FDA Issues VFD Final Rule

June 3, 2015 — 

On June 2, the U.S. Food and Drug Administration (FDA) issued the Veterinary Feed Directive (VFD) final rule, an important piece of the agency’s overall strategy to promote the judicious use of antimicrobials in food-producing animals. This strategy will bring the use of these drugs under veterinary supervision so that they are used only when necessary for assuring animal health. The VFD final rule outlines the process for authorizing use of VFD drugs (animal drugs intended for use in or on animal feed that require the supervision of a licensed veterinarian) and provides veterinarians in all states with a framework for authorizing the use of medically important antimicrobials in feed when needed for specific animal health purposes. The final rule becomes effective October 1, 2015. [Source: FDA, CVM News and Events]

The VFD final rule continues to require veterinarians to issue all VFDs within the context of a veterinarian-client-patient relationship (VCPR) and specifies the key elements that define a VCPR. These key elements include that the veterinarian engage the client (i.e., animal producer or caretaker) to assume responsibility for making clinical judgments about patient (i.e., animal) health, have sufficient knowledge of the animal by conducting examinations and/or visits to the facility where the animal is managed, and provide for any necessary follow-up evaluation or care. The final rule will require veterinarians to follow state-defined VCPR requirements; in states where the FDA determines that no applicable or appropriate state VCPR requirements exist, veterinarians will need to issue VFDs in compliance with federally defined VCPR requirements. All veterinarians will need to adhere to a VCPR that includes the key elements in the final rule.

FDA has also published a draft guidance document (#120) entitled “Veterinary Feed Directive Regulation Questions and Answers.” The purpose of this document is to describe the current Veterinary Feed Directive (VFD) requirements for veterinarians, feed manufacturers and other distributors, animal producers, and other parties involved in the distribution or use of medicated feed containing a veterinary feed directive drug (VFD feed). This draft revised guidance reflects changes to the VFD requirements under the VFD final rule.