The U.S. FDA on Tuesday took a final step in changing the way farmers and veterinarians administer antimicrobials to food animals, publishing the final version of its veterinary feed directive rule.
Under the rule, use of animal antimicrobials will be brought under veterinary supervision, and will be administered "only when necessary for assuring animal health," FDA said.
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 VFD final rule continues to require veterinarians to issue all VFDs within the context of a veterinarian-client-patient relationship and specifies the key elements that define a VCPR:
• The veterinarian engage with 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 said.
"The actions the FDA has taken to date represent important steps toward a fundamental change in how antimicrobials can be legally used in food-producing animals," said Michael Taylor, FDA deputy commissioner for foods. "The VFD final rule takes another important step by facilitating veterinary oversight in a way that allows for the flexibility needed to accommodate the diversity of circumstances that veterinarians encounter, while ensuring such oversight is conducted in accordance with nationally consistent principles."
In December 2013, the agency published a guidance document, which called on animal drug manufacturers of approved medically important antimicrobials that are put into water or feed of food-producing animals to voluntarily stop labeling them as drugs that can be used to promote animal growth.
The directive also requested manufacturers change the labeling of their products for the remaining uses to require veterinary oversight of these drugs when they are used for therapeutic purposes.
All of the affected makers of these drugs have committed in writing to participate in the strategy, FDA said.
The American Feed Industry Association, which has participated in efforts to design and improve the rule and processes, said additional time will be needed to review the final version, but a few things have come to the group's attention.
"At 100-plus pages, we have much to review, but at first glance we noticed the recordkeeping timeline is still a two-year requirement," said Richard Sellers, AFIA senior vice president of legislative and regulatory affairs. "That's a concern, as we believed we had convinced FDA the two-year requirement should be reduced to one year to agree with the one-year recordkeeping requirement that appears in the Current Good Manufacturing Practices regulations."
AFIA said it will evaluate the final rule and continue to work with AFIA members to implement the changes appropriately in the timeframe provided.