By Dave Fairfield, Senior Vice President of Feed Services
The U.S. Food and Drug Administration (FDA) recently made available a new video that provides an overview of the agency’s Veterinary Feed Directive (VFD) regulation that governs the use of medically important antimicrobials used in or on animal feed.
The approximately 7.5-minute video explains that medically important antimicrobials used in or on animal feed will become VFD drugs effective Jan. 1, 2017, and that VFD medicated feed must be authorized by a licensed veterinarian and distributed and used in compliance with the VFD regulation. In addition, the video highlights that VFD drugs are to be used only for therapeutic purposes, and no longer will be available for use to promote growth or feed efficiency.
On April 11, 2013, FDA announced its final Guidance for Industry (GFI) #209, in which the agency stated that the use of medically important antimicrobial drugs in feed or water for food-producing animals should be limited to those that: 1) are considered necessary for assuring animal health (i.e., medically important antimicrobial drugs should not be used to promote animal growth or to improve feed efficiency); and 2) include veterinary oversight or consultation (i.e., medically important antimicrobial drugs should not be used in or on the feed or drinking water for food-producing animals without veterinary oversight or consultation).
FDA on Dec. 12, 2013 issued its final GFI #213 in which the agency asked animal drug sponsors of medically important antimicrobials administered in feed or drinking water of food-producing animals to voluntarily remove from their product labels those indications for production purposes (i.e. growth promotion and feed efficiency), and bring the remaining therapeutic uses of these products under the oversight of a veterinarian by December 2016.
In response to GFI #209 and GFI #213, all of the affected drug sponsors committed to making the changes FDA requested. Accordingly, on Jan. 1, 2017, the marketing status of the affected drugs will change from over-the-counter (OTC) to either prescription (Rx) status for drugs administered in drinking water or Veterinary Feed Directive (VFD) status for drugs administered in or on animal feed. In some cases, drug sponsors may choose to withdraw a product approval completely. Drugs that have either an Rx or VFD marketing status only can be prescribed or authorized for use in animals by a licensed veterinarian. A listing of affected drug products approved for use in or on animal feed is available on FDA’s website.
In addition, FDA on June 2, 2015 issued its final rule that revised the agency’s VFD regulations. The revised 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 became effective on Oct. 1, 2015, and applies to veterinarians who authorize VFDs, distributors who manufacture and/or distribute VFD feed, and clients (animal producers) who use VFD feed.