[Congressional Bills 110th Congress]
[From the U.S. Government Publishing Office]
[H.R. 6353 Enrolled Bill (ENR)]

        H.R.6353

                       One Hundred Tenth Congress

                                 of the

                        United States of America


                          AT THE SECOND SESSION

          Begun and held at the City of Washington on Thursday,
            the third day of January, two thousand and eight


                                 An Act


 
  To amend the Controlled Substances Act to address online pharmacies.

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,
SECTION 1. 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.
        ``(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;
            ``(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
            ``(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--
                ``(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--
        (1) striking ``(d) Every'' and inserting ``(d)(1) Every''; and
        (2) adding at the end the following:
    ``(2) 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.  (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) A certification that the pharmacy is registered under 
    this part to deliver, distribute, or dispense by means of the 
    Internet controlled substances.
        ``(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 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 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 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 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 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 the Attorney 
    General the authorization of that emergency prescription.
    ``(j) Clarification 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) 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)--
            (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
                ``(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 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) 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 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 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 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.
            (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 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 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.
SEC. 4. 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.

                               Speaker of the House of Representatives.

                            Vice President of the United States and    
                                               President of the Senate.