Import for export; reporting and recordkeeping requirements for unapproved or violative products imported for further processing or incorporation and subsequent export--FDA. Proposed rule.
The Food and Drug Administration (FDA) is proposing reporting and recordkeeping regulations to implement certain sections of the Federal Food, Drug, and Cosmetic Act (the act) as amended by the FDA Export Reform and Enhancement Act of 1996. The proposed rule would require an importer to report to FDA each time it imports an unapproved or otherwise violative article that is to be exported after further processing or incorporation into another product in the United States and to keep records to ensure that the article is so processed or incorporated and then exported, and that any portion of the import that is not exported is destroyed.
D003132:Commerce / Q000331:legislation & jurisprudence*; D018795:Device Approval / Q000331:legislation & jurisprudence*; D004282:Documentation; D017277:Drug Approval / Q000331:legislation & jurisprudence*; D005568:Forms and Records Control / Q000331:legislation & jurisprudence; D007391:International Cooperation; D014481:United States; D014486:United States Food and Drug Administration