
    (d) The Laboratory shall qualify the result(s) of the analysis in 
the Agency's test report as:
    (1) Adverse Analytical Finding;
    (2) Atypical Finding;
    (3) Negative Finding; or
    (4) Not Analyzed.
    (e) Any Sample received at the Laboratory and not subject to 
Analytical Testing for a valid, documented reason (as instructed or 
agreed to by the Agency), such as Sample irregularities or intermediate 
Samples of a Sample Collection Session, shall be dealt with in 
accordance with ISO/IEC 17025.
    (f) Test report for Non-Threshold Substances.
    (1) A Sample test report.
    (i) The Laboratory is not required to report concentrations for 
Non-Threshold Substances. The Laboratory shall report the actual 
Prohibited Substance(s) or its Metabolite(s), or Marker(s) of the Use 
of Prohibited Substance(s) or Prohibited Method(s) present in the 
Sample and in accordance with any reporting requirements established by 
the Agency or in any applicable Technical Document.
    (ii) However, the Laboratory shall provide estimated concentrations 
when possible and for information purposes only, upon request by the 
Agency, if the detected level of the Non-Threshold Substance(s), its 
Metabolite(s), or Marker(s) may be relevant to the Results Management 
of an anti-doping case. In such instances, the Laboratory shall 
indicate the estimated concentration while making it clear to the 
Agency that the concentration was obtained by an Analytical Testing 
Procedure that has not been validated for quantitative purposes.
    (2) B Sample test report. For Non-Threshold Substances, 
irrespective of whether they have a Minimum Reporting Level, the 
Laboratory result for the B Sample shall only establish the presence 
(i.e., the identity) of the

[[Page 5186]]

Prohibited Substance(s) or its Metabolite(s) or Marker(s) in accordance 
with any reporting requirements established by the Agency or in 
relevant Technical Document(s). The Laboratory is not required to 
quantify or estimate the concentration of such Prohibited Substance, or 
its Metabolite(s) or Marker(s).
    (g) Test report for Threshold Substances. For Threshold Substances, 
the Laboratory test report for the A Sample shall establish that the 
identified Prohibited Substance(s) or its Metabolite(s) or Marker(s) is 
present at a concentration, ratio, or score of measured analytical 
values greater than the Threshold, or that the Prohibited Substance(s) 
or its Metabolite(s) or Marker(s) is of exogenous origin.
Rule 6317. Control of Nonconformities in Analytical Testing
    (a) The Laboratory shall have policies and procedures that shall be 
implemented when any aspect of its Analytical Testing does not comply 
with then-current requirements.
    (b) Any nonconformities in Analytical Testing shall be recorded and 
kept as part of the documentation of the Sample(s) involved.
    (c) When conducting a corrective action investigation, the 
Laboratory shall perform and record a thorough Root Cause Analysis of 
the nonconformity.
Rule 6318. Complaints
    Complaints shall be handled in accordance with ISO/IEC 17025.
Rule 6319. Storage of Samples
    (a) Storage of urine Samples. All urine Samples retained for 
storage in the Laboratory shall be stored frozen in a secure location 
under continuous Chain of Custody. The Laboratory shall keep all Chain 
of Custody and other records (either as hard-copy or in digital format) 
pertaining to those Samples unless and until notified in writing by the 
Agency that such records may be destroyed.
    (1) Urine Sample(s) without an Adverse Analytical Finding or 
Atypical Finding: The Laboratory shall retain the A and B urine 
Sample(s) without an Adverse Analytical Finding or Atypical Finding for 
a minimum of 3 months after reporting the final analytical result to 
the Agency, and they may be discarded after this time, unless the long-
term storage of the Sample(s) has been requested, in writing or 
electronically, by the Agency and unless the Agency requests the 
Laboratory retain the Sample for a longer period. The Laboratory may 
charge storage costs to the Agency, as applicable, for the storage of 
Samples for periods longer than the stated minimum storage times. 
However, the Laboratory may store Samples beyond the applicable minimum 
storage times at their own discretion and expense. In such cases, the 
Laboratory shall inform the Agency in writing. Any Further Analysis on 
these Samples will require the approval of the Agency. The maximum 
storage period is 10 years after the Sample collection date.
    (2) Urine Samples with irregularities: The Laboratory shall retain 
the A and B urine Sample(s) with irregularities for a minimum of 3 
months after reporting to the Agency, or for a longer period as 
determined by the Agency.
    (3) Urine Sample(s) with an Adverse Analytical Finding or Atypical 
Finding: The Laboratory shall retain the A and B urine Sample(s) with 
an Adverse Analytical Finding or Atypical Finding for a minimum of 6 
months after reporting the final analytical result for the A or the B 
Sample, as applicable to, the Agency and shall not dispose of any such 
Samples without approval by the Agency.
    (4) Urine Samples under challenge, dispute or investigation: If the 
Laboratory has been informed by the Agency (in writing and within the 
applicable storage period as defined in this Rule 6319) that the 
analysis of a urine Sample is challenged, disputed or under 
investigation, the Laboratory shall retain both the A and B Samples 
until further notice by the Agency, as applicable.
    (b) Storage of blood Samples.
    (1) Samples for which Analytical Testing has been performed on 
blood serum/plasma fraction only (not on cellular components):
    (i) All serum or plasma Samples retained for storage in the 
Laboratory shall be stored frozen according to established protocols in 
a secure location under continuous Chain of Custody. The Laboratory 
shall keep all Chain of Custody and other records (either as hard-copy 
or in digital format) pertaining to those Samples.
    (ii) Serum/plasma A and B Samples without an Adverse Analytical 
Finding or Atypical Finding: The Laboratory shall retain the serum/
plasma A and B Samples without an Adverse Analytical Finding or 
Atypical Finding for a minimum of 3 months after reporting the final 
analytical result to the Agency, unless long-term storage of the 
Sample(s) has been requested by the Agency or the Agency requests the 
Laboratory retain the Sample for a longer period.
    (iii) Unless otherwise requested by the Agency, serum/plasma 
Samples analyzed only for TCO2 and without an Adverse Analytical 
Finding or Atypical Finding, shall be retained unless and until the 
corresponding Post-Race Sample is analyzed and no Adverse Analytical 
Finding or Atypical Finding is reported (i.e., if the Post-Race Sample 
is analyzed and an Adverse Analytical Finding or Atypical Finding is 
reported, then the Agency may consider or conduct Further Analysis on 
the TCO2 Sample).
    (iv) Serum/plasma Samples with irregularities: The Laboratory shall 
retain the serum/plasma Samples with irregularities for a minimum of 3 
months after reporting the final analytical result to the Agency, or 
for a longer period if directed by the Agency.
    (v) Plasma/serum A and B Sample(s) with an Adverse Analytical 
Finding or Atypical Finding: The Laboratory shall retain A and B 
plasma/serum Sample(s) with an Adverse Analytical Finding or Atypical 
Finding for a minimum of 6 months after reporting the final analytical 
result (for the A or the B Sample, as applicable) to the Agency and 
shall not dispose of any such Samples without approval by the Agency. 
If the B Sample Confirmation Procedure is not performed, the Laboratory 
may dispose of both the A and B whole blood Samples 3 months after 
reporting the A Sample analytical result. However, if the B Sample 
Confirmation Procedure is performed, then the Laboratory shall retain 
both the A and B whole blood Sample(s) for a minimum of 3 months after 
reporting the B Sample analytical result.
    (vi) Plasma/serum A and B Sample(s) under challenge, dispute or 
investigation: If the Laboratory has been informed by the Agency (in 
writing and within the applicable storage period as defined in this 
Rule 6319) that the analysis of a serum/plasma Sample is challenged, 
disputed or under investigation, the Laboratory shall retain both the A 
and B Samples until further notice by the Agency, as applicable.
    (2) Samples for which Analytical Testing has been performed on 
cellular fractions of whole blood.
    (i) Whole blood A and B Samples without an Adverse Analytical 
Finding or Atypical Finding: The Laboratory shall retain the whole 
blood Samples without an Adverse Analytical Finding or Atypical Finding 
for a minimum of 1 month after reporting the final analytical result to 
the Agency, unless long-term storage of the Sample(s) has been 
requested by the Agency or the Agency requests the Laboratory retain 
the Sample for a longer period.
    (ii) Whole blood Samples with irregularities: The Laboratory shall

[[Page 5187]]

retain the whole blood Samples with irregularities for a minimum of 1 
month after reporting the final analytical results to the Agency, or 
for a longer period as requested by the Agency.
    (iii) Whole blood A and B Sample(s) with an Adverse Analytical 
Finding or Atypical Finding: The Laboratory shall retain A and B whole 
blood Sample(s) with an Adverse Analytical Finding or Atypical Finding 
for a minimum of 3 months after reporting the final analytical result 
(for the A or the B Sample, as applicable) to the Agency and shall not 
dispose of such Samples without approval by the Agency.
    (iv) Whole blood A and B Sample(s) under challenge, dispute or 
investigation: If the Laboratory has been informed by the Agency (in 
writing and within the applicable storage period as defined in this 
Rule 6319) that the analysis of a whole blood Sample is challenged, 
disputed or under investigation, the Laboratory shall retain both the A 
and B Samples until further notice by the Agency, as applicable, and 
shall not dispose of such Samples without approval by the Agency.
    (c) Storage of hair Samples. All hair Samples retained for storage 
in the Laboratory shall be stored for as long as requested by the 
Agency in a secure location under continuous chain of custody.
    (d) Storage of other Samples. All other Samples shall be stored for 
as long as requested by the Agency in optimal conditions based on the 
available information applicable to the Sample type, and at the 
direction of the Agency. They shall be stored in a secure location 
under continuous Chain of Custody.
    (e) Long-term storage of Samples.
    (1) At the direction of the Agency, any urine, serum/plasma, hair 
or other Sample may be stored in long-term storage after the Sample 
collection date for the purpose of Further Analysis, subject to the 
conditions set out in Rules 6313 and 6319.
    (2) Sample(s) may be stored in long-term storage under the custody 
of either a Laboratory or another Fit-for-Purpose facility under the 
responsibility of the Agency. The Agency shall retain the Sample 
collection records pertaining to all stored Samples for the duration of 
Sample storage.
    (3) Laboratories as Sample custodians:
    (i) The Laboratory shall ensure that Samples are stored according 
to established protocols in a secure location in the Laboratory's 
permanent controlled zone and under continuous Chain of Custody. The 
written request from the Agency for long-term storage of Samples shall 
be properly documented.
    (ii) Samples may also be transported for long-term storage to a 
specialized, secure Sample storage facility, which is located outside 
the Laboratory's permanent controlled zone and is under the 
responsibility of the Laboratory, or may be transported to another 
Laboratory. If the external Sample storage facility is not covered by 
the Laboratory's ISO/IEC 17025 accreditation, then the subcontracted 
external storage facility shall be Fit-for-Purpose and have its own ISO 
accreditation or certification (e.g., 17025, 20387, 9001). The transfer 
of the Samples to the external long-term storage facility or Laboratory 
shall be recorded.
    (iii) If Sample(s) are to be transported for storage at a location 
outside the secured area of the Laboratory that first analyzed the 
Sample(s), the Laboratory shall secure the A Sample(s) to be shipped 
either by re-sealing individual A Sample container(s) with a Tamper 
Evident sealing system, which has similar capabilities for security and 
integrity as the original sealing system, or by sealing the box in 
which the Sample(s) are shipped in a manner that maintains Sample 
integrity and Chain of Custody. For example, Sample(s) may be resealed 
with new resealing systems (e.g., new bottlecaps) produced by the 
manufacturer of an appropriate Sample collection equipment that 
replicates the security and Tamper Evident functionality of the 
original seal. The resealing system of shipped A Sample(s) shall be 
Tamper Evident.
    (iv) B Sample(s) to be shipped shall be individually sealed, either 
in the original, sealed B Sample container(s) or, if previously opened, 
by re-sealing the individual B Sample container(s) with a Tamper 
Evident sealing system, which has similar capabilities for security and 
integrity as the original sealing system.
    (v) During transport and long-term storage, Sample(s) shall be 
stored at a temperature appropriate to maintain the integrity of the 
Sample(s). In any Anti-Doping Rule Violation case, the issue of the 
Sample's transportation or storage temperature shall be considered 
where failure to maintain an appropriate temperature could have caused 
the Adverse Analytical Finding or other result upon which the Anti-
Doping Rule Violation is based.
    (vi) The Laboratory shall retain all Laboratory Internal Chain of 
Custody and technical records (as per ISO/IEC 17025) pertaining to a 
stored Sample for the duration of Sample storage, either as hard-copy 
or in digital format. In addition, the Laboratory may retain Sample 
analytical data which would allow retrospective analysis of such data, 
for example, for the purpose of identifying signals for novel 
Metabolite(s) of Prohibited Substance(s) or Marker(s) of Prohibited 
Substance(s) or Prohibited Method(s) (e.g., full-scan mass spectrometry 
data), as detailed in Rule 6313.
    (vii) If Sample(s) are transported to another Laboratory for long-
term storage, the Sample's external Chain of Custody and other non-
analytical records (e.g., Sample collection documentation) available to 
the transferring Laboratory shall also be transferred, immediately or 
upon later request, to the Laboratory storing the Samples or to the 
Agency, either as originals or copies.
    (4) The Agency as Sample custodians:
    (i) Sample(s) may also be transported for long-term storage to a 
Fit-for-Purpose, secure Sample storage facility, which is under the 
responsibility of the Agency. In such cases, the external storage 
facility shall have its own ISO accreditation or certification (e.g., 
17025, 20387, 9001) and shall maintain security requirements comparable 
to those applicable to a Laboratory. The Agency shall ensure that 
Samples are stored according to established protocols in a secure 
location under continuous Chain of Custody.
    (ii) The written request from the Agency for the transfer of the 
Sample(s) to long-term storage shall be properly documented. The 
transfer of the Samples to the external long-term storage facility 
shall also be recorded. The Laboratory shall secure the Sample(s) for 
transportation to the long-term storage facility as described above.
    (iii) The Laboratory shall retain all Laboratory Internal Chain of 
Custody and technical records (as per ISO/IEC 17025) pertaining to all 
Samples transferred for long-term storage for the duration of Sample 
storage, either as hard-copy or in digital format. In addition, the 
Laboratory may retain Sample analytical data which would allow 
retrospective analysis of such data. The Laboratory shall transfer the 
Sample's external Chain of Custody and other non-analytical records to 
the Agency, either as originals or copies, immediately or upon request.
    (f) For the purposes of this rule, ``storage'' refers to A and B 
Samples stored in Sample collection containers (urine collection 
bottles, blood collection tubes) and should not be confused with access 
to Aliquots, which should be accessible to analysts for the performance 
of Analytical Testing Procedures. However, minimum and maximum 
retention times apply to any

[[Page 5188]]

Aliquot(s) of a Sample that remains after completion of the Analytical 
Testing.
Rule 6320. Secondary Use or Disposal of Samples and Aliquots
    (a) The Laboratory shall maintain SOP(s) pertaining to the 
secondary use of Samples or Aliquots for research or quality assurance, 
as well as for the disposal of Samples and Aliquots.
    (b) If the Laboratory has discretion to dispose of a Sample, the 
Laboratory shall do one of the following with the Sample(s) and 
Aliquots as soon as practicable:
    (1) Disposal of the Sample(s) and Aliquots. Disposal of Samples and 
Aliquots shall be recorded under the Laboratory Internal Chain of 
Custody.
    (2) Secondary use of Samples and Aliquots for research and quality 
assurance. Samples and Aliquots shall be anonymized to ensure that any 
subsequent results cannot be traced back to a particular Covered Person 
or Covered Horse. Only after anonymization, may a Sample or Aliquot be 
used for:
    (i) Anti-doping research. The Covered Person or their 
representative's consent is not required for these purposes.
    (ii) Quality assurance, quality improvement of existing Test 
Methods, development or evaluation of Analytical Testing Procedures for 
Prohibited Substances or Prohibited Methods included in the Prohibited 
List at the time of Sample collection, or to establish reference 
population ranges or Thresholds or other statistical purposes. The 
Covered Person or their representative's consent is not required for 
these purposes.
    (c) The use of Samples and Aliquots for the purposes of this Rule 
6320 is subject to the following conditions:
    (1) The Laboratory must respect the Protocol and the Code of Ethics 
requirements related to research, types of permitted research, and 
respect of ethical standards for research or quality assurance studies 
involving equine subjects;
    (2) The Laboratory must not make any attempt to re-identify a 
Covered Person or Covered Horse from Samples or Aliquots used for the 
purposes of this Rule 6320 or data arising from any research or quality 
assurance analysis;
    (3) The Laboratory must consult the applicable State and Federal 
regulations, guidance, or authorities to determine whether a study 
shall be considered as falling under Rule 6320(c)(1) or (2) (if the 
Laboratory is unsure whether a study can proceed without consent after 
consulting the foregoing sources, the Laboratory shall consult with the 
Agency to determine whether it can proceed); and
    (4) In the event the Laboratory wishes to transfer Sample(s) or 
Aliquots to be used for the purposes of this Rule 6320 to another 
Laboratory or a third-party research institution or group, or wishes to 
partner with another Laboratory or research institution or group for 
the purpose of a study pursuant to Rule 6320(c)(1), the Laboratory 
shall subject the receiving party to the conditions described in this 
Rule 6320 by way of a written agreement and shall prohibit the 
receiving party from further transferring any Sample(s) or Aliquots or 
related data to another party.

6400. Evaluation of Laboratory EQAS

Rule 6410. Penalties
    (a) The Agency shall inform a Laboratory in writing about the 
imposition of penalties, corrective action, or other follow-up 
measures.
    (b) Technical or methodological error. If the Laboratory is able to 
remedy the technical or methodological error through the implementation 
of satisfactory corrective actions in a timely manner, as determined by 
the Agency, the Laboratory will not face any additional penalty.
    (c) Clerical/Administrative error. If the Laboratory is able to 
remedy the clerical or administrative error through the implementation 
of satisfactory corrective actions in a timely manner, as determined by 
the Agency, the Laboratory will not face any additional penalty. For 
the purposes of Laboratory performance evaluation, clerical/
administrative errors are defined as those incidental, non-systematic 
errors of no technical or methodological origin, which have been 
committed by the Laboratory during the performance of Analytical 
Testing (e.g., a typographical error when manually recording an 
analytical result). The Laboratory shall bear no responsibility for 
clerical/administrative errors reflected in the Laboratory 
documentation made by the Agency.
Rule 6420. Corrective Action Reports
    (a) A Corrective Action Report may be requested by the Agency. 
Where requested, it shall be submitted within the timeframe specified 
by the Agency in written notification about the unsatisfactory result. 
Failure to submit a satisfactory Corrective Action Report or the late 
submission of the Corrective Action Report without prior approval by 
the Agency may result in a penalty.
    (b) A Corrective Action Report related, for example, to 
nonconformities detected during the Agency Laboratory assessments, or 
to procedural or reporting nonconformities with the Laboratory 
Standards, Technical Documents or Technical Letters, or unsatisfactory 
performance in the analysis of EQAS samples (not related to a false 
Adverse Analytical Finding or false Negative Finding), shall be 
submitted to the Agency within 30 days of the Agency's notification to 
the Laboratory.
    (c) Unless otherwise agreed with the Agency, the corrective and 
preventive action(s) reported to and approved by the Agency shall be 
implemented immediately in the routine operations of the Laboratory.
    (d) The Corrective Action Report will be reviewed by the Agency as 
soon as practicable. If applicable, it will establish the source of the 
incorrect result as either a technical/methodological error or a 
clerical/administrative error.
    (e) Satisfactory Corrective Action Report. A Corrective Action 
Report will be considered as satisfactory when it meets the following 
criteria, as determined by the Agency:
    (1) Properly and concisely identifies the root cause(s) of the 
nonconformity, following an appropriate investigation into all the 
factors that may have caused the problem (Root Cause Analysis);
    (2) Leads to the documented implementation of effective corrective 
action(s) to solve the problem; and
    (3) Leads to the documented implementation of appropriate 
preventive actions, if applicable, to minimize the risk of recurrence 
of the problem.
    (f) A satisfactory Corrective Action Report shall include only the 
necessary supporting documentation (e.g., raw analytical data, data 
review files, evidence of procurement of Reference Materials) which 
demonstrates the implemented actions described in the Corrective Action 
Report.
    (g) Unsatisfactory Corrective Action Report. If the Laboratory's 
Corrective Action Report is considered unsatisfactory by the Agency, 
the Agency should provide feedback to the Laboratory and provide it 
with the opportunity to resubmit a revised Corrective Action Report 
within 7 days, or as otherwise agreed by the Agency.
    (h) If the Laboratory is unable to submit a satisfactory revised 
Corrective Action Report in a timely manner, as determined by the 
Agency, the Agency may impose a penalty.
Rule 6430. Laboratory Self-Reporting
    The Laboratory must identify and report all errors in Sample 
analysis resulting in a false Adverse Analytical

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Finding or a false Negative Finding. Self-reporting will be taken into 
consideration by the Agency in determining whether or not to impose a 
penalty (or what that penalty will be).
Rule 6440. Evaluation of EQAS Results
    (a) Satisfactory EQAS performance in a single EQAS round and over a 
consecutive 12-month period is necessary for maintaining HEAL 
accreditation. An EQAS round is a distribution of EQAS sample(s) to the 
Laboratories and the probationary laboratories for Analytical Testing 
(as defined by the Agency). The 12-month period is defined as the most 
recent consecutive 12-month interval starting either from the date that 
the Laboratory or the probationary laboratory reported the 
nonconforming result (EQAS or routine Analytical Testing, as 
applicable) to, and in a form designated by, the Agency, or from the 
date that the Laboratory or probationary laboratory is informed, in 
writing, of nonconformity by the Agency, whichever is more favorable to 
the Laboratory or the probationary laboratory.
    (b) Unsatisfactory performance in an educational EQAS for a new or 
the Agency-specific Analytical Testing Procedure may prevent the 
Laboratory from seeking an extension of the Laboratory's scope of ISO/
IEC 17025 accreditation for the Analytical Testing Procedure and from 
its application in routine Analytical Testing. In such circumstances, 
the Laboratory may only apply the new Agency-approved method or 
procedure for routine Sample analysis when it properly corrects the 
deficiencies identified in the educational EQAS (as determined by the 
Agency) and the method is included in the Laboratory's scope of ISO/IEC 
17025 accreditation. Some Analytical Testing Procedures are not 
eligible for a flexible scope of ISO/IEC 17025 accreditation and 
require specific Agency approval before the Laboratory can apply the 
procedure to the analysis of Samples. Agency approval will be based on 
its assessment of the Fitness-for-Purpose of the Analytical Testing 
Procedure, method validation by the Laboratory, and the successful 
Laboratory participation in an inter-laboratory collaborative study or 
the Agency EQAS round. The Agency will communicate which Analytical 
Testing Procedures fall into this category to the Laboratories and to 
the Accreditation Bodies.
Rule 6441. EQAS Samples Containing Non-Threshold Substances
    (a) When a qualitative determination of a Non-Threshold Substance 
has been reported, the Laboratory result will be evaluated on the basis 
of the correct reporting of the finding (e.g., Adverse Analytical 
Finding, Negative Finding) as intended in the preparation of the EQAS 
sample.
    (b) The results for any Non-Threshold Substance or its 
Metabolite(s) or Marker(s) at concentrations greater than (>) the MRPL 
(or exceeding 120% of the Minimum Reporting Level, when applicable) 
shall be evaluated.
    (c) The results for any Non-Threshold Substance or its 
Metabolite(s) or Marker(s) at concentrations between 50% of the MRPL 
and the MRPL (or less than 120% of the Minimum Reporting Level, when 
applicable) may require an internal investigation and Corrective Action 
Report from the Laboratory.
    (d) If the results for any Non-Threshold Substance or its 
Metabolite(s) or Marker(s) are at concentrations below (<) 50% of the 
applicable MRPL in an EQAS sample, the Laboratory shall report its 
finding(s) if the analyses are compliant with its validation data, 
SOPs, the Laboratory Standards, and any applicable Technical Document. 
Laboratories unable to report such substance(s) are encouraged, on 
receipt of the EQAS report, to consider re-assessment of their 
Analytical Testing Procedure.
Rule 6442. EQAS Samples Containing Threshold Substances
    (a) For EQAS samples containing Threshold Substances at levels 
greater than (>) 50% of the Threshold, the quantitative determination 
will be statistically evaluated (e.g., z-score, degree of equivalence 
analysis) to determine the compatibility of the reported result with 
the assigned value (reference, nominal or consensus value, as 
applicable).
    (b) A Laboratory is to achieve a satisfactory statistical 
evaluation of quantitative results reported based on the mean of 2 
replicate determinations. The overall evaluation of the quantitative 
performance is based on the criteria indicated in any relevant 
Technical Document or Technical Letter, or the Laboratory Guidelines.
    (c) The main criterion applied for the evaluation of EQAS results 
for the quantification of Threshold Substances is the compatibility of 
the reported Laboratory result with the assigned value. Therefore, the 
incorrect reporting of an EQAS sample as a Negative Finding or as an 
Adverse Analytical Finding, as applicable, when the assigned value of 
the Threshold Substance in the EQAS sample is close to the Threshold, 
is not considered as a false Negative Finding or false Adverse 
Analytical Finding, respectively, if the absolute z-score (truncated to 
one decimal place) for the Laboratory's quantitative result is <3.0.
    (d) Unsatisfactory quantitative result for Threshold Substances 
(absolute z-score >= 3.0). The Laboratory shall provide the Agency with 
a Corrective Action Report for an unsatisfactory quantitative result. 
The z-score is calculated according to the formula [z = (y-[ycirc])/
[delta]], where y is the mean value of the Laboratory's replicate 
determinations; [ycirc] is the assigned value (reference, nominal or 
consensus value, as applicable); [delta] is the target standard 
deviation (e.g., uc_Max or robust Reproducibility sR of results from 
all participant Laboratories). The z-score is truncated to one decimal 
place.
    (e) Questionable quantitative result (absolute z-score > 2.0 and < 
3.0). The Laboratory shall perform an internal investigation to 
determine the root cause(s) of the questionable result and implement 
appropriate corrective measures to resolve them.
    (f) EQAS evaluation of Laboratory performance. Where an EQAS result 
is reported incorrectly, the Laboratory shall provide the Agency with a 
Corrective Action Report.
    (g) Double-blind, blind EQAS and educational EQAS samples. Failure 
to report accurately, in accordance with criteria, 3 blind or double-
blind EQAS, or educational EQAS results within a continuous twelve 12-
month period may result in penalties imposed by the Agency, including, 
but not limited to, potential suspension or revocation of HEAL 
accreditation, or Analytical Testing Restrictions.
Rule 6443. False Adverse Analytical Finding or False Negative Finding
    (a) If the Laboratory discovers that it reported a false Adverse 
Analytical Finding or false Negative Finding, the Laboratory shall 
inform the Agency immediately.
    (b) When the false Adverse Analytical Finding or false Negative 
Finding is identified by the Agency, through the Agency's own Results 
Management activities or through any other means, the Agency shall 
inform the Laboratory as soon as practicable.
    (c) The Agency, considering the nature of the error that caused the 
false Adverse Analytical Finding or false Negative Finding, may impose 
a penalty, including, but not limited to, potential suspension or 
revocation of HEAL accreditation, or Analytical Testing Restrictions 
against the Laboratory for a particular Analytical Testing Procedure or 
for the analysis of a particular class of Prohibited Substances or 
Prohibited Methods, as

[[Page 5190]]

applicable, or other follow-up measures. For example, the Laboratory 
may be required by the Agency to analyze EQAS samples or to review the 
relevant analytical results and to re-analyze any relevant and 
available Samples previously reported as Adverse Analytical Findings 
during the preceding 12 months (or during a period otherwise determined 
by the Agency) within 7 days (unless informed otherwise by the Agency). 
Depending on the nature of the error that caused the false Adverse 
Analytical Finding or false Negative Finding, this re-analysis may be 
limited to one Analyte, a class of Prohibited Substances or Prohibited 
Methods, or may include any Prohibited Substance or Prohibited Method. 
A statement signed by the Laboratory Director shall record this re-
analysis. The retrospective review of the analytical results and re-
analysis of previous relevant Samples reported as Adverse Analytical 
Finding(s) shall be performed with the objective of determining whether 
any other related (i.e., produced by the same root cause(s)) false 
Adverse Analytical Finding(s) have been reported by the Laboratory. The 
discovery of additional false Adverse Analytical Finding(s) shall lead 
to the implementation of corrective measures and shall be communicated 
to the Agency.
    (1) During the period of suspension, the Laboratory shall follow 
the instructions provided in Rule 6561 in regard to Samples in the 
Laboratory's possession at the time of suspension. Alternatively, if an 
Analytical Testing Restriction has been imposed, the Laboratory shall 
subcontract the affected analyses as provided in Rules 6560 and 6302.
    (2) During the suspension or Analytical Testing Restriction period, 
the Agency will conduct an assessment (preferably on-site) of the 
Laboratory, including the analysis of further EQAS samples.
    (3) The suspension or Analytical Testing Restriction of the 
Laboratory shall be lifted only when the aforementioned conditions are 
satisfactorily completed, and the Laboratory provides sufficient 
evidence, as determined by the Agency and in the Agency's sole 
discretion, that appropriate steps have been taken to remedy the 
issue(s) that resulted in the suspension or Analytical Testing 
Restriction.
Rule 6450. Further Procedural Evaluations
    If the Agency considers that a Corrective Action Report is 
unsatisfactory, and the Laboratory is not able to provide a 
satisfactory revised Corrective Action Report within a reasonable time 
frame after receiving feedback from the Agency, the Laboratory may 
receive a penalty, at the Agency's discretion. Rule 6450 does not apply 
to the evaluation of Corrective Action Reports for false Adverse 
Analytical Findings or false Negative Findings, which are covered in 
Rule 6443.
Rule 6460. Overall Laboratory Evaluation
    (a) The Agency shall evaluate Laboratory EQAS performance for each 
EQAS round, as well as Laboratory performance for routine Analytical 
Testing, and assign penalties, including corrective actions or other 
follow-up measures, in the Agency's sole discretion.
    (b) If a Laboratory under suspension as a result of EQAS 
performance is not capable of correcting the issue(s) before the end of 
the suspension period, then the Agency may extend the Laboratory's 
suspension for up to an additional 6 months or until such a time when 
the Laboratory can satisfactorily correct all the issues identified (at 
the Agency's discretion). If the Laboratory under suspension fails to 
satisfy performance criteria during an extended period of suspension 
(beyond the initial 6 months), then the Agency may Revoke the 
Laboratory's accreditation.
    (c) Laboratories under an Analytical Testing Restriction remain 
operational (except for any activities under the Analytical Testing 
Restriction) and, therefore, are evaluated during the Analytical 
Testing Restriction as any other, fully operational Laboratory.
Rule 6470. Probationary Period and Probationary Laboratory Evaluation
    (a) The probationary EQAS is a part of the initial evaluation of a 
probationary laboratory seeking HEAL accreditation. Successful 
participation in the Agency probationary EQAS is required before a 
probationary laboratory is eligible to be considered for full HEAL 
accreditation. The Agency may decide, based on its evaluation of the 
overall performance of the probationary laboratory, to extend the 
probationary period of accreditation.
    (b) The Agency will evaluate probationary laboratory EQAS 
performance.
    (c) Serious and repeated issues in the probationary EQAS shall 
result in the removal of the laboratory's status as a probationary 
laboratory by the Agency.
    (d) Any false Adverse Analytical Finding or false Negative Finding 
of a technical or methodological nature reported automatically suspends 
a probationary laboratory from further consideration for HEAL 
accreditation.
    (e) A suspended probationary laboratory wishing to re-enter the 
probationary EQAS is required to provide documentation of corrective 
and preventive action(s) no later than 30 days prior to the end of the 
suspension period (unless otherwise indicated by the Agency). Failure 
to do so will preclude the laboratory from participating in the 
probationary EQAS.
    (f) Lifting of the suspension occurs only when proper corrective 
and preventive actions have been implemented and reported to the 
Agency. The Agency may choose, at its sole discretion, to submit 
additional EQAS samples to the laboratory or to require that the 
laboratory be reassessed, at the expense of the laboratory. 
Laboratories re-entering the probationary EQAS shall be considered 
candidate laboratories and are required to provide the applicable 
accreditation fee and documentation to the Agency.
Rule 6480. Removal of Samples by the Agency for Analysis or Further 
Analysis
    (a) Within the context of an investigation or Laboratory 
performance monitoring activity (for example, during an on-site Agency 
Laboratory assessment), the Agency, initially at its expense, may 
remove Sample(s) from a Laboratory to conduct Further Analysis, or 
analysis of the Sample if the analytical results for that Sample have 
not yet been reported, for any purpose described in the Protocol. The 
Agency shall retain the right to request analysis or Further Analysis, 
at its expense, as permitted by the Protocol.
    (b) The Agency may delegate an observer to monitor the removal of 
the Samples, which shall be implemented in accordance with the Agency's 
instructions. During the removal of Samples, the Agency shall be 
responsible for maintaining proper Sample Chain of Custody 
documentation and the safety and integrity of the Samples until receipt 
by the other Laboratory(-ies).
    (c) The Agency may also require that the Laboratory transfer the 
Samples to other Laboratories selected by the Agency. In such 
situations, the Laboratory shall be responsible for maintaining proper 
Chain of Custody documentation for all transferred Samples and the 
safety and integrity of the Samples until receipt by the receiving 
Laboratory(-ies).
    (d) Where for any reason (except where Rule 6312 applies), a 
Laboratory transfers a Sample to another Laboratory, the first 
Laboratory shall

[[Page 5191]]

send the Sample within 5 business days following receipt by the first 
Laboratory of the request to transfer the Sample.
    (e) In connection with its monitoring of Laboratory performance, 
the Agency may direct Further Analysis of a Sample which has resulted 
in an Anti-Doping Rule Violation without consent of the Covered Person 
or approval from an adjudication body, as provided in the Protocol.
Rule 6490. Removal of Samples by the Agency for Laboratory Quality 
Assessment
    The Agency may also direct the re-analysis of anonymized Samples, 
which have met the conditions described in Rule 6320, for purposes of 
Laboratory quality assurance and education, including the 
implementation of a system of transfer of Samples reported as Negative 
Findings between Laboratories. In this regard, the number of Samples 
directed by the Agency for re-analysis may vary.

6500. Withdrawal of HEAL Accreditation

Rule 6510. Withdrawal of HEAL Accreditation
    (a) A Laboratory's HEAL accreditation may be suspended, Revoked, or 
subject to an Analytical Testing Restriction, whenever the Laboratory 
fails to comply with the Laboratory Standards, Technical Documents, or 
Technical Letters, or where the suspension, Revocation or Analytical 
Testing Restriction is otherwise required to protect the integrity of 
the Samples, the Analytical Testing process or the interests of the 
anti-doping community.
    (b) The imposition of an Analytical Testing Restriction or the 
suspension of a Laboratory's HEAL accreditation shall not imply the 
automatic withdrawal of its ISO/IEC 17025 accreditation. The status of 
the Laboratory's ISO/IEC 17025 accreditation is to be independently 
assessed by the relevant accreditation body.
    (c) The Agency may suspend a Laboratory's HEAL accreditation or 
impose an Analytical Testing Restriction against a Laboratory if the 
Agency identifies noncompliance with the Laboratory Standards, 
Technical Documents, or Technical Letters based on the Laboratory's 
performance during the EQAS or during routine Analytical Testing.
    (d) The Laboratory may not challenge the penalty imposed by the 
Agency.
Rule 6520. Noncompliance With the Laboratory Standards
    (a) Noncompliance with the Laboratory Standards that may lead to an 
Analytical Testing Restriction, suspension or Revocation of HEAL 
accreditation, or other follow-up measures include, but are not limited 
to:
    (1) Suspension or withdrawal of ISO/IEC 17025 accreditation;
    (2) Failure to establish or maintain administrative and operational 
independence as described in paragraph (b)(7) of Rule 6110;
    (3) Failure to analyze the minimum number of Samples indicated in 
paragraph (i) of Rule 6130 (except where the Agency fails to send the 
minimum annual number of Samples to the Laboratory);
    (4) Reporting of false Adverse Analytical Findings or false 
Negative Findings;
    (5) Failure to implement a Technical Document or Technical Letter 
by the effective date without prior approval of the Agency;
    (6) Failure to comply with any of the requirements or standards 
listed in the Laboratory Standards, Technical Documents or Technical 
Letters;
    (7) Noncompliance with results reporting timelines in Rule 6316;
    (8) Failure to take appropriate corrective action after an 
unsatisfactory performance during routine Analytical Testing or in a 
blind EQAS or double-blind EQAS round;
    (9) Failure to take appropriate corrective action for Laboratory 
Standards, Technical Document(s), or Technical Letter(s) 
noncompliance(s) identified from the Agency Laboratory assessment(s);
    (10) Analysis of Samples from the Agency in violation of a 
suspension or Analytical Testing Restriction decision;
    (11) Failure to cooperate with the Agency in providing 
documentation or other requested information;
    (12) Noncompliance with the Code of Ethics; or
    (13) Any other cause that materially affects the ability of the 
Laboratory to ensure the full reliability and accuracy of Analytical 
Testing and the accurate reporting of test results.
    (b) Laboratory staff or management issues which may lead to an 
Analytical Testing Restriction, suspension or Revocation of HEAL 
accreditation, or other follow-up measures include, but are not limited 
to:
    (1) Major changes in senior Laboratory management positions (e.g., 
Laboratory Director, Quality Manager) without proper and timely 
notification (usually within 30 days) to the Agency;
    (2) Failure to appoint a permanent Laboratory Director or other 
senior management positions (e.g., Quality Manager) within a reasonable 
time period;
    (3) Failure to guarantee the competence or proper training of 
scientific staff including, for example, the qualification of analysts 
as Certifying Scientists and Laboratory Supervisory Personnel;
    (4) Significant loss or lack of experienced staff (e.g., Certifying 
Scientists) that affects, as determined by the Agency, the Laboratory's 
ability to ensure the full reliability and accuracy of Analytical 
Testing and reporting of test results;
    (5) Conviction of any key personnel for any criminal offence that 
is determined by the Agency to impact the operations of the Laboratory;
    (6) Loss of sufficient Laboratory support and resources that 
affects, as determined by the Agency, the quality or viability of the 
Laboratory; or
    (7) Failure to cooperate in any Agency inquiry in relation to the 
activities of the Laboratory.
Rule 6530. Notification of Penalty Decision
    The Agency shall provide the Laboratory with written notice of its 
decision regarding penalties. This notice shall state the following:
    (a) That the Laboratory's HEAL accreditation has been maintained 
(including warnings, if applicable); or
    (b) That the Laboratory's HEAL accreditation has been suspended or 
Revoked or that an Analytical Testing Restriction has been imposed 
against the Laboratory. Such notice shall include:
    (1) the reason(s) for suspension, Revocation, or the imposition of 
an Analytical Testing Restriction;
    (2) the terms of the suspension, Revocation, or Analytical Testing 
Restriction;
    (3) the period of suspension or Analytical Testing Restriction, if 
applicable; and
    (4) Any corrective actions or other follow-up requirements imposed 
upon the Laboratory by the Agency.
Rule 6540. Effective Date and Appeals
    (a) A Revocation, suspension, or Analytical Testing Restriction is 
effective immediately upon receipt of notification of the Agency's 
decision.
    (b) The Agency's decision is not subject to appeal.
Rule 6550. Public Notice
    (a) The Agency shall publicly announce a change in a Laboratory's 
accreditation status (including, if appropriate, any Analytical Testing 
Restriction) on its website as soon as practicable after the Laboratory 
is notified by the Agency of its decision.

[[Page 5192]]

    (b) The Agency's website shall be updated regarding a Laboratory's 
accreditation status when:
    (1) the Laboratory's HEAL accreditation is reinstated following a 
suspension;
    (2) an Analytical Testing Restriction is removed (if appropriate); 
or
    (3) a Laboratory whose accreditation has previously been Revoked is 
re-accredited.
Rule 6560. Consequences of an Analytical Testing Restriction
    (a) If the Agency determines that the noncompliance(s) are limited 
to a class of Prohibited Substances or Prohibited Methods or to a 
specific Analytical Testing Procedure, which are not included in the 
standard Analytical Testing menu requested by the Agency for Samples 
received by the Laboratory, the Agency may impose an Analytical Testing 
Restriction for that class of Prohibited Substance(s) or Prohibited 
Method(s) or for the specific Analytical Testing Procedure in which the 
noncompliance(s) occurred.
    (b) If the reason for the Analytical Testing Restriction was 
related to the reporting of false Adverse Analytical Finding(s), all 
analyses employing the affected Analytical Testing Procedure(s) shall 
cease immediately.
    (c) The Laboratory under an Analytical Testing Restriction shall 
contact the Agency to arrange for the transfer of the relevant Samples 
to subcontracted Laboratory(-ies), selected by the Agency, within 30 
days of being notified of the Analytical Testing Restriction decision. 
All associated costs shall be borne by the Laboratory under Analytical 
Testing Restriction. The Laboratory shall transfer the following 
Samples (A and B Samples) in the Laboratory's custody, which involve 
the analysis of the same class of Prohibited Substances or Prohibited 
Methods, or the application of the affected Analytical Testing 
Procedure(s) subjected to the Analytical Testing Restriction, to 
another Laboratory(-ies) for the performance of the A and, if needed, 
the B Confirmation Procedures, unless otherwise instructed by the 
Agency:
    (1) Samples which had been previously reported as an Adverse 
Analytical Finding (as requested by the Agency);
    (2) Samples which had been opened and were undergoing analysis for 
the Initial Testing Procedure(s) at the time of the Analytical Testing 
Restriction decision;
    (3) Samples for which, at the time of the Analytical Testing 
Restriction decision, Initial Testing Procedure(s) had been completed 
and had produced Presumptive Adverse Analytical Findings requiring 
Confirmation Procedures, and Samples that are the subject of other 
Confirmation Procedures;
    (4) Samples for which the A or B Confirmation Procedures had been 
completed, but results of the analysis had not been reported by the 
Analytical Testing Restriction date, and Samples which were undergoing 
A or B Confirmation Procedures at the time of the imposition of the 
Analytical Testing Restriction;
    (5) Samples which had been reported as Adverse Analytical Findings 
based on the A Confirmation Procedure prior to the imposition of the 
Analytical Testing Restriction. These Samples shall be kept in the 
Laboratory under proper Laboratory Internal Chain of Custody and 
appropriate storage conditions. Should a B Confirmation Procedure be 
requested during the period of the Analytical Testing Restriction, both 
A and B Samples shall be transferred to another Laboratory(-ies) 
selected by the Agency for the A Confirmation Procedure to be performed 
again and for the performance of the B Confirmation Procedure, if 
applicable; and
    (6) If the Analytical Testing Restriction was caused by the 
reporting of false Negative Finding(s), and further investigation 
reveals that other Negative Finding(s) had been reported for Samples 
that are still stored in the Laboratory, the Laboratory shall inform 
the Agency. In such cases, both the A and B containers of the relevant 
Samples shall be transferred to another Laboratory(-ies) selected by 
the Agency for Further Analysis, as determined by the Agency. These re-
analyses may be applied to the class of Prohibited Substances or 
Prohibited Methods or to the Analytical Testing Procedure(s) that were 
associated with the Negative Finding(s), as determined by the Agency.
Rule 6561. Consequences of Suspension
    (a) A Laboratory whose HEAL accreditation has been suspended is 
ineligible to perform Analytical Testing of Samples.
    (b) Suspension for violation of the Code of Ethics. If the reason 
for the suspension was related to a violation of the Code of Ethics, 
all Analytical Testing in the suspended Laboratory shall cease 
immediately and the Laboratory shall transfer all Samples (both the A 
and B Samples) in the Laboratory's custody to other Laboratory(-ies) 
selected by the Agency.
    (c) Suspension for reporting of false Adverse Analytical 
Finding(s). If the reason for the suspension was related to the 
reporting of false Adverse Analytical Finding(s), all Analytical 
Testing shall cease immediately. In addition, the Laboratory shall 
transfer the following Samples (A and B Samples) in the Laboratory's 
custody to another Laboratory(-ies) selected by the Agency for the 
performance of the A and, if needed, the B Confirmation Procedures, 
unless otherwise instructed by the Agency:
    (1) Samples which had been previously reported as an Adverse 
Analytical Finding for the same class of Prohibited Substances or 
Prohibited Methods when applying the same Confirmation Procedure (as 
requested by the Agency);
    (2) Samples for which, at the time of the suspension decision, 
Initial Testing Procedure(s) had been completed and had produced 
Presumptive Adverse Analytical Findings requiring Confirmation 
Procedures, and Samples that are the subject of other Confirmation 
Procedures;
    (3) Samples which had been opened and were undergoing analysis for 
the Initial Testing Procedure(s) at the time of the suspension;
    (4) Samples which had been received at the Laboratory but had not 
been opened at the time of the suspension. (These Samples shall be kept 
sealed in the Laboratory under proper Laboratory Internal Chain of 
Custody and appropriate storage conditions until transfer to another 
Laboratory(-ies) selected by the Agency);
    (5) Samples for which A or B Confirmation Procedures had been 
completed, but results of the analysis had not been reported by the 
suspension date, and Samples which were undergoing A or B Confirmation 
Procedures at the time of the suspension; and
    (6) Samples which had been reported as Adverse Analytical Findings 
based on the A Confirmation Procedure prior to the suspension.
    (d) Suspension for other reasons. A Laboratory that has had its 
HEAL accreditation suspended for reasons other than a violation of the 
Code of Ethics or the reporting of false Adverse Analytical Findings(s) 
shall take the following steps with respect to the Samples in the 
Laboratory's custody, unless otherwise instructed by the Agency:
    (1) Samples which had been analyzed and reported as a Negative 
Finding, and which have either been stored in the Laboratory for a 
period of less than 3 months or have been placed in long-term storage 
upon request by the Agency shall be kept in the Laboratory

[[Page 5193]]

under proper Laboratory Chain of Custody and appropriate storage 
conditions. The Laboratory shall inform the Agency of such actions, 
including the provision of the Sample codes.
    (2) If the suspension was caused by the reporting of false Negative 
Finding(s), and further investigation reveals that other Negative 
Finding(s) had been reported by the Laboratory, the Laboratory shall 
inform the Agency. In such cases, both the A and B containers of the 
relevant Samples shall be transferred to another Laboratory(-ies) 
selected by the Agency for Further Analysis, as determined by the 
Agency. These analyses may be applied for all the Prohibited Substances 
and Prohibited Methods included in the Analytical Testing menu 
requested by the Agency or be limited to the class of Prohibited 
Substances or Prohibited Methods or to the Analytical Testing 
Procedure(s) that were associated with the Negative Finding(s), as 
determined by the Agency.
    (3) Samples for which Initial Testing Procedures had been 
completed, but results had not been reported at the time of the 
suspension:
    (i) If the Initial Testing Procedure(s) produced Presumptive 
Adverse Analytical Finding(s) or other Confirmation Procedures were 
required, both the A and B Samples shall be transferred to another 
Laboratory(-ies) selected by the Agency for the performance of the A 
and, if needed, the B Confirmation Procedures.
    (ii) In addition, if the suspension was caused by the reporting of 
false Negative Finding(s) and the Initial Testing Procedure(s) had 
produced negative results, both the A and B Samples shall also be 
transferred to another Laboratory(-ies) selected by the Agency for the 
repetition of the Initial Testing Procedure(s) and, if needed, the 
performance of Confirmation Procedures. These analyses may be applied 
for all the Prohibited Substances and Prohibited Methods included in 
the Analytical Testing menu requested by the Agency or be limited to 
the class of Prohibited Substances or Prohibited Methods or to the 
Analytical Testing Procedure(s) that were associated with the Negative 
Finding, as determined by the Agency.
    (iii) If the reason for the suspension was not related to the 
reporting of false Negative Findings and the Initial Testing Procedures 
had produced negative results, the Sample(s) shall be reported to the 
Agency as Negative Finding(s). These Samples shall be kept in the 
Laboratory under proper Laboratory Internal Chain of Custody and 
appropriate storage conditions until further notice by the Agency. The 
Laboratory shall inform the Agency of such actions including the 
provision of the Sample codes.
    (4) Samples which had been opened and were undergoing analysis for 
the Initial Testing Procedure(s) at the time of the suspension:
    (i) If the reason for suspension was not related to the reporting 
of false Negative Finding(s), the Laboratory shall continue to analyze 
the relevant Samples until all Initial Testing Procedures are 
completed. If the Initial Testing Procedures produce Negative Findings, 
the Laboratory shall report these findings to, and in a form designated 
by, the Agency, and these Samples shall be kept in the Laboratory under 
proper Laboratory Chain of Custody and appropriate storage conditions 
until further notice by the Agency. The Laboratory shall inform the 
Agency of such actions, including the provision of the Sample codes.
    (ii) However, if the Initial Testing Procedure produced a 
Presumptive Adverse Analytical Finding, both the A and B Samples shall 
be transferred to another Laboratory(-ies) selected by the Agency for 
the performance of the A and, if needed, the B Confirmation Procedures.
    (iii) If the suspension was caused by the reporting of false 
Negative Finding(s), then the Laboratory shall cease all Analytical 
Testing and have the A and B Samples transferred to another 
Laboratory(-ies) selected by the Agency for the performance of the A 
and, if needed, the B Confirmation Procedures.
    (5) Samples which had been received at the Laboratory but had not 
been opened yet at the time of the suspension: these Samples shall be 
kept sealed in the Laboratory under proper Laboratory Chain of Custody 
and appropriate storage conditions until transfer to another 
Laboratory(-ies) selected by the Agency for Analytical Testing.
    (6) Samples for which A or B Confirmation Procedures had been 
completed, but results of analysis had not been reported by the 
suspension date, and Samples which were undergoing A or B Confirmation 
Procedures at the time of the suspension: both the A and B Samples 
shall be transferred to another Laboratory(-ies) selected by the Agency 
for the repetition of the A and, if applicable, the B Confirmation 
Procedures.
    (7) Samples which had been reported as an Adverse Analytical 
Finding based on the A Confirmation Procedure prior to the suspension:
    (i) These Samples shall be kept in the Laboratory under proper 
Laboratory Internal Chain of Custody and appropriate storage 
conditions. Should a B Confirmation Procedure be requested during the 
suspension, both A and B Samples shall be transferred to another 
Laboratory(-ies) selected by the Agency for the A Confirmation 
Procedure to be performed again and for the performance of the B 
Confirmation Procedure, if applicable.
    (ii) During a suspension or Analytical Testing Restriction period, 
the Laboratory shall continue to participate in the Agency EQAS 
program. The Agency may require the Laboratory to analyze additional 
blind EQAS samples or perform a Laboratory assessment, at any time and 
at the expense of the Laboratory, in order to evaluate the Laboratory's 
status.
Rule 6562. Revocation
    (a) A laboratory whose HEAL accreditation has been revoked is 
ineligible to perform Analytical Testing of Samples. The Laboratory 
Internal Chain of Custody maintained by a revoked laboratory for stored 
Samples is valid until such time that arrangements can be made, in 
consultation with the Agency, for the transfer of relevant Samples to a 
Laboratory(-ies) selected by the Agency.
    (b) A laboratory whose HEAL accreditation has been revoked shall 
arrange the transfer of Samples in the laboratory's custody to a 
Laboratory(-ies) selected by the Agency, respectively, within 30 days 
of being notified of the decision revoking its HEAL accreditation. In 
such circumstances, the Samples to be transferred shall be selected by 
the Agency. The laboratory transferring the Samples shall inform the 
Agency and provide the relevant Sample codes and the selected 
Laboratory(-ies). In addition, the revoked laboratory shall assist with 
the transfer of the relevant Sample data and records to the 
Laboratory(-ies) that have been selected to receive the Samples.
    (c) The revoked laboratory shall transfer all Samples in its 
custody for which the Analytical Testing process has not been completed 
at the time of the Revocation. The Agency may also choose to transfer 
additional Samples retained in the laboratory in accordance with 
paragraphs (a) through (d) of Rule 6319, or other Samples for which it 
is the owner pursuant to the Testing and Investigations Standards and 
that had been analyzed and were in long-term storage at the time of the 
Revocation of the laboratory's HEAL accreditation. In addition, the 
Agency may identify and

[[Page 5194]]

request that Samples be transferred to another Laboratory(-ies) 
selected by the Agency.
Rule 6563. Reinstatement of Suspended Accreditation or Lifting of 
Analytical Testing Restriction
    The Agency shall lift the suspension of the Laboratory's HEAL 
accreditation or lift the Analytical Testing Restriction only when the 
Laboratory provides satisfactory evidence, as determined by the Agency 
in its sole discretion, that appropriate steps have been taken to 
remedy the noncompliance(s) that resulted in the suspension of the 
Laboratory's HEAL accreditation or the imposition of the Analytical 
Testing Restriction, and that proper measures have been implemented to 
satisfactorily address the condition(s) specified, if any, for 
reinstatement of HEAL accreditation.
Rule 6564. Extension of Suspension or Analytical Testing Restriction
    (a) If a Laboratory whose HEAL accreditation has been suspended or 
which has been the subject of an Analytical Testing Restriction has not 
satisfactorily corrected the Laboratory Standards, Technical 
Document(s), or Technical Letter(s) noncompliance(s) that resulted in 
the suspension or Analytical Testing Restriction, or if the Agency 
identifies any additional Laboratory Standards, Technical Document(s) 
or Technical Letter(s) noncompliance(s) during an Agency Laboratory 
assessment conducted during the initial suspension or Analytical 
Testing Restriction period, either the suspension of the Laboratory's 
HEAL accreditation or the Analytical Testing Restriction may be further 
extended, or the Laboratory's accreditation shall be revoked, as 
determined by the Agency. The suspension or Analytical Testing 
Restriction period may be extended up to an additional 6 months, if the 
Laboratory provides valid explanation(s) for the delay, as determined 
by the Agency, in addressing the conditions to lift the suspension or 
Analytical Testing Restriction (including the submission of 
satisfactory corrective actions).
    (b) If applicable, a delay in the delivery of the ISO/IEC 17025 
accreditation to the Laboratory by the relevant accreditation body may 
also constitute grounds to extend the suspension of the Laboratory's 
HEAL accreditation.
    (c) The decision to extend the suspension of a Laboratory's HEAL 
accreditation or the period of the Analytical Testing Restriction shall 
be made in the Agency's sole discretion.
    (d) If, in accordance with the terms of the extension of the 
suspension of the Laboratory's HEAL accreditation or the terms of the 
extension of the Analytical Testing Restriction, the Laboratory 
provides evidence determined to be satisfactory by the Agency that all 
of the identified Laboratory Standards, Technical Document(s), or 
Technical Letter(s) noncompliance(s) have been corrected, the 
Laboratory's accreditation may be re-instated or the Analytical Testing 
Restriction may be lifted by decision of the Agency in its sole 
discretion.
    (e) If the Laboratory has not provided evidence determined to be 
satisfactory by the Agency at the end of the extended suspension or 
extended Analytical Testing Restriction period, the Agency may Revoke 
the Laboratory's accreditation.
    (f) The Agency will notify the Laboratory of its decision to revoke 
the Laboratory's HEAL accreditation in accordance with Rule 6530.
Rule 6565. Revoked Accreditation
    (a) If a laboratory whose HEAL accreditation has been revoked 
wishes to seek a new HEAL accreditation, it must apply for HEAL 
accreditation as a new laboratory in accordance with Rule 6110.
    (b) When seeking a new HEAL accreditation, the laboratory may 
request that the Agency expedite the laboratory re-accreditation 
procedure, which may be approved by the Agency. To do so the laboratory 
shall provide the Agency, as part of its application for a new 
accreditation, information that it considers constitutes ``exceptional 
circumstances'' as justification for modifying the requirements of Rule 
6110 to expedite the entry of the laboratory into, or shortening the 
duration of, the probationary phase of accreditation. At its sole 
discretion, the Agency may determine whether such modifications are 
justified, and which steps must be followed prior to granting approval 
to the laboratory to enter the probationary phase of accreditation.
Rule 6570. Voluntary Cessation of Laboratory Operations
    (a) A Laboratory may decide to voluntarily cease its anti-doping 
Analytical Testing operations on either a temporary or permanent basis, 
despite not having been found to have committed any analytical failures 
or other Laboratory Standards noncompliance(s) and not having been 
subject to an Analytical Testing Restriction or suspension or 
Revocation of its HEAL accreditation.
    (b) In such circumstances, the Laboratory shall inform the Agency 
and provide, in writing, the reason(s) for the cessation of anti-doping 
Analytical Testing operations as soon as the decision is made to cease 
its operations and, in any event, no later than 3 months prior to the 
date on which its decision shall take effect. The Laboratory shall also 
take all necessary measures to notify all its clients of the decision 
to cease its operations and to arrange, in consultation with its 
clients, to transfer Samples to another Laboratory(-ies) selected by 
the Agency, in accordance with Rule 6561 (temporary closure) or Rule 
6562 (permanent closure).
    (c) If a Laboratory voluntarily ceases its anti-doping Analytical 
Testing operations on a temporary basis, the Laboratory shall maintain 
satisfactory performance in the analysis of EQAS samples during the 
period of inactivity. The period of temporary cessation of Analytical 
Testing activities shall not exceed 6 months, with one possible 
extension of up to 6 months (as determined by the Agency). If the 
Laboratory is unable to resume its Analytical Testing operations within 
a 12-month period, the Agency shall revoke the Laboratory's 
accreditation, unless otherwise approved by the Agency.
    (d) If a Laboratory decides to cease its operations on a permanent 
basis, the Laboratory shall assist the Agency with the transfer of 
relevant Sample data and records to the Laboratory(-ies) that have been 
selected by the Agency to receive the Samples.

6600. Code of Ethics for Laboratories and Research and Development 
Activity Requirements

Rule 6610. Code of Ethics for Laboratories
    (a) Compliance. Directors of Laboratories, their delegates and all 
Laboratory staff shall respect and comply with the Laboratory Standards 
and the Protocol. Laboratories and all of their staff shall maintain 
the confidentiality of all of data, items and information received in 
connection with Doping Control and Medication Control, including, but 
not limited to, Samples, Testing documentation, and communications with 
the Agency.
    (b) Research in support of Doping Control.
    (1) Laboratories shall participate in research programs, provided 
that the Laboratory Director is satisfied with their bona fide nature 
and the program(s) have received proper ethical approval, if 
applicable. The Laboratory

[[Page 5195]]

shall not engage in any research activity that undermines or is 
detrimental to the purposes of the Act.
    (2) Laboratories are expected to develop a research and development 
program to support and expand the scientific foundation of Doping 
Control. This research may consist of the development of new methods or 
technologies, the pharmacological characterization of a new doping 
agent, the characterization of a masking agent or method, and other 
topics relevant to the field of Doping Control.
    (3) Laboratories are expected to conduct research on Equine (and 
other animal species) subjects.
    (4) Laboratories shall follow institutional animal care and use 
guidelines and requirements regarding the use of animal subjects in 
research.
    (5) Covered Horses who may undergo Doping Control Testing shall not 
be the subjects of drug administration studies that include Prohibited 
Substances or Prohibited Methods.
    (c) Controlled substances. Laboratories are expected to comply with 
the relevant and applicable local, State, and Federal laws regarding 
the handling, storage, and discarding of controlled or illegal 
substances.
    (d) Analysis. Laboratories shall not engage in any analysis or 
activity that undermines or is detrimental to the purposes of the Act.
    (e) Analytical Testing for other anti-doping organizations. 
Laboratories shall accept Samples for Analytical Testing only if all 
the following conditions have been met:
    (1) The Sample matrix is of the proper type (e.g., blood, urine, 
hair or other Samples) for the requested analyses;
    (2) The Samples have been collected, sealed and transported to the 
Laboratory in accordance with procedures equivalent to the Testing and 
Investigations Standards; and
    (3) The collection is a part of a legitimate anti-doping and 
medication control program, as determined by the Agency, or satisfies 
any of the conditions for Sample analysis indicated in Rule 6307.
    (f) Analytical Testing for Covered Persons or those acting on their 
behalf. Laboratories shall not accept Samples directly from individual 
Covered Persons or from individuals or organizations acting on his or 
her behalf (unless approved in writing and in advance by the Agency and 
on the condition that Samples will be treated as Samples under the 
Protocol). Proceedings may be brought against the relevant Covered 
Person(s) if evidence of an Anti-Doping Rule Violation or a Controlled 
Medication Rule Violation emerges from such Sample analysis.
    (g) Other analytical activities.
    (1) Laboratories shall not provide analytical services in a Doping 
Control adjudication, unless specifically requested by the Agency or an 
adjudication body as part of a Results Management process.
    (2) Laboratories shall not engage in analyzing commercial material 
or preparations (e.g., dietary or herbal supplements), unless:
    (i) Specifically requested by the Agency or an adjudication body as 
part of a Results Management process;
    (ii) If done as part of a legitimate anti-doping research program, 
as determined by the Agency; or
    (iii) If a request is made by a Covered Person or his or her 
representative, a Laboratory may conduct the analysis if agreed in 
advance and in writing by the Agency, which may also specify conditions 
that must be followed prior to or during the analysis (e.g., 
verification of original sealed packages, product batch number).
    (3) Laboratories shall not provide results, documentation or advice 
that, in any way, could be used as an endorsement of products or 
services.
    (4) Analytical activities performed outside the Act will not fall 
under Agency-accredited status of the laboratory and shall not 
negatively affect the Analytical Testing of Samples from the Agency. 
Laboratory test reports or other documentation or correspondence 
related to these other analytical activities shall not declare or 
represent that any such testing is covered under the Laboratory's 
Agency-accredited status.
    (h) Sharing of knowledge.
    (1) When information on new doping substance(s), method(s), or 
practice(s) is known to a Laboratory, such information shall be shared 
with the Agency within 60 days. When possible, Laboratories shall share 
information with the Agency regarding the detection of potentially new 
or rarely detected doping agents as soon as possible. Immediately after 
having been notified of the Use of a new substance or method as a 
doping agent, the Agency will inform all Laboratories.
    (2) The Laboratory Director or staff shall participate in 
developing standards for best practice and enhancing uniformity of 
Analytical Testing in the HEAL-accredited laboratory system.
    (i) Duty to preserve the integrity of the Program contemplated in 
the Act and to avoid any detrimental conduct.
    (1) Laboratory employees and consultants shall not engage in 
conduct or activities that undermine or are detrimental to the anti-
doping and medication control program contemplated in the Act. Such 
conduct includes, but is not limited to, fraud, embezzlement, perjury, 
or any other conduct that might cast doubt on the integrity of the 
anti-doping and medication control program.
    (2) Laboratory employees and consultants shall maintain the 
confidentiality of all of data, items and information received in 
connection with Doping Control and Medication Control, including, but 
not limited to, Samples, Testing documentation, and communications with 
the Agency.
    (3) No employee or consultant of any Laboratory may (directly or 
indirectly) provide counsel, advice, or information to Covered Persons 
or others regarding techniques or methods used to mask or avoid 
detection of, alter metabolism of, or suppress excretion of a 
Prohibited Substance or its Metabolite(s), or Marker(s) of a Prohibited 
Substance or Prohibited Method in order to avoid an Adverse Analytical 
Finding.
    (4) No employee or consultant of any Laboratory may (directly or 
indirectly) provide information about a Test Method to a Covered Person 
(or to any individual or organization acting on his or her behalf) that 
could be used to avoid the detection of doping. Instead, any such 
Covered Person (or individual or organization) will be referred to the 
Agency.
    (5) No employee or consultant of any Laboratory may (directly or 
indirectly) assist a Covered Person in avoiding collection of a Sample 
(e.g., advice on masking strategies or detection windows). However, 
this paragraph does not prohibit the publication or presentation of 
scientific research results, general presentations to educate Covered 
Persons, students, or others concerning anti-doping programs and 
Prohibited Substances or Prohibited Methods.
    (6) If an employee or consultant of a Laboratory is requested to 
provide evidence in anti-doping proceedings, he or she is expected to 
provide independent, scientifically valid expert testimony.
    (7) Laboratories shall not issue any statements related to their 
analytical processes or findings, unless otherwise provided in the 
Protocol or as directed by the Agency or Authority. The responsibility 
for evaluation of these findings with further action and publication, 
if considered necessary, shall be the sole responsibility of the 
Agency.
    (j) Breach and enforceability.

[[Page 5196]]

    (1) A failure to respect any of the provisions of this Code of 
Ethics may result in a Laboratory being subject to Disciplinary 
Proceedings instituted by the Agency to either suspend or revoke its 
HEAL accreditation or its Agency approval, as applicable.
    (2) In addition, a failure to respect any of the provisions of this 
Code of Ethics may result in staff of a Laboratory being subject to 
disciplinary action by the Laboratory, resulting in consequences beyond 
those stipulated under the Laboratory Standards, including potential 
termination of employment or, where applicable, the imposition of 
criminal charges.
Rule 6620. Research and Development Activity Requirements
    (a) Laboratories must receive a minimum score of 10 points 
annually:
    (1) 5 points for each peer-reviewed manuscript;
    (2) 5 points for the production of educational materials;
    (3) 5 points for each funded research project;
    (4) 5 points for hosting hands-on training workshop for all HEAL 
Laboratories; and
    (5) 2 points for each Laboratory (internal) method development.
    (b) The validation or implementation of established anti-doping 
methods with only minor adjustments, or the repetition of research 
previously published or presented by others, is not sufficient to be 
considered as a research and development activity.

7000. Arbitration Procedures

Rule 7010. Applicability
    The Arbitration Procedures set forth in this Rule 7000 Series shall 
apply to all adjudications arising out of the Rule 3000 Series.
Rule 7020. Delegation of Duties
    (a) Subject to Rule 3249, Anti-Doping Rule Violations arising out 
of the Rule 3000 Series and violations of Rule 3229 (together, ``EAD 
Violations'') shall be adjudicated by an independent arbitral body (the 
``Arbitral Body'') in accordance with the Rule 3000 Series and these 
Arbitration Procedures. The Arbitral Body may also adjudicate any other 
matter referred to it under the Protocol, and any other matter that 
might arise from time to time under the Protocol that the Agency 
considers should be determined by the Arbitral Body. The Arbitral Body 
is selected by mutual agreement of the Authority and the Agency. The 
Arbitral Body will ordinarily assign a sole arbitrator to hear a case 
concerning an EAD Violation. However, the Arbitral Body may assign 3 
arbitrators to hear a case involving an EAD Violation upon request by 
the Agency, based on the nature or complexity of the case.
    (b) Subject to Rule 3349, Controlled Medication Rule Violations 
arising out of the Rule 3000 Series, violations of Rule 3329, and 
violations of Rule 3510 (ECM or Other Violations) shall be adjudicated 
by an adjudication panel (the Internal Adjudication Panel) in 
accordance with the Rule 3000 Series and these Arbitration Procedures. 
The Internal Adjudication Panel may also adjudicate any other matter 
referred to it under the Protocol, and any other matter that might 
arise from time to time under the Protocol that the Agency considers 
should be determined by the Internal Adjudication Panel. The Internal 
Adjudication panel is selected by mutual agreement of the Authority and 
the Agency. The Internal Adjudication Panel will ordinarily assign a 
single Internal Adjudication Panel member to adjudicate a case 
involving an ECM or Other Violation; in exceptional circumstances only, 
the Internal Adjudication Panel may assign 3 members to adjudicate a 
case upon request by the Agency.
    (c) Final decisions issued by the Arbitral Body or Internal 
Adjudication Panel are subject to review as specified in section 3058 
of the Act.
Rule 7030. Arbitral Body
    (a) The Arbitral Body shall have a pool of arbitrators consisting 
of a minimum of 5 members appointed by mutual agreement of the 
Authority and the Agency.
    (b) Arbitrators shall be appointed for 4-year terms. Candidate 
arbitrators shall complete an application in a form designated by the 
Authority.
    (c) Candidates shall not be or have been in the previous 2 years an 
officer, director, trustee, employee, consultant, or official, or be in 
a policy making position for any Equine Constituencies or the Agency, 
except that this requirement does not apply to former State Racing 
Commission officials or employees.
    (d) Candidate arbitrators shall be required to submit on request to 
a background check before appointment and shall commit in writing to 
accept appointment to all cases to which they are selected except:
    (1) when they have been involved in the Provisional Hearing for the 
matter;
    (2) when they have an actual or perceived conflict of interest; or
    (3) for personal hardship (candidates shall agree not to decline 
appointment for personal hardship in more than 2 cases in any 12-month 
period, except in exceptional circumstances).
    (e) If an arbitrator dies, resigns, becomes incapacitated during 
the arbitrator's term (legal incapacity is not required), or is removed 
for an ethical breach or deficiency in carrying out his or her duties, 
a new arbitrator shall be selected and appointed for a full 4-year 
term, following the procedures set forth in this Rule 7030.
Rule 7040. Internal Adjudication Panel
    (a) The Internal Adjudication Panel shall consist of impartial 
members appointed by mutual agreement of the Authority and the Agency 
to hear ECM and Other Violations (``IAP members''). The Internal 
Adjudication Panel shall have a pool of IAP members. The Authority and 
the Agency may appoint as many IAP members as they consider necessary 
to the pool of IAP members in accordance with the Arbitration 
Procedures.
    (b) Candidate IAP members shall be required to submit on request to 
a background check before appointment and shall commit in writing to 
accept appointment to all cases to which they are selected except:
    (1) when they have been involved in the Provisional Hearing for the 
matter;
    (2) when they have an actual or perceived conflict of interest; or
    (3) for personal hardship (candidates shall agree to not decline 
appointment for personal hardship in more than 2 cases in any 12-month 
period, except in exceptional circumstances).
    (c) IAP members are appointed for 4-year terms.
    (d) Apart from appointment to the Internal Adjudication Panel, IAP 
members shall not have any business or economic interest with a party 
in a case.
    (e) If an IAP member dies, resigns, becomes incapacitated during 
the IAP member's term (legal incapacity is not required), or commits an 
ethical breach or deficiency, the Authority or the Agency may remove 
the IAP member from the Internal Adjudication Panel. The Agency will 
publish a list of members of the Internal Adjudication Panel on its 
website.
    (f) A person is not precluded from serving as an IAP member 
concomitantly with his or her service as an association or state 
steward, provided that doing so does not put that him or her in a 
position of actual or perceived conflict of interest.
Rule 7050. Training of Arbitrators and IAP Members
    Arbitrators and IAP members shall receive at least 2 hours of 
continuing education each year on issues related to

[[Page 5197]]

proper and efficient handling of cases. The education must be approved 
by the Authority. Failure to complete this required continuing 
education is grounds for immediate dismissal.
Rule 7060. Initiation by the Agency
    (a) EAD Violations. Unless Rule 3249 applies, if the Agency charges 
a Covered Person with an EAD Violation, the Agency shall initiate 
proceedings with the Arbitral Body. If a Covered Person is charged with 
both an EAD Violation and an ECM or Other Violation, the procedures for 
EAD Violations apply. The parties to the proceeding shall be the Agency 
and the Covered Person(s) charged. The Owner and the Authority shall be 
invited to join in the proceedings as observers and, if accepted as 
such, receive copies of the filings in the case. In the context of EAD 
Violation cases, the Owner may be permitted to intervene and make 
written or oral submissions.
    (b) ECM and Other Violations. Unless Rule 3349 applies, if the 
Agency charges a Covered Person with an ECM or Other Violation, the 
Agency shall initiate proceedings with the Internal Adjudication Panel. 
The Covered Person may request a hearing before the Internal 
Adjudication Panel. However, the Internal Adjudication Panel may decide 
in its sole discretion to determine the matter based solely on the 
written submissions without a hearing, if the Internal Adjudication 
Panel considers itself sufficiently well-informed to render a decision 
on the written submissions alone. The parties to the proceeding shall 
be the Agency and the Covered Person(s) charged. The Owner and the 
Authority shall be invited to join in the proceedings as observers and, 
if accepted as such, receive copies of the filings in the case. In the 
context of ECM and Other Violation cases, the Owner shall not be 
permitted to intervene or make written or oral submissions.
    (c) Only the following persons may attend hearings as the Owner of 
the Covered Horse, unless otherwise agreed by the hearing panel:
    (1) if the Covered Horse is owned by one individual, that 
individual;
    (2) if the Covered Horse is owned by more than one individual or by 
a partnership, corporation, limited liability company, syndicate, or 
other association or entity, either or both the Designated Owner or 
Managing Owner.
Rule 7070. New or Additional Charges
    If after charging a Covered Person with a violation, the Agency has 
cause to bring any new or different charge(s) against the Covered 
Person, the charge shall be made in writing and filed with the other 
party or parties and (as applicable) the Internal Adjudication Panel or 
Arbitral Body. The arbitrator(s) or IAP member(s) appointed to hear the 
case shall decide whether the charges should be consolidated and heard 
in the same proceedings or whether the new or additional charge(s) 
should be heard separately.
Rule 7080. Expedited Procedures
    (a) At the request of any party, any time period set forth in the 
Arbitration Procedures may be shortened by the arbitrator(s) or IAP 
member(s) if doing so is reasonably necessary to resolve any Covered 
Person's or Covered Horse's eligibility before a Covered Horserace, 
while continuing to protect the right of a Covered Person to a fair 
process.
    (b) Pursuant to Rule 3262 or Rule 3362, the Agency may, in its sole 
discretion, shorten any deadlines within the Arbitration Procedures 
proportionately to ensure resolution prior to a Covered Horserace.
    (c) If the Agency does not agree to the process being expedited, 
the arbitrator(s) or IAP member(s), as applicable, shall determine 
whether the adjudication process shall be expedited and the schedule 
pursuant to which the process shall proceed.
Rule 7090. Jurisdiction
    (a) An arbitrator or IAP member shall have the authority to rule on 
his or her own jurisdiction, including any objections with respect to 
the existence, scope, or validity of the applicable rules.
    (b) A party must object to the jurisdiction of the arbitrator(s) or 
IAP member(s) or to the arbitrability of a charge by the Agency no 
later than the filing of the answering statement to the charge that 
gives rise to the objection. The arbitrator(s) or IAP member(s) may 
rule on such objections as a preliminary matter or as part of the final 
decision, in his or her sole discretion.
Rule 7100. Consolidation
    Matters involving more than one Covered Person may, in the Agency's 
discretion, be consolidated into a single matter. If an EAD Violation 
is alleged by the Agency against any of the Covered Persons who are 
parties in the consolidated matter, the process for EAD Violations will 
be followed.
Rule 7110. Location and Means of Conducting Hearings
    (a) Hearings regarding EAD Violations shall take place in person, 
unless the arbitrator(s) order(s) the hearing (or parts thereof) to 
take place by use of an audio-visual teleconferencing system.
    (b) Hearings regarding ECM or Other Violations shall take place by 
use of an audio-visual teleconferencing system, unless the IAP 
member(s) order(s) the hearing to take place in person.
    (c) In-person hearings shall be held in the United States at a 
location determined by the arbitrator(s) or IAP member(s).
Rule 7120. Qualifications
    Any arbitrator(s) or IAP member(s) appointed pursuant to Rule 7130 
shall be subject to disqualification for the reasons specified in Rule 
7140.
Rule 7130. Appointment of Hearing Panels To Adjudicate Cases
    (a) The arbitrator(s) shall be appointed in the following manner: 
immediately after the initiation of a proceeding by the Agency as set 
forth in Rule 7060, the Arbitral Body shall appoint a single arbitrator 
or 3 arbitrators from the pool of arbitrator(s) on a rotating basis, 
after confirming that the arbitrator(s) will not decline the 
appointment due to personal hardship. The arbitrator(s) adjudicating 
the Provisional Hearing shall not serve as an arbitrator determining 
the merits of the charge against the Covered Person. The Arbitral Body 
shall communicate to the parties the name of the arbitrator(s) 
appointed to hear the matter within 3 days of initiation by the Agency.
    (b) The IAP member(s) shall be appointed in the following manner: 
Immediately after the initiation of a proceeding by the Agency as set 
forth in Rule 7060, the Internal Adjudication Panel shall appoint a 
single IAP member (or in exceptional cases three IAP members) from the 
pool of IAP members on a rotating basis, after confirming that the IAP 
member(s) will not decline the appointment due to personal hardship. 
The IAP member(s) adjudicating the Provisional Hearing shall not serve 
as the IAP member(s) determining the merits of the charge against the 
Covered Person. The Internal Adjudication Panel shall communicate to 
the parties the name of the IAP member(s) appointed to hear the matter 
within 3 days of initiation by the Agency.
    (c) Once appointed, the arbitrator(s) and IAP member(s) shall 
receive an electronic copy of the charge letter, Arbitration 
Procedures, Rule 3000 Series and related rule series, and the Billing 
Standards.
Rule 7140. Disclosure and Challenge Procedure
    (a) Each arbitrator and IAP member appointed to hear a particular 
case shall

[[Page 5198]]

disclose to the parties any circumstance likely to affect his or her 
impartiality, including any bias or any financial or personal interest 
in the result of the case, or any past or present relationship with the 
parties or their representatives.
    (b) Upon objection of a party to the continued service of an 
arbitrator or IAP member, the Arbitral Body or Internal Adjudication 
Panel (as applicable) shall determine whether the arbitrator or IAP 
member is evidently partial, and (if so) the arbitrator or IAP member 
shall be disqualified. The Arbitral Body or Internal Adjudication Panel 
shall inform the parties of its decision, which shall be final and not 
subject to review or any other challenge.
Rule 7150. Communication
    Once appointed, no party and no Person acting on behalf of any 
party shall communicate unilaterally concerning the case with any 
arbitrator or IAP member appointed to hear the case. All communications 
with the Arbitral Body or Internal Adjudication Panel or any arbitrator 
or IAP member concerning the case shall include the other party or 
parties.
Rule 7160. Vacancies
    If for any reason following assignment to the case an arbitrator or 
IAP member becomes unable to perform his or her duties in a particular 
case, the Arbitral Body or Internal Adjudication Panel (as applicable) 
may fill the vacancy on a rotating basis as described in these rules.
Rule 7170. Procedures for EAD Violations
    (a) For matters involving an alleged EAD Violation arising from an 
Adverse Analytical Finding, each Covered Person's pre-hearing 
submission must be filed with the Arbitral Body on or before 14 days 
after submitting a request for a hearing (or after the deadline to make 
such request expires), and the Agency's pre-hearing submission must be 
filed with the Arbitral Body on or before 14 days after the last 
Covered Person's pre-hearing submission. There shall be no reply pre-
hearing submission unless ordered otherwise by the arbitrator(s), but 
each party may present rebuttal evidence at the hearing.
    (b) For matters involving an alleged EAD Violation involving a non-
analytical violation or a violation of Rule 3229, the Agency's initial 
pre-hearing submission must be filed with the Arbitral Body on or 
before 14 days after the last Covered Person requests a hearing (or 
after the deadline to make such request expires). Each Covered Person's 
pre-hearing submission must be filed with the Arbitral Body on or 
before 14 days after the Agency's initial pre-hearing submission, and 
the Agency's reply pre-hearing submission must be filed with the 
Arbitral Body seven 7 days after the last Covered Person's pre-hearing 
submission.
    (c) A Covered Person's pre-hearing submission shall include a brief 
not to exceed 30 double-spaced single-sided pages and shall include all 
exhibits, schedules, witness statements, expert reports, and all other 
evidence (except summaries and demonstrative aides) that the Covered 
Person intends to rely upon at the hearing. The Covered Person's pre-
hearing submission shall include a designation of witnesses providing 
the identity of witnesses, or name of the organization (in the case of 
an organization representative) expected to be called to testify at the 
hearing, along with signed statements for each of those witnesses. For 
expert witnesses, the pre-hearing submission shall include a C.V. and 
expert report, identifying all opinions to which they will testify and 
the facts and scientific methods upon which those opinions are based, 
as well as to identify all scientific treatises, studies, or articles 
on which the expert relies in rendering their opinion(s), for each 
expert included in the witness designations.
    (d) The Agency's initial pre-hearing submission shall include a 
brief not to exceed 30 single-sided double-spaced pages for each 
Covered Person charged in the case and shall include all exhibits, 
schedules, witness statements, expert reports, and all other evidence 
(except impeachment evidence, summaries, and demonstrative aides) that 
the Agency intends to rely upon at the hearing. The Agency's initial 
pre-hearing submission shall include a designation of witnesses 
providing the identity of witnesses, or name of the organization (in 
the case of an organization representative) expected to be called to 
testify at the hearing, along with signed statements for each of those 
witnesses. For expert witnesses, the initial pre-hearing submission 
shall include a C.V. and expert report, identifying all opinions to 
which the expert will testify, and the facts and scientific methods 
upon which those opinions are based. The submission shall identify all 
scientific treatises, studies, or articles on which the expert relies 
in rendering his or her opinion(s), for each expert included in the 
witness designations. The Agency's reply pre-hearing submission shall 
include all additional evidence upon which it intends to rely for 
rebuttal (except impeachment evidence, summaries, and demonstrative 
aides) and a reply brief not to exceed 15 single-sided double-spaced 
pages for each Covered Person charged in the case.
    (e) Each party is responsible for updating its disclosures as such 
information becomes available. If a party should have submitted 
evidence in the party's pre-hearing submission but did not submit such 
evidence, the arbitrator(s) shall not admit such evidence absent a 
showing of good cause.
    (f) The hearing should take place no more than 60 days from the 
date the last Covered Person requested a hearing in a particular case.
    (g) At the request of any party, or at the discretion of the 
arbitrator(s), the arbitrator(s) may schedule, as soon as practicable, 
a preliminary hearing with the parties or their representatives. The 
preliminary hearing shall be conducted by telephone or video 
conference. During the preliminary hearing, the parties and the 
arbitrator(s) shall discuss any preliminary matters to ensure 
compliance with the procedures herein.
    (h) Upon a showing of exceptional circumstances, the arbitrator(s) 
may extend any of the deadlines set forth in Rule 7170 for the minimum 
time necessary to address the circumstance. If all parties agree to an 
alternative schedule in a particular case, the arbitrator(s) shall 
alter dates accordingly.
    (i) If any of the dates described in Rule 7170 fall on a weekend or 
a Federal holiday, they shall be moved to the next business day.
Rule 7180. Procedures for ECM and Other Violations
    (a) Subject to paragraph (b) below, the IAP member(s) may determine 
to hold a hearing and require written submissions to be filed prior to 
the hearing, or to require written submissions and determine the matter 
based solely on the written submissions without a hearing. The IAP 
member(s) shall have wide discretion to determine the conduct of the 
proceedings in order to ensure that they are commensurate to the 
violations at issue. The IAP member(s) may issue directions to the 
parties as necessary. The IAP member(s) shall also have discretion to 
amend any time limits as they see fit in the circumstances, but any 
extension of deadlines shall be granted only for the minimum time 
necessary to address the circumstance, as all matters before the IAP 
member(s) shall proceed expeditiously.
    (b) A person charged with a violation may request that the IAP 
member waive the requirement that written submissions be filed by the 
parties, and permit the person charged to make an

[[Page 5199]]

oral presentation at a hearing. The IAP member may grant the request in 
the interest of justice, if the conduct of the hearing will not 
prejudice any of the other parties. The IAP member(s) shall provide the 
Agency the opportunity to respond to the oral presentation and shall 
have wide discretion to determine the conduct and scope of the hearing. 
The person charged may request that he or she be assisted by legal 
counsel or other representative at the hearing.
    (c) If the IAP member(s) order the parties to produce written 
submissions, and the matter involves an alleged ECM or Other Violation 
arising from an Adverse Analytical Finding, each Covered Person's 
submission must be filed with the Internal Adjudication Panel on or 
before 7 days after submitting a request for a hearing before the 
Internal Adjudication Panel (or after the deadline to make such request 
expires), and the Agency's submission must be filed with the Arbitral 
Body on or before 7 days after the last Covered Person's submission. 
There shall be no reply submissions unless ordered otherwise by the IAP 
member(s).
    (d) If the IAP member(s) order the parties to produce written 
submissions, and the matter involves a non-analytical ECM Violation or 
Other Violation, the Agency's initial submission must be filed with the 
Internal Adjudication Panel on or before 7 days after the last Covered 
Person requests a hearing before the Internal Adjudication Panel (or 
after the deadline to make such request expires). Each Covered Person's 
submission must be filed with the Arbitral Body on or before 7 days 
after the Agency's initial submission. There shall be no reply 
submissions unless ordered otherwise by the IAP member(s).
    (e) If the IAP member(s) order the parties to produce written 
submissions, the submissions of each party shall ordinarily not exceed 
15 single-sided double-spaced pages and shall include all supporting 
documentation on which the party relies. If any party intends to call a 
witness or expert to testify at the hearing, a signed witness statement 
and expert report (as applicable) shall be filed with the written 
submission.
    (f) If any of the dates described in Rule 7180 fall on a weekend or 
a Federal holiday, the date shall be moved to the next business day.
Rule 7190. Exchange of Information
    Information shall be exchanged electronically, unless otherwise 
agreed by the parties. The arbitrator(s) and IAP member(s) are 
authorized to resolve any disputes concerning the exchange of 
information between the parties consistent with the expedited nature of 
the proceedings.
Rule 7200. Participation
    The Arbitral Body and Internal Adjudication Panel (and their 
respective members) shall maintain the confidentiality of the 
proceedings. The arbitrator(s) or IAP member(s) may proceed without the 
participation of any party or representative who, after due notice, 
fails to be present or make a submission. If a party defaults, the 
arbitrator(s) or IAP member(s) may require the party who is present to 
submit such evidence and documents as the arbitrator(s) or IAP 
member(s) may require for the making of a final decision. Hearings are 
not open to the media or the public. However, the arbitrator(s) or IAP 
member(s) may permit one or more third parties to attend the hearing.
Rule 7210. Representation
    Any party may be represented by legal counsel or other 
representative. The legal counsel or other representative shall provide 
a letter of representation notifying the other party and the Arbitral 
Body or Internal Adjudication Panel (as applicable) of his or her name, 
phone number, email, and mailing address. A party shall be bound by the 
statements made and positions taken by its legal counsel or other 
representative.
Rule 7220. Oaths
    All testimony at hearings shall be taken under oath or affirmation.
Rule 7230. Stenographic Record
    Any party desiring a stenographic record of all or a portion of the 
hearing shall notify the other parties of the request at least 7 days 
in advance of the start of the hearing, unless ordered otherwise by the 
arbitrator(s) or IAP member(s). The Agency shall identify the court 
reporter to be used for transcription services, and an electronic copy 
of the transcript shall be provided to the arbitrator(s) or IAP 
member(s) (as applicable) and to the parties. Parties are responsible 
for the costs of any transcript they request.
Rule 7240. Interpreters
    All proceedings shall take place in English. Any party wishing to 
have an interpreter present during proceedings shall make all 
arrangements directly with the interpreter. Interpreters shall have no 
prior relationship with a party or have any interest in the proceeding, 
and the arbitrator(s) or IAP member(s) (as applicable) must approve the 
interpreter in advance. The costs of the interpreter shall be split 
between the parties. Any document that is not in English shall be 
officially translated by a certified translator paid for by the party 
offering or relying upon the document.
Rule 7250. Conduct of Hearings
    (a) The Agency shall present evidence to support its charge. The 
Covered Person(s) charged shall then present evidence to support the 
Covered Person(s) defense. The Agency is then entitled to present 
rebuttal evidence. Witnesses for each party shall also submit to 
questions from the arbitrator(s) or IAP member(s) and the adverse 
party. The arbitrator(s) or IAP member(s) may vary this procedure, 
provided that the parties are treated equally and that each party has 
the right to be heard and is given a fair opportunity to present its 
case.
    (b) The arbitrator(s) or IAP member(s) shall have the power to 
require the sequestration of any witness, other than a party or other 
essential person, during the testimony of any other witness. It shall 
be within the discretion of the arbitrator(s) or IAP member(s) to 
determine the propriety of the attendance of any other person other 
than a party and its representatives and the observers identified in 
Rule 7060.
    (c) The arbitrator(s) or IAP member(s) may direct the order of 
proof, bifurcate proceedings, and direct the parties to focus their 
presentations on issues the decision of which could dispose of all or 
part of the case.
    (d) The parties may agree to waive oral hearings.
Rule 7260. Evidence
    (a) The parties may offer such evidence as is relevant and material 
to the dispute and shall produce such evidence as the arbitrator(s) or 
IAP member(s) may deem necessary to make a determination in a case.
    (b) Prior to or during the hearing, a party may also request the 
arbitrator(s) or IAP member(s) to order production of any document 
which the party believes to be relevant and material to the dispute. 
The arbitrator(s) or IAP member(s) shall have discretion to grant or 
reject such a request as they see fit in the circumstances. However, 
requests for discovery and wide-ranging or otherwise disproportionate 
document requests shall not be permitted.
    (c) The arbitrator(s) or IAP member(s) may retain an expert or seek 
independent evidence only if (i) agreed to by all of the parties and 
(ii) the parties or the Agency agree(s) to pay for the cost of such 
expert or independent evidence. The parties shall have the right to 
examine any expert retained by the

[[Page 5200]]

arbitrator(s) or IAP member(s) and shall have the right to respond to 
any independent evidence obtained by the arbitrator(s) or IAP 
member(s).
    (d) The arbitrator(s) or IAP member(s) shall determine the 
admissibility, relevance, and materiality of the evidence offered, 
including hearsay evidence, and may exclude evidence deemed cumulative 
or irrelevant. Conformity to legal rules of evidence shall not be 
necessary, but the Federal Rules of Evidence may be used for guidance. 
Evidentiary and other rules for proving violations of the Protocol are 
also set out in Rule 3120.
    (e) The arbitrator(s) or IAP member(s) shall apply relevant 
principles of legal privilege, including those involving the 
confidentiality of communications between an attorney and client and 
the investigative privilege.
    (f) The arbitrator(s) or IAP member(s) may issue subpoenas for 
witnesses, documents, information, or other evidence upon the request 
of any party, keeping in mind the expedited nature of the proceedings 
and the procedures set forth in Rules 7170 and 7180. The arbitrator(s) 
or IAP member(s) shall not issue a subpoena for a deposition, because 
depositions (along with formal written discovery in civil litigation) 
are not in keeping with the expedited nature of the Arbitration 
Procedures.
Rule 7270. Inspection
    If the arbitrator(s) or IAP member(s) consider it necessary to make 
an inspection in connection with a proceeding, the arbitrator(s) or IAP 
member(s) shall so advise the parties. The arbitrator(s) or IAP 
member(s) shall set the date and time that shall not delay the 
procedures in Rules 7170 and 7180 and shall notify the parties. Any 
party who so desires may be present at such an inspection. If one or 
all parties are not present at the inspection, the arbitrator(s) or IAP 
member(s) shall make an oral or written report to the parties and 
afford them an opportunity to comment.
Rule 7280. Interim Rulings and Measures
    The arbitrator(s) or IAP member(s) may make interim rulings and 
orders and may order whatever interim measures they deem necessary to 
provide any party an immediate protection of rights.
Rule 7290. Provisional Hearings
    Hearings to resolve challenges to Provisional Suspensions shall be 
held in accordance with Rule 3247 or 3347, as applicable. Hearsay 
evidence shall be admissible in a Provisional Hearing.
Rule 7300. Closing of Hearing
    Subject to Rule 7310, the arbitrator(s) or IAP member(s) shall 
declare the hearing closed after the conclusion of closing arguments. 
Post-hearing briefs shall not be permitted, except as ordered by the 
arbitrator(s) or IAP members(s) in complex or otherwise exceptional 
cases. The time limit to issue the final decision shall commence upon 
the closing of the hearing.
Rule 7310. Reopening of Hearing
    To avoid manifest injustice, the hearing may be reopened on the 
initiative of the arbitrator(s) or IAP member(s), or upon application 
of a party, at any time before the final decision is made. At the 
request of a party, the arbitrator(s) or IAP member(s) will determine 
if the applicable standard has been met to reopen the hearing.
Rule 7320. Waiver of Rules
    Any party who proceeds with the adjudication under these rules 
after knowledge that any provision or requirement of these rules has 
not been complied with and who fails to state an objection in writing 
shall be deemed to have waived the right to object.
Rule 7330. Serving of Notice
    (a) Any papers, notices, or process necessary or proper for the 
initiation or continuation of a proceeding under these rules, and any 
final decision made under these rules may be served by mail or email 
addressed to the party or its representative at the last known address 
or by personal service in or outside the state where the arbitration is 
to be held.
    (b) Unless otherwise instructed by the Arbitral Body or Internal 
Adjudication Panel, any documents submitted by any party to the 
Arbitral Body or Internal Adjudication Panel shall simultaneously be 
provided to the other party or parties to the proceeding.
Rule 7340. Final Decision
    A final decision shall be in writing and signed by the 
arbitrator(s) or IAP member(s). The arbitrator(s) shall issue the final 
decision on or before 14 days after the close of the hearing. The IAP 
member(s) shall issue the final decision on or before 14 days after the 
last written submission contemplated in Rule 7180 or after the close of 
the hearing (as applicable). The 14-day time limit may be extended if 
additional time is needed due to the complexity of the case or 
exceptional circumstances.
Rule 7350. Scope of Final Decision
    Arbitrators and IAP members may grant any remedy or relief 
authorized by the Act or the Rules issued pursuant to the Act.
Rule 7360. Case Resolution During Proceedings
    If the parties settle the case during the course of the proceedings 
in accordance with Rule 3249 or 3349, the Arbitral Body or the Internal 
Adjudication Panel shall issue an order terminating the proceedings.
Rule 7370. Notification of Final Decision
    (a) The final decision shall be served on all parties by first 
class mail, email, or personal service. Interested Parties shall also 
be notified of the final decision.
    (b) The final decision shall be Publicly Disclosed and shall not be 
considered confidential, unless provided otherwise in the applicable 
rules.
Rule 7380. Modification of Final Decision
    Within 7 days of the issuance of a final decision, any party, upon 
notice to the other parties, may request the Arbitral Body or Internal 
Adjudication Panel to correct any clerical, typographical, or 
computational errors in the final decision. The other parties shall 
ordinarily be given 5 days to respond to the request.
Rule 7390. Release of Documents for Judicial Proceedings
    The Arbitral Body and Internal Adjudication Panel (as applicable) 
shall, upon the written request of a party, furnish to the party, at 
the party's expense, certified copies of any papers in the Arbitral 
Body's or Internal Adjudication Panel's possession that may be required 
in judicial proceedings relating to the proceeding. If the matter is 
subject to review by an administrative law judge in accordance with the 
Act, the Arbitral Body and Internal Adjudication Panel (as applicable) 
shall furnish copies of any documents requested by the administrative 
law judge to such judge in connection with that proceeding.
Rule 7400. Right of Review
    The final decision of the Arbitral Body or Internal Adjudication 
Panel is subject to review in accordance with section 3058 of the Act. 
Notwithstanding any provision set forth in these Arbitration 
Procedures, nothing herein shall alter the standards of review set 
forth in the Act.

[[Page 5201]]

Rule 7410. Applications to Court and Exclusion of Liability
    (a) Arbitration is intended to be the exclusive remedy in all cases 
arising under the Rule 3000 Series, subject to appeal as described in 
the Rule 3000 Series and the Act.
    (b) No civil action commenced by a party relating to the subject 
matter of the proceeding under the Arbitration Procedures shall be 
deemed a waiver of any party's right to adjudicate that party's case 
under the Arbitration Procedures.
    (c) Neither the Arbitral Body nor the Internal Adjudication Panel 
(nor any arbitrator or IAP member) in a proceeding under these rules is 
a necessary party in judicial proceedings relating to that proceeding.
    (d) Parties to a proceeding under the Arbitration Procedures shall 
be deemed to have consented that a final decision may be entered in any 
Federal or State court having jurisdiction, unless the party seeks 
review pursuant to section 3058 of the Act.
    (e) None of the Authority, Agency, Arbitral Body, Internal 
Adjudication Panel, arbitrators, or IAP members shall be liable to any 
party for any act or omission in connection with any proceedings 
conducted under these Arbitration Procedures.
Rule 7420. Costs
    (a) The Arbitral Body shall prescribe filing and other 
administrative fees and service charges to compensate it for the cost 
of providing administrative services. The fees in effect when the fee 
or charge is incurred shall be applicable. The Arbitral Body's filing 
fee and any other administrative fee or charge shall be split equally 
amongst the parties, and the Agency's portion shall be paid by the 
Authority.
    (b) The Arbitral Body shall split the costs of the proceeding 
before an arbitrator (including arbitrator fees and expenses, but 
excluding attorney, witness, and party expert fees) equally amongst the 
parties with the Agency's portion being paid by the Authority. The 
Arbitral Body, in its discretion, may require advanced costs be paid by 
the parties to ensure payment is made.
    (c) A party's failure to pay costs or advanced costs by the 
deadlines imposed by the Arbitral Body will, if not rectified 
immediately, result in a waiver of charges or defenses to charges (as 
applicable) and result in imposition and publication of sanctions 
requested by the Agency.
    (d) The Authority shall be solely responsible for the 
administrative costs stemming from IAP member-resolved cases as 
described in the Arbitration Procedures.
Rule 7430. Expenses
    The expenses of witnesses for any party shall be paid by the party 
producing such witnesses. Each party shall bear its own attorneys' fees 
and other expenses.
Rule 7440. Arbitrator's Compensation
    (a) Arbitrators shall be compensated and reimbursed in a manner 
consistent with the Billing Standards.
    (b) If there is disagreement concerning the terms of compensation, 
the disagreement shall be resolved as described in the Billing 
Standards.
    (c) Any arrangement for the compensation or reimbursement of an 
arbitrator shall be made through the Arbitral Body and not directly 
between the parties and the arbitrator.
    (d) Arbitrator fees and IAP member fees shall be paid in accordance 
with Rule 7420.
Rule 7450. Application of Rules
    The Rule 1000-9000 Series shall be considered part of the agreement 
to arbitrate and in all instances the arbitrators and IAP members are 
required to apply the provisions of that arbitration agreement and 
conform to its terms.

    By direction of the Commission.
Joel Christie,
Acting Secretary.
[FR Doc. 2023-00957 Filed 1-25-23; 8:45 am]
 BILLING CODE 6750-01-P