Animal & Veterinary
Regulatory Activities - January/February 2004
by Linda A. Grassie, Director, Communications Staff
FDA Veterinarian Newsletter January/February 2004 Volume XIX, No 1
The following firms/individuals re-ceived Warning Letters for offering animals for slaughter that contained illegal residues:
- Fred M. Cox, Jr., Owner, Fred M. Cox, Jr. Farm, Talala, OK
- Tom Osterkamp, Owner, Osterkamp Dairy, Corona, CA
- Frank N. Konyn, Partner, Frank Konyn Dairy, Escondido, CA
- Hans N. Nederend, Owner, Mirada Dairy, Homedale, ID
- Jacobus L. De Groot, Partner and John De Groot, Partner, Visalia, CA
- Henry J. te Velde, D.V.M., President, JVJ Dairy, Inc., AKA Meadow Dairy, Winton, CA
- Henry C. Hafliger, Owner, Desert Rose Farms, Filer, ID
- Daniel E. Dallmann, President, Dallmann Farms, Inc., Brillion, WI
- Christopher J. Elbe, Owner, Christopher & Tracy Elbe Dairy, West Bend, WI
- Carlos C. Lourenco, Owner, Carlos Lourenco Dairy, Merced, CA
- Hector Stechnij, Owner, Hector Stechnij Dairy, Mesa, AZ
- Peter J. Vander Poel, Sr., Pete Vander Poel Dairy, Tulare, CA
- Jack Hanke, Owner, Hanke Farms, Inc., Sheboygan Falls, WI
- Hein Hettinga and E. J. (Amos) Degroot, Partners, Pahrump Dairy, Pahnlmp, NV
- Mr. & Mrs. Henry A. Vander Poel, Co-Owners and John C. Vander Poel, Co-Owner, Whiteside Dairy, Wasco, CA
The above violations involved sulfadimethoxine in cows, penicillin in cows, flunixin in cows, gentamicin in cows and ivermectin in a bull.
Warning Letters were sent to the following individuals and firms for significant deviations from the Current Good Manufacturing Practice (cGMP) regulations for Medicated Feeds.
- Austin J. DeCoster, Owner, DeCoster Feeds, Turner, ME
- Donald L. Pope, President, Brookhurst Mill, Riverside, CA
- David A. Robertson, President, Allen Robertson & Company, Inc., Louisville, KY
- Rich Dwyer, President, Kent Feeds, Inc., Muscatine, IA
Warning Letters were sent to the following individuals/firms because they compounded and distributed veterinary drug products that were considered adulterated under the Federal Food, Drug, and Cosmetic Act (the Act). A new animal drug is deemed unsafe unless an approved New Animal Drug Application (NADA) is in effect for the specific product in question. None of the animal drugs compounded and distributed by these firms were the subject of an approved NADA. The only legal compounding of animal drugs is provided under the Animal Medicinal Drug Use Clarification Act and its implementing regulations at Title 21 of the Code of Federal Regulations (CFR) Part 530, Extralabel Drug Use in Animals.
- Dr. Warren B. Lee, President, Lee Pharmacy, Inc., Fort Smith, AR
- Mr. John R. Rains, R. Ph., CEO, Plum Creek Pharmaceuticals, Inc., Amarillo, TX
- Mr. Jack R. Munn, R. Ph., President, Medical Park Pharmacy, Dallas, TX
A Warning Letter was issued to Robert H. Douglas, Ph.D., BET Pharm LLC, Lexington, KY, because, while the firm purports to be a compounding pharmacy for veterinary drugs, FDA investigation determined that the firm exceeds the scope of the regular course of the practice of pharmacy. The firm's activities go beyond that of a pharmacy and into the activities of a drug manufacturer. The only legal compounding of animal drugs is provided under the Animal Medicinal Drug Use Clarification Act and its implementing regulations at Title 21 of the Code of Federal Regulations (CFR) Part 530, Extralabel Drug Use in Animals.
A Warning Letter was issued to Kenneth L. Collier, DVM, Co-owner, Friendship Valley, LLC, Clintonville, WI, because an investigation into an illegal tissue residue in a dairy cow sold for slaughter as human food by the firm revealed serious deviations from the regulations for Extralabel Drug Use in Animals. These deviations caused an animal drug to be used in a manner that was unsafe and adulterated under the Act.
A Warning Letter was issued to Timothy J. Dennis, DVM, Partner, Eastview Veterinary Clinic P.C., Penn Yan, NY, because an investigation revealed serious deviations from Extralabel Drug Use in Animals. The extralabel use of approved animal drugs by veterinarians is allowed under the Act 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 contained in 21 CFR Part 530 renders the drug unsafe under Section 512 and thus adulterated under Section 501 (a)(5) of the Act.
A Warning Letter was issued to Mr. Richard Chapman, President, North Country Dairy Supply, Inc., West Rutland, VT, for significant deviations from FDA's regulations establishing cGMPs for finished pharmaceuticals.