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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Chosen Valley Veterinary Clinic 21-Sep-05

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

Public Health Service
Food and Drug Administration
 Minneapolis District Office
Central Region
212 Third Avenue South
Minneapolis, MN 55401
Telephone: (612) 758-7133
FAX: (612) 334-4142


 


September 21, 2005

WARNING LETTER

CERTIFIED MAIL
RETURN RECEIPT REQUESTED

Refer to MIN 05-22

Gary D. Daniels, DVM
Dale A. Timm, DVM
Myron A. Cyphers, DVM
Henry Peeters, DVM
Chosen Valley Veterinary Clinic
115 South Main
Chatfield, MN 55923

Dear Drs. Daniels, Timm, Cyphers, and Peeters:

An investigation of your veterinary practice located at 115 South Main, Chatfield, Minnesota, conducted by a representative of the U.S. Food and Drug Administration (FDA) on May 31 and June 6, 2005, confirmed that you caused the new animal drugs sulfadimethoxine and gentamicin sulfate 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 drugs were used in a manner that did not conform with their approved uses or the regulations for Extralabel Drug Use in Animals, codified in Title 21, Code of Federal Regulations, Part 530 (21 CFR 530). In addition, our investigation found that you were compounding and distributing an unapproved new animal drug. You can find the Act and its associated regulations on the Internet through links on the FDA's web page at www.fda.gov.

Between June 21, 2002, and August 24, 2004, testing by the United States Department of Agriculture (USDA) detected illegal residues of gentamicin in edible tissues of four cattle marketed for human food by clients of your veterinary clinic. Dr. Cyphers and Dr. Daniels were individually informed of two of these tissue residue violations in letters dated May 15, 2003, and June 10, 2003. Copies of those letters are enclosed for your reference. By letter dated June 23, 2003 (copy enclosed), Dr. Daniels stated that he stopped using gentamicin in food producing animals. However, during our most recent investigation, he described the continued use of gentamicin. Based on that investigation, and the aforementioned gentamicin residues, your veterinary practice is not taking appropriate measures to guard against illegal drug residues and to comply with the regulations for Extralabel Drug Use in Animals, 21 CFR 530.

The extralabel 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 21 U.S.C. 360b(a)(5)] and 21 CFR 530. Our investigation found that Chosen Valley Veterinary Clinic failed to comply with 21 CFR 530 in that:

1. You prescribed and dispensed sulfadimethoxine 12.5% oral solution for intravenous use to treat mastitis in lactating dairy cattle. This is an extralabel use. The extralabel use of sulfonamide drugs in lactating dairy cattle is prohibited by 21 CFR 530.41(a)(9). Although approved uses of sulfadimethoxine 12.5% oral solution, listed in 21 CFR 520.2220a, are not prohibited by this regulation, your use was not an approved use. We are enclosing a copy of 21 CFR 520.2220a for your reference.

2. You prescribed and dispensed products containing gentamicin sulfate for extralabel use (i.e ., scours and pneumonia in calves) without establishing a substantially extended withdrawal period, supported by appropriate scientific information as required by 21 CFR 530.20(a)(2)(ii). Additionally, you failed to take appropriate measures to ensure that assigned timeframes for withdrawal are met and that no illegal residues occur in any food producing animals subjected to extralabel treatment as required by 21 CFR 530.20(a)(2)(iv).

You caused the aforementioned animal drugs 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 the drugs were used in a manner that did not conform with their approved uses and their extralabel use did not conform with Sections 512(a)(4) and 512(a)(5) of the Act [21 U.S.C. 360b(a)(4) and 21 U.S.C. 360b(a)(5)] and the regulations for Extralabel Drug Use in Animals, 21 CFR 530. We have enclosed a copy of 21 CFR 530 for your reference. We strongly suggest that you review 21 CFR 530 and become familiar with all of its requirements so that you can prevent future violations of the Act.

In addition, the GM 100 drug product compounded and distributed by your clinic is a new animal drug as defined under Section 201(v) of the Act. The composition is such that the drug is not generally recognized, among experts qualified by scientific training and experience to evaluate the safety and effectiveness of animal drugs, as safe and effective for use under the conditions prescribed, recommended, or suggested in its labeling. The drug is adulterated under Section 501(a)(5) of the Act because it is unsafe within the meaning of Section 512 of the Act. Section 512 in part deems a new animal drug to be unsafe unless an approved new animal drug application (NADA) is in effect for the specific product in question. Your clinic holds no FDA approval of an application for its GM 100 drug product. Sections 512(a)(4) and 512(a)(5) of the Act [21 U.S.C. 360b(a)(4) and 21 U.S.C. 360b(a)(5)] and 21 CFR 530 allow some extralabel use of approved animal and human drugs, including compounding from approved animal and human drugs. These provisions, however, apply only to approved drugs and do not permit compounding from bulk drugs (e.g., dimethyl sulfoxide). [See 21 CFR 530 .13(a).]

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.

You should notify this office in writing of the steps you have taken to bring your veterinary practice 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 corrections 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.

Your response should be sent to Timothy G. Philips, Compliance Officer, U.S. Food and Drug Administration, Minneapolis District, 212 Third Avenue South, Minneapolis, Minnesota 55401. If you have any questions about this letter, please contact Compliance Officer Timothy G. Philips at (612) 758-7133.

Sincerely,

/S/

W. Charles Becoat
Director
Minneapolis District