Inspections, Compliance, Enforcement, and Criminal Investigations
Morris Veterinary Center, PSC 25-Jul-05
Department of Health and Human Services
Public Health Service
Minneapolis District Office
July 25, 2005
RETURN RECEIPT REQUESTED Refer to MIN 05 - 17
Eugene R. Anderson, DVM
Morris Veterinary Center, PSC
605 West Fifth Street
Morris, Minnesota 56267
Dear Dr. Anderson:
On April 26-28, 2005, an investigator from the Food and Drug Administration (FDA) conducted an investigation of the practices of your veterinary center. That investigation revealed that you caused animal drugs to be unsafe under Section 512(a) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. 360b, and adulterated within the meaning of Section 501(a)(5) of the Act (21 U.S.C. 351) because you prescribed drugs for use 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 extralabel use of approved veterinary or human drugs in animals is permitted only if such use complies with Sections 512(a)(4) and 512(a)(5) of the Act (21 U.S.C. 360b and 21 U.S.C. 351) and 21 CFR Part 530. Our investigation found that you failed to comply with 21 CFR Part 530 in that you prescribed sulfadimethoxine 40% injection in an extralabel manner (i.e., for toxic mastitis) in lactating dairy cattle. The extralabel use of sulfonamide drugs (such as sulfadimethoxine) in lactating dairy cattle is prohibited by 21 CFR 530.41(a)(9). While approved uses of sulfadimethoxine drugs, listed in 21 CFR 520.2220 (copy enclosed), are not prohibited by this regulation, treating toxic mastitis in lactating dairy cattle is not an approved use.
Our investigation also revealed that you prescribed oxytetracycline for use in lactating dairy cattle, which is an extralabel use, without meeting the requirements of 21 CFR Part 530. Specifically, in your veterinary prescription order for [redacted] substantially extended milk and meat withdrawal times supported by appropriate scientific evidence were not established as required by 21 CFR 530.20(a)(2)(ii), (copy enclosed).
You caused the aforementioned sulfadimethoxine and oxytetracycline animal drugs to be unsafe under Section 512(a) of the Act (21 U.S.C. 360b) and thus adulterated within the meaning of Section 501(a)(5) of the Act (21 U.S.C. 351) because you prescribed these drugs for extralabel use but did not comply with the regulations for Extralabel Drug Use in animals, 21 Part CPR 530.
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.
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, 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 within 15 working days of receipt of this letter of the specific steps you have taken to correct the above violations including the steps being taken to prevent the occurrence 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 Brian D. Garthwaite at the address indicated on the letterhead.
W. Charles Becoat