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FDA Releases Final Rule to Allow Certain Drugs to Be Imported from Canada

September 25, 2020

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CONTACTS
Mary Mullaney, Director, Hospital Payment Policies

The Food and Drug Administration (FDA) released a final rule on Sept. 24 to allow certain prescription drugs to be imported from Canada to increase affordability for consumers.

The final rule follows an executive order President Donald Trump signed on July 24 [see Washington Highlights, July 28] and describes procedures that drugmakers can follow, including obtaining a National Drug Code, to facilitate the importation of prescription drugs and biologics that are FDA-approved, manufactured abroad, authorized for sale in any foreign country, and originally intended for sale in that foreign country.

An importation program can be co-sponsored by a state, Indian tribe, pharmacist, or wholesaler. States would submit proposals to the FDA for review and authorization. The foreign seller must be licensed to sell wholesale drugs by Health Canada and registered with the FDA as a foreign seller; the importer must be a wholesale distributor or pharmacist licensed to operate in the United States. 

Eligible prescription drugs would have to be relabeled with the required U.S. labeling and undergo testing for authenticity and degradation and to ensure that the drugs meet established specifications and standards. These programs will also have to demonstrate significant cost reductions of the covered products to the American consumer. Prescription drugs, including biologics, that are imported under the pathway could be available to patients in a variety of settings, including hospitals, health care provider offices, or licensed pharmacies.

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