Prescribing an FDA-approved drug for a use, dose, or group not specified in its labeling.
Also known as: off-label prescribing
Off-label use is when a clinician prescribes an FDA-approved medication for a purpose, dose, or population not listed in its approved labeling. It is legal and common when supported by evidence and clinical judgment.
Many hormonal and metabolic medications are used off-label; the FDA notes that off-label use should be based on sound scientific rationale.