Virus serum toxin act

Rules of practice governing proceedings under the Virus-Serum-Toxin Act... 

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. 

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). 

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... 

Biologies as a class may be regulated as drugs but are defined within the Public Health Service Act [PHSA, 42 U.S.C. 262(a)] by category as a virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product, or analogous product, or arsphenamine (or any other trivalent organic arsenic compound), applicable to the prevention, treatment, or cure of diseases or injuries of humans [12],... 

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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