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. 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.
The FDA recognizes the need for continued education and outreach during the implementation of GFI #213 and has made presentations to dozens of stakeholders groups and responded to hundreds of individual questions over the past six months. The agency intends to continue these efforts in the future as resources permit.