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Importation Program under Section 804 of the FD&C Act

FDA has developed a pathway under section 804 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) that allows importation of certain prescription drugs from Canada to:

  • significantly 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. 

Section 804 Importation Program (SIP) Proposals

A SIP proposal needs to provide all the information required by the FD&C Act and FDA’s regulations. HHS provided information about demonstrating cost savings for the American consumer. A full list of requirements is provided in FDA’s regulations.

In particular, FDA regulations at 21 C.F.R. part 251 describe the requirements necessary for a sponsor of a SIP 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. 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.

Visit responses to comments in the rulemaking for more information.

FDA Review Process

FDA’s evaluation of 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


Policies and Actions

FDA Authorization

Contact Us

In accordance with Executive Order 14036, 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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