An Informational Outline of the Animal Medicinal Drug Use Clarification Act (AMDUCA)

American Veterinary Medical Association
1931 N. Meacham Rd., Suite 100
Schaumburg, IL 60173-4360
www.avma.org

If you have questions about the
regulations call the Food and Drug Administration,
Center for Veterinary Medicine at (240) 276-9200

Brochure originally prepared January 1998, revised September 2007.
© 2007 AVMA. To obtain copies call AVMA Scientific Activities at
847-925-8070.

• 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.†(See gray box below
)

• Chloramphenicol
• Clenbuterol
• Diethylstilbestrol (DES)
• Dimetridazole
• Ipronidazole
• Other Nitroimidazoles
• Furazolidone, Nitrofurazone, Other Nitrofurans
• Sulfonamide drugs in lactating dairy cows (except approved use of sulfadimethoxine, sulfabromomethazine, and sulfaethoxypyridazine)
• Fluoroquinolones
• Glycopeptides (example: vancomycin)
• Phenybutazone in female dairy cattle 20 months of age or older
• Adamantane and neuraminidase inhibitor classes of drugs that are approved for treating or preventing influenza A are prohibited therapy in chickens, turkeys, and ducks (Effective: June 20, 2006)

• Identify the animals, either as individuals or a group.
• Animal species treated.
• Numbers of animals treated.
• Conditions being treated.
• The established name of the drug and active ingredient.
• Dosage prescribed or used.
• Duration of treatment.
• Specified withdrawal, withholding, or discard time(s), if applicable, for meat, milk, eggs, or animal-derived food.
• Keep records for 2 years.
• FDA may have access to these records to estimate risk to public health.

• Name and address of the prescribing veterinarian.
• Established name of the drug.
• Any specified directions for use including the class/species or identification of the animal or herd, flock, pen, lot, or other group; the dosage frequency, and route of administration; and the duration of therapy.
• Any cautionary statements.
• Your specified withdrawal, withholding, or discard time for meat, milk, eggs, or any other food.