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 states and Indian tribes to import 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 a section 804 importation program (SIP) proposal. States and Indian tribes may submit importation program proposals to FDA for review and authorization.
FDA engages directly with states or Indian tribes who want to propose a program or would like more information about SIP proposals in accordance with Executive Order 14273.
State or Indian tribe representatives may ask questions or submit a SIP proposal by emailing SIPDrugImportsandRFP@fda.hhs.gov.
States and Indian tribes interested in working with the agency on a SIP proposal may contact FDA’s Intergovernmental Affairs Staff at IGA@fda.hhs.gov to begin the conversation.
