Glands, Organ Extracts & Heparin for Organo-Therapeutic Use

Dried glands, organ extracts, and other human or animal-derived materials prepared for organo-therapeutic use — most notably heparin and its salts — represent a biologically sensitive import category with significant supply-chain scrutiny following past adulteration incidents in the heparin supply chain. FDA regulates heparin as a drug and requires that foreign manufacturers of heparin API be registered and inspected; the agency has maintained heightened vigilance over porcine intestine-derived heparin sourcing. Importers should verify that each lot is accompanied by full traceability documentation back to the animal source, as FDA may detain shipments from facilities with unresolved inspection findings.

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