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, HHS and 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.
In September 2020, the FDA and the Department of Health and Human Services announced a final rule to implement a provision of federal law that allows FDA-authorized programs to import certain prescription drugs from Canada under specific conditions that ensure the importation poses no additional risk to the public’s health and safety while achieving a significant reduction in the cost of covered products to the American consumer.
In September 2020, FDA announced the availability of a final guidance for industry that describes procedures drug manufacturers can follow to facilitate importation of prescription drugs, including biological products, that are FDA-approved, manufactured abroad, authorized for sale in any foreign country, and originally intended for sale in that foreign country.
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.
- Safe Importation Action Plan (PDF - 363KB)
- Final Rule: Importation of Prescription Drugs
- Final Guidance for Industry: Importation of Certain FDA-Approved Human Prescription Drugs, Including Biological Products, and Combination Products under Section 801(d)(1)(B) of the Federal Food, Drug, and Cosmetic Act.
- Press Release announcing final rule and final guidance
- HHS Announces New Action Plan to Lay Foundation for Safe Importation
- Trump Administration’s Blueprint to Lower Drug Prices
- Advancing Patient Care Through Competition
- Capturing the Benefit of Competition for Patients