Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
22215 26th Ave SE, Suite 210
Bothell, WA 98021
November 24, 2015
In reply refer to Warning Letter SEA 16-03
Kevin D. Crandall, CVM, President
Rocky Mountain Veterinary Services, Inc.
994 East 1200 North
Shelley, Idaho 83274-5125
Dear Dr. Crandall:
On June 22, 2015, an investigator from the U.S. Food and Drug Administration (FDA) conducted an investigation involving the prescribing of drugs in your veterinary practice. Our investigation revealed that you caused the new animal drug PenOne Pro Penicillin G Procaine, NADA 065-010, to be unsafe under section 512(a)(1) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act), 21 U.S.C. § 360b(a)(1), 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). Your actions resulted in three animals being offered for sale for slaughter as food that were adulterated within the meaning of section 402(a)(2)(C)(ii) of the FD&C Act, 21 U.S.C. § 342(a)(2)(C)(ii). You can find the FD&C Act and its associated regulations on the Internet through the 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 sections 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.
Our investigation found that you failed to comply with 21 C.F.R Part 530 in that you prescribed PenOne Pro Penicillin G Procaine, NADA 065-010, in an extralabel manner, to cowsidentified with ear tags (b)(4) (back tag (b)(4)), (b)(4) (back tag (b)(4)), and (b)(4) (back tag (b)(4)) for lameness and metritis at (b)(4). Specifically, you prescribed a dose of 60 ml based on cows weighing an average of 1, 500 lb. Your withdrawal time was based on a consultation with FARAD for the administration of 4 cc/100 lb. equating 12,000 IU/lb of penicillin G procaine. Your prescription of 60 ml PenOne Pro Penicillin G Procaine for an 896 lb. cow (ear tag (b)(4)) and an 822 lb. cow (ear tag (b)(4)), approximately 6.7 cc/100 lb. and 7.3 cc/100 lb. respectively, did not apply to FARAD recommendation. You also failed to discuss with FARAD if the specific brand of penicillin was an extended release formula, which can affect withhold times. Furthermore, you failed to comply with 21 C.F.R. Part 530 in that you prescribed PenOne Pro Penicillin G Procaine, to be used in an extralabel manner without assuring the use of this drug would not result in a violative drug residue. Specifically, your prescribed extralabel use of this drug in food-producing animals did not meet the requirements of 21 C.F.R. 530.20(a)(2)(ii) and (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; 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.
(b)(4) offered three cows, identified with ear tags (b)(4), for slaughter as food that were subsequently found to contain illegal residues in the edible tissue.
Because your extralabel use of the approved animal drug penicillin was not in compliance with 21 C.F.R. Part 530, you caused this drug to become 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 violations described in this letter and to establish procedures to ensure these violations do not recur. Failure to do so may result in regulatory action without further notice, such as seizure and/or injunction.
FDA acknowledges the written response dated July 7, 2015 in response to the observations made. Although your letter indicates that you have taken steps to address the observations, you did not provide any evidence documenting the protocol has been updated. Additionally, your current prescription label does not include an adequate dose based on the weight of the animal.
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 Patricia A. Pinkerton, Compliance Officer, U.S. Food and Drug Administration, 22215 26th Avenue SE, Suite 210, Bothell, Washington 98021-4425. If you have any questions about this letter, please contact Compliance Officer Patricia Pinkerton at (425) 302-0428.
Miriam R. Burbach
Debra M. Lawrence, D.V.M.
Idaho State Department of Agriculture
Division of Animal Industries
P.O. Box 7249
Boise, Idaho 83707