Virus-Serum-Toxin Act
Encyclopedia
The Virus-Serum-Toxin Act or VST Act (P.L. 430 of 1913, as amended; 21 U.S.C. 151-158)was legislation designed to protect farmers and livestock raisers by regulating the quality of vaccine
Vaccine
A vaccine is a biological preparation that improves immunity to a particular disease. A vaccine typically contains an agent that resembles a disease-causing microorganism, and is often made from weakened or killed forms of the microbe or its toxins...

s and point-of-care diagnostics for animals.

Provisions

It makes it unlawful for any person, firm or corporation to engage in the "preparation, sale, barter, exchange, or shipment" of "worthless, contaminated, dangerous or harmful" virus
Virus
A virus is a small infectious agent that can replicate only inside the living cells of organisms. Viruses infect all types of organisms, from animals and plants to bacteria and archaea...

, serum, toxin
Toxin
A toxin is a poisonous substance produced within living cells or organisms; man-made substances created by artificial processes are thus excluded...

, or analogous animal biologicals in interstate commerce. The Act provides for licensing of products and establishments, and requires permits for the importation of animal biologicals. Regulations (9 CFR 101-117) require preparation of biologicals in accordance with an approved Outline of Production so as to meet prescribed test requirements for purity, safety, potency, and efficacy. Regulations also require approval of all labeling and claims to be made in advertising. Animal biologicals are subject to both the Federal Food, Drug, and Cosmetic Act
Federal Food, Drug, and Cosmetic Act
The United States Federal Food, Drug, and Cosmetic Act , is a set of laws passed by Congress in 1938 giving authority to the U.S. Food and Drug Administration to oversee the safety of food, drugs, and cosmetics. A principal author of this law was Royal S. Copeland, a three-term U.S. Senator from...

 (FFDCA; 21 U.S.C. 321 et seq.) and the VST Act. The USDA Animal and Plant Health Inspection Service
Animal and Plant Health Inspection Service
Animal and Plant Health Inspection Service is an agency of the United States Department of Agriculture responsible for protecting animal health, animal welfare, and plant health. APHIS is the lead agency for collaboration with other agencies to protect U.S. agriculture from invasive pests and...

 (APHIS) enforces the VST Act.

Controversy

There is controversy over whether the Act regulates testing for BSE
Bovine spongiform encephalopathy
Bovine spongiform encephalopathy , commonly known as mad-cow disease, is a fatal neurodegenerative disease in cattle that causes a spongy degeneration in the brain and spinal cord. BSE has a long incubation period, about 30 months to 8 years, usually affecting adult cattle at a peak age onset of...

in cows.

External links

The Virus-Serum-Toxin Act - a brief history and analysis.http://www.law.umaryland.edu/marshall/crsreports/crsdocuments/RS2201401032005.pdf
The source of this article is wikipedia, the free encyclopedia.  The text of this article is licensed under the GFDL.
 
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