113 HR 3715 IH: Personal Drug Importation Fairness Act of 2013 U.S. House of Representatives 2013-12-12 text/xml EN Pursuant to Title 17 Section 105 of the United States Code, this file is not subject to copyright protection and is in the public domain.

I113th CONGRESS1st SessionH. R. 3715IN THE HOUSE OF REPRESENTATIVESDecember 12, 2013Mr. Ellison (for himself and Mr. Rohrabacher) introduced the following bill; which was referred to the Committee on Energy and CommerceA BILLTo 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.