Implementation of the Ryan Haight Online Pharmacy Consumer Protection Act of 2008, 61594-61601 [2020-21310]

Agencies

• Drug Enforcement Administration
• Department of Justice

[Federal Register Volume 85, Number 190 (Wednesday, September 30, 2020)]
[Rules and Regulations]
[Pages 61594-61601]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-21310]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

21 CFR Parts 1300, 1301, 1304, and 1306

[Docket No. DEA-322]
RIN 1117-AB20


Implementation of the Ryan Haight Online Pharmacy Consumer 
Protection Act of 2008

AGENCY: Drug Enforcement Administration, Department of Justice.

ACTION: Final rule.

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SUMMARY: On April 6, 2009, the Drug Enforcement Administration 
published the interim final rule titled ``Implementation of the Ryan 
Haight Online Pharmacy Consumer Protection Act of 2008,'' which amended 
DEA's regulations by adding several new provisions to prevent the 
illegal distribution and dispensing of controlled substances by means 
of the internet. This action adopts the interim final rule as a final 
rule without change, apart from a minor technical amendment and certain 
changes to DEA regulations already made by intervening rules. This 
action also reinstates amendments that were inadvertently removed by 
the Controlled Substances and List I Chemical Registration and 
Reregistration Fees final rule published on March 15, 2012.

DATES: This final rule is effective October 30, 2020.

FOR FURTHER INFORMATION CONTACT: Scott A. Brinks, Diversion Control 
Division, Drug Enforcement Administration; Mailing Address: 8701 
Morrissette Drive, Springfield, VA 22152; Telephone: (571) 362-3261.

SUPPLEMENTARY INFORMATION:

Outline

I. Purpose of Regulatory Action
II. Summary of Key Provisions of the Ryan Haight Act
    A. In-Person Medical Evaluation
    B. Requirement of Modified Registration
    C. Criminal Offenses
III. The Interim Final Rule and Subsequent Changes to DEA 
Regulations
IV. Discussion of Comments
    A. Distributors' Responsibilities
    B. Pharmacies' Responsibilities
    C. Exceptions to the Definition of ``Online Pharmacy''
    D. Access to Medication
    E. Verification of Registration
V. Section-by-Section Summary of the Final Rule
VI. Regulatory Analyses

I. Purpose of Regulatory Action

    The Ryan Haight Online Pharmacy Consumer Protection Act of 2008 
(Pub. L. 110-425) (hereafter, the ``Ryan Haight Act'' or the ``Act'') 
was enacted on October 15, 2008. The Act amended the Controlled 
Substances Act (CSA) by adding various provisions to prevent the 
illegal distribution and dispensing of controlled substances by means 
of the internet. The Ryan Haight Act makes it illegal under Federal law 
to ``deliver, distribute, or dispense a controlled substance by means 
of the internet, except as authorized by [the CSA]'' or to aid or abet 
such activity. 21 U.S.C. 841(h)(1).
    On April 6, 2009, the Drug Enforcement Administration (DEA) 
published an interim final rule that served (1) to explain the Ryan 
Haight Act, (2) to announce amendments to DEA regulations that 
implemented the Act, and (3) to request comments on these amendments to 
the regulations. See 74 FR 15596.
    Through this final rule, DEA is responding to the comments it 
received on the April 6, 2009, interim final rule and adopting the 
interim final rule as final without change (aside from a minor 
technical amendment and certain minor changes, discussed below, that 
were already made by intervening rules).

II. Summary of Some of the Key Provisions of the Ryan Haight Act

    Congress passed the Ryan Haight Act because of ``the increasing use 
of prescription controlled substances by adolescents and others for 
non-medical purposes, which [had] been exacerbated by drug trafficking 
on the internet.'' \1\ Recognizing that rogue websites fueled the abuse 
of prescription controlled substances and thereby increased the number 
of resulting overdoses and other harmful consequences, Congress passed 
the Ryan Haight Act to prevent the internet from being exploited to 
facilitate such unlawful drug activity.
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    \1\ S. Rep. No. 110-521, at 1 (2008).
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    Consistent with the CSA, the Ryan Haight Act set out numerous 
regulatory requirements and other substantive provisions. These 
provisions and other aspects of the Act are explained in detail in the 
interim final rule. See 74 FR 15597-15610. For this final rule, a 
summary of three key provisions of the Act will suffice: The in-person 
medical evaluation requirement for prescribing practitioners, the 
modified registration requirement for online pharmacies, and the 
criminal offenses the Act added to the CSA.

[[Page 61595]]

A. In-Person Medical Evaluation Requirement

    One of the primary ways in which the Act combats the use of the 
internet to facilitate illegal sales of pharmaceutical controlled 
substances is by mandating, with limited exceptions, that the 
dispensing of controlled substances by means of the internet be 
predicated on a valid prescription issued by a practitioner who has 
conducted at least one in-person medical evaluation of the patient. 
While the lack of an in-person medical evaluation has always been 
viewed as highly probative evidence that a prescription has been issued 
outside of the usual course of professional practice and for other than 
a legitimate medical purpose, the Act makes it unambiguous that it is a 
per se violation of the CSA for a practitioner to issue a prescription 
for a controlled substance by means of the internet without having 
conducted at least one in-person medical evaluation, except in certain 
specified circumstances. However, as Congress expressly stated under 
the Act, the mere fact that the prescribing practitioner conducted one 
in-person medical evaluation does not demonstrate that the prescription 
was issued for a legitimate medical purpose within the usual course of 
professional practice. Even where the prescribing practitioner has 
complied with the requirement of at least one in-person medical 
evaluation, a prescription for a controlled substance must still 
satisfy the longstanding requirement of federal law that it must be 
issued for a legitimate medical purpose by a practitioner acting in the 
usual course of professional practice.\2\
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    \2\ 21 CFR 1306.04(a); United States v. Moore, 423 U.S. 122 
(1975). This requirement has been a part of federal law since the 
Harrison Narcotic Act of 1914. Id. at 131. For a detailed 
explanation of the ``legitimate medical purpose requirement,'' see 
71 FR 52716, 52717 (2006 DEA policy statement).
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B. Requirement of Modified Registration for Online Pharmacies

    Another one of the core provisions of the Act is the requirement 
that any person who operates a website that fits within the definition 
of an ``online pharmacy'' must obtain from DEA a modification of its 
DEA pharmacy registration that expressly authorizes such online 
activity. Only DEA-registered pharmacies are eligible under the Act to 
obtain such a modification of registration. One of the ramifications of 
this requirement is that those who are not DEA-registered pharmacies 
(for example, those non-registrants who have previously facilitated 
unlawful internet controlled substance sales by enlisting the services 
of illegitimate pharmacies and/or prescribing practitioners) are 
prohibited from operating online pharmacies.
    The Act's definition of ``online pharmacy'' encompasses more than 
merely legitimate pharmacies that may obtain a modification of their 
DEA registrations allowing them to dispense controlled substances by 
means of the internet. As explained below, the definition of ``online 
pharmacy'' includes, among others, those persons who operate the types 
of rogue websites that the Act was designed to eliminate. Consistent 
with the longstanding structure of the CSA (since it was enacted in 
1970), the Act prohibits all controlled substance activities by 
``online pharmacies'' except those expressly authorized by the Act. 
Again, only DEA-registered pharmacies may obtain a modification of 
their registration authorizing them to operate as online pharmacies. In 
addition, a pharmacy that has obtained such a modification of its 
registration may not operate as an online pharmacy unless it has 
notified DEA of its intent to do so and its website contains certain 
declarations designed to provide clear assurance that it is operating 
legitimately and in conformity with the Act.

C. Criminal Offenses

    The Act also adds two new criminal offenses to the CSA. The first 
new criminal offense makes it explicitly unlawful for any person to 
knowingly or intentionally dispense, distribute, or deliver a 
controlled substance by means of the internet or to aid and abet such 
actions, except as authorized by the CSA, as stated in 21 U.S.C. 
841(h)(1). The second new criminal offense added by the Act prohibits 
using the internet to knowingly or intentionally advertise illegal 
transactions of controlled substances that are not authorized by the 
CSA, as stated in 21 U.S.C. 841(h)(2). The Act contains specific 
examples of such conduct, as discussed in the interim final rule; 
however, it is important to note that the examples provided are not an 
exhaustive list of the types of conduct that constitute violations of 
21 U.S.C. 841(h)(1) and 21 U.S.C. 841(h)(2).

III. The Interim Final Rule and Subsequent Changes to DEA Regulations

    DEA published its interim final rule implementing the Ryan Haight 
Act at 74 FR 15596 on April 6, 2009. The interim final rule amended 
DEA's regulations at 21 CFR parts 1300, 1301, 1304, and 1306 to carry 
out the Act. The specific regulatory changes made by the interim final 
rule and herein adopted as a final rule are discussed in greater detail 
in Section V below.
    While this final rule is not making any changes to the provisions 
of the interim final rule aside from a minor technical amendment 
discussed below, there have been two amendments to DEA's regulations 
since the interim final rule was published that have further altered 
regulatory language that had been amended by the interim final rule.
    The first change occurred in 2011, when 21 CFR 1301.52(a) was 
amended to provide for immediate termination of a registration, and all 
modifications of that registration, upon surrender by the registrant. 
76 FR 61563. This final rule does not disturb that intervening 2011 
amendment.
    The second change occurred in 2012, when registration fees were 
increased for all business activities by amending DEA regulatory 
provisions including 21 CFR 1301.13(e)(1). 77 FR 15234. The change in 
2012 increased the three-year registration fee for dispensers (which 
includes pharmacies) from $551 to $731, but it did not impose any 
additional fee to apply for the online pharmacy modification. 
Unfortunately, however, this amendment--though solely intended to 
adjust fees--also inadvertently removed the interim final rule's 
changes to Sec.  1301.13(e)(1). In particular, the interim final rule 
had amended Sec.  1301.13(e)(1)(iv) to list ``Online Pharmacy'' as part 
of the business activity ``[d]ispensing or instructing''; to list the 
online pharmacy application form, 224c; and to indicate, under 
``[c]oincident activities allowed'' that ``[a]n online pharmacy may 
perform activities of retail pharmacy as well as online pharmacy 
activities.'' The revised version of Sec.  1301.13(e)(1) placed in the 
Code of Federal Regulations by the 2012 amendment not only changed the 
fees in Sec.  1301.13(e)(1), as intended, but also used an earlier 
version of the text of Sec.  1301.13(e)(1)(iv) that did not contain the 
interim final rule's additions, causing them to be inadvertently 
removed from Sec.  1301.13(e)(1).
    Thus, the current text of Sec. Sec.  1301.13(e)(1) and 1301.52(a) 
differs from that contained in the interim final rule as published on 
April 6, 2009, because of these intervening amendments. This final 
rule, while otherwise adopting the regulatory revisions of the interim 
final rule, does not disturb these intervening amendments, except to 
reinstate the interim final rule's changes to Sec.  1301.13(e)(1) that 
were inadvertently undone by the 2012 registration fee

[[Page 61596]]

amendment. In particular, through this action, Sec.  1301.13(e)(1)(iv) 
will be updated to: (1) Include online pharmacy as a type of 
``dispensing or instructing'' business activity; (2) add Form DEA-224c 
to DEA application forms column; and (3) include a statement that 
online pharmacies are allowed to perform activities of a retail 
pharmacy and online pharmacy as a coincident activity.
    Thus, the publication of this final rule does not alter the text of 
the Code of Federal Regulations except to reinstate the interim final 
rule's Sec.  1301.13(e)(1) amendments and to make one purely technical 
amendment to Sec.  1304.40(c) to remove outdated information that is 
further discussed below.

IV. Discussion of Comments

    DEA received nine comments on the interim final rule. Six 
commenters generally supported the rule while also raising issues of 
concern, and three commenters expressed opposition to the rule. The 
comments are summarized below, along with DEA's responses.

A. Distributors' Responsibilities

    Some commenters expressed concerns that the precise scope of 
distributors' obligations described in the interim final rule were 
unclear--in particular, distributors' duty to avoid supplying 
pharmacies that service the customers of rogue websites. Another 
commenter sought clarification of whether, when a pharmacy's buying 
patterns indicate a reasonable likelihood that it is supplying 
customers of a website, distributors are required to confirm only that 
the pharmacy has obtained a modified pharmacy registration under the 
Act, or must confirm that the pharmacy is in compliance with all 
requirements of the CSA. The same commenter argued that the language in 
the interim final rule suggested that distributors would be required to 
have knowledge of a pharmacy's buying patterns before any transactions 
occurred with the pharmacy.
    Some commenters stated that it is not feasible for distributors to 
know more about a pharmacy's online activities than what would be 
discovered by verifying the pharmacy's DEA registration status and 
conducting a routine due diligence investigation. The same commenters 
requested that DEA confirm whether it was the distributor's 
responsibility, when faced with a pharmacy whose buying patterns 
indicate a reasonable likelihood that it is supplying customers of a 
website, to either confirm that the pharmacy has a modified DEA 
registration, or to obtain a plausible alternative explanation to 
justify the buying pattern.
    DEA Response. With respect to the obligation to confirm a 
pharmacy's compliance with the requirements of the CSA, distributors, 
like all DEA registrants, have a duty to maintain effective controls 
against the diversion of controlled substances. 21 U.S.C. 823(b)(1), 
823(e)(1); 21 CFR 1301.71(a). Failure to comply with this or any other 
applicable regulatory requirements may, depending on the circumstances, 
result in civil monetary penalties and/or administrative revocation 
proceedings. In addition, a distributor that knowingly or intentionally 
distributes controlled substances to a pharmacy that is dispensing 
controlled substances in violation of the Ryan Haight Act is subject to 
criminal prosecution under 21 U.S.C. 841(h)(1).
    The Act introduces new requirements to ensure a pharmacy's 
compliance with the registration modification provisions. This final 
rule does not, however, relieve distributors of their existing duty to 
maintain effective controls against diversion, including the obligation 
to conduct adequate due diligence, not only prior to distributing 
controlled substances to a new customer but also throughout the course 
of a distributor's relationship with a customer.\3\
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    \3\ See Masters Pharmaceuticals, Inc., 80 FR 55418, 55477 
(2015). See also 21 CFR 1301.71(a) (``All applicants and registrants 
shall provide effective controls to guard against theft and 
diversion of controlled substances.''); Southwood Pharmaceuticals, 
Inc., 72 FR 36487, 36498-36500 (2007) (discussing inadequacy of 
distributor's due diligence efforts with respect to rogue internet 
pharmacies); 21 U.S.C. 823(b)(1) (directing the Attorney General to 
consider an applicant's/registrant's ``maintenance of effective 
controls against diversion of particular controlled substances into 
other than legitimate medical, scientific, and industrial channels'' 
when making the public interest determination with respect to the 
granting or revocation of a registration to distribute schedule I 
and II drugs); id. 823(e)(1) (same with respect to registration to 
distribute schedule III through V drugs).
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    There are several ways for a distributor to determine whether a 
pharmacy is properly registered to dispense controlled substances by 
means of the internet. A pharmacy's certificate of registration will 
state that it has obtained the requisite modification of its 
registration. A distributor can also verify the pharmacy's status using 
DEA's registration validation web tool. However, as DEA explained in 
both Southwood and Masters, ``doing `nothing more than verifying a 
pharmacy's DEA registration and state license' is not enough'' to 
comply with a distributor's ``duty to perform due diligence.'' \4\ In 
Masters, DEA further held that ``a distributor must conduct a 
reasonable investigation `to determine the nature of a potential 
customer's business before it' sells to the customer, and the 
distributor cannot ignore ``information which raise[s] serious doubt as 
to the legality of [a potential . . . customer's] business practices.'' 
\5\
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    \4\ Masters, 80 FR at 55477 (quoting Southwood, 72 FR at 36498).
    \5\ Id.
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    Continuing in Masters, DEA explained that where ``a customer 
provides information regarding its dispensing practices that is 
inconsistent with other information the distributor has obtained about 
or from the customer, or is inconsistent with information about 
pharmacies' dispensing practices generally, the distributor must 
conduct `additional investigation to determine whether [its customer 
is] filling legitimate prescriptions.' '' \6\ Finally, Masters 
explained that ``the obligation to perform due diligence is ongoing 
throughout the course of a distributor's relationship with its 
customer.'' \7\ Id.
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    \6\ Id. (quoting 72 FR at 55477).
    \7\ Id.
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    Thus, where a pharmacy's buying patterns suggest that the pharmacy 
is filling prescriptions for a rogue website, it is not enough for a 
distributor to confirm only that the pharmacy has a modified pharmacy 
registration under the Ryan Haight Act.\8\ Rather, the distributor must 
confirm that the pharmacy is in compliance with the CSA's requirement 
that it is filling only those prescriptions which have been issued by a 
practitioner acting in the usual course of professional practice for a 
legitimate medical purpose in accordance with 21 CFR 1306.04(a). 
Moreover, this requirement is not undermined by any contention that a 
pharmacy's buying patterns may not be known at the time of its first 
transaction with a specific distributor: Pursuant to section 3273(a) of 
the Substance Use-Disorder Prevention that Promotes Opioid Recovery and 
Treatment for Patients and Communities Act (SUPPORT Act), Public Law 
115-271, 132 Stat. 3894, DEA has created an online tool which allows 
distributors to obtain data as to the number of distributors that have 
sold to a prospective customer and the total quantity and type of 
opioids distributed to the prospective customer during the

[[Page 61597]]

last six months.\9\ The SUPPORT Act further provides that ``[a]ll 
registered manufacturers and distributors shall be responsible for 
reviewing this information'' and that, in determining whether to 
initiate proceedings to suspend or revoke a manufacturer's/
distributor's registration, DEA ``may take into account that this 
information . . . was available to the registrant.'' \10\ It should 
also be noted that federal law now provides that the failure to review 
this information is unlawful and is punishable by civil and criminal 
penalties.\11\
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    \8\ Indeed, as of the date of this rule, no person or entity 
holds a modified registration authorizing the dispensing of 
controlled substances by means of the internet.
    \9\ Press Release, Drug Enforcement Administration, DEA 
announces enhanced tool for registered drug manufacturers and 
distributors to combat opioid crisis (Feb. 26, 2019).
    \10\ 21 U.S.C. 827(f).
    \11\ 21 U.S.C. 842(a)(17), (c)(1)(B), (c)(2)(D).
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    In addition, nearly all pharmacies now use dispensing software 
which allows for the creation of a utilization/dispensing report. As 
Masters explains, a distributor, as part of its due diligence, should 
evaluate a customer's dispensing ratio of controlled to non-controlled 
drugs as well as such other relevant data, including the types of 
controlled substances, the dosage forms, and quantities dispensed, and 
base this evaluation on the most accurate information available.\12\ 
Thus, a distributor should be obtaining and reviewing utilization/
dispensing reports both upon taking on a new customer and periodically 
throughout the course of its relationship with its customer. As Masters 
makes amply clear, the failure to obtain and review this information 
may constitute strong evidence that a distributor has failed to 
maintain effective controls against diversion and support a finding 
that its registration is inconsistent with the public interest.
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    \12\ 80 FR at 55480-55481.
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    Accordingly, while it is true that information as to a pharmacy's 
buying patterns and/or dispensing activities may not point conclusively 
to a finding that the pharmacy is dispensing controlled substances in 
violation of the Ryan Haight Act, DEA's experience has been that rogue 
online pharmacies present many of the same indicia of illegal 
dispensing activity as do brick and mortar pharmacies engaged in drug 
trafficking. Thus, even if a distributor does not have actual knowledge 
that the pharmacy is operating through a rogue website, if the 
pharmacy's buying patterns or other circumstances surrounding an order 
create a reasonable suspicion that it is supplying customers of a 
website or otherwise engaging in practices that render it an online 
pharmacy within the meaning of the Act, the distributor should, prior 
to filling any order for controlled substances, confirm whether the 
pharmacy has a modified registration. The distributor should also 
assess the likelihood that the pharmacy is filling only controlled 
substance prescriptions that comply with 21 CFR 1306.04(a).
    In sum, if a pharmacy's buying patterns or the other circumstances 
of an order create a reasonable suspicion that it is supplying 
customers of a website or otherwise engaging in practices that render 
it an online pharmacy within the meaning of the Act, but nothing else 
about the order appears suspect or unlawful, a distributor will not be 
held liable for supplying the pharmacy controlled substances if the 
distributor has confirmed that the pharmacy holds a modified 
registration. However, merely confirming that the pharmacy holds a 
modified registration will not relieve the distributor of liability if 
the pharmacy's order raised grounds for suspicion that it was filling 
otherwise unlawful controlled substance prescriptions and the 
distributor did not properly resolve the grounds. Conversely, if a 
pharmacy's order initially indicates that it may be supplying customers 
of a website, but the distributor is able to confirm an alternative 
justification for the suspect features of the order, it may lawfully 
fill the order and supply the pharmacy with controlled substances. To 
be clear, however, the distributor must actually confirm the 
alternative justification; it cannot simply conceive of some 
theoretical set of circumstances under which the pharmacy's suspect 
order would be justified. As such, the commenters are correct that an 
alternative explanation can justify an otherwise suspect order, but as 
discussed above, distributors must conduct reasonable investigations to 
confirm the explanation.

B. Pharmacies' Responsibilities

    One commenter raised concerns regarding the variety of factors 
listed in the interim final rule as relevant to determining whether a 
prescription was issued by means of the internet. In particular, the 
commenter suggested that these factors are subjective. The same 
commenter requested that DEA define a reasonable distance between the 
pharmacy and a practitioner. This comment relates to DEA's statement in 
the interim final rule that, in some circumstances, the distance 
between a pharmacy and a practitioner may be a relevant factor in 
assessing the likelihood that a prescription has been issued by means 
of the internet in violation of the Ryan Haight Act. See 74 FR 15607. 
Another commenter urged DEA to enforce the pharmacy requirements in the 
manner outlined in the interim final rule, and not apply a more 
stringent standard than the ones discussed there.
    DEA Response. DEA appreciates the commenter's concerns regarding 
the factors to be considered when determining whether a pharmacist 
should reasonably suspect that a prescription was issued by means of 
the internet. Pharmacists have always had a responsibility to ensure 
the dispensing of controlled substances conforms with DEA's regulations 
and the CSA and to exercise professional judgment in determining 
whether a controlled substance prescription has been lawfully issued in 
accordance with all provisions of the CSA.\13\ While a pharmacist is 
not obligated to know what cannot be known through the exercise of 
sound professional pharmacy practice, the relevant factors set forth in 
the interim final rule for determining whether a pharmacist should 
reasonably know that a prescription was issued by means of the internet 
have been based on numerous decisions of both the federal courts and 
this Agency involving rogue internet pharmacies and the physicians who 
wrote the prescriptions that were filled by them.\14\ Indeed, an 
examination of these and other cases reveals that the factual 
circumstances surrounding the issuance of the controlled substance 
prescriptions was so obviously outside the usual course of professional 
practice and for other than a legitimate medical purpose that no 
reasonable pharmacist could claim ignorance of the unlawfulness of the 
prescriptions.\15\
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    \13\ See 21 CFR 1306.04(a); JM Pharmacy Group, Inc., 80 FR 
28667, 28670 (2015) (quoting Ralph J. Bertolino, 55 FR 4729, 4730 
(1990) (``a pharmacist must exercise professional judgment [and 
common sense] when filling a prescription''); id. (quoting Medic-Aid 
Pharmacy, 55 FR 30043, 30044 (1990) (``The administrative law judge 
concluded that it is not necessary to find that [the pharmacist] in 
fact knew that many prescriptions were presented to him that were 
not written for a legitimate medical purpose, for there is no 
question that a conscientious pharmacists would have been suspicious 
of these prescriptions and refused to fill them.'').
    \14\ See United States v. Smith, 573 F.3d 639, 657-658 (8th Cir. 
2009); United States v. Nelson, 383 F.3d 1227, 1231-1232 (10th Cir. 
2004); Nirmal Saran, M.D., & Nisha Saran, D.O., 73 FR 78827 (2008); 
Kamir Garces-Mejias, M.D., 72 FR 54931 (2007); William R. Lockridge, 
M.D., 73 FR 78827 (2006); Mario Alberto Diaz, 71 FR 70780 (2006); 
United Prescription Services, Inc., 72 FR 50397 (2007); Trinity 
Health Care Corp., d/b/a Oviedo Discount Pharmacy, 72 FR 30849 
(2007). See also Robert Raymond Reppy, 76 FR 61154 (2011); Sun & 
Lake Pharmacy, Inc., 76 FR 24523 (2011).
    \15\ Under 21 CFR 1306.04(a), a pharmacist who knowingly fills a 
controlled substance prescription which has been issued outside of 
the usual course of professional practice has engaged in an unlawful 
distribution of a controlled substance in violation of 21 U.S.C. 
841(a). So too, a pharmacist who knowingly or intentionally fills a 
controlled substance prescription issued in violation of the Ryan 
Haight Act commits a violation of 21 U.S.C. 841(h)(1).
     While the scienter for criminal violations of section 841 
requires proof that a pharmacist acted with intent, knowledge, or 
willful blindness, it should be noted that under the public interest 
standard applicable in revocation proceedings brought under 21 
U.S.C. 824(a), DEA is not necessarily required to show that a 
pharmacist violated either section 841 or 21 CFR 1306.04(a) to 
establish liability. Rather, DEA can establish that a pharmacy has 
committed acts which render its registration inconsistent with the 
public interest by showing that a pharmacist engaged in the reckless 
or negligent dispensing of a controlled substance by failing to 
resolve the suspicious circumstances presented by a prescription. 
Cf. Paul J. Caragine, Jr., 63 FR 51592, 51601 (1998).

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[[Page 61598]]

    DEA's obligations under the Ryan Haight Act do not require it to 
establish a particular distance between a practitioner and pharmacy 
beyond which a prescription should be presumed to have been issued by 
means of the internet. As DEA stated in the interim final rule, the 
distance between a prescribing practitioner and the pharmacy is just 
one factor potentially relevant to assessing whether a prescription was 
issued by means of the internet. The Act and this rule rely on 
pharmacists to consider all of the circumstances surrounding a 
controlled substance prescription and exercise their professional 
judgment in determining whether to dispense the prescription. To 
address the other commenter's concerns about how these provisions of 
the Act will be enforced, the commenter should look to the standards 
outlined in the interim final rule, which set out the basis for DEA's 
enforcement of the Act's pharmacy requirements. These standards are 
being adopted as a final rule in this rulemaking.

C. Exceptions to the Definition of ``Online Pharmacy''

    The interim final rule contains ten exceptions to its definition of 
``online pharmacy,'' eight taken directly from the Ryan Haight Act. See 
21 CFR 1300.04(h)(1)-(10); 21 U.S.C. 802(52)(B). Some commenters 
supported three particular exceptions: Pharmacies whose dispensing of 
controlled substances by means of the internet consists solely of (1) 
filling or refilling prescriptions for controlled substances in 
schedules III-V, as defined in the Act, 21 CFR 1300.04(h)(8); (2) 
filling prescriptions that were electronically prescribed in a manner 
otherwise consistent with the CSA, id. 1300.04(h)(9); or (3) 
transmitting prescription information between a pharmacy and an 
automated dispensing system located in a long term care facility, when 
the registration of the automated dispensing system is held by the 
pharmacy, id. Sec.  1300.04(h)(10).
    One commenter encouraged DEA to consistently emphasize this first 
exception in communications regarding the Act and its requirements. 
Another commenter expressed concern that the precise wording of the 
first and second exceptions is such that a pharmacy engaging in both 
filling or refilling prescriptions for controlled substances in 
schedules III-V, as defined in the Act, and filling prescriptions that 
were electronically prescribed in a manner otherwise consistent with 
the CSA would be considered an online pharmacy. Other commenters argued 
that additional exceptions to the definition of online pharmacy were 
required to properly exclude other activities conducted by means of the 
internet, such as central fill and processing and telepharmacy.
    DEA Response. DEA thanks the commenters for their support of the 
exceptions to the definition of online pharmacy.
    With respect to the concern that a pharmacy engaging in activity 
under each of the two separate exceptions (21 CFR 1300.04(h)(8), (9)) 
would be considered an online pharmacy, 21 CFR 1300.04(h)(9)(ii) 
already allows a registrant to engage in both categories of activity 
without being deemed an online pharmacy: ``A registered pharmacy will 
be deemed to meet this exception if, in view of all of its activities 
other than those referred to in paragraph (h)(9)(i) . . . it would fall 
outside the definition of an online pharmacy.'' Consistent with this 
section, if a pharmacy fills or refills prescriptions for controlled 
substances in schedules III-V and also fills prescriptions that were 
electronically prescribed, it could still qualify for the exception in 
paragraph (h)(9)(i) if, considering all the activity it engages in 
besides filling electronic prescriptions, including filling and 
refilling prescriptions for controlled substances in schedules III-V, 
it would not meet the definition of an online pharmacy.
    DEA does not believe that further limitations on the definition of 
an online pharmacy are necessary at this time. This rule already 
includes ten separate exceptions to the definition of an online 
pharmacy, covering a broad range of activities; a majority of 
pharmacies fit within one or more of these existing exceptions.

D. Access to Medication

    One commenter objected to the rule on the grounds that people with 
disabilities and people confined to their homes who do not have a care 
provider to pick up medications from a pharmacy will be unable to 
receive the medications they need. Another commenter opposed the rule, 
stating that some patients need more medication than one doctor is 
permitted to prescribe. This commenter argued that it was neither cheap 
nor easy to get controlled substances from reputable online pharmacies 
in the United States, and that imposing additional requirements would 
drive patients to foreign online pharmacies or ``street'' dealers. A 
third commenter objected to the rule on the basis that it would reduce 
access to phentermine.
    DEA Response. The ability of a patient or care provider to pick up 
medications from a pharmacy is outside of the scope of this rule. The 
amount of medication a doctor is permitted to prescribe and the costs 
of medication are outside of the scope of this rule. The Act provides 
that, subject to certain exceptions, controlled substances that are 
prescription drugs may not be dispensed by means of the internet 
without a valid prescription. In order to issue a valid prescription, 
the prescribing practitioner must have conducted at least one in-person 
medical evaluation of the patient, or else be a covering practitioner 
operating in a narrow set of circumstances. These requirements do not 
apply to the dispensing of controlled substances by practitioners 
engaged in the practice of telemedicine, but the Act did not modify the 
existing requirement that all controlled substance prescriptions, to be 
valid, must be issued for a legitimate medical purpose in the usual 
course of professional practice.
    Patients who previously filled valid prescriptions by mail can 
continue to do so. Patients will need to visit a practitioner's office 
for an initial in-person medical evaluation or take part in a 
telemedicine encounter before being issued a prescription, but the vast 
majority of patients were likely already doing this before the 
enactment of the Act. This final rule does not decrease access to 
specific prescriptions of controlled substances as this rule ensures 
that only legitimate law abiding websites dispense controlled 
substances via the internet. Phentermine is a schedule IV controlled 
substance and all the requirements specified for schedule IV controlled 
substances are applicable because the new requirements do not exclude 
or include specific controlled substances. Furthermore, under the CSA, 
it is unlawful to ship controlled substances from abroad into the 
United States for personal medical use, and

[[Page 61599]]

individuals who place an order for such a shipment are in violation of 
the CSA and subject to criminal prosecution. 21 U.S.C. 952, 957, 
960(a)(1).

E. Verification of Registration

    One commenter recommended that DEA create a ``list serve'' email 
system to provide distributors real-time notifications of changes in 
registrants' registration statuses, or to update the registration 
validation tool to allow registrants to check multiple DEA 
registrations automatically. The same commenter suggested DEA allow 
information obtained from the registration validation tool to be used 
as a suitable method of documenting verification of a customer's 
registration during DEA inspections. Finally, the commenter suggested 
DEA conduct a number of outreach efforts to increase awareness of and 
engagement with the new requirements of the rule among members of the 
public and non-registrant companies.
    DEA Response. DEA thanks the commenter for these suggestions. DEA 
strives to provide tools and resources to registrants and the public to 
discontinue the diversion and abuse of controlled substances, and 
always appreciates receiving additional ideas for how these goals can 
be achieved. The commenter's suggestions, however, are beyond the scope 
of this rule, are not necessary for DEA to implement the Ryan Haight 
Act, and would require additional DEA resources to realize. Thus, DEA 
is not acting on these suggestions as part of this final rule, but will 
consider them as appropriate as DEA continues to provide additional 
tools and resources to registrants and the public in the future.

V. Section-by-Section Discussion of the Final Rule

    As discussed above, DEA is adopting the interim final rule as a 
final rule without change, except for a technical amendment further 
explained below and certain minor changes already made by intervening 
rules. Thus, the interim final rule's more detailed discussion of its 
provisions generally remains valid. See 74 FR 15610-15613. In brief, 
however, the final rule consists of the following provisions, all of 
which were already added to the Code of Federal Regulations by the 
interim final rule.
    In part 1300 (definitions), Sec.  1300.04, containing definitions 
relating to the dispensing of controlled substances by means of the 
internet, was added by the interim final rule and remains unchanged. 
These definitions are from the definitions contained in the Act and 
include definitions of the following terms: ``covering practitioner,'' 
``deliver, distribute or dispense by means of the internet,'' ``filling 
new prescriptions for controlled substances in Schedule III, IV, or 
V,'' ``homepage,'' ``in-person medical evaluation,'' ``internet,'' 
``online pharmacy,'' ``practice of telemedicine,'' ``refilling 
prescriptions for controlled substances in Schedule III, IV, or V,'' 
``valid prescription,'' and the temporary definition of ``practice of 
telemedicine.'' \16\ As discussed in the interim final rule and as 
authorized by the Act, Sec.  1300.04 adds two exceptions to the 
definition of an online pharmacy beyond the eight exceptions provided 
for in the Act. See 21 CFR 1300.04(h); 21 U.S.C. 802(52)(B).
---------------------------------------------------------------------------

    \16\ As explained in the interim final rule, the Ryan Haight Act 
provided two definitions of the ``practice of telemedicine,'' a 
temporary definition and a permanent definition. See 74 FR 15603; 
Public Law 110-425, sec. 3(j). The interim final rule incorporated 
both of these definitions, with the permanent definition, 21 CFR 
1300.04(i), becoming effective on January 15, 2010, and the 
temporary definition, 21 CFR 1300.04(j), effective before that date. 
The permanent definition of the ``practice of telemedicine'' 
includes practice ``conducted by a practitioner who has obtained 
from the Administrator a special registration under section 311(h) 
of the Act (21 U.S.C. 831(h)).'' 21 CFR 1300.04(i)(5); 21 U.S.C. 
802(54)(B). The Act, as amended, contemplates that DEA will issue 
regulations effectuating this telemedicine special registration 
provision by October 24, 2019. 21 U.S.C. 831(h)(2). DEA will further 
address the definition and requirements of telemedicine in future 
rulemaking.
---------------------------------------------------------------------------

    In part 1301 (registration of manufacturers, distributors, and 
dispensers of controlled substances), Sec.  1301.11(b) restates the 
requirements of the Act that any person falling within the definition 
of an online pharmacy must be validly registered with a modification 
authorizing it to operate as an online pharmacy, and that only 
pharmacies registered under 21 U.S.C. 823(f) may apply for such 
modification.
    To address the modification of registration as an online pharmacy, 
the table in Sec.  1301.13(e)(1) was amended by the interim final rule. 
``Online Pharmacy'' was listed as a business activity falling under 
``(iv) Dispensing or instructing.'' The online pharmacy application 
form, 224c, was noted. And a comment was added in the ``Coincident 
activities allowed'' column to explain that an online pharmacy may 
perform the activities of both a retail and online pharmacy. As 
explained above, the table in Sec.  1301.13(e)(1) was again amended in 
2012 to increase registration fees. See 77 FR 15234. The revised 
version of the Sec.  1301.13(e)(1) table placed in the Code of Federal 
Regulations by the 2012 amendment, however, not only changed fees in 
Sec.  1301.13(e)(1) but also inadvertently removed the interim final 
rule's additions to Sec.  1301.13(e)(1). This final rule reinstates 
them.
    As added by the interim final rule, Sec.  1301.19 (special 
requirements for online pharmacies) provides in paragraphs (a), (c), 
and (f) that a pharmacy must request a modification of its registration 
authorizing it to operate as an online pharmacy by completing the 
online application process. This section also provides, consistent with 
the Act, that a pharmacy registrant may not operate as an online 
pharmacy until DEA Administrator grants the modified registration. 
Paragraph (b) requires, consistent with the Act, that an online 
pharmacy must comply with the pharmacy license requirements of not only 
the State where it is located, but also of any State to which it 
delivers, distributes, or dispenses controlled substances. Paragraph 
(d) requires a pharmacy that seeks to discontinue its authorization to 
operate as an online pharmacy to modify its registration to reflect 
this change in its business activity.
    Section 1301.52, which addresses termination of registrations, was 
revised by the interim final rule to include modification of 
registration within the meaning of the Act. As explained above, Sec.  
1301.52 was amended by another rule in 2011. See 76 FR 61563. This 2011 
revision did not disturb the interim final rule's changes, and thus the 
final rule requires no additional changes to Sec.  1301.52.
    Four new sections were added to 21 CFR part 1304 (records and 
reports of registrants) by the interim final rule to implement the 
reporting requirements of the Act for online pharmacies, and to specify 
the information the Act requires to be posted on an online pharmacy's 
website. This final rule leaves three of these sections unchanged, but 
makes a minor technical amendment to a paragraph of one of these 
sections, Sec.  1304.40(c).
    Section 1304.40(a) requires online pharmacies to notify the 
Administrator and State boards of pharmacy 30 days before offering to 
fill prescriptions for controlled substances by means of the internet. 
Notification to the Administrator is made by applying for a 
modification of DEA registration. Paragraph (b) of Sec.  1304.40 
contains a list of items that must be included in the notification.
    In the interim final rule, Sec.  1304.40(c) required online 
pharmacies in operation of the time the Act became effective (April 13, 
2009) to make this notification by May 13, 2009, and stated that, since 
April 13, 2009, it has been unlawful for any person to operate as an 
online pharmacy unless it has obtained

[[Page 61600]]

from DEA a modification of its registration authorizing it to do so. 
Given the passage of time since the publication of the interim final 
rule, the first portion of paragraph (c) is no longer relevant, 
specifically the text stating that an online pharmacy in operation at 
the time the Act became effective must make the required notification 
on or before May 13, 2009. As such, in this final rule, DEA is making a 
technical amendment to Sec.  1304.40(c) to remove this outdated text. 
The revised Sec.  1304.40(c) retains the rest of the interim final 
rule's paragraph (c), stating that it is unlawful for any person to 
operate as an online pharmacy unless it has obtained from DEA a 
modification of its registration authorizing it to do so.
    The remainder of Sec.  1304.40 remains unchanged. As in the interim 
final rule, Sec.  1304.40(d) requires that on and after an online 
pharmacy makes notification under this section, it shall display a 
declaration that it has done so. Under Sec.  1304.40(e), an online 
pharmacy must notify the Administrator of any changes to the 
information submitted in its notification thirty days prior to the 
change.
    Section 1304.45 specifies the data elements required to be posted 
on the website of online pharmacies in a visible and clear manner, as 
provided in the Act.
    To identify websites that are operating solely on behalf of DEA-
registered non-pharmacy practitioners who are acting within the scope 
of their registrations (and are thereby exempt from the definition of 
an online pharmacy), Sec.  1304.50 requires such websites that dispense 
controlled substances by means of the internet to display in a visible 
and clear manner a list of those DEA-registered non-pharmacy 
practitioners affiliated with the website.
    Section 1304.55 implements the requirement of the Act that each 
online pharmacy make a monthly report to DEA stating the total quantity 
of each controlled substance the pharmacy has dispensed the previous 
calendar month. This report must include not only the transactions made 
through the online pharmacy, but also any that the pharmacy made 
through mail order, face-to-face, or any other transaction when the 
pharmacy's total dispensing of controlled substances meets or exceeds 
the monthly threshold of either 100 prescriptions filled or 5,000 or 
more dosage units dispensed. Online pharmacies that do not meet this 
threshold in a given month are required to notify DEA.
    In part 1306 (prescriptions), Sec.  1306.09 includes requirements 
for prescriptions that track the requirements of the Act. Paragraph (a) 
specifies that no controlled substance may be delivered, distributed, 
or dispensed by means of the internet without a valid prescription 
(using the definition of a valid prescription contained in the Act). 
Also consistent with the Act, paragraph (b) provides that such 
prescriptions may only be filled by a pharmacy whose registration has 
been modified as specified in the Act. Finally, paragraph (c) applies 
to online pharmacies the requirements of Sec. Sec.  1306.15 and 1306.25 
regarding transfers of prescriptions between pharmacies.

VI. Regulatory Analyses

Executive Orders 12866, 13563, and 13771

    This rule was developed in accordance with the principles of 
Executive Orders (EOs) 12866 and 13563. E.O. 12866 directs agencies to 
assess all costs and benefits of available regulatory alternatives and 
when regulation is necessary, to select regulatory approaches that 
maximize net benefits (including potential economic, public health and 
safety, and environmental advantages; distributive impacts; and 
equity). E.O. 13563 is supplemental to and reaffirms the principles, 
structures, and definitions governing regulatory review as established 
in E.O. 12866. It defines a ``significant regulatory action'' requiring 
review by the Office of Management and Budget (OMB) as any regulatory 
action that is likely to result in a rule that may: (1) Have an annual 
effect on the economy of $100 million or more, or adversely affect in a 
material way the economy, a sector of the economy, productivity, 
competition, jobs, environment, public health or safety, or State, 
local, or tribal governments or communities; (2) create a serious 
inconsistency or otherwise interfere with an action taken or planned by 
another agency; (3) materially alter the budgetary impact of 
entitlements, grants, user fees, or loan programs or the rights and 
obligations of recipients thereof; or (4) raise novel legal or policy 
issues arising out of legal mandates, the President's priorities, or 
the principles set forth in the Executive order.
    As discussed above, this final rule adopts the interim final rule 
without change, apart from certain changes to DEA regulations already 
made by intervening rules and a minor technical amendment. Therefore, 
this final rule imposes no costs beyond the costs already imposed by 
the interim final rule and those intervening rules. OMB has determined 
that this final rule is not a ``significant regulatory action'' under 
E.O. 12866, section 3(f), Regulatory Planning and Review, and 
accordingly this rule has not been reviewed by OMB.
    This final rule is not a significant regulatory action under E.O. 
12866, and it does not impose a cost greater than zero. Therefore, this 
final rule is not an E.O. 13771 regulatory action.

Regulatory Flexibility Act

    The interim final rule was drafted in accordance with the 
Regulatory Flexibility Act (RFA), 5 U.S.C. 601-612. The RFA applies to 
rules for which an agency publishes a general notice of proposed 
rulemaking. As was explained in the interim final rule, the Ryan Haight 
Act expressly contemplated that DEA would issue interim rules under the 
``good cause'' provision of the APA as the agency deemed necessary to 
implement the Act prior to its effective date of April 13, 2009. Thus, 
Congress expressly granted DEA authority to issue regulations to 
implement the Act that become effective immediately, without the 
requirement of first seeking public comment through a notice of 
proposed rulemaking. Consequently, the requirements of the RFA did not 
apply to the interim final rule. Nonetheless, DEA did review the 
potential impacts, and determined that the rule was likely to affect a 
substantial number of small entities, but not likely to have a 
significant economic impact on those small entities. Furthermore, DEA 
sought comments in the interim final rule with respect to those parts 
of the regulatory text about which the agency has discretion. DEA 
received no comments regarding economic impacts. It seems unlikely, 
therefore, that small entities have been significantly impacted by this 
rule.

Paperwork Reduction Act

    This final rule does not create or modify a collection of 
information or impose recordkeeping or reporting requirements under the 
Paperwork Reduction Act of 1995 beyond those modified by the interim 
final rule. 44 U.S.C. 3501-3521. That information collection 
requirement was previously approved by OMB under the assigned OMB 
Control Number 1117-0014. An agency may not conduct or sponsor, and a 
person is not required to respond to, a collection of information 
unless it displays a currently valid OMB control number.

Executive Order 12988, Civil Justice Reform

    This final rule meets the applicable standards set forth in 
sections 3(a) and 3(b)(2) of Executive Order 12988, Civil

[[Page 61601]]

Justice Reform, to eliminate ambiguity, minimize litigation, establish 
clear legal standards, and reduce burden.

Executive Order 13132, Federalism

    This rulemaking does not have federalism implications warranting 
the application of Executive Order 13132. The final rule does not have 
substantial direct effects on the States, on the relationship between 
the National Government and the States, or the distribution of power 
and responsibilities among the various levels of government.

Executive Order 13175, Consultation and Coordination With Indian Tribal 
Governments

    This rule does not have substantial direct effects on the States, 
on the relationship between the National Government and the States, or 
the distribution of power and responsibilities between the Federal 
Government and Indian tribes.

Unfunded Mandates Reform Act of 1995

    This rule will not result in the expenditure by State, local, and 
tribal governments, in the aggregate, or by the private sector, of 
$100,000,000 or more (adjusted for inflation) in any one year, and will 
not significantly or uniquely affect small governments. Therefore, no 
actions were deemed necessary under the provisions of the Unfunded 
Mandates Reform Act of 1995, 2 U.S.C. 1532.

Congressional Review Act

    This rule is not a major rule as defined by the Congressional 
Review Act. 5 U.S.C. 804. This rule will not result in an annual effect 
on the economy of $100,000,000 or more; a major increase in costs or 
prices; or significant adverse effects on competition, employment, 
investment, productivity, innovation, or on the ability of United 
States-based companies to compete with foreign-based companies in 
domestic and export markets.

List of Subjects

21 CFR Part 1300

    Chemicals, Drug traffic control.

21 CFR Part 1301

    Administrative practice and procedure, Drug traffic control, 
Security measures.

21 CFR Part 1304

    Drug traffic control, Reporting and recordkeeping requirements.

21 CFR Part 1306

    Drug traffic control, Prescription drugs.

    For the reasons set out above, the interim final rule amending 21 
CFR parts 1300, 1301, 1304, and 1306, which was published at 74 FR 
15596 on April 6, 2009, and as subsequently amended at 76 FR 61563 and 
77 FR 15234, is adopted as final with the following changes to 21 CFR 
parts 1301 and 1304:

PART 1301--REGISTRATION OF MANUFACTURERS, DISTRIBUTORS, AND 
DISPENSERS OF CONTROLLED SUBSTANCES

0
1. The authority citation for part 1301 continues to read as follows:

    Authority:  21 U.S.C. 821, 822, 823, 824, 831, 871(b), 875, 877, 
886a, 951, 952, 956, 957, 958, 965 unless otherwise noted.


0
2. In Sec.  1301.13, revise paragraph (e)(1)(iv) to read as follows:


Sec.  1301.13   Application for registration; time for application; 
expiration date; registration for independent activities; application 
forms, fees, contents and signature; coincident activities.

    (e) * * *
    (1) * * *

--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                       Registration
         Business activity              Controlled substances        DEA  application     Application      period       Coincident activities allowed
                                                                           forms           fee  ($)       (years)
--------------------------------------------------------------------------------------------------------------------------------------------------------
 
                                                                      * * * * * * *
(iv) Dispensing or instructing      Schedules II-V...............  New--224 Renewal--            731             3   May conduct research and
 (includes Practitioner, Hospital/                                  224a Online                                       instructional activities with
 Clinic, Retail Pharmacy, Online                                    Pharmacy--224c.                                   those controlled substances for
 Pharmacy, Central Fill Pharmacy,                                                                                     which registration was granted,
 Teaching Institution).                                                                                               except that a mid-level
                                                                                                                      practitioner may conduct such
                                                                                                                      research only to the extent
                                                                                                                      expressly authorized under State
                                                                                                                      statute. A pharmacist may
                                                                                                                      manufacturer an aqueous or
                                                                                                                      oleaginous solution solid dosage
                                                                                                                      form containing a narcotic
                                                                                                                      controlled substance in Schedule
                                                                                                                      II-V in a proportion not exceeding
                                                                                                                      20% of the complete solution,
                                                                                                                      compound or mixture. A retail
                                                                                                                      pharmacy may perform central fill
                                                                                                                      pharmacy activities. An online
                                                                                                                      pharmacy may perform activities of
                                                                                                                      retail pharmacy, as well as online
                                                                                                                      pharmacy activities.
 
                                                                      * * * * * * *
--------------------------------------------------------------------------------------------------------------------------------------------------------

* * * * *

PART 1304--RECORDS AND REPORTS OF REGISTRANTS

0
3. The authority for citation for part 1304 continues to read as 
follows:

    Authority:  21 U.S.C. 821, 827, 831, 871(b), 958(e)-(g), and 
965, unless otherwise noted.


0
4. In Sec.  1304.40, revise paragraph (c) to read as follows:


Sec.  1304.40  Notification by online pharmacies.

* * * * *
    (c) It is unlawful for any online pharmacy to deliver, distribute, 
or dispense a controlled substance by means of the internet unless such 
online pharmacy is validly registered with a modification of such 
registration authorizing such activity.
* * * * *

Timothy J. Shea,
Acting Administrator.
[FR Doc. 2020-21310 Filed 9-29-20; 8:45 am]
BILLING CODE 4410-09-P