FDA WARNING_LETTER - Boonesboro Animal Clinic Corporation - June 25, 2009

On May 14, 15, and June 25, 2009, an FDA investigation at Boonesboro Animal Clinic Corporation revealed that Dr. Clifton Rex Smith caused the new animal drug, phenylbutazone, to be unsafe and adulterated under the Federal Food, Drug, and Cosmetic Act. Dr. Smith prescribed phenylbutazone boluses extra-label to an adult bull without complying with 21 CFR Part 530, Extra-label Drug Use in Animals regulations.

Specifically, the prescription lacked required labeling information per 21 CFR 530.12(b), (c), & (e), including the drug's established name, specific directions for use (animal identification, condition, dosage, frequency, route, duration), and a veterinarian-specified withdrawal time for meat. Furthermore, Dr. Smith failed to meet 21 CFR 530.20(a)(2)(iii) and (iv) by not instituting procedures to maintain the treated animal's identity or taking measures to ensure withdrawal times were met to prevent illegal residues. The drug was also prescribed for oral use in feed, which is prohibited for extra-label use under 21 CFR 530.11(b).

The FDA stated this is not an exhaustive list of violations and emphasized the responsibility to comply with the Act and extra-label use regulations. The clinic was instructed to take prompt corrective action and