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 In this section:

                Import & Exports

Import & Exports

                        Exporting - Animal Feed and Animal Drugs
          Import Tolerances
          Importing - Animal Food
          Importing - Veterinary Drugs Home
          Animal & Veterinary
          Products
          Import & Exports
          Exporting - Animal Feed and Animal DrugsImport & Exports Exporting - Animal Feed and Animal Drugs
  
  	
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    PrintSection 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. Therefore, FDA issues export certificates to provide those assurances, as well as to facilitate product registration, imports, or other processes in foreign countries.

Additionally, the FD&C Act 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) to be exported. Section 801(e)(1) of the Act permits exportation of products that:

meet the foreign purchaser’s specifications;
	are not in conflict with the laws of the country where they are being exported;
	are labeled that they are intended for export; and
	are not sold or offered for sale in domestic commerce.Within FDA, the Center for Veterinary Medicine's Division of Food Compliance and Division of Drug Compliance issue five types of export certificates. Foreign governments choose whether to require and/or accept any of the certificates issued by FDA. The following certificates are available:

The “**Current Good Manufacturing Practice (CGMP) Certificate**” certifies that a specific manufacturing facility is in compliance with the Current Good Manufacturing Practice requirements of the FD&C Act. Since it only relates to CGMP compliance, is applicable only to a single facility, and does not contain certifications related to the FD&C Act’s other requirements, it cannot be used as a substitute for the Certificate to Foreign Government that attests to the legality and exportability of a specific product. There is no fee associated with the issuance of this type of certificate. The certificate is valid for two years from the date of issuance.

The “**Certificate to Foreign Government**” 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. It 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 of the FD&C Act that relate to the product listed on the certificate, with the exception of certificates for animal devices because these products are not subject to a CGMP requirement. 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.

The “**Certificate of Free Sale**” 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**” 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 and 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 exportation 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**” 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 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.

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 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 asknies.products@usda.gov.

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.

Additional Information

FDA Export Certificates
	Apply for Animal Food and Drug Export Certificates Online via CVM eCATS

                                                                                  Content current as of:
      01/30/2024Import & Exports

          
                        Exporting - Animal Feed and Animal Drugs
          Import Tolerances
          Importing - Animal Food
          Importing - Veterinary Drugs
 
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