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[Congressional Bills 110th Congress]
[From the U.S. Government Publishing Office]
[S. 980 Engrossed in Senate (ES)]

  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
110th CONGRESS
  2d Session
                                 S. 980

_______________________________________________________________________

                                 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 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), (c), or 
                        (d) 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 (25 U.S.C. 450 et seq.);
                            ``(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 (42 U.S.C. 1395m(m)), and that--
                    ``(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 (25 U.S.C. 450 et 
                        seq.);
                            ``(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 (42 U.S.C. 247d); 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 
                subsection (b) or (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 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 that same 
                controlled substance other than by means of the 
                Internet and pursuant to the valid prescription of a 
                practitioner that meets the applicable requirements of 
                sections 309(b) or (c) (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) designating the text as paragraph (1); and
            (2) inserting after paragraph (1), as so designated by this 
        Act, 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 subsection, 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 of the Controlled 
        Substances Act (21 U.S.C. 829).'.
    ``(d) Notification.--(1) Thirty days prior to offering a controlled 
substance for sale, delivery, distribution, or dispensing, the online 
pharmacy shall notify the Attorney General, in the 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) 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) 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 the effective date of this section.
    ``(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 (25 U.S.C. 450 et seq.) 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 (25 U.S.C. 
                450 et seq.) 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 (C), by striking ``1 gram of'' 
                before ``flunitrazepam'';
                    (B) 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
                    (C) by adding at the end the following:
                    ``(E)(i) 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 20 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 ``6 
                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:
    ``(g) Offenses Involving Dispensing of Controlled Substances by 
Means of the Internet.--(1) 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 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 the submission to the Attorney 
        General under section 311.
    ``(3)(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 (47 
                U.S.C. 231)); 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 (47 
                U.S.C. 230(c)) 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) Any person who knowingly or intentionally violates this 
subsection shall be sentenced in accordance with subsection (b) of this 
section.''.
    (g) Publication.--Section 403(c) of the Controlled Substances Act 
(21 U.S.C. 843(c)) is amended by--
            (1) designating the text as paragraph (1); and
            (2) adding at the end the following:
    ``(2)(A) Except as authorized by this title, it shall be unlawful 
for any person by means of the Internet to knowingly advertise the sale 
or distribution of, or to offer to sell, distribute, or dispense, a 
controlled substance.
    ``(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 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)(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, 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) 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) 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 is created under this subsection.
    ``(6) 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) Forfeiture of Facilitating Property in Drug Cases.--Section 
511(a)(4) of the Controlled Substances Act (21 U.S.C. 881(a)(4)) is 
amended to read as follows:
            ``(4) Any property, real or personal, tangible or 
        intangible, used or intended to be used to commit, or to 
        facilitate the commission, of a violation of this title or 
        title III, and any property traceable thereto.''.
    (j) 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) striking ``imprisoned'' and all that follows 
                through the end of the paragraph and inserting 
                ``sentenced in accordance with section 401(b)(1)(D) of 
                this title (21 U.S.C. 841(b)(1)(E)).'';
            (2) by adding at the end the following:
            ``(5) In the case of a violation of subsection (a) of this 
        section involving a controlled substance in schedule III, such 
        person shall be sentenced in accordance with section 
        401(b)(1)(E).
            ``(6) In the case of a violation of subsection (a) of this 
        section involving a controlled substance in schedule IV (except 
        a violation involving flunitrazepam), such person shall be 
        sentenced in accordance with section 401(b)(2).
            ``(7) In the case of a violation of subsection (a) of this 
        section 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.
    (k) 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).
    (l) 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 
        provides, 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--
                    (A) shall consult with the Department of Justice, 
                experts and other affected parties concerning which 
                penalties for scheduled substances amended by this Act 
                should be reflected in the Federal sentencing 
                guidelines; and
                    (B) 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 a, or establish a new, guideline or 
                policy statement.
    (m) 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.

            Passed the Senate April 1 (legislative day, March 13), 
      2008.

            Attest:

                                                             Secretary.
110th CONGRESS

  2d Session

                                 S. 980

_______________________________________________________________________

                                 AN ACT

  To amend the Controlled Substances Act to address online pharmacies.
```