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.
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