FDA WARNING_LETTER - Country Road Veterinary Services LLC - February 02, 2010

On January 26 and February 2, 2010, FDA investigators inspected Country Road Veterinary Services, L.L.C., regarding drug use. The investigation revealed that Dr. Gary L. Topp caused the new animal drug sulfamethoxazole to be unsafe and adulterated under sections 512(a) and 501(a)(5) of the Federal Food, Drug, and Cosmetic Act (the Act), respectively. This was due to extralabel use of sulfamethoxazole and trimethoprim tablets (800 mg/160 mg) in a calf, which did not conform to approved uses or the regulations for Extralabel Drug Use in Animals, 21 C.F.R. Part 530.

Specifically, the extralabel prescription failed to meet 21 C.F.R. 530.12(c) and (e) because the labeling lacked adequate information for safe and proper use, including directions for use (animal identification, condition, dosage, frequency, route, duration) and the veterinarian's specified withdrawal time for meat. Additionally, the prescription did not comply with 21 C.F.R. 530.20(a)(2)(iv), which requires veterinarians to ensure withdrawal timeframes are met to prevent illegal residues in food-producing animals.

The FDA requires prompt corrective action to prevent recurrence of these violations