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Is Purchasing Canadian Drugs Legal?

  • November 17th, 2022

Closeup of woman's hands holding various pills and medications.The high costs of prescription drugs are a significant concern in the United States. According to the Peterson-Kaiser Family Foundation Health System Tracker, three-quarters of adults surveyed found prescription drugs unaffordable. One-third did not take prescribed medication because of its financial burden.

In Canada, prescription drugs can be a quarter to a half less expensive than in the U.S., the Kaiser Family Foundation reported. In Canada, the Patented Medicine Prices Review Board (PMPRB) reviews pharmaceutical prices and orders patent holders to lower costs if they are too high.

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Canada’s relatively low medicine costs have led some Americans to purchase from online pharmacies claiming to be Canadian. According to the National Association of Boards of Pharmacy (NABP), many of these online pharmacies are unsafe, purporting to market Canadian drugs when they sell medications from all over the world and thus are subject to less stringent regulations.

Is It Illegal to Buy Drugs From Canada?

In most cases, it is illegal to purchase drugs from Canada, per the Food and Drug Administration. The federal Food, Drug, and Cosmetic Act (FD&C Act) bars individuals from importing drugs from other countries for personal use.

Even when Health Canada, the Canadian equivalent to the FDA, has approved the drug, bringing it into the country is illegal if the FDA has not authorized it. The FDA cannot guarantee the drug is safe and effective.

Per its policy, however, the FDA does not object to individuals importing drugs from Canada in the following specific, limited circumstances:

  • The person uses the drug to treat a severe condition, and there is no effective treatment available in the U.S.
  • The maker of the drug does not market it in the U.S.
  • The risks of the drug are not unreasonable compared to the potential benefits.
  • The individual confirms in writing that the drug is for personal use.
  • The person provides the contact information for the treating physician or shows the medication is for the continuation of treatment begun outside the U.S.
  • The person must import less than a three-month supply of the medication.

Although the FDA stresses that it cannot guarantee that a Canadian drug is adequate, it does not actively prevent people from getting drugs from Canada when a drug is not available in the U.S. and the individual has a significant medical need for it.

Because of the prevalence of unsafe options online, those considering purchasing Canadian medications should review the Canadian International Pharmacy Association website or Pharmacy Checker before ordering from a Canadian pharmacy.

Can American Pharmacies Import Canadian Drugs?

Federal law regulates the importation of Canadian drugs by pharmacists and wholesalers. Congress amended the FD&C Act in 2000 and 2003, permitting pharmacists and wholesalers to bring prescription drugs from Canada into the U.S. in specific circumstances.

The Department of Health and Human Services Secretary must certify that the medication is not a risk to public health and safety, and significantly reduces the cost of covered products. If the Secretary determines that importation from Canada is no longer safe or cost-effective, he can terminate access to the drug.


Last Modified: 11/17/2022
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