FDA Letter to Potential Distributors of VFD Medicated Feed

Source: National Grain and Feed Association

The NGFA was informed by FDA that the agency emailed the attached letter to potential distributors of one or more animal drug products for use in feed or water for food animals whose marketing status will change from over-the-counter (OTC) to prescription (Rx) or to veterinary feed directive (VFD) at the end of calendar year 2016. The FDA letter provides information on the products transitioning from OTC to Rx or VFD status. It also describes VFD distributor requirements and the timing of actions for addressing current and future inventory of products affected by the pending transition.

Significantly, the letter includes information on:

1. Animal drugs administered in water whose marketing status will transition from OTC to Rx status.
2. Animal drugs administered in or on feed whose marketing status will transition from OTC to VFD status.
3. Requirements for distributors of VFD feed under the VFD final rule.
4. Plans for transitioning affected animal drugs and medicated feeds to the new labeling required by January 1, 2017.

Background

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 medicated 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 January 1, 2017, the marketing status of the affected drugs will change from OTC to either Rx status for drugs administered in medicated drinking water or VFD status for drugs administered in or on medicated feed. In some cases, drug sponsors may choose to withdraw a product approval completely. Drugs that have either an Rx or VFD marketing status can only be prescribed or authorized for use in animals by a licensed veterinarian.

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 U.S. 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 October 1, 2015, and applies to veterinarians who authorize VFDs, distributors who distribute VFD feed, and clients (animal producers) who use VFD feed.