Do-N-Joy Holsteins at Arlington, MN was charged in a May 11 warning letter from the U.S. Food and Drug Administration with misuse of the animal drug penicillin G procaine.
The warning letter stems from an inspection of the Arlington dairy operation last Dec. 14, in which the Minnesota Department of Agriculture said it found the dairy did not use penicillin G procaine as directed by the approved labeling, a violation of the Federal Food, Drug, and Cosmetic Act.
“The investigation found that you adulterated the new animal drug penicillin G procaine (b)(4), Sterile Penicillin G Procaine Injectable Suspension, NADA #(b)(4). Specifically, the investigation revealed that you did not use penicillin G procaine as directed by the approved labeling. Use of this drug in this manner is an extralabel use. See Title 21, Code of Federal Regulations, section 530.3(a), 21 CFR 530.3(a),” the FDA wrote.
FDA said so-called “extra-label use” of an approved animal drug, or treating animals with human drugs, is allowed only on the lawful order of a licensed veterinarian within the context of a valid veterinarian/client/patient relationship.
The warning letter said the Minnesota dairy did not follow dose amounts recommended on approved labeling and was not under the supervision of a licensed veterinarian.
FDA said the warning letter “is not intended to be an all-inclusive list of violations. As a producer of animals offered for use as food, you are responsible for ensuring that your overall operation and the food you distribute is in compliance with the law.”
The federal agency urged the dairy “to take prompt action to correct the violations described in this letter and to establish procedures to ensure that these violations do not recur. Failure to do so may result in regulatory action without further notice such as seizure and/or injunction.”
FDA requested a written response to its concerns within 15 working days of receiving the warning letter.
