Extralabel use is limited to circumstances when the health of an animal is threatened, or suffering or death may result from failure to treat. As we’ve already stated, extralabel use to enhance production is prohibited.
Examples of clinical circumstances in which ELDU might be employed/necessary are listed below:
- A horse needs to be treated with enrofloxacin based on the culture/sensitivity results of a tendon sheath infection. No horse-labeled enrofloxacin products are available, so the veterinarian could consider treating with the small animal- or bovine-labeled enrofloxacin product.
- A horse needs penicillin but the veterinarian determines the horse needs a larger dose than the labeled dose. This qualifies as an ELDU because the dose prescribed is not in accordance with the labeled dosage.
- A dog with a skin infection needs cephalexin, according to its veterinarian. There is no animal-labeled product, thus ELDU of the human product is acceptable.
- A dog is diagnosed with congestive heart failure by its veterinarian, and furosemide administration is part of the therapeutic plan. There are FDA-approved products labeled for use in dogs, including brand name and generic products, but the veterinarian recommends the human product from the local pharmacy for economic reasons. A prescription for ELDU of the human product is acceptable in this circumstance.
