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[House Report 110-869]
[From the U.S. Government Publishing Office]

110th Congress                                            Rept. 110-869
                        HOUSE OF REPRESENTATIVES
 2d Session                                                      Part 1

======================================================================

 
      RYAN HAIGHT ONLINE PHARMACY CONSUMER PROTECTION ACT OF 2008

                                _______
                                

 September 23, 2008.--Committed to the Committee of the Whole House on 
            the State of the Union and ordered to be printed

                                _______
                                

 Mr. Dingell, from the Committee on Energy and Commerce, submitted the 
                               following

                              R E P O R T

                        [To accompany H.R. 6353]

      [Including cost estimate of the Congressional Budget Office]

  The Committee on Energy and Commerce, to whom was referred 
the bill (H.R. 6353) to amend the Controlled Substances Act to 
address online pharmacies, having considered the same, report 
favorably thereon with an amendment and recommend that the bill 
as amended do pass.

                                CONTENTS

                                                                   Page
Amendment........................................................     1
Purpose and Summary..............................................    11
Background and Need for Legislation..............................    11
Hearings.........................................................    12
Committee Consideration..........................................    12
Committee Votes..................................................    12
Committee Oversight Findings.....................................    12
Statement of General Performance Goals and Objectives............    12
New Budget Authority, Entitlement Authority, and Tax Expenditures    12
Earmarks and Tax and Tariff Benefits.............................    12
Committee Cost Estimate..........................................    13
Congressional Budget Office Estimate.............................    13
Federal Mandates Statement.......................................    15
Advisory Committee Statement.....................................    15
Constitutional Authority Statement...............................    15
Applicability to Legislative Branch..............................    15
Section-by-Section Analysis of the Legislation...................    15
Changes in Existing Law Made by the Bill, as Reported............    17

                               Amendment

  The amendment is as follows:
  Strike all after the enacting clause and insert the 
following:

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.

                          Purpose and Summary

    The purpose of H.R. 6353, the Ryan Haight Online Pharmacy 
Consumer Protection Act of 2008, is to amend the Controlled 
Substances Act to prohibit the delivery, distribution, or 
dispensing of controlled substances over the Internet without a 
valid prescription.
    In an effort to address concerns about the purchase of 
controlled substances through online pharmacies, H.R. 6353 
defines a ``valid prescription'' as a prescription that is 
issued for a legitimate purpose by a practitioner who has 
conducted at least one in-person medical evaluation of the 
patient.
    H.R. 6353 imposes registration and reporting requirements 
on online pharmacies. H.R. 6353 requires an online pharmacy to: 
(1) display on its Internet homepage a statement that it 
complies with the requirements of this Act; (2) comply with 
State laws for the licensure of pharmacies in each State in 
which it operates or sells controlled substances; (3) post on 
its Internet homepage specified information, including the 
name, address, and telephone number of the pharmacy, the 
qualifications of its pharmacist-in-charge, and a certification 
of its registration under this Act; and (4) notify the Attorney 
General and applicable State boards of pharmacy at least 30 
days prior to offering to sell, deliver, distribute, or 
dispense controlled substances over the Internet.
    H.R. 6353 increases criminal penalties involving controlled 
substances in Schedules II, IV, and V of the Controlled 
Substances Act. H.R. 6353 also authorizes States to apply for 
injunctions or obtain damages and other civil remedies against 
online pharmacies that are deemed a threat to State residents.

                  Background and Need for Legislation

    According to the Drug Enforcement Agency (DEA), nearly 7 
million Americans are abusing prescription drugs, more than the 
numbers who are abusing cocaine, heroin, hallucinogens, 
Ecstasy, and inhalants, combined. The number of individuals 
abusing prescription drugs has increased 80 percent in the last 
6 years.
    Prescription pain relievers have replaced marijuana and 
cocaine as new drug users' drug of choice. Nearly 1 in 10 high 
school seniors admits to abusing powerful prescription 
painkillers. A shocking 40 percent of teenagers and an almost 
equal number of their parents think abusing prescription 
painkillers is safer than abusing ``street'' drugs. 
Prescription pain relievers appear to be among the drugs most 
heavily dispensed by certain Internet pharmacies through 
prescriptions that are issued based on online questionnaires. 
This practice has been abused by rogue pharmacy sites that 
dispense large quantities of addictive substances to customers 
seeking access to prescription painkillers, leading to 
instances of addiction, overdose, and death. As of July 2004, 
DEA investigations had discovered 14 deaths or overdoses and 15 
persons who have entered rehabilitation or sustained injuries 
from drugs obtained over the Internet.
    The Internet, through Internet pharmacies, has become one 
of the fastest growing methods used today to purchase huge 
quantities of controlled pharmaceuticals. It is estimated there 
are between 400 and 1,000 Web sites that both dispense and 
offer a prescribing service, half of which are located in 
foreign countries.

                                Hearings

    No hearings were held in connection with H.R. 6353.

                        Committee Consideration

    On Wednesday, September 17, 2008, the full Committee met in 
open markup session and ordered H.R. 6353 favorably reported to 
the House, amended, by a voice vote.

                            Committee Votes

    Clause 3(b) of rule XIII of the Rules of the House of 
Representatives requires the Committee to list the record votes 
on the motion to report legislation and amendments thereto. No 
record votes were taken on amendments or in connection with 
ordering H.R. 6353 reported to the House. A motion by Mr. 
Dingell to order H.R. 6353 favorably reported to the House, 
amended, was agreed to by a voice vote.

                      Committee Oversight Findings

    Regarding clause 3(c)(1) of rule XIII of the Rules of the 
House of Representatives, the oversight findings of the 
Committee regarding H.R. 6353 are reflected in this report.

         Statement of General Performance Goals and Objectives

    The objective of H.R. 6353 is to counter the growing sale 
of controlled substances over the Internet without adequate 
medical oversight.

   New Budget Authority, Entitlement Authority, and Tax Expenditures

    Regarding compliance with clause 3(c)(2) of rule XIII of 
the Rules of the House of Representatives, the Committee adopts 
as its own the estimate of budget authority and revenues 
regarding H.R. 6353 prepared by the Director of the 
Congressional Budget Office pursuant to section 402 of the 
Congressional Budget Act of 1974. The Committee finds that the 
bill would result in no new or increased entitlement authority 
or tax expenditures.

                  Earmarks and Tax and Tariff Benefits

    Regarding compliance with clause 9 of rule XXI of the Rules 
of the House of Representatives, H.R. 6353 does not contain any 
congressional earmarks, limited tax benefits, or limited tariff 
benefits as defined in clause 9(d), 9(e), or 9(f) of rule XXI.

                        Committee Cost Estimate

    The Committee adopts as its own the cost estimate on H.R. 
6353 prepared by the Director of the Congressional Budget 
Office pursuant to section 402 of the Congressional Budget Act 
of 1974.

                  Congressional Budget Office Estimate

    Pursuant to clause 3(c)(3) of rule XIII of the Rules of the 
House of Representatives, the following is the cost estimate on 
H.R. 6353 provided by the Congressional Budget Office pursuant 
to section 402 of the Congressional Budget Act of 1974:

                                                September 23, 2008.
Hon. John D. Dingell,
Chairman, Committee on Energy and Commerce,
House of Representatives, Washington, DC.
    Dear Mr. Chairman: The Congressional Budget Office has 
prepared the enclosed cost estimate for H.R. 6353, the Ryan 
Haight Online Pharmacy Consumer Protection Act of 2008.
    If you wish further details on this estimate, we will be 
pleased to provide them. The CBO staff contact is Mark 
Grabowicz, who can be reached at 226-2860.
            Sincerely,
                                                   Peter R. Orszag.
    Enclosure.

H.R. 6353--Ryan Haight Online Pharmacy Consumer Protection Act of 2008

    Summary: H.R. 6353 would permit the Drug Enforcement 
Administration (DEA) to authorize certain pharmacies to 
distribute controlled substances using the Internet. CBO 
estimates that implementing H.R. 6353 would have no significant 
net cost to the federal government. Enacting the bill could 
affect direct spending and revenues, but CBO estimates that any 
net effects would not be significant.
    H.R. 6353 contains an intergovernmental mandate as defined 
in the Unfunded Mandates Reform Act (UMRA) because it would 
preempt state regulations of controlled substances that are 
manufactured, distributed, or dispensed via the Internet. CBO 
estimates, however, that states would incur little, if any, 
costs as a result of that preemption, and the costs to comply 
with the mandate would be well below the threshold established 
in UMRA ($68 million in 2008, adjusted annually for inflation).
    The bill's registration and reporting requirements and the 
requirement of a valid prescription for Internet distribution 
of controlled substances constitute private-sector mandates as 
defined in UMRA. CBO estimates that the direct costs of those 
mandates would not exceed the threshold established in UMRA for 
private-sector mandates ($136 million in 2008, adjusted 
annually for inflation).
    Estimated cost to the Federal Government:

                   SPENDING SUBJECT TO APPROPRIATION

    H.R. 6353 would establish new crimes and increase penalties 
for activities relating to illegal use of controlled 
substances. Because the bill would establish new offenses, the 
government would be able to pursue cases that it otherwise 
would not be able to prosecute. We expect that H.R. 6353 would 
apply to a relatively small number of offenders, however, so 
any increase in costs for law enforcement, court proceedings, 
or prison operations would not be significant. Any such costs 
would be subject to the availability of appropriated funds.

                      DIRECT SPENDING AND REVENUES

    H.R. 6353 would permit the DEA to authorize certain 
pharmacies to distribute controlled substances using the 
Internet. The agency currently charges a registration fee of 
$551 for a three-year period. Based on information from the DEA 
about the likely number of new registrants resulting from 
enactment of H.R. 6353, CBO estimates that the agency would 
collect less than $1 million each year. The DEA would spend 
those fees without further appropriation, mostly in the same 
year, to conduct inspections and carry out administrative 
activities related to the new registrants. Thus, CBO estimates 
that H.R. 6353 would have no significant net effect on DEA 
spending.
    Because those prosecuted and convicted under H.R. 6353 
could be subject to criminal fines, the federal government 
might collect additional fines if the legislation is enacted. 
Criminal fines are recorded as revenues, then deposited in the 
Crime Victims Fund, and later spent. CBO expects that any 
additional revenues and direct spending would not be 
significant because of the small number of cases likely to be 
affected.
    Estimated impact on State, local, and tribal governments: 
H.R. 6353 contains an intergovernmental mandate as defined in 
UMRA because it would preempt state regulations of controlled 
substances that are manufactured, distributed, or dispensed via 
the Internet. Under current law, states license pharmacies and 
doctors to dispense controlled substances within each state. 
This bill would prohibit the sale of controlled substances that 
are sold over the Internet without a prescription and would 
require doctors to have at least one in-person consultation 
with patients for whom they prescribe controlled medications. 
Currently, all states allow medications to be purchased via the 
Internet, but some states do not specifically require in-person 
consultations for prescriptions. Enacting this provision would 
preempt state authority. CBO estimates, however, that states 
would incur little, if any costs, as a result of that 
preemption, and the costs to comply with the mandate would be 
well below the threshold established in UMRA ($68 million in 
2008, adjusted annually for inflation).
    Estimated impact on the private sector: The bill's 
registration and reporting requirements and the requirement of 
a valid prescription for Internet distribution of controlled 
substances would constitute private-sector mandates as defined 
by UMRA. CBO estimates that the direct costs of those mandates 
would not exceed the threshold established in UMRA ($136 
million in 2008, adjusted annually for inflation).
    Previous CBO estimate: On October 25, 2007, CBO transmitted 
a cost estimate for S. 980, the Ryan Haight Online Pharmacy 
Consumer Protection Act of 2007, as ordered reported by the 
Senate Committee on the Judiciary on September 27, 2007. The 
two bills are similar, and the cost estimates are nearly 
identical.
    Estimate prepared by: Federal Costs: Mark Grabowicz; Impact 
on State, Local, and Tribal Governments: Lisa Ramirez-Branum; 
Impact on the Private Sector: Colin Baker.
    Estimate approved by: Peter H. Fontaine, Assistant Director 
for Budget Analysis.

                       Federal Mandates Statement

    The Committee adopts as its own the estimate of Federal 
mandates regarding H.R. 6353 prepared by the Director of the 
Congressional Budget Office pursuant to section 423 of the 
Unfunded Mandates Reform Act.

                      Advisory Committee Statement

    No advisory committees within the meaning of section 5(b) 
of the Federal Advisory Committee Act would be created by H.R. 
6353.

                   Constitutional Authority Statement

    Pursuant to clause 3(d)(1) of rule XIII of the Rules of the 
House of Representatives, the Committee finds that the 
Constitutional authority for H.R. 6353 is provided in Article 
I, section 8, clause 3, which grants Congress the power to 
regulate commerce with foreign nations, among the several 
States, and with the Indian Tribes.

                  Applicability to Legislative Branch

    The Committee finds that H.R. 6353 does not relate to the 
terms and conditions of employment or access to public services 
or accommodations within the meaning of section 102(b)(3) of 
the Congressional Accountability Act of 1995.

             Section-by-Section Analysis of the Legislation

Section 1. Short title

    Section 1 establishes the short title as the Ryan Haight 
Online Pharmacy Consumer Protection Act of 2008.

Section 2. Requirement of a valid prescription for controlled 
        substances dispensed by means of the Internet

    Section 2 adds a new section 309(e) to the Controlled 
Substances Act requiring a valid prescription for the delivery 
or distribution of a controlled substance that is a 
prescription drug. A ``valid prescription'' is defined as a 
prescription issued for a legitimate medical purpose in the 
usual course of professional practice, by a practitioner who 
has conducted at least one in-person medical evaluation of the 
patient, or a covering practitioner (as requested by a 
practitioner who had conducted an in-person medical evaluation 
of the patient within the past 24 months). Certain telemedicine 
practices are exempted from the in-person medical evaluation 
requirement.

Section 3. Amendments to the Controlled Substances Act relating to the 
        delivery of controlled substances by means of the Internet

    Section 3(a) defines the following terms: Internet; 
deliver, distribute, or dispense by means of the Internet; 
online pharmacy; and practice of telemedicine.
    Section 3(a) exempts from the definition of ``online 
pharmacy'' non-pharmacy practitioners, hospitals, or medical 
facilities operated by agencies of the United States, health 
facilities owned by Indian Tribes carrying out contracts or 
compacts under the Indian Self Determination and Education 
Assistance Act, and mere advertisements that do not attempt to 
facilitate an actual transaction.
    Section 3(a) exempts pharmacies that use the Internet only 
to receive refill orders, or requests to contact a patient's 
physician.
    Section 3(b) requires pharmacies that seek to dispense 
controlled substances via the Internet to receive a 
modification of their existing registration to dispense 
controlled substances by means of the Internet.
    Section 3(c) requires pharmacies with a modified 
registration to report to the Attorney General the total 
quantity of each controlled substance dispensed per month. 
Reporting is required only when pharmacies dispense at least 
100 or more controlled substance prescriptions per month or 500 
or more controlled substance dosage units per month.
    Section 3(d) requires pharmacies to clearly display 
notification that they comply with the requirements of this 
Act. Pharmacies must post information regarding: name and 
address of the pharmacy as it appears on its DEA registration; 
a list of States in which the pharmacy is licensed to 
distribute prescription drugs or controlled substances; name 
and degree of pharmacist in charge; contact information for the 
pharmacist in charge; and the name and contact information of 
any practitioners with a contractual relationship to issue 
controlled substance prescriptions. Pharmacies must notify the 
U.S. Attorney General and State boards of pharmacy 30 days 
before delivering, distributing, or dispensing a controlled 
substance.
    Section 3(d) authorizes the Secretary to designate certain 
practitioners as ``Internet Eligible Controlled Substance 
Providers'' and allows the U.S. Attorney General to issue 
special registrations for the practice of telemedicine. Section 
3(d) describes reporting criteria for emergency prescriptions 
issued under the Veterans Health Administration emergency 
telemedicine exemption. Section 3(d) clarifies that any 
transfer of prescription information from one pharmacy to 
another must meet applicable requirements in the Controlled 
Substances Act.
    Section 3(e) increases the penalties for all illegal 
distributions of Schedule III, IV, and V controlled substances. 
For Schedule III controlled substances, maximum penalties are 
increased to 10 years for first offenders and 20 years for 
repeat offenders, or 15 and 30 years, respectively, if death or 
serious bodily injury results. For Schedule IV substances, the 
new penalties are 5 years for first offenders and 10 years for 
repeat offenders. For Schedule V repeat offenders, the maximum 
penalty increases to four years. Supervised release terms after 
imprisonment for a Schedule V offense are also authorized.
    Section 3(f) clarifies that knowingly or intentionally 
delivering, distributing, or dispensing controlled substances 
over the Internet in violation of this Act can be prosecuted 
and penalized just like hand-to-hand distributions. This 
provision does not apply, however, to persons who register and 
follow the requirements of this Act, to those who merely 
advocate usage or list pricing information, but do not promote 
or facilitate an actual transaction involving a controlled 
substance, or to anyone providing telecommunications or 
Internet services who are not acting in concert with persons 
violating this Act.
    Section 3(g) clarifies that Internet sales of controlled 
substances must follow the terms of this Act. The Act does not 
apply to material that advocates the use of controlled 
substances or does not attempt to facilitate an actual 
transaction.
    Section 3(h) authorizes State Attorneys General to file 
civil lawsuits in Federal court against online businesses if 
the residents of a State are threatened or adversely affected 
by noncompliance, so long as the U.S. Attorney General is 
notified in advance and given a chance to intervene within 120 
days.
    Section 3(j) applies the same penalty changes made to the 
Controlled Substances Act to the Import and Export Act.
    Section 3(k) establishes an effective date of 180 days 
after enactment. Section 3(k) also creates a temporary 
definition for ``practice of telemedicine'' that will apply for 
the first 15 months following enactment.
    Section 3(l) authorizes the U.S. Attorney General to 
promulgate and enforce any rules, regulations, and procedures 
as necessary for the efficient execution of functions under 
this Act. The United States Sentencing Commission is authorized 
to add or modify the Sentencing Guidelines as warranted. The 
Commission, however, 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.
    Section 3(m) requires the DEA to provide a report to 
Congress within 180 days after enactment, and annually for 2 
additional years, describing the foreign supply chains and 
sources of controlled substances illegally offered over the 
Internet, and the DEA's efforts and strategies to confront 
these global challenges.

Section 4. Rule of construction

    Section 4 clarifies that nothing in the Act shall be 
construed as authorizing, prohibiting, or limiting the use of 
electronic prescribing for controlled substances.

         Changes in Existing Law Made by the Bill, as Reported

  In compliance with clause 3(e) of rule XIII of the Rules of 
the House of Representatives, changes in existing law made by 
the bill, as reported, are shown as follows (existing law 
proposed to be omitted is enclosed in black brackets, new 
matter is printed in italic, existing law in which no change is 
proposed is shown in roman):

      COMPREHENSIVE DRUG ABUSE PREVENTION AND CONTROL ACT OF 1970

           *       *       *       *       *       *       *
                           table of contents

                   title ii--control and enforcement

       Part A--Short Title; Findings and Declaration; Definitions

Sec. 100. Short title.
     * * * * * * *

 Part C--Registration of Manufacturers, Distributors, and Dispensers of 
               Controlled Substances; Piperidine Reporting

Sec. 301. Rules and regulations.
     * * * * * * *
Sec. 311. Additional requirements relating to online pharmacies and 
          telemedicine.

           *       *       *       *       *       *       *

                   TITLE II--CONTROL AND ENFORCEMENT

       Part A--Short Title; Findings and Declaration; Definitions

                              short title

  Sec. 100. This title may be cited as the ``Controlled 
Substances Act''.

           *       *       *       *       *       *       *

                              DEFINITIONS

  Sec. 102. As used in this title:
  (1) * * *

           *       *       *       *       *       *       *

  (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.

           *       *       *       *       *       *       *

Part C--Registration of Manufacturers, Distributors, and Dispensers of 
Controlled Substances; Piperidine Reporting

           *       *       *       *       *       *       *

                       REGISTRATION REQUIREMENTS

  Sec. 303. (a) * * *

           *       *       *       *       *       *       *

  (f) The Attorney General shall register practitioners 
(including pharmacies, as distinguished from pharmacists) to 
dispense, or conduct research with, controlled substances in 
schedule II, III, IV, or V and shall modify the registrations 
of pharmacies so registered to authorize them to dispense 
controlled substances by means of the Internet, if the 
applicant is authorized to dispense, or conduct research with 
respect to, controlled substances under the laws of the State 
in which he practices. The Attorney General may deny an 
application for such registration [if he determines that the 
issuance of such registration] or such modification of 
registration if the Attorney General determines that the 
issuance of such registration or modification would be 
inconsistent with the public interest. In determining the 
public interest, the following factors shall be considered:
          (1) * * *

           *       *       *       *       *       *       *

                   RECORDS AND REPORTS OF REGISTRANTS

  Sec. 307. (a) * * *

           *       *       *       *       *       *       *

  [(d) Every] (d)(1) Every manufacturer registered under 
section 303 shall, at such time or times and in such form as 
the Attorney General may require, make periodic reports to the 
Attorney General of every sale, delivery or other disposal by 
him of any controlled substance, and each distributor shall 
make such reports with respect to narcotic controlled 
substances, identifying by the registration number assigned 
under this title the person or establishment (unless exempt 
from registration under section 302(d) to whom such sale, 
delivery, or other disposal was made.
  (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.

           *       *       *       *       *       *       *

                             PRESCRIPTIONS

  Sec. 309. (a) * * *

           *       *       *       *       *       *       *

  (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.

           *       *       *       *       *       *       *

 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.

                     Part D--Offenses and Penalties

                      PROHIBITED ACTS A--PENALTIES

  Sec. 401. (a) * * *
  (b) Except as otherwise provided in section 409, 418, 419, or 
420 any person who violates subsection (a) of this section 
shall be sentenced as follows:
  (1)(A) * * *

           *       *       *       *       *       *       *

  (D) In the case of less than 50 kilograms of marihuana, 
except in the case of 50 or more marihuana plants regardless of 
weight, 10 kilograms of hashish, or one kilogram of hashish oil 
[or in the case of any controlled substance in schedule III 
(other than gamma hydroxybutyric acid), or 30 milligrams of 
flunitrazepam], such person shall, except as provided in 
paragraphs (4) and (5) of this subsection, be sentenced to a 
term of imprisonment of not more than 5 years, a fine not to 
exceed the greater of that authorized in accordance with the 
provisions of title 18, United States Code, or $250,000 if the 
defendant is an individual or $1,000,000 if the defendant is 
other than an individual, or both. 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 10 years, a fine not to exceed 
the greater of twice that authorized in accordance with the 
provisions of title 18, United State Code, or $500,000 if the 
defendant is an individual or $2,000,000 if the defendant is 
other than an individual, or both. Notwithstanding section 3583 
of title 18, any sentence imposing a term of imprisonment under 
this paragraph shall, in the absence of such a prior 
conviction, impose a special parole term 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.
  (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 the case of a controlled substance in schedule IV, 
such person shall be sentenced to a term of imprisonment of not 
more than [3 years] 5 years, a fine not to exceed the greater 
of that authorized in accordance with the provisions of title 
18, United States Code, or $250,000 if the defendant is an 
individual or $1,000,000 if the defendant is other than an 
individual, or both. If any person commits such a violation 
[after one or more prior convictions of him for an offense 
punishable under this paragraph, or for a felony under any 
other provision of this title or title III or other law of a 
State, the United States, or a foreign country relating to 
narcotic drugs, marihuana, or depressant or stimulant 
substances, have become final,] 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 [6 years] 
10 years, a fine not to exceed the greater of twice the 
authorized in accordance with the provisions of title 18, 
United States Code, or $500,000 if the defendant is an 
individual or $2,000,000 if the defendant is other than an 
individual, or both. Any sentence imposing a term of 
imprisonment under this paragraph shall, in the absence of such 
a prior conviction, impose a term of supervised release of at 
least one year 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 2 years in addition to such term 
of imprisonment.
  (3) In the case of a controlled substance in schedule V, such 
person shall be sentenced to a term of imprisonment of not more 
than 1 year, a fine not to exceed the greater of that 
authorized in accordance with the provisions of title 18, 
United States Code, or $100,000 if the defendant is an 
individual or $250,000 if the defendant is other than an 
individual, or both. If any person commits such a violation 
[after one or more convictions of him for an offense punishable 
under this paragraph, or for a crime under any other provision 
of this title or title III or other law of a State, the United 
States, or a foreign country relating to narcotic drugs, 
marihuana, or depressant or stimulant substances, have become 
final,] 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 [2 years] 4 years, a fine not to 
exceed the provisions of title 18, United States Code, or 
$200,000 if the defendant is an individual or $500,000 if the 
defendant is other than an individual, or both. 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.

           *       *       *       *       *       *       *

  (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).

           *       *       *       *       *       *       *

                      PROHIBITED ACTS C--PENALTIES

  Sec. 403. (a) * * *

           *       *       *       *       *       *       *

  [(c)] (c)(1) It shall be unlawful for any person to place in 
any newspaper, magazine, handbill, or other publications, any 
written advertisement knowing that it has the purpose of 
seeking or offering illegally to receive, buy, or distribute a 
Schedule I controlled substance. As used in this section the 
term ``advertisement'' includes, in addition to its ordinary 
meaning, such advertisements as those for a catalog of Schedule 
I controlled substances and any similar written advertisement 
that has the purpose of seeking or offering illegally to 
receive, buy, or distribute a Schedule I controlled substance. 
The term ``advertisement'' does not include material which 
merely advocates the use of a similar material, which advocates 
a position or practice, and does not attempt to propose or 
facilitate an actual transaction in a Schedule I controlled 
substance.
  (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.

           *       *       *       *       *       *       *

Part E--Administrative and Enforcement Provisions

           *       *       *       *       *       *       *

                              INJUNCTIONS

  Sec. 512. (a) * * *

           *       *       *       *       *       *       *

  (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.

           *       *       *       *       *       *       *

   TITLE III--IMPORTATION AND EXPORTATION; AMENDMENTS AND REPEALS OF 
                              REVENUE LAWS

                              short title

  Sec. 1000. This title may be cited as the ``Controlled 
Substances Import and Export Act''.

           *       *       *       *       *       *       *

Part A--Importation and Exportation

           *       *       *       *       *       *       *

                      PROHIBITED ACTS A--PENALTIES

  Sec. 1010. (a) * * *
  (b)(1) * * *

           *       *       *       *       *       *       *

  (3) In the case of a violation under subsection (a) of this 
section involving a controlled substance in schedule I or II, 
gamma hydroxybutyric acid (including when scheduled as an 
approved drug product for purposes of section 3(a)(1)(B) of the 
Hillory J. Farias and Samantha Reid Date-Rape Drug Prohibition 
Act of 2000), or flunitrazepam, the person committing such 
violation shall, except as provided in paragraphs (1), (2), and 
(4), 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 less than twenty years and not more than 
life, a fine not to exceed the greater of 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. 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 30 years 
and if death or serious bodily injury results from the use of 
such substance shall be sentenced to life imprisonment, a fine 
not to exceed the greater of twice that authorized in 
accordance with the provisions of title 18, United States Code, 
or $2,000,000 if the defendant is an individual or $10,000,000 
if the defendant is other than an individual, or both. 
Notwithstanding section 3583 of title 18, any sentence imposing 
a term of imprisonment under this paragraph shall, in the 
absence of such a prior conviction, impose a term of 
suspervised release of at least 3 years in addition to such 
term of imprisonment and shall, if there was such a prior 
conviction, impose a term of suspervised release of at least 6 
years in addition to such term of imprisonment. Notwithstanding 
the prior sentence, and notwithstanding any other provision of 
law, the court shall not place on probation or suspend the 
sentence of any person sentenced under the provisions of this 
paragraph which provide for a mandatory term of imprisonment if 
death or serious bodily injury results[, nor shall a person so 
sentenced be eligible for parole during the term of such a 
sentence].
  (4) In the case of a violation under subsection (a) with 
respect to less than 50 kilograms of marihuana except in the 
case of 100 or more marihuana plants regardless of weight, less 
than 10 kilograms of hashish, or less than one kilogram of 
hashish oil, [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)] the person committing such violation 
shall be [imprisoned not more than five years, or be fined not 
to exceed the greater of that authorized in accordance with the 
provisions of title 18, United States Code, or $250,000 if the 
defendant is an individual or $1,000,000 if the defendant is 
other than an individual, or both.] sentenced in accordance 
with section 401(b)(1)(D).
  (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).

           *       *       *       *       *       *       *

                                  
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