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U.S. Department of Health and Human Services

Animal & Veterinary

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Regulatory Activities for October and November 2006

FDA Veterinarian Newsletter 2006 Volume XXI, No V

Significant deviations from the requirements from the regulations setting forth the animal proteins that are prohibited in ruminant feed (21 CFR 589.2000) were noted in a WARNING LETTER issued to Christopher V.B. Smith, corporate president and CEO of H.J. Baker & Bro., Inc., Westport, CT. Failure to follow the requirements set forth in these regulations resulted in the manufacture and distribution of products adulterated under section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (FFDCA) and misbranded under section 403(a)(1). The action followed an investigation that showed that the firm failed to establish and use cleanout procedures or other means to prevent carry-over of products that contain or may contain protein derived from mammalian tissues into animal protein or feeds that may be used for ruminants. Specifically, the firm used a screw auger to convey both prohibited and non-prohibited material to bulk storage bins. In addition, the firm failed to label all prohibitive or potentially prohibitive products with “Do not feed to cattle or other ruminants.”

A WARNING LETTER was issued to Miriam E. Harthill, president of Churchill Veterinary Supply Company, Inc., Irvine, CA, because an -inspection of this animal drug manufacturing facility revealed serious violations of the FFDCA. Specifically, the following products were being manufactured without an approved new animal drug application (NADA) on file with FDA to verify safety and effectiveness: Butecort Sweat, Fur-A-Sweat, Foot Freeze, Tie-Up Powder, After Firing Paint, Blue Splint Blister, Liquid Blister, and -Soluble -Iodine, Nascent. The drugs were adulterated because they are deemed unsafe in the absence of an approved NADA. In addition, two of the products—Blue Splint Blister and Liquid Blister—contain mercury bichloride (mercuric chloride), a chemical that FDA believes is not safe and effective; the Agency has reports of adverse drug reactions, including deaths in animals, resulting from the use of mercury-containing blistering products. FDA also has safety concerns for people who handle these products. As unapproved products, they were found to be misbranded under Section 352(f)(1) of the FFDCA because their labeling failed to bear adequate directions for use. The products are also misbranded under Section 352(o) of the Act because they were manufactured in a facility not registered with FDA.

Extralabel use of gentamicin sulfate in violation of 21 CFR Part 530 led to the issuance of a WARNING LETTER to Dr. Richard Price of Dairy Veterinary Services, P.A., Monroe, NH. Specifically, an investigation by FDA revealed that the firm had prescribed the intramammary infusion of the liquid form of gentamicin sulfate to treat coliform mastitis in lactating dairy cattle. The firm’s prescription for the extralabel use of gentamicin sulfate solution did not meet the requirements of 21 CFR 530.20, which require that the company: establish a substantially extended withdrawal period prior to marketing of edible products; institute procedures to ensure that the identity of the treated animal is carefully maintained; and take appropriate measures to ensure that assigned timeframes for withdrawal are met and that no illegal drug residues remain in any food-producing animal subjected to extralabel treatment.

Penicillin residues in the kidney tissues of a cow offered for sale as human food exceeding the established tolerance set forth in 21 CFR 556.510 resulted in the issuance of a WARNING LETTER to Gerald C. Thompson, owner of Gerald Thompson Farm, LaFargeville, NY. The presence of 0.17 parts per million penicillin in kidney tissue caused the animal to be adulterated within the meaning of section 402 of the FFDCA. An investigation of the farm also revealed that animals were being held under conditions so inadequate that medicated animals bearing potentially harmful drug residues were likely to enter the food supply. Mr. Thompson also failed to maintain written treatment records to document the identity of the animal, treatment dates, drugs administered, dosage administered, route of administration, and withdrawal times for milk and beef. In addition, Mr. Thompson adulterated Quartermaster penicillin-dihydrostreptomycin in oil because it was being used extralabel, since it was not being administered by a licensed veterinarian.

Penicillin residues in the kidney tissue of a dairy cow offered for sale as food exceeding the established tolerances set forth in 21 CFR 556.510 resulted in the issuance of a WARNING LETTER to -Michael H. Vermeer, general manager and co-owner of Vermeer Dairy, Caldwell, ID. The presence of penicillin G procaine at higher levels than authorized caused the animal to be adulterated under section 402 of the FFDCA. In addition, the firm adulterated the drug within the meaning of section 501 of the FFDCA because it was used extralabel and not administered in the presence of a licensed veterinarian. Adequate treatment records were also lacking.