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U.S. Department of Health and Human Services

Animal & Veterinary

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FDA Veterinarian Newsletter March/April 2000 Volume XV, No II

On November 22, 1999, Bradley J. Rabe D.V.M. was sentenced in U.S. District Court, District of Nebraska. Dr. Rabe was charged with the intentional misbranding of the prescription veterinary drug Baytril (enrofloxacin). The product was labeled as "Vitamin B1 - No Withdrawal" and distributed to food animal producers.

Enrofloxacin is in a group of drugs called fluoroquinolones. Initially approved for treating disease conditions in dogs, enrofloxacin is now approved in some food animals. However, the FDA has prohibited its extra-label use in animals due to concerns for antibiotic resistance, potentially transferred to humans from meat, poultry, eggs, and dairy products.

Dr. Rabe was sentenced to one-year probation, two hundred hours of community service, a one thousand dollar fine, and a one hundred dollar special assessment. The terms of Rabe's probation include that he must provide court access to his financial records; that he must provide the Food and Drug Administration (FDA) access to his place of business and veterinary practice records upon request; that he must comply with all Nebraska Department of Health Veterinary license requirements; and that he must comply with all FDA rules, regulations and policies.

Rabe’s sentencing stems from a Federal Grand Jury indictment on March 16, 1999, after FDA's Office of Criminal Investigations (OCI) determined that he was relabeling Baytril and selling it to local food animal producers both with and without the producer’s knowledge of what the product contained. The indictment charged Rabe with 5 counts of Title 21, intent to defraud by adulterating and misbranding Baytril after receipt in interstate commerce. The indictment also charged Title 18, Aiding and Abetting. At the time of Rabe's Baytril distribution, the drug was not approved for use in food-producing animals.

Between the time of Rabe's plea agreement and sentencing, the Nebraska Department of Agriculture reported to OCI that they had evidence that Rabe was continuing to misbrand prescription veterinary drugs which resulted in the adulteration of two loads of Grade A milk.