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  1. Import & Exports

Exporting - Animal Feed and Animal Drugs

Section 801 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) sets out the requirements for imports and exports of FDA regulated products.

Exports

Some foreign governments seek official assurance that products exported to their countries can be marketed in the exporting country or meet specific requirements, for example, Current Good Manufacturing Practice (CGMP) requirements. FDA issues export certificates to provide those assurances, as well as to facilitate product registration, imports, or other processes in foreign countries.

The FD&C Act also contains a provision that permits certain products that would otherwise be illegal to introduce into interstate commerce (e.g., food, drugs, and devices that are adulterated or misbranded under FDA regulations) to be exported. Section 801(e)(1) of the Act permits a product to be exported that:

  1. accords to the specifications of the foreign purchaser;
  2. is not in conflict with the laws of the country to which it is intended for export;
  3. is labeled on the outside of the shipping package that it is intended for export; and
  4. is not sold or offered for sale in domestic commerce.

The FDA Center for Veterinary Medicine's Office of Surveillance and Compliance issues five types of export certificates. Foreign governments choose whether to require or accept any of the certificates issued by FDA. The following certificates are available:

The “Certificate to Foreign Government” (CFG) is for the export of animal food, medicated feeds, animal drugs, and animal devices that meet the applicable requirements of the FD&C Act for marketing in the United States. The CFG certifies that a specific manufacturing facility(ies) which produces the product has been inspected and was in substantial compliance with the Current Good Manufacturing Practice requirements that relate to the product listed on the certificate. Therefore, a CGMP inspection that relates to the product listed on this type of certificate must have occurred prior to issuance. There is a fee associated with issuance of this type of certificate. The certificate is good for two years from the date of issuance.

Animal devices do not have CGMP requirements; therefore, a CFG certificate for animal devices would not certify compliance with CGMP requirements for animal devices.

The “Certificate of Free Sale” (COFS) is for the export of animal food, medicated feed, and animal drugs that meet the applicable requirements of the FD&C Act for marketing in the United States. No FDA CGMP inspection is required for FDA to issue this certificate, but an optional additional certification statement will appear on the certificate if the manufacturing facility(ies) were inspected and found to be in substantial compliance with the Current Good Manufacturing Practice requirements of the FD&C Act that relates to the product listed on the certificate. If the specific manufacturing facility is an animal food facility and has a current food facility registration, then a statement that the facility is registered as a food facility under section 415 of the FD&C Act will be applied to the certificate. There is a fee associated with issuance of this type of certificate. The certificate is good for two years from the date of issuance.

The “Certificate of Exportability” (COE) is for the export of animal food, medicated feed, 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, therefore, may be legally exported. Unlike the Certificate to Foreign Government, it does not contain a certification that the manufacturing facility(ies) is in compliance with Current Good Manufacturing Practice requirements of the FD&C Act to allow the Certificate of Exportability to be issued for export of products from facilities that have not yet been inspected by FDA. There is a fee associated with issuance of this type of certificate. The certificate is good for two years from the date of issuance.

The “Certificate of a Pharmaceutical Product” (CPP) 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 have been inspected and found to be in substantial compliance with the applicable Current Good Manufacturing Practice requirements of the FD&C Act. There is a fee associated with issuance of this type of certificate. The certificate is good for two years from the date of issuance.

The “Current Good Manufacturing Practice (CGMP) Certificate” is a type of certificate that may only be issued after one of the certificate types discussed above (CFG, COFS, COE, or CPP) is issued, which are referred to as the “associated certificate” in this application. The CGMP certificate may be thought of as an update to the associated certificate and certifies that the facility was in substantial compliance with the Current Good Manufacturing Practice requirements of the FD&C Act for the product listed on the associated certificate. The associated certificate number is referenced on the CGMP certificate, and the CGMP certificate may only cover the product(s) listed on the associated certificate. The CGMP certificate does not attest to the legality and exportability of a specific animal food or drug. The certificate may only be issued prior to the expiration date of the associated certificate and is issued at no charge. The certificate’s expiration date will be the same as the associated certificate’s expiration date.

For questions about exporting veterinary products, contact: CVMExportCertification@fda.hhs.gov.

Additional Information About Exporting Agricultural Products

Depending on the type of product you wish to export and the requirements of the importing country, you may need an export certificate issued by USDA in addition to, or instead of, an export certificate issued by FDA.

USDA’s Animal and Plant Health Inspection Service (APHIS) issues certificates for animal and plant products that are shipped to foreign countries. APHIS’ Veterinary Service (VS) officials and its Veterinary Export Trade Services (VETS) provide health certificates for animals and animal products designated for export. The specific information on foreign requirements for exporting animal products is available from the APHIS Service Center in your state. Scroll to the bottom of the page under Animal and Animal Product Imports and Exports in the hyperlink and select your state.

APHIS’ Plant Protection and Quarantine (PPQ) provides assurance that U.S. plant products meet the plant quarantine import requirements of foreign countries via phytosanitary certificates issued by PPQ or its State cooperators. For information on phytosanitary certificates and regulations governing exports of plant products, contact the PPQ Export Certification Specialist in your State. Scroll to the bottom of Plant and Plant Product Imports and Exports to Export Certification and select your state.

Additional Information

 

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