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Does FDA issue Export Certificates for unapproved products?
The 1996 FDA Export Reform amendments to the Act provided for FDA to issue certificates for exports of certain products even though the products are not allowed to be marketed in the United States. FDA issues Certificates of Exportability for biologics, animal drugs, and devices that may be exported under these provisions of the Act but may not otherwise be marketed, sold, offered for sale, or distributed in the United States. For human drug products, FDA issues a Certificate of a Pharmaceutical Product, containing a special notation that the product is unapproved, instead of a Certificate of Exportability. FDA does not issue Certificates of Exportability for foods, dietary supplements, and cosmetics.
U.S. Food and Drug Administration (FDA)
http://www.fda.gov
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