- Rupert Veterinary Clinic
- Issuing Office:
- New York District Office
| || |
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
New York District
158-15 Liberty Avenue
Jamaica, NY 11433
July 30, 2015
WARNING LETTER NYK-2015-44
VIA UNITED PARCEL SERVICE
DELIVERY SIGNATURE REQUESTED
Dr. Robert Ceglowski, DVM
Rupert Veterinary Clinic, LLC
PO Box 38
Rupert, Vermont 05768
Dear Dr. Ceglowski:
On May 29, 2015, an investigator from the U.S. Food and Drug Administration (FDA) conducted an investigation involving the prescribing of drugs in your veterinary practice located 2023 Route 153, Rupert, Vermont. Our investigation revealed that you caused the new animal drug (b)(4) (sulfadimethoxine), ANADA (b)(4), to be unsafe under section 512(a)(1) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act), 21 U.S.C. § 360b(a)(1), and adulterated within the meaning of section 501(a)(5) of the FD&C Act, 21 U.S.C. § 351(a)(5), because your practice did not comply with the regulations for Extralabel Drug Use in Animals, Title 21, Code of Federal Regulations (C.F.R.), Part 530 (21 C.F.R. Part 530).
In addition, when the new animal drug (b)(4)
(sulfadimethoxine), ANADA (b)(4)
, was added to animal feed (wasted milk for calves), it caused the animal feed to be unsafe under section 512(a)(2) of the Act, 21 U.S.C. §360b(a)(2), and adulterated within the meaning of section 501(a)(6) of the FD&C Act, 21 U.S.C. §351(a)(6). Your actions resulted in an animal being offered for sale for slaughter as food that was adulterated within the meaning of section 402(a)(2)(C)(ii) of the FD&C Act, 21 U.S.C. § 342(a)(2)(C)(ii). You can find the FD&C Act and its associated regulations on the Internet through the links on 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 FD&C Act, 21 U.S.C. § 360b(a)(4) and (5), and 21 C.F.R Part 530. Our investigation found that you failed to comply with 21 C.F.R Part 530 in that:
- You prescribed (b)(4) (sulfadimethoxine), ANADA (b)(4), to treat calves for pneumonia at (b)(4) located in (b)(4). Furthermore, you failed to comply with 21 C.F.R. Part 530 in that you prescribed (b)(4) (sulfadimethoxine), ANADA (b)(4), to be used in an extralabel manner without assuring the use of this drug would not result in a violative drug residue found in feed. Your prescription for the extralabel use of this drug did not meet the requirements of 21 C.F.R. 530.20(a)(2)(iv), which requires that you 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 bob veal calf for slaughter as food that was subsequently found to contain illegal residues in edible tissue.
Because your extralabel use of the approved animal drug sulfadimethoxine was not in compliance with 21 CFR Part 530, you caused this drug to become unsafe under section 512(a) of 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). In addition, by adding the (b)(4) (sulfadimethoxine), ANADA (b)(4), to milk in violation of 21 CFR 530.11(b), you caused that animal feed to become unsafe under section 512(a)(2) of the FD&C Act, 21 U.S.C. 360b(a)(2), and adulterated under section 501(a)(6) of the FD&C Act, 21 U.S.C. 351(a)(6).
Your use of this medicated feed without following the animal class as directed by the approved labeling caused this medicated feed to be unsafe within the meaning of section 512 of the FD&C Act, 21 U.S.C. § 360b. Section 512 of the FD&C Act, 21 U.S.C. § 360b and 21 C.F.R. 530.11(b) do not permit the extralabel use of medicated feeds.
The above is not intended to be an all-inclusive list of violations. As a licensed veterinarian, 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 violations described in this letter and to establish procedures to ensure these violations do not recur. Failure to do so may result in regulatory action without further notice, such as seizure and/or injunction.
FDA acknowledges the written response we received following our inspection conducted on May 29, 2015. A letter dated June 14, 2015, was received addressing the observations made during the inspection we conducted at your location in Rupert, Vermont. Although your letter indicates that your firm has taken steps to address our observations, your response was found to be inadequate. In regard to your statements about appropriate precautionary measures; we agree that your protocol of providing the firm with required information, both in writing and verbally, as well as the training you provide to your clients is appropriate, we are still concerned that there were not enough precautionary measures taken after the administration of the (b)(4) (sulfadimethoxine), ANADA (b)(4), to the entire ‘(b)(4).’ Your responsibility to ensure that appropriate measures are taken by the farm does not end once the drug is prescribed, but continues throughout the treatment of the animal.
Regarding extralabel use of the approved animal drug sulfadimethoxine; your practice of adding this drug to milk, instead of water as per the approved label, makes this a medicated feed. The term “animal feed”, as defined in section 201(w) of the FD&C Act , and in section 512, and in provisions of this Act referring to such paragraph or section, means an article which is intended for use for food for animals other than man and which is intended for use as a substantial source of nutrients in the diet of the animal, and is not limited to a mixture intended to be the sole ration of the animal. Extralabel use of a drug in animal feed (and milk is defined as a feed) is prohibited under 21 C.F.R. 530.11(b).
We have enclosed a copy of 21 C.F.R. Part 530 for your reference. We strongly suggest that you review 21 C.F.R. Part 530 and become familiar with all of its requirements so that you can prevent future violations of the FD&C Act.
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 LCDR Kristen C. Jackson, Compliance Officer, U.S. Food and Drug Administration, 158-15 Liberty Avenue, Jamaica, New York 11433. If you have any questions about this letter, please contact Compliance Officer LCDR Kristen C. Jackson at (718) 662-5711 or Email at Kristen.Jackson@fda.hhs.gov
Ronald M. Pace
New York District