Animal Drug Amendments

Animal Drug Amendments, 18 685 Animal fats, 5 27, 28 Animal feed binders... 

Animal Drug Amendments consolidates all regulations of new animal drugs under Section 512 making approvals more efficient. 

Animal Drug Amendments place all regulation of new animal drugs under one section of the Food, Drug, and Cosmetic Act—Section 512—making approval of animal drugs and medicated feeds more efficient. 

Since the animal drug amendments of 1968, veterinary drugs have had their own section of the Code of Federal Regulations (CFR), section 512. Under this section the sponsor of a new animal drug is required to demonstrate not only the efficacy of the drug, but also the safety to the target animal. These studies must be scientifically valid and well controlled to support the approval and are codified in 21 CFR 514. 

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. 

A distinct concern arises in the area of veterinary drugs because of the possibility that dmg residues may be conveyed to humans by the food-producing animals. Therefore, dmg residues and their safety in human food remain a central issue for the Center for Veterinary Medicine (CVM). Animal dmgs also include those products which promotional literature claims to improve feed efficiency and increase milk production. An animal food product is regulated under the 1968 Animal Dmg Amendments if it contains a dmg used in feed or premixes (25). 

The Food Additive Amendment of 1958, the Color Additives Amendment of 1960, and the Animal Drugs... 

The Minor Use and Minor Species (MUMS) amendments to the FD C Act (Sections 571, 572,573) were signed into US law in 2004. Their purpose is to make drugs legally available for use in minor species, or for the treatment of rare diseases in major species. Major animal species are defined as cattle, horses, swine, chickens, turkeys, dogs and cats. All other species are considered minor species. A drug developer can benefit from MUMS provisions in one of three ways. 

U.S. Food and Drug Administration. 1993. Food additives permitted in feed and drinking water of animals selenium stay of the 1987 amendments final rule. Feder. Regis. 58 (175) 47962-47973. 

The Delaney Amendment to the Food and Drug Act defined and controlled food additives any additives showing an increase in cancer tumors in rats, even if extremely large doses were used in the animal studies, had to be outlawed in foods recent debates have focused on a number of additives, including the artificial sweetener cyclamate. 

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 ... 

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