Monday, March 7, 2016
FDA request help from Beef producers.
Dear NACAA Member, The FDA is asking for your help. Because animal producers often receive current information about issues impacting animal agriculture from agricultural agents and university extension staff members, you can do us and animal producers a significant service. A major change is coming on January 1, 2017, for the judicious use of antimicrobials in medicated feed for food animals (such as livestock, poultry, and aquaculture). These changes mean some antimicrobial drugs used in medicated feed will change from over-the-counter (OTC) drugs to veterinary feed directive (VFD) drugs. To use a VFD drug in medicated feed the animal producer needs an order from a veterinarian. That order is called a veterinary feed directive (VFD). The FDA recently revised the rule for the authorization, manufacturing, distribution, and use of VFD drugs and VFD medicated feed. This rule impacts: veterinarians; the distributors of the VFD feed such as commercial feed mills or feed retailers; and the animal producers who are referred to in the rule as clients. This email contains resources for you to help animal producers understand this change and how it impacts them. You might ask, why should I participate in a program to describe an FDA rule? The simple answer is this – you can help your animal producer clients comply with the revised rule. In addition, by becoming knowledgeable and by providing information about the changes for certain antimicrobial drugs used in medicated feed and the VFD requirements, you are an important partner in FDA's strategy to promote the judicious use of antimicrobials in food-producing animals. FDA’s strategy to promote the judicious use of antimicrobials in food-producing animals will bring the use of certain drugs under veterinary supervision so they are used only when necessary for animal health. The VFD final rule outlines the process for authorizing use of VFD drugs (which are animal drugs intended for use in or on animal feed that require the supervision of a licensed veterinarian) and provides veterinarians in all states with a framework for authorizing the use of medically important antimicrobials in feed when needed for specific animal health purposes. In addition to the rule’s impact on medicated feed, affected water-soluble drugs will change from OTC status to prescription status. The following link will take you to CVM’s VFD webpage: http://www.fda.gov/AnimalVeterinary/DevelopmentApprovalProcess/ucm071807.htm For VFD questions and answers, please see: http://www.fda.gov/downloads/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/UCM052660.pdf For information about drugs transitioning from Over-the-Counter (OTC) to Veterinary Feed Directive (VFD) Status, please see: http://www.fda.gov/animalveterinary/developmentapprovalprocess/ucm482107.htm And for questions and answers about the VFD form common format, please see: http://www.fda.gov/downloads/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/UCM474640.pdf. We appreciate your help on this important public health issue. Should you have questions or would like to talk with someone please, contact AskCVM@fda.hhs.gov. Sincerely, The FDA Center for Veterinary Medicine Animal Feed Safety System Team