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CLOSEOUT LETTER

Thomas Veterinary Services PLC MARCS-CMS 491551 — Jun 02, 2016

Thomas Veterinary Services PLC - 491551 - 06/02/2016


Recipient:
Recipient Name
Roger C. Thomas, DVM
Thomas Veterinary Services PLC

156 Vincent Street

Smiths Grove, KY 42171
United States

Issuing Office:
Cincinnati District Office

United States


  

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

Public Health Service
Food and Drug Administration
 
Cincinnati District Office
Central Region
6751 Steger Drive
Cincinnati, OH 45237-3097
Telephone: (513) 679-2700
FAX: (513) 679-2775

 

WARNING LETTER
CIN-491551-17
 
June 2, 2016
 
United Parcel Service
                                                                                                    
Dr. Roger C. Thomas, President and Co-Owner
Thomas Veterinary Services, PLC
P.O. Box 309
Smiths Grove, KY 42171-8183
 
Dear Dr. Thomas:
 
On September 28 and October 8, 2015, the U.S. Food and Drug Administration (FDA) conducted an investigation involving the prescribing of drugs in your veterinary practice located at 156 Vincent Street, Smiths Grove, Kentucky 42171-8183. Our investigation revealed that you caused the new animal drug Nuflor Injectable Solution (Florfenicol, NADA #141-063), 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 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). You can find the FD&C Act and its associated regulations on the Internet through 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 section 512(a)(4) and 512(a)(5) of the FD&C Act, 21 U.S.C. 360b(a)(4) and 360b(a)(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:
 
1.     You failed to maintain complete records for the extralabel use of the new animal drug Nuflor (Florfenicol), you prescribed to treat a dairy cow identified with (b)(4) for bovine respiratory disease at (b)(4), in accordance with 21 CFR 530.5. Veterinary records of extralabel uses shall be adequate to provide the following information: The established name of the drug and its active ingredient, the condition treated, the species of treated animal, the dosage administered, the duration of treatment, the number of animals treated, and the withdrawal, withholding or discard times. However, your firm’s transaction records only include the drug name and dosage administered. 
 
2.     When prescribing Nuflor (Florfenicol) in an extralabel manner to treat a dairy cow (b)(4) you failed to establish a substantially extended meat withdrawal period supported by appropriate scientific information as required by 21 C.F.R. Part 530.20(a)(2)(ii). During the closeout meeting at the conclusion of the inspection, you indicated you intended to contact the Food Animal Residue Avoidance Databank (FARAD) to assist you with developing extended withdrawal times for Nuflor supported by appropriate scientific information, but had yet to do so.
 
3.    When prescribing Nuflor (Florfenicol) in an extralabel manner to treat a dairy cow (b)(4) you failed to 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 as required by 21 C.F.R. Part 530.20(a)(2)(iv). For example, you did not provide a clear withdrawal time to the producer when prescribing Nuflor in an extra label manner. You indicated you verbally directed the firm to split the dose between intramuscular and subcutaneous administration and that you directed the firm to follow the subcutaneous withdrawal period of 38 days. Although your prescription label added to the Nuflor bottle includes directions for administering the drug both intramuscular and subcutaneous, it does not instruct the firm whether or how to split the dose between the two routes of administration. In addition, your prescription label does not specifically direct the firm to follow a 38 day withdrawal period, but rather includes both withdraw times from the manufacturer’s label as follows: “WITHDRAW: MEAT 28 days (if given IM) or 38 days (if given SQ).”  Note: (b)(4) offered the identified dairy cow above (b)(4) for slaughter as food that was subsequently found to contain illegal Florfenicol residues in edible tissue. FDA issued a Warning Letter to the (b)(4) on January 22, 2016.
 
You caused the aforementioned animal drug to be unsafe under Section 512(a) and adulterated within the meaning of Section 501(a)(5) of the FD&C Act, 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 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 acknowledge the receipt of your letter dated “12/22”, received by the district office in 2015. The letter indicated that you are taking steps to address your failure to maintain veterinary treatment records for extralabel use of drugs by providing notebooks for recording treatment information. However, you did not discuss whether you are taking corrective actions on the remaining five observations identified at the conclusion of the inspection on October 8, 2015 (Form FDA 483, Inspectional Observations). 
 
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 Allison C. Hunter, Compliance Officer, U.S. Food and Drug Administration, 6751 Steger Drive, Cincinnati, Ohio 45237. If you have any questions about this letter, please contact Compliance Officer Allison C. Hunter at (513) 679-2700 Ext. 2134 or allison.hunter@fda.hhs.gov.
 
 
Sincerely yours,
/S/
Steven B. Barber
District Director
Cincinnati District 
 
cc:    Dr. Travis England, Co-Owner
         Thomas Veterinary Services, PLC
         156 Vincent Street
         Smiths Grove, KY 42171-8183
        
         Dr. Isabel Arrington, Director TA/C
         United Stated Department of Agriculture (USDA)
         Food Safety and Inspection Service
         Landmark Center, Suite 300
         1299 Farnam, Street
         Omaha, Nebraska 68102
 

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