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FDA Safe Importation Action Plan

Plan outlines pathways to lower prices and reduce out of pocket costs through safe importation of certain prescription drugs

Bringing more drug competition to the market and addressing the high cost of medicines is a top priority of the Administration, the Department of Health and Human Services (HHS), and FDA. In July 2019, FDA announced the Safe Importation Action Plan that outlines two potential pathways that would lay the foundation for the safe importation of certain drugs originally intended for foreign markets.

This page features news and information about the Safe Importation Action Plan, FDA efforts and accomplishments under the plan, and related updates. Additional Resources are also included.

Recent Updates

  • In December 2019, FDA issued a notice of proposed rulemaking (NPRM) that, if finalized, would allow for the importation of certain prescription drugs from Canada. 
  • In December 2019, FDA announced the availability of a new draft guidance for industry that describes procedures drug manufacturers can follow to facilitate importation of prescription drugs, including biological products, that are manufactured abroad, authorized for sale in any foreign country, and originally intended for sale in that foreign country.

Additional Resources

Further information on the Administration’s plan for bringing down the high price of drugs and reducing out-of-pocket costs for the American consumer, as well as additional details on FDA’s Safe Importation Action Plan, is available at the links below.

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