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U.S. Department of Health and Human Services

Animal & Veterinary

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Ask CVM - March/April 2005

FDA Veterinarian Newsletter March/April 2005 Volume XX, No II

Q: There has been information on the internet about using the drug formalin on goats that could have Caseous Lymphadenitis. Is using that drug in this way legal?

A: This use of formalin is not approved, and FDA has no data supporting the safety or effectiveness of this product for this use.

However, under the provisions of the Animal Medicinal Drug Use Clarification Act, a veterinarian could prescribe an approved formalin product for this use. FDA-approved animal or human drugs may be prescribed for extra-label use providing that certain conditions are met (those in Title 21, Part 530 of the Code of Federal Regulations [http://www.fda.gov/cvm/index/amducca/530.txt]). These conditions include establishing a sufficiently long withdrawal time so that food products from the goat do not contain unsafe residues of the drug. This can be done only under the prescription of a licensed veterinarian who is operating with a valid veterinarian-client-patient relationship. The veterinarian must be familiar with the animals involved and be working closely with the animals’ caretakers. The veterinarian has the responsibility to determine an adequate withdrawal time supported by appropriate scientific information to prevent residues in the edible tissues.

Because the only approval FDA has for formalin is for immersion of fin fish, we have no data available on the presence of this compound in tissue after injection. Nor do we have data on the safety of this product when injected.

Under law, the only formalin products a veterinarian could use are those that are legally on the market—that have been approved for other uses. CVM has a list of all approved products in the “Greenbook,” which is available on CVM’s website at (http://www.accessdata.fda.gov/scripts/AnimalDrugsAtFDA/). The “Green-book” shows three approved formalin products, and they are all for topical use in fin fish to control external parasites. They are Formalin-F, by Natchez Animal Supply Co. (NADA 137-687), Paracide-F by Argent Lab-oratories (NADA 140-831), and Parasite S® by Western Chemical, Inc. (NADA 140-989).

Q: Are the requirements for manufacturing veterinary drugs different than those for human drugs?

A: Veterinary and human pharmaceutical drug product manufacturers must comply with the same current Good Manufacturing Practice requirements. The requirements are listed in 21 CFR Parts 210 and 211. Veterinary and human pharmaceutical drug products also have similar filing requirements. Therefore, veterinary and human pharmaceutical drug products have comparable identity, strength, purity, potency, and quality.