Inspections, Compliance, Enforcement, and Criminal Investigations
Medford Veterinary Clinic 02/05/2009
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
|Minneapolis District Office|
250 Marquette Avenue, Suite 600
Minneapolis, MN 55401
Telephone: (612) 758-7132
FAX: (612) 334-4142
February 5, 2009
RETURN RECEIPT REQUESTED
Refer to MIN 09 - 11
Jean M. Osen, DVM
Medford Veterinary Clinic
898 Gibson Street
Medford, Wisconsin 54451-1521
Dear Dr. Osen:
On October 8 and 15, 2008, an investigator from the U.S. Food and Drug Administration (FDA) conducted an investigation regarding the use of drugs by your veterinary practice located in Medford, Wisconsin. Our investigation revealed that veterinarians from your firm caused the new animal drug sulfadimethoxine 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 your firm used the drug in a manner that did not conform with its approved uses or with the regulations for Extralabel Drug Use in Animals, Title 21, Code of Federal Regulations, Part 530 (21 CFR Part 530). You can find the Act and its associated regulations on the Internet through links on the 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 512(a)(5) of the Act, 21 U.S.C. § 360b(a)(4) and (5), and the implementing regulations. at 21 CFR 530. Our investigation found that your firm failed to comply with these requirements. For example:
1. Your firm used the drug (b)(4) Sulfadimethoxine (Concentrated Solution 12.5%) brand of sulfadimethoxine oral solution to treat a lactating dairy cow. This drug is not labeled for use in lactating dairy cows. Use of this drug in this manner is an extralabel use. The extralabel use of this drug in lactating dairy cattle is prohibited by 21 CFR 530.41(a)(9). Approved uses of sulfadimethoxine oral solution are listed in 21 CFR 520.2220a, copy enclosed.
2. Your firm recommended the oral bolus dosage form of the drug (b)(4) brand of sulfadimethoxine to treat mastitis in lactating dairy cattle. This is an extralabel use. The extralabel use of this drug in lactating dairy cattle is prohibited by 21 CFR 530.41(a)(9). Approved uses of sulfadimethoxine boluses are listed in 21 CFR 520.2220b, copy enclosed.
Because your firm's extralabel use of the new animal drug sulfadimethoxine was not in compliance with 21 CFR 530, your firm caused the drug 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).
The above is not intended to be an all-inclusive list of violations. Your firm is 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 530 for your reference. We strongly suggest that you review this document and become familiar with all of the requirements concerning extralabel use of new animal and human drugs so that you can prevent future violations of the Act.
You should notify this office in writing of the specific steps you have taken to bring your firm into compliance with the law within 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 15 working days of receiving this letter, state the reason for the delay and the time frame within which the corrections will be completed. We are particularly concerned that your clients may continue to use sulfadimethoxine oral solution to treat lactating dairy cattle or the oral bolus dosage form of the drug Albon® for mastitis. Please include information on how you intend to ensure such practice does not occur, and how you will educate your clients that such extralabel use would be in violation of the extralabel use regulations. Please include copies of any available documentation demonstrating that corrections have been made.
Your written response should be sent to Dr. Brian D. Garthwaite, Compliance Officer, at the address located on the letterhead. If you have any questions about this letter, please contact Dr. Garthwaite at (612) 758-7132.
W. Charles Becoat