Recent Updates

• On March 31, 2022, the FDA held a meeting with representatives from several states, the National Academy for State Health Policy, and the U.S. Department of Health and Human Services to discuss the development of Section 804 Importation Program proposals. This meeting is one of the steps that the FDA has taken to facilitate implementation of section 804 of the Food, Drug and Cosmetic Act and FDA’s regulations in order to reduce the cost of certain prescription drugs to the American consumer without imposing additional risk to public health and safety. FDA continues to proactively engage with states interested in the development of section 804 Importation Programs. 
  • FDA presentation: Section 804 Importation Program: Overview of Final Rule and Implementation (PDF - 898 KB)
  • HHS Presentation: Projecting Cost Savings for the American Consumer (PDF - 195 KB)

• In August 2021, the FDA provided additional information on the Human Drug Imports website for states and tribes interested in developing a Section 804 Importation Program, including contact information, to facilitate engagement between the agency and states and tribes, consistent with the Executive Order on Promoting Competition in the American Economy. States and tribes interested in developing a Program are encouraged to review this information.

• In July 2021, President Biden issued an Executive Order on Promoting Competition in the American Economy that directs the FDA to work with States and Indian Tribes that propose to develop Section 804 Importation Programs in accordance with section 804 of the Food, Drug, and Cosmetic Act and the FDA’s implementing regulations to reduce the cost of covered products to the American consumer without imposing additional risk to public health and safety.

• In October 2020, the FDA and the Department of Health and Human Services announced a final rule to implement section 804.  The rule allows FDA-authorized programs to import certain prescription drugs from Canada under specific conditions that ensure, as required by section 804, that 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 October 2020, the FDA also 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.