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.
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