title: Food and drug regulatory issues.
abstract: The Federal Food, Drug, and Cosmetic Act does not purport to interfere with the practice of veterinary medicine; however, it does regulate the drugs that veterinarians use in their practice. According to federal law, it is illegal for a veterinarian to use animal drugs in a manner other than that stated on the approved label, to use human-labeled drugs products to treat animals, or to compound drugs for their patients. Because the Act fails to meet the needs of the veterinary profession, the Food And Drug Administration (FDA) has adopted a policy of discretionary enforcement to "allow" veterinarians to use approved animal drugs in an extralabel fashion or to use human drugs to treat animals in certain situations. FDA will not enforce the law against practitioners treating companion, exotic, or sporting animals. Instead, enforcement effort will be directed to treating food-producing animals under conditions most likely to result in illegal drug residues. This is current effort to amend the Act in a way that will make it legal for the FDA to permit extralabel drug use rather than doing so only as a matter of enforcement discretion. Even so, practicing veterinarians will still be limited in how they can use drugs in everyday practice.
authors.affiliation: King & Spalding, Washington, DC.
authors.forename: J
authors.initials: J
authors.lastname: Stribling
authors.forename: C
authors.initials: C
authors.lastname: Picut
mesh_terms: D000818:Animals; D004339:Drug Compounding; D004348:Drug Labeling / Q000331:legislation & jurisprudence; D004350:Drug Residues; D007603:Jurisprudence; D007880:Legislation, Drug; D007881:Legislation, Food; D007886:Legislation, Veterinary; D014481:United States; D014486:United States Food and Drug Administration; D014730:Veterinary Medicine / Q000592:standards*