The new directive, released by the Food and Drug Administration (FDA) in 2012, is intended to promote judicious use of drugs to ensure animal health, remove growth promotion antibiotics and increase veterinarian involvement. Through the years, the directive has evolved and is giving manufacturers a chance to withdraw growth promotional claims and apply for therapeutic and prevention labels.

“The main concern centers around the idea that the use of these compounds in food animals may generate resistant pathogens that may affect people,” said Dr. John Hallberg, the director of regulatory affairs for Veterinary Medicine Research and Development.

Products will be removed from the shelves from Dec. 8-10, 2016, to get new labels approved and then back out on Jan. 1, 2017. More than 200 animal health products will change from over-the-counter to VFD status.

“The vast majority of antibiotics used in livestock will need to be prescribed via prescription or VFD, by a veterinarian,” Hallberg said.

All water-soluble, medically important antibiotics and feed additives will become prescription products.


Other VFD requirements include:

  1. No extra-label use of any antibiotics.
  2. Six months is the maximum expiration date of prescriptions (unless otherwise noted).
  3. Copies of the VFD prescription forms must be saved by the producer, veterinarian and feed mill.
  4. VFD prescription forms must be kept on file for at least two years.
  5. The veterinarian-client-patient relationship (VCPR) has to be documented, and the veterinarian is required to be certified in the state where the sick animals are located.

Dr. Paul Ruen, a veterinarian currently serving on the American Veterinary Medical Association (AVMA) Steering Committee for FDA Policy on Veterinary Oversight of Antimicrobials, mentioned in the webinar that electronic VFD forms and multiple-site prescriptions are details that are being modernized to give veterinarians and producers the necessary flexibility when it concerns sick animals.

“Hopefully this will help avoid some of the welfare concerns of farm animals not getting the necessary medication when they need it,” Ruen said. “It certaintly requires some effort on the side of the producers, the vet and the feed mills to get on the same page and make it as painless as possible.”

Dr. M. Gatz Riddell, executive vice president of the American Association of Bovine Practitioners (AABP), told ranchers to start planning now. Riddell suggested that producers should be having frequent conversations with their local veterinarians about their often-used antibacterial products and what’s the best way to go about accessing them.

“Make the determination of what needs to be used and what can be used,” Riddell said. “Develop and strengthen relationships, and make sure the products we need to keep animals healthy are available.”

Riddell encouraged ranchers to do the research and learn the different requirements needed to ensure antibiotics are being used legally and with the appropriate documentation.

“All of us involved in livestock agriculture have the opportunity and obligation to take the best care of the animals we are raising for food,” Ruen said. “The new VFD regulations for antibiotic use and feed will essentially document to the public how we’re already largely working together on this area.”

To learn more about the VFD, visit the Federal Register.  end mark