Summary: H.R.478 — 116th Congress (2019-2020)All Information (Except Text)

There is one summary for H.R.478. Bill summaries are authored by CRS.

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Introduced in House (01/10/2019)

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.