Deviation from ELDU regulations is an illegal action subject to prosecution by the FDA. The spirit of AMDUCA is to allow veterinarians flexibility in administering drugs that will help relieve animal pain and suffering. The overarching premise of the law is that extralabel use is acceptable when filling a medical need for an animal when its health is threatened.
For example, equine practitioners have inquired about the legality of treating horses with Previcox®(firocoxib), a nonsteroidal anti-inflammatory drug labeled for use in dogs, instead of Equioxx®, which contains the same ingredient but is labeled for use in horses. There can be a significant cost difference between the two products, which is the cause of the debate. According to AMDUCA, however, because Equioxx® is labeled for use in horses, the canine product cannot legally be used in an extralabel fashion in horses. Selecting a canine product over an equine product for any nonmedical reason, including economics, is not acceptable. Some clients or veterinarians asked if economic concerns are a valid reason to use or prescribe a drug in an extralabel manner—this is true only in that a veterinarian can select an approved human drug to relieve pain and suffering in a non-food producing animal even when an identical approved animal drug is available.
