Text: H.R.6353 — 110th Congress (2007-2008)All Bill Information (Except Text)

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Public Law No: 110-425 (10/15/2008)

 
[110th Congress Public Law 425]
[From the U.S. Government Printing Office]


[DOCID: f:publ425.110]

[[Page 4819]]

       RYAN HAIGHT ONLINE PHARMACY CONSUMER PROTECTION ACT OF 2008

[[Page 122 STAT. 4820]]

Public Law 110-425
110th Congress

                                 An Act


 
        To amend the Controlled Substances Act to address online 
           pharmacies. <<NOTE: Oct. 15, 2008 -  [H.R. 6353]>> 

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled, <<NOTE: Ryan Haight 
Online Pharmacy Consumer Protection Act of 2008.>> 
SECTION 1. <<NOTE: 21 USC 801 note.>> SHORT TITLE.

    This Act may be cited as the ``Ryan Haight Online Pharmacy Consumer 
Protection Act of 2008''.
SEC. 2. REQUIREMENT OF A VALID PRESCRIPTION FOR CONTROLLED 
                    SUBSTANCES DISPENSED BY MEANS OF THE INTERNET.

    Section 309 of the Controlled Substances Act (21 U.S.C. 829) is 
amended by adding at the end the following:
    ``(e) Controlled Substances Dispensed by Means of the Internet.--
            ``(1) No controlled substance that is a prescription drug as 
        determined under the Federal Food, Drug, and Cosmetic Act may be 
        delivered, distributed, or dispensed by means of the Internet 
        without a valid prescription.
            ``(2) As used in this subsection:
                    ``(A) The term `valid prescription' means a 
                prescription that is issued for a legitimate medical 
                purpose in the usual course of professional practice 
                by--
                          ``(i) a practitioner who has conducted at 
                      least 1 in-person medical evaluation of the 
                      patient; or
                          ``(ii) a covering practitioner.
                    ``(B)(i) The term `in-person medical evaluation' 
                means a medical evaluation that is conducted with the 
                patient in the physical presence of the practitioner, 
                without regard to whether portions of the evaluation are 
                conducted by other health professionals.
                    ``(ii) Nothing in clause (i) shall be construed to 
                imply that 1 in-person medical evaluation demonstrates 
                that a prescription has been issued for a legitimate 
                medical purpose within the usual course of professional 
                practice.
                    ``(C) The term `covering practitioner' means, with 
                respect to a patient, a practitioner who conducts a 
                medical evaluation (other than an in-person medical 
                evaluation) at the request of a practitioner who--
                          ``(i) has conducted at least 1 in-person 
                      medical evaluation of the patient or an evaluation 
                      of the patient through the practice of 
                      telemedicine, within the previous 24 months; and
                          ``(ii) is temporarily unavailable to conduct 
                      the evaluation of the patient.

[[Page 122 STAT. 4821]]

            ``(3) Nothing in this subsection shall apply to--
                    ``(A) the delivery, distribution, or dispensing of a 
                controlled substance by a practitioner engaged in the 
                practice of telemedicine; or
                    ``(B) the dispensing or selling of a controlled 
                substance pursuant to practices as determined by the 
                Attorney General by regulation, which shall be 
                consistent with effective controls against diversion.''.
SEC. 3. AMENDMENTS TO THE CONTROLLED SUBSTANCES ACT RELATING TO 
                    THE DELIVERY OF CONTROLLED SUBSTANCES BY MEANS 
                    OF THE INTERNET.

    (a) In General.--Section 102 of the Controlled Substances Act (21 
U.S.C. 802) is amended by adding at the end the following:
    ``(50) The term `Internet' means collectively the myriad of computer 
and telecommunications facilities, including equipment and operating 
software, which comprise the interconnected worldwide network of 
networks that employ the Transmission Control Protocol/Internet 
Protocol, or any predecessor or successor protocol to such protocol, to 
communicate information of all kinds by wire or radio.
    ``(51) The term `deliver, distribute, or dispense by means of the 
Internet' refers, respectively, to any delivery, distribution, or 
dispensing of a controlled substance that is caused or facilitated by 
means of the Internet.
    ``(52) The term `online pharmacy'--
            ``(A) means a person, entity, or Internet site, whether in 
        the United States or abroad, that knowingly or intentionally 
        delivers, distributes, or dispenses, or offers or attempts to 
        deliver, distribute, or dispense, a controlled substance by 
        means of the Internet; and
            ``(B) does not include--
                    ``(i) manufacturers or distributors registered under 
                subsection (a), (b), (d), or (e) of section 303 who do 
                not dispense controlled substances to an unregistered 
                individual or entity;
                    ``(ii) nonpharmacy practitioners who are registered 
                under section 303(f) and whose activities are authorized 
                by that registration;
                    ``(iii) any hospital or other medical facility that 
                is operated by an agency of the United States (including 
                the Armed Forces), provided such hospital or other 
                facility is registered under section 303(f);
                    ``(iv) a health care facility owned or operated by 
                an Indian tribe or tribal organization, only to the 
                extent such facility is carrying out a contract or 
                compact under the Indian Self-Determination and 
                Education Assistance Act;
                    ``(v) any agent or employee of any hospital or 
                facility referred to in clause (iii) or (iv), provided 
                such agent or employee is lawfully acting in the usual 
                course of business or employment, and within the scope 
                of the official duties of such agent or employee, with 
                such hospital or facility, and, with respect to agents 
                or employees of health care facilities specified in 
                clause (iv), only to the extent such individuals are 
                furnishing services pursuant to the contracts or 
                compacts described in such clause;
                    ``(vi) mere advertisements that do not attempt to 
                facilitate an actual transaction involving a controlled 
                substance;

[[Page 122 STAT. 4822]]

                    ``(vii) a person, entity, or Internet site that is 
                not in the United States and does not facilitate the 
                delivery, distribution, or dispensing of a controlled 
                substance by means of the Internet to any person in the 
                United States;
                    ``(viii) a pharmacy registered under section 303(f) 
                whose dispensing of controlled substances via the 
                Internet consists solely of--
                          ``(I) refilling prescriptions for controlled 
                      substances in schedule III, IV, or V, as defined 
                      in paragraph (55); or
                          ``(II) filling new prescriptions for 
                      controlled substances in schedule III, IV, or V, 
                      as defined in paragraph (56); or
                    ``(ix) any other persons for whom the Attorney 
                General and the Secretary have jointly, by regulation, 
                found it to be consistent with effective controls 
                against diversion and otherwise consistent with the 
                public health and safety to exempt from the definition 
                of an `online pharmacy'.

    ``(53) The term `homepage' means the opening or main page or screen 
of the website of an online pharmacy that is viewable on the Internet.
    ``(54) The term `practice of telemedicine' means, for purposes of 
this title, the practice of medicine in accordance with applicable 
Federal and State laws by a practitioner (other than a pharmacist) who 
is at a location remote from the patient and is communicating with the 
patient, or health care professional who is treating the patient, using 
a telecommunications system referred to in section 1834(m) of the Social 
Security Act, which practice--
            ``(A) is being conducted--
                    ``(i) while the patient is being treated by, and 
                physically located in, a hospital or clinic registered 
                under section 303(f); and
                    ``(ii) by a practitioner--
                          ``(I) acting in the usual course of 
                      professional practice;
                          ``(II) acting in accordance with applicable 
                      State law; and
                          ``(III) registered under section 303(f) in the 
                      State in which the patient is located, unless the 
                      practitioner--
                                    ``(aa) is exempted from such 
                                registration in all States under section 
                                302(d); or
                                    ``(bb) is--
                                            ``(AA) an employee or 
                                        contractor of the Department of 
                                        Veterans Affairs who is acting 
                                        in the scope of such employment 
                                        or contract; and
                                            ``(BB) registered under 
                                        section 303(f) in any State or 
                                        is utilizing the registration of 
                                        a hospital or clinic operated by 
                                        the Department of Veterans 
                                        Affairs registered under section 
                                        303(f);
            ``(B) is being conducted while the patient is being treated 
        by, and in the physical presence of, a practitioner--
                    ``(i) acting in the usual course of professional 
                practice;
                    ``(ii) acting in accordance with applicable State 
                law; and

[[Page 122 STAT. 4823]]

                    ``(iii) registered under section 303(f) in the State 
                in which the patient is located, unless the 
                practitioner--
                          ``(I) is exempted from such registration in 
                      all States under section 302(d); or
                          ``(II) is--
                                    ``(aa) an employee or contractor of 
                                the Department of Veterans Affairs who 
                                is acting in the scope of such 
                                employment or contract; and
                                    ``(bb) registered under section 
                                303(f) in any State or is using the 
                                registration of a hospital or clinic 
                                operated by the Department of Veterans 
                                Affairs registered under section 303(f);
            ``(C) is being conducted by a practitioner--
                    ``(i) who is an employee or contractor of the Indian 
                Health Service, or is working for an Indian tribe or 
                tribal organization under its contract or compact with 
                the Indian Health Service under the Indian Self-
                Determination and Education Assistance Act;
                    ``(ii) acting within the scope of the employment, 
                contract, or compact described in clause (i); and
                    ``(iii) who is designated as an Internet Eligible 
                Controlled Substances Provider by the Secretary under 
                section 311(g)(2);
            ``(D)(i) is being conducted during a public health emergency 
        declared by the Secretary under section 319 of the Public Health 
        Service Act; and
            ``(ii) involves patients located in such areas, and such 
        controlled substances, as the Secretary, with the concurrence of 
        the Attorney General, designates, provided that such designation 
        shall not be subject to the procedures prescribed by subchapter 
        II of chapter 5 of title 5, United States Code;
            ``(E) is being conducted by a practitioner who has obtained 
        from the Attorney General a special registration under section 
        311(h);
            ``(F) is being conducted--
                    ``(i) in a medical emergency situation--
                          ``(I) that prevents the patient from being in 
                      the physical presence of a practitioner registered 
                      under section 303(f) who is an employee or 
                      contractor of the Veterans Health Administration 
                      acting in the usual course of business and 
                      employment and within the scope of the official 
                      duties or contract of that employee or contractor;
                          ``(II) that prevents the patient from being 
                      physically present at a hospital or clinic 
                      operated by the Department of Veterans Affairs 
                      registered under section 303(f);
                          ``(III) during which the primary care 
                      practitioner of the patient or a practitioner 
                      otherwise practicing telemedicine within the 
                      meaning of this paragraph is unable to provide 
                      care or consultation; and
                          ``(IV) that requires immediate intervention by 
                      a health care practitioner using controlled 
                      substances to prevent what the practitioner 
                      reasonably believes in good faith will be imminent 
                      and serious clinical consequences, such as further 
                      injury or death; and
                    ``(ii) by a practitioner that--

[[Page 122 STAT. 4824]]

                          ``(I) is an employee or contractor of the 
                      Veterans Health Administration acting within the 
                      scope of that employment or contract;
                          ``(II) is registered under section 303(f) in 
                      any State or is utilizing the registration of a 
                      hospital or clinic operated by the Department of 
                      Veterans Affairs registered under section 303(f); 
                      and
                          ``(III) issues a controlled substance 
                      prescription in this emergency context that is 
                      limited to a maximum of a 5-day supply which may 
                      not be extended or refilled; or
            ``(G) is being conducted under any other circumstances that 
        the Attorney General and the Secretary have jointly, by 
        regulation, determined to be consistent with effective controls 
        against diversion and otherwise consistent with the public 
        health and safety.

    ``(55) The term `refilling prescriptions for controlled substances 
in schedule III, IV, or V'--
            ``(A) means the dispensing of a controlled substance in 
        schedule III, IV, or V in accordance with refill instructions 
        issued by a practitioner as part of a valid prescription that 
        meets the requirements of subsections (b) and (c) of section 
        309, as appropriate; and
            ``(B) does not include the issuance of a new prescription to 
        an individual for a controlled substance that individual was 
        previously prescribed.

    ``(56) The term `filling new prescriptions for controlled substances 
in schedule III, IV, or V' means filling a prescription for an 
individual for a controlled substance in schedule III, IV, or V, if--
            ``(A) the pharmacy dispensing that prescription has 
        previously dispensed to the patient a controlled substance other 
        than by means of the Internet and pursuant to the valid 
        prescription of a practitioner that meets the applicable 
        requirements of subsections (b) and (c) of section 309 (in this 
        paragraph referred to as the `original prescription');
            ``(B) the pharmacy contacts the practitioner who issued the 
        original prescription at the request of that individual to 
        determine whether the practitioner will authorize the issuance 
        of a new prescription for that individual for the controlled 
        substance described in subparagraph (A); and
            ``(C) the practitioner, acting in the usual course of 
        professional practice, determines there is a legitimate medical 
        purpose for the issuance of the new prescription.''.

    (b) Registration Requirements.--Section 303(f) of the Controlled 
Substances Act (21 U.S.C. 823(f)) is amended in the matter preceding 
paragraph (1)--
            (1) in the first sentence, by adding after ``schedule II, 
        III, IV, or V'' the following: ``and shall modify the 
        registrations of pharmacies so registered to authorize them to 
        dispense controlled substances by means of the Internet''; and
            (2) in the second sentence, by striking ``if he determines 
        that the issuance of such registration'' and inserting ``or such 
        modification of registration if the Attorney General determines 
        that the issuance of such registration or modification''.

    (c) Reporting Requirements.--Section 307(d) of the Controlled 
Substances Act (21 U.S.C. 827(d)) is amended by--

[[Page 122 STAT. 4825]]

            (1) striking ``(d) Every'' and inserting ``(d)(1) Every''; 
        and
            (2) adding at the end the following:

    ``(2) <<NOTE: Regulations.>> Each pharmacy with a modified 
registration under section 303(f) that authorizes the dispensing of 
controlled substances by means of the Internet shall report to the 
Attorney General the controlled substances it dispenses, in the amount 
specified, and in such time and manner as the Attorney General by 
regulation shall require, except that the Attorney General, under this 
paragraph, may not require any pharmacy to report any information other 
than the total quantity of each controlled substance that the pharmacy 
has dispensed each month. For purposes of this paragraph, no reporting 
shall be required unless the pharmacy has met 1 of the following 
thresholds in the month for which the reporting is required:
            ``(A) 100 or more prescriptions dispensed.
            ``(B) 5,000 or more dosage units of all controlled 
        substances combined.''.

    (d) Online Prescription Requirements.--
            (1) In general.--The Controlled Substances Act is amended by 
        inserting after section 310 (21 U.S.C. 830) the following:


``additional requirements relating to online pharmacies and telemedicine


    ``Sec. 311.  <<NOTE: 21 USC 831.>> (a) In General.--An online 
pharmacy shall display in a visible and clear manner on its homepage a 
statement that it complies with the requirements of this section with 
respect to the delivery or sale or offer for sale of controlled 
substances and shall at all times display on the homepage of its 
Internet site a declaration of compliance in accordance with this 
section.

    ``(b) Licensure.--Each online pharmacy shall comply with the 
requirements of State law concerning the licensure of pharmacies in each 
State from which it, and in each State to which it, delivers, 
distributes, or dispenses or offers to deliver, distribute, or dispense 
controlled substances by means of the Internet, pursuant to applicable 
licensure requirements, as determined by each such State.
    ``(c) Internet Pharmacy Site Disclosure Information.--Each online 
pharmacy shall post in a visible and clear manner on the homepage of 
each Internet site it operates, or on a page directly linked thereto in 
which the hyperlink is also visible and clear on the homepage, the 
following information for each pharmacy that delivers, distributes, or 
dispenses controlled substances pursuant to orders made on, through, or 
on behalf of, that website:
            ``(1) The name and address of the pharmacy as it appears on 
        the pharmacy's Drug Enforcement Administration certificate of 
        registration.
            ``(2) The pharmacy's telephone number and email address.
            ``(3) The name, professional degree, and States of licensure 
        of the pharmacist-in-charge, and a telephone number at which the 
        pharmacist-in-charge can be contacted.
            ``(4) A list of the States in which the pharmacy is licensed 
        to dispense controlled substances.
            ``(5) <<NOTE: Certification.>> A certification that the 
        pharmacy is registered under this part to deliver, distribute, 
        or dispense by means of the Internet controlled substances.

[[Page 122 STAT. 4826]]

            ``(6) The name, address, telephone number, professional 
        degree, and States of licensure of any practitioner who has a 
        contractual relationship to provide medical evaluations or issue 
        prescriptions for controlled substances, through referrals from 
        the website or at the request of the owner or operator of the 
        website, or any employee or agent thereof.
            ``(7) The following statement, unless revised by the 
        Attorney General by regulation: `This online pharmacy will only 
        dispense a controlled substance to a person who has a valid 
        prescription issued for a legitimate medical purpose based upon 
        a medical relationship with a prescribing practitioner. This 
        includes at least one prior in-person medical evaluation or 
        medical evaluation via telemedicine in accordance with 
        applicable requirements of section 309.'.

    ``(d) Notification.--
            ``(1) In <<NOTE: Deadline.>> general.--Thirty days prior to 
        offering a controlled substance for sale, delivery, 
        distribution, or dispensing, the online pharmacy shall notify 
        the Attorney General, in such form and manner as the Attorney 
        General shall determine, and the State boards of pharmacy in any 
        States in which the online pharmacy offers to sell, deliver, 
        distribute, or dispense controlled substances.
            ``(2) Contents.--The notification required under paragraph 
        (1) shall include--
                    ``(A) the information required to be posted on the 
                online pharmacy's Internet site under subsection (c) and 
                shall notify the Attorney General and the applicable 
                State boards of pharmacy, under penalty of perjury, that 
                the information disclosed on its Internet site under 
                subsection (c) is true and accurate;
                    ``(B) the online pharmacy's Internet site address 
                and a certification that the online pharmacy shall 
                notify the Attorney General of any change in the address 
                at least 30 days in advance; and
                    ``(C) the Drug Enforcement Administration 
                registration numbers of any pharmacies and practitioners 
                referred to in subsection (c), as applicable.
            ``(3) Existing online pharmacies.--
        An <<NOTE: Deadline.>> online pharmacy that is already 
        operational as of the effective date of this section, shall 
        notify the Attorney General and applicable State boards of 
        pharmacy in accordance with this subsection not later than 30 
        days after such date.

    ``(e) Declaration of Compliance.--On <<NOTE: Regulations.>> and 
after the date on which it makes the notification under subsection (d), 
each online pharmacy shall display on the homepage of its Internet site, 
in such form as the Attorney General shall by regulation require, a 
declaration that it has made such notification to the Attorney General.

    ``(f) Reports.--Any statement, declaration, notification, or 
disclosure required under this section shall be considered a report 
required to be kept under this part.
    ``(g) Notice and Designations Concerning Indian Tribes.--
            ``(1) In general.--For purposes of sections 102(52) and 
        512(c)(6)(B), the Secretary shall notify the Attorney General, 
        at such times and in such manner as the Secretary and the 
        Attorney General determine appropriate, of the Indian tribes or 
        tribal organizations with which the Secretary has contracted

[[Page 122 STAT. 4827]]

        or compacted under the Indian Self-Determination and Education 
        Assistance Act for the tribes or tribal organizations to provide 
        pharmacy services.
            ``(2) Designations.--
                    ``(A) In general.--The Secretary may designate a 
                practitioner described in subparagraph (B) as an 
                Internet Eligible Controlled Substances Provider. Such 
                designations shall be made only in cases where the 
                Secretary has found that there is a legitimate need for 
                the practitioner to be so designated because the 
                population served by the practitioner is in a 
                sufficiently remote location that access to medical 
                services is limited.
                    ``(B) Practitioners.--A practitioner described in 
                this subparagraph is a practitioner who is an employee 
                or contractor of the Indian Health Service, or is 
                working for an Indian tribe or tribal organization under 
                its contract or compact under the Indian Self-
                Determination and Education Assistance Act with the 
                Indian Health Service.

    ``(h) Special Registration for Telemedicine.--
            ``(1) In general.--The Attorney General may issue to a 
        practitioner a special registration to engage in the practice of 
        telemedicine for purposes of section 102(54)(E) if the 
        practitioner, upon application for such special registration--
                    ``(A) demonstrates a legitimate need for the special 
                registration; and
                    ``(B) is registered under section 303(f) in the 
                State in which the patient will be located when 
                receiving the telemedicine treatment, unless the 
                practitioner--
                          ``(i) is exempted from such registration in 
                      all States under section 302(d); or
                          ``(ii) is an employee or contractor of the 
                      Department of Veterans Affairs who is acting in 
                      the scope of such employment or contract and is 
                      registered under section 303(f) in any State or is 
                      utilizing the registration of a hospital or clinic 
                      operated by the Department of Veterans Affairs 
                      registered under section 303(f).
            ``(2) Regulations.--The Attorney General shall, with the 
        concurrence of the Secretary, promulgate regulations specifying 
        the limited circumstances in which a special registration under 
        this subsection may be issued and the procedures for obtaining 
        such a special registration.
            ``(3) Denials.--Proceedings to deny an application for 
        registration under this subsection shall be conducted in 
        accordance with section 304(c).

    ``(i) Reporting of Telemedicine by VHA During Medical Emergency 
Situations.--
            ``(1) In general.--Any <<NOTE: Regulations.>> practitioner 
        issuing a prescription for a controlled substance under the 
        authorization to conduct telemedicine during a medical emergency 
        situation described in section 102(54)(F) shall report to the 
        Secretary of Veterans Affairs the authorization of that 
        emergency prescription, in accordance with such requirements as 
        the Secretary of Veterans Affairs shall, by regulation, 
        establish.
            ``(2) To attorney general.--Not later than 30 days after the 
        date that a prescription described in subparagraph (A) is 
        issued, the Secretary of Veterans Affairs shall report to

[[Page 122 STAT. 4828]]

        the Attorney General the authorization of that emergency 
        prescription.

    ``(j) Clarification <<NOTE: Regulations.>> Concerning Prescription 
Transfers.--Any transfer between pharmacies of information relating to a 
prescription for a controlled substance shall meet the applicable 
requirements under regulations promulgated by the Attorney General under 
this Act.''.
            (2) Technical and conforming amendments.--The table of 
        contents for the Comprehensive Drug Abuse Prevention and Control 
        Act of 1970 (Public Law 91-513; 84 Stat. 1236) is amended by 
        inserting after the item relating to section 310 the following:

``Sec. 311. Additional requirements relating to online pharmacies and 
           telemedicine.''.

    (e) Offenses Involving Controlled Substances in Schedules III, IV, 
and V.--Section 401(b) of the Controlled Substances Act (21 U.S.C. 
841(b)) is amended--
            (1) in paragraph (1)--
                    (A) in subparagraph (D), by striking ``or in the 
                case of any controlled substance in schedule III (other 
                than gamma hydroxybutyric acid), or 30 milligrams of 
                flunitrazepam''; and
                    (B) by adding at the end the following:

    ``(E)(i) <<NOTE: Penalties.>> Except as provided in subparagraphs 
(C) and (D), in the case of any controlled substance in schedule III, 
such person shall be sentenced to a term of imprisonment of not more 
than 10 years and if death or serious bodily injury results from the use 
of such substance shall be sentenced to a term of imprisonment of not 
more than 15 years, a fine not to exceed the greater of that authorized 
in accordance with the provisions of title 18, United States Code, or 
$500,000 if the defendant is an individual or $2,500,000 if the 
defendant is other than an individual, or both.

    ``(ii) If any person commits such a violation after a prior 
conviction for a felony drug offense has become final, such person shall 
be sentenced to a term of imprisonment of not more than 20 years and if 
death or serious bodily injury results from the use of such substance 
shall be sentenced to a term of imprisonment of not more than 30 years, 
a fine not to exceed the greater of twice that authorized in accordance 
with the provisions of title 18, United States Code, or $1,000,000 if 
the defendant is an individual or $5,000,000 if the defendant is other 
than an individual, or both.
    ``(iii) Any sentence imposing a term of imprisonment under this 
subparagraph shall, in the absence of such a prior conviction, impose a 
term of supervised release of at least 2 years in addition to such term 
of imprisonment and shall, if there was such a prior conviction, impose 
a term of supervised release of at least 4 years in addition to such 
term of imprisonment.'';
            (2) in paragraph (2)--
                    (A) by striking ``3 years'' and inserting ``5 
                years'';
                    (B) by striking ``6 years'' and inserting ``10 
                years'';
                    (C) by striking ``after one or more prior 
                convictions'' and all that follows through ``have become 
                final,'' and inserting ``after a prior conviction for a 
                felony drug offense has become final,''; and
            (3) in paragraph (3)--

[[Page 122 STAT. 4829]]

                    (A) by striking ``2 years'' and inserting ``4 
                years'';
                    (B) by striking ``after one or more convictions'' 
                and all that follows through ``have become final,'' and 
                inserting ``after a prior conviction for a felony drug 
                offense has become final,''; and
                    (C) by adding at the end the following ``Any 
                sentence imposing a term of imprisonment under this 
                paragraph may, if there was a prior conviction, impose a 
                term of supervised release of not more than 1 year, in 
                addition to such term of imprisonment.''.

    (f) Offenses Involving Dispensing of Controlled Substances by Means 
of the Internet.--Section 401 of the Controlled Substances Act (21 
U.S.C. 841) is amended by adding at the end the following:
    ``(h) Offenses Involving Dispensing of Controlled Substances by 
Means of the Internet.--
            ``(1) In general.--It shall be unlawful for any person to 
        knowingly or intentionally--
                    ``(A) deliver, distribute, or dispense a controlled 
                substance by means of the Internet, except as authorized 
                by this title; or
                    ``(B) aid or abet (as such terms are used in section 
                2 of title 18, United States Code) any activity 
                described in subparagraph (A) that is not authorized by 
                this title.
            ``(2) Examples.--Examples of activities that violate 
        paragraph (1) include, but are not limited to, knowingly or 
        intentionally--
                    ``(A) delivering, distributing, or dispensing a 
                controlled substance by means of the Internet by an 
                online pharmacy that is not validly registered with a 
                modification authorizing such activity as required by 
                section 303(f) (unless exempt from such registration);
                    ``(B) writing a prescription for a controlled 
                substance for the purpose of delivery, distribution, or 
                dispensation by means of the Internet in violation of 
                section 309(e);
                    ``(C) serving as an agent, intermediary, or other 
                entity that causes the Internet to be used to bring 
                together a buyer and seller to engage in the dispensing 
                of a controlled substance in a manner not authorized by 
                sections 303(f) or 309(e);
                    ``(D) offering to fill a prescription for a 
                controlled substance based solely on a consumer's 
                completion of an online medical questionnaire; and
                    ``(E) making a material false, fictitious, or 
                fraudulent statement or representation in a notification 
                or declaration under subsection (d) or (e), 
                respectively, of section 311.
            ``(3) Inapplicability.--
                    ``(A) This subsection does not apply to--
                          ``(i) the delivery, distribution, or 
                      dispensation of controlled substances by 
                      nonpractitioners to the extent authorized by their 
                      registration under this title;
                          ``(ii) the placement on the Internet of 
                      material that merely advocates the use of a 
                      controlled substance or includes pricing 
                      information without attempting to propose or 
                      facilitate an actual transaction involving a 
                      controlled substance; or

[[Page 122 STAT. 4830]]

                          ``(iii) except as provided in subparagraph 
                      (B), any activity that is limited to--
                                    ``(I) the provision of a 
                                telecommunications service, or of an 
                                Internet access service or Internet 
                                information location tool (as those 
                                terms are defined in section 231 of the 
                                Communications Act of 1934); or
                                    ``(II) the transmission, storage, 
                                retrieval, hosting, formatting, or 
                                translation (or any combination thereof) 
                                of a communication, without selection or 
                                alteration of the content of the 
                                communication, except that deletion of a 
                                particular communication or material 
                                made by another person in a manner 
                                consistent with section 230(c) of the 
                                Communications Act of 1934 shall not 
                                constitute such selection or alteration 
                                of the content of the communication.
                    ``(B) The exceptions under subclauses (I) and (II) 
                of subparagraph (A)(iii) shall not apply to a person 
                acting in concert with a person who violates paragraph 
                (1).
            ``(4) Knowing or intentional violation.--Any person who 
        knowingly or intentionally violates this subsection shall be 
        sentenced in accordance with subsection (b).''.

    (g) Publication.--Section 403(c) of the Controlled Substances Act 
(21 U.S.C. 843(c)) is amended by--
            (1) striking ``(c)'' and inserting ``(c)(1)''; and
            (2) adding at the end the following:

    ``(2)(A) It shall be unlawful for any person to knowingly or 
intentionally use the Internet, or cause the Internet to be used, to 
advertise the sale of, or to offer to sell, distribute, or dispense, a 
controlled substance where such sale, distribution, or dispensing is not 
authorized by this title or by the Controlled Substances Import and 
Export Act.
    ``(B) Examples of activities that violate subparagraph (A) include, 
but are not limited to, knowingly or intentionally causing the placement 
on the Internet of an advertisement that refers to or directs 
prospective buyers to Internet sellers of controlled substances who are 
not registered with a modification under section 303(f).
    ``(C) Subparagraph (A) does not apply to material that either--
            ``(i) merely advertises the distribution of controlled 
        substances by nonpractitioners to the extent authorized by their 
        registration under this title; or
            ``(ii) merely advocates the use of a controlled substance or 
        includes pricing information without attempting to facilitate an 
        actual transaction involving a controlled substance.''.

    (h) Injunctive Relief.--Section 512 of the Controlled Substances Act 
(21 U.S.C. 882) is amended by adding at the end the following:
    ``(c) State Cause of Action Pertaining to Online Pharmacies.--
            ``(1) In general.--In any case in which the State has reason 
        to believe that an interest of the residents of that State has 
        been or is being threatened or adversely affected by the action 
        of a person, entity, or Internet site that violates the 
        provisions of section 303(f), 309(e), or 311, the State may

[[Page 122 STAT. 4831]]

        bring a civil action on behalf of such residents in a district 
        court of the United States with appropriate jurisdiction--
                    ``(A) to enjoin the conduct which violates this 
                section;
                    ``(B) to enforce compliance with this section;
                    ``(C) to obtain damages, restitution, or other 
                compensation, including civil penalties under section 
                402(b); and
                    ``(D) to obtain such other legal or equitable relief 
                as the court may find appropriate.
            ``(2) Service; intervention.--
                    ``(A) <<NOTE: Records.>> Prior to filing a complaint 
                under paragraph (1), the State shall serve a copy of the 
                complaint upon the Attorney General and upon the United 
                States Attorney for the judicial district in which the 
                complaint is to be filed. In any case where such prior 
                service is not feasible, the State shall serve the 
                complaint on the Attorney General and the appropriate 
                United States Attorney on the same day that the State's 
                complaint is filed in Federal district court of the 
                United States. Such proceedings shall be independent of, 
                and not in lieu of, criminal prosecutions or any other 
                proceedings under this title or any other laws of the 
                United States.
                    ``(B) Upon receiving notice respecting a civil 
                action pursuant to this section, the United States shall 
                have the right to intervene in such action and, upon so 
                intervening, to be heard on all matters arising therein, 
                and to file petitions for appeal.
                    ``(C) Service of a State's complaint on the United 
                States as required in this paragraph shall be made in 
                accord with the requirements of rule 4(i)(1) of the 
                Federal Rule of Civil Procedure.
            ``(3) Powers conferred by state law.--For purposes of 
        bringing any civil action under paragraph (1), nothing in this 
        Act shall prevent an attorney general of a State from exercising 
        the powers conferred on the attorney general of a State by the 
        laws of such State to conduct investigations or to administer 
        oaths or affirmations or to compel the attendance of witnesses 
        of or the production of documentary or other evidence.
            ``(4) Venue.--Any civil action brought under paragraph (1) 
        in a district court of the United States may be brought in the 
        district in which the defendant is found, is an inhabitant, or 
        transacts business or wherever venue is proper under section 
        1391 of title 28, United States Code. Process in such action may 
        be served in any district in which the defendant is an 
        inhabitant or in which the defendant may be found.
            ``(5) No private right of action.--No private right of 
        action is created under this subsection.
            ``(6) Limitation.--No civil action may be brought under 
        paragraph (1) against--
                    ``(A) the United States;
                    ``(B) an Indian Tribe or tribal organization, to the 
                extent such tribe or tribal organization is lawfully 
                carrying out a contract or compact under the Indian 
                Self-Determination and Education Assistance Act; or
                    ``(C) any employee of the United States or such 
                Indian tribe or tribal organization, provided such agent 
                or employee is acting in the usual course of business or

[[Page 122 STAT. 4832]]

                employment, and within the scope of the official duties 
                of such agent or employee therewith.''.

    (i) Import and Export Act.--Section 1010(b) of the Controlled 
Substances Import and Export Act (21 U.S.C. 960(b)) is amended--
            (1) in paragraph (4)--
                    (A) by striking ``or any quantity of a controlled 
                substance in schedule III, IV, or V, (except a violation 
                involving flunitrazepam and except a violation involving 
                gamma hydroxybutyric acid)'';
                    (B) by inserting ``or'' before ``less than one 
                kilogram of hashish oil''; and
                    (C) by striking ``imprisoned'' and all that follows 
                through the end of the paragraph and inserting 
                ``sentenced in accordance with section 401(b)(1)(D).'';
            (2) by adding at the end the following:

    ``(5) In the case of a violation of subsection (a) involving a 
controlled substance in schedule III, such person shall be sentenced in 
accordance with section 401(b)(1).
    ``(6) In the case of a violation of subsection (a) involving a 
controlled substance in schedule IV, such person shall be sentenced in 
accordance with section 401(b)(2).
    ``(7) In the case of a violation of subsection (a) involving a 
controlled substance in schedule V, such person shall be sentenced in 
accordance with section 401(b)(3).''; and
            (3) in paragraph (3), by striking ``, nor shall a person so 
        sentenced be eligible for parole during the term of such a 
        sentence'' in the final sentence.

    (j) Effective <<NOTE: 21 USC 802 note.>> Date.--
            (1) In general.--Except as provided in paragraph (2), the 
        amendments made by this Act shall take effect 180 days after the 
        date of enactment of this Act.
            (2) Definition of practice of telemedicine.--
                    (A) In general.--Until <<NOTE: Deadline.>> the 
                earlier of 3 months after the date on which regulations 
                are promulgated to carry out section 311(h) of the 
                Controlled Substances Act, as amended by this Act, or 15 
                months after the date of enactment of this Act--
                          (i) the definition of the term ``practice of 
                      telemedicine'' in subparagraph (B) of this 
                      paragraph shall apply for purposes of the 
                      Controlled Substances Act; and
                          (ii) the definition of the term ``practice of 
                      telemedicine'' in section 102(54) of the 
                      Controlled Substances Act, as amended by this Act, 
                      shall not apply.
                    (B) Temporary phase-in of telemedicine regulation.--
                During the period specified in subparagraph (A), the 
                term ``practice of telemedicine'' means the practice of 
                medicine in accordance with applicable Federal and State 
                laws by a practitioner (as that term is defined in 
                section 102 of the Controlled Substances Act (21 U.S.C. 
                802)) (other than a pharmacist) who is at a location 
                remote from the patient and is communicating with the 
                patient, or health care professional who is treating the 
                patient, using a telecommunications system referred to 
                in section 1834(m) of the Social Security Act (42 U.S.C. 
                1395m(m)), if the practitioner is using an interactive 
                telecommunications system that satisfies the 
                requirements of section 410.78(a)(3) of title 42, Code 
                of Federal Regulations.

[[Page 122 STAT. 4833]]

                    (C) Rule of construction.--Nothing in this 
                subsection may be construed to create a precedent that 
                any specific course of conduct constitutes the 
                ``practice of telemedicine'' (as that term is defined in 
                section 102(54) of the Controlled Substances Act, as 
                amended by this Act) after the end of the period 
                specified in subparagraph (A).

    (k) Guidelines and Regulations.--
            (1) In <<NOTE: 21 USC 802 note.>> general.--The Attorney 
        General may promulgate and enforce any rules, regulations, and 
        procedures which may be necessary and appropriate for the 
        efficient execution of functions under this Act or the 
        amendments made by this Act, and, with the concurrence of the 
        Secretary of Health and Human Services where this Act or the 
        amendments made by this Act so provide, promulgate any interim 
        rules necessary for the implementation of this Act or the 
        amendments made by this Act, prior to its effective date.
            (2) Sentencing <<NOTE: 28 USC 994 note.>> guidelines.--The 
        United States Sentencing Commission, in determining whether to 
        amend, or establish new, guidelines or policy statements, to 
        conform the Federal sentencing guidelines and policy statements 
        to this Act and the amendments made by this Act, should not 
        construe any change in the maximum penalty for a violation 
        involving a controlled substance in a particular schedule as 
        being the sole reason to amend, or establish a new, guideline or 
        policy statement.

    (l) Annual Report.--Not later than 180 days after the date of 
enactment of this Act, and annually for 2 years after the initial 
report, the Drug Enforcement Administration, in consultation with the 
Department of State, shall submit to Congress a report describing--
            (1) the foreign supply chains and sources of controlled 
        substances offered for sale without a valid prescription on the 
        Internet;
            (2) the efforts and strategy of the Drug Enforcement 
        Administration to decrease the foreign supply chain and sources 
        of controlled substances offered for sale without a valid 
        prescription on the Internet; and
            (3) the efforts of the Drug Enforcement Administration to 
        work with domestic and multinational pharmaceutical companies 
        and others to build international cooperation and a commitment 
        to fight on a global scale the problem of distribution of 
        controlled substances over the Internet without a valid 
        prescription.

[[Page 122 STAT. 4834]]

SEC. 4. <<NOTE: 21 USC 802 note.>> RULE OF CONSTRUCTION.

    Nothing in this Act or the amendments made by this Act shall be 
construed as authorizing, prohibiting, or limiting the use of electronic 
prescriptions for controlled substances.

    Approved October 15, 2008.

LEGISLATIVE HISTORY--H.R. 6353 (S. 980):
---------------------------------------------------------------------------

HOUSE REPORTS: No. 110-869, Pt. 1 (Comm. on Energy and Commerce).
CONGRESSIONAL RECORD, Vol. 154 (2008):
            Sept. 23, considered and passed House.
            Sept. 30, considered and passed Senate.

                                  <all>