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Compounding for Animals: The AVMA Perspective

Drug compounding is reported to be necessary in all areas of veterinary medicine. As the American Veterinary Medicine Association (AVMA) Task Force Report of 1993 states, “Give the range of species, variety of animals within a species, and ecologic niches occupied by animals for which veterinarians are responsible, it is virtually inconceivable that there will ever be FDA-approved drugs labeled for every therapeutic need. “The need for veterinary compounding to fill therapeutic needs will certainly continues, necessitated by the difficulties and costs associated with the drug approval process in the introduction of new therapeutic entities.

When to Consider Compounding for an Animal

According to the AVMA, veterinary compounding can be considered when:

  • There are no effective Food and Drug Administration (FDA) - approved products for treatment of the disease or condition diagnosed by the veterinarian, and the failure to treat would result in patient suffering or death.
  • Available dosage forms are inappropriate because of patient species, age, size, physiology; safety, or individual patient sensitivity/idiosyncrasy; because multiple injections or administrations would be required or large volumes would be necessary; and because safety of personnel might be compromised in an attempt to restrain dangerous animals.
  • Multiple and concurrent disease states are present.
  • An addictive therapeutic effect could be obtained from simultaneous administration of two or more products or to minimize side effects. For example, combing specific anesthetic agents increases analgesic and muscle-relaxant effects, while reducing the total dose of anesthetics used. This minimizes adverse cardiac and respiratory effects. Combining intra-articular medications for single injection minimizes both discomfort to the patient and the probability of introducing pathogenic microorganisms into the joint.
  • Extreme situations occur such that economic realities would preclude treatment with the approved product. In such situations, pain, suffering, or even death would result from the failure to treat.
  • Compounding would encourage compliance by animal owners or their agents instructed to administer two or more products as part of a treatment regimen.
Guidelines for Veterinary Pharmaceutical Compounding

The following are excerpted from the AVMA Guidelines for Pharmaceutical Compound-ing. They were approved by the AVMA House of Delegates in July 1991 and amended by the AVMA Executive Board in November 1991.

The actual guidelines are as follows:

  • The resulting medicament [veterinary compound] is a restricted product that:
  • Must be used only by or on the order of a licensed veterinarian.
  • Must be used only within the confines of a valid veterinarian/client/patient relationship and follow the AVMA Guidelines for Supervising Use and Distribution of Veterinary Prescription Drugs.
  • May be used or dispensed only for treatment or prevention of disease or to improve the health and/or welfare of the animal(s).
  • May be used only when a need has been established and FDA-approved products are not available or clinically effective.
  • The veterinarian must use professional judgment consistent with currently acceptable veterinary medical practice in ensuring the safety and efficacy of the medicament including:
    • The safety for the target animal.
    • he avoidance of violative residues in meat, milk, or eggs when administered to a food-producing animal.
 
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