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U.S. Department of Health and Human Services

International Programs

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Sections 801 and 802 of the Federal Food, Drug, & Cosmetic Act (FD&C Act) govern when it is permissible to export an unapproved, adulterated or misbranded product.  This page contains links to FDA guidance documents and other resources relating to implementation of these authorities.

Exports Under Section 802(b)(2)