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February 10, 2026
Approximately 5 minutes
U.S. FDA Export Requirements for Human Drugs
U.S. FDA Export Requirements for Human Drugs
1. Regulatory Framework
The Federal Food, Drug, and Cosmetic Act (FD&C Act) and Code of Federal Regulations (CFR) set requirements for human drug exports intended for commercial purposes and investigational use. General requirements for export are outlined in section 801 of the FD&C Act (21 U.S.C. § 381). Requirements for the export of unapproved human drugs are in section 802 of the FD&C Act (21 U.S.C. § 382). Investigational new human drugs follow 21 CFR 312.110. Notification and recordkeeping are detailed in 21 CFR 1.101. Source: https://www.fda.gov/drugs/human-drug-exports/export-requirements-human-drugs
2. Key Guidance Documents
FDA provides guidance explaining requirements under the FDA Export Reform and Enhancement Act of 1996 for exporting human drugs. A separate guidance offers a general description of FDA’s export certification process. Source: https://www.fda.gov/drugs/human-drug-exports/export-requirements-human-drugs
3. Exporting for Personal Use
Exporting human drugs for personal use does not fall within the FD&C Act. Only commercial human drug exports are under FDA’s purview. FDA does not issue export certificates for drugs intended for individual personal use. Patients should consult U.S. Customs and Border Protection and the importing country for personal importation rules. Source: https://www.fda.gov/drugs/human-drug-exports/export-requirements-human-drugs
4. Practical Advice
Exporters must ensure compliance with all applicable U.S. requirements before shipping. For detailed procedures, refer to the listed statutes, CFR sections, and FDA guidance documents. Source: https://www.fda.gov/drugs/human-drug-exports/export-requirements-human-drugs
5. Contact for Assistance
For questions regarding human drug export requirements, contact CDERexports@fda.hhs.gov. Source: https://www.fda.gov/drugs/human-drug-exports/export-requirements-human-drugs
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