Safe and Affordable Drugs from Canada Act of 2025

This legislation aims to amend the Federal Food, Drug, and Cosmetic Act, enabling individuals to import specific prescription drugs from Canada for personal use. It mandates the Secretary of Health and Human Services to establish regulations within 180 days, allowing the personal importation of up to a 90-day supply of medication, provided it is not for resale. To be eligible, imported drugs must be purchased from an approved Canadian pharmacy , dispensed by a licensed Canadian pharmacist, and correspond to a valid prescription from a U.S. physician, ensuring consistency with domestically available medications. The bill explicitly excludes certain categories of drugs from importation, including controlled substances , biological products, infused or injected drugs, and those requiring refrigeration. Approved Canadian pharmacies must be physically located in Canada and certified by the Secretary, meeting rigorous criteria such as being in existence for at least five years, adhering to provincial pharmacy standards, and implementing comprehensive quality assurance programs . These certified pharmacies must also agree to product testing by Secretary-approved laboratories and establish grievance resolution processes, with the Secretary tasked to publish a list of these approved pharmacies to facilitate safe access.