Human Research Protections
Definition: 

A virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product, protein (except any chemically synthesized polypeptide), or analogous product, or arsphenamine or derivative of arsphenamine (or any other trivalent organic arsenic compound), used for the prevention, treatment, or cure of a disease or condition of human beings. Biological products include bacterial vaccines, allergenic extracts, gene therapy products, growth factors, cytokines, monoclonal antibodies, and recombinant DNA. Biological products may be considered drugs.