HR-478 : Still Just a Bill

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.