21.06.2016

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. 
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.