Virginia-Maryland Regional College of Veterinary Medicine
The American Veterinary Medical Association has assembled a brochure to help
you comply with new regulations concerning Extra-Label Drug Use (ELDU). These
regulations are the result of FDACVM's interpretation of the Animal Medical
Drug Use Clarification Act (AMDUCA).
We have converted this brochure to an interactive algorithm for your use. Please read the general "Requirements for Extra-label Drug Use" listed below before you enter the algorithm. AVMA has also provided a list of label requirments and record requirments that are part of full compliance with AMDUCA.
Requirements for Extra-label Drug Use
- ELDU is permitted only by or under the supervision of a veterinarian.
- ELDU is allowed only for FDA approved animal and human drugs.
- A valid Veterinarian/Client/Patient Relationship is a prerequisite for all ELDU.
- ELDU for therapeutic purposes only (animal's health is suffering or threatened), not drugs for production use.
- Rules apply to dosage form drugs and drugs administered in water. ELDU in feed is prohibited.
- ELDU is not permitted if it results in a violative food residue, or any residue which may present a risk to public health.
- FDA prohibition of a specific ELDU precludes such use.
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