FDA WARNING_LETTER - Midstate Veterinary Services, PLLC - December 04, 2009

On November 25 and December 4, 2009, an FDA investigation at Midstate Veterinary Services, PLLC, revealed violations regarding extralabel drug use. The practice, led by Dr. Paul B. Coen, caused the animal drug sulfadimethoxine to be unsafe and adulterated under sections 512(a) and 501(a)(5) of the Federal Food, Drug, and Cosmetic Act (the Act), respectively.

Specifically, the investigation found non-compliance with 21 C.F.R. Part 530, Extralabel Drug Use in Animals. The practice failed to comply with 21 C.F.R. Part 530.41(a) by prescribing sulfadimethoxine for extralabel use in lactating dairy cows, which did not conform to its approved uses or the regulations.

While the FDA acknowledged the practice's December 17, 2009, response to the FDA-483 regarding penicillin, the response was deemed inadequate concerning sulfadimethoxine. The revised drug protocol for Albon (sulfadimethoxine) did not specify that the drug must be used in accordance with the approved label for lactating dairy cattle. Furthermore, the response did not address steps to ensure future extralabel use of approved human or animal drugs complies with sections 512(a)(4) and (5) of the Act