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  1. Guidance, Compliance, & Regulatory Information

Human Drug Exports

The agency works to protect patients around the world and ensure exported drugs integrity by assuring drugs exported from the U.S. are compliant with FDA requirements.

Electronic Certificates of Pharmaceutical Product: General Information

Access information on electronic certificate of pharmaceutical products

CGMP Declarations


Access information on current good manufacturing practice declarations

Human Drug Export Resources for Foreign Governments

Find export resources for foreign governments

Export Requirements for Unapproved Drugs

Find information on export notifications for unapproved drugs

Online Verification of eCPPs for Human Drug Products

Verify your electronic certificate of pharmaceutical product online

Exporting Investigational New Drugs

Exporting investigational new drugs

Export Regulations and Guidance Documents
The Federal Food Drug and Cosmetics Act and Code of Federal Regulations (CFR) requirements are applicable to human drug exports for commercial purposes and investigational use.

Exporting Drugs for Personal Use
Exporting human drugs for personal use does not fall within the FD&C Act. Only commercial human drug exports fall under FDA’s purview. The agency does not issue export certificates for drugs being used by individuals for personal use.

FDA recommends patients consult U.S. Customs and Border Protection and the importing country for additional information on personal importation.

Additional Information


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