08.07.2016

In December 2013, the agency took a significant step forward in addressing antimicrobial resistance by publishing Guidance #213, which calls on animal drug sponsors of approved medically important antimicrobials administered to food-producing animals through medicated feed or water to remove from their product labels indications for use related to growth promotion, and to bring the remaining therapeutic uses of these products under the oversight of a veterinarian by the end of December 2016.
All of the affected drug sponsors have committed in writing to making the changes described in the guidance by the end of 2016. The FDA fully expects this process to be completed by this deadline.
There were 293 applications initially affected by Guidance for Industry (GFI) #213. Many of these sponsors have already started implementing the recommended changes to their affected antimicrobial products: four applications have been converted from over-the-counter to prescription dispensing status; production indications have been withdrawn from one application; and 41 affected applications have been completely withdrawn. On May 11, 2016, the FDA sent a letter to remind affected drug sponsors about the agreed-upon timeframe (the end of 2016) for aligning their product with GFI #213.
Once the changes recommended in GFI #213 have been made, these products will only be obtainable upon the valid order of a licensed veterinarian and can legally only be used for therapeutic indications.The FDA issued a letter on June 20, 2016, reminding retail establishments that sell medically important antimicrobials for use in feed or water for food animals that the marketing status of those products will change from over-the-counter (OTC) to prescription (Rx) or to veterinary feed directive (VFD) at the end of calendar year 2016. Once the changes are in place, distributors of those medically important antimicrobials will need to comply with appropriate requirements for Rx and VFD drugs when dispensing these products. 
In March 2016, the FDA announced a funding opportunity for antimicrobial use and resistance data collection. These collection efforts are intended to provide part of the baseline information on antimicrobial use practices in the four major food-producing animal groups (cattle, swine, chickens, and turkeys), a critical element in measuring overall impact of the agency’s judicious use strategy. The data collection efforts are also expected to provide important information on methodologies to help optimize long-term strategies for collecting and reporting such data.
To further promote the judicious use of antimicrobials in food-producing animals, the FDA issued a final rule on May 10, 2016, revising the annual reporting requirements for drug sponsors of antimicrobials sold or distributed for use in food-producing animals.