When a clinician legally prescribes an FDA-approved drug for a use, dose, or group that isn't on its official label, for example, using diabetes-labeled Ozempic or Mounjaro for weight loss. Off-label prescribing is common and legal, but it can affect insurance coverage, since plans often tie coverage to the approved indication. It's different from using a non-approved compounded product.
Related terms: FDA approval · Ozempic · Mounjaro · Prior authorization (PA)