Animal drug

An animal drug (also veterinary drug) refers to a drug intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in animals.

Regulation

United States

The U.S. Food and Drug Administration (FDA) has the broad mandate under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321 et seq.) to assure the safety and effectiveness of animal drugs and their use in all animals, including farm animals. The division of the FDA responsible for this is the Center for Veterinary Medicine (CVM).[1] The equivalents of the Investigational New Drug and New Drug Application are known as the Investigational New Animal Drug and New Animal Drug Application, respectively.

Before CVM formally approves an animal drug, the sponsor or manufacturer of the drug must document in scientific testing that the drug has been found "safe and effective". The testing data also must demonstrate that a methodology is available to detect and measure any residue left in edible animal products. Farmers and veterinarians using drugs on farm animals must adhere to guidelines about how much time must elapse before a treated animal can be slaughtered, and any other use constraints or warnings stated on the drug label.

Animal biologics (e.g., vaccines and tests) are regulated by the Animal and Plant Health Inspection Service.

See also

References
  1. Post, Lynn O (2007). "Chapter 7: Regulatory considerations in veterinary toxicology". In Gupta, RC (ed.). Veterinary toxicology basic and clinical principles (1st, revised ed.). New York: Academic Press. pp. 92–109. ISBN 9780080481609.
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