Human Blood, Animal Blood Preparations, Toxins, Ferments & Related Products

Antiallergenic preparations — such as allergen extracts used in immunotherapy — are regulated by FDA CBER as biological products and require a valid biologics license application (BLA) for the specific product and manufacturer. Importers must verify that the foreign establishment is FDA-registered and that the specific allergen extract formulation is covered by an approved or authorized BLA before shipment.

Yes. Whole human blood is subject to stringent FDA CBER oversight, including donor screening, infectious disease testing, and labeling requirements equivalent to those applied to domestically collected blood. Importation is rare and typically occurs only under specific research or emergency protocols. Any commercial importation requires prior FDA authorization, and shipments are subject to reinspection at the port of entry.