Middlebury Large Animal Clinic 11/30/11

Department of Health and Human Services	Public Health Service Food and Drug Administration
	New England District One Montvale Avenue Stoneham, Massachusetts 02180 Phone: (781) 587-7500 FAX: (781) 587-7556

Warning Letter
CMS#246214

VIA OVERNIGHT UPS

November 30, 2011

Dr. Donald C. Hunt
Middlebury Large Animal Clinic
1396 Route 7 S
Middlebury, Vermont 05753

Dear Dr. Hunt:

On October 19 and 28, 2011, investigators from Food and Drug Administration (FDA) conducted an investigation involving the use of drugs in your veterinary practice located at 1396 Route 7 S, Middlebury, Vermont. This investigations revealed that you caused the drug sulfamethoxazolc 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 (C.F.R.), 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 animal or human drugs in animals is allowed under the FD&C Act only if the extralabel use complies with section 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, including that the use must be by or on the lawful order of a licensed veterinarian within the context of a valid veterinarian/client/patientrelationship.

Our investigation found that you failed to comply with these requirements in that you prescribed sulfamethoxazole and trimethoprim tablet (b)(4) in an extralabel manner to be used in a calf without meeting the 530. FDA has not established a tolerance for residues of sulfamethoxazole in the edible tissues of cattle.

Your prescription for extra label use of this drug did not meet the requirements of 21 C.F.R. 530.12(c) and (e) which require that any animal or human 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 or human 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 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).

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 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 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.

FDA acknowledges that during the FDA inspection conclusion on October 28, 2011, you pointed out the implementation of new policies to provide prescriptions with the proper information. Although you indicated that you have taken steps to address our observations, your response did not contain enough detail for us to evaluate.

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 Todd Maushart, Compliance Officer, U.S. Food and Drug Administration, One Montvale Avenue, Stoneham, Massachusetts 02180. If you have any questions about the content of this letter please contact: Todd Maushmt at (781) 587-7486.

Sincerely,

/s/

Mutahar S.Shamsi
District Director
New England District