FDA has developed a pathway under the Federal Food, Drug, and Cosmetic Act (FD&C Act) that allows importation of certain prescription drugs from Canada to:
- Reduce the cost of these drugs to the American consumer, without imposing additional risk to public health and safety.
FDA is committed to continuing to work with states and Indian tribes that seek to develop an importation proposal. States and Indian tribes may submit importation program proposals to FDA for review and authorization. FDA will update this page as new information arises.
Section 804 Importation Program (SIP) Proposals
A SIP proposal needs to provide all of the information required by the FD&C Act and FDA’s regulations. FDA provided an overview of the SIP proposal requirements and HHS provided information about demonstrating cost savings for the American consumer. A full list of requirements is provided in FDA’s regulations. For more information, see FDA responses to comments in the rulemaking.
Additionally, FDA has developed a resource, Tips for SIPs, which provides information to assist sponsors as they work to develop and implement a SIP proposal. A small entity compliance guide in question and answer format is also available to help in proposal development.
FDA Review Process
FDA’s evaluation of the SIP proposals may include requests for additional information necessary to ensure the proposal meets the requirements in the statute and final rule. An example of FDA’s SIP proposal evaluation and potential implementation process is depicted below.
Laws and Policies
Learn more about the state importation program, applicable federal law, and FDA policies.
- 21 U.S.C. 384(b) through (h) provides statutory authority for the program.
- 21 CFR Part 251 describes the requirements necessary for a sponsor to demonstrate that their importation program will result in a significant reduction in the cost of eligible prescription drugs to the American consumer without posing any additional risk to the public’s health and safety.
- The final rule, Importation of Prescription Drugs, describes the program and provides FDA responses to comments about the program requirements.
- The FDA guidance for industry: Importation of Prescription Drugs Final Rule Questions and Answers; Small Entity Compliance Guide was published in May 2022 to help small entities better understand the final rule.
- March 2022 - FDA held a meeting with representatives from several states, the National Academy for State Health Policy, and HHS to discuss the development of SIP proposals.
- 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)
- July 2021 - Executive Order on Promoting Competition in the American Economy
- October 2020 - FDA and the Department of Health and Human Services announced the final rule.
- July 2020 - Executive Order on Increasing Drug Importation to Lower Prices for American Patients
FDA engages directly with states or Indian tribes who want to propose a program or would like more information about SIP proposals.
If you represent a state or Indian tribe, ask questions or submit a SIP proposal by emailing the FDA at: SIPDrugImportsandRFP@fda.hhs.gov.
States and Indian tribes interested in working with the agency on a SIP proposal can also contact FDA’s Intergovernmental Affairs Staff at IGA@fda.hhs.gov to begin the conversation.