Off-label use
Off-label use is the prescribing of an approved drug or device for an indication, population, or dosage not specified in its regulatory labeling. The practice is legal and often evidence-based for physicians, but manufacturers face strict limits on promoting unapproved uses.
What is off-label use?
Off-label use is the practice of prescribing an approved drug or device for an indication, patient population, or dosage that is not described in its official regulatory labeling. The product itself is approved, but the specific application falls outside what the label spells out.
This is a common and legal part of medicine, since physicians may use their clinical judgment to apply approved products in ways supported by evidence and experience.
Why does off-label use matter?
Off-label prescribing lets clinicians treat conditions for which no formally approved option exists, and much of it rests on solid published evidence. At the same time, it can carry more uncertainty than on-label use, so informed judgment is important.
A key distinction is that while clinicians may prescribe off-label, manufacturers face strict legal limits on promoting unapproved uses, a boundary that has been central to many enforcement actions in the pharmaceutical and device industries.
- what is off-label use
- off label use meaning
- off label prescribing definition
- off label drug use
- is off-label use legal
- off-label medication examples