| Public Health Service Food and Drug Administration |
Atlanta District Office 60 Eighth Street N.E. Atlanta, GA 30309 Telephone: 404-253-1161 |
Department of Health and Human Services
February 17, 2011
VIA UNITED PARCEL SERVICE
WARNING LETTER
(11-ATL-04)
Truman R. Sanner, DVM
Rocky Creek Veterinary Service
178 Holstein Lane
Olin, NC 28660
Dear Dr. Sanner:
On December 7 and 10, 2010, an investigator from the U.S. Food and Drug Administration (FDA) conducted an investigation involving the use of drugs in your veterinary practice. That investigation revealed that you caused the animal drug sulfadimethoxine to be unsafe under section 512(a) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act), 21 U.S.C. § 360b(a), and adulterated within the meaning of section 501(a)(5) of the FD&C Act, 21 U.S.C. § 351(a)(5), because the drug was used in a manner that did not conform with the approved uses or the regulations for Extralabel Drug Use in Animals, Title 21, Code of Federal Regulations (21 CFR), Part 530 (21 CFR Part 530).
The extralabel use of approved veterinary or human drugs in animals is permitted only if it complies with section 512(a)(4) and (5) of the FD&C Act, 21 U.S.C. § 360b(a)(4) and (5), and 21 CFR Part 530. Our investigation found that you failed to comply with 21 CFR Part 530 in that you verbally prescribed sulfadimethoxine to treat lactating dairy cattle for diarrhea at the (b)(4) located in (b)(4). This is an extralabel use. 21 CFR § 530.41(a)(9) prohibits sulfadimethoxine from extralabel use in lactating dairy cattle. In addition, even if sulfadimethoxine were not on the list of drug prohibited from extralabel use in 21 CFR 530.41, you did not comply with 21 CFR 530.20(a)(2), which requires that you make a careful diagnosis and evaluation of the conditions for which the drug was to be used, take appropriate measures to assure that the assigned timeframes for withdrawal are met and no illegal drug residues occur in any food producing animal subject to extralabel treatment. (b)(4) offered a culled dairy cow for slaughter as food that was subsequently found to contain illegal residues in edible tissue.
The above is not intended to be an all-inclusive list of violations. You are responsible for complying with the requirements of the FD&C Act, including the extralabel use regulations promulgated under the FD&C 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 21 CFR Part 530 and become familiar with all of its requirements so that you can prevent future violations of the FD&C Act. In addition, we are enclosing a copy of 21 CFR § 520.2220b, which lists approved uses of sulfadimethoxine boluses.
FDA acknowledges the written response we received following our inspection. A letter dated December 20, 2010, was received addressing the observations made during the inspection conducted on December 7 and 10, 2010. Although your letter indicates that you have taken steps to address our observations, your response did not contain enough detail for us to evaluate. You made statements like you are now familiar with the regulations/requirements of extralabel use and prohibited use of veterinary drugs and that you will educate yourself with the “sulfa” regulations and “therapeutic agents”, but you also failed to mention if you plan on addressing the “extralabel use” issue with any of your other clients. These are just some of the issues that will need to be evaluated and verified in the near future.
You should notify this office in writing of the 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. Please include copies of any available documentation demonstrating that corrections have been made.
Your written response should be sent to Ms. Marie F. Mathews, Compliance Officer, U.S. Food and Drug Administration, 60 Eighth Street NE, Atlanta, Georgia 30309. If you have any questions about this letter, please contact Ms. Marie Mathews at (404) 253-1279 or via e-mail at Marie.Mathews@fda.hhs.gov.
Sincerely,
/S/
John R. Gridley, Director
Atlanta District
Enclosure
cc: Ben A. Shelton, DVM
Rocky Creek Veterinary Service
178 Holstein Lane
Olin, NC 28660
cc: (b)(4)
cc: North Carolina Veterinary Medical Board
1611 Jones Franklin Road, Suite 106
Raleigh, NC 27606
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