Implementation of the Ryan Haight Online Pharmacy Consumer Protection Act of 2008, 15596-15625 [E9-7698]

Agencies

• Drug Enforcement Administration
• Department of Justice

[Federal Register Volume 74, Number 64 (Monday, April 6, 2009)]
[Rules and Regulations]
[Pages 15596-15625]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-7698]



[[Page 15595]]

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Part II





Department of Justice





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Drug Enforcement Administration



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21 CFR Part 1300, 1301, 1304, et al.



Implementation of the Ryan Haight Online Pharmacy Consumer Protection 
Act of 2008; Final Rule

Federal Register / Vol. 74, No. 64 / Monday, April 6, 2009 / Rules 
and Regulations

[[Page 15596]]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

21 CFR Parts 1300, 1301, 1304, 1306

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


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

AGENCY: Drug Enforcement Administration (DEA), Department of Justice.

ACTION: Interim final rule with request for comments.

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SUMMARY: The Ryan Haight Online Pharmacy Consumer Protection Act, which 
was enacted on October 15, 2008, amended the Controlled Substances Act 
and Controlled Substances Import and Export Act by adding several new 
provisions to prevent the illegal distribution and dispensing of 
controlled substances by means of the Internet. DEA is hereby issuing 
an interim rule to amend its regulations to implement the legislation 
and is requesting comments on the interim rule.

DATES: This interim rule is effective April 13, 2009, except Sec. Sec.  
1300.04, 1301.19, and 1304.40, which are effective April 6, 2009. 
Section 1300.04(i) (the definition of ``practice of telemedicine'') has 
an implementation date of January 15, 2010, unless such date is 
superseded by future regulatory actions as explained in the 
SUPPLEMENTARY INFORMATION section.
    Written comments must be postmarked on or before June 5, 2009, and 
electronic comments must be sent on or before midnight Eastern time 
June 5, 2009.

ADDRESSES: To ensure proper handling of comments, please reference 
``Docket No. DEA-322'' on all written and electronic correspondence. 
Written comments being sent via regular or express mail should be sent 
to the Drug Enforcement Administration, Attention: DEA Federal Register 
Representative/ODL, 8701 Morrissette Drive, Springfield, VA 22152. 
Comments may be sent to DEA by sending an electronic message to 
dea.diversion.policy@usdoj.gov. Comments may also be sent 
electronically through https://www.regulations.gov using the electronic 
comment form provided on that site. An electronic copy of this document 
is also available at the https://www.regulations.gov Web site. DEA will 
accept attachments to electronic comments in Microsoft Word, 
WordPerfect, Adobe PDF, or Excel file formats only. DEA will not accept 
any file formats other than those specifically listed here.
    Please note that DEA is requesting that electronic comments be 
submitted before midnight Eastern time on the day the comment period 
closes because https://www.regulations.gov terminates the public's 
ability to submit comments at midnight Eastern time on the day the 
comment period closes. Commenters in time zones other than Eastern time 
may want to consider this so that their electronic comments are 
received. All comments sent via regular or express mail will be 
considered timely if postmarked on the day the comment period closes.

FOR FURTHER INFORMATION CONTACT: Mark W. Caverly, Chief, Liaison and 
Policy Section, Office of Diversion Control, Drug Enforcement 
Administration, 8701 Morrissette Drive, Springfield, VA 22152; 
Telephone: (202) 307-7297.

SUPPLEMENTARY INFORMATION: Posting of Public Comments: Please note that 
all comments received are considered part of the public record and made 
available for public inspection online at https://www.regulations.gov 
and in the DEA's public docket. Such information includes personal 
identifying information (such as your name, address, etc.) voluntarily 
submitted by the commenter.
    If you want to submit personal identifying information (such as 
your name, address, etc.) as part of your comment, but do not want it 
to be posted online or made available in the public docket, you must 
include the phrase ``PERSONAL IDENTIFYING INFORMATION'' in the first 
paragraph of your comment. You must also place all the personal 
identifying information you do not want posted online or made available 
in the public docket in the first paragraph of your comment and 
identify what information you want redacted.
    If you want to submit confidential business information as part of 
your comment, but do not want it to be posted online or made available 
in the public docket, you must include the phrase ``CONFIDENTIAL 
BUSINESS INFORMATION'' in the first paragraph of your comment. You must 
also prominently identify confidential business information to be 
redacted within the comment. If a comment has so much confidential 
business information that it cannot be effectively redacted, all or 
part of that comment may not be posted online or made available in the 
public docket.
    Personal identifying information and confidential business 
information identified and located as set forth above will be redacted 
and the comment, in redacted form, will be posted online and placed in 
the DEA's public docket file. Please note that the Freedom of 
Information Act applies to all comments received. If you wish to 
inspect the agency's public docket file in person by appointment, 
please see the ``For Further Information'' paragraph.

Preamble

I. Legislation Upon Which These Regulations Are Based

    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) and Controlled Substances Import and Export Act 
(CSIEA) by adding various provisions to prevent the illegal 
distribution and dispensing of controlled substances by means of the 
Internet.\1\ The law becomes effective April 13, 2009 (except for one 
provision relating to telemedicine discussed below). Thus, as of April 
13, 2009, it will be 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). The Act applies to all controlled 
substances in all schedules.
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    \1\ Consistent with the CSA itself, the Ryan Haight Act relates 
solely to controlled substances. Controlled substances are those 
psychoactive drugs and other substances--including narcotics, 
stimulants, depressants, hallucinogens, and anabolic steroids--that 
are placed in one of the five schedules of the CSA due to their 
potential for abuse and likelihood that they may cause psychological 
or physical dependence when abused.
    Controlled substances constitute only a small percentage of all 
pharmaceutical drugs. Approximately 10 percent of all drug 
prescriptions written in the United States are for controlled 
substances, with the remaining approximately 90 percent of 
prescriptions being written for noncontrolled substances. The 
amendments to the CSA made by the Ryan Haight Act, as well as the 
regulations being issued here, do not apply to noncontrolled 
substances.
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    This document serves three purposes: (1) To explain the new 
legislation; (2) to announce the amendments to the DEA regulations that 
implement the new legislation; and (3) to request comments on the 
amendments to the regulations, which are being issued as an interim 
rule as contemplated in the legislation.

II. Authority in Ryan Haight Act To Issue Regulations

    The Ryan Haight Act contains various provisions that call upon the 
Attorney

[[Page 15597]]

General to issue regulations to implement the Act. Among these is the 
following general grant of authority:

    The Attorney General may promulgate and enforce any rules, 
regulations, and procedures which may be necessary and appropriate 
for the efficient execution of functions under this Act or the 
amendments made by this Act, and, with the concurrence of the 
Secretary of Health and Human Services where this Act or the 
amendments made by this Act so provide, promulgate any interim rules 
necessary for the implementation of this Act or the amendments made 
by this Act, prior to its effective date.\2\
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    \2\ Public Law 110-425, sec. 3(k)(1).

    This regulatory authority of the Attorney General has been 
delegated to the Administrator of DEA.\3\ It is evident from the 
foregoing provision of the Act that Congress contemplated it would be 
necessary for DEA to issue regulations on an interim basis in order to 
implement the Act within the relatively short time period between the 
passage of the Act (October 15, 2008) and its effective date (April 13, 
2009). Indeed, Congress envisioned that DEA would need to issue interim 
rules ``prior to its effective date'' (i.e., before April 13, 2009) to 
effectively implement the new requirements of the Act.\4\ Accordingly, 
the rules published here are effective immediately while at the same 
time the agency is seeking public comment on them. Following the 
comment period, DEA will review the comments and make any modifications 
to the interim rule that are appropriate. Also, as explained below, the 
Act contemplates that DEA will, with the concurrence of the Secretary 
of Health and Human Services, promulgate regulations governing the 
issuance to practitioners of a special registration relating to the 
practice of telemedicine. Those regulations will be issued separately 
at a later date.
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    \3\ Functions vested in the Attorney General under the CSA have 
been delegated to the Administrator of DEA. 28 CFR 0.100. 
Accordingly, in this document, ``DEA Administrator'' will be used in 
place of all statutory references to the Attorney General.
    \4\ Congress's express grant of authority under the Ryan Haight 
Act to issue interim rules as the DEA Administrator finds necessary 
to implement the Act prior to its effective date forms the basis for 
the DEA Administrator's conclusion, as is set forth in Section X 
below, that ``good cause'' exists under the Administrative Procedure 
Act (APA) for the issuance of interim rules (those which take effect 
immediately on an interim basis prior to the public comment period) 
because ``notice and public procedure thereon are impracticable, * * 
*[and] contrary to the public interest.'' See 5 U.S.C. 553(b)(B).
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III. Overview of the Legislation

A. Reasons for the Legislation

    The unlawful use of pharmaceutical controlled substances has 
reached alarming levels in the United States in recent years, causing a 
substantial detrimental effect on the public health and safety. 
According to the most recently published National Survey on Drug Use 
and Health (2007),\5\ 6.9 million Americans reported using 
psychotherapeutic drugs \6\ nonmedically during the prior month.\7\ 
With specific regard to pain relievers, 5.2 million respondents 
reported abusing these drugs,\8\ which is an 18 percent increase from 
2004.\9\ This study further indicates that, in the United States, the 
abuse of prescription drugs is second only to that of marijuana and is 
higher than the abuse of cocaine, heroin and hallucinogens 
combined.\10\ Among persons aged 12 and older who reported using 
illicit drugs for the first time in 2007, abuse of pain relievers was 
the most common category of first-time illicit drug use.\11\
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    \5\ Available at https://www.oas.samhsa.gov/nsduh/2k7nsduh/2k7Results.pdf.
    \6\ The study states: ``Psychotherapeutics include the 
nonmedical use of any prescription-type pain relievers, 
tranquilizers, stimulants, or sedatives. Over-the-counter substances 
are not included.'' Id. at 55.
    \7\ Id. at 1.
    \8\ Id.
    \9\ Compare 2004 National Survey on Drug Use and Health at 1, 
available at https://www.oas.samhsa.gov/nsduh/2k4nsduh/2k4results.pdf.
    \10\ See id. at 73.
    \11\ Id. at 4.
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    The false sense of security that some associate with the abuse of 
these substances is also alarming. Many mistakenly believe that if a 
drug may be prescribed for medical use, abusing that drug cannot be as 
harmful as abusing more conventional ``street'' drugs, such as heroin 
or cocaine. According to the 2005 Partnership Attitude Tracking Study 
\12\, 40 percent of teens surveyed believe that prescription medicines 
are ``much safer'' to use than illegal drugs. Furthermore, the same 
study concluded that 31 percent believe there is ``nothing wrong'' with 
using prescription medicines without a prescription ``once in awhile.'' 
\13\
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    \12\ Partnership for a Drug-Free America; Partnership Attitude 
Tracking Study, Teens in grades 7 through 12, 2005; https://www.drugfree.org/Files/Full_Teen_Report (page 21).
    \13\ Id. at 20-21.
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    One of the main factors contributing to the nationwide increase in 
the diversion of pharmaceutical controlled substances has been the rise 
in the number of Internet sites that sell or facilitate the sale of 
these drugs for other than legitimate medical purposes. While in-person 
``prescription mills'' (practitioners' offices that readily supply drug 
seekers with prescriptions for controlled substances without 
establishing a legitimate medical basis for doing so) have always been, 
and remain, a significant source of diversion, the advent of rogue Web 
sites that cater to those who abuse pharmaceutical controlled 
substances has allowed the criminal operators of these sites to exploit 
the anonymity of the Internet to generate illicit sales of controlled 
substances (and/or prescriptions therefor) that far exceed those of any 
in-person prescription mill. This is particularly evident when 
examining the data relating to the sales of hydrocodone, which is the 
most widely abused pharmaceutical controlled substance in the United 
States. According to data registered distributors of controlled 
substances provided to DEA \14\ in 2006, 34 pharmacies in the United 
States that were supplying rogue Internet sites dispensed a total of 
more than 98 million dosage units of hydrocodone. Hence, these 
pharmacies each dispensed an average of approximately 2.9 million 
dosage units of hydrocodone per pharmacy in a single year. By means of 
comparison, the average pharmacy in the United States dispenses 
approximately 88,000 dosage units of hydrocodone per year.
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    \14\ Distributors are required to submit certain reports to 
DEA's ARCOS unit, as provided in 21 CFR 1304.33.
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    Congress passed the Ryan Haight Act precisely because of ``the 
increasing use of prescription controlled substances by adolescents and 
others for nonmedical purposes, which has been exacerbated by drug 
trafficking on the Internet.'' \15\ The person for whom the Act was 
named, Ryan Haight, was ``a California high school honors student and 
athlete who died in 2001 from an overdose of controlled substances that 
he had purchased from a rogue online pharmacy.'' \16\ According to the 
Senate Report accompanying the legislation, ``Ease of access to the 
Internet, combined with lack of medical supervision, has led to tragic 
consequences in the online purchase of prescription controlled 
substances.'' \17\ The Senate Report then cited a list of examples of 
persons in the United States who had died from overdoses of controlled 
substances obtained via the Internet.\18\
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    \15\ S. Rep. No. 110-521, at 1 (2008).
    \16\ Id. at 12.
    \17\ Id. at 5.
    \18\ Id. at 5-6.

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B. Common Methods Employed by Operators of Rogue Web Sites That Sell 
Pharmaceutical Controlled Substances

    The rogue Web sites that the Ryan Haight Act seeks to eliminate 
take on a variety of appearances and use a variety of methods. One 
common factor is that all these Web sites are marketed toward drug 
seekers who are willing to pay a premium to obtain pharmaceutical 
controlled substances without having a legitimate medical need for 
them. While the ``business models'' that the operators of these sites 
employ to evade detection by law enforcement and/or to create the 
facade of compliance with the law have evolved significantly over time, 
there tend to be three categories of participants in these schemes: the 
prescribing practitioner; the pharmacy that fills the prescriptions; 
and the criminal facilitator (a non-DEA registrant) who runs the 
operation.\19\
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    \19\ The ``business models'' described here are not the only 
ones employed by operators of rogue sites; methods other than those 
described above have been utilized by those who divert controlled 
substances by means of the Internet.
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    While it has always been illegal to dispense a controlled substance 
without a legitimate medical purpose, prior to the Act, a rogue 
operator could design a site that would make it clear to drug seekers 
that pharmaceutical controlled substances could be obtained through the 
site without a legitimate medical purpose. For example, a typical rogue 
site would display prominently on its homepage a list of the 
pharmaceutical controlled substances that it sold and prompt customers 
to click on their desired drugs. These Web sites could easily be found 
by using any of various Internet search engines and entering search 
terms such as ``hydrocodone no prescription.'' Unsolicited e-mails or 
other forms of online advertising and marketing often steered potential 
customers to these Web sites; the advertisements announced that 
controlled substances could be readily obtained through the Web site 
without an in-person medical evaluation and sometimes without even a 
prescription--thus insuring a drug seeking customer could obtain the 
controlled substance without a legitimate medical need.
    Thus, prior to passage of the Act, attracting customers was 
relatively easy for these rogue Web sites. However, to deliver the 
goods that the customers were seeking (pharmaceutical controlled 
substances and/or prescriptions for such), the operator of the rogue 
Web site usually had to enlist the services of two types of DEA 
registrants: a practitioner and pharmacy. Thus, the typical criminal 
facilitator had to recruit an unscrupulous practitioner willing to 
prescribe controlled substances without a legitimate medical evaluation 
obtained through a bona fide doctor-patient relationship. While the 
overwhelming majority of practitioners would want no part of this type 
of improper arrangement, criminal facilitators were able to find some 
unscrupulous practitioners willing to participate. Investigations have 
revealed that these facilitators often target practitioners who carry 
significant debt, such as those recently graduated from medical school, 
or those who have retired and are looking for some ``extra income.'' 
Regardless of the motivations of the participating practitioners, the 
facilitator would persuade them to enter into an agreement whereby they 
would agree to write prescriptions for controlled substances without 
adhering to the standard professional practices employed by 
practitioners when evaluating the medical condition of patients and 
determining the appropriate treatment in return for payment from the 
facilitator based on the number of prescriptions they would write. 
These arrangements operated in several ways. In some instances, the 
facilitator would arrange for a practitioner to issue prescriptions for 
controlled substances based solely on reviewing online questionnaires 
the customers submitted to the Web site. Other schemes involved 
facilitators requiring the customers of the Web site to fax some 
documentation that purported to be the customers' ``medical records'' 
and then having an unscrupulous practitioner issue prescriptions for 
controlled substances based on a ``review'' of these faxed documents. A 
third type of scheme involved the facilitator having customers of the 
Web site call a telephone number staffed by employees of the site, 
answer a series of questions purporting to create a ``medical 
history,'' and then have unscrupulous practitioners write the 
prescriptions based on these answers. Whatever the methods employed, 
these rogue Web site operations were merely a sham, as every step in 
the process was designed to sell customers controlled substances and/or 
prescriptions for controlled substances without regard to actual 
medical need.
    Some criminal facilitators have been content to take in the profits 
associated with selling the prescriptions for controlled substances. 
(Some rogue Web sites charge customers a separate fee for arranging the 
issuance of prescriptions.) Others have sought to increase their 
profits by also having customers fill the prescriptions through a 
pharmacy affiliated with the Web site. To achieve the latter, the 
criminal facilitator needed to enter into an agreement with an 
unscrupulous pharmacy that was willing--for a fee--to fill 
prescriptions for controlled substances with essentially no questions 
asked and for as many prescriptions as the Web site could steer toward 
the pharmacy.\20\ In addition to paying the pharmacy for the cost of 
the drugs, the criminal facilitator would also typically pay the 
pharmacy an agreed upon amount that, in some instances, amounted to 
millions of dollars. Given the amount of money to be made from these 
arrangements, DEA has seen pharmacies close their doors completely to 
walk-in customers and convert their entire business to filling orders 
generated from rogue Web sites. In some instances, criminal 
facilitators have used multiple brick and mortar pharmacies to service 
their list of drug seeking customers. In other cases, a single pharmacy 
has supplied multiple rogue Web sites.
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    \20\ The small percentage of pharmacies who have so participated 
in these rogue Web site schemes have, in many cases, filled 
extraordinary numbers of prescriptions for controlled substances 
that dwarf the sales figures of walk-in pharmacies.
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    These rogue Web sites generally provide the customer with a wide 
variety of quick and easy payment methods, such as cash-on-delivery, 
lines of credit, and credit ``gift'' cards. They also typically 
structure the various steps of the ordering process so as to link and 
shift the buyer to different Web sites, making it difficult for 
investigators to connect payments, products, and Web providers 
together. Rarely do such rogue Web sites contain any identifying 
information about where the online pharmacy is located or who owns or 
operates the Web site. On the contrary, these Web sites frequently 
fluctuate in name and number minute by minute. Finally, the typical 
rogue Web site fails to provide any information on how a patient may 
contact the prescribing practitioner or the pharmacist to consult with 
them about the drug(s) ordered, including drug interactions and adverse 
reactions.
    Recognizing that these rogue Web sites fuel the abuse of 
prescription controlled substances and thereby increase 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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IV. Brief Summary of Some of the Key Provisions of the Legislation

    Before examining the legislation in detail, the following is a 
brief recitation of two of the most important new statutory 
requirements: the in-person medical evaluation requirement for 
prescribing practitioners and the modified registration requirement for 
online pharmacies.
    A. In-person medical evaluation requirement--One of the primary 
ways in which the Ryan Haight 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 involving at least one in-person medical evaluation. While 
the lack of an in-person medical evaluation has always been viewed as a 
``red flag'' indicating that diversion might be occurring, the Ryan 
Haight 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. At the same time, it is crucial to bear in mind that, 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 additional, fundamental 
prerequisite that has been legally mandated for more than 90 years: it 
must be issued for a legitimate medical purpose by a practitioner 
acting in the usual course of professional practice.\21\
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    \21\ 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 of the core provisions of the Act is the requirement that any 
person who operates a Web site 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 nonregistrants who have heretofore facilitated unlawful 
Internet controlled substance sales by enlisting the services of 
unscrupulous 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 Web sites that the Act was designed to eliminate. Consistent 
with the longstanding structure of the CSA (since it was enacted in 
1970), the Ryan Haight 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 Web site 
contains certain declarations designed to provide clear assurance that 
it is operating legitimately and in conformity with the Act. (These 
requirements are discussed at length below.)

V. Detailed Explanation of the Legislation

    Consistent with the structure of the CSA, the Ryan Haight Act sets 
out numerous regulatory requirements and other substantive provisions 
and makes it unlawful to ``knowingly or intentionally * * * deliver, 
distribute, or dispense a controlled substance by means of the 
Internet, except as authorized by [the Act].'' \22\ Thus, this 
explanation of the Act will be divided into two main parts: (1) 
Explaining the Act's regulatory requirements and other substantive 
provisions and (2) explaining what it means to ``knowingly or 
intentionally * * * deliver, distribute, or dispense a controlled 
substance by means of the Internet.''
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    \22\ 21 U.S.C. 841(h)(1)(A).
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A. New definitions under the Act

    The Act adds several new definitions to the CSA. These new 
statutory definitions are being added to the DEA regulations as part of 
this Interim Rule. While many of the new definitions are self-
explanatory, some are discussed in this preamble to assist in 
understanding the Act.
    The following are two of the key definitions in the Act, which are 
set forth in 21 U.S.C. 802:

    (51) The term ``deliver, distribute, or dispense by means of the 
Internet'' refers, respectively, to any delivery, distribution, or 
dispensing of a controlled substance that is caused or facilitated 
by means of the Internet.

This definition is plainly broad in scope, encompassing any activity 
utilizing the Internet that causes or facilitates the delivery, 
distribution, or dispensing of a controlled substance. This definition 
is incorporated into the Act's definition of an ``online pharmacy'':

    (52) The term ``online pharmacy'' * * * means [with certain 
exceptions discussed below] a person, entity, or Internet site, 
whether in the United States or abroad, that knowingly or 
intentionally delivers, distributes, or dispenses, or offers or 
attempts to deliver, distribute, or dispense, a controlled substance 
by means of the Internet.

The definition of ``online pharmacy'' is also broad in scope. First, it 
includes not only a ``person'' \23\ but also any other ``entity'' or 
``Internet site''--``whether in the United States or abroad''--that 
otherwise meets the definition of an ``online pharmacy.'' Second, it 
also includes not only any such person, entity or Internet site ``that 
knowingly or intentionally delivers, distributes, or dispenses * * * a 
controlled substance by means of the Internet,'' but also any such one 
who ``offers or attempts'' to do so.
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    \23\ As set forth in 1 U.S.C. 7, the word ``person'' includes 
``corporations, companies, associations, firms, partnerships, 
societies, and joint stock companies, as well as individuals.'' 
Consistent therewith, the DEA regulations define ``person'' to 
include ``any individual, corporation, government or governmental 
subdivision or agency, business trust, partnership, association, or 
other legal entity.'' 21 CFR 1300.01(b)(34).
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    Hence, the term ``online pharmacy'' includes, among other things: 
(i) Any Web site that sells, or offers to sell, any controlled 
substance or a prescription therefor to a person in the United States; 
(ii) any person who operates such a Web site; \24\ (iii) any person who 
pays a practitioner to write prescriptions for controlled substances 
for customers of such a Web site; (iv) any person who pays a pharmacy 
to fill prescriptions for controlled substances that were issued

[[Page 15600]]

to customers of such a Web site; (v) any pharmacy that knowingly or 
intentionally fills prescriptions for controlled substances that were 
issued to customers of such a Web site; and (vi) any person who sends 
an e-mail that: Offers to sell a controlled substance or a prescription 
for a controlled substance in a manner not authorized by the Act; 
directs buyers to a Web site operating in violation of the Act; or 
otherwise causes or facilitates the delivery, distribution, or 
dispensing of a controlled substance in a manner not authorized by the 
Act.
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    \24\ The Act exempts certain categories of persons from the 
application of 21 U.S.C. 841(h)(1), such as Internet service 
providers and Web hosting services, so long as such persons do not 
act in concert with others who violate the Act.
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    While the general scope of the definition of an ``online pharmacy'' 
is broad, the definition expressly excludes the following categories:

    (i) Manufacturers or distributors registered under subsection 
(a), (b), (d), or (e) of [21 U.S.C. 823] who do not dispense 
controlled substances to an unregistered individual or entity;
    (ii) Nonpharmacy practitioners who are registered under [21 
U.S.C. 823(f)] and whose activities are authorized by that 
registration;
    (iii) Any hospital or other medical facility that is operated by 
an agency of the United States (including the Armed Forces), 
provided such hospital or other facility is registered under [21 
U.S.C. 823(f)];
    (iv) A health care facility owned or operated by an Indian tribe 
or tribal organization, only to the extent such facility is carrying 
out a contract or compact under the Indian Self-Determination and 
Education Assistance Act;
    (v) Any agent or employee of any hospital or facility referred 
to in clause (iii) or (iv), provided such agent or employee is 
lawfully acting in the usual course of business or employment, and 
within the scope of the official duties of such agent or employee, 
with such hospital or facility, and, with respect to agents or 
employees of health care facilities specified in clause (iv), only 
to the extent such individuals are furnishing services pursuant to 
the contracts or compacts described in such clause;
    (vi) Mere advertisements that do not attempt to facilitate an 
actual transaction involving a controlled substance;
    (vii) A person, entity, or Internet site that is not in the 
United States and does not facilitate the delivery, distribution, or 
dispensing of a controlled substance by means of the Internet to any 
person in the United States;
    (viii) A pharmacy registered under [21 U.S.C. 823(f)] whose 
dispensing of controlled substances via the Internet consists solely 
of--
    (I) Refilling prescriptions for controlled substances in 
schedule III, IV, or V, as defined in paragraph [21 U.S.C. 802(55)]; 
or
    (II) Filling new prescriptions for controlled substances in 
schedule III, IV, or V, as defined in paragraph [21 U.S.C. 802(56)]; 
or
    (ix) Any other persons for whom the [DEA Administrator] and the 
Secretary [of Health and Human Services] have jointly, by 
regulation, found it to be consistent with effective controls 
against diversion and otherwise consistent with the public health 
and safety to exempt from the definition of an ``online pharmacy''.

21 U.S.C. 802(52)(B).
    To elaborate briefly on these exceptions, under exception (i), a 
DEA-registered manufacturer or distributor \25\ that uses the Internet 
to facilitate activities permitted by its DEA registration does not 
constitute an online pharmacy. Under exception (ii), a DEA-registered 
nonpharmacy practitioner (e.g., physician, dentist, veterinarian, 
scientific investigator, hospital, or other person authorized by his 
registration to dispense controlled substances) may do so by means of 
the Internet without being an online pharmacy. Under exceptions (iii) 
through (v), certain hospitals and other health care facilities 
associated with the United States government, as well as agents and 
employees acting in the course of their duties for such institutions, 
are not online pharmacies. Under exception (vi), an advertisement is 
not an online pharmacy, provided the advertisement does not ``attempt 
to facilitate an actual transaction involving a controlled substance.''
---------------------------------------------------------------------------

    \25\ Under the CSA, a DEA-registered ``distributor'' delivers 
controlled substances to other DEA registrants; it may not 
administer, dispense, or otherwise deliver controlled substances to 
patients. See 21 U.S.C. 802(11), 822(a), 822(b), 828(a).
---------------------------------------------------------------------------

    Under exception (vii), a person, entity, or Internet site located 
outside the United States is only excepted from the definition of an 
online pharmacy if it ``does not facilitate the delivery, distribution, 
or dispensing of a controlled substance by means of the Internet to any 
person in the United States.'' (Emphasis added.) Thus, Web sites 
operated by persons located abroad, along with persons who operate the 
sites, do fall within the definition of an online pharmacy if they sell 
or offer to sell controlled substances to persons in the United States 
or otherwise ``facilitate the delivery, distribution, or dispensing of 
a controlled substance by means of the Internet to any person in the 
United States.''
    Under exception (viii), a DEA-registered pharmacy is excepted from 
the definition of an online pharmacy if it dispenses controlled 
substances via the Internet solely by ``refilling prescriptions for 
controlled substances in schedule III, IV, or V'' and ``filling new 
prescriptions for controlled substances in schedule III, IV, or V'' (as 
those terms are defined in the Act). Finally, under exception (ix), the 
DEA Administrator and the Secretary of Health and Human Services have 
the authority to jointly decide to issue regulations making further 
exceptions to the definition of an online pharmacy, where they 
determine that doing so is ``consistent with effective controls against 
diversion and otherwise consistent with the public health and safety.'' 
Pursuant to this clause, the regulations being issued here contain two 
exceptions to the definition of an online pharmacy: One relating to 
electronic prescribing of controlled substances and the other to the 
use of automated dispensing systems. These exceptions are explained 
below.

B. In-Person Medical Evaluation Requirement

    To directly prohibit what had been the practice of many rogue Web 
sites--allowing customers to buy controlled substances and/or 
prescriptions for controlled substances via the Internet without ever 
seeing the prescribing practitioner in person--the Ryan Haight Act 
includes as one of its central features the ``valid prescription'' 
requirement. This requirement is set forth in 21 U.S.C. 829(e)(1): ``No 
controlled substance that is a prescription drug as determined under 
the Federal Food, Drug, and Cosmetic Act \26\ may be delivered, 
distributed, or dispensed by means of the Internet without a valid 
prescription.''
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    \26\ Nearly every pharmaceutical controlled substance is a 
prescription drug under the Federal Food, Drug, and Cosmetic Act 
(FDCA). In the very rare instance where a drug contains a controlled 
substance but may be dispensed under the FDCA without a 
prescription, the DEA regulations specify the procedures a 
pharmacist must follow to dispense such a drug lawfully to a 
purchaser. 21 CFR 1306.26.
---------------------------------------------------------------------------

    The Act further defines the meaning of ``valid prescription'' in 21 
U.S.C. 829(e)(2)(A): ``The term `valid prescription' means a 
prescription that is issued for a legitimate medical purpose in the 
usual course of professional practice by--(i) a practitioner who has 
conducted at least 1 in-person medical evaluation of the patient; or 
(ii) a covering practitioner.'' The Act explains the meaning of ``in-
person medical evaluation'' in 21 U.S.C. 829(e)(2)(B):

    (i) The term ``in-person medical evaluation'' means a medical 
evaluation that is conducted with the patient in the physical 
presence of the practitioner, without regard to whether portions of 
the evaluation are conducted by other health professionals.
    (ii) Nothing in clause (i) shall be construed to imply that 1 
in-person medical evaluation demonstrates that a prescription has 
been issued for a legitimate medical purpose within the usual course 
of professional practice.

    Thus, for every controlled substance that is delivered, 
distributed, or dispensed by means of the Internet,

[[Page 15601]]

there must be a ``valid prescription,'' which means not only that the 
prescription must comply with the longstanding requirement of being 
issued for a legitimate medical purpose by a practitioner acting in the 
usual course of professional practice, but also that the prescribing 
practitioner must either (i) have conducted at least one in-person 
medical evaluation of the patient or (ii) meet the definition of a 
``covering practitioner'' (explained below). Any practitioner who 
writes a prescription for a controlled substance that fails to comply 
with this provision of the Act, as well as any pharmacy that knowingly 
or intentionally fills such a prescription, violates 21 U.S.C. 
841(h)(1).
    Hence, the Act makes it unambiguous that, except in limited and 
specified circumstances, 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. However, the Act also expressly provides that a 
prescribing practitioner does not automatically meet the requirement of 
issuing a prescription for a legitimate medical purpose while acting in 
the usual course of professional practice merely by having conducted a 
single in-person medical evaluation of the patient. Rather, as with all 
situations in which a prescription for a controlled substance is 
issued, all the facts and circumstances surrounding the issuance of the 
prescription must be evaluated in determining whether it was issued for 
a legitimate medical purpose by a practitioner acting in the usual 
course of professional practice.\27\ A rogue Internet operation cannot, 
for example, defeat the purpose of the Act by establishing a method of 
operation in which a practitioner conducts a perfunctory in-person 
``evaluation'' of each ``patient'' simply for the purpose of selling 
prescriptions for controlled substances to the patient in perpetuity 
with no follow-up visits. This topic is addressed further below in 
Section VII, which provides additional information for practitioners.
---------------------------------------------------------------------------

    \27\ For a detailed explanation of the ``legitimate medical 
purpose requirement,'' see 71 FR 52716, 52717 (2006 DEA policy 
statement). See also, 21 CFR 1306.04(a); United States v. Moore, 423 
U.S. 122 (1975).
---------------------------------------------------------------------------

    With respect to the term ``covering practitioner,'' the Act states 
(21 U.S.C. 829(e)(2)(C)):

    The term ``covering practitioner'' means, with respect to a 
patient, a practitioner who conducts a medical evaluation (other 
than an in-person medical evaluation) at the request of a 
practitioner who--(i) has conducted at least 1 in-person medical 
evaluation of the patient or an evaluation of the patient through 
the practice of telemedicine, within the previous 24 months; and 
(ii) is temporarily unavailable to conduct the evaluation of the 
patient.

Thus, a prescribing practitioner who falls within the above definition 
of a ``covering practitioner'' need not conduct an in-person medical 
evaluation as a prerequisite to prescribing a controlled substance to a 
given patient, provided that the practitioner for whom the covering 
practitioner is covering has conducted an in-person medical evaluation 
of that patient and provided further that this covering arrangement is 
taking place on only a temporary basis. Moreover, just as with the 
primary practitioner, the requirement that the prescription must be 
issued in the usual course of professional practice for a legitimate 
medical purpose applies with equal force to a ``covering 
practitioner.''
    The Act also provides for an exception to the requirement of an in-
person medical evaluation for practitioners who are engaged in the 
``practice of telemedicine'' within the meaning of the Act. 21 U.S.C. 
829(e)(3)(A). Of course, a practitioner engaged in the ``practice of 
telemedicine'' remains subject to the requirement that every 
prescription for a controlled substance be issued for a legitimate 
medical purpose by a practitioner acting in the usual course of 
professional practice. The Act provides a temporary definition of the 
``practice of telemedicine'' pending issuance of new regulations 
addressing ``telemedicine.'' The topic of ``telemedicine'' is further 
addressed in paragraph D below.

C. Requirements for Online Pharmacies

    Modified Registration Requirement--The Act imposes various 
requirements for those persons and other entities that fit within the 
Act's definition of an online pharmacy. To begin with, an online 
pharmacy may only operate lawfully as an online pharmacy if it is a 
DEA-registered pharmacy that has obtained from DEA a modification of 
its registration authorizing it to engage in such activity. 21 U.S.C. 
823(f), 841(h)(1). An online pharmacy that is not validly registered 
with a modification authorizing it to operate as an online pharmacy as 
required by 21 U.S.C. 823(f) will violate 21 U.S.C. 841(h)(1) if it 
knowingly or intentionally delivers, distributes, or dispenses a 
controlled substance by means of the Internet. Moreover, under the Act, 
the only type of online pharmacy that is eligible to apply to DEA for 
such modification of registration is a DEA-registered pharmacy. 21 
U.S.C. 823(f). Thus, any person, entity, or Internet site that falls 
within the definition of an online pharmacy--and is not a DEA-
registered pharmacy that has obtained a modification of its 
registration authorizing it to operate as an online pharmacy--is 
necessarily violating the Act if it knowingly or intentionally 
delivers, distributes, or dispenses a controlled substance by means of 
the Internet.
    The regulations being issued here set forth the process by which a 
DEA-registered pharmacy may apply online for a modification of its 
registration authorizing it to operate as an online pharmacy. Under the 
Act, DEA must base its decision on whether to grant or deny such an 
application for a modification of registration on the same statutory 
criteria that it must consider in evaluating an application for 
registration submitted by a pharmacy or other practitioner. 21 U.S.C. 
823(f).
    Reporting Requirement--A pharmacy that has obtained a modification 
of its registration authorizing it to dispense controlled substances by 
means of the Internet must report to DEA, on a monthly basis, the total 
amount of each controlled substance it dispenses. 21 U.S.C. 827(d)(2). 
For pharmacies that are subject to this requirement, the monthly report 
must include all controlled substances dispensed by any means--not just 
controlled substances dispensed by means of the Internet. Id. However, 
if a pharmacy with such a modified registration dispenses an amount 
that falls below the threshold in a given month, it is not required to 
submit a report for that month. Id. The monthly threshold is either (A) 
100 or more prescriptions for controlled substances filled by the 
pharmacy or (B) 5,000 or more total dosage units of controlled 
substances dispensed. Id. Again, these threshold amounts include all 
controlled substances dispensed by the pharmacy by any means (through 
walk-in business, by mail, by means of the Internet, or otherwise). Id. 
If the pharmacy meets or exceeds either of the foregoing amounts in a 
given month, it must report to DEA the total amount of controlled 
substances it dispensed by any means during that month. Id. The 
regulations being issued here specify the time and manner in which such 
reports must be filed.
    Statements that must appear on an online pharmacy's Web site--Every 
online pharmacy is required under the Act to ``display in a visible and 
clear manner on its homepage a statement that it complies with the 
requirements of [21 U.S.C. 831] with respect to the delivery or sale or 
offer for sale of

[[Page 15602]]

controlled substances and shall at all times display on the homepage of 
its Internet site a declaration of compliance in accordance with this 
section.'' 21 U.S.C. 831(a).
    In addition, the Act requires every online pharmacy to satisfy the 
following requirement relating to what the Act refers to as the 
``Internet Pharmacy Site Disclosure Information.'' As set forth in 21 
U.S.C. 831(c), each online pharmacy shall post in a visible and clear 
manner on the homepage of each Internet site it operates, or on a page 
directly linked thereto in which the hyperlink is also visible and 
clear on the homepage, the following information for each pharmacy that 
delivers, distributes, or dispenses controlled substances pursuant to 
orders made on, through, or on behalf of, that Web site:
     The name and address of the pharmacy as it appears on the 
pharmacy's Drug Enforcement Administration Certificate of Registration.
     The pharmacy's telephone number and e-mail address.
     The name, professional degree, and States of licensure of 
the pharmacist-in-charge, and a telephone number at which the 
pharmacist-in-charge can be contacted.
     A list of the States in which the pharmacy is licensed to 
dispense controlled substances.
     A certification that the pharmacy is registered under this 
part to deliver, distribute, or dispense by means of the Internet 
controlled substances.
     The name, address, telephone number, professional degree, 
and States of licensure of any practitioner who has a contractual 
relationship to provide medical evaluations or issue prescriptions for 
controlled substances, through referrals from the Web site or at the 
request of the owner or operator of the Web site, or any employee or 
agent thereof.
     The following statement, unless revised by the [DEA 
Administrator] by regulation: ``This online pharmacy will only dispense 
a controlled substance to a person who has a valid prescription issued 
for a legitimate medical purpose based upon a medical relationship with 
a prescribing practitioner. This includes at least one prior in-person 
medical evaluation or medical evaluation via telemedicine in accordance 
with applicable requirements of section 309.''
    While the foregoing requirements are largely self-explanatory, some 
aspects warrant special emphasis. The requirement that an online 
pharmacy post the foregoing information ``in a visible and clear manner 
on the homepage of each Internet site it operates, or on a page 
directly linked thereto in which the hyperlink is also visible and 
clear on the homepage'' is intended to ensure that members of the 
public who visit such Web sites are informed about the Ryan Haight 
Act's core requirements and to ensure that the DEA-registered 
pharmacies and prescribing practitioners affiliated with the site, if 
any, are clearly identified. Any effort by an online pharmacy to hide 
or reduce the visibility on the Web site of this required information 
will subject those responsible to potential criminal and civil 
liability and, in the case of DEA registrants, potential loss of 
registration. The required information must be displayed ``for each 
pharmacy that delivers, distributes, or dispenses controlled substances 
pursuant to orders made on, through, or on behalf of, that Web site.'' 
Thus, if multiple pharmacies dispense controlled substances pursuant to 
orders made on, through, or on behalf of, that Web site, each required 
category of information must be displayed for each such pharmacy.
    The requirement (under paragraph (4)) that an online pharmacy list 
the States in which it is licensed to dispense controlled substances is 
designed to ensure that an online pharmacy only dispenses controlled 
substances to patients in States in which it is authorized to practice 
pharmacy. Dispensing beyond the scope of State licensure is one of the 
recurring transgressions of some rogue online pharmacies and generally 
violates State law.\28\
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    \28\ A State may bring a civil action in federal court to enjoin 
any violation of the Ryan Haight Act--not merely those violations of 
State law--and to obtain other appropriate legal or equitable 
relief. 21 U.S.C. 882(c).
---------------------------------------------------------------------------

    State licensure requirement--The Act also requires that online 
pharmacies comply with State licensure requirements. Specifically, the 
Act requires that:

    Each online pharmacy shall comply with the requirements of State 
law concerning the licensure of pharmacies in each State from which 
it, and in each State to which it, delivers, distributes, or 
dispenses or offers to deliver, distribute, or dispense controlled 
substances by means of the Internet, pursuant to applicable 
licensure requirements, as determined by each such State.

21 U.S.C. 831(b).
    Required notification to DEA--The Act contains a provision that is 
designed to ensure that DEA, and the applicable State boards of 
pharmacy, are aware of the existence of an online pharmacy before it 
commences operation. The Act's notification requirements are set forth 
in 21 U.S.C. 831(d)(1):

    Thirty days prior to offering a controlled substance for sale, 
delivery, distribution, or dispensing, the online pharmacy shall 
notify the [DEA Administrator], in such form and manner as the 
[Administrator] shall determine, and the State boards of pharmacy in 
any States in which the online pharmacy offers to sell, deliver, 
distribute, or dispense controlled substances.

Pursuant to this provision, the regulations being issued here provide 
that such notification to DEA shall be made by the pharmacy as part of 
the process by which it applies to DEA for a modification of its 
registration authorizing it to operate as an online pharmacy. The Act 
specifies that the foregoing notification must include the following 
information:

    (A) The information required to be posted on the online 
pharmacy's Internet site under [21 U.S.C. 831(c)] and shall notify 
the [DEA Administrator] and the applicable State boards of pharmacy, 
under penalty of perjury, that the information disclosed on its 
Internet site under [21 U.S.C. 831(c)] is true and accurate;
    (B) The online pharmacy's Internet site address and a 
certification that the online pharmacy shall notify the 
[Administrator] of any change in the address at least 30 days in 
advance; and
    (C) the Drug Enforcement Administration registration numbers of 
any pharmacies and practitioners referred to in [21 U.S.C. 831(c)], 
as applicable.

21 U.S.C. 831(d)(2).
    Thus, the information that an online pharmacy is required to post 
on its Web site must also be provided to DEA as part of the application 
for a modification of its DEA registration in order to satisfy part of 
the notification requirement.
    Declaration of compliance--Beginning on the date on which the 
online pharmacy makes the notification to DEA required by 21 U.S.C. 
831(d), and continuing thereafter, it must ``display on the homepage of 
its Internet site, in such form as the [DEA Administrator] shall by 
regulation require, a declaration that it has made such notification to 
the [Administrator].'' 21 U.S.C. 831(e). The regulations being issued 
here specify precisely the form in which this declaration must be made.
    Additional considerations regarding statements, declarations, 
notifications, and disclosures required under the Act--As stated in 21 
U.S.C. 831(f): ``Any statement, declaration, notification, or 
disclosure required under [21 U.S.C. 831] shall be considered a report 
required to be kept under [the CSA].'' One important effect of this 
provision is that, in conjunction with 21 U.S.C. 843(a)(4), it is a 
felony violation of the CSA to furnish false or fraudulent

[[Page 15603]]

material information in, or omit any material information from, any 
statement, declaration, notification, or disclosure required under 21 
U.S.C. 831.\29\
---------------------------------------------------------------------------

    \29\ In addition, the Act lists the following as an example of a 
violation of 21 U.S.C. 841(h)(1): ``making a material false, 
fictitious, or fraudulent statement or representation in a 
notification or declaration under [21 U.S.C. 831(d) or (e)].'' 21 
U.S.C. 841(h)(2)(E). Such conduct might also subject the offender to 
liability under 18 U.S.C. 1001(a).
---------------------------------------------------------------------------

D. Telemedicine

    As indicated above, ``a practitioner engaged in the practice of 
telemedicine'' within the meaning of the Act is exempt from the 
requirement of an in-person medical evaluation as a prerequisite to 
prescribing or otherwise dispensing controlled substances by means of 
the Internet. Before explaining the meaning of the ``practice of 
telemedicine,'' it bears repeated emphasis that all practitioners who 
prescribe controlled substances--even those engaged in the practice of 
telemedicine--remain subject to the requirement that the prescription 
be issued for a legitimate medical purpose by a practitioner acting in 
the usual course of professional practice. Prescribing a controlled 
substance without conducting an in-person medical evaluation has always 
been, and remains under the Act, a strong indication (or ``red flag'') 
of likely diversion.\30\ The Act simply made the failure to perform an 
in-person medical evaluation in certain circumstances \31\ an automatic 
violation of the CSA, while leaving it as a factor indicative of 
possible diversion in all other circumstances.
---------------------------------------------------------------------------

    \30\ See, e.g., United States v. Rosen, 582 F.2d 1032, 1036 (5th 
Cir. 1978).
    \31\ These circumstances are specified in 21 U.S.C. 829(e) and 
discussed above.
---------------------------------------------------------------------------

    The definition of the ``practice of telemedicine'' includes seven 
distinct categories that involve circumstances in which the prescribing 
practitioner might be unable to satisfy the Act's in-person medical 
evaluation requirement, yet nonetheless has sufficient medical 
information to prescribe a controlled substance for a legitimate 
medical purpose in the usual course of professional practice. In these 
circumstances, provided certain safeguards are in place to ensure that 
the practitioner who is engaged in the practice of telemedicine is able 
to conduct a bona fide medical evaluation of the patient at the remote 
location, and is otherwise acting in the usual course of professional 
practice, the Act contemplates that the practitioner will be permitted 
to prescribe controlled substances by means of the Internet despite not 
having conducted an in-person medical evaluation. The Act defines these 
categories, through the definition of ``practice of telemedicine,'' 
which is set forth in 21 U.S.C. 802(54).
    The Act specifies that the definition of the ``practice of 
telemedicine'' found in 21 U.S.C. 802(54) does not take effect at the 
same time the rest of the Act takes effect (April 13, 2009). Rather, 
the Act provides for a temporary definition of the ``practice of 
telemedicine'' that will apply beginning April 13, 2009, and continuing 
until the earlier of two dates: (i) three months after the date on 
which regulations are promulgated to carry out 21 U.S.C. 831(h) 
[relating to the issuance of a special registration to practice 
telemedicine] or (ii) January 15, 2010.\32\ Until the first of the 
foregoing two dates is reached, the Act states that the following 
definition applies:
---------------------------------------------------------------------------

    \32\ Public Law 110-425, section 3(j).

    [T]he term ``practice of telemedicine'' means the practice of 
medicine in accordance with applicable Federal and State laws by a 
practitioner (as that term is defined in section 102 of the 
Controlled Substances Act (21 U.S.C. 802)) (other than a pharmacist) 
who is at a location remote from the patient and is communicating 
with the patient, or health care professional who is treating the 
patient, using a telecommunications system referred to in section 
1834(m) of the Social Security Act (42 U.S.C. 1395m(m)), if the 
practitioner is using an interactive telecommunications system that 
satisfies the requirements of section 410.78(a)(3) of title 42, Code 
---------------------------------------------------------------------------
of Federal Regulations.

The rule being issued today contains both definitions of the practice 
of telemedicine (temporary and permanent), with the respective 
effective dates indicated.
    Special registration for telemedicine--A practitioner who is 
engaged in the practice of telemedicine within the meaning of the Act 
is not subject to the mandatory in-person medical evaluation 
requirement of 21 U.S.C. 829(e) (although such practitioner remains 
subject to the requirement that all prescriptions for controlled 
substances be issued for a legitimate medical purpose). The Act's 
permanent definition of the ``practice of telemedicine'' includes, as 
an example, ``a practitioner who has obtained from the [DEA 
Administrator] a special registration under [21 U.S.C. 831(h)].'' 21 
U.S.C. 802(54)(E). The Act specifies certain criteria that DEA must 
consider when evaluating an application for such a registration. 
However, the Act contemplates that DEA must issue certain regulations 
to effectuate this special registration provision. Specifically, the 
Act states: ``The [DEA Administrator] shall, with the concurrence of 
the Secretary [of Health and Human Services], promulgate regulations 
specifying the limited circumstances in which a special registration 
under [21 U.S.C. 831(h)] may be issued and the procedures for obtaining 
such a special registration.'' DEA will issue a separate rule 
promulgating regulations consistent with this directive. As explained 
above, until such regulations are promulgated, or until January 15, 
2010 (whichever comes first), the temporary definition of the practice 
of telemedicine recited above remains in effect.

E. Exemptions for Electronic Prescribing of Controlled Substances and 
Automated Dispensing Systems

    Electronic prescribing of controlled substances--On June 27, 2008, 
DEA published in the Federal Register a Notice of Proposed Rulemaking 
that would amend the DEA regulations to allow practitioners to 
electronically prescribe controlled substances (73 FR 36722). DEA is 
currently developing a final rule on electronic prescribing of 
controlled substances that takes into account the numerous public 
comme