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When do I need an FDA Certificate of Exportability?
The 'Certificate of Exportability' is for the export of human drugs and biologics, animal drugs, and devices that cannot be legally marketed in the United States, but meet the requirements of sections 801(e) or 802 of the Act and may be legally exported. (CBER, CDRH, and CVM)
U.S. Food and Drug Administration (FDA)
http://www.fda.gov
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