Section 804 Importation Program Policies and Authorizations
FDA has issued policies and taken actions to implement section 804 of the Federal Food, Drug and Cosmetic Act, which allows states and Indian tribes to import certain prescription drugs from Canada to significantly reduce the cost of these drugs without imposing additional risk to public health and safety.
Actions
- State importation program enhancements (July 2025)
- FDA takes steps to enhance state importation programs to help lower prescription drug prices (May 2025)
- Executive Order 14273 on Lowing Drug Prices by Once Again Putting Americans First (April 2025)
- FDA published Importation of Prescription Drugs Final Rule Questions and Answers; Small Entity Compliance Guide to help small entities better understand the final rule (May 2022)
- FDA met with representatives from several states, the National Academy for State Health Policy and HHS to discuss the development of SIP proposals (March 2022).
- FDA issued a final rule, Importation of Prescription Drugs, which describes the requirements for SIPs and provides FDA responses to comments about the proposed rule (October 2020)
FDA authorizations
FDA authorized Florida’s drug importation program under section 804 of the FD&C Act in January 2024:
- Florida SIP authorization extension letter, November 2025 (PDF - 215 KB)
- Florida SIP authorization extension letter, June 2025 (PDF - 250 KB)
- Florida SIP authorization extension letter, December 2024 (PDF - 114 KB)
- FDA authorizes Florida’s drug importation program
- FDA authorization letter to Florida’s Agency for Health Care Administration