FDA Releases Guidance and Draft Guidance to Restrict Subtherapeutic Uses of Animal Drugs

The Food and Drug Administration (FDA) recently released two guidance documents designed to restrict the use of medically important new animal drugs at subtherapeutic levels in the feed or water of food-producing animals. Guidance for Industry (GFI) #209 was released in its final form and requests that industry voluntarily limit the use of medically important new animal drugs in food producing animals to medically necessary uses under the supervision of a veterinarian. GFI # 213 has been released in draft form and requests that new animal drug sponsors voluntarily withdraw conditions of use that are inconsistent with the principles outlined in GFI # 209.