[Congressional Bills 108th Congress]
[From the U.S. Government Publishing Office]
[H.R. 2717 Introduced in House (IH)]







108th CONGRESS
  1st Session
                                H. R. 2717

   To amend the Federal Food, Drug, and Cosmetic Act to establish a 
  program to provide for the voluntary certification of Internet and 
   mail-order pharmacies, to amend such Act to authorize, subject to 
  certain conditions, the importation by individuals of prescription 
      drugs from Canada for personal use, and for other purposes.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                             July 14, 2003

Mr. Brown of Ohio (for himself, Mr. Stark, and Mr. Hinchey) introduced 
 the following bill; which was referred to the Committee on Energy and 
                                Commerce

_______________________________________________________________________

                                 A BILL


 
   To amend the Federal Food, Drug, and Cosmetic Act to establish a 
  program to provide for the voluntary certification of Internet and 
   mail-order pharmacies, to amend such Act to authorize, subject to 
  certain conditions, the importation by individuals of prescription 
      drugs from Canada for personal use, and for other purposes.

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Affordable Medicine Safety and 
Access Act''.

              TITLE I--INTERNET AND MAIL-ORDER PHARMACIES

SEC. 101. VOLUNTARY CERTIFICATIONS REGARDING INTERNET AND MAIL-ORDER 
              PHARMACIES.

    (a) In General.--Chapter 5 of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 351 et seq.) is amended by inserting after section 503A 
the following section:

``SEC. 503B. VOLUNTARY CERTIFICATIONS REGARDING INTERNET AND MAIL-ORDER 
              PHARMACIES.

    ``(a) In General.--The Secretary, directly or through contract with 
one or more public or nonprofit private entities, shall establish a 
program under which Internet and mail-order pharmacies, on a voluntary 
basis, are certified by the Secretary as meeting the requirements of 
this section for certification.
    ``(b) Seal.--The Secretary shall provide for a seal that Internet 
and mail-order pharmacies certified under subsection (a) are authorized 
to display for purposes of indicating to the public the fact of such 
certification.
    ``(c) Conditions for Certification.--As a condition of certifying 
an Internet or mail-order pharmacy under subsection (a), the Secretary 
shall require the following with respect to such pharmacy:
            ``(1) Verification that, in each State in which the 
        pharmacy engages in pharmaceutical activities, the pharmacy, 
        and all the employees and agents of the pharmacy, are in 
        compliance with applicable laws regarding--
                    ``(A) the practice of pharmacy, including licensing 
                laws; and
                    ``(B) the manufacturing and distribution of 
                controlled substances, including with respect to 
                mailing or shipping such substances to consumers.
            ``(2) Controls to ensure that a prescription drug is 
        dispensed by the pharmacy only pursuant to a valid 
        prescription, including circumstance in which the drug is 
        shipped or mailed from a country under whose laws the drug is 
        not a prescription drug.
            ``(3) The prominent display of contact information for the 
        pharmacy, including a telephone number, an electronic mail 
        address, a mailing address, and (if different from the mailing 
        address) the address for the physical location of the principal 
        place of business of the pharmacy.
            ``(4) The prominent display of complete and accurate 
        information concerning the ownership and management of the 
        pharmacy, including addresses and contact information.
            ``(5) A certification from the person who owns or manages 
        the pharmacy that a certification under subsection (a) for the 
        pharmacy has not previously been terminated by the Secretary, 
        and that no other Internet or mail-order pharmacy owned or 
        managed by such person has received a certification under 
        subsection (a) that has been terminated by the Secretary.
            ``(6) An agreement by the pharmacy that, upon certification 
        under subsection (a), the facilities and business practices of 
        the pharmacy will be subject to inspection by the Secretary to 
        the extent appropriate to determine whether the pharmacy is in 
        compliance with conditions under this subsection.
            ``(7) Meaningful and accessible opportunities for a 
        consumer to consult with a licensed pharmacist regarding a drug 
        prior to the time at which the pharmacy dispenses the drug to 
        the consumer.
            ``(8) Controls to ensure that, prior to dispensing a drug 
        to a consumer, a prospective review of the use of the drug by 
        the consumer is completed, based on accurate information about 
        the consumer and the medication profiles of the consumer and 
        other pertinent medical information.
            ``(9) Effective, accessible systems for communication with 
        consumers, including systems for consumer reporting of adverse 
        drug reactions and errors, systems by which consumers can 
        effectively track and report problems with unfulfilled orders, 
        systems for the investigation and redress of consumer 
        complaints, and systems facilitating effective communication 
        between the pharmacy and consumers concerning drug recalls.
            ``(10) Controls to ensure the protection of patient privacy 
        and confidentiality, including but not limited to the 
        prevention of unauthorized internal and external use of 
        personally-identifiable patient information.
            ``(11) An agreement by the pharmacy that the pharmacy will 
        notify the Secretary within 10 days concerning any change in 
        information submitted under this subsection as a condition of 
        certification under subsection (a).
            ``(12) Such additional criteria as the Secretary 
        determines, after notice and opportunity for comment, to be 
        appropriate for the sound operation of certified pharmacies or 
        the protection of consumers.
    ``(d) Annual Application; Duration of Certification.--
            ``(1) In general.--The Secretary may certify an Internet or 
        mail-order pharmacy under subsection (a) only if the pharmacy 
        submits to the Secretary an application for such certification 
        that demonstrates compliance with the conditions under 
        subsection (c) and is in such form, and is made in such manner, 
        as the Secretary may require. The Secretary shall establish an 
        application form for purposes of the preceding sentence, 
        including an electronic application form.
            ``(2) Duration of certification; renewal.--
                    ``(A) In general.--A certification under subsection 
                (a) is effective for the one-year period beginning on 
                the date on which the application under paragraph (1) 
                for such certification is approved by the Secretary. 
                The Secretary may renew the certification, pursuant to 
                the submission of an additional application under 
                paragraph (1), and the number of renewals of the 
                certification is not limited. The Secretary may 
                establish an abbreviated process for such renewal 
                applications.
                    ``(B) Renewal evaluation.--Before renewing a 
                certification under subsection (a), the Secretary shall 
                conduct an evaluation to determine whether the pharmacy 
                involved is in compliance with the conditions under 
                subsection (c). The evaluation, at the Secretary's 
                discretion and as applicable, may include testing of 
                the Internet site of the pharmacy or other systems 
                through which the pharmacy communicates with consumers, 
                and may include physical inspection of the records and 
                premises of the pharmacy pursuant to subsection (c)(6).
    ``(e) Fees.--The Secretary may impose a fee on the submission of an 
application under subsection (d). Any such fee is due upon the 
submission of the application. To the extent provided in appropriations 
Acts, such fees are available to the Secretary for carrying out this 
section.
    ``(f) Information Campaign.--The Secretary shall carry out 
activities to inform the public of the program under subsection (a), 
including information on the significance of the seal under subsection 
(b) when displayed by an Internet or mail-order pharmacy, and including 
information on the benefits of doing business with a pharmacy certified 
under subsection (a) as compared to a pharmacy that is not so 
certified.
    ``(g) Termination of Certification.--The Secretary, upon the own 
initiative of the Secretary or a petition by an interested person, may 
terminate a certification under subsection (a), after notice to the 
Internet or mail-order pharmacy involved and an opportunity for a 
hearing.
    ``(h) Contract for Operation of Program.--
            ``(1) Determination regarding use of contract authority.--
        The Secretary may award a contract under subsection (a) for the 
        operation of the program under such subsection only if the 
        Secretary determines that the administration by the contractor 
        of such program would be as protective or more protective of 
        the public than direct administration of the program by the 
        Secretary.
            ``(2) Certain requirements.--With respect to a contract 
        under subsection (a):
                    ``(A) The duration of the contract may not exceed 
                two years.
                    ``(B) The Secretary may renew the contract, subject 
                to compliance with subparagraph (A).
                    ``(C) The Secretary shall annually review 
                performance under the contract.
                    ``(D) The contract shall specify that the Secretary 
                may terminate the contract for unsatisfactory 
                performance under the contract.
    ``(i) Definitions.--For purposes of this section:
            ``(1) The term `Internet pharmacy' means a pharmacy that, 
        by shipping, mailing, or transporting a prescription drug, 
        dispenses such drug pursuant to a sale of the drug by the 
        pharmacy in circumstances in which the purchaser of the drug 
        submitted the purchase order for the drug, or conducted any 
        other part of the sales transaction for the drug, through an 
        Internet site.
            ``(2) The term `mail-order pharmacy' means a pharmacy that, 
        by shipping, mailing, or transporting a prescription drug, 
        dispenses such drug pursuant to a sale of the drug by the 
        pharmacy in circumstances in which the purchaser of the drug 
        submitted the purchase order for the drug, or conducted any 
        other part of the sales transaction for the drug, through the 
        mail or through any telecommunications means other than an 
        Internet site.
            ``(3)(A) Subject to subparagraph (B), the term `pharmacy' 
        means an organization licensed by a State to practice pharmacy, 
        including the dispensing and selling of prescription drugs.
            ``(B) The Secretary shall consider an organization as 
        meeting the definition established in subparagraph (A) if the 
        Secretary determines that the organization would qualify for 
        licensure in at least one of the States but for a policy of 
        such State that denies licensure as a pharmacy on the basis 
        that the organization dispenses prescription drugs from 
        locations in Canada or dispenses prescription drugs obtained by 
        such organization from an entity in Canada.
            ``(4) The term `prescription drug' means a drug subject to 
        section 503(b).''.
    (b) Unauthorized Display of Seal; False Claims.--Section 301 of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 331) is amended by 
adding at the end the following:
    ``(hh) The display by an Internet or mail-order pharmacy of the 
seal under section 503B without a certification in effect under such 
section for the pharmacy, or the making by such a pharmacy of a false 
claim that such a certification is in effect for the pharmacy.''.

    TITLE II--PERSONAL IMPORTATION OF PRESCRIPTION DRUGS FROM CANADA

                     Subtitle A--Waiver Requirement

SEC. 201. WAIVER REQUIREMENT FOR PERSONAL IMPORTATION OF PRESCRIPTION 
              DRUGS FROM CANADA.

    Chapter VIII of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
381 et seq.) is amended by adding at the end the following section:

  ``waiver requirement for personal importation of prescription drugs 
                              from canada

    ``Sec. 805. With respect to the importation by individuals of 
prescription drugs from Canada, the Secretary shall in accordance with 
this section establish by regulation a waiver of prohibitions under 
this Act that apply to the importation of drugs. Such a waiver shall 
permit an individual to import into the United States any prescription 
drug that--
            ``(1) is imported from Canada for personal use by the 
        individual (not for resale);
            ``(2) is approved by the Secretary under section 505, is 
        manufactured in an establishment registered with the Secretary 
        under section 510, and is not a controlled substance in 
        schedule I, II, or III under section 202(c) of the Controlled 
        Substances Act;
            ``(3) is imported from a Canadian pharmacy that has 
        submitted to the Secretary a registration that identifies the 
        pharmacy and provides documentation that the pharmacy is 
        licensed in Canada;
            ``(4) is imported in a quantity that does not (for that 
        instance of importation) exceed a 90-day supply;
            ``(5) at the time of importation, is accompanied by a copy 
        of a valid prescription for the drug for the individual, issued 
        in the United States by a practitioner in accordance with 
        section 503(b), or is accompanied by documentation that 
        verifies the issuance of such a prescription for the 
        individual;
            ``(6) is in the form of a final finished dosage; and
            ``(7) is imported under such other conditions as the 
        Secretary determines to be necessary to ensure public 
        safety.''.

                          Subtitle B--Studies

SEC. 211. STUDY REGARDING IN-PERSON PERSONAL IMPORTATION FROM CANADA.

    (a) In General.--The Secretary of Health and Human Services 
(referred to in this subtitle as the ``Secretary''), acting through the 
Commissioner of Food and Drugs, shall conduct a study for the purpose 
of developing recommendations regarding any legislative or 
administrative changes that may be necessary to provide reasonable 
assurance concerning the safety and effectiveness of prescription drugs 
that are purchased in-person at a licensed pharmacy in Canada and 
imported from Canada into the United States for personal use by 
individuals who are not in the business of importing such drugs 
(referred to in this section with respect to such drugs as ``in-person 
personal importation''). Not later than 18 months after the date of the 
enactment of this Act, the Secretary shall submit to the Congress a 
report describing the findings of such study.
    (b) Certain Requirements.--The activities of the Secretary in 
carrying out the study under subsection (a) shall include the 
following:
            (1) With respect to prescription drugs that are commonly 
        purchased from Canadian pharmacies for in-person personal 
        importation, the purchase of a representative sample of such 
        drugs at randomly-selected Canadian pharmacies that are 
        representative of Canadian pharmacies from which prescription 
        drugs are purchased for personal importation.
            (2) Determining, for purposes of laws and regulations 
        administered by the Food and Drug Administration, the safety 
        and effectiveness of the prescription drugs that are purchased 
        under paragraph (1).
            (3) Making a comparison of laws and regulations referred to 
        in paragraph (2) with the Canadian system for the regulation of 
        the safety and effectiveness of prescription drugs.
    (c) Advisory Board.--The Secretary shall establish an advisory 
board for the purpose of providing advice to the Secretary regarding 
the design of the study under subsection (a) and regarding the 
development of recommendations in the study. The membership of the 
advisory board shall include representatives of the Directorate of 
Border and Transportation Security (Department of Homeland Security); 
the comparable agency or agencies of the Canadian government; health 
officials of State and local governments; pharmacists in the United 
States; and physicians and patients in the United States.

SEC. 212. STUDY REGARDING INTERNET AND MAIL-ORDER PHARMACIES CLAIMING 
              CANADIAN SOURCES FOR PRESCRIPTION DRUGS.

    With respect to prescription drugs that are commonly prescribed in 
the United States, the Secretary, acting through the Commissioner of 
Food and Drugs, shall conduct a study through which the Secretary--
            (1) makes purchases of such drugs from Internet pharmacies 
        and mail-order pharmacies that make sales to consumers in the 
        United States and claim such drugs are obtained from Canadian 
        pharmacies or wholesalers, which purchases are a representative 
        sample of such drugs purchased from such pharmacies; and
            (2) determines whether the drugs purchased under paragraph 
        (1) are approved for commercial distribution in Canada and are 
        obtained from Canadian pharmacies or wholesalers.
The Secretary shall seek the cooperation of the Government of Canada in 
making the determination under paragraph (2). Not later than 18 months 
after the date of the enactment of this Act, the Secretary shall submit 
to the Congress a report describing the findings of such study.
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