Hetacillin

Cracking the Code on Illegal Animal Drug Sales

It was like Sherlock Holmes, "Miami Vice," and "Hee-Haw" all rolled into one: secret codes, undercover drug buys, and a farm supply and veterinary drug wholesaler who thought he could pull the wool over FDA's eyes. The wholesaler ended up with the dubious distinction of sharing in a "first" for FDA: His firm was the first to be ordered by a court to pay restitution to the agency for the costs of its investigation into his illegal sales of prescription animal drugs.

The firm was Vernon Agri Service in Vernon Center, N.Y. The investigation into its illegal activities began in May 1984 with a call from the U.S. Department of Agriculture to FDA's Buffalo district staff.

USDA said that inspectors had found chloramphenicol residues in the meat of a slaughtered calf. Chloramphenicol is a potent prescription veterinary drug. It should not be given to food-producing animals because exposure to residues of the drug can cause aplastic anemia in people sensitive to it. Aplastic anemia is often fatal.

USDA said the calf had been sold by Di Nitto Farms in Marcy, N.Y. When Buffalo district investigator William Chilton visited the farm, he learned that the chloramphenicol had been purchased from Vernon Agri Service without a veterinarian's prescription. So Chilton went to Vernon Agri Service.

The Vernon Center firm was a family affair, run by Roman J. Wilczak and his wife and son. The firm sells veterinary products and farm supplies, such as drugs, vaccines, detergents, sanitizers, milking-machine parts, and insecticides. It is licensed by New York State as a wholesaler of prescription veterinary drugs but is not licensed to sell drugs to individual users, even those with prescriptions.

Roman Wilczak admitted to Chilton that he had been routinely selling prescription veterinary drugs to dairy farmers without prescriptions.

The Buffalo district director then sent a letter to Wilczak warning that this illegal sale of prescription veterinary drugs must stop. Wilczak's lawyer wrote back, saying that Vernon Agri Service had stopped selling prescription veterinary drugs.

To see if Vernon Agri was doing as it said, another Buffalo district investigator, David McNew, began ordering prescription veterinary drugs by mail from the firm. The investigator, of course, did not mention that he worked for FDA.

He received what he ordered, including Hetacillin potassium and oxytocin. Hetacillin potassium is a semi-synthetic penicillin; it should not be used by lay persons because excessive use could lead to the development of antibiotic-resistant strains of Staphylococcus bacteria in humans. Oxytocin is used to induce labor; if not administered properly to an animal, the fetus or mother could die. The drugs were clearly labeled, "CAUTION: Federal law restricts this drug to use by or on the order of a licensed veterinarian."

Buffalo district investigators also inspected a large veterinary prescription drug firm that had supplied Vernon Agri. The president of the firm admitted that he used a coding system on the invoices to conceal the true identities of the drugs and the fact that they were prescription. For instance, oxytocin was listed as "Penn G" and Hetacin-K (Hetacillin potassium) as "Mastitis Treatment." The records showed that Vernon Agri had recently purchased a number of prescription veterinary drugs, which had been shipped with invoices using the code names.

The investigators also questioned the owner of a farm in Higginsville, N.Y., and found that he had recently purchased some prescription drugs from Vernon Agri. He had not needed a prescription to do so.

Investigator Chilton, accompanied by a second investigator, returned to inspect Vernon Agri Service. Wilczak told the two that he was not engaged in buying or selling prescription drugs. He showed them records of purchases, including those from the firm using the code names and claimed that the encoded prescription drugs were really over-the-counter drugs. There were no prescription drugs in evidence, and Wilczak said he did not have any other storage facility.

During a break in the inspection, Investigator McNew arrived. Posing as a customer, he said he wanted to buy more Hetacin-K and oxytocin. Wilczak explained, out of the other investigators' hearing, that he had moved all the prescription drugs off the premises until the FDA inspection was over. McNew asked why, and Wilczak told him that it was illegal to sell prescription drugs to people without a prescription. He offered to send the drugs to McNew after the FDA inspection was finished.

The Buffalo district office requested that legal action be taken against Vernon Agri Service. Because the inspection had clearly shown that the firm was attempting to conceal from FDA its illegal activities, the agency obtained a temporary restraining order. Eleven days later, on July 12, 1985, the firm signed a consent decree of permanent injunction in the U.S. District Court for the Northern District of New York. The complaint ordered Vernon Agri Service and Roman Wilczak to stop selling prescription veterinary drugs to people without prescriptions and reclaimed for FDA the costs involved in supervising the terms of the injunction. In addition, Wilczak was ordered to reimburse FDA $7,000 for the costs of the inspections that led up to the injunction. This is the first time FDA has sought and obtained restitution for pre-injunction costs.

COPYRIGHT 1986 U.S. Government Printing Office
COPYRIGHT 2004 Gale Group