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.

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.

• General requirements for the export of human drugs under section 801 of the FD&C Act (21 U.S.C. § 381): 21 USC 381: Imports and exports
• Requirements for the export of unapproved human drugs under section 802 of the FD&C Act (21 U.S.C. § 382): 21 USC 382: Exports of certain unapproved products
• Requirements for the export of investigational new human drugs: 21 CFR 312.110 – Import and export requirements
• Notification and recordkeeping requirements for the export of human drugs: 21 CFR 1.101—Notification and recordkeeping
• Guidance document that explains requirements under the FDA Export Reform and Enhancement Act of 1996 for exporting human drugs: Exports Under the FDA Export Reform and Enhancement Act of 1996 Guidance
• Guidance document that provides a general description of FDA’s export certification: FDA Export Certificate Guidance

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

• Human drugs exports flyer
• Hemispherx export letter

Contact
CDERexports@fda.hhs.gov