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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Midstate Veterinary Services, PLLC 5/10/10

  

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

Public Health Service
Food and Drug Administration
 New York District
158-15 Liberty Avenue
Jamaica, NY 11433


May 10, 2010


WARNING LETTER NYK 2010-15

 


VIA UNITED PARCEL SERVICE


Paul B. Coen, DVM
Midstate Veterinary Services, PLLC
987 Route 222
Cortland, New York 13045-9388


Dear Dr. Coen:


On November 25 and December 4, 2009, 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 an animal drug to be unsafe under section 512(a) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 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 or the regulations for Extralabel Drug Use in Animals, Title 21, Code of Federal Regulations, Part 530 (21 C.F.R. Part 530).


The extra1abe1 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 21 C.F.R. Part 530. Our investigation found that you failed to comply with the requirements in 21 C.F.R. Part 530. For example, you did not comply with 21 C.F.R. Part 530.41 (a) when you prescribed sulfadimethoxine to be used in an extralabel manner to treat lactating dairy cows.


You caused the animal drug sulfadimethoxine to be unsafe under section 512(a) of the Act, 21 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 this 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 a licensed veterinarian, 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 acknowledge receipt of your written response dated December 17, 2009, to the Form FDA483 issued at the conclusion of the investigation and have taken into consideration the corrective actions you have taken in regard to the extralabel use of penicillin. However, your response does not adequately address the steps your practice is taking or will take to ensure that sulfadimethoxine is not prescribed for extralabel use in the future. Your revised drug protocol for the use of Albon (sulfadimethoxine) is inadequate in that it does not specify that this drug can only be used in accordance with the approved label when used in lactating dairy cattle. In addition, your response does not address the steps your practice is taking or will take to ensure that future extralabel use of approved human or animal drugs are only prescribed in compliance with sections 512(a)(4) and (5) of the Act, 21 U.S.C. 360b(a)(4) and (5), and 21 C.F.R. Part 530. 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 that you become familiar with all of its requirements so that your prescribing practices will prevent any future violations of the Act.


Please 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, 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.


Please send your reply to the Food and Drug Administration, Attention: Patricia A. Clark, Compliance Officer, 300 Pearl Street, Suite 100, Buffalo, New York, 14202. If you have questions about this letter, please contact Ms. Clark at 716-551-4461, ext 3168.

 

Sincerely,

/S/
Ronald M. Pace
District Director
New York District


Enclosures: 21 C.F.R. Part 530


cc: David Brandstadt, DVM
Midstate Veterinary Services
987 State Route 222
Cortland, NY 13045-9388


cc: Kenneth Osborn, DVM
Midstate Veterinary Services
987 State Route 222
Cortland, NY 13045-9388


cc: Benjamin Turner, DVM 
Midstate Veterinary Services
987 State Route 222
Cortland, NY 13045-9388


cc: USDA FSIS Technical Service Center
Attn: Mr. Haroon Mian, District Manager
230 Washington Ave. Extension
Albany, NY12203-5369


cc: NYS Education Department
Office of the Professions
State Board for Veterinary Medicine
89 Washington Avenue
Albany, NY 12234-1000