In Guidance For Industry (GFI) #213, the FDA 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 – changes that are critical to ensure these drugs are used judiciously and only when appropriate for specific animal health purposes.

On June 17, 2016, FDA sent a letter to registered animal food facilities conducting activities associated with mixed feed, as they may be potential distributors (retailers) 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.

Information was provided on the products transitioning from OTC to Rx or VFD status. The letter also describes VFD distributor requirements and the timing of actions for addressing current and future inventory of products affected by GFI #213.

• Letter to Retail Establishments