[Congressional Bills 107th Congress]
[From the U.S. Government Publishing Office]
[S. 1229 Introduced in Senate (IS)]







107th CONGRESS
  1st Session
                                S. 1229

To amend the Federal Food, Drug, and Cosmetic Act to permit individuals 
         to import prescription drugs in limited circumstances.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                             July 24, 2001

 Mr. Wellstone (for himself and Ms. Stabenow) introduced the following 
  bill; which was read twice and referred to the Committee on Health, 
                     Education, Labor, and Pensions

_______________________________________________________________________

                                 A BILL


 
To amend the Federal Food, Drug, and Cosmetic Act to permit individuals 
         to import prescription drugs in limited circumstances.

    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 ``Personal Prescription Drug Import 
Fairness Act''.

SEC. 2. IMPORTATION OF PRESCRIPTION DRUGS BY INDIVIDUALS.

    (a) In General.--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:

``SEC. 805. IMPORTATION OF PRESCRIPTION DRUGS BY INDIVIDUALS.

    ``(a) Definitions.--In this section:
            ``(1) Import form.--The term `import form' means a form 
        prescribed by the Secretary, in consultation with the Secretary 
        of the Treasury, that discloses--
                    ``(A) the name, address, and telephone number of an 
                individual who imports a prescription drug;
                    ``(B) the name, address, and telephone number of 
                the pharmacy or other entity that dispensed the 
                prescription drug to the individual or ships the 
                prescription drug to the individual in the United 
                States;
                    ``(C)(i) the name, address, and telephone number of 
                the health care practitioner licensed to prescribe 
                drugs in the United States who is responsible for the 
                individual's treatment with the prescription drug; or
                    ``(ii) evidence that the prescription drug is for 
                the continuation of treatment begun outside the United 
                States;
                    ``(D) the location of the establishment that 
                manufactured the prescription drug, to the extent 
                known; and
                    ``(E) such other information as the Secretary may 
                require.
            ``(2) Prescription drug.--The term `prescription drug' 
        means a drug subject to section 503(b), other than a controlled 
        substance (as defined in section 102 of the Controlled 
        Substances Act (21 U.S.C. 802)) or a biological product (as 
        defined in section 351(i) of the Public Health Service Act (42 
        U.S.C. 262(i))).
    ``(b) Regulations.--The Secretary, after consultation with the 
United States Trade Representative and the Commissioner of Customs, 
shall promulgate regulations permitting individuals to import into the 
United States in personal baggage or by mail (or by other approved 
delivery service) a prescription drug that--
            ``(1) is imported for personal use by an individual, not 
        for resale, at intervals of not less than approximately 90 days 
        in quantities that do not exceed a 90-day supply;
            ``(2) is imported from a country, union, or economic area 
        referred to in section 802(b)(1)(A) and is a legally dispensed 
        drug in that country, union, or economic area;
            ``(3) is a prescription drug approved by the Secretary 
        under chapter V;
            ``(4) is in the form of a final finished dosage that was 
        manufactured in an establishment registered under section 510;
            ``(5) is accompanied by an import form; and
            ``(6) is imported under such other conditions as the 
        Secretary determines to be necessary to ensure public safety.
    ``(c) Records.--The Secretary shall collect, and maintain for a 
period of time that the Secretary determines to be necessary, records 
of imports of prescription drugs under this section.
    ``(d) List of Drugs Manufactured Outside the United States.--
            ``(1) In general.--The Secretary shall maintain and make 
        readily available to the public a list of drugs approved under 
        chapter V that--
                    ``(A) are manufactured in establishments outside 
                the United States that are registered under section 
                510; or
                    ``(B) are manufactured in establishments inside the 
                United States that are registered under section 510 and 
                are exported to a country, union, or economic area 
                referred to in section 802(b)(1)(A).
            ``(2) Authorization of appropriations.--There is authorized 
        to be appropriated to carry out this subsection $1,000,000.''.
    (b) Conforming Amendment.--Section 801(d)(1) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 821(d)(1)) is amended by striking 
``section 804'' and inserting ``sections 804 and 805''.
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