Safe and Affordable Drugs from Canada Act of 2025
Safe and Affordable Drugs from Canada Act of 2025
Plain Language Summary
# Safe and Affordable Drugs from Canada Act of 2025 - Summary **What the Bill Does:** This bill would allow Americans to legally import prescription medications from Canada for personal use, with FDA oversight. Under the proposal, individuals could buy drugs from approved Canadian pharmacies (up to a 90-day supply) if the medications are prescribed by a U.S. doctor and match FDA-approved drugs in their active ingredients and dosage. The FDA would maintain a list of approved Canadian pharmacies and set quality standards they must meet. **Who It Affects and Key Restrictions:** The bill primarily affects Americans seeking lower-cost prescription drugs, as medications are often cheaper in Canada than the U.S.
However, several drug categories would be excluded from this program, including controlled substances (like opioids), biological products (like insulin), and intravenously injected drugs. Only individual personal importation is allowed—bulk purchasing or resale would not be permitted. **Current Status:** The bill (S. 641) was introduced by Senator Amy Klobuchar (D-Minnesota) in the 119th Congress and is currently in committee, meaning it has not yet been debated or voted on by the full Senate. It would require FDA approval and regulatory framework before implementation.
CRS Official Summary
Safe and Affordable Drugs from Canada Act of 2025This bill requires the Food and Drug Administration (FDA) to allow for the personal importation of prescription drugs from Canada in certain instances.Such a drug must (1) be purchased from an approved Canadian pharmacy and dispensed by a pharmacist licensed in Canada; (2) be purchased by an individual for personal use only and in quantities not to exceed a 90-day supply; (3) be filled using a valid prescription from a physician licensed in a U.S. state; and (4) have the same active ingredients, route of administration, dosage form, and strength as an FDA-approved drug. Certain types of drugs may not be imported under this program, such as controlled substances, biological products, or intravenously injected drugs.An approved pharmacy under this program must be located and licensed in Canada and meet additional requirements, such as participation in ongoing and comprehensive quality assurance programs.The FDA must publish a list of approved Canadian pharmacies on its website.
Latest Action
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.