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Importation Program under Section 804 of the FD&C Act


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.


Section 804 Importation

Laws and Policies

Learn more about the state importation program, applicable federal law, and FDA policies.

Additional Actions

Contact Us

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.

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