Inspections, Compliance, Enforcement, and Criminal Investigations
North Valley Veterinary Clinic, Inc.
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
22201 23rd Drive SE
Bothell, WA 98021-4421
RETURN RECEIPT REQUESTED
In reply refer to Warning Letter SEA 09-18
Michael D. Holland, DVM, Secretary
North Valley Veterinary Clinic, Inc.
2154 Hwy 46
Gooding, Idaho 83330
Dear Dr. Holland,
On February 26 and March 2, 2009, the U.S. Food and Drug Administration (FDA), conducted an investigation regarding the use of drugs in your veterinary practice located in Gooding, Idaho. Our investigation revealed that you caused the new animal drug, sulfadimethoxine, to be unsafe under section 512(a)(1) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 360b(a)(1), and adulterated within the meaning of section 501 (a)(5) of the Act, 21 U.S.C. § 351(a)(5), because the drug was used in a manner that did not conform with its approved uses or with the regulations for Extralabel Drug Use in Animals, Title 21, Code of Federal Regulations. Part 530 (21 CFR Part
530). You can find the Act and its associated regulations on the Internet through links on the FDA's web page at www.fda.gov.
The extralabel use of approved veterinary or human drugs in animals is permitted only if it complies with sections 512(a)(4) and (5) of the Act, 21 U.S.C. § 360b(a)(4) and (5), and the implementing regulations at 21 CFR Part 530. Our investigation"found that you
failed to comply with these requirements. For example, you prescribed sulfadimethoxine injection-40%, administered intravenously at a dosage of 60 cc's daily for 3 days for use in lactating dairy cows to treat diarrhea. This is an extralabel use of sulfadimethoxine. This drug has not been approved for the treatment of diarrhea in dairy cows. In addition, for the uses for which the drug is approved in dairy cattle, the label for this drug states that the drug is to be administered in amounts to provide 25 mg/lb (55 mg/kg) for the initial dose, followed by 12.5 mg/lb (27.5 mg/kg) for maintenance doses every 24 hours. Extralabel use of any sulfonamide drugs in lactating dairy cows is prohibited under 21 CFR 530.41 (a)(9). Because your extralabel use of the new animal drug sulfadimethoxine was not in compliance with 21 CFR Part
530, your firm caused the drug to be unsafe under section 512(a)(1 )of the Act, 21 U.S.C. § 360b(a)(1), and adulterated within the meaning of section 501 (a)(5) of the Act, 21 U.S.C. 351 (a)(5).
The above is not intended to be an all-inclusive list of violations. You are responsible for complying with the requirements of the Act, and the extralabel use regulations promulgated under the Act. You should take prompt action to correct the above violations and to establish procedures whereby such violations do not recur. Failure to do so may result in regulatory action without further notice such as seizure and/or injunction.
We have enclosed a copy of 21 CFR Part 530 for your reference. We strongly suggest that you review this document and become familiar with all of the requirements concerning extralabel use of new animal and human drugs so that you can prevent future violations of the Act.
You should notify this office in writing of the specific steps you have taken to bring your firm into compliance with the law within fifteen (15) working days of receiving this letter. Your response should include each step that has been taken or will be taken to correct the violations and prevent their recurrence. If corrective action cannot be completed within fifteen (15) working days of receiving this letter, state the reason for the delay and the time frame within which the corrections will be completed. We are particularly concerned that your clients may continue to use sulfadimethoxine injection-40% in the dosage you have prescribed to treat lactating dairy cattle. Please include information on how you intend to ensure such practice does not occur, and educate your clients that such extralabel use would be illegal. Please include copies of any available documentation demonstrating that corrections have been made.
Your written response should be sent to Lisa M. Elrand, Compliance Officer, U.S. Food and Drug Administration, 22201 23rd Drive SE, Bothell, Washington 98021-4421. If you have any questions about this letter, please contact Compliance Officer Lisa M. Elrand at (425) 483-4913.
Charles M. Breen
Enclosures: 21 CFR 522.2220
21 CFR Part 530
cc: Dr. Bill Barton
Division of Animal Industries
Idaho State Department of
P.O. Box 7249
Boise, ID 83707
U.S. Department of Agriculture
Food Safety and Inspection Service
Denver Federal Center
P.O. Box 25387, Building 45
Denver, Co 80225