Ambergris, Castoreum, Civet, Musk, Cantharides, Bile, and Animal Glands for Pharmaceutical Use

Animal-derived glandular materials destined for pharmaceutical manufacturing are subject to FDA review as drug substance precursors or biological materials. Importers must ensure the foreign supplier meets applicable FDA current Good Manufacturing Practice (cGMP) standards, and the shipment may be subject to FDA examination at the port of entry. Prior consultation with a licensed customs broker and regulatory counsel is advisable for first-time importers of pharmaceutical-grade animal secretions.

Musk from musk deer (Moschus spp.) is subject to CITES Appendix II controls, requiring export permits from the country of origin. Civet from African or Asian civet cats may also be subject to CITES controls depending on the species. Synthetic musk substitutes are not covered by this heading. Importers should confirm the biological source and obtain appropriate CITES documentation before shipment to avoid detention by USFWS at entry.