Drug export certificates are handled by OC. As provided in sections 801(e) and 802 of the FD&C Act, drug export certificates are issued to companies that are either manufacturing products that are legally manufactured for legal distribution in the United States. Or, these could be a product that is not approved in the United States but is manufactured in the United States and is going to be shipped directly to a foreign country.
Some countries may require a certificate as to the status of the product. The shipment addresses whether or not the product that is being shipped was manufactured in compliance with cGMPs. FDA will ensure that an inspection took place within a recent period and that all of the profiles have been updated. The certificate applies to a single shipment and does not provide blanket coverage.
If a company is not in compliance, does not have a cGMP status, or if the status is bad, FDA will not issue a certificate of export.If the product is not for U.S. marketing, such as a product approved in another country, it would be up to the receiving country to exercise any type of regulatory discretion to accept the product. FDA will not issue a certificate in this instance.
For more information on drug export certificates:
FDA Guidance for Industry
