Virus, Serum, and Toxins Act

Mathieu M, ed. Biologies Development A Regulatory Overview. 2004. See also Pub. F. No. 57-244, 32 Stat. 728, 1902. (An Act to Regulate the Sale of Viruses, Serums, Toxins, and Analogous Products in the District of Columbia, to Regulate Interstate Traffic in Said Articles, and for Other Purposes). 

Any food, food additive, color additive, drug, cosmetic, or medical or veterinary device labeled under the Federal Food, Drug, and Cosmetic Act or the Virus-Serum-Toxin Act. 

The regulation of biologically derived therapeutics actually has a long history, and has also continued to evolve (see Table 12.4) (Weissinger, 1989, Korwek, 1997). This history led to the PHS Act providing a somewhat mixed description of the products under its authority, which in turn serves to define biologies for CBER [A biologic is] any virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood... 

The distinction between biopharmaceuticals under the jurisdiction of OBP and ONDG stems from the definition of a biological product in the PHS Act (42 USG 351 [262] (i)) a virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product, or analogous product, or arsphenamine or derivative of arsphenamine (or any other tri-valent organic arsenic compound), applicable to the prevention, treatment, or cure of a disease or condition of human beings. Biopharmaceuticals under the jurisdiction of OBP are analogous products under this definition. 

The reader may find of interest some of the following papers in which aldehydes (principally formaldehyde) have been allowed to act on serum proteins (256) gelatin (257,246) the enzymes pancreatic amylase (186) and chymotrypsin (51) antibodies (179, 258) the hormones, insulin (259, 102, 260), gonadotrophin (116), lactogenic (261), and luteinizing (262) the toxins of purified diphtheria (173,236,253,255), tetanus (251), and meningococcus (263) and the viruses of eastern equine encephalomyelitis (264), potato X virus (265), influenza (266, 267), foot and mouth disease (153), vaccinia (268), Jap. B. encephcMtia (269,270, 379), typhus (357), and scrub typhus (380). 

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