Understanding Drug Use Regulations in Food-producing Animals

Christine Navarre  |  7/30/2018 9:59:47 PM

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Disclaimer: This is not a complete description of the regulations and is valid as of 10/2016. Please contact your veterinarian for specific drug use recommendations in animals.

Who makes the laws?

Veterinary pharmaceutical use is governed by the Food and Drug Administration (FDA) at the federal level and the Louisiana Board of Veterinary Examiners via the Louisiana Practice Act at the state level. The Environmental Protec- tion Agency (EPA) approves some pesticides for animal use (fly tags, pour-ons for lice, flies, etc).

  • FDA approves drugs for either prescription (Rx), over-the-counter (OTC), and veterinary feed directive (VFD) use.
    • Prescription (Rx) and Veterinary Feed Directive (VFD): For use only by or on the order of a licensed vet- erinarian within the context of a veterinarian-client-patient relationship (VCPR).
      • ¨A VCPR exists when all of the following conditions have been met:
      • The veterinarian has assumed the responsibility for making clinical judgments regarding the health of the animal(s) and the need for medical treatment, and the client has agreed to follow the veterinarian's instructions.
      • The veterinarian has sufficient knowledge of the animal(s) to initiate at least a general or prelim- inary diagnosis of the medical condition of the animal(s). This means that the veterinarian has recently seen and is personally acquainted with the keeping and care of the animal(s) by virtue of an examination of the animal(s) or by medically appropriate and timely visits to the premises where the animal(s) are kept.
      • The veterinarian is readily available for follow-up evaluation, or has arranged for emergency coverage, in the event of adverse reactions or failure of the treatment regimen.
      • Over-the-Counter: Products available for purchase by laypersons that do not require a prescrip- tion.
  • Only FDA or EPA approved products are allowed. Products from other countries may not be used legally in the U.S.

What is a “food animal”?

FDA considers cattle, swine, sheep, goats, poultry, rabbits and fish food animal species (refer to FDA policy for com- plete list). While owners may have these species as pets, when it comes to pharmaceutical use, they must be treat- ed as food animals.

What is the difference between “label drug use” and “extra-label drug use” (ELDU)?

Label drug use is exactly what it implies-using a drug exactly as it is labeled including species, indication, dose, route, frequency and duration of administration.

ELDU is defined as any use of a drug in an animal in a manner that is not in accordance with the approved labeling. This includes but is not limited to use in species not listed in the labeling, use for indications (disease and other con- ditions) not listed in the labeling, use at dosage levels, frequencies, duration or routes of administration other than those stated in the labeling, and deviation from labeled withdrawal times based on these different uses. See full text.


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