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Understanding the VFD and Potential Liability Risks

Any veterinarian who treats food animals must be familiar with the new VFD rules and product labels. With these changes in marketing status, some veterinarians are concerned about potential liability. Widespread, significantly increased liability is not foreseen. [Source: AVMA PLIT Risk Awareness Alert, Fall 2016]

Veterinarians make therapeutic product selection decisions on a daily basis in their practices, and potential liability for such decision-making in a healthcare context is a fact of life. To reduce your risk, remember some of the basic risk mitigation steps that are applicable anytime a veterinarian is involved in the diagnosis and treatment of patients. Issue orders, prescriptions, or VFDs, in the context of a VCPR as required by federal and/or state authorities where you are licensed. Maintain clear and complete records supporting your diagnosis, treatment decisions, and the establishment of a VCPR. Fill out prescription or VFD orders correctly and accurately.

Because extra-label use of VFD drugs is not authorized under the Federal Food Drug & Cosmetic Act, VFDs must be in compliance with the product label. Using an electronic VFD service is a good way to reduce the potential for authorizing a VFD in a manner inconsistent with the label. Failure to write VFDs in compliance with the product label will weaken the defense of a veterinarian in litigation or before a state board of veterinary medicine. For those who treat minor species, FDA is aware of the paucity of available therapeutic drugs. FDA is expected to provide a new Compliance Policy Guide (CPG) addressing the use of VFD drugs in minor species. Once finalized, veterinarians should follow the conditions set forth in the CPG when authorizing VFDs for minor species. [Editor’s note: The FDA issued this compliance policy guide on December 2, 2016. Click here to view the http://www.fda.gov/ICECI/ComplianceManuals/CompliancePolicyGuidanceManual/ucm074659.htm revised CPG.]

For additional information about liability concerns with the Veterinary Feed Directive, visit the Fall 2016 issue of AVMA PLIT Risk Awareness Alert.