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U.S. Department of Health and Human Services

Animal & Veterinary

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Clarification - FDA Veterinarian Newsletter 2006 Volume XXI, No V

by Jennifer Matysczak, V.M.D., Aquaculture Drugs Team, Office of New Animal Drug Evaluation
FDA Veterinarian Newsletter 2007 Volume XXII, No I

In issue 2006 – No. V, FDA Veterinarian reported on two Warning Letters issued because violative penicillin residues found in tissues of animals offered for sale for human food. The FDA Veterinarian reports incorrectly implied that a veterinarian must personally administer the drugs used extralabel or be in violation of the animal drug regulations. The regulations do not require that veterinarians personally administer drugs. The regulations require that the drugs used extralabel be administrated under the direction of a licensed veterinarian who is functioning under a valid Veterinarian/Client/Patient Relationship, and that other precautions be taken.

Three Important Approvals Under the MUMS Act

35% PEROX-AID® Garners Approval for Bacterial Ailments

A chemical firm, taking advantage of a key provision of the Minor Use and Minor Species Animal Health Act (MUMS Act), has used data developed through an aquaculture drug public partnership to gain approval of an important drug for finfish.

The company, Eka Chemicals, Inc., Marietta, GA, is the sponsor of the approved aquaculture drug, 35% PEROX-AID®. The drug’s active ingredient is hydrogen peroxide.

35% PEROX-AID® was approved for the 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).

Bacterial gill disease and external columnaris disease are two significant hatchery diseases, and 35% PEROX-AID® is the first drug approved to treat these diseases.

The product was approved for over-the-counter sale. The approved method of administration for all claims is immersion. The withdrawal time (the time before the fish can be harvested for market or be released into public waters) is zero days.

Eka Chemicals, principally a chemical supplier to the pulp and paper industries, leveraged data generated in the public sector to demonstrate the safety and effectiveness of hydrogen peroxide and demonstrated that it could produce 35% PEROX-AID® under Good Manufacturing Practices.

35% PEROX-AID® is the first new immersion therapeutic drug approved for finfish in 20 years. This approval is also the first original drug approval with multiple claims encompassing a variety of finfish species and life stages.

MUMS designation

35% PEROX-AID® was designated for the three approved claims under the MUMS Act. A sponsor can apply to CVM to have a drug given designation status under the MUMS Act prior to approval or conditional approval. Designation status provides benefits to drug sponsors to encourage them to develop drugs for minor uses and minor species. Sponsors who gain approval for designated new animal drugs will be granted 7 years of exclusive marketing rights, which means the sponsor will face no competition in the marketplace for the approved use of the drug for that time period. Eka Chemicals has marketing exclusivity for each of the three approved claims.

35% PEROX-AID® is the second aquaculture drug approval to benefit from the designation provisions of the MUMS Act. The first was AQUAFLOR® Type A Medicated Article (florfenicol), an antimicrobial for the control of mortality due to enteric septicemia of catfish. Currently, 40 of the 44 drug designations granted by CVM are for claims for aquatic species.

The MUMS Act, patterned after the successful human Orphan Drug Act of 1983, was a response to the lack of economic incentive for drug sponsors to develop drugs for minor species and for minor uses (rare diseases) in major species. The MUMS Act defines “major species” as cattle, horses, swine, chickens, turkeys, dogs, and cats. “Minor species” are species not listed as one of the seven major species. Therefore, under the MUMS Act, fish are minor species.

Data development by the public sector

The Federal-State Aquaculture Drug Approval Partnership Project contributed funds towards hydrogen peroxide research efforts. The partnership involves 38 states, each of which contributed $20,000 per year for 8 years (1994-2002) to aid in the development of drugs needed for aquaculture. Hydrogen peroxide is one of eight project drugs the partnership identified as important. The others are flor-fenicol, oxytetracycline, isoeugenol, chloramine-T, copper sulfate, potassium permanganate, and formalin. The program has resulted in approvals for a significant number of label claims for four of these products, and work continues.

The Upper Midwest Environmental Sciences Center (UMESC), which is part of the United States Geological Survey, generated effectiveness and target animal safety data necessary for the approval. UMESC, located in La Crosse, WI, also prepared the environmental assessment for the application.

UMESC’s work is available in a Public Master File that can be referenced by a drug or chemical company to complete a New Animal Drug Application. For example, the target animal safety data generated by UMESC can be used to support additional claims for the use of hydrogen peroxide on freshwater-reared finfish and eggs.

Environmental considerations

Working with the U.S. Environmental Protection Agency, CVM developed an acute water quality benchmark for hydrogen peroxide. Users of 35% PEROX-AID® should inform the appropriate authority under the National Pollutant Discharge Elimination System (NPDES) of their intent to use the drug. The acute benchmark concentration is not an effluent discharge limit, but the appropriate -NPDES authority can use it in conjunction with site-specific information to determine if a specific discharge limit, effluent monitoring, or both, are required at specific aquaculture facilities. For more information regarding the acute water quality benchmark for hydrogen peroxide, go to CVM’s Web site.

New horizon for aquaculture drugs

The approval of 35% PEROX-AID® expands the medicine chest available to those caring for fish. Data development sponsored by the Federal-State Aquaculture Drug Approval Partnership Project and other public entities, in addition to traditional drug development by pharmaceutical sponsors, continues with the goal of approval for more drugs and claims for aquaculture use.