FDA WARNING_LETTER - Yancey, Samuel DVM - February 22, 2010

On February 12 and 22, 2010, FDA investigators found that Dr. Samuel Yancey's veterinary practice caused Phenylbute Injection 20% (phenylbutazone), ANADA 200-371, to be unsafe and adulterated under sections 512(a) and 501(a)(5) of the Federal Food, Drug, and Cosmetic Act. This was due to extralabel drug use in a manner not conforming with approved uses and 21 CFR Part 530, Extralabel Drug Use in Animals. Additionally, a cow sold for slaughter became adulterated under section 402(2)(C)(ii).

Specifically, Dr. Yancey failed to comply with 21 CFR 530.41(a)(12) by prescribing phenylbutazone, approved for horses only, for female dairy cattle 20 months or older and for downer animals. This regulation explicitly prohibits extralabel use of phenylbutazone in female dairy cattle of that age. Furthermore, the extralabel prescription lacked required labeling information per 21 CFR 530.12(a),(c),(d), and (e), including the veterinarian's name/address, directions for use, cautionary statements, and withdrawal time for meat. The practice also failed to meet 21 CFR 530.20(a)(