FDA WARNING_LETTER - Hull Veterinary Clinic, PC - May 06, 2008

The FDA issued a Warning Letter to Hull Veterinary Clinic, PC, following an investigation on April 23, 29, and May 6, 2008, concerning drug use in their veterinary practice in Hull, Iowa. The investigation revealed that the clinic caused the new animal drug sulfachlorpyridazine and the human drug amoxicillin to be unsafe and adulterated under sections 512(a)(1) and 501(a)(5) of the Federal Food, Drug, and Cosmetic Act, respectively, due to extralabel drug use not conforming to approved uses or 21 CFR Part 530. Additionally, animal feed was rendered unsafe and adulterated under sections 512(a)(2) and 501(a)(6). Specific violations included selling human amoxicillin for extralabel use without a valid veterinary/client/patient relationship, as required by 21 CFR 530.10(a). The clinic also compounded "Vetisulid Injection" from sulfachlorpyridazine oral powder and sold it for intravenous use in lactating dairy cows, which is prohibited for sulfonamides under 21 CFR 530.41(a)(9). Further, they compounded and used this product for oral and intramuscular administration in calves for diarrhea despite approved alternatives, violating 21 CFR 530.13(b)(2). Lastly, the compounded product was used in milk replacer, an animal feed, for calves, which is explicitly prohibited for extralabel drug use by 21 CFR 530.11(b) and section 512(a)(4) of the Act. The FDA requires prompt corrective action and establishment of preventative procedures. A written response detailing corrective steps and timelines is due within fifteen working days to avoid potential regulatory actions like seizure or injunction. The clinic must review 21 CFR Part 530 to ensure future compliance.