Human Blood, Prepared Animal Blood, Toxins & Microbial Cultures

Organisms and toxins listed as select agents — including certain bacterial toxins and pathogenic cultures — require that both the importer and the receiving facility be registered with the CDC or USDA Select Agent Program. Shipments of select agents must be pre-authorized, and unauthorized possession or transfer carries severe civil and criminal penalties. Importers should screen the specific organism or toxin against the current select agent list before initiating any import.

Yes. Human blood and its components are regulated as biologics by FDA CBER, while prepared animal blood for diagnostic or research use may fall under different FDA pathways or, if intended for veterinary therapeutic use, USDA oversight. The intended end use — human therapeutic, veterinary, or in vitro diagnostic — determines which regulatory framework and admissibility review applies.