VETERINARY FEED DIRECTIVE REGULATIONS FOR ANIMAL DRUGS

On December 12, 2013, the Food and Drug Administration (FDA) proposed to change its animal drug regulations to improve the efficiency for stakeholders using veterinary feed directive (VFD) drugs while continuing to protect human and animal health. The VFD drug class was created in 1996 by the Animal Drug Availability Act, and they are intended for use in or on animal feed under a veterinarian's order and professional supervision. The FDA established the VFD program in 2000. Changes to the VFD regulation are important as FDA implements the judicious use principles for medically important antimicrobial new animal drugs approved for use in food-producing animals, based on the framework set forth in Guidance for Industry (GFI) #209 issued April 13, 2012 and the process and timeline in GFI #213 issued December 13, 2013. Antimicrobials must continue to be available to combat disease in animals, including treatment, control, and prevention, while preserving availability of effective drugs. The primary concern is the continued effectiveness of "medically important" drugs. One important change in GFI #213 is to include veterinary involvement in the use of these antimicrobials by changing the drug marketing status of antimicrobial drugs from over the counter to prescription or VFD drugs to be used for therapeutic uses only. This means a VFD order from a licensed veterinarian will be needed to obtain medicated feeds containing VFD drugs. This order must include information on the number and type of animals to be treated. This keeps veterinarians included in the decision-making process to use medically important antimicrobials. FDA has secured the cooperation of drug manufacturers to change the drug marketing status and remove the production uses from these drug approvals. To improve the VFD process, FDA introduced several key changes in the new VFD rule such as allowing the VFD to be issued according to the federally defined veterinarian-client-patient-relationship requirement (VCPR), or according to a VCPR as defined by the State (when certain conditions are met), eliminating the automatic classification of VFD drugs as Category II, and modifying recordkeeping requirements.  New VFD rule was published on June 3, 2015 and came to effect on October 1, 2015.