H.R. 478

Referred to Committee

Safe and Affordable Drugs from Canada Act of 2019

Introduced 1/10/2019•116th Congress•House

Congress.gov

Latest Action

Referred to the Subcommittee on Health.

1/25/2019 • House

Summary

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.

Introduced in House • 1/10/2019

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Topics & Subjects

Policy Area: Health

Administrative law and regulatory proceduresCanadaDepartment of Health and Human ServicesDrug safety, medical device, and laboratory regulationGovernment information and archivesPrescription drugsTrade restrictions