Export Requirements for Products Not Approved for Sale in the United States
This guidance summarizes and explains the requirements and procedures under the FDA Export Reform and Enhancement Act of 1996 for exporting human drugs, animal drugs, biological products, devices, food, food additives, color additives, and dietary supplements that may not be sold or distributed in the United States.
Recommended Actions
- Determine appropriate export pathway based on product type and destination country
- Verify compliance with basic export requirements:
- Foreign purchaser specifications
- Compliance with importing country laws
- Proper labeling for export
- No US sales/distribution
- Implement recordkeeping system to document:
- Product specifications
- Export compliance
- Shipping records
- Foreign approvals/authorizations
- Establish process for FDA notifications when required
- Ensure manufacturing compliance with cGMPs
- Develop labeling that meets both US and foreign requirements
- Create procedures for maintaining export documentation
- Train relevant personnel on export requirements and procedures
- Conduct periodic audits of export compliance program
- Monitor changes to export regulations and update procedures as needed
Key Considerations
Labelling
- Must be labeled on the outside of the shipping package that it is intended for export
- Must be labeled in accordance with the requirements and conditions of use in the listed country
- Must be labeled in the language and units of measurement used in or designated by the country to which the product would be exported
- For drugs with unapproved uses, labeling must state that those uses are not approved under the Act
Safety
- Must not expose patients to unreasonable risk of illness or injury
- Must have probable benefit that outweighs risks
- Must not be adulterated or contain filthy, putrid or decomposed substances
- Must be manufactured in substantial conformity with cGMPs
Other considerations
- Must comply with laws of importing country
- Must meet foreign purchaser’s specifications
- Must not be sold or offered for sale in US
- Must maintain records of all exported products and countries
- Must provide notification to FDA when exporting under certain provisions
- Special provisions exist for:
- Design Controls for Medical Device Manufacturers
- Quality System Information Requirements for Premarket Submissions
- Current Good Manufacturing Practice Requirements for Combination Products
- Compliance Policy for Combination Product Postmarketing Safety Reporting Requirements
Related references and norms
- 21 CFR Part 210/211: Current Good Manufacturing Practice for Drugs
- 21 CFR Part 820: Quality System Regulation for Medical Devices
- 21 CFR Part 606: Current Good Manufacturing Practice for Blood and Blood Components
- 21 CFR Part 812: Investigational Device Exemption
- 21 CFR Part 312: Investigational New Drug Application
Original guidance
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