Drug Efficacy Amendment Administration

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. 

U.S. Food and Drug Administration. 2002. FDA Amends Its Regulations to Provide for Approval of Certain New Pharmaceutical Products Based on Animal Efficacy Data, FDA News, P02-17, Department of Health and Human Services, May 30. Available online at . 

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