What Qualifies as Extra Label Drug Use

Q: How do I know what qualifies as ELDU?

A: Specific criteria must be followed:

  • A valid VCPR is a prerequisite for all ELDU;
  • Only a veterinarian can determine that ELDU is needed and can administer, prescribe or dispense a medication extralabelly. The veterinarian must direct or supervise ELDU in an animal;
  • ELDU rules only apply to FDA-approved animal and human drugs;
  • ELDU is intended for prevention, treatment, and control purposes only when an animal’s health is threatened. ELDU of drugs for production use and/or in feed is not approved;
  • ELDU is not permitted if it results in an illegal food residue, or any residue which may present a risk to public health;
  • A veterinarian must not pursue use of certain FDA-prohibited drugs in food-producing animals.

ELDU of an FDA approved drug may be used if:

  • There is no approved animal drug that is labeled for such use, or that contains the same active ingredient in the required dosage form and concentration.
  • Alternatively, an approved animal drug for that species and condition exists, but a veterinarian finds, within the context of a VCPR, that the approved drug is clinically ineffective for its labeled use.

There are few restrictions on extralabel use in non-food-producing animals compared to food-producing animals. If the intended use is in a non-food-producing animal, then an approved human drug may be considered for extralabel use even when an approved animal drug for that species and condition exists. Economic reasons for ELDU of a human drug over the approved drug for that species are valid to treat the medical condition. Veterinarians should recognize, however, that human-labeled drugs are approved based on studies in people and their use in animals could vary. In addition, minor differences in the formulation may produce alterations in the pharmacokinetics and biological availability in the animal species compared to humans. Also keep in mind that consistent use of human-labeled drugs when approved animal-labeled drugs are available could create relative disincentives for the animal health industry to pursue new animal drug approvals and could further limit the availability of veterinary drugs.

The following additional conditions must be met for ELDU in food-producing animals:

  • Such use must be accomplished in accordance with an appropriate medical rationale; and
  • If scientific information on the human food safety aspect of the use of the drug in food producing animals is not available, the veterinarian must take appropriate measures to assure that the animal and its food products will not enter the human food supply.

If the veterinarian determines the food-producing animal needs a drug administered in an extralabel fashion, an approved animal drug must be considered for the particular use before a drug labeled for humans is considered. The prescribed or dispensed extralabel drug (prescription legend or over-the-counter) must bear labeling information which is adequate to assure the safe and proper use of the product.