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:
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: