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February 11, 2026
Approximately 5 minutes
Export Requirements for Unapproved Human Drugs by the U.S. FDA
Export Requirements for Unapproved Human Drugs by the U.S. FDA
1. Overview
Drugs made in the U.S. are not always approved by FDA but may be approved by regulatory authorities in other countries. Exporters must comply with U.S. federal law when exporting drugs the agency has not reviewed for safety, effectiveness or quality. Source: https://www.fda.gov/drugs/human-drug-exports/export-requirements-unapproved-drugs
2. Legal Basis
Section 802 of the Federal Food, Drug, and Cosmetic Act (21 USC § 382) allows unapproved human drugs to be exported to any country if the drug complies with the laws of the importing country and has valid marketing authorization from listed countries. The listed countries are Australia, Canada, Israel, Japan, New Zealand, Switzerland, South Africa and the countries in the European Union (EU) and the European Economic Area (EEA). Source: https://www.fda.gov/drugs/human-drug-exports/export-requirements-unapproved-drugs
3. Export Notifications
The FD&C Act requires an exporter of a drug to provide a simple notification to the agency that identifies the drug and the country it is being exported to when the exporter begins to export. This requirement applies to listed and non-listed countries. The FD&C Act also requires the exporter to maintain records of all drugs exported and the countries to which they were exported. Source: https://www.fda.gov/drugs/human-drug-exports/export-requirements-unapproved-drugs
4. Simple Notification Submission
Companies may request an export certificate if an importing country requires an export certificate for an unapproved drug. FDA evaluates these requests on a case-by-case basis and may issue an export certificate if certain requirements are met. Submit simple notifications using CDER Export Certification Application and Tracking System (CDEReCATS). Detailed instructions are available on the FDA website. Source: https://www.fda.gov/drugs/human-drug-exports/export-requirements-unapproved-drugs
5. Homeopathic Products
Homeopathic products must conform to the requirements for unapproved drug products under section 802 of the FD&C Act. A new functionality in CDEReCATS allows issuance of unapproved electronic Certificates of Pharmaceutical Product (eCPP) for homeopathic products. Applicants must provide evidence that the product intended for export is not sold or offered for sale in the U.S. Source: https://www.fda.gov/drugs/human-drug-exports/export-requirements-unapproved-drugs
6. Outsourcing Facilities and Compounded Drugs
Compounded drugs are not FDA-approved. If an importing country requires an export certificate for a compounded drug product, entities may request a certificate. FDA will evaluate these requests on a case-by-case basis. Source: https://www.fda.gov/drugs/human-drug-exports/export-requirements-unapproved-drugs
7. Contact for Assistance
For questions regarding human drug export requirements for unapproved drugs, contact CDERexports@fda.hhs.gov. Source: https://www.fda.gov/drugs/human-drug-exports/export-requirements-unapproved-drugs
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