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U.S. Department of Health and Human Services

International Programs

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Export Certificates

The Federal Food, Drug, & Cosmetic Act (FD&C Act) provides certain obligations for FDA with regard to the issuance of export certificates for FDA-regulated products. This page contains information and links to guidance documents and other resources relating to implementation of these obligations.

General Guidance:
FDA Export Certificates: Guidance for Industry - FDA Export Certificates


For the export of Food :


For the export of Biologics


General information on CDER Small Business and Industry Assistance (CDER SBIA): Import and Export of Human Drugs and Biologics