By December 2016, it will be illegal to use certain antibiotics in food-producing animals’ feed or water unless (1) the animal producer obtains authorization from a licensed veterinarian and (2) the drug is used only for prevention, control, or treatment of a specifically identified disease.

The U.S. Food and Drug Administration (“FDA”) announced the new Veterinary Feed Directive (“VFD”) Final Rule on June 2, which applies to antimicrobial drugs that are medically important in human medicine and also are used in food-producing animals. It is the latest step in the agency’s efforts to eliminate the use of such drugs for production purposes (i.e., growth promotion and feed efficiency) and bring their remaining therapeutic uses under the supervision of licensed veterinarians to ensure that the drugs are used judiciously and only when appropriate for specific animal health purposes.

Moreover, veterinarians may only prescribe such drugs in the context of a veterinarian-client-patient relationship under state-defined requirements. However, in states where the FDA determines that no applicable or appropriate state VCPR requirements exist, veterinarians will be required to issue VFDs in compliance with federally-defined VCPR requirements. In practical terms, this means the veterinarian must:

  • engage with the animal producer to make clinical judgments about the animal’s health,
  • have sufficient knowledge of the animal by examining it and visiting its facility, and
  • provide for any necessary follow-up evaluation or care.

Tuesday’s final rule follows two Guidance for Industry (“GFI”) documents published by the FDA in April 2012 (GFI #209) and December 2013 (GFI #213), both of which set forth the FDA’s principles and voluntary framework for the prudent use of medically important antimicrobial drugs in food-producing animals.

These earlier voluntary guidelines recommended that animal drug manufacturers stop labeling antimicrobials as drugs that can be used to promote animal growth, and instead, change the labeling to require veterinary oversight of the drugs when used for therapeutic purposes. While all makers of these drugs have committed in writing to participate in the voluntary strategy, the requirements in the final rule are now mandatory.

The FDA has stated that it intends to use a phased enforcement strategy for implementation of the final rule as over-the-counter drugs transition to regulated VFD drugs, first offering education and training. It will then engage in risk-based general surveillance and for-cause inspection assignments, focusing on industry metrics such as history of VFD use and the volume of VFD feed being produced.

The Health Law Pulse previously reported on a related proposed rule from the FDA, which would require animal drug manufacturers to track drug sales by species. Both rules are part of a continued Obama administration effort to combat antibiotic resistance in humans, including an executive order issued last September, a National Action Plan published in March, and a White House Forum on Antibiotic Stewardship scheduled this week.

The following resources provide additional information: