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H.R. 478 (116th): Safe and Affordable Drugs from Canada Act of 2019


We don’t have a summary available yet.

The summary below was written by the Congressional Research Service, which is a nonpartisan division of the Library of Congress, and was published on Jan 10, 2019.


Safe and Affordable Drugs from Canada Act of 2019

This bill requires the Food and Drug Administration (FDA)to promulgate regulations within 180 days permitting individuals to import a prescription drug purchased from an approved Canadian pharmacy if the drug

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 ingredients, route of administration, dosage form, and strength as a prescription drug approved by the FDA. Under the bill, certain drugs may not be imported, including controlled substances and biological products.

The bill establishes a certification process for approving Canadian pharmacies. The FDA must publish a list of approved Canadian pharmacies.