Safe and Affordable Drugs from Canada Act of 2025
The Safe and Affordable Drugs from Canada Act of 2025 would create a new pathway for individuals in the United States to import prescription drugs from approved Canadian pharmacies for personal use. The bill requires the Secretary of Health and Human Services to issue regulations within 180 days that allow safe importation of drugs meeting specific criteria: they must be purchased from an FDA-approved list of Canadian pharmacies, dispensed by licensed Canadian pharmacists, and used for personal, non-resale purposes in quantities no greater than a 90-day supply. Importantly, the drugs must have the same active ingredients, route of administration, dosage form, and strength as a drug approved by the FDA, and they must be prescribed by a U.S.-licensed physician. The bill also establishes stringent eligibility and safety requirements for Canadian pharmacies, including certifications, ongoing quality assurance, testing, grievance processes, and assurances against reselling Canadian drugs to Americans. Several categories of drugs are explicitly excluded, such as most biologics, controlled substances, infused or intravenously administered drugs, certain biotech-derived products, drugs requiring refrigeration at any point, and photoreactive drugs. In short, the bill aims to lower costs and expand access to medications by permitting personal importation from a regulated set of Canadian pharmacies, while maintaining safety standards through FDA oversight, pharmacy certification, and quality testing.
Key Points
- 1Pathway for personal importation: Individuals may import prescription drugs from approved Canadian pharmacies for personal use, with a limit of up to a 90-day supply per order, and only if the drug has a U.S. FDA-approved equivalent and is prescribed by a U.S.-licensed physician.
- 2Regulatory timeline: The Secretary must issue regulations within 180 days of enactment to implement this program.
- 3Drug eligibility and safeguards: The imported drug must be the same active ingredient, route, dosage form, and strength as an FDA-approved drug; it must not be a controlled substance, a biological product, an infused or intravenously injected drug, a biotech-derived product, a drug requiring refrigeration at any point, or a photoreactive drug.
- 4Approved Canadian pharmacies: The Secretary will publish a list of approved Canadian pharmacies on FDA’s website. To qualify, a pharmacy must be in Canada, well-established (at least 5 years in existence), operate under Canadian provincial pharmacy rules, maintain compliance with licensing and data reporting laws, and participate in ongoing quality assurance with testing.
- 5Quality and accountability requirements: Approved pharmacies must implement QA programs (including blind testing), use laboratories approved by the Secretary for testing, maintain grievance processes, and agree not to resell Canadian drugs to U.S. customers. The Secretary can establish additional criteria as needed.