FDA Releases Proposed Rule and Draft Guidance on Drug Importation Into U.S.

January 21, 2020

As part of the Administration’s push to lower prescription drug prices, the Food and Drug Administration (FDA) released a proposed rule and draft guidance on drug importation into the Unites States (U.S.). The proposed rule would authorize states, wholesalers, or pharmacists to submit proposals to import prescription drugs from Canada into the U.S. The rule, however, would exclude the importation of biologics and infused drugs.

The draft guidance describes pathways that drug manufacturers would be able to use to import prescription drugs (including biologics) into the U.S. that are FDA-approved, manufactured abroad, and originally intended for sale in a foreign country.

The proposed rule and the draft guidance come following the July 2019 announcement of the Department of Health and Human Services’ (HHS) Safe Importation Action Plan, which outlined proposed pathways to importing certain prescription drugs into the U.S. 

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