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U.S. Department of Health and Human Services

Animal & Veterinary

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REGULATORY ACTIVITIES - September/October 2000

FDA Veterinarian Newsletter September/October 2000 Volume XV, No. V

The following firms/individuals received warning letters for offering animals for slaughter that contained illegal drug residues:

  • Frank J. Garcia, Jr. and Danny Garcia, Garcia Brothers Dairy, Tulare, CA
  • Douglas G. Brunner, Edward DeJager, and Edgar DeJager, DeJager Dairy South, Chowchilla, CA
  • John R. Wigle, Latrobe, PA

These violations involved illegal residues of streptomycin in a dairy cow; penicillin in a dairy cow; and gentamicin in dairy cows.

Warning letters were sent to the following veterinarians as a result of illegal residues reported in animals treated by these individuals:

  • James E. O’Shea, D.V.M., New Berlin, NY
  • Benjamin F. Turner, D.V.M., Cortland, NY
  • Douglas E. Evans, D.V.M., Georgetown, NY

All of these residues involved the illegal prescription and dispensing of gentamicin in dairy cows that were later offered for sale for human food. There is no permitted level for residues of gentamicin in edible tissue of cattle.

A warning letter was sent to Richard L. Lawson, President of Products Carousel, Inc., Sanger, CA. FDA analyses of Choo-HoovesPressed Sticks revealed contamination with Salmonella, a pathogenic bacteria. As a manufacturer of pet foods, it is Mr. Lawson’s responsibility to assure that his products are safe, wholesome, and not contaminated with pathogenic bacteria.

A warning letter was also sent to Dr. Praful R. Patel, President of National Biochemicals Corp., Twinsburg, OH, for violations related to the repackaging and distribution of bulk active pharmaceutical ingredients (API’s). Twenty-one Code of Federal Regulations 201.122 states that API’s used to produce new animal drugs are exempt from the requirement for adequate directions for use under 502(f)(1) if used to produce an animal drug that is covered by an approved new animal drug application. Conversely, an API that is used to produce an unapproved new animal drug is not exempt from the requirement for adequate directions for use and is therefore misbranded under 502(f)(1).

The regulation, 21 CFR 201.150, requires a written agreement between API shippers and recipients, assuring that the API’s will not be adulterated or misbranded by the end users. Distributors will be held accountable when drugs (API’s) they sell are used to manufacture unapproved drug products and they have not taken proper steps to prevent such illegal use.

Robert E. Hinckley, President/CEO of Bimeda Animal Health, Inc., Riverside, MO, received a warning letter for improper sales of veterinary prescription drugs. Sales were made without a valid veterinarian/client/patient relationship (VCPR) or to firms who are not lawfully engaged in distributing prescription drugs. Mr. Hinckley’s firm was selling prescription veterinary drugs such as Gentamicin Sulfate Solution, Cyanocobalamin Injection, Vitamin B-12, and Hypertonic Saline Solution, which are misbranded within the meaning of Section 502(f)(1) of the Federal Food, Drug, and Cosmetic Act in that they do not have adequate directions for use.

Within a valid VCPR, prescription animal drugs are exempt from adequate directions for lay use; the veterinarian’s supervision can be substituted for the legal requirement that drugs be labeled with adequate directions for use. Without supervision, prescription drugs are misbranded because they lack adequate directions for the layperson to use them safely.