Personal Drug Importation Fairness Act of 2013

Personal Drug Importation Fairness Act of 2013 - Allows a drug to be imported into the United States, and re-imported into the United States by a person other than the drug's manufacturer, if the drug: (1) has the same active ingredients, route of administration, and strength as a prescription drug approved under provisions of the Federal Food, Drug, and Cosmetic Act (FFDCA) regarding adulterated drugs; (2) may be lawfully marketed in, and is imported or reimported from, a qualified country; (3) is dispensed by a licensed pharmacist; (4) is shipped directly to, or is imported by, the ultimate consumer from the qualified country; (5) is shipped or imported in quantities that do not exceed a 90-day supply; and (6) is accompanied by a copy of a valid prescription.

Defines: (1) "drug" for purposes of this Act as excluding any controlled substance; and (2) "qualified country" to mean any of specified countries (Australia, Canada, Israel, Japan, New Zealand, Switzerland, South Africa, a member-state of the European Union, or a country in the European Economic Area) that is determined by the Commissioner of Food and Drugs (FDA) to have standards for ensuring drug safety and effectiveness that are at least as protective as U.S. standards.

[Congressional Bills 113th Congress]
[From the U.S. Government Publishing Office]
[H.R. 3715 Introduced in House (IH)]

113th CONGRESS
  1st Session
                                H. R. 3715

   To reduce prescription drug costs by allowing the importation and 
                    reimportation of certain drugs.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                           December 12, 2013

Mr. Ellison (for himself and Mr. Rohrabacher) introduced the following 
    bill; which was referred to the Committee on Energy and Commerce

_______________________________________________________________________

                                 A BILL


 
   To reduce prescription drug costs by allowing the importation and 
                    reimportation of certain drugs.

    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 Drug Importation Fairness 
Act of 2013''.

SEC. 2. REDUCING PRESCRIPTION DRUG COSTS BY ALLOWING CERTAIN DRUGS TO 
              BE IMPORTED OR REIMPORTED.

    (a) In General.--Notwithstanding any provision of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 301 et seq.), a drug may be imported 
into the United States, and may be reimported into the United States by 
a person other than the drug's manufacturer, if the drug--
            (1) has the same active ingredients, route of 
        administration, and strength as a prescription drug approved 
        under chapter V of such Act (21 U.S.C. 351 et seq.);
            (2) may be lawfully marketed in, and is imported or 
        reimported from, a qualified country;
            (3) is dispensed by a licensed pharmacist;
            (4) is shipped directly to, or is imported by, the ultimate 
        consumer from the qualified country;
            (5) is shipped or imported in quantities that do not exceed 
        a 90-day supply; and
            (6) is accompanied by a copy of a valid prescription.
    (b) Definitions.--In this Act:
            (1) The term ``drug'' has the meaning given to such term in 
        section 201 of the Federal Food, Drug, and Cosmetic Act (21 
        U.S.C. 321), except that such term excludes any controlled 
        substance (as defined in section 102 of the Controlled 
        Substances Act (21 U.S.C. 802)).
            (2) The term ``prescription drug'' means a drug subject to 
        section 503(b)(1) of the Federal Food, Drug, and Cosmetic Act 
        (21 U.S.C. 353(b)(1)).
            (3) The term ``qualified country'' means a country that--
                    (A) is Australia, Canada, Israel, Japan, New 
                Zealand, Switzerland, South Africa, a member-state of 
                the European Union, or a country in the European 
                Economic Area; and
                    (B) is determined by the Commissioner of Food and 
                Drugs to have standards for ensuring the safety and 
                effectiveness of drugs that are at least as protective 
                as such standards in the United States.
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