[Congressional Bills 110th Congress]
[From the U.S. Government Publishing Office]
[H.R. 6353 Engrossed in House (EH)]

  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
110th CONGRESS
  2d Session
                                H. R. 6353

_______________________________________________________________________

                                 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.

            Passed the House of Representatives September 23, 2008.

            Attest:

                                                                 Clerk.
110th CONGRESS

  2d Session

                               H. R. 6353

_______________________________________________________________________

                                 AN ACT

  To amend the Controlled Substances Act to address online pharmacies.