Lower Cost Prescription Drugs from Canada, Is It Legal?

Lower Cost Prescription Drugs from Canada, Is It Legal?

When you think of getting cheaper prescription drugs from Canada, do visions of senior citizens cramming onto buses in the early morning to make the trip across the border come to mind? Well, that used to be the only way to get your prescriptions from Canada but not any longer.

New Laws

In the early 2000s, the FDA set up guidelines in the Regulatory Procedures Manual (RPM) that permitted prescription drugs to be imported from other countries if the patient met very strict guidelines. Just stating that the patient needed the drug due to cost savings was not a justification to obtain the drug. That all changed in 2016 when the Trump administration and congress started to pressure the pharmaceutical industry to lower the cost of their drugs and passed several rules that opened the door for the importation of prescription drugs from Canada.

On September 24, 2020, the Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA) announced a Final Rule and FDA Guidance for the importation of certain prescription drugs. The Final Rule allows for the importation of certain drugs from Canada through certain state programs or wholesaler distributors.

But are these prescription drugs safe?

Drugs from Canada are regulated by Health Canada, the equivalent of the FDA. The Canadian health ministry states that all imported drugs must be equally safe and effective whether they are for use by Canadians or for export. Currently, 40 percent of all drugs sold in the United States are already imported and 80 percent of active ingredients used in US drugs come from abroad; however, you should be careful if you are buying them over the internet. Many companies may advertise they are selling Canadian drugs, but these drugs may be from elsewhere and could be expired, misbranded, or counterfeit. Your best protection to ensure the drugs you are receiving are safe is to utilize a pharmacy benefit manager (PBM) that offers an international pharmacy program, check for the VIPPS, the Verified Internet Pharmacy Practice Site, or check CIPA, the Canadian International Pharmacy Association’s website.

Why are drugs from Canada cheaper?

The Canadian government regulates and controls drug pricing—something the US government does not want to get involved with and pharma opposes. Overall savings vary from 25-80 percent for brand-name drugs but vary depending on the drug and strength. Brand-name drugs have the greatest savings largely because they are more expensive than generics while competition in the US generic drug market has kept prices down.

State by State Drug Importation A 2019 law allows states to create an importation program if approved by the federal government, and a federal policy change made in 2020 allows states with authorized programs to import certain prescription drugs from Canada. Florida was the first state to file an application with the Federal Government, but, nearly two years later it still hasn’t received an answer. On August 31, 2022, Gov. Ron DeSantis and Attorney General Ashley Moody announced Florida is suing the Food and Drug Administration (FDA) to get approval for Florida to import a limited list of drugs for chronic conditions from Canada.

Photo by Dima Mukhin on Unsplash.

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Lower Cost Prescription Drugs from Canada, Is It Legal?

In the early 2000s, the FDA set up guidelines in the Regulatory Procedures Manual (RPM) that permitted prescription drugs to be imported from other countries if the patient met very strict guidelines. Just stating that the patient needed the drug due to cost savings was not a justification to obtain the drug.

Read More »