Current approved drugs for aquatic species.

A quaculture is an important developing international industry. Approved pharmaceutical agents available to veterinarians in the United States are limited in their therapeutic scope and efficacy. Ensuring preharvest food safety and preventing illegal drug residues are extremely important issues in the selection of therapeutic regimens for aquatic species. Currently available therapeutic substances used in aquaculture can be classified as FDA-approved drugs, FDA-unapproved low-regulatory-priority treatments (LRPTs), Environmental Protection Agency (EPA)-registered products (eg, algaecides, herbi-cides, and fish toxicants), USDA-licensed biologics (eg, bacterins and diagnostics), and feeds (eg, glycans and pro-biotics). 1,2 As for other food-producing species, extralabel use of drugs in feed formulations is illegal. 3 However, a recent compliance policy guideline 3 outlines criteria by which veterinarians may use extralabel treatments in the feed of minor species on a limited basis. This Food Animal Residue Avoidance Databank Digest reviews drugs currently approved for use in aquatic species (Appendix 1), 1,4-9 chemicals that are not approved but are considered by the FDA' s Center for Veterinary Medicine (CVM) to be of low regulatory priority (Appendix 2), 2 and policies that can affect the use of these products. A number of substances commonly used in the treatment of diseases and production enhancement 1,2 in aquatic species have not been approved by the FDA (Appendix 2). Technically, these compounds cannot be administered in a manner that is in compliance with the Animal Medicinal Drug Use Clarification Act's (AMDUCA's) definition of extralabel drug use. The FDA has reviewed the use of a number of compounds and has classified them as new animal drugs of low priority. It is unlikely that the FDA will object to use of these substances if the following criteria are met 2 (Appendix 2): ' The substances are used for specific indications, species, and life stage(s). ' The substances are used according to good management practices. ' The product is of an appropriate food or medical grade for the use in food-producing animals. ' The substance is used at prescribed dosages. ' Adverse effects on the environment must be negligible. The FDA has reserved the right to consider these drugs and products as unacceptable for use in food-producing animals in the future. The FDA' s enforcement position on the use of LRPT should not be misconstrued as an approval or support of safety or effectiveness. These substances must comply with the EPA' s National Pollutant Discharge Elimination System requirements. Facilities and …