June 20, 2016
The U.S. Food and Drug Administration (FDA) has issued a letter 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. The letter also provides retail establishments with recommendations for addressing current and future inventory of medically important antimicrobials for use in feed or water for food animals.
In December 2013, the FDA 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 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 notified the FDA of their intent to make the recommended changes to their products within the established timeframe.
By January 1, 2017, the FDA expects all drug sponsors will complete the necessary label changes of their affected products and then changes in drug use practices will begin. The marketing status of affected drugs will change from OTC to Rx status for drugs administered through drinking water or to VFD for drugs administered in medicated feeds. Distributors or retail establishments that handle these products will be required to meet all applicable State and Federal regulations for Rx and VFD drugs when dispensing these products.
In addition, the FDA recently published the VFD final rule, which outlines the revised process for authorizing use of VFD drugs (animal drugs intended for use in or on animal feed and that require the supervision of a licensed veterinarian). The VFD rule also 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 includes specific requirements for distributors of these products.
Additional information regarding the products that are transitioning from OTC to Rx or VFD marketing status and requirements for retail establishments is provided in the Retail Establishment Letter, dated June 17, 2016.
Veterinary Feed Directive (VFD) Judicious Use of Antimicrobials Drugs Transitioning from Over-the-Counter (OTC) to Prescription (Rx) Status Drugs Transitioning from Over-the-Counter (OTC) to Veterinary Feed Directive (VFD) Status Letter to Potential Distributors (Retailers) Regarding Implementation of GFI 213