Sponsors (8)
The bill expands access to lower-cost, FDA-equivalent prescription drugs for many patients by allowing certified Canadian pharmacy imports while adding regulatory oversight that can create administrative costs, procedural delays, narrower supplier eligibility, and privacy risks — and it excludes important categories of medicines like biologics.
Patients with chronic conditions and uninsured individuals can purchase FDA-equivalent prescription drugs from certified Canadian pharmacies for up to a 90-day supply, likely lowering their out-of-pocket drug costs.
Patients (and hospitals/health systems) gain safety protections because imported drugs must match the active ingredient/route/dosage/strength of an FDA-approved drug and the program requires FDA-approved testing, Secretary-approved labs, blind testing, and QA programs to reduce the risk of counterfeit or substandard drugs.
Consumers gain clearer information about approved foreign suppliers because the FDA must publish a list of certified Canadian pharmacies and their website addresses.
Patients who need biologics, many controlled substances, IV/infused, or refrigerated medicines (including many Medicare beneficiaries) remain excluded from the program, so those patients will not benefit from potential cost savings or access improvements.
Patients and health providers may face delays or added difficulty obtaining imported drugs because the program requires use of Secretary-approved labs, additional U.S.-style prescription validation steps, and other procedural checks.
Limiting eligible suppliers to Canadian pharmacies with at least five years in operation could narrow the pool of qualifying vendors and reduce patient access or competition.
Based on analysis of 2 sections of legislative text.
Creates an FDA‑regulated pathway letting individuals import certain noncontrolled prescription drugs from FDA‑certified Canadian pharmacies for personal use (≤90‑day supply) under a U.S. prescription.
Introduced February 19, 2025 by Amy Klobuchar · Last progress February 19, 2025
Creates a new FDA regulatory pathway that lets individuals import certain prescription drugs from FDA‑certified Canadian pharmacies for personal use. The FDA must issue implementing regulations within 180 days and publish a list of approved Canadian pharmacies. The imported drug must be dispensed by a Canadian‑licensed pharmacist, bought from an FDA‑certified Canadian pharmacy, filled using a valid U.S. state prescription, and be no more than a 90‑day supply. Many categories are excluded (controlled substances, biologics, refrigerated drugs, many injectable/infused and certain biotech products). Certified Canadian pharmacies must meet several requirements, including Canadian licensure, at least five years in operation, compliance with provincial pharmacy rules, quality testing and grievance processes, and use of Secretary‑approved labs for product testing.