Allows individuals to import prescription drugs from approved Canadian pharmacies for personal use, subject to certain restrictions and excluding specific types of drugs.
Amy Klobuchar
Senator
MN
The "Safe and Affordable Drugs from Canada Act of 2025" allows individuals to import prescription drugs from approved Canadian pharmacies under specific conditions, including a valid U.S. prescription and adherence to quality and safety standards. The imported drugs must be for personal use, up to a 90-day supply, and must match the U.S.-approved version in active ingredients, dosage, and strength. Certain types of drugs, like controlled substances and biological products, are excluded from importation. The Secretary will establish and maintain a list of approved Canadian pharmacies that meet strict criteria to ensure drug safety and quality.
New Bill Allows Importation of Some Prescription Drugs from Canada Starting in 2025
The "Safe and Affordable Drugs from Canada Act of 2025" greenlights importing prescription medications from Canada, but with a lot of fine print. The Secretary of Health and Human Services has 180 days from passage to set up the system. Here’s the breakdown:
Prescription Pathway
The core idea is to let Americans buy cheaper drugs from up north. But it's not a free-for-all. You'll need a valid prescription from a U.S. doctor, and the drug has to be the exact same (active ingredients, dosage, strength, etc.) as what's approved here. Think of it like getting the generic version, but from Canada. You're limited to a 90-day supply, and it's strictly for personal use (SEC. 2).
Canada's Corner
Not every Canadian pharmacy qualifies. The bill sets up an "approved Canadian pharmacy" list, maintained by the FDA. To get on the list, a pharmacy has to be physically located in Canada, licensed, in operation for at least 5 years (for reasons other than participating in the program), and follow Canadian pharmacy standards. They also need quality assurance programs, Secretary-approved labs, and a way to handle complaints. Plus, they can't just resell drugs from other online pharmacies outside of Canada (SEC. 2).
Real-World Impact and Limitations
For someone taking a common, non-refrigerated medication like a statin for high cholesterol, this could mean significant savings. Imagine Sarah, a freelance graphic designer juggling bills and healthcare costs. If her medication is eligible, she could potentially cut her drug expenses by importing from an approved Canadian pharmacy. This bill could be a lifeline for people struggling with high drug costs, especially those on fixed incomes or with chronic conditions that require long-term medication use, assuming their medication is eligible.
However, there are major limitations. The bill excludes a whole bunch of drugs: controlled substances, biologics, infused or intravenously injected drugs, inhaled drugs during surgery, those made through biotechnology processes, drugs needing refrigeration, and photoreactive drugs (SEC. 2). This means many patients, like those with diabetes needing insulin (a biologic that needs refrigeration), or those undergoing cancer treatments (which often involve infused or injected drugs) won't see any benefit. It also presents a challenge for those with rare conditions, where treatment may involve drugs created using biotechnology processes.
Challenges Ahead
While the bill aims for safety, ensuring compliance from Canadian pharmacies operating under U.S. rules could be tricky. How will the FDA effectively monitor and enforce these regulations across the border? The bill also creates a complex regulatory framework, and the Secretary's regulations could be subject to change. The 90-day supply limit, while intended to prevent abuse, might also be a hurdle for people who rely on long-term medications and prefer to stock up.
The Connection to Existing Laws
This bill is a modification of the existing Federal Food, Drug, and Cosmetic Act, adding a new pathway for drug importation. It does not eliminate existing regulations and oversight by the FDA.