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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Hometown Veterinary Care, P.C. 2/11/14

  

Department of Health and Human Services logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
 
New England District Office
One Montvale Avenue, 4th floor
Stoneham, MA 02180
Phone 781.587.7500
Fax 781.587.7556

 

WARNING LETTER
CMS # 419520
 
VIA UPS Next Day Air
 
 
February 11, 2014
 
Matthew C. Townsend, D.V.M., Owner
Hometown Veterinary Care, P.C.
51 Western Avenue, Suite 1
Fairfield, Maine 04937
 
Dear Dr. Townsend:
 
On January 14, 2014 and January 17, 2014, 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) of the Federal Food, Drug, and Cosmetic Act (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 drugs were used in a manner that did not conform 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).
 
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 sections 512(a)(4) and 512(a)(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 Hometown Veterinary Care, P.C., prescribed the new animal drug Furosemide Injection 5% (b)(4) to be administered to cattle for the treatment of edema secondary to periparturient syndrome or heart disease at the (b)(4) Farm around August 2, 2013. This is an extralabel use for this approved new animal drug. Your firm failed to comply with 21 C.F.R. Part 530 in that:
 
1. The labeling for the product Furosemide Injection 5%) did not contain directions for use specified by the veterinarian as required by 21 C.F.R. 530.12(c).
2. The labeling for the product Furosemide Injection 5% did not contain the veterinarian’s specified withdrawal time for meat and milk as required by 21 C.F.R. 530.12(e).
3. You prescribed the use of the product Furosemide Injection 5% to treat edema secondary to periparturient syndrome or heart disease in cattle without including a withdrawal period for meat and milk.  Your prescription for the extralabel use of this drug did not meet the requirements of 21 C.F.R. 530.20(a)(2)(ii), 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.
 
You caused the aforementioned animal 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), because the drug was prescribed and used in a manner that did not conform with its approved uses or the regulations for Extralabel Drug Use in Animals, 21 C.F.R. Part 530.
 
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.
 
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 the Food and Drug Administration, Attention: Scott M. Loughan, One Montvale Avenue, Stoneham, Massachusetts 02180. If you have questions regarding any issues in this letter, please contact Mr. Loughan at 802-868-4725 x 109.
 
                                                                                   
Sincerely,
/S/ 
Miguel A. Hernandez
Acting District Director
New England District