The draft Guidance for Industry: Exports Under the FDA Export Reform and Enhancement Act of 1996 summarizes and explains the basic requirements and procedures for exporting human drugs (also drug components) and biologics that may not be sold or distributed in the United States. This guidance document also summarizes and explains the requirements for exporting drugs that are approved for marketing in the United States, but which are being exported for an unapproved use. The guidance also provides contacts for additional information.

Firms exporting products from the United States are often asked by foreign customers or foreign governments to supply a certification relating to products subject to the Act. An export certificate is a document prepared by FDA containing information about a product's regulatory or marketing status.

Relevant Resources:

Small Business Assistance: Import and Export of Human Drugs and Biologics

Guidance for Industry - FDA Export Certificates