Personal Drug Importation Fairness Act of 2013

Bill: 113-hr-3715
Sponsor: full_name: Rep. Ellison, Keith [D-MN-5]
Introduced: 2013-12-12
Policy area: Health
Subjects: Africa

Asia

Australia

Canada

Drug safety, medical device, and laboratory regulation

Europe

European Union

Israel

Japan

New Zealand

Oceania

Prescription drugs

South Africa

Switzerland

Trade restrictions
Latest action: action_date: 2013-12-13
text: Referred to the Subcommittee on Health.

Summaries:
action_date: 2013-12-12
action_desc: Introduced in House
text: <p>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.</p> <p>Defines: (1) &quot;drug&quot; for purposes of this Act as excluding any controlled substance; and (2) &quot;qualified country&quot; 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.</p>

tv_txt: I 113th CONGRESS 1st Session H. R. 3715 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.

1. Short title This Act may be cited as the Personal Drug Importation Fairness Act of 2013 . 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.