New Antibiotic Regulations

observing-animals-2On Jan. 1, 2017, the U.S. Food and Drug Administration’s (FDA) new regulations addressing on-farm antibiotic use in food-animal production will take effect. The agency’s effort is aimed at eliminating the use of medically important (to treat human infections) antibiotics for growth promotion purposes in food-animal production and bringing therapeutic use in feed and water – to treat, control or prevent specific disease – under additional veterinary oversight. Producers, veterinarians, feed mills and suppliers, will all face new requirements.

All sectors of animal agriculture — from drug companies to producers and veterinarians to feed mills — are collaborating to implement the new FDA antibiotic regulations:

feedGuidance 209: In 2010, FDA outlined its intent and recommendations regarding growth promotion uses of medically important antibiotics in food animal production. FDA also specified that veterinarian oversight will increase for the remaining therapeutic applications (prevention, treatment and control) of medically important antibiotics. This action applies to both feed-grade and water-based antibiotics.

Guidance 213:
On Dec. 11, 2013, FDA initiated a three-year transition process to complete its food-animal antibiotic strategy. This action requests animal-health companies to outline intentions to voluntarily remove any production/growth-promotion uses from product labels of medically important antibiotics. The guidance also eliminates over-the-counter status of these medications and increases veterinary oversight for on-farm therapeutic use by requiring a veterinary feed directive (VFD) for feed applications and a prescription for water treatments. Jan. 1, 2017, is when implementation must be completed.

Final VFD Rule: On June 3, 2015, FDA announced the final VFD rule. The final rule outlines specific requirements of the VFD process for medically important (to treat human infections) feed-grade antibiotics.