Guidance for Industry: Exports Under the FDA Export Reform and Enhancement Act of 19961

• Date: December 16, 2009
• Source: www.fda.gov

This guidance represents the Food and Drug Administration's (FDA's) current thinking on this topic and replaces FDA’s previous guidance on exports entitled, “A Review of FDA’s Implementation of the Drug Export Amendments of 1986.” It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations. If you want to discuss an alternative approach, contact the FDA staff responsible for implementing this guidance. If you cannot identify the appropriate FDA staff, call the appropriate number listed on the title page of this guidance.

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