Sponsors (8)
The bill permits limited importation of FDA-equivalent prescription drugs from certified Canadian pharmacies to lower costs and increases supplier transparency and quality checks, but its benefits are constrained by excluded drug categories, program setup costs, potential supply delays, and cross-border privacy risks.
Patients with chronic conditions and uninsured individuals can buy FDA-equivalent prescription drugs from certified Canadian pharmacies for a personal ≤90-day supply, which can lower out-of-pocket drug costs.
Patients (and health systems that serve them) gain safety protections because imported drugs must match the FDA-approved active ingredient, route, dosage form, and strength, require a valid U.S. prescription, and suppliers/labs are subject to FDA-required testing and QA, reducing the risk of counterfeit or substandard drugs.
Consumers gain more transparency about approved foreign suppliers because the FDA must publish a list of certified Canadian pharmacies and their website addresses.
Patients who rely on biologics, many controlled substances, IV/infused or refrigerated drugs, and other excluded categories (including many Medicare beneficiaries) will not benefit because those medicines are ineligible for import.
Patients may face delays, reduced access, or extra procedural hurdles because qualification rules (e.g., Canadian pharmacies needing ≥5 years in operation), Secretary-approved labs, and U.S.-style prescription validation narrow the supplier pool and add steps to imports.
Taxpayers and consumers could incur increased administrative costs to establish and operate the certification, testing, and oversight program required within 180 days.
Based on analysis of 2 sections of legislative text.
Authorizes a regulated pathway for individuals to import certain non‑excluded prescription drugs from FDA‑certified Canadian pharmacies for up to a 90‑day personal supply.
Official title: Amend the Federal Food, Drug, and Cosmetic Act to allow for the personal importation of safe and affordable drugs from approved pharmacies in Canada.
Introduced February 19, 2025 by Amy Klobuchar · Last progress February 19, 2025
Creates a new FDA regulatory pathway allowing individuals to import certain prescription drugs from FDA‑certified Canadian pharmacies for personal use (up to a 90‑day supply) if the drug matches the FDA‑approved product and is dispensed by a Canadian‑licensed pharmacist and filled using a valid U.S. state prescription. The FDA must publish an approved‑pharmacy list and issue implementing regulations within 180 days, while excluding controlled substances, many biologics and specified biotech or temperature‑sensitive products, and imposing certification and quality‑assurance requirements on participating Canadian pharmacies.