Inspections, Compliance, Enforcement, and Criminal Investigations
Willow Creek Veterinary Service 06-Mar-06
Department of Health and Human Services
Public Health Service
Kansas City District
March 6, 2006
RETURN RECEIPT REQUESTED
Chris P. Hytrek, DVM, Owner
Willow Creek Veterinary Service
3 627 West Aspen Road
Cortland, NE 68331
Dear Dr. Hytrek:
On October 21, 2005, investigators from the U.S. Food and Drug Administration (FDA) conducted an investigation involving the use of drugs in your veterinary practice. Our 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 uses or the regulations for Extralabel Drug Use in Animals; Title 21, Code of Federal Regulations (21 CFR), Part 530.
The investigation revealed that you prescribed the drugs kanamycin and amikacin to Wil Mar Sen Dairy. A USDA analysis (Laboratory Report #429144) of tissue samples collected September 14, 2005, identified the presence of kanamycin and amikacin in the kidney tissue of a cow offered for sale for slaughter as food from Wil Mar Sen Dairy. Neither kanamycin nor amikacin is approved for use in cattle . No tolerance levels have been established for these drugs inedible tissues from cattle. The detectable presence of kanamycin and amikacin in the edible tissues of the animal causes the food to be adulterated within the meaning of Section 402(a)(2)(C)(ii) of the Act [21 U.S.C. 342(a)(2)(C)(ii)].
The extra label 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 21 CFR Part 530. You prescribed the.drug Kantrim® brand of kanamycin sulfate, and prescribed the compounded drug "AV", a product containing the drug Amiglyde-V brand of amikacin sulfate, for the treatment of dairy cows without meeting the requirements of 21 CFR Part 530. Our investigation found that you failed to comply with 21 CFR Part 530 in that::
1 . You failed to establish substantially extended withdrawal periods supported by appropriate scientific information for the extralabel use of kanamycin and amikacin in food producing animals. [21 CFR Part 530.20(a)(2)(ii)]
2. You failed to institute procedures to assure that the identity of treated animals was carefully maintained. [21 CFR 530 .20(a)(2)(iii)]
3. You did not take appropriate measure to assure there are no illegal drug residues in the dairy cows for which you have prescribed the extralabel use of kanamycin and amikacin [21 CFR Part 530.20(a)(2)(iv)]
Because you did not prescribe kanamycin and amikacin in conformance with 21 CFR Part 530, you caused these drugs to be unsafe under section 512(a) of the Act and therefore adulterated under section 501(a)(5) of the Act.
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, and 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 CFR Part 530 for your reference. We strongly suggest that you review 21 CFR 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 within 15 working days of receiving this letter of the specific steps you have taken to correct the noted violations, including an explanation of each step being taken to prevent the recurrence of similar violations. If corrective action cannot be completed within 15 working days, state the reason for the delay and the time within which the corrections will be completed. Also, include copies of any available documentation demonstrating that your corrections have been made.
Your reply should be directed to Compliance Officer Ralph J. Gray at the address indicated on the letterhead.
John T. Thorsky