| Public Health Service Food and Drug Administration |
New York District Jamaica, NY 11433 |
Department of Health and Human Services
May 28, 2010
WARNING LETTER NYK 2010-20
VIA UNITED PARCEL SERVICE
Samuel Yancey, DVM
9430 State Route 812
Croghan, New York 13327
Dear Dr. Yancey:
On February 12 and 22, 2010, investigators from the U.S. Food and Drug Administration (FDA) conducted an investigation involving the use of drugs in your veterinary practice. That revealed that you caused the animal drug Phenylbute Injection 20% (phenylbutazone), ANADA 200-371, to be unsafe under section 512(a) of the Federal Food, and Cosmetic Act (the 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 the regulations for Extralabel Drug Use in Animals, Title 21, Code of Federal Regulations, Part 530 (21 C.F.R. Part 530). In addition, your actions caused a cow sold for slaughter as food to become adulterated within the meaning of section 402(2)(C)(ii) of the Act, 21 U.S.C. § 342(2)(C)(ii). You can find the Act and its associated regulations on through 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 (5), and the implementing regulations at 21 C.F.R Part 530. Our investigation found that you failed to comply with 21 C.F.R. 530.41(a)(12) in that you prescribed Phenylbute Injection 20% (phenylbutazone), ANADA 200-371, a drug approved for use in horses only, for use in female dairy cattle20 months age or older under the terms of extralabel use and for the use in downer animals at the (b)(4), without meeting the requirements of 21 C.F.R. Part C.F.R. Part 530.41(a)(12) prohibits phenylbutazone from extralabel use in female dairy cattle months of age or older.
In addition, even if phenylbutazone was not on the list drugs prohibited from extralabel use C.F.R. Part 530.41(a)(12), you did not comply with the requirements of 21 C.F.R. 530.12 (a),(c),(d), 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) The name and address of the prescribing veterinarian.
(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) Any cautionary statements.
(4) 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)(i), (iii), and (iv), which require that prior to prescribing or dispensing an approved new animal drug for an extralabel use in food animals, the veterinarian must:
(1) Make a careful diagnosis and evaluation of the condition for which the drug is to be used.
(2) Institute procedures to assure that the identity of the treated animal is carefully maintained.
(3) 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.
The above is not intended to be an all-inclusive list of violations. You 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.
We have enclosed a copy of 21 C.F.R. 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 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 response should be sent to Patricia A. Clark, Compliance Officer, U.S. Food and Drug Administration, 300 Pearl St, Suite 100, Buffalo,New York 14202. If you have any questions about this letter, please contact Compliance Officer Patricia A. Clark at 716-551-4461. ext 3168.
Sincerely yours,
/S/
Ronald M. Pace
District Director
New York District
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