Guidelines for Exports Under the FDA Export Reform and Enhancement Act of 1996

• Date: May 05, 2011
• Source: http://www.fda.gov

This guidance document summarizes and explains the basic requirements and procedures under the FDA Export Reform and Enhancement Act of 1996 (Public Law 104-134, as amended by Public Law 104-180) 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. This law amended sections 801 and 802 of the Federal Food, Drug, and Cosmetic Act (the Act), as well as section 351(h) of the Public Health Service Act, simplifying the requirements for exporting unapproved human drugs, biological products, and devices. In addition, the FDA Export Reform and Enhancement Act substantially reduced the requirements for exporting unapproved new animal drugs and provided a new option for exporting unapproved devices.

The 1996 Amendments did not change the general export requirements in section 801(e)(1) of the Act with respect to foods or cosmetics. This document provides guidance on these general export requirements under section 801(e)(1) of the Act for all products that are subject to this provision. Guidance is also provided on the export requirements for unapproved human drugs, biological products and devices in sections 801 and 802 of the Act resulting from the 1996 Amendments.

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