For a non-food-producing animal, ELDU of a drug labeled for another animal species can be used if there is no approved, appropriate drug that is labeled for use in the patient’s species or if an approved drug exists for the patient’s species but is found by the veterinarian to be clinically ineffective.
If the patient is a food-producing animal, ELDU of a drug labeled for use in another food-producing animal species is acceptable only if:
- There is no approved drug labeled for such use (or is the same drug labeled for a different use) in that species; or
- The approved drug exists for that species but is found by the veterinarian to be clinically ineffective.
- However, the veterinarian must establish a substantially extended withdrawal period, maintain identity of the animal, and take measures to ensure that no illegal drug residues in food result from the use of that drug.
If the patient is a food-producing animal and the drug being considered for ELDU is a human drug or drug approved for non-food-producing animals, the above conditions must be met and in addition, there must be adequate scientific information available to determine a withdrawal time, or else the veterinarian must take measures to ensure that animal never enters the human food supply.
Labeling and record maintenance is of utmost importance when an extralabel use of a drug is prescribed. AMDUCA does not permit extralabel use of any drug if public health is threatened.
