One must go back to 1996 to trace the history of government oversight on antibiotics. That’s when Congress enacted the Animal Drug Availability Act (ADAA), thereby establishing a new regulatory category for certain animal drugs used in animal feed. This new category became known as the veterinary feed directive drugs (VFD drugs).
Prior to 1996, the Food and Drug Administration (FDA) had two categories of drugs – over-the-counter (OTC) and prescription (Rx). Most drugs used in animal feeds were OTC, and the FDA felt the two categories didn’t provide the means for the safe use of new animal drugs, particularly new antimicrobial drugs. In late 2000, FDA established the VFD-related provisions of the ADAA and determined that veterinary oversight was critical to assuring the safe and appropriate use of certain animal drugs. It further stated further stated that FDA should approve the use of these drugs only if the medicated feeds were administered under a veterinarian’s order and professional supervision.
More recently, the FDA published Guidance #209 and #213 that established two principles: 1) The use of medically important antimicrobial drugs in food-producing animals should be limited to uses that are considered necessary to assuring animal health; and 2) The use of medically important antimicrobial drugs should include veterinary oversight or consultation. This meant a change from OTC to VFD status for medicated feed products containing medically important antimicrobial drugs.
In the proposed rule, FDA is revising the VFD definition so that veterinarians ordering the use of VFD drugs must be “in compliance with all applicable veterinary licensing and practice requirements.” This change is meant to provide greater flexibility for veterinarians by deferring to the individual states for the criteria for acceptable veterinary professional conduct, rather than relying on a more rigid federal standard.
Good in Theory
If veterinarians work across state lines, or who work with operations with farms in different states, potential challenges exist. A letter from the American Association of Veterinary State Boards to FDA suggested the FDA include a provision in the final rule that mandates those jurisdictions that don’t have a legal definition of the Veterinary-Client-Patient Relationship to use one prescribed by FDA.
In many states, the definition is already the same, but it will be up to veterinarians to review the legal definitions if they do business in other states.
Veterinarians should monitor the activity of the state licensing boards in the states in which they practice to determine if changes to the state laws are being proposed, particularly if this provision to the rule is included in the final Directive.