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U.S. Department of Health and Human Services

Animal & Veterinary

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Regulatory Activities - January/February 2005

FDA Veterinarian Newsletter January/February 2005 Volume XX, No I

The following individuals and firms received Warning Letters for offering animals for slaughter that contained illegal tissue residues:

  • David L. and Nancy E. Huebner, Owners, Huebner Farm, Columbus, WI
  • Daniel W. Thuemmel, President, Thuemmel Dairy, Inc., Port Austin, MI
  • Jay L. DeJong, Owner, Rhody Dairy, Sumas, WA

The above violations involved penicillin, gentamicin, and flunixin in dairy cows.

Warning Letters were issued to Roger Nutsch, Partner, U R Farms, Jerome, ID; Daniel W. Nolan, Owner, Nolan Livestock, Bonduel, WI; and Laurens A.T.M. Schilderink, President, Spandet Dairy, Inc., Hart, TX, because investigations found they were offering animals for slaughter that contained illegal tissue residues. The investigations further revealed deviations from rules for Extralabel Drug Use in Animals. The extralabel use of approved animal drugs by veterinarians is allowed by law, provided that the regulations contained in 21 CFR Part 530 are followed. Extralabel use of an approved animal drug that is not in compliance with the regulations renders the drug unsafe under Section 512 and thus adulterated under Section 501(a)(5) of the Federal Food, Drug, and Cosmetic Act (the Act).

A Warning Letter was issued to -Joseph A. Gingerich, Co-Owner, Prime Veal Feed, Ltd., Kensington, OH, for selling and dispensing veterinary prescription drug products without a lawful order from a licensed veterinarian, which caused the products to be misbranded within the meaning of Section 503(f)(1)(C) of the Act. Examples of veterinary prescription drugs dispensed without the order from a licensed veterinarian include Banamine (flunixin meglumine), Micotil (tilmicosin), and Nuflor (florfenicol). In addition, these prescription veterinary drugs were misbranded within the meaning of 502(f)(1) of the Act because they did not bear adequate directions for use, and they do not fall into an exception to that requirement. FDA has defined “adequate directions for use” as “directions under which the layman can use a drug safely and for the purposes for which it is intended.” Inspection also revealed the firm dispensed Flunixin Meglumine Injection bearing a Dexamethasone label and Selenium-Vitamin E Injection (Mu-Se) bearing an Amoxicillin label. These drugs are misbranded under section 502(a) of the Act, because labeling is false or misleading, and 502(i)(3), in that they were offered for sale under the name of another drug. In addition, the inspection found the dispensing of human prescription drugs, such as Sulfamethoxazole and Trimethoprim tablets, Cephalexin capsules, and Amoxicillin capsules, for extralabel use in animals.

A Warning Letter was issued to Alan O. Bostick, President, Sunshine Mills, Inc., Red Bay, AL, because inspection at his feed manufacturing facility in Tupelo, MS, revealed significant deviations from the requirements sent forth in Title 21, Code of Federal Regulations (CFR), Part 589.2000 – Animal Proteins Prohibited in Ruminant Feed. This regulation is intended to prevent the establishment and amplification of bovine spongiform encephalopathy. The inspection indicated the manufacturing of products containing beef meat and bone meal that require the cautionary statement, “Do not feed to cattle or other ruminants,” and the firm failed to label the products with this statement. Specifically, the products that contained protein derived from mammalian tissues, but lacked the required statement included “Happy Fishman” and “Premier” catfish feeds.

A Warning Letter was issued to -William B. Parrish, Chairman of the Board, Parrish & Heimbecker, Limited, Winnipeg, Manitoba, Canada, because inspection of his feed mill operation, Conway Feed, Inc., located in Conway, WA, found significant deviations from the requirements set forth in 21 CFR 589.2000. The investigation found that because the operation failed to adequately inspect the label of a raw material, an ingredient with the cautionary statement “Do not feed to cattle or other ruminants” was used in the manufacture of the finished product Game Bird Crum/Pellet. This final product did not display the cautionary statement that is required because this fish meal may contain prohibited animal proteins. Any product produced from the fish meal must also have the cautionary label. The investigation also revealed that the label of the Game Bird Crum/Pellet feed did not list fish meal as an ingredient. According to the information collected during the inspection fish meal is routinely added to this ration. Pursuant to 21 CFR 501.4(a), all ingredients required to be listed on the label in descending order of predominance by weight.

Correction

The November/December 2004 issue of FDA Veterinarian incorrectly listed in the Regulatory Activities section the location of Lake Country Veterinary Service, P.S. It is in Albany, MN.