Non-FDA Approved Drug Use And Veterinarian Liability

Most veterinarians follow specific standards of care when treating client horses, but off-label and compounded medication use is common in equine veterinary practices. What happens when a horse in their care has an adverse reaction to meds that are compounded or used off-label?

There are some very basic criteria that should be followed to ensure that the veterinarian is as protected as much as possible from the potential issues arising from using non-FDA approved pharmaceuticals, reports EquiManagement. The American Association of Equine Practitioners (AAEP) and the American Veterinary Medical Association (AVMA) have guidelines for compliance to help achieve the best liability protection. These include:

  • No non-FDA-approved product should be used when there is an FDA-approved product available
  • A valid veterinarian-client-patient relationship must be in place
  • Medication used in a joint must be labeled for use in a joint
  • When possible, obtain written consent from an owner after explaining use of a non-FDA-approved drug
  • A dispensed product must be properly labeled and state clearly that it is not FDA-approved
  • Use a compounding pharmacy that is licensed in your state of practice, and preferably use one that is accredited by the Pharmacy Compounding Accreditation Board

There are a few products used in equine veterinary medicine that do not meet the above criteria, like those that are FDA-approved, but not for use in horses. Use of products that are not labeled specifically for horses is difficult to defend if the case goes to court.

The goal is to comply with the standard of care that most veterinarians are using and to have confidence that a board-certified expert witness can attest to its legitimate use in horses if they are called upon to testify in court, reports EquiManagement.

Read more at EquiManagement.

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