| 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) 679-2761 |
Department of Health and Human Services
January 14, 2010
VIA FEDERAL EXPRESS
WARNING LETTER CIN-1O-84244-02
Barry Lynn Skaggs, DVM, President
Boonesboro Animal Clinic Corporation
1500 Boonesboro Road
Winchester, Kentucky 40391
Dear Dr. Skaggs,
On May 14, 15 and June 25, 2009, an investigator from the U.S. Food and Drug Administration (FDA) conducted an investigation regarding the use of drugs in your veterinary practice. That investigation revealed that a veterinarian in your practice, Dr. Clifton Rex Smith, caused the new animal drug, phenylbutazone, 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 Extra-label 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 extra-label 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 CFR Part 530. Our investigation found that Dr. Smith failed to comply with these requirements in that he prescribed phenylbutazone boluses (1 gram) in an Extra-label manner to an adult bull cow without meeting the requirements of 21 CFR Part 530.
Dr. Smith's prescription for extra-label use of this drug did not meet the requirements of 21 CFR 530.12(b), (c), & (e) which require that any animal drug prescribed and dispensed for Extra-label 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) The established name of the drug.
(2) 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.
(3) The veterinarian's specified withdrawal time for meat which might be derived from the treated animal.
Dr. Smith's prescription for extra-label use also did not meet the requirements of 21 CFR 530.20(a)(2)(iii) and (iv), which require that prior to prescribing or dispensing an approved new animal drug for an Extra-label use in food animals, the veterinarian must:
(1) Institute procedures to assure that the identity of the treated animal is carefully maintained.
(2) Take appropriate measures to assure that assigned timeframes for withdrawal are met and no illegal residues occur in any food-producing animals subject to Extra-label treatment.
Furthermore, Dr. Smith prescribed the drug for oral use at a dosage of two boluses daily in feed for seven days. Extra-label use of an approved new animal drug or human drug in or on an animal feed is prohibited under 21 CFR 530.11(b).
Dr. Smith caused the aforementioned drug to be unsafe under section 512(a)(1) 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)] because the drug was prescribed and used in a manner that did not conform with its approved uses or the regulations for Extra-label Drug Use in Animals, 21 CFR Part 530.
The above is not intended to be an all-inclusive list of violations. You and your employees are responsible for complying with the requirements of the Act, including the extra-label 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 extra-label use of new animal and human drug so that you can prevent future violations of the Act.
You should notify this office in writing within 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 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 Stephen J. Rabe, Compliance Officer, at the address located on the letterhead. If you have any questions about this letter, please contact Mr. Rabe at: (513) 679-2700 ext 163; email: stephen.rabe@fda.hhs.gov.
Sincerely,
/s/
Teresa C. Thompson
Director
Cincinnati District
cc: Dr. Clifton Rex Smith
Encl. 21 CFR Part 530
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