title: Treatment of animal toxicoses: a regulatory perspective.
abstract: This article focuses on the regulatory issues to consider when veterinarians are called upon to treat animal toxicoses, in particular those involving food-producing animals. The lack of Food and Drug Administration-approved drugs to treat animal toxicoses has been a long-standing problem. This article reviews extralabel drug use regulations, and the responsibilities of the treating veterinarian. It discusses the legal implications of compounding and the use of unapproved drugs to treat animal toxicoses. Efforts should be made to increase the availability of life-saving antidotal therapies.
authors.affiliation: Division of Veterinary Product Safety, Office of Surveillance & Compliance, Center for Veterinary Medicine, Food and Drug Administration, 7519 Standish Place, Rockville, MD 20855, USA. susan.bright@fda.hhs.gov
authors.forename: Susan J
authors.initials: SJ
authors.lastname: Bright
authors.forename: Michael J
authors.initials: MJ
authors.lastname: Murphy
authors.forename: Janice C
authors.initials: JC
authors.lastname: Steinschneider
authors.forename: Randall A
authors.initials: RA
authors.lastname: Lovell
authors.forename: Lynn O
authors.initials: LO
authors.lastname: Post
mesh_terms: D000820:Animal Diseases / Q000139:chemically induced* / Q000188:drug therapy; D000818:Animals; D000931:Antidotes / Q000008:administration & dosage / Q000627:therapeutic use*; D001688:Biological Products / Q000627:therapeutic use; D017277:Drug Approval; D004350:Drug Residues; D007880:Legislation, Drug; D058751:Livestock; D056687:Off-Label Use / Q000331:legislation & jurisprudence / Q000662:veterinary; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D000931:Antidotes; D001688:Biological Products