Bill > S641

This bill amends the Federal Food, Drug, and Cosmetic Act to create a regulated pathway for Americans to import prescription drugs directly from Canadian pharmacies for personal use. Under the proposed regulations, individuals would be allowed to purchase prescription drugs from approved Canadian pharmacies, subject to strict conditions: the drugs must be purchased for personal use (not resale), limited to a 90-day supply, dispensed by a licensed Canadian pharmacist, and filled with a valid U.S. physician's prescription. The bill establishes a comprehensive certification process for Canadian pharmacies, requiring them to have been in operation for at least 5 years, comply with provincial pharmacy regulations, maintain quality assurance programs, and undergo product testing. Importantly, the bill excludes many specialized medications from importation, such as controlled substances, biological products, injectable drugs, biotechnology-derived medications, and drugs requiring refrigeration. The Secretary of Health and Human Services would be responsible for publishing a list of approved Canadian pharmacies on the FDA website and developing specific implementation regulations within 180 days of the act's enactment, with the primary goal of providing Americans access to more affordable prescription medications while maintaining rigorous safety standards.

Health and Social Services

https://www.congress.gov/bill/119th-congress/senate-bill/641/all-info