|Straus, David - Dave|
Submitted to: Society of Toxicology
Publication Type: Abstract Only
Publication Acceptance Date: 10/20/2000
Publication Date: 10/20/2000
Citation: STRAUS, D.L., GRIFFIN, B.R. AN OVERVIEW OF THERAPEUTIC EVALUATION AT THE HARRY K. DUPREE - STUTTGART NATIONAL AQUACULTURE RESEARCH CENTER.. SOCIETY OF TOXICOLOGY. 2000. p.41-42.
Technical Abstract: In the 1990's, the U.S. FDA - Center for Veterinary Medicine (CVM) revised its procedures for issuing investigational new animal drug (INAD) exemptions and guidelines on therapeutic uses, questioned many previous rulings on aquaculture chemicals, and required that new data be provided to prove efficacy and to ensure their safety to humans and the environment. To consider a new therapeutant for approval, the FDA requires data on efficacy, environmental risk, human food safety, mammalian toxicology, product chemistry, and target animal safety. Therapeutants being studied at the HKD - SNARC are copper sulfate, potassium permanganate and oxytetracycline. A protocol for the target animal safety study is currently under review by the FDA, and the remaining required data have been submitted for the use of copper sulfate to control a common ectoparasite on channel catfish. Research has shown that this therapeutant is safe for the animal, efficacious, and is not a threat to humans or the environment. When approved, this will be the first new aquaculture therapeutant since formalin was approved in 1986. Current research focuses on potassium permanganate, which could be used in a situation where copper sulfate would not be suitable.