US Food and Drug Administration's perspective on aquaculture drug residues

The U.S. Food and Drug Administration's (FDA) Center for Veterinary Medicine (CVM) evaluates the safety and efficacy of each animal drug prior to its approval. Human food safety data must be provided on the safety of the drug residues remaining in the animal's edible tissue after treatment and the time that residues take to deplete to an acceptable level. Conducting human food safety studies with aquatic species is very different from similar studies in terrestrial animals. Sponsors are permitted to generate preliminary data under compassionate investigational new animal drug applications (INAD's). CVM's recent studies to bridge microbiological and chemical methods, FDA's compliance program for seafood, and the implication of recent legislation on drugs approved for minor use is discussed.