FDA Will Make Importing Prescription Drugs From Canada Easier for States

The FDA announced new pathways under section 804 of the Federal Food, Drug, and Cosmetics Act that will allow states and Indian tribes to import certain prescription drugs from Canada to reduce the cost of drugs to Americans.¹

“For too long, Americans have been getting taken advantage of. Drug prices in the U.S. are sometimes 5 [to] 10 times higher than in wealthy European countries,” Marty Makary, MD, MPH, commissioner of the FDA, said in a news release.¹ “Today’s actions will support the ability to import drugs at much lower prices while also maintaining the high quality and safety of medicines that Americans expect and deserve.”

States can submit a draft proposal for pre-review and meet with the FDA before formally submitting the section 804 importation program proposal. Meetings are optional and informal, aimed at reducing the burden on the state. This effort is part of an executive order to lower drug prices in the US.¹

However, importing prescription drugs from Canada weakens the pharmaceutical supply chain, posing increased risks to the safety of patients, according to an article published in the AMA Journal of Ethics. As part of the drug importation rule, US law enforcement will be monitoring counterfeit drugs.

Counterfeit drugs are a major concern in the pharmaceutical supply chain—but, the rule only controls importation from Canada to the US. However, there is still concern over where the Canadian drugs are coming from. In 2019, approximately 33% of all medications in Canada were affected by shortages, and in 2022, there were approximately 2700 drug shortages.²

The FDA gave Florida approval to import drugs in bulk from Canada in 2024, estimating that it could save the state $180 million annually. Under the program, Florida can purchase and distribute Canadian wholesale medications to individuals who are part of the state’s Medicaid program, government clinics, and prisons. The authorization was 2 years from the first shipment date. The FDA required the state’s Agency for Health Care Administration to submit quarterly reports to the FDA about the imported drugs, financial data, and any shipment issues.³

However, this program has received opposition from nearly 75 pharmacy organizations across the US. In a joint statement spearheaded by the American Society of Health-System Pharmacists, pharmacy organizations stated that there was no evidence that the plan will reduce costs without imposing additional risks to the health and safety of Americans.⁴

“While our organizations share concerns regarding the high cost of medicines in the United States, patient safety should not be compromised under any circumstance,” the organizations stated.⁴ “As pharmacists, we are on the front lines protecting our nation’s drug supply chain and ensuring the delivery of safe and effective medicines to our patients. State importation programs introduce several opportunities for mix-ups, mishandling, mislabeling, and other rogue activity that would place some of our most vulnerable patient communities at risk.”

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REFERENCES

1. FDA takes steps to enhance state importation programs to help lower prescription drug prices. News release. FDA. May 21, 2025. Accessed May 22, 2025. https://www.fda.gov/news-events/press-announcements/fda-takes-steps-enhance-state-importation-programs-help-lower-prescription-drug-prices

2. Nowosielski B. Canadian Drug Importation May Do More Harm Than Good. Drug Topics. May 31, 2024. Accessed May 22, 2025. https://www.drugtopics.com/view/canadian-drug-importation-may-do-more-harm-than-good

3. Massaro L. FDA Approval Makes Florida First State to Import Drugs From Canada. Drug Topics. January 5, 2024. Accessed May 22, 2025. https://www.drugtopics.com/view/fda-approval-makes-florida-first-state-to-import-drugs-from-canada

4. Massaro L. Florida Drug Importation Program Faces Nationwide Opposition From Pharmacy Organizations. Drug Topics. January 18, 2024. Accessed May 22, 2025. https://www.drugtopics.com/view/florida-drug-importation-program-faces-nationwide-opposition-from-pharmacy-organizations