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U.S. Department of Health and Human Services

Animal & Veterinary

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FDA Removes Hydrogen Peroxide From Low-Regulatory Priority List

FDA Veterinarian Newsletter 2007 Volume XXII, No II

When the Food and Drug Administration approved 35% PEROX-AID® earlier this year, it removed hydrogen peroxide from a list of “Low Regulatory Priority Aquaculture Drugs.” This change means that only the approved product may be legally used, and if an aquaculture producer continues to use any hydrogen peroxide other than the approved product, that use could now result in a citation from an FDA investigator.

FDA maintains a low-regulatory priority list of products that can be used by the aquaculture industry for specified indications without drawing a regulatory enforcement response from FDA.

The list, available at http://www.fda.gov/cvm/Documents/LRPDrugs.pdf, is part of the Center for Veterinary Medicine’s Policies and Procedures Manual. FDA has reviewed the products and indications on the list and decided that the agency is unlikely to object to the use of these compounds for the indications and levels listed if the compounds are used according to good management practices. Also, producers must be sure the low-regulatory priority products they use are suitable for use in food-producing animals, and that the use is not likely to harm the environment. This list does not affirm the safety or efficacy of these compounds.

FDA had hydrogen peroxide on the low regulatory priority list for controlling fungi on all species and life stages of fish, including eggs.

However, following the approval of 35% PEROX-AID®, aquaculture producers should not use other hydrogen peroxide products. The approved product has undergone FDA review and was found to be safe and effective when used according to label directions.

35% PEROX-AID® was approved for control of mortality in freshwater-reared finfish eggs, due to saprolegniasis; freshwater-reared salmonids, due to bacterial gill disease associated with Flavobacterium branchiophilum; and freshwater-reared coolwater finfish and channel catfish, due to external columnaris disease associated with Flavobacterium columnare (Flexibacter columnaris). The sponsor is Eka Chemicals, Inc., Marietta, GA.