What does the term "off-label use" refer to in medical practice?

The term "off-label use" specifically refers to the practice of prescribing medications or using medical devices for indications that have not been explicitly approved by regulatory agencies, such as the Food and Drug Administration (FDA) in the United States. This situation often arises when healthcare providers believe that a particular treatment may be beneficial for conditions beyond those formally approved, either based on clinical experience or emerging evidence in the medical literature.

Off-label use is legal and can be appropriate in many cases, particularly when adequate evidence supports the off-label indication. Healthcare professionals must rely on their clinical judgment and may also consider peer-reviewed studies and expert opinion when recommending such treatments to patients. This practice is common in areas like oncology, psychiatry, and pediatrics.

Prescribing a medication or a device according to its approved label is categorized under standard practice, which would not qualify as off-label use. Options suggesting the recommendation of over-the-counter products for prescription use or the promotion of untested medical devices misrepresent the concept of off-label use, as they involve either improper channels for dispensing medication or devices or a complete lack of regulatory approval.