Section 801 of the Federal Food, Drug, and Cosmetic Act (FFDCA) sets out the requirements for imports and exports of FDA regulated products.
The FDA Export Reform and Enhancement Act amended in 1996 changed the rules for the importation of products considered violative under U.S. law if they are intended to be further manufactured and then exported. Where this was previously illegal, it is now legal provided certain requirements are met.
Until the passage of the FDA Export Reform and Enhancement Act, new animal drugs intended for feed use could not be exported unless they were approved in the U.S. or intended to be sold to certain countries. Non-drug feed and feed components considered violative in the U.S could be exported as long as they met the provisions of 801(e). These 801(e) requirements are that the products must:
- meet the foreign purchaser’s specifications,
- not be in conflict with the laws of the country where they are being exported,
- be labeled that they are intended for export and
- not have been offered for sale in domestic commerce.
The Center for Veterinary Medicine issues six types of certificates: The certificates are issued by the Division of Compliance.
- The “Certificate of Animal Food Facility Registration” certifies that a specific manufacturing facility is registered with FDA.
- The “Current Good Manufacturing Practice (CGMP) Certificate” certifies that a specific manufacturing facility is in compliance with Current Good Manufacturing Practice regulations as required by the FD&C Act. Since it only relates to the manufacturing facility, it cannot be used as a substitute for the Certificate to Foreign Government that attests to the exportability of a specific product.
- The “Certificate to Foreign Government” is for the export of animal food, animal drugs, medicated feeds and animal devices that meet the applicable requirements of the FD&C Act for marketing in the United States. It certifies that a specific manufacturing facility(ies) is in compliance with Current Good Manufacturing Practice regulations as required by the FD&C Act, with the exception of an animal-only device manufacturing facility which is not subject to FDA inspection.
- The “Certificate of Free Sale” is for the export of animal food, animal drugs and medicated feeds that meet the applicable requirements of the FD&C Act for marketing in the United States. Unlike the Certificate to Foreign Government, it does not state that the facility(ies) is in compliance with Current Good Manufacturing Practice regulations as required by the FD&C Act to allow for the use of the Certificate of Free Sale for exportation of products from facilities that have not yet been inspected by FDA.
- The “Certificate of Exportability” is for the export of animal food and unapproved animal drugs which cannot be legally marketed in the United States, but meet the requirements of section 801(e) of the FD&C Act and may be legally exported. The manufacturing facility must be in compliance with Current Good Manufacturing Practice regulations as required by the FD&C Act.
- The “Certificate of a Pharmaceutical Product” is issued for approved and unapproved animal drugs, Type A medicated articles and APIs. The certificate conforms to the format established by the World Health Organization (WHO) and is usually used by the importing country when considering whether to authorize the drug in question for sale in that country. The manufacturing facility must be in compliance with Current Good Manufacturing Practice regulations as required by the FD&C Act.
For questions about exporting veterinary products, contact CVMExportCertification@fda.hhs.gov.
To facilitate agricultural exports, Animal and Plant Health Inspection Service (APHIS, USDA) officials certify animal and plant products that are shipped to foreign countries. APHIS’ Veterinary Service (VS) officials and its National Center for Import and Export provide health certificates for animals and animal products designated for export. The specific information on requirements for exporting animal products is available from the APHIS Veterinary Service area office serving your state. For additional information on foreign requirements governing exports of animal products, phone (301) 851-3300, or email firstname.lastname@example.org.
APHIS’ Plant Protection and Quarantine (PPQ) provides assurance that U.S. plant products meet the plant quarantine import requirements of foreign countries. This assurance is in the form of a phytosanitary certificate, issued by PPQ or its State cooperators. For information on phytosanitary certificates and regulations governing exports of plant products, phone or email the PPQ Export Certification Specialist in your State.