| Public Health Service Food and Drug Administration |
| Cincinnati District Office Central Region 6751 Steger Drive Cincinnati, OH 45237-3097 Telephone: (513) 679-2700 FAX: (513) 679-2771 |
Department of Health and Human Services
July 6, 2010
WARNING LETTER
CIN-10-107809-16
VIA United Parcel Service
Gary L. Topp, D.V.M., Co-Owner
Country Road Veterinary Services, L.L.C.
6732 Dover Road
Apple Creek, Ohio 44606
Dear Dr. Topp,
On January 26 and February 2, 2010, Investigators from the U.S. Food and Drug Administration (FDA) conducted an investigation in regard to the use of drugs in your veterinary practice. That investigation revealed that you caused the new animal drug, sulfamethoxazole, to be unsafe under section 512(a) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 360b(a), 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 C.F.R. 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 512(a)(5) of the Act, 21 U.S.C. § 360b(a)(4) and § 360b(a)(5), and the implementing regulations at 21 C.F.R. Part 530. Our investigation found that you failed to comply with these requirements in that you prescribed sulfamethoxazole and trimethoprim tablets (800 mg/160 mg per tablet) in an extralabel manner to a calf without meeting the requirements of21 C.F.R. Part 530.
Your prescription for extralabel use of this drug did not meet the requirements of21 C.F.R. 530.12(c) and (e) which require that any animal drug prescribed and dispensed for extralabel use by a veterinarian shall bear or be accompanied by labeling information adequate to assure the safe and proper use of the product. The required labeling information includes:
(1) Any directions for use specified by the veterinarian, including the identification of the animal, condition to be treated, dosage, frequency, route of administration, and duration of therapy; and,
(2) The veterinarian's specified withdrawal time for meat which might be derived from the treated animal.
Your prescription for extralabel use also did not meet the requirements of 21 C.F.R. 530.20(a)(2)(iv), which requires that prior to prescribing or dispensing an approved new animal drug for an extralabel use in food animals, the veterinarian must take appropriate measures to assure that assigned timeframes for withdrawal are met and no illegal residues occur in any food-producing animals subject to extralabel treatment.
Because the drug, sulfamethoxazole was prescribed and used in a manner that did not conform with its approved uses or in compliance with 21 CFR Part 530, you caused the drug to be unsafe under section 512(a) of the Act, 21 U.S.C. 360b(a), 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 and your partners are responsible for complying with the requirements of the Act, including 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.
You should notify this office in writing within fifteen (15) working days of receiving this letter of the specific steps you have taken to correct the noted violations, including an explanation of each step being taken to prevent the recurrence of similar violations. 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. Also, include copies of any available documentation demonstrating that corrections have been made.
Your written response should be sent to Mark E. Parmon, Compliance Officer, U.S. Food and Drug Administration, 6751 Steger Drive, Cincinnati, Ohio 45237. If you have any questions about this letter, please contact Compliance Officer Mark E. Parmon at (513) 679-2700, Ext. 162, or via email at mark.parmon@fda.hhs.gov.
Sincerely,
/S/
Teresa C. Thompson
District Director
Cincinnati District
cc: Dr. Tony Forshey, Acting Chief
Ohio Department of Agriculture
8995 East Main Street
Reynoldsburg, OH 43068-3399
Atlee W. Hostetler
1553 Harrison Road
Apple Creek, Ohio 44606
No comments:
Post a Comment