May 2, 2007
FDA Removes Hydrogen Peroxide from the List of Low Regulatory Priority Aquaculture Drugs
The Food and Drug Administration (FDA) is announcing today the removal of hydrogen peroxide from the list of Low Regulatory Priority Aquaculture Drugs identified in the Program Policy and Procedures Manual Guide 1240.4200 http://www.fda.gov/cvm/Documents/LRPDrugs.pdf.
FDA, under enforcement discretion, had previously not objected to the use of hydrogen peroxide to control fungi on all species and life stages of fish, including eggs; however, hydrogen peroxide is now the subject of an FDA-approved new animal drug application with the trade name 35%PEROX-AID http://www.fda.gov/cvm/CVM_Updates/perox-aid.htm. Therefore, the only approved hydrogen peroxide product that can be used in fish production is 35%PEROX-AID. There is no longer any enforcement discretion for the use of hydrogen peroxide to control fungi on all species and life stages of fish, including eggs, or for its use to treat any other fish disease.
Aquaculture producers raising fish for human food consumption should not use drug compounds other than the approved product because it can be unsafe for your fish. In addition, the effectiveness of unapproved drug compounds is questionable.
The FDA is also reminding food animal producers to read veterinary drug labels carefully and follow label directions to help avoid causing illegal residues in their products.
Questions concerning the use of hydrogen peroxide in aquaculture may be directed to Fran Pell, Consumer Safety Officer, FDA/Center for Veterinary Medicine, Division of Compliance, 240-276-9211, frances.pell@fda.hhs.gov.
Issued by:
FDA, Center for Veterinary Medicine,
Communications Staff, HFV-12
7519 Standish Place, Rockville, MD 20855
Telephone: (240) 276-9300 FAX: (240) 276-9115
Internet Web Site: http://www.fda.gov/cvm
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