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FDA Regulatory Activities 2004FDA Regulatory Activities 2004
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Subjects > World > Countries?Create > United States > United States Government Agencies > U.S. Food And Drug Administration > FDA And Animals
Regulatory Activities
by Linda A. Grassie, Director, Communications Staff
The following firms/individuals re-ceived Warning Letters for offering animals for slaughter that contained illegal residues:
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.
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.
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.
See also FDA And Animals and other animal related topics:
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