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Implementation of the Ryan Haight Online Pharmacy Consumer

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Implementation of the Ryan Haight Online Pharmacy Consumer Powered By Docstoc
					                                                                                                                              Monday,
                                                                                                                              April 6, 2009




                                                                                                                              Part II

                                                                                                                              Department of
                                                                                                                              Justice
                                                                                                                              Drug Enforcement Administration

                                                                                                                              21 CFR Part 1300, 1301, 1304, et al.
                                                                                                                              Implementation of the Ryan Haight
                                                                                                                              Online Pharmacy Consumer Protection
                                                                                                                              Act of 2008; Final Rule
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                                        15596                Federal Register / Vol. 74, No. 64 / Monday, April 6, 2009 / Rules and Regulations

                                        DEPARTMENT OF JUSTICE                                   comments in Microsoft Word,                             Personal identifying information and
                                                                                                WordPerfect, Adobe PDF, or Excel file                 confidential business information
                                        Drug Enforcement Administration                         formats only. DEA will not accept any                 identified and located as set forth above
                                                                                                file formats other than those specifically            will be redacted and the comment, in
                                        21 CFR Parts 1300, 1301, 1304, 1306                     listed here.                                          redacted form, will be posted online and
                                        [Docket No. DEA–322I]                                      Please note that DEA is requesting                 placed in the DEA’s public docket file.
                                                                                                that electronic comments be submitted                 Please note that the Freedom of
                                        RIN 1117–AB20                                           before midnight Eastern time on the day               Information Act applies to all comments
                                                                                                the comment period closes because                     received. If you wish to inspect the
                                        Implementation of the Ryan Haight                       http://www.regulations.gov terminates                 agency’s public docket file in person by
                                        Online Pharmacy Consumer Protection                     the public’s ability to submit comments               appointment, please see the ‘‘For
                                        Act of 2008                                             at midnight Eastern time on the day the               Further Information’’ paragraph.
                                        AGENCY: Drug Enforcement                                comment period closes. Commenters in
                                                                                                                                                      Preamble
                                        Administration (DEA), Department of                     time zones other than Eastern time may
                                        Justice.                                                want to consider this so that their                   I. Legislation Upon Which These
                                        ACTION: Interim final rule with request                 electronic comments are received. All                 Regulations Are Based
                                        for comments.                                           comments sent via regular or express                     The Ryan Haight Online Pharmacy
                                                                                                mail will be considered timely if                     Consumer Protection Act of 2008 (Pub.
                                        SUMMARY: The Ryan Haight Online                         postmarked on the day the comment                     L. 110–425) (hereafter, the ‘‘Ryan Haight
                                        Pharmacy Consumer Protection Act,                       period closes.                                        Act’’ or the ‘‘Act’’) was enacted on
                                        which was enacted on October 15, 2008,                  FOR FURTHER INFORMATION CONTACT:                      October 15, 2008. The Act amended the
                                        amended the Controlled Substances Act                   Mark W. Caverly, Chief, Liaison and                   Controlled Substances Act (CSA) and
                                        and Controlled Substances Import and                    Policy Section, Office of Diversion                   Controlled Substances Import and
                                        Export Act by adding several new                        Control, Drug Enforcement                             Export Act (CSIEA) by adding various
                                        provisions to prevent the illegal                       Administration, 8701 Morrissette Drive,               provisions to prevent the illegal
                                        distribution and dispensing of                          Springfield, VA 22152; Telephone: (202)               distribution and dispensing of
                                        controlled substances by means of the                   307–7297.                                             controlled substances by means of the
                                        Internet. DEA is hereby issuing an                      SUPPLEMENTARY INFORMATION: Posting of                 Internet.1 The law becomes effective
                                        interim rule to amend its regulations to                Public Comments: Please note that all                 April 13, 2009 (except for one provision
                                        implement the legislation and is                        comments received are considered part                 relating to telemedicine discussed
                                        requesting comments on the interim                      of the public record and made available               below). Thus, as of April 13, 2009, it
                                        rule.                                                   for public inspection online at http://               will be illegal under federal law to
                                        DATES: This interim rule is effective                   www.regulations.gov and in the DEA’s                  ‘‘deliver, distribute, or dispense a
                                        April 13, 2009, except §§ 1300.04,                      public docket. Such information                       controlled substance by means of the
                                        1301.19, and 1304.40, which are                         includes personal identifying                         Internet, except as authorized by [the
                                        effective April 6, 2009. Section                        information (such as your name,                       CSA]’’ or to aid or abet such activity. 21
                                        1300.04(i) (the definition of ‘‘practice of             address, etc.) voluntarily submitted by               U.S.C. 841(h)(1). The Act applies to all
                                        telemedicine’’) has an implementation                   the commenter.                                        controlled substances in all schedules.
                                        date of January 15, 2010, unless such                      If you want to submit personal                        This document serves three purposes:
                                        date is superseded by future regulatory                 identifying information (such as your                 (1) To explain the new legislation; (2) to
                                        actions as explained in the                             name, address, etc.) as part of your                  announce the amendments to the DEA
                                        SUPPLEMENTARY INFORMATION section.                      comment, but do not want it to be                     regulations that implement the new
                                           Written comments must be                             posted online or made available in the                legislation; and (3) to request comments
                                        postmarked on or before June 5, 2009,                   public docket, you must include the                   on the amendments to the regulations,
                                        and electronic comments must be sent                    phrase ‘‘PERSONAL IDENTIFYING                         which are being issued as an interim
                                        on or before midnight Eastern time June                 INFORMATION’’ in the first paragraph                  rule as contemplated in the legislation.
                                        5, 2009.                                                of your comment. You must also place                  II. Authority in Ryan Haight Act To
                                        ADDRESSES: To ensure proper handling                    all the personal identifying information              Issue Regulations
                                        of comments, please reference ‘‘Docket                  you do not want posted online or made
                                        No. DEA–322’’ on all written and                        available in the public docket in the first              The Ryan Haight Act contains various
                                        electronic correspondence. Written                      paragraph of your comment and identify                provisions that call upon the Attorney
                                        comments being sent via regular or                      what information you want redacted.
                                                                                                                                                         1 Consistent with the CSA itself, the Ryan Haight
                                        express mail should be sent to the Drug                    If you want to submit confidential
                                                                                                                                                      Act relates solely to controlled substances.
                                        Enforcement Administration, Attention:                  business information as part of your                  Controlled substances are those psychoactive drugs
                                        DEA Federal Register Representative/                    comment, but do not want it to be                     and other substances—including narcotics,
                                        ODL, 8701 Morrissette Drive,                            posted online or made available in the                stimulants, depressants, hallucinogens, and
                                        Springfield, VA 22152. Comments may                     public docket, you must include the                   anabolic steroids—that are placed in one of the five
                                                                                                                                                      schedules of the CSA due to their potential for
                                        be sent to DEA by sending an electronic                 phrase ‘‘CONFIDENTIAL BUSINESS                        abuse and likelihood that they may cause
                                        message to                                              INFORMATION’’ in the first paragraph                  psychological or physical dependence when
                                        dea.diversion.policy@usdoj.gov.                         of your comment. You must also                        abused.
                                        Comments may also be sent                               prominently identify confidential                        Controlled substances constitute only a small
                                                                                                                                                      percentage of all pharmaceutical drugs.
                                        electronically through http://                          business information to be redacted                   Approximately 10 percent of all drug prescriptions
                                        www.regulations.gov using the                           within the comment. If a comment has                  written in the United States are for controlled
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                                        electronic comment form provided on                     so much confidential business                         substances, with the remaining approximately 90
                                        that site. An electronic copy of this                   information that it cannot be effectively             percent of prescriptions being written for
                                                                                                                                                      noncontrolled substances. The amendments to the
                                        document is also available at the http://               redacted, all or part of that comment                 CSA made by the Ryan Haight Act, as well as the
                                        www.regulations.gov Web site. DEA will                  may not be posted online or made                      regulations being issued here, do not apply to
                                        accept attachments to electronic                        available in the public docket.                       noncontrolled substances.



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                                                              Federal Register / Vol. 74, No. 64 / Monday, April 6, 2009 / Rules and Regulations                                                  15597

                                        General to issue regulations to                           III. Overview of the Legislation                      than legitimate medical purposes. While
                                        implement the Act. Among these is the                                                                           in-person ‘‘prescription mills’’
                                                                                                  A. Reasons for the Legislation
                                        following general grant of authority:                                                                           (practitioners’ offices that readily
                                                                                                     The unlawful use of pharmaceutical                 supply drug seekers with prescriptions
                                           The Attorney General may promulgate and                controlled substances has reached
                                        enforce any rules, regulations, and
                                                                                                                                                        for controlled substances without
                                                                                                  alarming levels in the United States in               establishing a legitimate medical basis
                                        procedures which may be necessary and                     recent years, causing a substantial
                                        appropriate for the efficient execution of
                                                                                                                                                        for doing so) have always been, and
                                                                                                  detrimental effect on the public health               remain, a significant source of
                                        functions under this Act or the amendments                and safety. According to the most
                                        made by this Act, and, with the concurrence                                                                     diversion, the advent of rogue Web sites
                                                                                                  recently published National Survey on                 that cater to those who abuse
                                        of the Secretary of Health and Human                      Drug Use and Health (2007),5 6.9
                                        Services where this Act or the amendments                                                                       pharmaceutical controlled substances
                                                                                                  million Americans reported using                      has allowed the criminal operators of
                                        made by this Act so provide, promulgate any
                                                                                                  psychotherapeutic drugs 6 nonmedically                these sites to exploit the anonymity of
                                        interim rules necessary for the
                                                                                                  during the prior month.7 With specific                the Internet to generate illicit sales of
                                        implementation of this Act or the
                                                                                                  regard to pain relievers, 5.2 million                 controlled substances (and/or
                                        amendments made by this Act, prior to its
                                                                                                  respondents reported abusing these                    prescriptions therefor) that far exceed
                                        effective date.2
                                                                                                  drugs,8 which is an 18 percent increase               those of any in-person prescription mill.
                                           This regulatory authority of the                       from 2004.9 This study further indicates              This is particularly evident when
                                        Attorney General has been delegated to                    that, in the United States, the abuse of              examining the data relating to the sales
                                        the Administrator of DEA.3 It is evident                  prescription drugs is second only to that             of hydrocodone, which is the most
                                        from the foregoing provision of the Act                   of marijuana and is higher than the                   widely abused pharmaceutical
                                                                                                  abuse of cocaine, heroin and                          controlled substance in the United
                                        that Congress contemplated it would be
                                                                                                  hallucinogens combined.10 Among                       States. According to data registered
                                        necessary for DEA to issue regulations
                                                                                                  persons aged 12 and older who reported                distributors of controlled substances
                                        on an interim basis in order to                           using illicit drugs for the first time in
                                        implement the Act within the relatively                                                                         provided to DEA 14 in 2006, 34
                                                                                                  2007, abuse of pain relievers was the                 pharmacies in the United States that
                                        short time period between the passage                     most common category of first-time
                                        of the Act (October 15, 2008) and its                                                                           were supplying rogue Internet sites
                                                                                                  illicit drug use.11                                   dispensed a total of more than 98
                                        effective date (April 13, 2009). Indeed,                     The false sense of security that some
                                        Congress envisioned that DEA would                                                                              million dosage units of hydrocodone.
                                                                                                  associate with the abuse of these
                                        need to issue interim rules ‘‘prior to its                                                                      Hence, these pharmacies each
                                                                                                  substances is also alarming. Many
                                                                                                                                                        dispensed an average of approximately
                                        effective date’’ (i.e., before April 13,                  mistakenly believe that if a drug may be
                                                                                                  prescribed for medical use, abusing that              2.9 million dosage units of hydrocodone
                                        2009) to effectively implement the new
                                                                                                  drug cannot be as harmful as abusing                  per pharmacy in a single year. By means
                                        requirements of the Act.4 Accordingly,
                                                                                                  more conventional ‘‘street’’ drugs, such              of comparison, the average pharmacy in
                                        the rules published here are effective                                                                          the United States dispenses
                                        immediately while at the same time the                    as heroin or cocaine. According to the
                                                                                                  2005 Partnership Attitude Tracking                    approximately 88,000 dosage units of
                                        agency is seeking public comment on                                                                             hydrocodone per year.
                                        them. Following the comment period,                       Study 12, 40 percent of teens surveyed
                                                                                                  believe that prescription medicines are                  Congress passed the Ryan Haight Act
                                        DEA will review the comments and                                                                                precisely because of ‘‘the increasing use
                                        make any modifications to the interim                     ‘‘much safer’’ to use than illegal drugs.
                                                                                                  Furthermore, the same study concluded                 of prescription controlled substances by
                                        rule that are appropriate. Also, as                                                                             adolescents and others for nonmedical
                                                                                                  that 31 percent believe there is ‘‘nothing
                                        explained below, the Act contemplates                                                                           purposes, which has been exacerbated
                                                                                                  wrong’’ with using prescription
                                        that DEA will, with the concurrence of                    medicines without a prescription ‘‘once               by drug trafficking on the Internet.’’ 15
                                        the Secretary of Health and Human                         in awhile.’’ 13                                       The person for whom the Act was
                                        Services, promulgate regulations                             One of the main factors contributing               named, Ryan Haight, was ‘‘a California
                                        governing the issuance to practitioners                   to the nationwide increase in the                     high school honors student and athlete
                                        of a special registration relating to the                 diversion of pharmaceutical controlled                who died in 2001 from an overdose of
                                        practice of telemedicine. Those                           substances has been the rise in the                   controlled substances that he had
                                        regulations will be issued separately at                  number of Internet sites that sell or                 purchased from a rogue online
                                        a later date.                                             facilitate the sale of these drugs for other          pharmacy.’’ 16 According to the Senate
                                                                                                                                                        Report accompanying the legislation,
                                          2 Public  Law 110–425, sec. 3(k)(1).                       5 Available at http://www.oas.samhsa.gov/nsduh/    ‘‘Ease of access to the Internet,
                                          3 Functions   vested in the Attorney General under      2k7nsduh/2k7Results.pdf.                              combined with lack of medical
                                        the CSA have been delegated to the Administrator             6 The study states: ‘‘Psychotherapeutics include
                                                                                                                                                        supervision, has led to tragic
                                        of DEA. 28 CFR 0.100. Accordingly, in this                the nonmedical use of any prescription-type pain      consequences in the online purchase of
                                        document, ‘‘DEA Administrator’’ will be used in           relievers, tranquilizers, stimulants, or sedatives.
                                                                                                  Over-the-counter substances are not included.’’ Id.   prescription controlled substances.’’ 17
                                        place of all statutory references to the Attorney
                                        General.                                                  at 55.                                                The Senate Report then cited a list of
                                           4 Congress’s express grant of authority under the
                                                                                                     7 Id. at 1.                                        examples of persons in the United
                                        Ryan Haight Act to issue interim rules as the DEA
                                                                                                     8 Id.
                                                                                                                                                        States who had died from overdoses of
                                                                                                     9 Compare 2004 National Survey on Drug Use and
                                        Administrator finds necessary to implement the Act                                                              controlled substances obtained via the
                                        prior to its effective date forms the basis for the DEA   Health at 1, available at http://
                                                                                                  www.oas.samhsa.gov/nsduh/2k4nsduh/
                                                                                                                                                        Internet.18
                                        Administrator’s conclusion, as is set forth in
                                        Section X below, that ‘‘good cause’’ exists under the     2k4results.pdf.
                                                                                                     10 See id. at 73.                                    14 Distributors are required to submit certain
                                        Administrative Procedure Act (APA) for the
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                                        issuance of interim rules (those which take effect           11 Id. at 4.                                       reports to DEA’s ARCOS unit, as provided in 21
                                        immediately on an interim basis prior to the public          12 Partnership for a Drug-Free America;            CFR 1304.33.
                                                                                                                                                          15 S. Rep. No. 110–521, at 1 (2008).
                                        comment period) because ‘‘notice and public               Partnership Attitude Tracking Study, Teens in
                                                                                                                                                          16 Id. at 12.
                                        procedure thereon are impracticable, * * *[and]           grades 7 through 12, 2005; http://www.drugfree.org/
                                        contrary to the public interest.’’ See 5 U.S.C.           Files/Full_Teen_Report (page 21).                       17 Id. at 5.

                                        553(b)(B).                                                   13 Id. at 20–21.                                     18 Id. at 5–6.




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                                        15598                Federal Register / Vol. 74, No. 64 / Monday, April 6, 2009 / Rules and Regulations

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



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                                                             Federal Register / Vol. 74, No. 64 / Monday, April 6, 2009 / Rules and Regulations                                                      15599

                                        IV. Brief Summary of Some of the Key                    obtain such a modification of                             regulations as part of this Interim Rule.
                                        Provisions of the Legislation                           registration. One of the ramifications of                 While many of the new definitions are
                                           Before examining the legislation in                  this requirement is that those who are                    self-explanatory, some are discussed in
                                        detail, the following is a brief recitation             not DEA-registered pharmacies (for                        this preamble to assist in understanding
                                        of two of the most important new                        example, those nonregistrants who have                    the Act.
                                        statutory requirements: the in-person                   heretofore facilitated unlawful Internet                    The following are two of the key
                                        medical evaluation requirement for                      controlled substance sales by enlisting                   definitions in the Act, which are set
                                        prescribing practitioners and the                       the services of unscrupulous                              forth in 21 U.S.C. 802:
                                        modified registration requirement for                   pharmacies and/or prescribing                               (51) The term ‘‘deliver, distribute, or
                                        online pharmacies.                                      practitioners) are prohibited from                        dispense by means of the Internet’’ refers,
                                           A. In-person medical evaluation                      operating online pharmacies.                              respectively, to any delivery, distribution, or
                                                                                                   The Act’s definition of ‘‘online                       dispensing of a controlled substance that is
                                        requirement—One of the primary ways
                                                                                                pharmacy’’ encompasses more than                          caused or facilitated by means of the Internet.
                                        in which the Ryan Haight Act combats
                                                                                                merely legitimate pharmacies that may                     This definition is plainly broad in
                                        the use of the Internet to facilitate illegal
                                                                                                obtain a modification of their DEA                        scope, encompassing any activity
                                        sales of pharmaceutical controlled
                                                                                                registrations allowing them to dispense                   utilizing the Internet that causes or
                                        substances is by mandating, with
                                                                                                controlled substances by means of the                     facilitates the delivery, distribution, or
                                        limited exceptions, that the dispensing
                                                                                                Internet. As explained below, the                         dispensing of a controlled substance.
                                        of controlled substances by means of the
                                                                                                definition of ‘‘online pharmacy’’                         This definition is incorporated into the
                                        Internet be predicated on a valid                       includes, among others, those persons
                                        prescription involving at least one in-                                                                           Act’s definition of an ‘‘online
                                                                                                who operate the types of rogue Web                        pharmacy’’:
                                        person medical evaluation. While the                    sites that the Act was designed to
                                        lack of an in-person medical evaluation                 eliminate. Consistent with the                              (52) The term ‘‘online pharmacy’’ * * *
                                        has always been viewed as a ‘‘red flag’’                longstanding structure of the CSA (since                  means [with certain exceptions discussed
                                        indicating that diversion might be                                                                                below] a person, entity, or Internet site,
                                                                                                it was enacted in 1970), the Ryan Haight                  whether in the United States or abroad, that
                                        occurring, the Ryan Haight Act makes it                 Act prohibits all controlled substance
                                        unambiguous that it is a per se violation                                                                         knowingly or intentionally delivers,
                                                                                                activities by ‘‘online pharmacies’’                       distributes, or dispenses, or offers or attempts
                                        of the CSA for a practitioner to issue a                except those expressly authorized by the                  to deliver, distribute, or dispense, a
                                        prescription for a controlled substance                 Act. Again, only DEA-registered                           controlled substance by means of the
                                        by means of the Internet without having                 pharmacies may obtain a modification                      Internet.
                                        conducted at least one in-person                        of their registration authorizing them to                 The definition of ‘‘online pharmacy’’ is
                                        medical evaluation, except in certain                   operate as online pharmacies. In                          also broad in scope. First, it includes
                                        specified circumstances. At the same                    addition, a pharmacy that has obtained                    not only a ‘‘person’’ 23 but also any other
                                        time, it is crucial to bear in mind that,               such a modification of its registration                   ‘‘entity’’ or ‘‘Internet site’’—‘‘whether in
                                        as Congress expressly stated under the                  may not operate as an online pharmacy                     the United States or abroad’’—that
                                        Act, the mere fact that the prescribing                 unless it has notified DEA of its intent                  otherwise meets the definition of an
                                        practitioner conducted one in-person                    to do so and its Web site contains                        ‘‘online pharmacy.’’ Second, it also
                                        medical evaluation does not                             certain declarations designed to provide                  includes not only any such person,
                                        demonstrate that the prescription was                   clear assurance that it is operating                      entity or Internet site ‘‘that knowingly or
                                        issued for a legitimate medical purpose                 legitimately and in conformity with the                   intentionally delivers, distributes, or
                                        within the usual course of professional                 Act. (These requirements are discussed                    dispenses * * * a controlled substance
                                        practice. Even where the prescribing                    at length below.)                                         by means of the Internet,’’ but also any
                                        practitioner has complied with the
                                                                                                V. Detailed Explanation of the                            such one who ‘‘offers or attempts’’ to do
                                        requirement of at least one in-person
                                                                                                Legislation                                               so.
                                        medical evaluation, a prescription for a
                                                                                                                                                             Hence, the term ‘‘online pharmacy’’
                                        controlled substance must still satisfy                    Consistent with the structure of the                   includes, among other things: (i) Any
                                        the additional, fundamental prerequisite                CSA, the Ryan Haight Act sets out                         Web site that sells, or offers to sell, any
                                        that has been legally mandated for more                 numerous regulatory requirements and                      controlled substance or a prescription
                                        than 90 years: it must be issued for a                  other substantive provisions and makes                    therefor to a person in the United States;
                                        legitimate medical purpose by a                         it unlawful to ‘‘knowingly or                             (ii) any person who operates such a Web
                                        practitioner acting in the usual course of              intentionally * * * deliver, distribute,                  site; 24 (iii) any person who pays a
                                        professional practice.21                                or dispense a controlled substance by                     practitioner to write prescriptions for
                                           B. Requirement of modified                           means of the Internet, except as                          controlled substances for customers of
                                        registration for online pharmacies—                     authorized by [the Act].’’ 22 Thus, this                  such a Web site; (iv) any person who
                                        Another of the core provisions of the                   explanation of the Act will be divided                    pays a pharmacy to fill prescriptions for
                                        Act is the requirement that any person                  into two main parts: (1) Explaining the                   controlled substances that were issued
                                        who operates a Web site that fits within                Act’s regulatory requirements and other
                                        the definition of an ‘‘online pharmacy’’                substantive provisions and (2)                               23 As set forth in 1 U.S.C. 7, the word ‘‘person’’
                                        must obtain from DEA a modification of                  explaining what it means to ‘‘knowingly                   includes ‘‘corporations, companies, associations,
                                        its DEA pharmacy registration that                      or intentionally * * * deliver,                           firms, partnerships, societies, and joint stock
                                        expressly authorizes such online                                                                                  companies, as well as individuals.’’ Consistent
                                                                                                distribute, or dispense a controlled                      therewith, the DEA regulations define ‘‘person’’ to
                                        activity. Only DEA-registered                           substance by means of the Internet.’’                     include ‘‘any individual, corporation, government
                                        pharmacies are eligible under the Act to                                                                          or governmental subdivision or agency, business
                                                                                                A. New definitions under the Act                          trust, partnership, association, or other legal
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                                          21 21  CFR 1306.04(a); United States v. Moore, 423      The Act adds several new definitions                    entity.’’ 21 CFR 1300.01(b)(34).
                                        U.S. 122 (1975). This requirement has been a part       to the CSA. These new statutory                              24 The Act exempts certain categories of persons

                                        of federal law since the Harrison Narcotic Act of                                                                 from the application of 21 U.S.C. 841(h)(1), such as
                                        1914. Id. at 131. For a detailed explanation of the     definitions are being added to the DEA                    Internet service providers and Web hosting services,
                                        ‘‘legitimate medical purpose requirement,’’ see 71                                                                so long as such persons do not act in concert with
                                        FR 52716, 52717 (2006 DEA policy statement).              22 21   U.S.C. 841(h)(1)(A).                            others who violate the Act.



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                                        15600                Federal Register / Vol. 74, No. 64 / Monday, April 6, 2009 / Rules and Regulations

                                        to customers of such a Web site; (v) any                and safety to exempt from the definition of            the definition of an online pharmacy,
                                        pharmacy that knowingly or                              an ‘‘online pharmacy’’.                                where they determine that doing so is
                                        intentionally fills prescriptions for                   21 U.S.C. 802(52)(B).                                  ‘‘consistent with effective controls
                                        controlled substances that were issued                     To elaborate briefly on these                       against diversion and otherwise
                                        to customers of such a Web site; and (vi)               exceptions, under exception (i), a DEA-                consistent with the public health and
                                        any person who sends an e-mail that:                    registered manufacturer or distributor 25              safety.’’ Pursuant to this clause, the
                                        Offers to sell a controlled substance or                that uses the Internet to facilitate                   regulations being issued here contain
                                        a prescription for a controlled substance               activities permitted by its DEA                        two exceptions to the definition of an
                                        in a manner not authorized by the Act;                  registration does not constitute an                    online pharmacy: One relating to
                                        directs buyers to a Web site operating in               online pharmacy. Under exception (ii),                 electronic prescribing of controlled
                                        violation of the Act; or otherwise causes               a DEA-registered nonpharmacy                           substances and the other to the use of
                                        or facilitates the delivery, distribution,              practitioner (e.g., physician, dentist,                automated dispensing systems. These
                                        or dispensing of a controlled substance                 veterinarian, scientific investigator,                 exceptions are explained below.
                                        in a manner not authorized by the Act.                  hospital, or other person authorized by                B. In-Person Medical Evaluation
                                          While the general scope of the                        his registration to dispense controlled                Requirement
                                        definition of an ‘‘online pharmacy’’ is                 substances) may do so by means of the
                                        broad, the definition expressly excludes                                                                          To directly prohibit what had been
                                                                                                Internet without being an online
                                        the following categories:                                                                                      the practice of many rogue Web sites—
                                                                                                pharmacy. Under exceptions (iii)
                                                                                                                                                       allowing customers to buy controlled
                                           (i) Manufacturers or distributors registered         through (v), certain hospitals and other
                                                                                                                                                       substances and/or prescriptions for
                                        under subsection (a), (b), (d), or (e) of [21           health care facilities associated with the
                                        U.S.C. 823] who do not dispense controlled                                                                     controlled substances via the Internet
                                                                                                United States government, as well as
                                        substances to an unregistered individual or                                                                    without ever seeing the prescribing
                                                                                                agents and employees acting in the
                                        entity;                                                                                                        practitioner in person—the Ryan Haight
                                                                                                course of their duties for such
                                           (ii) Nonpharmacy practitioners who are                                                                      Act includes as one of its central
                                        registered under [21 U.S.C. 823(f)] and whose
                                                                                                institutions, are not online pharmacies.
                                                                                                                                                       features the ‘‘valid prescription’’
                                        activities are authorized by that registration;         Under exception (vi), an advertisement
                                                                                                                                                       requirement. This requirement is set
                                           (iii) Any hospital or other medical facility         is not an online pharmacy, provided the
                                                                                                                                                       forth in 21 U.S.C. 829(e)(1): ‘‘No
                                        that is operated by an agency of the United             advertisement does not ‘‘attempt to
                                                                                                                                                       controlled substance that is a
                                        States (including the Armed Forces),                    facilitate an actual transaction involving
                                        provided such hospital or other facility is                                                                    prescription drug as determined under
                                                                                                a controlled substance.’’
                                        registered under [21 U.S.C. 823(f)];                       Under exception (vii), a person,                    the Federal Food, Drug, and Cosmetic
                                           (iv) A health care facility owned or                 entity, or Internet site located outside               Act 26 may be delivered, distributed, or
                                        operated by an Indian tribe or tribal
                                                                                                the United States is only excepted from                dispensed by means of the Internet
                                        organization, only to the extent such facility                                                                 without a valid prescription.’’
                                        is carrying out a contract or compact under             the definition of an online pharmacy if
                                                                                                                                                          The Act further defines the meaning
                                        the Indian Self-Determination and Education             it ‘‘does not facilitate the delivery,
                                                                                                                                                       of ‘‘valid prescription’’ in 21 U.S.C.
                                        Assistance Act;                                         distribution, or dispensing of a
                                                                                                                                                       829(e)(2)(A): ‘‘The term ‘valid
                                           (v) Any agent or employee of any hospital            controlled substance by means of the
                                                                                                                                                       prescription’ means a prescription that
                                        or facility referred to in clause (iii) or (iv),        Internet to any person in the United
                                        provided such agent or employee is lawfully                                                                    is issued for a legitimate medical
                                                                                                States.’’ (Emphasis added.) Thus, Web
                                        acting in the usual course of business or                                                                      purpose in the usual course of
                                                                                                sites operated by persons located
                                        employment, and within the scope of the                                                                        professional practice by—(i) a
                                                                                                abroad, along with persons who operate
                                        official duties of such agent or employee,                                                                     practitioner who has conducted at least
                                        with such hospital or facility, and, with               the sites, do fall within the definition of
                                                                                                                                                       1 in-person medical evaluation of the
                                        respect to agents or employees of health care           an online pharmacy if they sell or offer
                                                                                                                                                       patient; or (ii) a covering practitioner.’’
                                        facilities specified in clause (iv), only to the        to sell controlled substances to persons
                                                                                                                                                       The Act explains the meaning of ‘‘in-
                                        extent such individuals are furnishing                  in the United States or otherwise
                                                                                                                                                       person medical evaluation’’ in 21 U.S.C.
                                        services pursuant to the contracts or                   ‘‘facilitate the delivery, distribution, or
                                        compacts described in such clause;                                                                             829(e)(2)(B):
                                                                                                dispensing of a controlled substance by
                                           (vi) Mere advertisements that do not                 means of the Internet to any person in                    (i) The term ‘‘in-person medical
                                        attempt to facilitate an actual transaction             the United States.’’                                   evaluation’’ means a medical evaluation that
                                        involving a controlled substance;                                                                              is conducted with the patient in the physical
                                           (vii) A person, entity, or Internet site that
                                                                                                   Under exception (viii), a DEA-                      presence of the practitioner, without regard
                                        is not in the United States and does not                registered pharmacy is excepted from                   to whether portions of the evaluation are
                                        facilitate the delivery, distribution, or               the definition of an online pharmacy if                conducted by other health professionals.
                                        dispensing of a controlled substance by                 it dispenses controlled substances via                    (ii) Nothing in clause (i) shall be construed
                                        means of the Internet to any person in the              the Internet solely by ‘‘refilling                     to imply that 1 in-person medical evaluation
                                        United States;                                          prescriptions for controlled substances                demonstrates that a prescription has been
                                           (viii) A pharmacy registered under [21               in schedule III, IV, or V’’ and ‘‘filling              issued for a legitimate medical purpose
                                        U.S.C. 823(f)] whose dispensing of controlled           new prescriptions for controlled                       within the usual course of professional
                                        substances via the Internet consists solely                                                                    practice.
                                        of—
                                                                                                substances in schedule III, IV, or V’’ (as
                                                                                                those terms are defined in the Act).                     Thus, for every controlled substance
                                           (I) Refilling prescriptions for controlled
                                        substances in schedule III, IV, or V, as                Finally, under exception (ix), the DEA                 that is delivered, distributed, or
                                        defined in paragraph [21 U.S.C. 802(55)]; or            Administrator and the Secretary of                     dispensed by means of the Internet,
                                           (II) Filling new prescriptions for controlled        Health and Human Services have the
                                                                                                                                                         26 Nearly every pharmaceutical controlled
                                        substances in schedule III, IV, or V, as                authority to jointly decide to issue
                                        defined in paragraph [21 U.S.C. 802(56)]; or                                                                   substance is a prescription drug under the Federal
                                                                                                regulations making further exceptions to               Food, Drug, and Cosmetic Act (FDCA). In the very
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                                           (ix) Any other persons for whom the [DEA
                                                                                                                                                       rare instance where a drug contains a controlled
                                        Administrator] and the Secretary [of Health               25 Under the CSA, a DEA-registered ‘‘distributor’’   substance but may be dispensed under the FDCA
                                        and Human Services] have jointly, by                    delivers controlled substances to other DEA            without a prescription, the DEA regulations specify
                                        regulation, found it to be consistent with              registrants; it may not administer, dispense, or       the procedures a pharmacist must follow to
                                        effective controls against diversion and                otherwise deliver controlled substances to patients.   dispense such a drug lawfully to a purchaser. 21
                                        otherwise consistent with the public health             See 21 U.S.C. 802(11), 822(a), 822(b), 828(a).         CFR 1306.26.



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                                        there must be a ‘‘valid prescription,’’                 patient or an evaluation of the patient               pharmacy. 21 U.S.C. 823(f). Thus, any
                                        which means not only that the                           through the practice of telemedicine, within          person, entity, or Internet site that falls
                                        prescription must comply with the                       the previous 24 months; and (ii) is                   within the definition of an online
                                                                                                temporarily unavailable to conduct the
                                        longstanding requirement of being                       evaluation of the patient.
                                                                                                                                                      pharmacy—and is not a DEA-registered
                                        issued for a legitimate medical purpose                                                                       pharmacy that has obtained a
                                        by a practitioner acting in the usual                   Thus, a prescribing practitioner who                  modification of its registration
                                        course of professional practice, but also               falls within the above definition of a                authorizing it to operate as an online
                                        that the prescribing practitioner must                  ‘‘covering practitioner’’ need not                    pharmacy—is necessarily violating the
                                        either (i) have conducted at least one in-              conduct an in-person medical                          Act if it knowingly or intentionally
                                        person medical evaluation of the patient                evaluation as a prerequisite to                       delivers, distributes, or dispenses a
                                        or (ii) meet the definition of a ‘‘covering             prescribing a controlled substance to a               controlled substance by means of the
                                        practitioner’’ (explained below). Any                   given patient, provided that the                      Internet.
                                        practitioner who writes a prescription                  practitioner for whom the covering                       The regulations being issued here set
                                        for a controlled substance that fails to                practitioner is covering has conducted                forth the process by which a DEA-
                                        comply with this provision of the Act,                  an in-person medical evaluation of that               registered pharmacy may apply online
                                        as well as any pharmacy that knowingly                  patient and provided further that this                for a modification of its registration
                                        or intentionally fills such a prescription,             covering arrangement is taking place on               authorizing it to operate as an online
                                        violates 21 U.S.C. 841(h)(1).                           only a temporary basis. Moreover, just                pharmacy. Under the Act, DEA must
                                           Hence, the Act makes it unambiguous                  as with the primary practitioner, the                 base its decision on whether to grant or
                                        that, except in limited and specified                   requirement that the prescription must                deny such an application for a
                                        circumstances, it is a per se violation of              be issued in the usual course of                      modification of registration on the same
                                        the CSA for a practitioner to issue a                   professional practice for a legitimate                statutory criteria that it must consider in
                                        prescription for a controlled substance                 medical purpose applies with equal                    evaluating an application for
                                        by means of the Internet without having                 force to a ‘‘covering practitioner.’’                 registration submitted by a pharmacy or
                                        conducted at least one in-person                           The Act also provides for an                       other practitioner. 21 U.S.C. 823(f).
                                        medical evaluation. However, the Act                    exception to the requirement of an in-                   Reporting Requirement—A pharmacy
                                        also expressly provides that a                          person medical evaluation for                         that has obtained a modification of its
                                        prescribing practitioner does not                       practitioners who are engaged in the                  registration authorizing it to dispense
                                        automatically meet the requirement of                   ‘‘practice of telemedicine’’ within the               controlled substances by means of the
                                        issuing a prescription for a legitimate                 meaning of the Act. 21 U.S.C.                         Internet must report to DEA, on a
                                        medical purpose while acting in the                     829(e)(3)(A). Of course, a practitioner               monthly basis, the total amount of each
                                        usual course of professional practice                   engaged in the ‘‘practice of                          controlled substance it dispenses. 21
                                        merely by having conducted a single in-                 telemedicine’’ remains subject to the                 U.S.C. 827(d)(2). For pharmacies that
                                        person medical evaluation of the                        requirement that every prescription for               are subject to this requirement, the
                                        patient. Rather, as with all situations in              a controlled substance be issued for a                monthly report must include all
                                        which a prescription for a controlled                   legitimate medical purpose by a                       controlled substances dispensed by any
                                        substance is issued, all the facts and                  practitioner acting in the usual course of            means—not just controlled substances
                                        circumstances surrounding the issuance                  professional practice. The Act provides               dispensed by means of the Internet. Id.
                                        of the prescription must be evaluated in                a temporary definition of the ‘‘practice              However, if a pharmacy with such a
                                        determining whether it was issued for a                 of telemedicine’’ pending issuance of                 modified registration dispenses an
                                        legitimate medical purpose by a                         new regulations addressing                            amount that falls below the threshold in
                                        practitioner acting in the usual course of              ‘‘telemedicine.’’ The topic of                        a given month, it is not required to
                                        professional practice.27 A rogue Internet               ‘‘telemedicine’’ is further addressed in              submit a report for that month. Id. The
                                        operation cannot, for example, defeat                   paragraph D below.                                    monthly threshold is either (A) 100 or
                                        the purpose of the Act by establishing                                                                        more prescriptions for controlled
                                                                                                C. Requirements for Online Pharmacies
                                        a method of operation in which a                                                                              substances filled by the pharmacy or (B)
                                        practitioner conducts a perfunctory in-                    Modified Registration Requirement—                 5,000 or more total dosage units of
                                        person ‘‘evaluation’’ of each ‘‘patient’’               The Act imposes various requirements                  controlled substances dispensed. Id.
                                        simply for the purpose of selling                       for those persons and other entities that             Again, these threshold amounts include
                                        prescriptions for controlled substances                 fit within the Act’s definition of an                 all controlled substances dispensed by
                                        to the patient in perpetuity with no                    online pharmacy. To begin with, an                    the pharmacy by any means (through
                                        follow-up visits. This topic is addressed               online pharmacy may only operate                      walk-in business, by mail, by means of
                                        further below in Section VII, which                     lawfully as an online pharmacy if it is               the Internet, or otherwise). Id. If the
                                        provides additional information for                     a DEA-registered pharmacy that has                    pharmacy meets or exceeds either of the
                                        practitioners.                                          obtained from DEA a modification of its               foregoing amounts in a given month, it
                                           With respect to the term ‘‘covering                  registration authorizing it to engage in              must report to DEA the total amount of
                                        practitioner,’’ the Act states (21 U.S.C.               such activity. 21 U.S.C. 823(f), 841(h)(1).           controlled substances it dispensed by
                                        829(e)(2)(C)):                                          An online pharmacy that is not validly                any means during that month. Id. The
                                                                                                registered with a modification                        regulations being issued here specify the
                                          The term ‘‘covering practitioner’’ means,
                                        with respect to a patient, a practitioner who           authorizing it to operate as an online                time and manner in which such reports
                                        conducts a medical evaluation (other than an            pharmacy as required by 21 U.S.C.                     must be filed.
                                        in-person medical evaluation) at the request            823(f) will violate 21 U.S.C. 841(h)(1) if               Statements that must appear on an
                                        of a practitioner who—(i) has conducted at              it knowingly or intentionally delivers,               online pharmacy’s Web site—Every
                                        least 1 in-person medical evaluation of the             distributes, or dispenses a controlled                online pharmacy is required under the
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                                                                                                substance by means of the Internet.                   Act to ‘‘display in a visible and clear
                                          27 For a detailed explanation of the ‘‘legitimate
                                                                                                Moreover, under the Act, the only type                manner on its homepage a statement
                                        medical purpose requirement,’’ see 71 FR 52716,
                                        52717 (2006 DEA policy statement). See also, 21
                                                                                                of online pharmacy that is eligible to                that it complies with the requirements
                                        CFR 1306.04(a); United States v. Moore, 423 U.S.        apply to DEA for such modification of                 of [21 U.S.C. 831] with respect to the
                                        122 (1975).                                             registration is a DEA-registered                      delivery or sale or offer for sale of


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                                        15602                Federal Register / Vol. 74, No. 64 / Monday, April 6, 2009 / Rules and Regulations

                                        controlled substances and shall at all                  operates, or on a page directly linked                     Thirty days prior to offering a controlled
                                        times display on the homepage of its                    thereto in which the hyperlink is also                   substance for sale, delivery, distribution, or
                                        Internet site a declaration of compliance               visible and clear on the homepage’’ is                   dispensing, the online pharmacy shall notify
                                        in accordance with this section.’’ 21                   intended to ensure that members of the                   the [DEA Administrator], in such form and
                                                                                                                                                         manner as the [Administrator] shall
                                        U.S.C. 831(a).                                          public who visit such Web sites are                      determine, and the State boards of pharmacy
                                           In addition, the Act requires every                  informed about the Ryan Haight Act’s                     in any States in which the online pharmacy
                                        online pharmacy to satisfy the following                core requirements and to ensure that the                 offers to sell, deliver, distribute, or dispense
                                        requirement relating to what the Act                    DEA-registered pharmacies and                            controlled substances.
                                        refers to as the ‘‘Internet Pharmacy Site               prescribing practitioners affiliated with
                                        Disclosure Information.’’ As set forth in                                                                        Pursuant to this provision, the
                                                                                                the site, if any, are clearly identified.
                                        21 U.S.C. 831(c), each online pharmacy                                                                           regulations being issued here provide
                                                                                                Any effort by an online pharmacy to
                                        shall post in a visible and clear manner                                                                         that such notification to DEA shall be
                                                                                                hide or reduce the visibility on the Web
                                        on the homepage of each Internet site it                                                                         made by the pharmacy as part of the
                                                                                                site of this required information will
                                        operates, or on a page directly linked                  subject those responsible to potential                   process by which it applies to DEA for
                                        thereto in which the hyperlink is also                  criminal and civil liability and, in the                 a modification of its registration
                                        visible and clear on the homepage, the                  case of DEA registrants, potential loss of               authorizing it to operate as an online
                                        following information for each                          registration. The required information                   pharmacy. The Act specifies that the
                                        pharmacy that delivers, distributes, or                 must be displayed ‘‘for each pharmacy                    foregoing notification must include the
                                        dispenses controlled substances                         that delivers, distributes, or dispenses                 following information:
                                        pursuant to orders made on, through, or                 controlled substances pursuant to orders                   (A) The information required to be posted
                                        on behalf of, that Web site:                            made on, through, or on behalf of, that                  on the online pharmacy’s Internet site under
                                           • The name and address of the                        Web site.’’ Thus, if multiple pharmacies                 [21 U.S.C. 831(c)] and shall notify the [DEA
                                        pharmacy as it appears on the                           dispense controlled substances pursuant                  Administrator] and the applicable State
                                                                                                                                                         boards of pharmacy, under penalty of
                                        pharmacy’s Drug Enforcement                             to orders made on, through, or on behalf
                                                                                                                                                         perjury, that the information disclosed on its
                                        Administration Certificate of                           of, that Web site, each required category                Internet site under [21 U.S.C. 831(c)] is true
                                        Registration.                                           of information must be displayed for                     and accurate;
                                           • The pharmacy’s telephone number                    each such pharmacy.                                        (B) The online pharmacy’s Internet site
                                        and e-mail address.                                        The requirement (under paragraph                      address and a certification that the online
                                           • The name, professional degree, and                 (4)) that an online pharmacy list the                    pharmacy shall notify the [Administrator] of
                                        States of licensure of the pharmacist-in-               States in which it is licensed to                        any change in the address at least 30 days in
                                        charge, and a telephone number at                       dispense controlled substances is                        advance; and
                                        which the pharmacist-in-charge can be                   designed to ensure that an online                          (C) the Drug Enforcement Administration
                                        contacted.                                              pharmacy only dispenses controlled                       registration numbers of any pharmacies and
                                           • A list of the States in which the                  substances to patients in States in which                practitioners referred to in [21 U.S.C. 831(c)],
                                        pharmacy is licensed to dispense                                                                                 as applicable.
                                                                                                it is authorized to practice pharmacy.
                                        controlled substances.                                  Dispensing beyond the scope of State                     21 U.S.C. 831(d)(2).
                                           • A certification that the pharmacy is               licensure is one of the recurring                           Thus, the information that an online
                                        registered under this part to deliver,                  transgressions of some rogue online                      pharmacy is required to post on its Web
                                        distribute, or dispense by means of the                 pharmacies and generally violates State                  site must also be provided to DEA as
                                        Internet controlled substances.                         law.28                                                   part of the application for a
                                           • The name, address, telephone                          State licensure requirement—The Act                   modification of its DEA registration in
                                        number, professional degree, and States                 also requires that online pharmacies                     order to satisfy part of the notification
                                        of licensure of any practitioner who has                comply with State licensure                              requirement.
                                        a contractual relationship to provide                   requirements. Specifically, the Act                         Declaration of compliance—
                                        medical evaluations or issue                            requires that:                                           Beginning on the date on which the
                                        prescriptions for controlled substances,                                                                         online pharmacy makes the notification
                                                                                                   Each online pharmacy shall comply with
                                        through referrals from the Web site or at               the requirements of State law concerning the             to DEA required by 21 U.S.C. 831(d),
                                        the request of the owner or operator of                 licensure of pharmacies in each State from               and continuing thereafter, it must
                                        the Web site, or any employee or agent                  which it, and in each State to which it,                 ‘‘display on the homepage of its Internet
                                        thereof.                                                delivers, distributes, or dispenses or offers to         site, in such form as the [DEA
                                           • The following statement, unless                    deliver, distribute, or dispense controlled              Administrator] shall by regulation
                                        revised by the [DEA Administrator] by                   substances by means of the Internet, pursuant            require, a declaration that it has made
                                        regulation: ‘‘This online pharmacy will                 to applicable licensure requirements, as                 such notification to the
                                                                                                determined by each such State.
                                        only dispense a controlled substance to                                                                          [Administrator].’’ 21 U.S.C. 831(e). The
                                        a person who has a valid prescription                   21 U.S.C. 831(b).                                        regulations being issued here specify
                                        issued for a legitimate medical purpose                   Required notification to DEA—The                       precisely the form in which this
                                        based upon a medical relationship with                  Act contains a provision that is                         declaration must be made.
                                        a prescribing practitioner. This includes               designed to ensure that DEA, and the                        Additional considerations regarding
                                        at least one prior in-person medical                    applicable State boards of pharmacy, are                 statements, declarations, notifications,
                                        evaluation or medical evaluation via                    aware of the existence of an online                      and disclosures required under the
                                        telemedicine in accordance with                         pharmacy before it commences                             Act—As stated in 21 U.S.C. 831(f): ‘‘Any
                                        applicable requirements of section 309.’’               operation. The Act’s notification                        statement, declaration, notification, or
                                           While the foregoing requirements are                 requirements are set forth in 21 U.S.C.                  disclosure required under [21 U.S.C.
                                        largely self-explanatory, some aspects                  831(d)(1):                                               831] shall be considered a report
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                                        warrant special emphasis. The                                                                                    required to be kept under [the CSA].’’
                                                                                                  28 A State may bring a civil action in federal court
                                        requirement that an online pharmacy                                                                              One important effect of this provision is
                                                                                                to enjoin any violation of the Ryan Haight Act—not
                                        post the foregoing information ‘‘in a                   merely those violations of State law—and to obtain
                                                                                                                                                         that, in conjunction with 21 U.S.C.
                                        visible and clear manner on the                         other appropriate legal or equitable relief. 21 U.S.C.   843(a)(4), it is a felony violation of the
                                        homepage of each Internet site it                       882(c).                                                  CSA to furnish false or fraudulent


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                                        material information in, or omit any                     despite not having conducted an in-                     concurrence of the Secretary [of Health
                                        material information from, any                           person medical evaluation. The Act                      and Human Services], promulgate
                                        statement, declaration, notification, or                 defines these categories, through the                   regulations specifying the limited
                                        disclosure required under 21 U.S.C.                      definition of ‘‘practice of telemedicine,’’             circumstances in which a special
                                        831.29                                                   which is set forth in 21 U.S.C. 802(54).                registration under [21 U.S.C. 831(h)]
                                                                                                    The Act specifies that the definition                may be issued and the procedures for
                                        D. Telemedicine                                          of the ‘‘practice of telemedicine’’ found               obtaining such a special registration.’’
                                           As indicated above, ‘‘a practitioner                  in 21 U.S.C. 802(54) does not take effect               DEA will issue a separate rule
                                        engaged in the practice of telemedicine’’                at the same time the rest of the Act takes              promulgating regulations consistent
                                        within the meaning of the Act is exempt                  effect (April 13, 2009). Rather, the Act                with this directive. As explained above,
                                        from the requirement of an in-person                     provides for a temporary definition of                  until such regulations are promulgated,
                                        medical evaluation as a prerequisite to                  the ‘‘practice of telemedicine’’ that will              or until January 15, 2010 (whichever
                                        prescribing or otherwise dispensing                      apply beginning April 13, 2009, and                     comes first), the temporary definition of
                                        controlled substances by means of the                    continuing until the earlier of two dates:              the practice of telemedicine recited
                                        Internet. Before explaining the meaning                  (i) three months after the date on which                above remains in effect.
                                        of the ‘‘practice of telemedicine,’’ it                  regulations are promulgated to carry out
                                        bears repeated emphasis that all                         21 U.S.C. 831(h) [relating to the                       E. Exemptions for Electronic Prescribing
                                        practitioners who prescribe controlled                   issuance of a special registration to                   of Controlled Substances and
                                        substances—even those engaged in the                     practice telemedicine] or (ii) January 15,              Automated Dispensing Systems
                                        practice of telemedicine—remain                          2010.32 Until the first of the foregoing                   Electronic prescribing of controlled
                                        subject to the requirement that the                      two dates is reached, the Act states that               substances—On June 27, 2008, DEA
                                        prescription be issued for a legitimate                  the following definition applies:                       published in the Federal Register a
                                        medical purpose by a practitioner acting                    [T]he term ‘‘practice of telemedicine’’              Notice of Proposed Rulemaking that
                                        in the usual course of professional                      means the practice of medicine in accordance            would amend the DEA regulations to
                                        practice. Prescribing a controlled                       with applicable Federal and State laws by a             allow practitioners to electronically
                                        substance without conducting an in-                      practitioner (as that term is defined in section        prescribe controlled substances (73 FR
                                        person medical evaluation has always                     102 of the Controlled Substances Act (21                36722). DEA is currently developing a
                                        been, and remains under the Act, a                       U.S.C. 802)) (other than a pharmacist) who is           final rule on electronic prescribing of
                                        strong indication (or ‘‘red flag’’) of likely            at a location remote from the patient and is            controlled substances that takes into
                                        diversion.30 The Act simply made the                     communicating with the patient, or health               account the numerous public comments
                                                                                                 care professional who is treating the patient,
                                        failure to perform an in-person medical                  using a telecommunications system referred              that were submitted in response to the
                                        evaluation in certain circumstances 31                   to in section 1834(m) of the Social Security            proposed rule. Once the rule is finalized
                                        an automatic violation of the CSA,                       Act (42 U.S.C. 1395m(m)), if the practitioner           and published in the Federal Register,
                                        while leaving it as a factor indicative of               is using an interactive telecommunications              practitioners will be permitted to
                                        possible diversion in all other                          system that satisfies the requirements of               electronically prescribe controlled
                                        circumstances.                                           section 410.78(a)(3) of title 42, Code of               substances in accordance with the
                                           The definition of the ‘‘practice of                   Federal Regulations.                                    requirements in the regulations. In most
                                        telemedicine’’ includes seven distinct                   The rule being issued today contains                    cases, electronic prescribing of
                                        categories that involve circumstances in                 both definitions of the practice of                     controlled substances will occur by
                                        which the prescribing practitioner might                 telemedicine (temporary and                             means of the Internet. Given the Act’s
                                        be unable to satisfy the Act’s in-person                 permanent), with the respective                         definitions, a pharmacy that knowingly
                                        medical evaluation requirement, yet                      effective dates indicated.                              or intentionally fills an electronic
                                        nonetheless has sufficient medical                          Special registration for telemedicine—               prescription for a controlled substance
                                        information to prescribe a controlled                    A practitioner who is engaged in the                    would (in the likely event that such an
                                        substance for a legitimate medical                       practice of telemedicine within the                     electronic prescription were transmitted
                                        purpose in the usual course of                           meaning of the Act is not subject to the                via the Internet) fall within the Act’s
                                        professional practice. In these                          mandatory in-person medical evaluation                  definition of an online pharmacy.
                                        circumstances, provided certain                          requirement of 21 U.S.C. 829(e)                            As indicated above, the Act gives the
                                        safeguards are in place to ensure that                   (although such practitioner remains                     DEA Administrator, acting jointly with
                                        the practitioner who is engaged in the                   subject to the requirement that all                     the Secretary of Health and Human
                                        practice of telemedicine is able to                      prescriptions for controlled substances                 Services, authority to exempt by
                                        conduct a bona fide medical evaluation                   be issued for a legitimate medical                      regulation certain persons from the
                                        of the patient at the remote location, and               purpose). The Act’s permanent                           definition of an ‘‘online pharmacy,’’
                                        is otherwise acting in the usual course                  definition of the ‘‘practice of                         where the Administrator and the
                                        of professional practice, the Act                        telemedicine’’ includes, as an example,                 Secretary have found that doing so is
                                        contemplates that the practitioner will                  ‘‘a practitioner who has obtained from                  ‘‘consistent with effective controls
                                        be permitted to prescribe controlled                     the [DEA Administrator] a special                       against diversion and otherwise
                                        substances by means of the Internet                      registration under [21 U.S.C. 831(h)].’’                consistent with the public health and
                                                                                                 21 U.S.C. 802(54)(E). The Act specifies                 safety.’’ 21 U.S.C. 802(52)(B)(ix).
                                          29 In addition, the Act lists the following as an
                                                                                                 certain criteria that DEA must consider                 Pursuant to this authority, the
                                        example of a violation of 21 U.S.C. 841(h)(1):           when evaluating an application for such                 regulations being issued here today
                                        ‘‘making a material false, fictitious, or fraudulent
                                        statement or representation in a notification or         a registration. However, the Act                        contain a provision that exempts from
                                        declaration under [21 U.S.C. 831(d) or (e)].’’ 21        contemplates that DEA must issue                        the definition of an online pharmacy
                                        U.S.C. 841(h)(2)(E). Such conduct might also             certain regulations to effectuate this                  any DEA-registered pharmacy ‘‘whose
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                                        subject the offender to liability under 18 U.S.C.        special registration provision.                         delivery, distribution, or dispensing of
                                        1001(a).
                                          30 See, e.g., United States v. Rosen, 582 F.2d 1032,
                                                                                                 Specifically, the Act states: ‘‘The [DEA                controlled substances by means of the
                                        1036 (5th Cir. 1978).                                    Administrator] shall, with the                          Internet consists solely of * * * filling
                                          31 These circumstances are specified in 21 U.S.C.                                                              prescriptions that were electronically
                                        829(e) and discussed above.                                32 Public   Law 110–425, section 3(j).                prescribed in a manner authorized by


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                                        this chapter and otherwise in                           that installs and operates an automated               authorizing such activity as required by [21
                                        compliance with the Act.’’ 21 CFR                       dispensing system at a long term care                 U.S.C. 823(f)] (unless exempt from such
                                        1300.04(h)(9). To eliminate any possible                facility must maintain a separate                     registration);
                                        confusion as to how this exception                      registration at each long term care                      (B) Writing a prescription for a controlled
                                                                                                                                                      substance for the purpose of delivery,
                                        applies, this provision of the regulations              facility in which its automated                       distribution, or dispensation by means of the
                                        further states: ‘‘A registered pharmacy                 dispensing systems are located. Id.                   Internet in violation of [21 U.S.C. 829(e)];
                                        will be deemed to meet this exception                   Prescription information may be                          (C) Serving as an agent, intermediary, or
                                        if, in view of all of its activities other              transmitted by the retail pharmacy to                 other entity that causes the Internet to be
                                        than [the acceptance of electronic                      the automated dispensing system via the               used to bring together a buyer and seller to
                                        prescriptions for controlled substances                 Internet. Therefore, a pharmacy that                  engage in the dispensing of a controlled
                                        transmitted in accordance with the                      operates an automated dispensing                      substance in a manner not authorized by [21
                                        requirements of this chapter], it would                 system at a long term care facility could             U.S.C. 823(f) or 829(e)];
                                        fall outside the definition of an online                potentially fall within the Act’s                        (D) Offering to fill a prescription for a
                                        pharmacy.’’ A DEA-registered pharmacy                                                                         controlled substance based solely on a
                                                                                                definition of an online pharmacy.                     consumer’s completion of an online medical
                                        that is so exempted from the definition                 Pursuant to 21 U.S.C. 802(52)(B)(ix), the             questionnaire; and
                                        of an online pharmacy is not required to                DEA Administrator and the Secretary                      (E) Making a material false, fictitious, or
                                        obtain a modified registration and is not               have jointly concluded that it would be               fraudulent statement or representation in a
                                        subject to the reporting requirement of                 consistent with effective controls                    notification or declaration under [21 U.S.C.
                                        21 U.S.C. 827(d)(2) or the additional                   against diversion and otherwise                       831(d) or (e)].
                                        requirements relating to online                         consistent with the public health and                 As these examples are largely self-
                                        pharmacies set forth in 21 U.S.C. 831.                  safety to issue the following exemption.              illuminating, and some have already
                                           It should be understood that the                     As set forth in 21 CFR 1300.04(h)(10), if             been addressed in this preamble, only
                                        exception provided in 21 CFR                            a DEA-registered retail pharmacy does
                                        1300.04(h)(9) cannot take effect until                                                                        limited further amplification is
                                                                                                not deliver, distribute, or dispense, or              provided here. Paragraph (C), in
                                        DEA issues regulations allowing for the                 offer to deliver, distribute, or dispense,
                                        electronic prescribing of controlled                                                                          particular, reflects that the Act was
                                                                                                controlled substances by means of the                 intended not only to prohibit DEA
                                        substances. Until then, electronic                      Internet, other than to communicate
                                        prescribing of controlled substances is                                                                       registrants from using the Internet to
                                                                                                prescription information to an                        facilitate the unlawful dispensing of
                                        not permitted by the DEA regulations                    automated dispensing system for which
                                        and thus cannot form the basis for any                                                                        controlled substances, but to also
                                                                                                it holds a separate registration at a long            prohibit non-DEA registrants from doing
                                        exception to the requirement of a                       term care facility, that retail pharmacy
                                        modified registration for DEA-registered                                                                      so. Most notably, paragraph (C) is aimed
                                                                                                is exempted from the definition of an                 squarely at the criminal facilitator
                                        pharmacies.                                             online pharmacy. As a result, such a
                                           It should also be clear from the                                                                           whose ‘‘business plan’’ for operating a
                                                                                                pharmacy is not required to obtain a                  rogue online pharmacy is to recruit an
                                        language of 21 CFR 1300.04(h)(9) that                   modified registration and is not subject
                                        this exception provides no loophole for                                                                       unscrupulous practitioner to write
                                                                                                to the reporting requirement of 21                    prescriptions based on insufficient or
                                        operators of rogue Internet Web sites or
                                                                                                U.S.C. 827(d)(2) or the additional                    nonexistent medical evaluations and/or
                                        unscrupulous pharmacies that fill
                                                                                                requirements relating to online                       an unscrupulous pharmacist to fill such
                                        prescriptions generated through such
                                                                                                pharmacies set forth in 21 U.S.C. 831.                prescriptions.
                                        sites. The mere fact that a pharmacy
                                        accepts electronic prescriptions does                   VI. Criminal Provisions of the Ryan                      The Act contains certain categories of
                                        not, in any way, immunize the                           Haight Act                                            conduct that do not result in the
                                        pharmacy from the requirements of the                                                                         participants falling within the Act’s
                                                                                                  The Ryan Haight Act adds two new
                                        Act. Likewise, a rogue Web site that                                                                          definition of an online pharmacy.
                                                                                                criminal offenses to the CSA. The first
                                        operates in violation of the Act cannot                                                                       Specifically, 21 U.S.C. 841(h)(3) states:
                                                                                                new offense is set forth in 21 U.S.C.                    (A) This subsection [21 U.S.C.
                                        escape liability simply by having either                841(h)(1), which states:
                                        (i) unscrupulous practitioners who have                                                                       841(h)(1)] does not apply to:
                                        a contract to write prescriptions on                       It shall be unlawful for any person to
                                                                                                                                                        (i) The delivery, distribution, or
                                                                                                knowingly or intentionally–
                                        behalf of the site issue such                              (A) Deliver, distribute, or dispense a             dispensation of controlled substances by
                                        prescriptions electronically or (ii)                    controlled substance by means of the                  nonpractitioners to the extent authorized by
                                        unscrupulous pharmacies that have a                     Internet, except as authorized by [the CSA];          their registration under [the CSA];
                                        contract to fill such prescriptions do so               or                                                      (ii) The placement on the Internet of
                                        through the acceptance of electronic                       (B) Aid or abet (as such terms are used in         material that merely advocates the use of a
                                                                                                section 2 of title 18, United States Code) any        controlled substance or includes pricing
                                        prescriptions. To the contrary, the
                                                                                                activity described in subparagraph (A) that is        information without attempting to propose or
                                        regulation is written so that the                                                                             facilitate an actual transaction involving a
                                        exception cannot possibly be utilized by                not authorized by [the CSA].
                                                                                                                                                      controlled substance; or
                                        a rogue Web site; only a DEA-registered                 The Act contains specific examples of                   (iii) except as provided in subparagraph
                                        pharmacy is eligible for the exception                  conduct which would violate 21 U.S.C.                 (B), any activity that is limited to—
                                        and only to the extent it is otherwise                  841(h)(1). These examples in the Act,                   (I) the provision of a telecommunications
                                        acting in conformity with the CSA and                   however, are not an exclusive list of the             service, or of an Internet access service or
                                        the DEA regulations.                                    types of conduct that constitute                      Internet information location tool (as those
                                           Exemption for automated dispensing                   violations of 21 U.S.C. 841(h)(1). With               terms are defined in section 231 of the
                                        systems—Under current DEA                               this proviso made clear, 21 U.S.C.                    Communications Act of 1934) [47 U.S.C.
                                        regulations, a DEA-registered retail                                                                          231]; or
                                                                                                841(h)(2) lists the following as examples
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                                                                                                                                                        (II) the transmission, storage, retrieval,
                                        pharmacy may install and operate an                     of violations:                                        hosting, formatting, or translation (or any
                                        automated dispensing system at a long                     (A) Delivering, distributing, or dispensing         combination thereof) of a communication,
                                        term care facility under certain specified              a controlled substance by means of the                without selection or alteration of the content
                                        conditions. 21 CFR 1301.27. Among                       Internet by an online pharmacy that is not            of the communication, except that deletion of
                                        other requirements, any retail pharmacy                 validly registered with a modification                a particular communication or material made



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                                                             Federal Register / Vol. 74, No. 64 / Monday, April 6, 2009 / Rules and Regulations                                                   15605

                                        by another person in a manner consistent                Web site is not a DEA-registered                        The term ‘‘deliver, distribute, or dispense
                                        with section 230(c) of the Communications               pharmacy with a modification                          by means of the Internet’’ refers, respectively,
                                        Act of 1934 [47 U.S.C. 230(c)] shall not                authorizing it to operate as an online                to any delivery, distribution, or dispensing of
                                        constitute such selection or alteration of the                                                                a controlled substance that is caused or
                                                                                                pharmacy. As another example, it is                   facilitated by means of the Internet.
                                        content of the communication.
                                          (B) The exceptions under subclauses (I)
                                                                                                unlawful under the Act to knowingly or
                                                                                                intentionally place an advertisement on               21 U.S.C. 802(51) (emphasis added).
                                        and (II) of subparagraph (A)(iii) shall not
                                                                                                the Internet that offers to sell a                    Given that the phrase ‘‘deliver,
                                        apply to a person acting in concert with a
                                        person who violates paragraph (1).                      controlled substance without a                        distribute, or dispense by means of the
                                                                                                prescription or that directs persons to a             Internet’’ has the foregoing definition,
                                        Thus, paragraph (A)(i) allows DEA-                                                                            the next question is: What does it mean
                                        registered nonpractitioners (such as                    Web site through which a controlled
                                                                                                substance may be purchased without a                  to ‘‘knowingly or intentionally’’ deliver,
                                        manufacturers and distributors) to                                                                            distribute, or dispense a controlled
                                        utilize the Internet in carrying out                    prescription.
                                                                                                                                                      substance by means of the Internet?
                                        activities authorized by their DEA                         Two important points should be                       The phrase ‘‘knowingly or
                                        registrations (and otherwise in                         noted with respect to 21 U.S.C.                       intentionally’’ has been a part of the
                                        conformity with the CSA) without being                  843(c)(2)(A). First, to establish a                   CSA since its enactment in 1970.
                                        subject to liability under 21 U.S.C.                    violation of this felony provision, it is             Among other provisions, 21 U.S.C.
                                        841(h)(1). Paragraph (A)(ii) allows for                 not necessary that the person placing                 841(a)(1) (the most widely utilized
                                        Web sites that advocate the use of                      the advertisement actually engage in a                criminal provision of the CSA) makes it
                                        controlled substances or contain pricing                transaction involving a controlled                    an offense to ‘‘knowingly or
                                        information ‘‘without attempting to                     substance. Rather, merely placing on the              intentionally * * * manufacture,
                                        propose or facilitate an actual                         Internet an advertisement that is                     distribute, or dispense, or possess with
                                        transaction involving a controlled                      designed to facilitate, or offers to                  intent to manufacture, distribute, or
                                        substance.’’ Paragraph (A)(iii) exempts                 facilitate, an illegal sale of a controlled           dispense, a controlled substance’’
                                        from application of 21 U.S.C. 841(h)(1)                 substance is sufficient to violate 21                 except as authorized by the CSA. There
                                        Internet service providers, Web hosting                 U.S.C. 843(c)(2)(A). Second, the Act                  are numerous reported federal cases,
                                        services, and certain other specified                   applies to advertisements relating to                 some of which are discussed below, in
                                        entities that do not alter content of                   violations not only of the CSA, but also              which practitioners and pharmacists
                                        Internet transmissions. However, it is                  of the Controlled Substances Import and               have been convicted of violating 21
                                        crucial to bear in mind that the                        Export Act (CSIEA, which is found in 21               U.S.C. 841(a)(1). These cases establish
                                        exception of paragraph (A)(iii) does not                U.S.C. 951 through 971). Thus, it is a                clear precedent for interpreting the
                                        apply to ‘‘a person acting in concert                   violation of 21 U.S.C. 843(c)(2)(A) to                phrase ‘‘knowingly or intentionally’’ in
                                        with a person who violates [21 U.S.C.                   place an advertisement on the Internet                the context of practitioners who
                                        841(h)(1)].’’ Thus, any person whose                    that offers, for example, to ship                     unlawfully prescribe controlled
                                        conduct would be sufficient to prove                    controlled substances into the United                 substances and pharmacists who
                                        that he conspired to violate 21 U.S.C.                  States for personal medical use, since                unlawfully fill prescriptions for
                                        841(h)(1), or aided and abetted such                    doing so would violate the                            controlled substances. Specifically, a
                                        violation, is not immune from                           CSIEA.33 What It Means to ‘‘Knowingly                 practitioner may be convicted of
                                        prosecution under paragraph (A)(iii).                   or intentionally deliver, distribute, or              knowingly or intentionally dispensing
                                           The second new criminal offense                      dispense a controlled substance by                    controlled substances in violation of the
                                        added by the Act is 21 U.S.C.                           means of the Internet.’’                              CSA where the practitioner either (i)
                                        843(c)(2)(A). This provision expressly                     The Ryan Haight Act is structured                  had actual knowledge of the illegal
                                        prohibits using the Internet to advertise               around the phrase ‘‘knowingly or                      activity or (ii) was presented with facts
                                        illegal transactions in controlled                      intentionally deliver, distribute, or                 that put him on notice that criminal
                                        substances. Specifically, this provision                dispense a controlled substance by                    activity was particularly likely and yet
                                        states:                                                 means of the Internet.’’ The meaning of               intentionally failed to investigate those
                                          It shall be unlawful for any person to                this phrase is therefore essential to the             facts.34 The following statement by one
                                        knowingly or intentionally use the Internet,            meaning of the Act. To explain its                    federal court of appeals exemplifies the
                                        or cause the Internet to be used, to advertise          meaning, it is helpful to divide the                  standard under which pharmacists may
                                        the sale of, or to offer to sell, distribute, or        phrase into two parts, starting with the              be held liable for knowingly or
                                        dispense, a controlled substance where such             latter half (‘‘deliver, distribute, or                intentionally dispensing controlled
                                        sale, distribution, or dispensing is not                dispense a controlled substance by                    substances in violation of the CSA:
                                        authorized by [the CSA] or by the Controlled            means of the Internet’’). The Act itself
                                        Substances Import and Export Act.                                                                               The question, then, in any case where a
                                                                                                contains the following definition:                    pharmacist is charged with illegal
                                        The Act further states:                                                                                       distribution of controlled substances, is
                                          Examples of activities that violate [21                 33 Under the CSIEA, the importation of controlled   whether he knew that the purported
                                        U.S.C. 843(c)(2)(A)] include, but are not               substances into the United States is prohibited       prescription was not issued for a legitimate
                                                                                                except by persons registered with DEA to do so or     medical purpose or in the usual course of
                                        limited to, knowingly or intentionally
                                                                                                persons exempted from such requirement. 21 U.S.C.     medical practice. The key element of
                                        causing the placement on the Internet of an             952, 957, 960. In accordance with the CSIEA, DEA
                                        advertisement that refers to or directs                                                                       knowledge may be shown by proof that the
                                                                                                has issued a regulation authorizing a person to
                                        prospective buyers to Internet sellers of                                                                     defendant deliberately closed his eyes to the
                                                                                                import certain controlled substances for personal
                                        controlled substances who are not registered            medical use, provided the person has the drugs in
                                                                                                                                                      true nature of the prescription.35
                                        with a modification under [21 U.S.C. 823(f)].           his possession upon entering the United States,         Another federal court has similarly
                                                                                                makes the required declaration to the U.S. Customs
                                        Thus, for example, it is unlawful under                 and Border Protection, and otherwise complies
                                                                                                                                                      stated that a pharmacist may be
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                                        the Act to knowingly or intentionally                   fully with the requirements of the regulation. 21
                                                                                                                                                        34 United States v. Katz, 445 F.3d 1023, 1031 (8th
                                        place an advertisement on the Internet                  CFR 1301.26; 69 FR 55343 (2004). Under no
                                                                                                circumstances is it permissible under the CSIEA or    Cir. 2006), cert. denied, 127 S.Ct. 421 (2006).
                                        that directs persons to a Web site that                 the regulations for a person to have controlled         35 United States v. Lawson, 682 F.2d 480, 482 (4th
                                        sells prescriptions for controlled                      substances shipped into the United States for         Cir. 1982) (citations omitted), cert. denied, 459 U.S.
                                        substances where the operator of the                    personal medical use.                                 991 (1982).



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                                        15606                 Federal Register / Vol. 74, No. 64 / Monday, April 6, 2009 / Rules and Regulations

                                        convicted of unlawfully dispensing                       the definition of an ‘‘online pharmacy,’’            application process for registrants to
                                        controlled substances where the                          your pharmacy must, beginning on                     apply for such modification of
                                        evidence establishes that the pharmacist                 April 13, 2009, obtain from DEA a                    registration.
                                        ‘‘deliberately closed his eyes to                        modification of its registration                        In addition, as explained earlier in
                                        wrongdoing that should have been                         authorizing it to operate as an online               this preamble, any pharmacy that fits
                                        obvious to him.’’36 Courts have referred                 pharmacy. (DEA will issue to the                     within the Act’s definition of an online
                                        to such conduct as ‘‘willful blindness’’                 pharmacy a Certificate of Registration               pharmacy must display certain
                                        or ‘‘deliberate ignorance.’’ As one court                indicating the modification of                       information on its Web site and make
                                        has stated:                                              registration.) The Ryan Haight Act                   certain notifications to DEA, as required
                                           Ignorance is deliberate if the defendant was          contains several exceptions to the                   by the Act and the regulations being
                                        presented with facts that put her on notice              definition of an online pharmacy, so                 issued here. Also, if a pharmacy has
                                        that criminal activity was particularly likely           you should review carefully these                    applied for and been granted a
                                        and yet she intentionally failed to investigate          exceptions before submitting an                      modification of its registration
                                        those facts.* * * If, in light of certain                application for such modification of                 authorizing it to operate as an online
                                        obvious facts, reasonable inferences support             registration. Among other things,                    pharmacy, it is obligated to submit
                                        a finding that a defendant’s failure to                                                                       monthly reports of all controlled
                                        investigate is equivalent to ‘burying one’s              particular consideration should be given
                                                                                                 to the exception set forth in 21 U.S.C.              substances dispensed by any means
                                        head in the sand,’ the jury may consider
                                        willful blindness as a basis for knowledge.37            802(52)(B)(viii) that excludes from the              (walk-in business, dispensing by mail,
                                                                                                 definition of an online pharmacy those               or any other type of dispensing—
                                           Thus, a pharmacist who fills a                                                                             whether by means of the Internet or
                                        prescription that was issued in violation                DEA-registered pharmacies ‘‘whose
                                                                                                 dispensing of controlled substances via              not), provided such dispensing meets or
                                        of any provision of the Act may be held                                                                       exceeds the threshold amounts.
                                        criminally liable under 21 U.S.C.                        the Internet consists solely of * * * (I)
                                                                                                 refilling prescriptions for controlled                  A pharmacist has always had a
                                        841(h)(1) if he did so knowingly or                                                                           corresponding responsibility to ensure
                                        intentionally—that is, if he either (i) had              substances in schedule III, IV, or V, as
                                                                                                 defined in paragraph [21 U.S.C. 802(55)]             that any dispensing of controlled
                                        actual knowledge of the violation or (ii)                                                                     substances conforms with the CSA and
                                        deliberately disregarded facts that                      or (II) filling new prescriptions for
                                                                                                 controlled substances in schedule III,               DEA regulations.38 That same
                                        would have led a reasonable pharmacist                                                                        corresponding responsibility now
                                        to be highly suspicious about the                        IV, or V, as defined in paragraph [21
                                                                                                 U.S.C. 802(56)].’’                                   applies with respect to the new
                                        likelihood of such a violation. Likewise,                                                                     requirements of the Ryan Haight Act
                                        a practitioner who writes a prescription                    Also, the regulations being issued                and the implementing regulations. That
                                        in violation of the Act may be held                      here exempt from the definition of                   is, a pharmacist’s corresponding
                                        criminally liable under 21 U.S.C.                        online pharmacy any registered                       responsibility now includes ensuring
                                        841(h)(1) if he did so knowingly or                      pharmacy ‘‘whose delivery, distribution,             that controlled substances are dispensed
                                        intentionally—which can be proven by                     or dispensing of controlled substances               in conformity with the Ryan Haight Act.
                                        showing that either (i) the practitioner                 by means of the Internet consists solely             For example, under the Act, a
                                        had actual knowledge of the violation or                 of * * * filling prescriptions that were             pharmacist may not knowingly or
                                        (ii) the practitioner deliberately                       electronically prescribed in a manner                intentionally fill a prescription for a
                                        disregarded facts that would have led a                  authorized by this chapter and                       controlled substance that was issued in
                                        reasonable practitioner to be highly                     otherwise in compliance with the Act.’’              violation of the inperson medical
                                        suspicious about the likelihood of such                  Given these exceptions to the definition             evaluation requirement of 21 U.S.C.
                                        a violation.                                             of an online pharmacy, DEA anticipates               829(e).
                                                                                                 that the overwhelming majority of                       How does a pharmacist, when
                                        VII. Additional Information About the
                                                                                                 pharmacies in the United States, if they             presented with a prescription (whether
                                        Ryan Haight Act for Pharmacists,
                                                                                                 follow their current practices, will not,            it is a written prescription presented in
                                        Practitioners, Other Registrants, and
                                                                                                 as of April 13, 2009, fall within the                person, an oral prescription, a faxed
                                        Members of the Public
                                                                                                 definition of an online pharmacy.                    prescription, or otherwise) know
                                           This section provides additional                      However, as of April 13, 2009, if a                  whether the prescription was
                                        information specifically tailored to                     pharmacist knowingly or intentionally                ‘‘dispensed by means of the Internet,’’
                                        various categories of persons who are                    dispenses a controlled substance by                  and thus subject to the requirements of
                                        likely to be affected by, or otherwise                   means of the Internet, and the pharmacy              the Act? Again, under the law, a
                                        have an interest in, the Ryan Haight Act.                fits within the definition of an online              pharmacist has a corresponding
                                        This information must be read in                         pharmacy, but does not hold a modified               responsibility to ensure that any
                                        conjunction with the general                             DEA registration authorizing it to                   prescription filled was issued in
                                        information explaining the Act provided                  operate as an online pharmacy, the                   conformity with the law and
                                        above. For example, the definitions of                   pharmacy and the pharmacist are                      regulations. The same legal standard
                                        the terminology used in the Act will not                 violating 21 U.S.C. 841(h)(1) and subject            that has always applied in determining
                                        be repeated in this section (due to their                to potential criminal prosecution and                whether a pharmacist met this
                                        length) and should be reviewed as                        loss of the pharmacy’s DEA registration.             responsibility will also apply in
                                        necessary by returning to the                            Accordingly, if the anticipated activities           determining whether the pharmacist
                                        appropriate sections of the preamble.                    of your pharmacy will render it an                   acted properly in filling a prescription
                                        A. Additional Specific Information for                   online pharmacy within the meaning of                subject to the requirements of the Ryan
                                        Pharmacists                                              the Act, you should submit to DEA your               Haight Act. If the pharmacist either (i)
                                                                                                 application for a modified registration              had actual knowledge that the
                                          If you are a pharmacist, and your
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                                        DEA-registered pharmacy falls within                     as early as possible, since you will not             prescription was issued by means of the
                                                                                                 be permitted to engage in the activities             Internet and that the requirements of the
                                          36 United States v. Veal, 23 F.3d 985, 988 (6th Cir.   of an online pharmacy until DEA has                  Act were not met or (ii) in view of all
                                        1994).                                                   approved such application. To expedite
                                          37 Katz, 445 F.3d at 1031.                             matters, DEA has established an online                 38 See   21 CFR 1306.04(a).



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                                                             Federal Register / Vol. 74, No. 64 / Monday, April 6, 2009 / Rules and Regulations                                                    15607

                                        the circumstances surrounding a                         medical purpose in the usual course of                absolutely unnecessary for a pharmacy
                                        particular prescription, and, in the                    professional practice. For example, if                to apply for a modification of its DEA
                                        exercise of proper professional practice,               the pharmacist knows that a                           registration authorizing it to operate as
                                        should have known of such violation, or                 prescription for a controlled substance               an online pharmacy for the sole purpose
                                        deliberately closed his eyes to                         was issued by a practitioner who works                of ensuring that it does not—despite the
                                        circumstances indicative of a possible                  for a Web site that sends its customers               exercise of sound professional
                                        violation, or otherwise failed to take                  to practitioners for a one-time sham                  judgment—inadvertently fill a
                                        appropriate steps that a professional                   medical evaluation with the intent to                 prescription that was issued by means
                                        pharmacist should take to investigate                   sell prescriptions to the customers                   of the Internet.
                                        suspicious circumstances, the pharmacy                  repeatedly thereafter with no in-person
                                                                                                                                                      B. Additional Specific Information for
                                        and pharmacist may be deemed to have                    follow-up evaluations, the fact that the
                                                                                                                                                      Practitioners
                                        knowingly or intentionally violated 21                  practitioner conducted an in-person
                                        U.S.C. 841(h)(1).                                       ‘‘evaluation’’ purporting to comply with                 If you are a physician, dentist,
                                           Depending on the circumstances, the                  the Act does not excuse the pharmacist                veterinarian, mid-level practitioner, or
                                        relevant factors for this inquiry might                 from fulfilling his corresponding                     other practitioner registered with DEA
                                        include: the number of prescriptions                    responsibility to fill only those                     to prescribe, administer, or dispense
                                        received from a practitioner; the                       prescriptions for controlled substances               controlled substances, and your
                                        practitioner’s pattern of prescribing; the              that were issued for a legitimate medical             activities involving controlled
                                        address of the patient in relation to that              purpose in the usual course of                        substances are limited to those
                                        of the practitioner; and the distance                   professional practice.                                authorized by your registration, you are
                                        from the practitioner to the pharmacy.                     To list another common practice of                 exempted under the Ryan Haight Act
                                        If, taking factors such as these into                   rogue Internet site operators, if you are             from the definition of an ‘‘online
                                        account, the pharmacist either (a)                      an owner of a pharmacy and you are                    pharmacy.’’ As a result, you are not
                                        actually knows that the patient to whom                 approached by an ‘‘entrepreneur’’ who                 subject to the requirement of obtaining
                                        a prescription for a controlled substance               offers to funnel to you large quantities              a modified DEA registration that applies
                                        was issued was steered to the                           of prescriptions for filling in exchange              to pharmacies that dispense controlled
                                        practitioner through a Web site or (b)                  for a fee, there is a strong possibility that         substances by means of the Internet.
                                        should reasonably suspect so and fails                  you are being asked to serve as the                   Nonetheless, there are other
                                        to verify, the pharmacist who fills such                supplier to a rogue Web site. This is                 requirements of the Act and the
                                        a prescription will have knowingly or                   especially so if such ‘‘entrepreneur’’ is             implementing regulations that,
                                        intentionally dispensed a controlled                    not affiliated with a legitimate health               depending on the nature of your
                                        substance by means of the Internet. If                  care organization. Again, the rogue Web               practice, might apply to you.
                                        such dispensing occurs, both the                        sites that the Act was designed to                       DEA believes that the overwhelming
                                        pharmacy and the pharmacist fall                        eliminate often depend on the                         majority of practitioners in the United
                                        within the definition of an online                      assistance of DEA-registered                          States, based on their current practices,
                                        pharmacy, and both will automatically                   pharmacies. If you as a pharmacy owner                do not engage in activities that
                                        violate 21 U.S.C. 841(h)(1) if the                      or pharmacist are asked to participate in             constitute delivering, distributing, or
                                        pharmacy does not have a modified                       a scheme that raises suspicions about                 dispensing controlled substances by
                                        DEA registration authorizing it to                      compliance with the Act, you are                      means of the Internet.39 Accordingly,
                                        operate as an online pharmacy. Again,                   risking potential criminal liability and              the overwhelming majority of
                                        such a violation, or any other                          loss of DEA registration if you agree to              practitioners need not change their
                                        transgression by a pharmacist of the                    participate without taking reasonable                 practices because of the enactment of
                                        corresponding responsibility as it                      steps to rule out the possibility that the            the Ryan Haight Act. However, if you
                                        pertains to the requirements of the Act                 scheme will violate the Act.                          are a DEA-registered practitioner who
                                        may result in criminal prosecution of                      A pharmacist is not, however,                      prescribes or otherwise dispenses a
                                        the pharmacist and/or administrative                    obligated to know what cannot be                      controlled substance by means of the
                                        proceedings to revoke the pharmacy’s                    known through the exercise of sound                   Internet, you must comply with the
                                        registration.                                           professional pharmacy practice. For                   provisions of the Act that apply to you.
                                           Pharmacists should also note that the                example, it is conceivable that a                       First, if you are a DEA-registered
                                        new requirements of the Act are in                      customer could walk into a pharmacy                   practitioner who prescribes or otherwise
                                        addition to, and not in lieu of, the                    with a prescription that was issued by                dispenses a controlled substance by
                                        longstanding requirement that all                       means of the Internet (or such a                      means of the Internet, you must comply
                                        prescriptions for controlled substances                 prescription could be faxed to a
                                                                                                                                                        39 As discussed above, the electronic prescribing
                                        be issued by a practitioner acting in the               pharmacy) with the pharmacist having
                                                                                                                                                      of controlled substances is not currently permitted
                                        usual course of professional practice                   no reasonable basis to know or suspect                under the DEA regulations, but DEA has proposed
                                        and otherwise in conformity with the                    that it was issued by means of the                    regulations that, once finalized, will allow such
                                        CSA and DEA regulations. Thus, when                     Internet. As long as the pharmacist                   practice. The electronic prescribing of controlled
                                        a prescription for a controlled substance               meets his corresponding responsibility                substances through use of the Internet does, as
                                                                                                                                                      explained above, constitute delivering, distributing,
                                        has been issued by means of the                         to take reasonable steps under the                    or dispensing controlled substances by means of the
                                        Internet, even if the pharmacy that fills               circumstances to ensure that the                      Internet. Nonetheless, since the overwhelming
                                        the prescription has obtained from DEA                  prescription was issued in accordance                 majority of practitioners only prescribe controlled
                                        a modification of its registration, and                 with the requirements of the Ryan                     substances to patients for whom they have
                                                                                                                                                      conducted an in-person medical evaluation, and
                                        even if the pharmacist has confirmed                    Haight Act (as well as all other                      only for a legitimate medical purpose in the usual
                                        that the prescribing practitioner has                   applicable requirements of the CSA and                course of professional practice, it is anticipated that
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                                        conducted at least one in-person                        DEA regulations), the pharmacist will                 the overwhelming majority of practitioners will
                                        medical evaluation of the patient, the                  not be held strictly liable for filling a             continue this practice once electronic prescribing of
                                                                                                                                                      controlled substances becomes permissible under
                                        pharmacist still has the corresponding                  prescription that he could not                        the DEA regulations. If so, such practitioners would
                                        responsibility to ensure that the                       reasonably have known was issued by                   satisfy the ‘‘valid prescription’’ requirement of the
                                        prescription was issued for a legitimate                means of the Internet. Thus, it is                    Ryan Haight Act.



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                                        15608                Federal Register / Vol. 74, No. 64 / Monday, April 6, 2009 / Rules and Regulations

                                        with the provision of the Act relating to               name (along with the names of your                         he is being asked to dispense controlled
                                        the in-person medical evaluation                        fellow practitioners who write                             substances by means of the Internet
                                        requirement, which is set forth in 21                   prescriptions on behalf of the site) are                   within the meaning of the Act. (As most
                                        U.S.C. 829(e). Certain exceptions apply                 posted in a visible and clear manner on                    practitioners would immediately
                                        to this requirement, as are discussed                   the homepage of the Web site, or on a                      recognize, such a proposal is inherently
                                        above in this preamble. Note, however,                  page directly linked thereto in which                      suspect, since the legitimate practice of
                                        that the Act expressly states that                      the hyperlink is also visible and clear on                 medicine is not structured around
                                        compliance by a practitioner with the                   the homepage.41 It is anticipated that                     writing prescriptions for controlled
                                        in-person medical evaluation                            most every medical office in the United                    substances and being compensated
                                        requirement does not, by itself, satisfy                States that currently has a Web site is                    primarily or exclusively on that
                                        the requirement that every prescription                 already in compliance with this                            basis.) 43 The profitability of rogue
                                        be issued for a legitimate medical                      provision as it is common practice for                     Internet Web sites typically depends on
                                        purpose in the usual course of                          such Web sites to post in such manner                      the ability of the criminal facilitator
                                        professional practice. Whether a                        the names of the practitioners. If,                        who operates the site to recruit
                                        prescription was issued for a legitimate                however, you are one of what is                            unscrupulous practitioners to enter into
                                        medical purpose in the usual course of                  anticipated to be a very small number of                   such types of contractual arrangements.
                                        professional practice must, as always, be               practitioners who, beginning on or after                      In response to the enactment of the
                                        determined based on the totality of the                 April 13, 2009 (the effective date of the                  Ryan Haight Act, some rogue Web sites
                                        circumstances under which a particular                  Ryan Haight Act), writes prescriptions                     have come up with the following
                                        prescription was issued to a particular                 on behalf of a Web site of a DEA-                          approach in an effort to circumvent the
                                        patient. As DEA has previously stated,                  registered pharmacy, the Act requires                      new law. Drug-seeking customers who
                                        ‘‘DEA recognizes that the overwhelming                  the Web site to post additional                            visit the rogue Web site are told that
                                        majority of American physicians who                     information identifying you.                               they should arrange a visit with one of
                                        prescribe controlled substances do so                   Specifically, the Web site must post the                   the practitioners affiliated with the site
                                        for legitimate medical purposes [and]                   following information in a visible and                     to satisfy the Act’s requirement of an in-
                                        exercise the appropriate degree of                      clear manner on the homepage of each                       person medical evaluation. Once the
                                        medical supervision—as part of their                    Internet site it operates, or on a page                    practitioner has gone through the
                                        routine practice during office visits.’’40              directly linked thereto in which the                       motions of conducting what purports to
                                        However, this favorable characterization                hyperlink is also visible and clear on the                 be a medical evaluation, the ‘‘patient’’
                                        cannot be applied to the very small                     homepage: ‘‘The name, address,                             will be permitted to purchase controlled
                                        percentage of practitioners who write                   telephone number, professional degree,                     substances (or prescriptions therefor)
                                        prescriptions on behalf of rogue Internet               and States of licensure of any                             through the Web site in perpetuity,
                                        Web sites. Indeed, the main reason                      practitioner who has a contractual                         without having to see the practitioner in
                                        Congress enacted the Ryan Haight Act                    relationship to provide medical                            person again. A practitioner who might
                                        was to bring an end to the rogue Web                    evaluations or issue prescriptions for                     be inclined to consider entering into a
                                        sites that hire unscrupulous                            controlled substances, through referrals                   contract with the operator of such a
                                        practitioners to write prescriptions                    from the Web site or at the request of the                 rogue Web site should consider that, in
                                        without a legitimate medical purpose                    owner or operator of the Web site, or                      all likelihood, such an operation
                                        and outside the usual course of                         any employee or agent thereof.’’ 42                        violates the Act—despite its purported
                                        professional practice.                                     How does a practitioner know                            compliance with the in-person medical
                                           If you are a practitioner who                        whether he is writing prescriptions that                   evaluation requirement. For one, under
                                        knowingly or intentionally prescribes or                are issued through, or on behalf of, a                     the Act, the only persons who may
                                        otherwise dispenses controlled                          Web site? In some cases, this will be                      operate Web sites through which
                                        substances on behalf of a particular Web                obvious to the practitioner. For                           controlled substances are prescribed or
                                        site, and if that Web site is not                       example, if a practitioner is approached                   otherwise dispensed are DEA-registered
                                        compliant with the requirements of the                  by a person who offers to pay the                          practitioners (pharmacies and
                                        Act and the implementing regulations,                   practitioner to write prescriptions for                    nonpharmacy practitioners).44 Thus, a
                                        you are dispensing controlled                           ‘‘patients’’ who will be routed to the                     non-DEA registrant may not operate a
                                        substances by means of the Internet in                  practitioner through the Web site, the                     Web site that constitutes an ‘‘online
                                        a manner not authorized by the Act.                     practitioner has actual knowledge that                     pharmacy’’ within the meaning of the
                                        Doing so constitutes a violation of 21                                                                             Act (which includes, for example, a
                                        U.S.C. 841(h)(1) and may result in                         41 As stated in 21 CFR 1304.50: ‘‘For a Web site
                                                                                                                                                           Web site that sells prescriptions for
                                                                                                to identify itself as being exempt from the definition
                                        criminal prosecution and/or                             of an online pharmacy by virtue of section                 controlled substances or fills such
                                        administrative proceedings to revoke                    102(52)(B)(ii) of the Act (21 U.S.C. 802(52)(B)(ii)),      prescriptions). Second, even in the
                                        your DEA registration.                                  the Web site shall post in a visible and clear manner      unlikely event that the person who is
                                           If you are a practitioner who writes                 on its homepage, or on a page directly linked
                                                                                                                                                           offering the practitioner the opportunity
                                        prescriptions on behalf of a particular                 thereto in which the hyperlink is also visible and
                                                                                                clear on the homepage, a list of the DEA-registered        to participate in such a Web site is a
                                        Web site, your name must appear                         nonpharmacy practitioners who are affiliated with          DEA registrant with the appropriate
                                        prominently on that Web site. (This                     the Web site. Any nonpharmacy practitioner                 registration allowing it to dispense
                                        requirement helps to distinguish those                  affiliated with such a Web site is responsible for
                                                                                                compliance with this section. An institutional             controlled substances by means of the
                                        Web sites that are compliant with the                   practitioner that otherwise complies with the
                                        Act and the implementing regulations                    requirements of the Act and this chapter will be              43 Such an arrangement whereby compensation is

                                        from those that are not compliant.) If                  deemed to meet the requirements of this section if,        based primarily or exclusively on the number of
                                        such Web site is operated on behalf of                  in lieu of posting the names of each affiliated            prescriptions for controlled substances issued is a
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                                                                                                individual practitioner, it posts its name (as it          ‘‘red flag’’ indicating that diversion of controlled
                                        a group medical practice in which you                   appears on its Certificate of Registration) in a visible   substances into illicit channels might be
                                        participate, it is sufficient that your                 and clear manner on its homepage and in a manner           occurring—regardless of whether the Internet is
                                                                                                that identifies itself as being responsible for the        involved.
                                          40 71 FR 52716, 52719 & 52723 (2006 DEA policy        operation of the Web site.’’                                  44 See 21 U.S.C. 802(51), 802(52), 823(f), &

                                        statement).                                                42 21 U.S.C. 831(c)(6).                                 841(h)(1).



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                                                             Federal Register / Vol. 74, No. 64 / Monday, April 6, 2009 / Rules and Regulations                                                       15609

                                        Internet, the prescribing practitioner                  distributing, or dispensing controlled                     registration authorizing it to operate as
                                        must ensure that the Web site properly                  substances by means of the Internet.                       an online pharmacy. Under such
                                        displays his name and the other                         This means that the vast majority of                       circumstances, if the pharmacy does not
                                        required information in the manner                      practitioners need not alter their current                 have such a modified registration, it
                                        required by the Act and the                             practices to conform to the requirements                   would be unlawful for you as a
                                        implementing regulations.                               of the Ryan Haight Act.                                    distributor to supply the pharmacy with
                                           Further, even if the Web site has the                                                                           controlled substances. (The pharmacy’s
                                        required registration and posts the                     C. Additional Specific Information for                     Certificate of Registration will reflect its
                                        required information, it is difficult to                DEA-Registered Distributors                                status as an online pharmacy in its
                                        envision how a conscientious                              The ability of rogue Internet sites to                   business activity designation.) 46
                                        practitioner could enter into a contract                supply controlled substances to persons                      Even if you do not have actual
                                        to provide medical evaluations and/or                   who seek them for other than legitimate                    knowledge that the pharmacy is
                                        issue prescriptions through referrals                   medical purposes depends largely on                        operating through a Web site, if the
                                        from a Web site that is designed                        the existence of DEA-registered                            pharmacy’s buying patterns are of a
                                        primarily to attract and supply persons                 pharmacies that are willing to supply                      volume or otherwise of a nature
                                        seeking to obtain controlled substances                 the customers of these Web sites. As the                   indicating a reasonable likelihood that
                                        for other than legitimate medical                       data provided at the beginning of this                     the pharmacy is supplying customers of
                                        purposes (rather than to provide                        preamble illustrates, it takes only a                      a Web site or otherwise engaging in
                                        legitimate medical care to patients                     relatively small number of                                 practices that render it an online
                                        without a predetermined goal of selling                 unscrupulous pharmacies, working in                        pharmacy within the meaning of the
                                        drugs or prescriptions). Indeed, a Web                  conjunction with rogue Internet sites, to                  Ryan Haight Act, the sound course of
                                        site that operates in such a manner—                    supply enormous quantities of                              action for the distributor would be to
                                        such as by offering to arrange in-person                hydrocodone and other controlled                           confirm that the pharmacy is complying
                                        ‘‘medical evaluations’’ for the purpose                 substances, causing a substantial                          with the Act prior to supplying the
                                        of allowing customers to obtain                         detrimental effect on the public health                    pharmacy with controlled substances.47
                                        controlled substances through the Web                   and welfare. Accordingly, if you are a
                                        site indefinitely thereafter—should be                                                                             D. Additional Specific Information for
                                                                                                DEA-registered distributor, it is critical                 Consumers
                                        viewed by a practitioner as a ‘‘red flag’’              that you are vigilant in taking
                                        indicating that diversion of controlled                 appropriate steps to avoid supplying the                      The full title of the Ryan Haight Act
                                        substances to illicit channels might be                 pharmacies that service the customers of                   is ‘‘The Ryan Haight Online Pharmacy
                                        occurring.                                              rogue Web sites.                                           Consumer Protection Act of 2008.’’ As
                                           The same considerations apply if you,                  In a September 27, 2006, letter to all                   this title implies, a primary purpose of
                                        as a practitioner, are offered a contract               DEA-registered distributors, DEA                           the Act is to protect consumers by
                                        or otherwise presented with a proposal                  specified a number of pharmacy                             ensuring that only legitimate, law-
                                        to write prescriptions to customers of a                practices that might be indicative of                      abiding Web sites dispense controlled
                                        Web site based on reviewing online                      diversion. While all the considerations                    substances via the Internet. One of the
                                        questionnaires or faxed ‘‘medical                       set forth in that letter remain valid                      ways the Act achieves this goal is by
                                        records’’ or by answering telephone                     today, the enactment of the Ryan Haight                    allowing only pharmacies who are
                                        calls through a phone number affiliated                 Act should further assist distributors in                  properly registered with DEA to operate
                                        with the Web site. If these customers are               avoiding distributing controlled                           Web sites through which prescriptions
                                        being referred to you through the Web                   substances to pharmacies that are                          for controlled substances are filled. In
                                        site or at the request of the owner or                  supplying customers of rogue Web sites.                    addition, the Act and the implementing
                                        operator of the Web site, any                                                                                      regulations require such Web sites to
                                                                                                For example, if you are a distributor and
                                        prescriptions for controlled substances                                                                            fully disclose to consumers certain basic
                                                                                                you know that a pharmacy is soliciting
                                        you write for the customers constitute                                                                             information, such as the name and
                                                                                                buyers of controlled substances via the
                                        ‘‘dispensing by means of the Internet’’                                                                            telephone number of the pharmacist-in-
                                                                                                Internet, or is associated with an
                                        within the meaning of the Act. As                                                                                  charge, a list of the states in which the
                                                                                                Internet site that solicits orders for
                                        explained above, a practitioner who                                                                                pharmacy is authorized to dispense
                                                                                                controlled substances,45 you are on
                                        dispenses a controlled substance by                                                                                controlled substances, the names of any
                                                                                                notice that the pharmacy is an ‘‘online
                                        means of the Internet in violation of the
                                                                                                pharmacy’’ under the Act. If so, it is
                                        Act may be held criminally liable under                                                                              46 DEA provides a ‘‘Registration Validation’’ tool
                                                                                                unlawful, per se, for the pharmacy to be
                                        21 U.S.C. 841(h)(1) if he did so                                                                                   on its Web site, through which DEA registrants may
                                        knowingly or intentionally—which can                    operating without a modified DEA                           query DEA’s registration database regarding another
                                                                                                                                                           DEA registrant to gather specific information about
                                        be proven by showing that either (i) the                   45 As explained earlier in this preamble, the Ryan      that registrant. Information available includes: The
                                        practitioner had actual knowledge of the                Haight Act contains an exception from the                  registrant’s name, address, and DEA registration
                                        violation or (ii) the practitioner                      definition of ‘‘online pharmacy’’ for any pharmacy         number; the date of expiration of the registration;
                                        deliberately disregarded facts that                     registered under 21 U.S.C. 823(f) whose dispensing         business activity; and the schedules of controlled
                                                                                                of controlled substances via the Internet consists         substances the registrant is authorized to handle.
                                        would have led a reasonable
                                                                                                solely of ‘‘refilling prescriptions for controlled           47 As with all DEA registrants, distributors have
                                        practitioner to be highly suspicious                    substances in schedule III, IV, or V’’ or ‘‘filling new    a duty to maintain effective controls against
                                        about the likelihood of such a violation.               prescriptions for controlled substances in schedule        diversion of controlled substances. 21 U.S.C.
                                        In addition, any transgression of the Act               III, IV, or V’’ (as those terms are defined in 21 U.S.C.   823(b)(1), 823(e)(1); 21 CFR 1301.71(a). As part of
                                        may result in administrative action to                  802(55) and (56)). 21 U.S.C. 802(52)(B)(viii). Given       this responsibility, all distributors must design and
                                                                                                these and other exceptions in the Act, it is               operate a system to disclose to the registrant
                                        revoke the practitioner’s DEA                           anticipated that most pharmacies, if they continue         suspicious orders of controlled substances and must
                                        registration.                                           their current practices, will not fall within the          report to DEA any such suspicious orders of
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                                           With the foregoing considerations in                 definition of an online pharmacy. However, a               controlled substances in accordance with 21 CFR
                                        mind, DEA again emphasizes that the                     pharmacy that actively solicits buyers of controlled       1301.74(b). Failure to comply with these or any
                                                                                                substances via the Internet or is associated with a        other applicable regulatory requirements may,
                                        current practices of the overwhelming                   Web site that does so cannot fall within the               depending on the circumstances, result in civil
                                        majority of practitioners in the United                 foregoing exception and, therefore, does constitute        monetary penalties and/or administrative
                                        States do not involve delivering,                       an online pharmacy.                                        revocation proceedings, among other things.



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                                        15610                Federal Register / Vol. 74, No. 64 / Monday, April 6, 2009 / Rules and Regulations

                                        practitioners who have a contractual                    such claim is flatly wrong. In fact, as                modification would be inconsistent
                                        relationship to issue prescriptions for                 explained earlier in this preamble, it has             with the public interest. 21 CFR
                                        controlled substances through referrals                 always been unlawful under the                         1301.19. The same statutory criteria
                                        from the Web site, and a certification                  Controlled Substances Import and                       used in determining the public interest
                                        that the Web site is acting in compliance               Export Act (CSIEA) (even prior to the                  for purposes of evaluating an
                                        with the Act. Accordingly, the Act                      Ryan Haight Act) to ship controlled                    application for registration—those
                                        should make it easier for consumers to                  substances into the United States for                  found in 21 U.S.C. 823(f)—will be used
                                        differentiate between legitimate and                    personal medical use. Any person who                   in evaluating an application for a
                                        illegitimate Web sites that sell                        ships controlled substances from abroad                modification of registration to operate as
                                        controlled substances.                                  into the United States illegally, along                an online pharmacy.
                                           One strong indicator of an unlawful                  with the person in the United States                      An online pharmacy must make a
                                        Web site is that it lets you as a customer              who places the order for such a                        separate thirty-day advance notice to the
                                        pick the controlled substance and then                  shipment and thereby causes the                        State boards of pharmacy in each State
                                        charges you a fee to arrange for a                      controlled substances to be illegally                  in which it intends to offer to sell,
                                        practitioner to prescribe that controlled               shipped into the United States, violates               deliver, distribute, or dispense
                                        substance to you. An unlawful Web site                  the CSIEA and is subject to criminal                   controlled substances.
                                        might further offer to refund all or part               prosecution.49                                            In accordance with 21 U.S.C. 831, the
                                        of your fee if you are not sold the                                                                            following information must be included
                                                                                                VIII. Regulatory Changes To Implement                  in the notification to DEA that must be
                                        prescription for your drug of choice. A
                                                                                                the Ryan Haight Act                                    submitted as part of the Application for
                                        Web site that engages in such practices
                                        is virtually certain to be a rogue Web                    This section summarizes the                          Modification of Registration:
                                        site that is not operating in compliance                regulations contained in this Interim                     • All Internet pharmacy site
                                        with the Ryan Haight Act.                               Rule, which are being issued to                        disclosure information as listed below.
                                           Consumers should also be aware that                  implement the Ryan Haight Act. This                       • A certification, under penalty of
                                        the Act also prohibits certain                          section should be viewed as merely a                   perjury, that the Internet pharmacy site
                                        advertising practices relating to the                   summary provided for the convenience                   disclosure information that is posted on
                                        types of criminal activities the Act is                 of the reader, and any registrant subject              the online pharmacy’s Web site is true
                                        designed to eliminate. Specifically, the                to the Ryan Haight Act should read                     and accurate.
                                        Act makes it a crime to place an                        carefully the entire preamble along with                  • A listing of all Internet Web site
                                        advertisement on the Internet that offers               the text of the regulations being issued               addresses (also known as the uniform
                                        to sell a controlled substance or a                     here.                                                  resource locator or URL) owned by the
                                        prescription for a controlled substance                                                                        online pharmacy to conduct its online
                                                                                                A. Notification and Registration
                                        in a manner that would be illegal (in                                                                          business activities.
                                        violation of the CSA or the CSIEA).48                      As provided in 21 CFR 1304.40, all                     • A certification that the online
                                        For example, the Act makes it unlawful                  online pharmacies that intend to                       pharmacy will notify DEA of any
                                        to place an advertisement on the                        dispense controlled substances by                      changes to any of its Internet Web site
                                        Internet stating: ‘‘Hydrocodone! No                     means of the Internet must provide DEA                 addresses (URLs) at least 30 days in
                                        Prescription Needed!’’ (or words to the                 with a thirty-day notice of such intent.               advance.
                                        same effect). This provision of the Act                 To do this, they must apply for a                         • The name, address, telephone
                                        also makes it illegal to place an                       modified registration via the online                   number, professional degree, DEA
                                        advertisement on the Internet that refers               application process. The Administrator                 registration numbers and States of
                                        consumers to a Web site that is                         must approve the application for a                     licensure of any practitioner who has a
                                        operating in violation of the Act (such                 modified registration and issue a                      contractual relationship to provide
                                        as one that sells controlled substances                 Certificate of Registration indicating the             medical evaluations or issue
                                        but is not properly registered with                     modification before the online                         prescriptions for controlled substances,
                                        DEA). This ban on illegal Internet                      pharmacy may engage in any activity of                 through referrals from the Web site or at
                                        advertising also applies to unsolicited                 an online pharmacy. As discussed                       the request of the owner or operator of
                                        commercial e-mail, which is sometimes                   previously in the preamble, the only                   the Web site, or any employee or agent
                                        referred to as ‘‘spam’’ or ‘‘junk e-mail.’’             entities that may apply for a modified                 thereof.
                                                                                                registration are registrants with a valid                 • The DEA registration numbers of
                                        Consequently, beginning on April 13,
                                                                                                Certificate of Registration (DEA Form                  each pharmacy that delivers, distributes,
                                        2009, if you as a consumer receive an
                                                                                                223) as a pharmacy. If you are not                     or dispenses controlled substances
                                        unsolicited commercial e-mail with the
                                                                                                registered with DEA as a pharmacy and                  pursuant to orders made on, through, or
                                        subject line: ‘‘Hydrocodone! No
                                                                                                you intend to dispense controlled                      on behalf of the online pharmacy.
                                        Prescription Needed!,’’ the sender of
                                                                                                substances by means of the Internet, you                  Pharmacies that intend to dispense
                                        that e-mail has violated the law.
                                                                                                must first apply for registration as a                 controlled substances by means of the
                                        Likewise, if you receive spam directing
                                                                                                pharmacy in accordance with 21 CFR                     Internet must apply for the modified
                                        you to a Web site that is operating in
                                                                                                1301.13. Upon receipt of the Certificate               registration using the online registration
                                        violation of the Act, the spammer has
                                                                                                of Registration as a pharmacy from the                 process by going to the DEA Office of
                                        also violated the Act.
                                                                                                Administrator, you may then apply for                  Diversion Control Web site at http://
                                           Consumers should also be wary of
                                                                                                a modification to your registration to                 www.deadiversion.usdoj.gov.
                                        rogue Web sites falsely claiming that
                                                                                                operate as an online pharmacy.                         Registrants must positively
                                        they are allowed to sell controlled
                                                                                                   The Administrator may deny an                       acknowledge and agree to several
                                        substances without complying with the
                                                                                                application for such registration or such              statements during the application
                                        Ryan Haight Act because they are
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                                                                                                modification of registration if the                    process. These acknowledgements will
                                        located outside the United States. Any
                                                                                                Administrator determines that the                      be printed on the registrant’s receipt of
                                          48 The exact wording of this provision is found in    issuance of such registration or                       registration for future reference. The
                                        21 U.S.C. 843(c)(2) and is recited above in this                                                               following is a list of the
                                        preamble.                                                 49 21   U.S.C. 952, 957, 960(a)(1).                  acknowledgments with which a


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                                                             Federal Register / Vol. 74, No. 64 / Monday, April 6, 2009 / Rules and Regulations                                            15611

                                        registrant must agree as part of the                       8. Pursuant to section 311(a) of the               Web site, under penalty of perjury, is true
                                        online pharmacy application process:                    Controlled Substances Act (21 U.S.C. 831(a)),         and accurate.
                                                                                                you, as an online pharmacy, agree to display            12. Pursuant to section 311(d) of the
                                           1. Pursuant to section 309(e) of the                 at all times on your homepage, in a visible           Controlled Substances Act (21 U.S.C. 831(d)),
                                        Controlled Substances Act (21 U.S.C. 829(e)),           and clear manner, a statement that your               you, as an online pharmacy, acknowledge
                                        you, as an online pharmacy, acknowledge                 online pharmacy complies with the                     and agree that, thirty days prior to offering
                                        and agree that no controlled substance that             requirements of section 311 of the Act (21            a controlled substance for sale, delivery,
                                        is a prescription drug may be delivered,                U.S.C. 831) with respect to the delivery or           distribution, or dispensing, you must notify
                                        distributed, or dispensed by means of the               sale or offer for sale of controlled substances.      the Administrator and the State boards of
                                        Internet without a valid prescription.                     9. Pursuant to section 311(b) of the               pharmacy in any States in which you offer
                                           2. Pursuant to 21 CFR 1306.09, you, as an            Controlled Substances Act (21 U.S.C. 831(b)),         to sell, deliver, distribute, or dispense
                                        online pharmacy, acknowledge and agree                  you, as an online pharmacy, acknowledge               controlled substances. By fully completing
                                        that a prescription for a controlled substance          and agree to comply with the requirements             and submitting this application, you will
                                        may only be dispensed by means of the                   of State law concerning the licensure of              satisfy this requirement with respect to
                                        Internet by a pharmacist, acting in the usual           pharmacies in each State from which and to            notifying the Administrator. However, you
                                        course of his professional practice, and                which you, deliver, distribute, or dispense, or       must separately notify the State boards of
                                        employed in a pharmacy whose registration               offer to deliver, distribute, or dispense             pharmacy as required by the Act. You
                                        has been modified to authorize it to operate            controlled substances by means of the                 understand that subsequent online pharmacy
                                        as an online pharmacy.                                  Internet.                                             registration renewals will be accomplished
                                           3. You, as an online pharmacy,                          10. Pursuant to section 311(c) of the              by the online process and the appropriate
                                        acknowledge and understand that you may                 Controlled Substances Act (21 U.S.C. 831(c)),         renewal fee will apply.
                                        not engage in any activity of an online                 you, as an online pharmacy, acknowledge                 13. You understand that in accordance
                                        pharmacy, as defined in 21 CFR 1300.04(h),              and agree to post the following Internet              with section 401(h) of the Act (21 U.S.C.
                                        until your application for modified                     Pharmacy Site Disclosure information in a             841(h)), as of April 13, 2009, it is unlawful
                                        registration to operate as an online pharmacy           visible and clear manner on the homepage of           for any online pharmacy to deliver,
                                        is granted and a Certificate of Registration            each Internet site you operate, or on a page          distribute, or dispense a controlled substance
                                        indicating the modification is issued by the            directly linked thereto in which the                  by means of the Internet unless such online
                                        Administrator (DEA Form 223).                           hyperlink is also visible and clear on the            pharmacy is validly registered with a
                                           4. You, as an online pharmacy, understand            homepage:                                             modification of DEA registration authorizing
                                        that the Administrator may deny an                         (A) The name and address of the pharmacy           the dispensing of controlled substances by
                                        application for a modification of registration          as it appears on the pharmacy’s DEA                   means of the internet.
                                                                                                                                                        14. Pursuant to section 311(e) of the
                                        if the Administrator determines that the                Certificate of Registration.
                                                                                                                                                      Controlled Substances Act (21 U.S.C. 831(e)),
                                        issuance of such modification would be                     (B) The pharmacy’s telephone number and
                                                                                                                                                      you, as an online pharmacy, understand and
                                        inconsistent with the public interest. In               e-mail address.
                                                                                                                                                      agree that on and after the date you apply for
                                        determining the public interest, the                       (C) Name of pharmacist-in charge,
                                                                                                                                                      a modified registration, you will display on
                                        Administrator considers the factors listed in           professional degree, States of licensure, and         your homepage, in the manner described in
                                        21 U.S.C. 823(f).                                       telephone number.                                     21 CFR 1304.40(d), a declaration that you
                                           5. Pursuant to section 303(f) of the                    (D) List of States in which the pharmacy           have made the required notifications to the
                                        Controlled Substances Act (21 U.S.C. 823(f)),           is licensed to dispense controlled substances.        DEA Administrator.
                                        you, as an online pharmacy, certify that you               (E) Certification that the pharmacy is
                                        are authorized by the appropriate state                 registered to deliver, distribute, or dispense           There is no fee to apply for
                                        authority(ies) to modify your existing DEA              by means of the Internet, controlled                  modification of an existing DEA
                                        registration to authorize you to dispense               substances.                                           registration. When a pharmacy makes
                                        schedule II–V controlled substances by                     (F) Practitioner’s name, address, telephone        application for a modified registration to
                                        means of the Internet.                                  number, professional degree, and States of            conduct business as an online
                                           6. Pursuant to 21 CFR 1301.19, if you, as            licensure of any practitioner who has a               pharmacy, and the Administrator issues
                                        an online pharmacy, cease to dispense                   contractual relationship to provide medical           a Certificate of Registration for the
                                        controlled substances by means of the                   evaluations or issue prescriptions for
                                        Internet, you acknowledge and agree that you            controlled substances, through referrals from
                                                                                                                                                      modification to that pharmacy, the
                                        shall promptly notify the Administrator by              the Web site or at the request of the owner           registration period continues from the
                                        modifying your registration to reflect the              or operator of the Web site, or any employee          date of the pharmacy’s prior
                                        appropriate business activity.                          or agent thereof.                                     registration. When, however, an online
                                           7. Pursuant to section 307(d) of the                    (G) The following statement: ‘‘This online         pharmacy makes application to renew
                                        Controlled Substances Act (21 U.S.C. 827(d)),           pharmacy is obligated to comply fully with            the modified registration, it will incur
                                        you, as an online pharmacy, understand you              the Controlled Substances Act and DEA                 the appropriate application fee and, if
                                        are required to report the dispensing of                regulations. As part of this obligation, this         approved, a new three-year registration
                                        controlled substances by means of the                   online pharmacy has obtained a modified               period will begin.
                                        Internet to the Administrator in the manner             DEA registration authorizing it to operate as            An online pharmacy that seeks to
                                        set forth in 21 CFR 1304.55. This report will           an online pharmacy. In addition, this online          discontinue its modification of
                                        include the total quantity of each controlled           pharmacy will only dispense a controlled
                                        substance that the pharmacy dispenses each              substance to a person who has a valid
                                                                                                                                                      registration authorizing it to dispense
                                        calendar month. The report must be                      prescription issued for a legitimate medical          controlled substances by means of the
                                        submitted to DEA electronically via online              purpose based upon a medical relationship             Internet, but continue its business
                                        reporting, electronic file upload, or other             with a prescribing practitioner. This includes        activity as a pharmacy, must so notify
                                        means as approved by DEA. The monthly                   at least one prior in-person medical                  the Administrator through the online
                                        report shall include the date range of the              evaluation in accordance with section 309 of          application process for modification of
                                        reporting period, the NDC, and total quantity           the Controlled Substances Act (21 U.S.C.              registration. The Administrator will
                                        of each controlled substance dispensed.                 829), or a medical evaluation via                     issue a new Certificate of Registration to
                                        Reporting shall include all controlled                  telemedicine in accordance with section               the pharmacy based on the changes
                                        substances dispensed via Internet                       102(54) of the Controlled Substances Act (21          made to its registration. Once the
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                                        transactions, mail-order, face-to-face                  U.S.C. 802(54)).’’
                                        transactions, or any other means. The report               11. Pursuant to section 311(d)(2)(A) of the
                                                                                                                                                      registration has been changed back to its
                                        shall be submitted to DEA by the 15th day               Controlled Substances Act (21 U.S.C.                  previous status (retail pharmacy), the
                                        of the following month. (For threshold                  831(d)(2)(A)), you, as an online pharmacy,            pharmacy is no longer authorized to
                                        amounts refer to DEA Web site: http://                  certify that the Internet Pharmacy Site               dispense controlled substances by
                                        www.deadiversion.usdoj.gov.)                            Disclosure information disclosed on your              means of the Internet.


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                                        15612                      Federal Register / Vol. 74, No. 64 / Monday, April 6, 2009 / Rules and Regulations

                                        B. Licensure                                              pursuant to orders made on, through, or               XYZ Pharmacy is licensed in [State(s)] to
                                                                                                  on behalf of, that Web site:                          dispense controlled substances. The
                                          An online pharmacy must comply                             • The name and address of the                      pharmacist-in-charge may be contacted at the
                                        with the requirements of State law                                                                              above telephone number. XYZ Pharmacy
                                                                                                  pharmacy as it appears on the                         does not have any contractual relationships
                                        concerning the licensure of pharmacies                    pharmacy’s DEA Certificate of                         with any practitioner to provide medical
                                        in each State from which it, and in each                  Registration.                                         evaluations or issue prescriptions for
                                        State to which it, delivers, distributes,                    • The pharmacy’s telephone number                  controlled substances through referrals from
                                        or dispenses or offers to deliver,                        and active business e-mail address.                   this Web site or at the request of the owner
                                        distribute, or dispense controlled                           • The name, professional degree, and               or operator of this Web site, or any employee
                                        substances by means of the Internet. 21                   States of licensure of the pharmacist-in-             or agent thereof. This online pharmacy is
                                        U.S.C. 831(b).                                            charge, and a telephone number at                     obligated to comply fully with the Controlled
                                                                                                                                                        Substances Act and DEA regulations. As part
                                        C. Online Pharmacy Internet Site                          which the pharmacist-in-charge can be                 of this obligation, this online pharmacy has
                                        Disclosure                                                contacted.                                            obtained a modified DEA registration
                                                                                                     • A list of the States in which the                authorizing it to operate as an online
                                           Online pharmacies have a continual                     pharmacy is licensed to dispense                      pharmacy. In addition, this online pharmacy
                                        obligation under the Ryan Haight Act to                   controlled substances.                                will only dispense a controlled substance to
                                        make certain disclosures on their Web                        • A certification that the pharmacy is             a person who has a valid prescription issued
                                        sites required by the Act. Consequently,                  registered under 21 CFR Part 1301 to                  for a legitimate medical purpose based upon
                                                                                                  deliver, distribute, or dispense                      a medical relationship with a prescribing
                                        an online pharmacy must maintain an
                                                                                                                                                        practitioner. This includes at least one prior
                                        active Web site to post the required                      controlled substances by means of the                 in-person medical evaluation in accordance
                                        information, statements, and other                        Internet.                                             with section 309 of the Controlled
                                        disclosures required by the Act and                          • The name, address, telephone                     Substances Act (21 U.S.C. 829) or a medical
                                        update the information as necessary.                      number, professional degree, and States               evaluation via telemedicine in accordance
                                                                                                  of licensure with State license number                with section 102(54) of the Controlled
                                        D. Statement of Compliance                                of any practitioner who has a                         Substances Act (21 U.S.C. 802(54)).
                                          The Act requires that each online                       contractual relationship to provide                   F. Declaration of Compliance
                                        pharmacy shall display, at all times and                  medical evaluations or issue
                                                                                                  prescriptions for controlled substances,                 On and after the date on which an
                                        in a visible and clear manner, on its                                                                           online pharmacy makes the notification
                                        homepage a statement that it complies                     through referrals from the Web site or at
                                                                                                  the request of the owner or operator of               and applies for a modified registration,
                                        with the requirements of section 311(a)                                                                         it must display, on the homepage of its
                                        of the Act (21 U.S.C. 831(a)) with                        the Web site, or any employee or agent
                                                                                                  thereof.                                              Web site, a declaration that it has made
                                        respect to the delivery or sale or offer for                                                                    such notification/application to the
                                        sale of controlled substances. This                          • The following statement: ‘‘This
                                                                                                  online pharmacy is obligated to comply                Administrator.
                                        requirement is reiterated in the
                                        regulations being issued here in 21 CFR                   fully with the Controlled Substances                  G. Reporting
                                        1304.45(a). This regulation does not                      Act and DEA regulations. As part of this
                                                                                                                                                           The Act requires,51 and 21 CFR
                                        require specific language to be used for                  obligation, this online pharmacy has
                                                                                                                                                        1304.55 reiterates, that each online
                                        this statement, but the statement must                    obtained a modified DEA registration
                                                                                                                                                        pharmacy must submit a monthly report
                                        include the name of the pharmacy as                       authorizing it to operate as an online
                                                                                                                                                        to the Administrator of the total
                                        displayed on its DEA Certificate of                       pharmacy. In addition, this online
                                                                                                                                                        quantity of each controlled substance it
                                        Registration and clearly state that the                   pharmacy will only dispense a
                                                                                                                                                        has dispensed the previous calendar
                                        pharmacy is in compliance with 21                         controlled substance to a person who
                                                                                                                                                        month. This report will be due on or
                                        U.S.C. 831(a). The following is an                        has a valid prescription issued for a
                                                                                                                                                        before the 15th day of the following
                                        example of a statement a pharmacy may                     legitimate medical purpose based upon
                                                                                                                                                        month. The report must include the
                                        post on its Web site that would meet the                  a medical relationship with a
                                                                                                                                                        total amount of such dispensing by any
                                        requirements of this provision:                           prescribing practitioner. This includes
                                                                                                                                                        means, including all controlled
                                                                                                  at least one prior in-person medical
                                          XYZ Pharmacy is in full compliance with                                                                       substances dispensed via Internet
                                                                                                  evaluation in accordance with section
                                        the requirements of section 311(a) of the                                                                       transactions, mail-order transactions,
                                                                                                  309 of the Controlled Substances Act
                                        Controlled Substances Act (21 U.S.C. 831(a))                                                                    face-to-face transactions, or any other
                                                                                                  (21 U.S.C. 829) or a medical evaluation
                                        with respect to the delivery or sale or offer                                                                   means. It is not required that the online
                                                                                                  via telemedicine in accordance with
                                        for sale of controlled substances.                                                                              pharmacy identify the means of the
                                                                                                  section 102(54) of the Controlled
                                                                                                                                                        dispensing in its report. The report is
                                                                                                  Substances Act (21 U.S.C. 802(54)).’’
                                        E. Internet Pharmacy Site Disclosure                                                                            required for every month in which the
                                                                                                     The following is a hypothetical
                                        Information                                                                                                     total amount of dispensing of controlled
                                                                                                  example of a statement that would
                                                                                                                                                        substances by the pharmacy is either (i)
                                           The Act 50 and the regulations being                   comply with all of the requirements of
                                                                                                                                                        over 100 prescriptions filled or (ii) 5,000
                                        issued here (21 CFR 1304.45(b)) require                   21 CFR 1304.45(b) (assuming the
                                                                                                                                                        or more dosage units dispensed of all
                                        that each online pharmacy shall post in                   assertions were true):
                                                                                                                                                        controlled substances combined.
                                        a visible and clear manner on the                         XYZ Pharmacy,                                            Each online pharmacy shall report a
                                        homepage of each Internet Web site it                     1 Main Street,                                        negative response to the Administrator
                                        operates, or on a page directly linked                    [City, State, zip code],                              if, during a given calendar month, its
                                        thereto in which the hyperlink is also                    [Area code and telephone number],                     total quantity of dispensing of
                                        visible and clear on the homepage, the                    pharmacist@xyzpharmacy.com.                           controlled substances falls below both
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                                        following information for each                            John H. Smith, R.Ph., Pharmacist-in-                  of the thresholds listed above.
                                        pharmacy that delivers, distributes, or                      Charge, licensed in State.                            The reporting required by online
                                        dispenses controlled substances                             The XYZ Pharmacy is in full compliance              pharmacies under 21 CFR 1304.55 must
                                                                                                  with the requirements of section 311(a) of the
                                          50 21   U.S.C. 831(c).                                  Controlled Substances Act (21 U.S.C. 831(a)).           51 21   U.S.C. 827(d)(2).



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                                                             Federal Register / Vol. 74, No. 64 / Monday, April 6, 2009 / Rules and Regulations                                         15613

                                        be submitted to the Administrator                       only pharmacies registered under 21                   addition, paragraph (d) requires that on
                                        electronically via online reporting,                    U.S.C. 823(f) may apply for such                      and after an online pharmacy makes
                                        electronic file upload, or other means as               modification.                                         notification under this section, it shall
                                        approved by DEA. The report shall                          To address the modification of                     display a declaration that it has done so.
                                        identify controlled substances by                       registration as an online pharmacy, the               Under § 1304.40(e), an online pharmacy
                                        National Drug Code (NDC) number                         table in § 1301.13(e)(1) is amended in                must notify the Administrator of any
                                        assigned to the product under the                       ‘‘(iv) Dispensing or instructing’’ to                 changes to the information submitted in
                                        National Drug Code System of the Food                   specify the application for an online                 its notification thirty days prior to the
                                        and Drug Administration.                                pharmacy. A comment has been added
                                                                                                                                                      change.
                                          Online pharmacies must maintain                       in the ‘‘Coincident activities allowed’’
                                        these records for at least two years. The               column to explain that an online                         New section 1304.45 specifies the
                                        information must be easily accessible                   pharmacy may perform the activities of                data elements required to be posted on
                                        and available for inspection by                         both a retail and online pharmacy.                    the Web site of online pharmacies in a
                                        authorized DEA employees.                                  New § 1301.19 (special requirements                visible and clear manner, as provided in
                                          A pharmacy that has changed its                       for online pharmacies) provides in                    the Act.
                                        registration status from that of an online              paragraphs (a), (c), and (f) that a                      To identify Web sites that are
                                        pharmacy back to a retail pharmacy                      pharmacy must request a modification
                                                                                                                                                      operating solely on behalf of DEA-
                                        remains responsible for submitting                      of its registration authorizing it to
                                                                                                                                                      registered nonpharmacy practitioners
                                        reports in accordance with § 1304.55 of                 operate as an online pharmacy by
                                        this chapter with respect to any                        completing the online application                     who are acting within the scope of their
                                        controlled substances that it dispensed                 process. This section also provides,                  registrations (and thereby exempt from
                                        while it was registered with a                          consistent with the Ryan Haight Act,                  the definition of an online pharmacy),
                                        modification authorizing it to operate as               that a pharmacy registrant may not                    new § 1304.50 requires such Web sites
                                        an online pharmacy.                                     operate as an online pharmacy until the               that dispense controlled substances by
                                                                                                DEA Administrator grants the modified                 means of the Internet to display in a
                                        IX. Section-by-Section Discussion of the                                                                      visible and clear manner a list of those
                                                                                                registration. Paragraph (b) requires,
                                        Interim Final Rule                                                                                            DEA-registered nonpharmacy
                                                                                                consistent with the Ryan Haight Act,
                                           In part 1300, new § 1300.04,                         that an online pharmacy must comply                   practitioners affiliated with the Web
                                        containing definitions relating to the                  with the pharmacy license requirements                site.
                                        dispensing of controlled substances by                  of not only the State where it is located,               New § 1304.55 implements the
                                        means of the Internet, is added. These                  but also of any State to which it
                                        definitions are from the definitions                                                                          requirement of the Act that each online
                                                                                                delivers, distributes, or dispenses
                                        contained in the Ryan Haight Act. This                                                                        pharmacy make a monthly report to
                                                                                                controlled substances. Paragraph (d)
                                        includes definitions of the terms                                                                             DEA stating the total quantity of each
                                                                                                requires a pharmacy that seeks to
                                        ‘‘covering practitioner,’’ ‘‘deliver,                   discontinue its authorization to operate              controlled substance the pharmacy has
                                        distribute or dispense by means of the                  as an online pharmacy to modify its                   dispensed the previous calendar month.
                                        Internet,’’ ‘‘filling new prescriptions for             registration to reflect this change in its            This report must include not only the
                                        controlled substances in Schedule III,                  business activity.                                    transactions made through the online
                                        IV, or V,’’ ‘‘homepage,’’ ‘‘in-person                      Section 1301.52, which addresses                   pharmacy, but also any that the
                                        medical evaluation,’’ ‘‘Internet,’’ ‘‘online            termination of registrations, is revised to           pharmacy made through mail order,
                                        pharmacy,’’ ‘‘practice of telemedicine,’’               include modification of registration                  face-to-face, or any other transaction
                                        ‘‘refilling prescriptions for controlled                within the meaning of the Act.                        when the pharmacy’s total dispensing of
                                        substances in Schedule III, IV, or V,’’                    Four new sections are added to 21                  controlled substances meets or exceeds
                                        ‘‘valid prescription,’’ and the temporary               CFR part 1304 (records and reports of                 the monthly threshold of either 100
                                        definition of ‘‘practice of telemedicine.’’             registrants) to implement the reporting               prescriptions filled or 5,000 or more
                                        However, please note that the                           requirements of the Ryan Haight Act for               dosage units dispensed. Online
                                        regulations being issued here expand                    online pharmacies, and to specify the                 pharmacies that do not meet this
                                        upon the exceptions to the definition of                information the Act requires to be                    threshold in a given month are required
                                        an online pharmacy contained in the                     posted on an online pharmacy’s Web                    to so notify DEA.
                                        Act. Specifically, as discussed above,                  site. New § 1304.40(a) requires online
                                        the regulations add two exceptions to                   pharmacies to notify the Administrator                   In part 1306 (prescriptions), new
                                        the definition of ‘‘online pharmacy’’:                  and State boards of pharmacy 30 days                  § 1306.09 includes requirements for
                                        One relating to electronic prescriptions                before offering to fill prescriptions for             prescriptions that track the
                                        for controlled substances issued in a                   controlled substances. Notification to                requirements of the Act. Paragraph (a)
                                        manner permitted by the DEA                             the DEA Administrator will be made by                 specifies that no controlled substance
                                        regulations and another relating to the                 applying for a modification of DEA                    may be delivered, distributed, or
                                        utilization by retail pharmacies of                     registration. Paragraph (b) of § 1304.40              dispensed by means of the Internet
                                        automated dispensing systems at long                    contains a list of items that must be                 without a valid prescription (using the
                                        term care facilities in a manner                        included in the notification. Paragraph               definition of a valid prescription
                                        permitted by the DEA regulations.                       (c) requires online pharmacies in                     contained in the Act). Also consistent
                                           In part 1301 (registration of                        operation at the time the Ryan Haight                 with the Act, paragraph (b) provides
                                        manufacturers, distributors, and                        Act becomes effective (April 13, 2009)                that a prescription may only be filled by
                                        dispensers of controlled substances),                   to make this notification by May 13,                  a pharmacy whose registration has been
                                        new § 1301.11(b) restates the                           2009, but this paragraph also makes                   modified as specified in the Act.
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                                        requirements of the Act that any person                 clear that, as of April 13, 2009, it is               Finally, paragraph (c) applies to online
                                        falling within the definition of an online              unlawful for any person to operate as an              pharmacies the requirements of sections
                                        pharmacy must be validly registered                     online pharmacy unless it has obtained                1306.15 and 1306.25 regarding transfers
                                        with a modification authorizing it to                   from DEA a modification of its                        of prescriptions between pharmacies.
                                        operate as an online pharmacy and that                  registration authorizing it to do so. In


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                                        15614                  Federal Register / Vol. 74, No. 64 / Monday, April 6, 2009 / Rules and Regulations

                                        X. Regulatory Certifications                              immediately while at the same time the                site is largely the same as that required
                                                                                                  agency is seeking public comment on                   for the notification, so the pharmacist’s
                                        A. Administrative Procedure Act
                                                                                                  them.                                                 work will also provide the information
                                           The Administrative Procedure Act                          Under the APA, 5 U.S.C. 553(d),                    needed for the Web site.
                                        (APA) generally requires agencies to                      agencies must generally provide a 30-                    Since an online pharmacy must have
                                        publish a notice of proposed rulemaking                   day delayed effective date for final                  a Web site to operate, the initial cost of
                                        and allow for a period of public                          rules. An agency may dispense with the                setting up the Web site is not a cost of
                                        comment prior to implementing new                         30-day delayed effective date                         the rule. (In fact, it is now commonplace
                                        rules. The APA also provides, however,                    requirement ‘‘for good cause found and                for even small retail establishments to
                                        that agencies can be excepted from these                  published with the rule.’’ 5 U.S.C.                   have Web sites.) The only cost is that of
                                        requirements ‘‘when the agency for good                   553(d)(3). For the reasons just                       entering the required information and
                                        cause finds (and incorporates the                         discussed, DEA concludes that such                    certifications on the site. Given that the
                                        finding and a brief statement of reasons                  good cause exists to justify an                       site is already, or must be, in place, DEA
                                        therefor in the rules issued) that notice                 immediate effective date. In addition to              estimates that such revisions will be
                                        and public procedure thereon are                          the reasons provided above, DEA had to                relatively minor in nature. Modification
                                        impracticable, unnecessary, or contrary                   make this rule effective immediately to               of the Web site to include the required
                                        to the public interest.’’ 5 U.S.C.                        have in place regulatory procedures that              information will, however, require
                                        553(b)(B). DEA has concluded that                         will allow legitimate pharmacies that                 additional work—work that requires
                                        ‘‘good cause’’ exists to promulgate this                  wish to conduct activity as an ‘‘online               some technical expertise with computer
                                        rule as an Interim Final Rule rather than                 pharmacy’’ to do so upon the effective                systems and programs, including Web
                                        a proposed rule for the following                         date of the Act. With the immediate                   sites. DEA expects that a computer
                                        reasons.                                                  effective date of these regulations,                  support specialist (SOC 15–1041) will
                                           As explained above, the Ryan Haight                    pharmacies may, sufficiently in advance               be required for this work.
                                        Act contains the following provision                      of the effective date of the Act, submit                 Completion of the online application
                                        specifically addressing the issuance of                   applications to modify their                          for modification of registration will
                                        interim rules to implement the Act:                       registrations as required by the Act.                 require fifteen minutes of the
                                                                                                                                                        pharmacist’s time and half an hour of
                                           The [DEA Administrator] may promulgate                 B. Executive Order 12866                              the computer support specialist’s time
                                        and enforce any rules, regulations, and
                                        procedures which may be necessary and
                                                                                                     The Deputy Administrator certifies                 to update the Web site with the required
                                        appropriate for the efficient execution of                that this rulemaking has been drafted in              information. The Web site will require
                                        functions under this Act or the amendments                accordance with the principles in                     ongoing maintenance as information
                                        made by this Act, and, with the concurrence               Executive Order 12866 Section 1(b). It                changes. This will require one hour per
                                        of the Secretary of Health and Human                      has been determined that this is ‘‘a                  year of the computer-support
                                        Services where this Act or the amendments                 significant regulatory action.’’                      specialist’s time.
                                        made by this Act so provide, promulgate any               Therefore, this action has been reviewed                 Section 1304.55 requires online
                                        interim rules necessary for the                           by the Office of Management and                       pharmacies to report to DEA the total
                                        implementation of this Act or the                         Budget. As discussed above, this action               quantity of each controlled substance
                                        amendments made by this Act, prior to its
                                                                                                  is largely codifying statutory provisions             that the pharmacy has dispensed each
                                        effective date.52
                                                                                                  and involves limited agency discretion.               calendar month. The report must
                                           It is evident from the foregoing                          Costs. It should be noted that the costs           include the total quantity of such
                                        provision that Congress envisioned that                   identified here are costs associated with             dispensing by any means, regardless of
                                        DEA might need to issue regulations on                    activities that online pharmacies are                 whether the controlled substances are
                                        an interim basis to implement the Ryan                    obligated to carry out to comply with                 dispensed by means of the Internet.
                                        Haight Act prior to the Act’s effective                   the statutory requirements of the Ryan                Such reporting is required for every
                                        date (April 13, 2009). This provision                     Haight Act. The regulatory provisions                 calendar month in which the total
                                        indicates that, given the 180 days                        listed here are those which carry                     quantity of controlled substances
                                        between enactment of the Act and its                      forward the statutory requirements                    dispensed by the pharmacy meets or
                                        effective date, Congress recognized it                    mandated by the Act.                                  exceeds one of the following thresholds:
                                        could be impracticable for DEA to                            Pharmacies with existing online                    100 or more prescriptions for controlled
                                        complete notice-and-comment                               operations and those that wish to begin               substances filled; or 5,000 or more
                                        rulemaking within a time frame that                       dispensing controlled substances by                   dosage units dispensed of all controlled
                                        would have allowed for regulations to                     means of the Internet must apply to                   substances combined.
                                        become effective prior to the effective                   DEA to modify their registrations.                       Such reporting is not required now
                                        date of the Act. Similarly, this provision                Section 1304.40 requires notification to              from pharmacies of any kind. Based
                                        indicates that Congress believed it                       DEA. The application for modification                 upon common industry practice, DEA
                                        would be contrary to the public interest                  of registration includes the notifications            believes that virtually all pharmacies
                                        to delay the promulgation of regulations                  required by the Act; application to DEA               will have internal electronic
                                        in a manner that would prevent                            is made with an online form. The                      recordkeeping systems which will
                                        implementation of the Act upon its                        information required is straightforward:              include the necessary data. A computer
                                        effective date. Delaying the effective                    Names, addresses, telephone numbers,                  programmer (SOC 15–1021) will be
                                        date of the regulations past the effective                the name, professional degree, and                    required to set up a system that will
                                        date of the Act would also be confusing                   telephone number of the pharmacist-in-                extract the required data from existing
                                        to the public and would frustrate the                     charge, and required certifications.                  records and put it in a form that meets
                                        intent of Congress to have the new                           Assembly of this information and                   the rule and is suitable for transmission
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                                        provisions of the Act take effect on                      putting it in the online form in the                  to DEA. DEA estimates that the initial
                                        April 13, 2009. Accordingly, the rules                    proper manner can be accomplished by                  set-up will take two hours of the
                                        published here are effective                              a pharmacist (Standard Occupational                   programmer’s time. DEA expects that
                                                                                                  Code (SOC) 29–1051). The information                  maintenance of the reporting system
                                          52 Public   Law 110–425, sec. 3(k)(1).                  required for the online pharmacy Web                  will not entail any increment in cost


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                                                                   Federal Register / Vol. 74, No. 64 / Monday, April 6, 2009 / Rules and Regulations                                                                                                    15615

                                        beyond the initial work of setting up the                                  month to transmit the monthly report to
                                        system. DEA further assumes that a                                         DEA.
                                        pharmacist will require ten minutes per                                     Table 1 presents initial unit costs.

                                                                                                                            TABLE 1—INITIAL UNIT COSTS
                                                                                                                                                                                                 Unit time                 Hourly wage,
                                                                                                    Requirement                                                                                                                                       Unit cost
                                                                                                                                                                                                 (in hours)                 fully loaded

                                        Application for Modification of Registration (pharmacist) ..........................................................                                                   0.25                 $104.40                $26.10
                                        Revision of pharmacy Web site (computer support specialist) .................................................                                                          0.5                    47.79                 23.89
                                        Establishing reporting system (programmer) ............................................................................                                                2.0                    75.96                151.93

                                             Total ....................................................................................................................................     ..........................   ........................          201.92



                                          Annual ongoing costs for online                                          Act. As noted previously, DEA assumes                                          time for those modifications and two
                                        pharmacies comprise the cost of filing                                     that Web site modifications can be                                             hours a year for the pharmacist to file
                                        monthly reports with DEA and revising                                      handled by a computer support                                                  the reports. Table 2 presents annual
                                        the pharmacy Web site as needed to                                         specialist. DEA assumes one hour per                                           ongoing costs for online pharmacies.
                                        comply with the requirements of the                                        year of a computer support specialist’s

                                                                                                                      TABLE 2—ANNUAL ONGOING COSTS
                                                                                                                                                                                                  Unit time                Hourly wage,
                                                                                                     Requirement                                                                                                                                      Unit cost
                                                                                                                                                                                                  (in hours)                fully loaded

                                        Pharmacy Web site modification (computer support specialist) .................................................                                                           1.0                     $47.79            $47.79
                                        Sending monthly report to DEA (pharmacist) .............................................................................                                                 2.0                     104.40            208.80

                                             Total ......................................................................................................................................     ........................   ........................          256.59



                                           Total costs. To estimate total costs, it                                retail pharmacies. DEA estimates an                                                  TABLE 4—UNDISCOUNTED TOTAL
                                        is necessary to estimate the number of                                     annual attrition rate of 2.0 percent for                                                       COSTS
                                        firms that will seek to modify their                                       online pharmacies. The table below
                                        registration to that of online pharmacies.                                 shows the estimated number of online                                                                   Initial         Ongoing        Total
                                        DEA estimates that 250 pharmacies will                                     pharmacy registrations and registrants
                                        initially apply for such modification of                                   in operation, year by year.                                                    Year     1 .....       $50,480           $64,147      $114,628
                                        registration. It is also necessary to                                                                                                                     Year     2 .....         6,058            70,562        76,620
                                                                                                                                                                                                  Year     3 .....         5,048            75,566        80,614
                                        estimate the number of pharmacies that                                              TABLE 3—ONLINE PHARMACY                                               Year     4 .....         4,038            79,186        83,225
                                        will apply for such modification of                                                        REGISTRANTS                                                    Year     5 .....         4,038            82,734        86,773
                                        registration in the future. DEA estimates                                                                                                                 Year     6 .....         2,019            83,646        85,665
                                        that there would be a moderate number                                                                                        Registrants in               Year     7 .....         2,019            84,538        86,558
                                                                                                                                        Registrations
                                        of registrants applying to modify their                                                                                       operation                   Year     8 .....         2,019            85,414        87,433
                                        registrations in the two years after the                                                                                                                  Year     9 .....         1,817            86,015        87,832
                                        first year as some other pharmacies find                                   Year     1 ...                         250                             250     Year     10 ...          1,615            86,347        87,962
                                                                                                                   Year     2 ...                          30                             275     Year     11 ...          1,413            86,416        87,830
                                        advantage in an online presence. After
                                                                                                                   Year     3 ...                          25                             295     Year     12 ...          1,212            86,227        87,439
                                        that, DEA estimates the number of                                                                                                                         Year     13 ...          1,010            85,786        86,795
                                        pharmacies applying to modify their                                        Year     4 ...                          20                             309
                                                                                                                                                                                                  Year     14 ...          1,010            85,353        86,363
                                        registrations will decline steadily, as                                    Year     5 ...                          20                             322
                                                                                                                                                                                                  Year     15 ...          1,010            84,929        85,939
                                                                                                                   Year     6 ...                          10                             326
                                        few pharmacies will find benefit. Each
                                                                                                                   Year     7 ...                          10                             329
                                        year it is expected that a number of                                                                                                                        Table 5 shows the present value and
                                                                                                                   Year     8 ...                          10                             333
                                        registrants applying to modify their                                                                                                                      annualized cost at 7.0 percent and 3.0
                                                                                                                   Year     9 ...                           9                             335
                                        registrations may drop out for various                                                                                                                    percent discount rates, over fifteen
                                                                                                                   Year     10                              8                             337
                                        reasons. The total number of pharmacies                                                                                                                   years.
                                                                                                                   Year     11                              7                             337
                                        in the United States has been declining.                                   Year     12                              6                             336
                                        Data from the Economic Census indicate                                     Year     13                              5                             334
                                                                                                                                                                                                         TABLE 5—PRESENT VALUE AND
                                        that the number of retail pharmacies fell                                  Year     14                              5                             333                 ANNUALIZED COSTS
                                        at an annual rate of 1.7 percent from                                      Year     15                              5                             331
                                        1998 through 2006.53 DEA estimates                                                                                                                                                                   7.0           3.0
                                        that the number of online pharmacy                                                                                                                                                                 Percent       Percent
                                        registrants will decline at a slightly                                       To obtain undiscounted costs, year by
                                                                                                                   year, the unit cost estimates—$201.92                                          Year     1   .......................     $114,628     $114,628
                                        faster rate, because some pharmacies                                                                                                                      Year     2   .......................       71,607       74,388
                                        will drop their online pharmacy                                            for initial start-up, $256.59 for ongoing
                                                                                                                                                                                                  Year     3   .......................       70,411       75,986
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                                        registrations but stay in business as                                      costs—are applied, respectively, to the                                        Year     4   .......................       67,936       76,162
                                                                                                                   number of online pharmacy                                                      Year     5   .......................       66,198       77,096
                                          53 Economic Census, Statistics of U.S. Businesses,
                                                                                                                   registrations and the number of                                                Year     6   .......................       61,078       73,895
                                        2006, available at http://www.census.gov/epcd/                             operating registrants in each year. The                                        Year     7   .......................       57,677       72,491
                                        susb/latest/us/US44.HTM#N446.                                              results are shown in the following table.                                      Year     8   .......................       54,449       71,091



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                                        15616                      Federal Register / Vol. 74, No. 64 / Monday, April 6, 2009 / Rules and Regulations

                                            TABLE 5—PRESENT VALUE AND                               with enhanced tools to determine the                  prescriptions for controlled substances
                                            ANNUALIZED COSTS—Continued                              legitimacy of the online pharmacy.                    in schedule III, IV, or V, as defined in
                                                                                                                                                          paragraph [21 U.S.C. 802(55)] or (II)
                                                                                                    C. Regulatory Flexibility Act
                                                                             7.0         3.0                                                              filling new prescriptions for controlled
                                                                           Percent     Percent         The Deputy Administrator hereby                    substances in schedule III, IV, or V, as
                                                                                                    certifies that this rulemaking has been               defined in paragraph [21 U.S.C.
                                        Year   9 .......................    51,119        69,335    drafted in accordance with the                        802(56)].’’ Also, the regulations being
                                        Year   10 .....................     47,846        67,416    Regulatory Flexibility Act (RFA) (5
                                        Year   11 .....................     44,648        65,354                                                          issued here exempt from the definition
                                                                                                    U.S.C. 601–612). The RFA applies to a                 of online pharmacy any registered
                                        Year   12 .....................     41,542        63,168
                                        Year   13 .....................     38,538        60,877    rule that is published by the agency as               pharmacy ‘‘whose delivery, distribution,
                                        Year   14 .....................     35,837        58,809    a notice of proposed rulemaking. As                   or dispensing of controlled substances
                                        Year   15 .....................     33,328        56,816    explained above, the Ryan Haight Act                  by means of the Internet consists solely
                                                                                                    expressly contemplates that DEA will                  of * * * filling prescriptions that were
                                             Total ...................     856,843    1,077,511     issue interim rules under the ‘‘good                  electronically prescribed in a manner
                                                                                                    cause’’ provision of the APA as the                   authorized by this chapter and
                                             Annualized .........           94,077        90,259    agency deems necessary to implement                   otherwise in compliance with the Act.’’
                                                                                                    the Act prior to its effective date (April            Given these exceptions to the definition
                                           The costs are relatively modest; the                     13, 2009). Thus, Congress has expressly
                                        annualized sum of the present values is                                                                           of an online pharmacy, DEA anticipates
                                                                                                    granted DEA authority to issue                        that the overwhelming majority of
                                        less than $100,000 at both discount                         regulations to implement the Act that
                                        rates. Further, Table 4 shows that the                                                                            pharmacies in the United States, if they
                                                                                                    become effective immediately without                  follow their current practices, will not,
                                        undiscounted annual cost never exceeds                      the requirement of first seeking public
                                        $100,000 after the first year with its                                                                            as of April 13, 2009, fall within the
                                                                                                    comment through a notice of proposed                  definition of an online pharmacy.
                                        relatively large number of registrations.                   rulemaking. Consequently, the
                                           Benefits. The Ryan Haight Online                         requirements of the RFA do not apply                     Further, as DEA stated previously, as
                                        Pharmacy Consumer Protection Act is                         to this rule.                                         long as the pharmacist meets his
                                        designed to save lives by reducing                             It also should be noted that only a                corresponding responsibility to take
                                        deaths from drug overdoses and                              limited portion of the regulatory text                reasonable steps under the
                                        otherwise lessen the detrimental                            being issued here is subject to                       circumstances of the dispensing of any
                                        consequences of pharmaceutical                              modification following the comment                    particular prescription to ensure that the
                                        controlled substance abuse by                               period as the bulk of the regulatory text             prescription was issued in accordance
                                        restricting the ability of rogue Internet                   is taken verbatim from, and mandated                  with the requirements of the Ryan
                                        pharmacies to illegally divert dangerous                    by, the Ryan Haight Act. DEA is seeking               Haight Act (as well as all other
                                        controlled substance prescription drugs                     public comment with respect to those                  applicable requirements of the CSA and
                                        to millions of people, including teens,                     parts of the regulatory text about which              DEA regulations), the pharmacist will
                                        without valid prescriptions issued                          the agency has discretion.                            not be held strictly liable for filling a
                                        under a legitimate physician’s care.54                         Although the RFA does not apply to                 prescription that he could not
                                        The regulations promulgated based on                        this Interim Final Rule, DEA has                      reasonably have known was issued by
                                        this legislation will address the ‘‘wide-                   reviewed the potential impacts. The rule              means of the Internet. Thus, it is
                                        open channel of distribution’’ that                         is likely to affect a substantial number              absolutely unnecessary for a pharmacy
                                        currently exists for prescription                           of small entities, but DEA does not                   to apply for a modification of its DEA
                                        controlled substances sold over the                         believe that it will have a significant               registration authorizing it to operate as
                                        Internet, which represents an ‘‘easy                        economic impact on small entities.                    an online pharmacy for the sole purpose
                                        availability [that] has enormous                               DEA is uncertain which pharmacies                  of ensuring that it does not—despite the
                                        implications for public health,                             will apply to modify their registrations              exercise of sound professional
                                        particularly the health of our children.55                  to that of online pharmacies. While it is             judgment—inadvertently fill a
                                        A key provision of this law, the                            possible that such applicants will be a               prescription that was issued by means
                                        requirement for practitioners to conduct                    mixture of independent pharmacies and                 of the Internet.
                                        at least one in-person medical                              chains, DEA believes it unlikely that                    The small-business size standard for
                                        evaluation of the patient before they                       many chain pharmacies will fall within                retail pharmacies is annual revenue of
                                        prescribe a prescription for a controlled                   the definition of an online pharmacy                  $7.0 million.56 From the 2002 Economic
                                        substance, is a major step toward                           and thereby need to apply for the                     Census, there are data on revenue of
                                        combating the use of the Internet to                        modified registration. As discussed                   pharmacies by revenue class. The class
                                        facilitate illegal sales of pharmaceutical                  previously, the Ryan Haight Act                       with the lowest average revenue is
                                        controlled substances. Also, requiring                      contains several exceptions to the                    pharmacies with sales of less than
                                        online pharmacies to post the required                      definition of ‘‘online pharmacy’’                     $250,000 per year. Average revenue for
                                        site disclosure information,                                including the exception set forth in 21               this group is $132,000. Table 6 shows
                                        certifications, and other information on                    U.S.C. 802(52)(B)(viii) that excludes                 Small Business Administration
                                        their homepage provides consumers                           from the definition of an online                      standards for these and larger firms that
                                          54 Office of National Drug Control Policy, Press
                                                                                                    pharmacy those DEA-registered                         dispense controlled substances.
                                        Release, March 1, 2008, available at http://                pharmacies ‘‘whose dispensing of
                                        www.ondcp.gov/pda/030108.html.                              controlled substances via the Internet                  56 Small Business Administration, Table of Small
                                          55 S. Rep. No. 110–521, at 68 (2008).                     consists solely of * * * (I) refilling                Business Size Standards, August 22, 2008.
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                                                                     Federal Register / Vol. 74, No. 64 / Monday, April 6, 2009 / Rules and Regulations                                                                                    15617

                                                                                                            TABLE 6—SBA DEFINITIONS OF SMALL ENTITIES
                                                                                                                                                                                                                                          Small
                                                                                                                                                                                                                                        business
                                                                                                               Industry description                                                                                     NAICS code      definition
                                                                                                                                                                                                                                       (sales in $)

                                        Pharmacies and Drug Stores ..................................................................................................................................                        446110       7,000,000
                                        Supermarkets and Other Grocery Stores ................................................................................................................                               445110      27,000,000
                                        Discount Department Stores ...................................................................................................................................                       452112      27,000,000
                                        Warehouse Clubs and Supercenters ......................................................................................................................                              452910      25,000,000
                                        Mail Order Houses ...................................................................................................................................................                454113      25,000,000



                                          DEA estimates the annual cost of                                          a 15-year stream of ongoing costs and                                        annualized cost of about $275. Even for
                                        compliance with the Interim Final Rule                                      the initial start-up cost. Table 7 shows                                     the smallest pharmacies, that is not a
                                        for an individual pharmacy is the                                           these values for 7.0 percent and 3.0                                         significant economic impact.57
                                        annualized sum of the present value of                                      percent discount rates. The result is

                                                                                                    TABLE 7—ANNUALIZED COST FOR AN ONLINE PHARMACY
                                                                                                                                                                                                                        7.0 Percent    3.0 Percent

                                        Annual Ongoing Cost ..............................................................................................................................................                   $256.59       $256.59
                                        PV of Ongoing Cost .................................................................................................................................................                2,337.00       3,063.15
                                        Initial Cost ................................................................................................................................................................         201.92         201.92
                                        Sum of PV and Initial Cost ......................................................................................................................................                   2,538.92       3,265.07
                                        Annualized Cost .......................................................................................................................................................               278.76         273.50



                                        D. Paperwork Reduction Act                                                  State licensure information should be                                          DEA estimates that 250 pharmacies
                                           The Ryan Haight Act requires                                             readily available as well.                                                   will apply to modify their registrations
                                        pharmacies that dispense controlled                                            DEA believes that very few legitimate                                     to that of online pharmacies. DEA
                                        substances by means of the Internet to                                      pharmacies (i.e., those that comply with                                     estimates that it will take a pharmacy 15
                                        obtain a modification of their existing                                     the law) will be affiliated with more                                        minutes (0.25 hours) to complete an
                                        DEA registration to that of an online                                       than one Web site. Nor does it seem                                          Application for Modification of
                                        pharmacy (21 U.S.C. 823(f), 21 CFR                                          likely that such pharmacies will have                                        Registration for Online Pharmacies
                                        1301.11). To address this, DEA is                                           contractual relationships with                                               (DEA Form 224c), and that it will take
                                        revising its existing information                                           practitioners to issue prescriptions for                                     an online pharmacy 15 minutes (0.25
                                        collection, ‘‘Application for Registration                                  controlled substances through referrals                                      hours) to renew its online pharmacy
                                        (DEA Form 224), Application for                                             from the Web site or at the request of the                                   registration. DEA notes that the
                                        Registration Renewal (DEA Form 224a),                                       owner or operator of the Web site, or                                        Application for Modification of
                                        Affidavit for Chain Renewal (DEA Form                                       any employee or agent thereof. Thus,                                         Registration for Online Pharmacies
                                        224b)’’ [information collection 1117–                                       DEA believes that the reporting of this                                      (DEA Form 224c) is completed and
                                        0014] to add an Application for                                             type of information should be minimal,                                       submitted online through the DEA
                                        Modification of Registration for Online                                     if at all, and will not be burdensome for                                    Office of Diversion Control Web site.
                                        Pharmacies (DEA Form 224c). This form                                       the vast majority of the limited number                                      Because those applying for a
                                        will be completed online by pharmacies                                      of pharmacies likely to apply to modify                                      modification of registration must
                                        requesting to modify their registrations                                    their registrations.                                                         already be registered with DEA, the
                                        to that of an online pharmacy.                                                 DEA believes that the certifications                                      overall number of respondents will not
                                           Application for modification of                                          required of the online pharmacies are                                        change. To account for the new
                                        registration—The application for                                            straightforward and can easily be                                            requirement, the number of respondents
                                        modification of registration will require                                   included on pharmacies’ Web sites and                                        using DEA–224a has been reduced by
                                        an online pharmacy applicant to                                             reported to DEA. DEA has provided                                            the 250 respondents DEA estimates will
                                        provide to DEA certain information, as                                      examples of those certifications for                                         apply for a modification using DEA–
                                        discussed above. For purposes of this                                       potential use by pharmacies applying to                                      224c. As a result, the total burden for
                                        reporting, DEA believes that the Internet                                   modify their registrations.                                                  DEA–224a has been reduced by 16.7
                                        Pharmacy Site Disclosure information                                           While the new reporting and                                               hours. DEA estimates that DEA–224c
                                        that applicants must supply will be                                         application requirements will request                                        will have a total of 62.5 burden hours
                                        immediately obtainable with minimal                                         information not previously requested by                                      for an overall increase of 46.2 burden
                                        effort. Information such as the                                             DEA (as the Ryan Haight Act mandates),                                       hours.
                                        pharmacy’s name, registration number,                                       DEA believes that much of the                                                  Reports of dispensing of controlled
                                        and contact information will be                                             information required to be provided as                                       substances by online pharmacies—The
                                        populated by DEA on the online form                                         part of the applications is readily                                          Ryan Haight Act requires those
                                        completed by the pharmacy applicant.                                        available and retrievable, thus limiting                                     pharmacies with modified registrations
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                                        Contact information for the pharmacist-                                     the impact of the burden for completion                                      to report certain information regarding
                                        in-charge should be readily available.                                      of this application.                                                         their dispensing of controlled


                                          57 Economic Census, Establishment and Firm

                                        Size, 2002, Table 4.


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                                        15618                Federal Register / Vol. 74, No. 64 / Monday, April 6, 2009 / Rules and Regulations

                                        substances to DEA. Specifically, online                    The Department of Justice, Drug                                (2) Title of the Form/Collection:
                                        pharmacies are required to report to                    Enforcement Administration, has                                   Application for Registration (DEA
                                        DEA the total quantity of controlled                    submitted the following information                             Form 224);
                                        substances that the pharmacy has                        collection requests to the Office of                              Application for Registration Renewal
                                        dispensed during each calendar month                    Management and Budget (OMB) for                                 (DEA Form 224a);
                                        by any means, regardless of whether the                 review and clearance in accordance                                Affidavit for Chain Renewal (DEA
                                        controlled substances are dispensed by                  with the review procedures of the                               Form 224b);
                                        means of the Internet. Reports are                      Paperwork Reduction Act of 1995. The
                                                                                                                                                                  Application for Modification of
                                        required to be filed by every pharmacy                  information collections are published to
                                                                                                                                                                Registration for Online Pharmacies
                                        that, at any time during a calendar                     obtain comments from the public and
                                                                                                                                                                (DEA Form 224c)
                                        month, holds a modified registration                    affected agencies.
                                        authorizing it to operate as an online                     All comments and suggestions, or                               (3) Agency form number, if any, and
                                        pharmacy, regardless of whether the                     questions regarding additional                                  the applicable component of the
                                        online pharmacy dispenses any                           information, to include obtaining a copy                        Department of Justice sponsoring the
                                        controlled substances by means of the                   of the proposed information collection                          collection:
                                        Internet during the month. Reports are                  instrument with instructions, should be                           Form Number: DEA Form 224, 224a,
                                        required when the total quantity of                     directed to Mark W. Caverly, Chief,                             224b, 224c;
                                        controlled substances dispensed meets                   Liaison and Policy Section, Office of                             Component: Office of Diversion
                                        or exceeds either 100 or more                           Diversion Control, Drug Enforcement                             Control, Drug Enforcement
                                        prescriptions for controlled substances                 Administration, 8701 Morrissette Drive,                         Administration, U.S. Department of
                                        filled, or 5,000 or more dosage units                   Springfield, VA 22152, Telephone (202)                          Justice.
                                        dispensed of all controlled substances                  307–7297.                                                         (4) Affected public who will be asked
                                        combined, in the calendar month for                        Written comments and suggestions                             or required to respond, as well as a brief
                                        which reporting is required. If a                       from the public and affected agencies                           abstract:
                                        pharmacy fills fewer than 100                           concerning the required collections of                            Primary: Business or other for-profit.
                                        prescriptions for controlled substances,                information are encouraged. Your                                  Other: Not-for-Profit Institutions;
                                        and dispenses fewer than 5,000 dosage                   comments on the information                                     State, Local or Tribal Government.
                                        units of all controlled substances                      collection-related aspects of this rule                           Abstract: All firms and individuals
                                        combined, in the calendar month for                     should address one or more of the                               who distribute or dispense controlled
                                        which reporting is required, a negative                 following four points:                                          substances must register with the DEA
                                        response indicating that reporting is not                  • Evaluate whether the collection of
                                                                                                                                                                under the Controlled Substances Act.
                                        required must be received by DEA.                       information is necessary for the proper
                                                                                                                                                                Pharmacies wishing to be online
                                        Thus, each online pharmacy will report                  performance of the functions of the
                                                                                                                                                                pharmacies must apply to modify their
                                        every month to DEA, either by                           agency, including whether the
                                        providing actual dispensing information                                                                                 registrations. Such registration is
                                                                                                information will have practical utility.
                                        or by providing a negative response.                       • Evaluate the accuracy of the                               mandatory under the law and needed
                                           DEA believes that, of the limited                    agency’s estimate of the burden of the                          for control measures over legal handlers
                                        number of pharmacies expected to be                     proposed collection of information,                             of controlled substances and to monitor
                                        subject to the reporting requirement of                 including the validity of the                                   their activities.
                                        the Act, few are likely to submit                       methodology and assumptions used.                                 (5) An estimate of the total number of
                                        negative responses. It is reasonable to                    • Recommendations to enhance the                             respondents and the amount of time
                                        assume that online pharmacies subject                   quality, utility, and clarity of the                            estimated for an average respondent to
                                        to the reporting requirement will either                information to be collected.                                    respond is provided in the table below.
                                        fill 100 or more prescriptions for                         • Recommendations to minimize the                            Please note that the number of
                                        controlled substances, or 5,000 or more                 burden of the collection of information                         respondents using DEA–224a has been
                                        dosage units of all controlled substances               on those who are to respond, including                          reduced by the 250 respondents that
                                        combined, in any calendar month.                        through the use of appropriate                                  DEA estimates will apply for a
                                        Therefore, DEA has assumed for                          automated, electronic, mechanical, or                           modification using DEA–224c. Because
                                        purposes of these estimates that all                    other technological collection                                  those applying for a modification of
                                        online pharmacies will report                           techniques or other forms of information                        registration must be currently registered
                                        dispensing information to DEA.                          technology, e.g., permitting electronic                         with DEA, the overall number of
                                           DEA estimates that 250 online                        submission of responses.                                        respondents will not increase. The total
                                        pharmacies will file monthly reports                       Overview of information collection                           response time has increased by 46.2
                                        with DEA regarding their dispensing of                  1117–0014:                                                      hours as a result of the 11 additional
                                        controlled substances. DEA estimates                       (1) Type of Information Collection:                          minutes it is estimated it will take each
                                        that it will take each pharmacy 10                      Revision of a currently approved                                respondent to complete DEA–224c as
                                        minutes to file this report.                            collection.                                                     compared to DEA–224a.

                                                                                                                                                 Number of                                                 Total
                                                                  Form                                             Completed                                          Time per response
                                                                                                                                                respondents                                             (in hours)

                                        Application for Registration (DEA–224) .....................    Paper ...............................          12,094    0.2 hours (12 minutes) ....                 2,418.8
                                        Application for Registration (DEA–224) .....................    Electronic .........................           59,283    0.13 hours (8 minutes) ....                 7,904.4
                                        Application for Registration Renewal (DEA–224a) ....            Paper ...............................         159,678    0.2 hours (12 minutes) ....                31,935.6
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                                        Application for Registration Renewal (DEA–224a) ....            Electronic .........................          209,285    0.06 hours (4 minutes) ....                13,952.3
                                        Affidavit for Chain Renewals (DEA–224b) .................       Electronic .........................               16    5 hours ............................           80
                                        Application for Modification of Registration for Online         Electronic .........................              250    0.25 hours (15 minutes) ..                     62.5
                                          Pharmacies (DEA–224c).




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                                                                   Federal Register / Vol. 74, No. 64 / Monday, April 6, 2009 / Rules and Regulations                                                                                        15619

                                                                                                                                                                         Number of                                                          Total
                                                                          Form                                                         Completed                                                 Time per response
                                                                                                                                                                        respondents                                                      (in hours)

                                             Total ....................................................................    ..........................................         440,606       ..........................................       56,354



                                           (6) An estimate of the total public                                   Justice, Patrick Henry Building, Suite                                 21 CFR Part 1301
                                        burden (in hours) associated with the                                    1600, 601 D Street, NW., Washington,                                     Administrative practice and
                                        collection: It is estimated that this                                    DC 20530.                                                              procedure, Drug traffic control, Security
                                        collection will create a burden of 56,354                                                                                                       measures.
                                        annual burden hours.                                                     E. Executive Order 12988
                                           Overview of new information                                                                                                                  21 CFR Part 1304
                                                                                                                   This regulation meets the applicable
                                        collection:                                                                                                                                       Drug traffic control, Reporting and
                                                                                                                 standards set forth in sections 3(a) and
                                           (1) Type of Information Collection:                                                                                                          recordkeeping requirements.
                                        New collection.                                                          3(b)(2) of Executive Order 12988, Civil
                                           (2) Title of the Form/Collection:                                     Justice Reform.                                                        21 CFR Part 1306
                                        Reports of dispensing of controlled                                      F. Executive Order 13132                                                 Drug traffic control, Prescription
                                        substances by online pharmacies.                                                                                                                drugs.
                                           (3) Agency form number, if any, and                                     This rulemaking does not impose
                                        the applicable component of the                                          enforcement responsibilities on any                                    ■ For the reasons set out above, 21 CFR
                                        Department of Justice sponsoring the                                     State; nor does it diminish the power of                               parts 1300, 1301, 1304, and 1306 are
                                        collection:                                                              any State to enforce its own laws.                                     amended as follows:
                                           Form Number: DEA Form 332.                                            Accordingly, this rulemaking does not
                                           Component: Office of Diversion                                                                                                               PART 1300—DEFINITIONS
                                                                                                                 have federalism implications warranting
                                        Control, Drug Enforcement                                                the application of Executive Order                                     ■  1. The authority citation for part 1300
                                        Administration, U.S. Department of                                       13132.                                                                 is revised to read as follows:
                                        Justice.
                                           (4) Affected public who will be asked                                 G. Unfunded Mandates Reform Act of                                       Authority: 21 U.S.C. 802, 821, 829, 871(b),
                                                                                                                                                                                        951, 958(f).
                                        or required to respond, as well as a brief                               1995
                                        abstract:                                                                                                                                       ■ 2. Section 1300.04 is added to read as
                                           Primary: Business or other for-profit.                                   This rule will not result in the                                    follows:
                                           Other: Not-for-Profit Institutions;                                   expenditure by State, local, and tribal
                                        State, Local or Tribal Government.                                       governments, in the aggregate, or by the                               § 1300.04 Definitions relating to the
                                           Abstract: The Controlled Substances                                   private sector, of $120,000,000 or more                                dispensing of controlled substances by
                                        Act (21 U.S.C. 827(d)(2)) requires online                                (adjusted for inflation) in any one year,                              means of the Internet.
                                        pharmacies to report to DEA the total                                    and will not significantly or uniquely                                    (a) Any term not defined in this part
                                        quantity of controlled substances that                                   affect small governments. Therefore, no                                or elsewhere in this chapter shall have
                                        the pharmacy has dispensed during                                        actions were deemed necessary under                                    the definition set forth in sections 102
                                        each calendar month by any means,                                        the provisions of the Unfunded                                         and 309 of the Act (21 U.S.C. 802, 829).
                                        regardless of whether the controlled                                     Mandates Reform Act of 1995.                                              (b) The term covering practitioner
                                        substances are dispensed by means of                                                                                                            means, with respect to a patient, a
                                        the Internet. Reports are required to be                                 H. Congressional Review Act                                            practitioner who conducts a medical
                                        filed by every pharmacy that, at any                                                                                                            evaluation (other than an in-person
                                                                                                                    This rule is not a major rule as                                    medical evaluation) at the request of a
                                        time during a calendar month, holds a
                                                                                                                 defined by section 804 of the Small                                    practitioner who:
                                        modified registration authorizing it to
                                        operate as an online pharmacy,                                           Business Regulatory Enforcement                                           (1) Has conducted at least one in-
                                        regardless of whether the online                                         Fairness Act of 1996 (Congressional                                    person medical evaluation of the patient
                                        pharmacy dispenses any controlled                                        Review Act). This rule will not result in                              or an evaluation of the patient through
                                        substances by means of the Internet                                      an annual effect on the economy of                                     the practice of telemedicine, within the
                                        during the month. Such reporting is                                      $100,000,000 or more; a major increase                                 previous 24 months; and
                                        mandated by the Ryan Haight Act and                                      in costs or prices; or significant adverse                                (2) Is temporarily unavailable to
                                        permits DEA to monitor the dispensing                                    effects on competition, employment,                                    conduct the evaluation of the patient.
                                        of controlled substances by online                                       investment, productivity, innovation, or                                  (c) The term deliver, distribute, or
                                        pharmacies.                                                              on the ability of United States-based                                  dispense by means of the Internet refers,
                                           (5) An estimate of the total number of                                companies to compete with foreign-                                     respectively, to any delivery,
                                        respondents and the amount of time                                       based companies in domestic and                                        distribution, or dispensing of a
                                        estimated for an average respondent to                                   export markets. Further, as noted above                                controlled substance that is caused or
                                        respond: It is estimated that 250 persons                                in the Administrative Procedure Act                                    facilitated by means of the Internet.
                                        respond to this collection at 0.25 hours                                 certification, DEA has concluded that                                     (d) The term filling new prescriptions
                                        per person per month, for a total of 750                                 ‘‘good cause’’ exists to promulgate this                               for controlled substances in Schedule
                                        hours per year.                                                          rule as an Interim Final Rule effective as                             III, IV, or V means filling a prescription
                                           (6) An estimate of the total public                                   set forth in the DATES section of the                                  for an individual for a controlled
                                        burden (in hours) associated with the                                    preamble pursuant to 5 U.S.C. 553(b)(B)                                substance in Schedule III, IV, or V, if:
                                        collection: 750 annual burden hours.                                     and 5 U.S.C. 553(d)(3).                                                   (1) The pharmacy dispensing that
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                                           If additional information is required                                                                                                        prescription has previously dispensed
                                        contact: Lynn Bryant, Department                                         List of Subjects                                                       to the patient a controlled substance
                                        Clearance Officer, Information                                           21 CFR Part 1300                                                       other than by means of the Internet and
                                        Management and Security Staff, Justice                                                                                                          pursuant to the valid prescription of a
                                        Management Division, Department of                                           Chemicals, Drug traffic control.                                   practitioner that meets the applicable


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                                        15620                Federal Register / Vol. 74, No. 64 / Monday, April 6, 2009 / Rules and Regulations

                                        requirements of subsections (b) and (c)                    (1) Manufacturers or distributors                  prescribed in a manner authorized by
                                        of section 309 of the Act (21 U.S.C. 829)               registered under subsection (a), (b), (d),            this chapter and otherwise in
                                        and §§ 1306.21 and 1306.22 of this                      or (e) of section 303 of the Act (21                  compliance with the Act.
                                        chapter (for purposes of this definition,               U.S.C. 823(a), (b), (d), or (e)) (§ 1301.13              (ii) A registered pharmacy will be
                                        such a prescription shall be referred to                of this chapter) who do not dispense                  deemed to meet this exception if, in
                                        as the ‘‘original prescription’’);                      controlled substances to an unregistered              view of all of its activities other than
                                           (2) The pharmacy contacts the                        individual or entity;                                 those referred to in paragraph (h)(9)(i) of
                                        practitioner who issued the original                       (2) Nonpharmacy practitioners who                  this section, it would fall outside the
                                        prescription at the request of that                     are registered under section 303(f) of the            definition of an online pharmacy; or
                                        individual to determine whether the                     Act (21 U.S.C. 823(f)) (§ 1301.13 of this                (10)(i) Any registered pharmacy
                                        practitioner will authorize the issuance                chapter) and whose activities are                     whose delivery, distribution, or
                                        of a new prescription for that individual               authorized by that registration;                      dispensing of controlled substances by
                                        for the controlled substance described                     (3) Any hospital or other medical                  means of the Internet consists solely of
                                        in paragraph (d)(1) of this section (i.e.,              facility that is operated by an agency of             the transmission of prescription
                                        the same controlled substance as                        the United States (including the Armed                information between a pharmacy and an
                                        described in paragraph (d)(1)); and                     Forces), provided such hospital or other              automated dispensing system located in
                                           (3) The practitioner, acting in the                  facility is registered under section 303(f)           a long term care facility when the
                                        usual course of professional practice,                  of the Act (21 U.S.C. 823(f)) (§ 1301.13              registration of the automated dispensing
                                        determines there is a legitimate medical                of this chapter);                                     system is held by that pharmacy as
                                        purpose for the issuance of the new                        (4) A health care facility owned or                described in §§ 1301.17 and 1301.27
                                        prescription.                                           operated by an Indian tribe or tribal                 and the pharmacy is otherwise
                                           (e) The term homepage means the                      organization, only to the extent such                 complying with this chapter.
                                        opening or main page or screen of the                   facility is carrying out a contract or                   (ii) A registered pharmacy will be
                                        Web site of an online pharmacy that is                  compact under the Indian Self-                        deemed to meet this exception if, in
                                        viewable on the Internet.                               Determination and Education                           view of all of its activities other than
                                           (f) The term in-person medical                       Assistance Act;                                       those referred to in paragraph (h)(10)(i)
                                        evaluation means a medical evaluation                      (5) Any agent or employee of any                   of this section, it would fall outside the
                                        that is conducted with the patient in the               hospital or facility referred to in                   definition of an online pharmacy.
                                        physical presence of the practitioner,                  paragraph (h)(3) or (h)(4) of this section,              (i) Effective January 15, 2010, the term
                                        without regard to whether portions of                   provided such agent or employee is                    practice of telemedicine means the
                                        the evaluation are conducted by other                   lawfully acting in the usual course of                practice of medicine in accordance with
                                        health professionals. Nothing in this                   business or employment, and within the                applicable Federal and State laws by a
                                        paragraph shall be construed to imply                   scope of the official duties of such agent            practitioner (other than a pharmacist)
                                        that one in-person medical evaluation                   or employee, with such hospital or                    who is at a location remote from the
                                        demonstrates that a prescription has                    facility, and, with respect to agents or              patient and is communicating with the
                                        been issued for a legitimate medical                    employees of health care facilities                   patient, or health care professional who
                                        purpose within the usual course of                      specified in paragraph (h)(4) of this                 is treating the patient, using a
                                        professional practice.                                  section, only to the extent such                      telecommunications system referred to
                                           (g) The term Internet means                          individuals are furnishing services                   in section 1834(m) of the Social Security
                                        collectively the myriad of computer and                 pursuant to the contracts or compacts                 Act (42 U.S.C. 1395m(m)), which
                                        telecommunications facilities, including                described in such paragraph;                          practice falls within a category listed in
                                        equipment and operating software,                          (6) Mere advertisements that do not                the following paragraphs (i)(1) through
                                        which comprise the interconnected                       attempt to facilitate an actual                       (7):
                                        worldwide network of networks that                      transaction involving a controlled                       (1) Treatment in a hospital or clinic.
                                        employ the Transmission Control                         substance;                                            The practice of telemedicine is being
                                        Protocol/Internet Protocol, or any                         (7) A person, entity, or Internet site             conducted while the patient is being
                                        predecessor or successor protocol to                    that is not in the United States and does             treated by, and physically located in, a
                                        such protocol, to communicate                           not facilitate the delivery, distribution,            hospital or clinic registered under
                                        information of all kinds by wire or                     or dispensing of a controlled substance               section 303(f) of the Act (21 U.S.C.
                                        radio.                                                  by means of the Internet to any person                823(f)) by a practitioner acting in the
                                           (h) The term online pharmacy means                   in the United States;                                 usual course of professional practice,
                                        a person, entity, or Internet site,                        (8) A pharmacy registered under                    who is acting in accordance with
                                        whether in the United States or abroad,                 section 303(f) of the Act (21 U.S.C.                  applicable State law, and who is
                                        that knowingly or intentionally delivers,               823(f)) (§ 1301.13 of this chapter) whose             registered under section 303(f) of the
                                        distributes, or dispenses, or offers or                 dispensing of controlled substances via               Act (21 U.S.C. 823(f)) in the State in
                                        attempts to deliver, distribute, or                     the Internet consists solely of:                      which the patient is located, unless the
                                        dispense, a controlled substance by                        (i) Refilling prescriptions for                    practitioner:
                                        means of the Internet. The term                         controlled substances in Schedule III,                   (i) Is exempted from such registration
                                        includes, but is not limited to, a                      IV, or V, as defined in paragraph (k) of              in all States under section 302(d) of the
                                        pharmacy that has obtained a                            this section; or                                      Act (21 U.S.C. 822(d); or
                                        modification of its registration pursuant                  (ii) Filling new prescriptions for                    (ii) Is an employee or contractor of the
                                        to §§ 1301.13 and 1301.19 of this                       controlled substances in Schedule III,                Department of Veterans Affairs who is
                                        chapter that currently authorizes it to                 IV, or V, as defined in paragraph (d) of              acting in the scope of such employment
                                        dispense controlled substances by                       this section;                                         or contract, and registered under section
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                                        means of the Internet, regardless of                       (9)(i) Any registered pharmacy whose               303(f) of the Act (21 U.S.C. 823(f)) in
                                        whether the pharmacy is currently                       delivery, distribution, or dispensing of              any State or is utilizing the registration
                                        dispensing controlled substances by                     controlled substances by means of the                 of a hospital or clinic operated by the
                                        means of the Internet. The term does not                Internet consists solely of filling                   Department of Veterans Affairs
                                        include:                                                prescriptions that were electronically                registered under section 303(f);


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                                                             Federal Register / Vol. 74, No. 64 / Monday, April 6, 2009 / Rules and Regulations                                             15621

                                           (2) Treatment in the physical presence                  (A) That prevents the patient from                 health care professional who is treating
                                        of a practitioner. The practice of                      being in the physical presence of a                   the patient, using a telecommunications
                                        telemedicine is being conducted while                   practitioner registered under section                 system referred to in section 1834(m) of
                                        the patient is being treated by, and in                 303(f) of the Act (21 U.S.C. 823(f)) who              the Social Security Act (42 U.S.C.
                                        the physical presence of, a practitioner                is an employee or contractor of the                   1395m(m)), if the practitioner is using
                                        acting in the usual course of                           Veterans Health Administration acting                 an interactive telecommunications
                                        professional practice, who is acting in                 in the usual course of business and                   system that satisfies the requirements of
                                        accordance with applicable State law,                   employment and within the scope of the                section 410.78(a)(3) of title 42, Code of
                                        and who is registered under section                     official duties or contract of that                   Federal Regulations.
                                        303(f) of the Act (21 U.S.C. 823(f)) in the             employee or contractor;                                  (k) The term refilling prescriptions for
                                        State in which the patient is located,                     (B) That prevents the patient from                 controlled substances in Schedule III,
                                        unless the practitioner:                                being physically present at a hospital or             IV, or V:
                                           (i) Is exempted from such registration               clinic operated by the Department of                     (1) Means the dispensing of a
                                        in all States under section 302(d) of the               Veterans Affairs registered under                     controlled substance in Schedule III, IV,
                                        Act (21 U.S.C. 822(d)); or                              section 303(f) of the Act (21 U.S.C.                  or V in accordance with refill
                                           (ii) Is an employee or contractor of the             823(f));                                              instructions issued by a practitioner as
                                        Department of Veterans Affairs who is                      (C) During which the primary care                  part of a valid prescription that meets
                                        acting in the scope of such employment                  practitioner of the patient or a                      the requirements of subsections (b) and
                                        or contract, and registered under section               practitioner otherwise practicing                     (c) of section 309 of the Act (21 U.S.C.
                                        303(f) of the Act (21 U.S.C. 823(f)) in                 telemedicine within the meaning of this               829) and §§ 1306.21 and 1306.22 of this
                                        any State or is using the registration of               paragraph is unable to provide care or                chapter, as appropriate; and
                                        a hospital or clinic operated by the                    consultation; and                                        (2) Does not include the issuance of
                                        Department of Veterans Affairs                             (D) That requires immediate                        a new prescription to an individual for
                                        registered under section 303(f);                        intervention by a health care                         a controlled substance that individual
                                           (3) Indian Health Service or tribal                  practitioner using controlled substances              was previously prescribed.
                                        organization. The practice of                           to prevent what the practitioner                         (l)(1) The term valid prescription
                                        telemedicine is being conducted by a                    reasonably believes in good faith will be             means a prescription that is issued for
                                        practitioner who is an employee or                      imminent and serious clinical                         a legitimate medical purpose in the
                                        contractor of the Indian Health Service,                consequences, such as further injury or               usual course of professional practice by:
                                        or is working for an Indian tribe or tribal             death; and                                               (i) A practitioner who has conducted
                                                                                                   (ii) By a practitioner that:                       at least one in-person medical
                                        organization under its contract or                         (A) Is an employee or contractor of the
                                        compact with the Indian Health Service                                                                        evaluation of the patient; or
                                                                                                Veterans Health Administration acting                    (ii) A covering practitioner.
                                        under the Indian Self-Determination                     within the scope of that employment or                   (2) Nothing in this paragraph (l) shall
                                        and Education Assistance Act; who is                    contract;                                             be construed to imply that one in-
                                        acting within the scope of the                             (B) Is registered under section 303(f)             person medical evaluation demonstrates
                                        employment, contract, or compact; and                   of the Act (21 U.S.C. 823(f)) in any State            that a prescription has been issued for
                                        who is designated as an Internet Eligible               or is utilizing the registration of a                 a legitimate medical purpose within the
                                        Controlled Substances Provider by the                   hospital or clinic operated by the                    usual course of professional practice.
                                        Secretary of Health and Human Services                  Department of Veterans Affairs
                                        under section 311(g)(2) of the Act (21                  registered under section 303(f); and                  PART 1301—REGISTRATION OF
                                        U.S.C. 831(g)(2));                                         (C) Issues a controlled substance                  MANUFACTURERS, DISTRIBUTORS,
                                           (4) Public health emergency declared                 prescription in this emergency context                AND DISPENSERS OF CONTROLLED
                                        by the Secretary of Health and Human                    that is limited to a maximum of a five-               SUBSTANCES
                                        Services. The practice of telemedicine is               day supply which may not be extended
                                        being conducted during a public health                  or refilled; or                                       ■  3. The authority citation for part 1301
                                        emergency declared by the Secretary of                     (7) Other circumstances specified by               is revised to read as follows:
                                        Health and Human Services under                         regulation. The practice of telemedicine                Authority: 21 U.S.C. 821, 822, 823, 824,
                                        section 319 of the Public Health Service                is being conducted under any other                    831, 871(b), 875, 877, 886a, 951, 952, 953,
                                        Act (42 U.S.C. 247d), and involves                      circumstances that the Administrator                  956, 957, 958.
                                        patients located in such areas, and such                and the Secretary of Health and Human
                                        controlled substances, as the Secretary                                                                       ■ 4. Section 1301.11 is revised to read
                                                                                                Services have jointly, by regulation,                 as follows:
                                        of Health and Human Services, with the                  determined to be consistent with
                                        concurrence of the Administrator,                       effective controls against diversion and              § 1301.11 Persons required to register;
                                        designates, provided that such                          otherwise consistent with the public                  requirement of modification of registration
                                        designation shall not be subject to the                 health and safety.                                    authorizing activity as an online pharmacy.
                                        procedures prescribed by the                               (j) Temporary definition of practice of               (a) Every person who manufactures,
                                        Administrative Procedure Act (5 U.S.C.                  telemedicine. Prior to January 15, 2010,              distributes, dispenses, imports, or
                                        551–559 and 701–706);                                   or as otherwise specified by regulation               exports any controlled substance or who
                                           (5) Special registration. The practice               prior to that date, instead of the                    proposes to engage in the manufacture,
                                        of telemedicine is being conducted by a                 definition in paragraph (i), the term                 distribution, dispensing, importation or
                                        practitioner who has obtained from the                  practice of telemedicine means the                    exportation of any controlled substance
                                        Administrator a special registration                    practice of medicine in accordance with               shall obtain a registration unless
                                        under section 311(h) of the Act (21                     applicable Federal and State laws by a                exempted by law or pursuant to
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                                        U.S.C. 831(h));                                         practitioner (as that term is defined in              §§ 1301.22 through 1301.26. Except as
                                           (6) Department of Veterans Affairs                   section 102 of the Act (21 U.S.C. 802))               provided in paragraph (b) of this
                                        medical emergency. The practice of                      (other than a pharmacist) who is at a                 section, only persons actually engaged
                                        telemedicine is being conducted:                        location remote from the patient and is               in such activities are required to obtain
                                           (i) In a medical emergency situation:                communicating with the patient, or                    a registration; related or affiliated


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                                        15622                Federal Register / Vol. 74, No. 64 / Monday, April 6, 2009 / Rules and Regulations

                                        persons who are not engaged in such                     or this chapter). The Act further                             eligible to obtain such a modification of
                                        activities are not required to be                       provides that the Administrator may                           registration but remain liable under
                                        registered. (For example, a stockholder                 only issue such modification of                               section 401(h) of the Act (21 U.S.C.
                                        or parent corporation of a corporation                  registration to a person who is registered                    841(h)) if they deliver, distribute, or
                                        manufacturing controlled substances is                  as a pharmacy under section 303(f) of                         dispense a controlled substance while
                                        not required to obtain a registration.)                 the Act (21 U.S.C. 823(f)). Accordingly,                      acting as an online pharmacy without
                                           (b) As provided in sections 303(f) and               any pharmacy registered pursuant to                           being validly registered with a
                                        401(h) of the Act (21 U.S.C. 823(f) and                 § 1301.13 of this part that falls within                      modification authorizing such activity.
                                        841(h)), it is unlawful for any person                  the definition of an online pharmacy
                                        who falls within the definition of                      and proposes to dispense controlled                           ■ 5. Section 1301.13 is amended by
                                        ‘‘online pharmacy’’ (as set forth in                    substances by means of the Internet                           revising paragraph (e)(1)(iv) and (e)(3) to
                                        section 102(52) of the Act (21 U.S.C.                   must obtain a modification of its                             read as follows:
                                        802(52)) and § 1300.04(h) of this                       registration authorizing such activity                        § 1301.13 Application for registration; time
                                        chapter) to deliver, distribute, or                     following the submission of an                                for application; expiration date; registration
                                        dispense a controlled substance by                      application in accordance with                                for independent activities; application
                                        means of the Internet if such person is                 § 1301.19 of this part. This requirement                      forms, fees, contents and signature;
                                        not validly registered with a                           does not apply to a registered pharmacy                       coincident activities.
                                        modification of such registration                       that does not fall within the definition                      *       *    *        *     *
                                        authorizing such activity (unless such                  of an online pharmacy set forth in
                                        person is exempt from such modified                     § 1300.04(h). Under the Act, persons                              (e) * * *
                                        registration requirement under the Act                  other than registered pharmacies are not                          (1) * * *

                                                                                                                                     Application           Registration
                                                                                      Controlled         DEA application
                                                 Business activity                                                                      fee                  period             Coincident activities allowed
                                                                                     substances              forms                    (dollars)              (years)


                                                   *                    *                       *                        *                             *                       *                      *
                                        (iv) Dispensing or instructing (in-       Schedules II–V         New—224 .........                       551                      3   May conduct research and in-
                                           cludes Practitioner, Hospital/                                Renewal—224a                            551                           structional activities with those
                                           Clinic, Retail Pharmacy, Online                                 Online Phar-                                                        substances for which registra-
                                           Pharmacy, Central fill phar-                                    macy—224c.                                                          tion was granted, except that a
                                           macy, Teaching Institution).                                                                                                        mid-level practitioner may con-
                                                                                                                                                                               duct such research only to the
                                                                                                                                                                               extent expressly authorized
                                                                                                                                                                               under State statute. A phar-
                                                                                                                                                                               macist may manufacture an
                                                                                                                                                                               aqueous or oleaginous solution
                                                                                                                                                                               or solid dosage form con-
                                                                                                                                                                               taining 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 on-
                                                                                                                                                                               line pharmacy may perform ac-
                                                                                                                                                                               tivities of retail pharmacy as
                                                                                                                                                                               well as online pharmacy activi-
                                                                                                                                                                               ties.

                                                  *                       *                        *                          *                        *                        *                    *



                                        *      *    *     *      *                              § 1301.19 Special requirements for online                     listed in section 303(f) of the Act (21
                                                                                                pharmacies.                                                   U.S.C. 823(f)).
                                           (3) Registrants will receive renewal
                                        notifications approximately 60 days                        (a) A pharmacy that has been issued                           (b) Each online pharmacy shall
                                        prior to the registration expiration date.              a registration under § 1301.13 may                            comply with the requirements of State
                                        DEA Forms 224a, 225a, and 363a may                      request that the Administrator modify                         law concerning licensure of pharmacies
                                        be mailed, as applicable, to registrants;               its registration to authorize the                             in each State from which it, and in each
                                        if any registered person does not receive               pharmacy to dispense controlled                               State to which it, delivers, distributes,
                                        such notification within 45 days before                 substances by means of the Internet as                        or dispenses, or offers to deliver,
                                        the registration expiration date, the                   an online pharmacy. The Administrator                         distribute, or dispense controlled
                                        registrant must promptly give notice of                 may deny an application for a                                 substances by means of the Internet.
                                        such fact and may request such forms by                 modification of registration if the                              (c) Application for a modified
                                        writing to the Registration Section, Drug               Administrator determines that the                             registration authorizing the dispensing
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                                        Enforcement Administration.                             issuance of a modification would be                           of controlled substances by means of the
                                                                                                inconsistent with the public interest. In                     Internet will be made by an online
                                        *      *    *     *      *                                                                                            application process as specified in
                                                                                                determining the public interest, the
                                        ■ 6. Section 1301.19 is added to read as                                                                              § 1301.13 of this part. Subsequent
                                                                                                Administrator will consider the factors
                                        follows:                                                                                                              online pharmacy registration renewals


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                                                             Federal Register / Vol. 74, No. 64 / Monday, April 6, 2009 / Rules and Regulations                                         15623

                                        will be accomplished by an online                       ■ 9. Section 1304.01 is revised to read               pursuant to orders made on, through, or
                                        process.                                                as follows:                                           on behalf of, more than one Web site,
                                           (d) A pharmacy that seeks to                                                                               the pharmacy shall provide, for
                                                                                                § 1304.01    Scope of part 1304.                      purposes of complying with this
                                        discontinue its modification of
                                        registration authorizing it to dispense                   Inventory and other records and                     paragraph, the Internet site address of
                                        controlled substances by means of the                   reports required under section 307,                   each such site.
                                        Internet as an online pharmacy (but                     section 311, or section 1008(e) of the                   (4) The DEA registration numbers of:
                                        continue its business activity as a non-                Act (21 U.S.C. 827, 831, and 958(e))                     (i) Every pharmacy that delivers,
                                        online pharmacy) shall so notify the                    shall be in accordance with, and contain              distributes, or dispenses controlled
                                        Administrator by requesting to modify                   the information required by, those                    substances pursuant to orders made on,
                                        its registration to reflect the appropriate             sections and by the sections of this part.            through, or on behalf of, each Web site
                                        business activity. Once the registration                ■ 10. An undesignated heading and                     referred to in paragraph (b)(3) of this
                                        has been so changed, the pharmacy may                   §§ 1304.40, 1304.45, 1304.50 and                      section; and
                                        no longer dispense controlled                           1304.55 are added to read as follows:                    (ii) Every practitioner who has a
                                        substances by means of the Internet. A                                                                        contractual relationship to provide
                                                                                                Online Pharmacies
                                        pharmacy that has so changed its                                                                              medical evaluations or issue
                                                                                                1304.40 Notification by online pharmacies.            prescriptions for controlled substances,
                                        registration status back to that of a non-              1304.45 Internet Web site disclosure
                                        online pharmacy remains responsible                                                                           through referrals from the Web site or at
                                                                                                    requirements.
                                        for submitting reports in accordance                    1304.50 Disclosure requirements for Web
                                                                                                                                                      the request of the owner or operator of
                                        with § 1304.55 of this chapter with                         sites of nonpharmacy practitioners that           the Web site, or any employee or agent
                                        respect to any controlled substances that                   dispense controlled substances by means           thereof.
                                                                                                    of the Internet.                                     (c) An online pharmacy that is in
                                        it dispensed while it was registered with
                                                                                                1304.55 Reports by online pharmacies.                 operation at the time Public Law 110–
                                        a modification authorizing it to operate
                                                                                                                                                      425 becomes effective (April 13, 2009)
                                        as an online pharmacy.                                  Online Pharmacies                                     must make the notifications required in
                                           (e) Registrants applying for modified
                                                                                                § 1304.40 Notification by online                      this section on or before May 13, 2009.
                                        registrations under this section must
                                                                                                pharmacies.                                           However, in accordance with section
                                        comply with notification and reporting                                                                        401(h) of the Act (21 U.S.C. 841(h)), as
                                        requirements set forth in §§ 1304.40,                      (a) Thirty days prior to offering a
                                                                                                controlled substance for sale, delivery,              of April 13, 2009, it is unlawful for any
                                        1304.45, 1304.50, and 1304.55 of this                                                                         online pharmacy to deliver, distribute,
                                        chapter.                                                distribution, or dispensing by means of
                                                                                                the Internet, an online pharmacy shall:               or dispense a controlled substance by
                                           (f) No person (including a registrant)                                                                     means of the Internet unless such online
                                        required to obtain a modification of a                     (1) Notify the Administrator of its
                                                                                                intent to do so by submitting an                      pharmacy is validly registered with a
                                        registration under §§ 1301.11(b) and                                                                          modification of such registration
                                        1301.13 of this part authorizing it to                  application for a modified registration
                                                                                                in accordance with §§ 1301.13 and                     authorizing such activity.
                                        operate as an online pharmacy may                                                                                (d) On and after the date an online
                                        engage in any activity for which such                   1301.19 of this chapter, with such
                                                                                                application containing the information                pharmacy makes the notifications
                                        modification of registration is required                                                                      required under this section, each online
                                        until the application for such modified                 required by this section; and
                                                                                                   (2) Notify the State boards of                     pharmacy shall display on the
                                        registration is granted and an active                                                                         homepage of its Internet site, a
                                                                                                pharmacy in any States in which the
                                        Certificate of Registration indicating the                                                                    declaration that it has made such
                                                                                                online pharmacy offers to sell, deliver,
                                        modification of the registration has been                                                                     notifications to the Administrator in the
                                                                                                distribute, or dispense controlled
                                        issued by the Administrator to such                                                                           following form: ‘‘In accordance with the
                                                                                                substances.
                                        person.                                                    (b) The following information must be              Controlled Substances Act and the DEA
                                        ■ 7. Section 1301.52 is amended by                      included in the notification submitted                regulations, this online pharmacy has
                                        revising paragraph (a) to read as follows:              under paragraph (a) of this section:                  made the notifications to the DEA
                                                                                                   (1) The pharmacy’s Internet Pharmacy               Administrator required by 21 U.S.C. 831
                                        § 1301.52 Termination of registration;                  Site Disclosure information required to               and 21 CFR 1304.40.’’
                                        transfer of registration; distribution upon             be posted on the homepage of the online                  (e)(1) Except as provided in
                                        discontinuance of business.                             pharmacy’s Internet site under section                paragraphs (e)(2) and (e)(3) of this
                                          (a) Except as provided in paragraph                   311(c) of the Act (21 U.S.C. 831(c)) and              section, if any of the information
                                        (b) of this section, the registration of any            § 1304.45 of this part.                               required to be submitted under this
                                        person, and any modifications of that                      (2) Certification that the information             section changes after the online
                                        registration, shall terminate if and when               disclosed on its Internet site under the              pharmacy submits the notification to the
                                        such person dies, ceases legal existence,               Internet Pharmacy Site Disclosure is                  Administrator, the online pharmacy
                                        or discontinues business or professional                true and accurate. The statement shall                shall notify the Administrator of the
                                        practice. Any registrant who ceases legal               be in a form similar to the following:                updated information no later than 30
                                        existence or discontinues business or                   ‘‘The above-named pharmacy, a DEA                     days before the change becomes
                                        professional practice shall notify the                  registrant, certifies, under penalty of               effective via the online process.
                                        Administrator promptly of such fact.                    perjury, that the information contained                  (2) If a pharmacy referred to in
                                        *      *     *    *      *                              in this statement is true and accurate.’’             paragraph (b)(4)(i) of this section ceases
                                                                                                   (3) Each Internet site address utilized            to deliver, distribute, or dispense
                                        PART 1304—RECORDS AND                                   by the online pharmacy and a                          controlled substances pursuant to orders
                                        REPORTS OF REGISTRANTS                                  certification that the online pharmacy                made on, through, or on behalf of, each
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                                                                                                shall notify the Administrator of any                 Web site referred to in paragraph (b)(3)
                                        ■  8. The authority citation for part 1304              change in any such Internet address at                of this section, the online pharmacy
                                        is revised to read as follows:                          least 30 days in advance. In the event                shall notify the Administrator no later
                                          Authority: 21 U.S.C. 821, 827, 831, 871(b),           that a pharmacy delivers, distributes, or             than 30 days after the change becomes
                                        958(e), 965, unless otherwise noted.                    dispenses controlled substances                       effective via the online process.


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                                        15624                Federal Register / Vol. 74, No. 64 / Monday, April 6, 2009 / Rules and Regulations

                                          (3) If a practitioner referred to in                  Act and DEA regulations. As part of this              dispensing. Such reporting is required
                                        paragraph (b)(4)(ii) of this section ceases             obligation, this online pharmacy has                  for every calendar month in which the
                                        to have a contractual relationship with                 obtained a modified DEA registration                  total quantity of controlled substances
                                        the online pharmacy, the online                         authorizing it to operate as an online                dispensed by the pharmacy meets or
                                        pharmacy shall notify the Administrator                 pharmacy. In addition, this online                    exceeds one of the following thresholds:
                                        no later than 30 days after the change                  pharmacy will only dispense a                           (1) 100 or more prescriptions for
                                        becomes effective via the online                        controlled substance to a person who                  controlled substances filled; or
                                        process.                                                has a valid prescription issued for a                   (2) 5,000 or more dosage units
                                                                                                legitimate medical purpose based upon                 dispensed of all controlled substances
                                        § 1304.45 Internet Web site disclosure                  a medical relationship with a                         combined.
                                        requirements.
                                                                                                prescribing practitioner. This includes                 (b) Each online pharmacy shall report
                                           (a) Each online pharmacy shall                       at least one prior in-person medical                  a negative response if, during a given
                                        display, at all times and in a visible and              evaluation in accordance with section                 calendar month, its total dispensing of
                                        clear manner, on its homepage a                         309 of the Controlled Substances Act                  controlled substances falls below both
                                        statement that it complies with the                     (21 U.S.C. 829) or a medical evaluation               of the thresholds in paragraph (a) of this
                                        requirements of section 311 of the Act                  via telemedicine in accordance with                   section.
                                        (21 U.S.C. 831) with respect to the                     section 102(54) of the Controlled                       (c) The reporting requirements of this
                                        delivery or sale or offer for sale of                   Substances Act (21 U.S.C. 802(54)).’’                 section apply to every pharmacy that, at
                                        controlled substances. This statement                                                                         any time during a calendar month,
                                        must include the name of the pharmacy                   § 1304.50 Disclosure requirements for
                                                                                                                                                      holds a modified registration
                                        as it appears on the DEA Certificate of                 Web sites of nonpharmacy practitioners
                                                                                                that dispense controlled substances by                authorizing it to operate as an online
                                        Registration.                                                                                                 pharmacy, regardless of whether the
                                           (b) Each online pharmacy shall clearly               means of the Internet.
                                                                                                   For a Web site to identify itself as               online pharmacy dispenses any
                                        display the following information on the
                                                                                                being exempt from the definition of an                controlled substances by means of the
                                        homepage of each Internet site it
                                                                                                online pharmacy by virtue of section                  Internet during the month.
                                        operates, or on a page directly linked to
                                                                                                102(52)(B)(ii) of the Act (21 U.S.C.                    (d) Reports will be submitted to DEA
                                        the homepage. If the information is
                                                                                                802(52)(B)(ii)) and § 1300.04(h)(2) of                electronically via online reporting,
                                        displayed on a page directly linked to
                                                                                                this chapter, the Web site shall post in              electronic file upload, or other means as
                                        the homepage, that link on the
                                                                                                a visible and clear manner on its                     approved by DEA.
                                        homepage must be visible and clear.
                                                                                                homepage, or on a page directly linked                  (e) Reports shall be filed every month
                                        The information must be displayed for
                                                                                                thereto in which the hyperlink is also                not later than the fifteenth day of the
                                        each pharmacy that delivers, distributes,
                                                                                                visible and clear on the homepage, a list             month succeeding the month for which
                                        or dispenses controlled substances
                                                                                                of the DEA-registered nonpharmacy                     they are submitted.
                                        pursuant to orders made on, through, or
                                                                                                practitioners who are affiliated with the               (f) An online pharmacy filing a report
                                        on behalf of that Web site.
                                                                                                Web site. Any nonpharmacy                             under paragraph (a) of this section shall
                                           (1) The name and address of the
                                                                                                practitioner affiliated with such a Web               utilize the National Drug Code number
                                        pharmacy as it appears on the
                                                                                                site is responsible for compliance with               assigned to the product under the
                                        pharmacy’s DEA Certificate of
                                                                                                this section. An institutional                        National Drug Code System of the Food
                                        Registration.
                                           (2) The pharmacy’s telephone number                  practitioner that otherwise complies                  and Drug Administration, and indicate
                                        and e-mail address.                                     with the requirements of the Act and                  the total number of dosage units
                                           (3) The name, professional degree,                   this chapter will be deemed to meet the               dispensed for each such National Drug
                                        and States of licensure of the                          requirements of this section if, in lieu of           Code number.
                                        pharmacist-in-charge, and a telephone                   posting the names of each affiliated                    (g) Records required to be kept under
                                        number at which the pharmacist-in-                      individual practitioner, it posts its name            this section must be kept by the
                                        charge can be contacted.                                (as it appears on its Certificate of                  registrant for at least two years from the
                                           (4) A list of the States in which the                Registration) in a visible and clear                  date of such records. The information
                                        pharmacy is licensed to dispense                        manner on its homepage and in a                       shall be readily retrievable from the
                                        controlled substances.                                  manner that identifies itself as being                ordinary business records of the
                                           (5) A certification that the pharmacy                responsible for the operation of the Web              registrant and available for inspection
                                        is registered under part 1301 of this                   site.                                                 and copying by authorized employees of
                                        chapter with a modification of its                                                                            the Administration.
                                        registration authorizing it to deliver,                 § 1304.55    Reports by online pharmacies.
                                        distribute, or dispense controlled                         (a) Each online pharmacy shall report              PART 1306—PRESCRIPTIONS
                                        substances by means of the Internet.                    to the Administrator the total quantity
                                                                                                                                                      ■ 11. The authority citation for part
                                           (6) The name, address, telephone                     of each controlled substance that the
                                                                                                                                                      1306 is revised to read as follows:
                                        number, professional degree, and States                 pharmacy has dispensed each calendar
                                        of licensure with State license number                  month. The report must include the                      Authority: 21 U.S.C. 821, 829, 831, 871(b),
                                        of any practitioner who has a                           total quantity of such dispensing by any              unless otherwise noted.
                                        contractual relationship to provide                     means, regardless of whether the                      ■ 12. Section 1306.09 is added to read
                                        medical evaluations or issue                            controlled substances are dispensed by                as follows:
                                        prescriptions for controlled substances,                means of the Internet. Thus, such
                                        through referrals from the Web site or at               reporting shall include all controlled                § 1306.09 Prescription requirements for
                                        the request of the owner or operator of                 substances dispensed via Internet                     online pharmacies.
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                                        the Web site, or any employee or agent                  transactions, mail-order transactions,                  (a) No controlled substance that is a
                                        thereof.                                                face-to-face transactions, or any other               prescription drug may be delivered,
                                           (7) The following statement: ‘‘This                  means. However, the pharmacy is not                   distributed, or dispensed by means of
                                        online pharmacy is obligated to comply                  required to describe in its report to the             the Internet without a valid
                                        fully with the Controlled Substances                    Administrator such means of                           prescription.


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                                                             Federal Register / Vol. 74, No. 64 / Monday, April 6, 2009 / Rules and Regulations                                          15625

                                          (b) In accordance with the Act, it is                 practice and is acting on behalf of a                 must do so in accordance with the
                                        unlawful for any person to knowingly or                 pharmacy whose registration has been                  requirements of §§ 1306.15 and 1306.25
                                        intentionally fill a prescription for a                 modified under sections 1301.13 and                   of this part.
                                        controlled substance that was issued in                 1301.19 of this chapter to authorize it to              Dated: April 1, 2009.
                                        a manner that constitutes dispensing by                 operate as an online pharmacy.                        Michele M. Leonhart,
                                        means of the Internet unless such                         (c) Any online pharmacy that                        Deputy Administrator.
                                        person is a pharmacist who is acting in                 participates in the transfer between                  [FR Doc. E9–7698 Filed 4–3–09; 8:45 am]
                                        the usual course of his professional                    pharmacies of prescription information                BILLING CODE 4410–09–P
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