Inspections, Compliance, Enforcement, and Criminal Investigations
Dairy Veterinary Services, P.A. 04-Oct-06
Department of Health and Human Services
Public Health Service
New England District
VIA CERTIFIED MAIL
RETURN RECEIPT REQUESTED
October 4, 2006
Dr. Richard Price
Dairy Veterinary Services, P .A.
41 Barnet Road
Monroe, NH 03771
Dear Dr. Price:
On June 15, 2006, an investigator from the U.S. Food and Drug Administration (FDA) conducted an investigation involving the use of drugs in your veterinary practice. That investigation revealed that you caused animal drugs to be unsafe under section 512(a) [21 U.S.C. § 360b(a)] of the Federal Food, Drug, and Cosmetic Act (the Act) and adulterated within the meaning of section 501(a)(5) [21 U.S.C. § 351(a)(5)] of the Act because the drugs were used in a manner that did not conform with their approved applications. Additionally, your actions resulted in two animals for sale for slaughter as food being adulterated within the meaning of section 402(a)(2)(C)(ii) [21 U.S.C. § 342(a)(2)(C)(ii)] of the Act.
The extralabel use of approved veterinary or human drugs in animals is permitted only if it complies with sections 512(a)(4) [21 U.S.C. § 360b(a)(4)] and 512(a)(5) [21 U.S.C. § 360b(a)(5)] of the Act and the regulations for Extralabel Drug Use in Animals, Title 21, Code of Federal Regulations, Part 530 (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 the drug, [redacted], gentamicin sulfate solution, to be used in an extralabel manner by [redacted] without meeting the requirements of 21 C.F.R. Part 530. You prescribed the intramammary infusion of the liquid form of the drug [redacted] gentamicin sulfate to treat coliform mastitis inlactating dairy cattle. This is an extralabel use. The approved uses of gentamicin sulfate solution are listed in 21 C.F.R. § 529.1044a, copy enclosed. Your prescription for the extralabel use of [redacted] Gentamicin Sulfate Solution did not meet the requirements of 21 C.F.R. §§ 530.20(a)(2)(ii) - (iv), which require that you:
(ii) Establish a substantially extended withdrawal period prior to marketing of milk, meat, eggs, or other edible products supported by appropriate scientific information, if applicable;
(iii) Institute procedures to assure that the identity of the treated animal or animals is carefully maintained; and
(iv) Take appropriate measures to assure that assigned timeframes for withdrawal are met and no illegal drug residues occur in any food-producing animal subjected to extralabel treatment.
The above is not intended to be an all-inclusive list of violations. As licensed veterinarians, 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 21 C.F.R. Part 530 and become familiar with all of its requirements so that you can prevent future violations of the Act.
We also recommend that you provide a new, extended withdrawal period supported by appropriate scientific information to the owners of any dairy cattle for which you or your practice prescribed the extralabel use of gentamicin, so that additional illegal drug residues can be avoided.
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 the corrective action cannot be completed within fifteen (15) working days, 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 response should be sent to Ann Simoneau, Compliance Officer, U.S. Food and Drug Administration, One Montvale Avenue, 4th floor, Stoneham, MA 02108.
Gail T. Costello, District Director
New England District Office