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Minnesota Dairy Charged With Misuse of Penicillin

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.

© Food Safety News
  • Adam

    NEW animal drug???? Procaine Penicillin has been around for DECADES!!!!!!!

  • Charles Hjerpe, DVM

    Procaine penicillin G is not a new drug. It has been used by veterinarians since the 1950’s, certainly since 1958 when I graduated from vet school.

  • Ron Gaskin

    Penicillin G procaine is not a new drug. Just a rearrangement in the name of it. It has been around for decades. Because of the penicillin resistant bacteria emergence from penicillinase production by these bacteria, dairymen have long been injecting 2-10x the bottle dose in an attempt to get it to work. The worst violations of drug residues occurred when streptomycin was included with the procaine penicillin G and the dose was extra label increased. Streptomycin residues were found in the kidneys with the FAST test well after the 30 day clearance time for slaughter. Pen/Strep was discontinued in the USA because of this abuse. In my opinion neither drug works anyway so no loss. The big question is did a CHARM II milk test show penicillin in this producer’s milk? Was the public endangered by this dairy farm’s product? What prompted the inspection?
    a former dairy vet

  • mrothschild

    This was my error. I had edited out the full name of this drug, which is penicillin G procaine (b)(4), Sterile Penicillin G Procaine Injectable Suspension, NADA #(b)(4). I’ve restored the language used by the FDA in the warning letter and changed the headline. Thanks to all who pointed out this mistake.

  • Minkpuppy

    It was probably found during the routine milk testing done at the milk processor before pasteurization or possibly in cows at slaughter. The article would be more helpful if stated when and where the residues were actually found.
    If this drug is so ineffective that farmers are using 2-10x the normal dose, why are they wasting their money on it? Common sense would have me looking for a better antibiotic to treat my cows even if it did cost a little more.

  • vet4humanefoodproduction

    Maybe if dairy cows weren’t overmilked and subjected to poor animal husbandry, as is often the case with factory farms, there would less cases of mastitis and therefore less need for the use of antibiotics in these animals…

  • Mary Rothschild

    This was my error. I had edited out the full name of this drug, which is penicillin G procaine (b)(4), Sterile Penicillin G Procaine Injectable Suspension, NADA #(b)(4). I’ve restored the language used by the FDA in the warning letter and changed the headline. Thanks to all who pointed out this mistake.