ASEANFSN

US New “Guide for Approved Aquaculture Drugs”

Aquaculture is one of main sources of food with increasing quantities of human consumption as well as trade (volume and value). As a consequence, the numbers of aquaculture facilities have been growing. Therefore, it is needed to specify safe and effective drugs for the use in aquaculture.

The U.S. Food and Drug Administration’s Center for Veterinary Medicine (CVM) is responsible for approval of all drugs used in the aquaculture to treat and control diseases, induce spawning, change gender, or in any other way change the structure or function of aquatic species (and all animals for that matter). The following table summarizes the list of drugs currently approved by CVM for use on/in aquatic species.

Current Drugs Approved by CVM for Use on/in Aquatic Species

Treatment Regimens

Approved Drugs

Product name and supplier

Immersion

Chloramine-T

Halamid^® Aqua

Formalin

Parasite-S, Formalin-F, and Formacide-B

Hydrogen peroxide

35% Perox-Aid^®

Oxytetracycline hydrochloride

- Pennox 343^®

- Oxytetracycline HCl Soluble Powder-343

- Terramycin-343

- Tetroxy® Aquatic Soluble Powder

Tricaine methanesulfonate

Tricaine-S

Injectable

Chorionic gonadotropin

Chorulon^®

Medicated Articles/Feeds

Florfenicol

Aquaflor^®

Oxytetracycline dehydrate

Terramycin^® 200 for Fish

Sulfadimethoxine/ormetoprim

Romet^® 30 & Romet^®TC

Source: CVM’s list of approved aquaculture drugs

(http://www.fda.gov/ AnimalVeterinary/ Development ApprovalProcess/ Aquaculture/ ucm132954.htm)

It can be seen that the use of U.S. approved aquaculture drugs are considered challenge and complication due to a variety of approved products are available, each with specific permitted treatment regimens.

Therefore, in order to support farmers and other fisheries professionals, the new “Guide for Approved Aquaculture Drugs” was published in 2015 by the U.S. Fish and Wildlife Service’s Aquatic Animal Drug Approval Partnership (AADAP) program, the American Fisheries Society’s Fish Culture and Fish Health Sections, and the Association of Fish and Wildlife Agencies - Fisheries and Water Resources Policy Committee’s Drug Approval Working Group.

It is described that the new document is a “Quick Reference Guide to Approved Drugs for Use in Aquaculture” that provides recent information on all approved drugs for aquaculture. These include:

In addition, its format is intended to be proper for use in hatchery and laboratory settings, as well as in the office, classroom, or in the field. Importantly, the guide will be periodically updated when new and/or expanded uses of aquaculture drugs are approved by FDA.

Furthermore, the new guide provides example treatment scenarios and suggested treatment calculations are provided for each drug. The suggested treatment calculations are provided as examples for consideration, as it is realized that there is more than one way to calculate the correct amount of an aquaculture drug needed for a given treatment scenario. However, it is emphasized that users should always refer to the product label when using any drug or chemical.

To access full “Guide for Approved Aquaculture Drugs”, please go to http://www.fws.gov/fisheries/AADAP/drug_info_materials.html.