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H.R. 2228 (114th): Safe and Affordable Drugs from Canada Act of 2015


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The summary below was written by the Congressional Research Service, which is a nonpartisan division of the Library of Congress, and was published on May 1, 2015.


Safe and Affordable Drugs from Canada Act of 2015

Amends the Federal Food, Drug, and Cosmetic Act (FFDCA) to require the Department of Health and Human Services (HHS) to promulgate regulations within 180 days permitting individuals to import a prescription drug purchased from an approved Canadian pharmacy that:

is dispensed by a pharmacist licensed in Canada; is purchased for personal use in quantities not greater than a 90-day supply; is filled using a valid prescription issued by a physician licensed to practice in the United States; and has the same active ingredient or ingredients, route of administration, dosage form, and strength as a prescription drug approved under the FFDCA. Sets forth exceptions, including for controlled substances and biological products.

Establishes a certification process for approving Canadian pharmacies. Requires HHS to publish a list of approved Canadian pharmacies.