AVMA - Animal Medicinal Drug Use Clarification Act (AMDUCA)

​Extralabel drug use algorithm
 

NO: Is there a drug approved for food animals which could be used extralabelly? 

  

Yes

Proceed with extralabel use of food animal drug. Establish extended withdrawal time. Ensure food safety. Maintain required records.* Label drug appropriately.**

 * and ** - See record and label requirements.

* RECORD REQUIREMENTS

  • 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.

** LABEL REQUIREMENTS

  • Name and address of the prescribing veterinarian.
  • Established name of the drug.
  • Any specified direction 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.