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U.S. Department of Health and Human Services

For Industry

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How do I import a biological product regulated by FDA?

If the biological product being imported falls under FDA's jurisdiction, it is subject to FDA review. Section 801 of the Federal Food, Drug, and Cosmetic Act (21 USC 381) sets out basic standards and procedures for FDA review of imports under its jurisdiction. Section 801(a) provides for examination of imports and also authorizes FDA to refuse admission of imports that appear, from examination or otherwise, to violate FDA requirements. FDA regulations (21 CFR 1271.420) set out the basic standards and procedures for importing human tissues. FDA and Customs and Border Patrol (CBP) have coordinated their efforts and work together to ensure the smooth processing of FDA-regulated imports. Specific information including instructions and questions and answers for importing biological products into the U.S. is available on the web.

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