Extralabel Drug Use In Small Ruminants

Small ruminants are classified as minor species according to FDA definitions.
Because of a lack of drugs approved for use in small ruminants, veterinarians often resort to using FDA approved drugs in an extralabel manner. 

ELDU is the use of a FDA approved drug in an animal in a manner that differs in any way from the drug's approved labeling.  ​ELDU includes using a drug in one or more of the following ways:
  • In a species or production class not listed on the label
  • For an indication not listed on the label
  • At a different dose than listed on the label
  • At a different volume per injection site than what is listed on the label
  • At a different administration frequency than listed on the label
  • For a different treatment duration than listed on the label
  • Via a different route of administration than listed on the label

ELDU is allowed under the Animal Medicinal Drug Use Clarification Act (AMDUCA).  FDA regulations addressing ELDU are covered in 21 CFR 530

The following must be met in order to use a FDA approved drug in an extra label manner in a small ruminant:
  • Only a licensed veterinarian, with a valid veterinarian-client-patient relationship (VCPR), can use and prescribe a drug in an extra label manner.
    • ​ This means it is considered illegal extra label drug use if a producer initiates use of a drug extra label without the supervision or direction of a veterinarian.
  • Only animal or human FDA approved drugs may be used in an extra label manner.
    • This includes both Over The Counter (OTC) and prescription (Rx) only drugs.
    • This also means that pesticides, which are approved by the Environmental Protection Agency (EPA), not FDA, may not be used in an extra label manner.
  •  Drugs can only be used in an extra label manner in feed under certain circumstances in minor species. More information can be found below or in CPG 615.115 .
  • The use of a drug extra label is only  for therapeutic purposes or where suffering or death may result from failure to treat
    • This means a drug may not be used in an extra label manner for the purpose of increasing production (i.e.  increasing milk production, weight gain of the animal, or for reproduction).


Requirements for Veterinarians
  • Diagnose and evaluate the condition for which the drug is to be used
  • Institute procedures to ensure the identification of the treated animal(s) is maintained
  • Establish a science based and substantially extended withdrawal period
  • Take appropriate measures to ensure the withdrawal time period is met by the clients
  • Maintain treatment records
Responsibility of Producers
  • Engage a veterinarian to develop and oversee a drug management program
  • Maintain records of treated animals
  • Maintain identification of treated animals
  • Have a control system in place to prevent contamination of the human food chain
  • Maintain storage and accounting of drugs on the premises

Medicated Feed Use in Small Ruminants