Currently, “Guidance for Industry” (GFI) 213 is being finalized. This defines the procedures for completing the goals of an earlier guidance, GFI 209, which is final and states the following:

  • Pharmaceutical companies will be asked to voluntarily remove production claims such as “improved feed efficiency” or “increased rate of gain” and, where appropriate, revise labels to include only those scientifically supported disease control and treatment uses.
  • Companies will be asked to inform the FDA of their intentions to engage in this voluntary process within three months after the final GFI 213 is published.
  • Only antibiotics that are deemed “medically important” for human health will be affected.
  • Affected products can be used in feed or water only on the order of a veterinarian for control, prevention or treatment of disease.
  • Ionophores are not used in human medicine and will not be affected.
  • Evaluation of progress towards the goals of GFI 209 will occur three years from the date of the publication of the final GFI 213.
  • GFI 209 is not a regulation. It is guidance asking for voluntary action.

After GFI 213 is finalized, continuing education classes are expected to help producers, nutritionists and veterinarians familiarize themselves with the ruling.

 

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