Food and Drug Administration Center for Veterinary Medicine

Guideline for Approval No. 3 General Principles for Evaluating the Safety of Compounds Used in Food-producing Animals. Revised July 1994. US Department of Health and Human Services, Public Health Service, Food and Drug Administration, Center for Veterinary Medicine, RockvUle, MD(1994). 

FOOD AND DRUG ADMINISTRATION CENTER FOR VETERINARY MEDICINE... 

Keller, W.C., Bataller, N. and Oeller, D.S. (1998). Processing and evaluation of adverse drug experience reports at the Food and Drug Administration Center for Veterinary Medicine. 

Food and Drug Administration-Center for Veterinary Medicine. 2000, October 18 (revised January 5, 2001). The Human Health Impact of Fluoroquinolone Resistant Campylobacter Attributed to the Consumption of Chicken. http //www.fda.gov/cvm/Documents/ RevisedRA.pdf (accessed June 16, 2006). 

United States of America Food and Dmg Administration Center for Veterinary Medicine FDA/CVM Federal Food, Drug and Cosmetic Act 1996, as amended, and associated regulations... 

U.S. Food and Drug Administration, Center for Drug Evaluation and Research (CDER), Center for Veterinary Medicine (CVM), May 2001, Guidance for industry—bioanalytical method validation. http //www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ ucm064964.htm... 

The US Food and Drug Administration (FDA) evaluates methods to be used in government regulatory laboratories for the determination and confirmation of drug residues in food derived from animal products. The FDA Center for Veterinary Medicine (CVM) oversees the validation (i.e., demonstration that the method is suitable for use) via a protocol known as a method trial. CVM ensures that the appropriate government laboratories have the tools needed to monitor the Nation s food supply. 

In the United States, the Center for Veterinary Medicine of the Food and Drug Administration (FDA) has... 

Drug Stability Guidelines, Center for Veterinary Medicine, Food and Drug Administration, Fourth Revision, 1990, pp. 2-23. 

Since 1969, the Food and Drug Administration s Center for Veterinary Medicine (formerly the Bureau of Veterinary Medicine) has had cause for concern that the subtherapeutic use of antibiotics in animal feeds may cause bacteria in animals to become resistant to antibiotics. This resistance to antibiotics is said by many knowledgeable scientists to be transferred to bacteria in humans, thus making these antibiotics ineffective in treating human bacterial infections due to compromise of therapy. For this reason, FDA proposed in 1977 to withdraw the use of penicillin in animal feed and restrict the use of the tetracyclines (chlortetracycline and oxytetracycline) to certain uses in animal feed. This talk will focus on FDA s efforts to finalize its review of the issue and present an update on the current status of the 1977 proposals. 

The use of antibiotics at any level in animal feed is strictly regulated by the Center for Veterinary Medicine of the Food and Drug Administration, acting under the US Food, Drug and Cosmetic Act of 1938 as amended in 1958 and 1963 (7). Twelve different antibiotics are approved for use in livestock feeds ... 

The Food Drug Administration has the responsibility for the premarket clearance of all animal drugs. The 1958 food additive amendment to the Federal Food, Drug Cosmetic Act requires sponsors to demonstrate the safety of their products. The Kefauver-Harris amendment of 1962 requires the sponsors to demonstrate, in addition to safety, the efficacy of their drugs. Safety implies safety to the animal as well as to the consumers of animal products. The role of the Center for Veterinary Medicine in the premarket approval process is to establish conditions of drug use and to establish the allowable tolerances for drug residues in animal-derived food products. 

In the USA, regulation of OP veterinary medicines is broadly similar to that in the EU but a major difference is that veterinary ectoparasiticides are regulated by the USEPA under the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) as amended, as pesticides. The Food and Drug Administration s Center for Veterinary Medicine (CVM) regulates active ingredients that exert an effect by systemic absorption and distribution under the Federal Food, Drug, and Cosmetic Act (1938) as amended. 

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