S. 641 — Safe and Affordable Drugs from Canada Act of 2025

This section directs the Secretary of Health and Human Services (HHS), within 180 days of enactment, to promulgate regulations permitting individuals to import into the United States, for personal use and not for resale, a 90-day supply of prescription drugs from approved Canadian pharmacies using a valid prescription from a U.S. state-licensed physician. Eligible drugs must have the same active ingredient(s), route of administration, dosage form, and strength as an FDA-approved drug and exclude controlled substances; biological products; infused, intravenously injected, inhaled (during surgery), parenteral, or refrigerated drugs; biotech-manufactured drugs (e.g., therapeutic DNA plasmids, synthetic peptides of ≤40 amino acids, monoclonal antibodies for in vivo use, recombinant DNA-derived products); and photoreactive drugs. An approved Canadian pharmacy must be physically located in Canada; licensed to dispense there; in existence for at least five years with a purpose other than this program; compliant with Canadian pharmacy standards; engaged in quality assurance (including blind testing and FDA-approved lab testing); equipped for grievance resolution and accountability; not reselling from non-Canadian online pharmacies; and meeting any additional Secretary criteria. The Secretary must publish a list of approved pharmacies, including website addresses, on the FDA website.