Draft Food and Drug Administration (FDA) Circular "Guidelines for the Importation and Exportation of Finished Drug Products and Raw Materials"

Protection of human health or safety (TBT)

Pharmaceutics (ICS code(s): 11.120)

Link to ePing

11.120 - Pharmaceutics

Human health

The proposed policy aims to provide detailed guidelines and clear procedures in the issuance of Clearance for Customs Release (CFCR) for finished drug products and raw materials and to conduct inspections of entry/exit ports authorized by the Bureau of Customs (BOC) for finished drug products and raw materials. This proposed policy shall apply to all FDA-licensed drug establishments [Manufacturer/Trader/Distributor (Importer/Exporter)] involved in the manufacture, importation, and exportation of finished drug products and raw materials intended for distribution. However, it shall not cover drug products and raw materials used in clinical trials/product development/research, drug products for personal use, donations, and under Compassionate Special Permit, and shall be processed based on existing rules and regulations.

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