FDA works to promote and protect the public health by promoting supply chain integrity of human drug exports. Companies exporting drugs from the U.S. as well as foreign regulatory authorities frequently ask FDA to supply an export certificate for products regulated by the FDA.
FDA issues certificates of pharmaceutical product (CPP) and current good manufacturing practice (CGMP) declarations for human drugs. See the human drugs exports flyer for more information.
Export guidance and additional information
- Exports Under the FDA Export Reform and Enhancement Act of 1996 Guidance
- FDA Export Certificate Guidance
- Hemispherx export letter
CPPs provide information about the drug’s U.S. marketing status and the manufacturer’s compliance with quality manufacturing requirements. CPPs are requested by companies to help them qualify their product for importation into a foreign market or to receive approval, licensing or registration of the drug abroad. Applications may be submitted using our online platform or by paper using FDA form 3613f.
CDER previously issued foreign exported CPPs for FDA-approved drugs and biologics that were exported from a country other than the U.S. CDER no longer intends to issue foreign exported CPPs given the other resources available for stakeholders to verify whether a drug or biologic is FDA approved and to view FDA’s classifications of its inspections of manufacturing facilities. See CPPs for more information.
CGMP declarations information
FDA issues letters, called CGMP declarations, to foreign regulators to convey the CGMP compliance status of manufacturing facilities located in the U.S. The status is based on FDA’s most recent inspection. These letters help streamline other regulatory authorities’ need to reinspect facilities in the U.S. Foreign regulators can also find the inspection classification of an establishment by checking the inspection classification database. A CGMP declaration should only be requested if a foreign regulator does not accept a valid certificate of pharmaceutical product (CPP) and wants additional assurance of a facility’s CGMP status.
CDER electronic certificate application and tracking system (CDEReCATS)
CDER has an electronic system called CDER export certification and tracking system (CDEReCATS) which allows users to request a CPP or CGMP declaration online. See the application guide for step-by-step instructions on how to use CDEReCATS to request an export certificate.