FDA WARNING_LETTER - Northwest Veterinary Associates, Inc. - June 19, 2013

An FDA investigation conducted from May 22 to June 19, 2013, revealed that Northwest Veterinary Associates, Inc. caused animal drugs to be unsafe and adulterated under sections 512(a) and 501(a)(5) of the FD&C Act, respectively. This was due to extralabel drug use that did not conform with 21 C.F.R. Part 530, the regulations for Extralabel Drug Use in Animals. Specifically, the firm prescribed the human drug Sulfamethoxazole and Trimethoprim Double Strength Tablets, USP, for extralabel administration to calves for scours by dissolving it in milk replacer between September 2011 and June 2013. This extralabel use failed to meet the requirements of 21 C.F.R. 530.20(a)(2)(i)-(iv). These requirements include making a careful diagnosis, establishing a substantially extended withdrawal period, instituting procedures to maintain treated animal identity, and taking measures to assure withdrawal timeframes are met to prevent illegal drug residues in food-producing animals. The firm's July 8, 2013, response was deemed inadequate. The FDA requires prompt corrective action and establishment of preventative procedures. The firm must notify the FDA within fifteen working days, detailing corrective steps, timelines, and supporting documentation, to avoid potential regulatory actions like seizure or injunction. The letter emphasizes the responsibility of licensed veterinarians to comply with the Act and its extralabel use regulations.