Off-label use means using an FDA-approved medication in a way that hasn’t been approved by the FDA. For example, a medication may be used for a different health condition or at a different dose. Both prescription drugs and over-the-counter drugs (OTCs) can be used in off-label ways, although most studies of off-label use focus on prescription drugs. Off-label use is very common and generally legal unless it violates ethical guidelines or safety regulations. Has your healthcare provider ever talked to you about using an FDA-approved drug for an unapproved use (sometimes called an “off-label” use) to treat your disease or medical condition? Off-label use refers to a range of prescribing that is outside approved indications by the Food and Drug Administration (FDA). Off-label use of drugs is widely known as unapproved use of approved drugs, and it can be perceived as a relatively simple concept. Even though it has been in existence for many years, prescribing and dispensing of drugs in an off-label regimen is. Off-label use refers to prescribing a medication for a different purpose than those formally approved by the FDA and found in the package labeling of the drug. The FDA approves medications that are shown to be safe and effective for a particular use. Off-label medicines use is for an indication, dose, route or age other than what has been approved by a medicines regulator. It is sometimes needed and appropriate but is associated with important clinical, safety, ethical, and financial consequences. The meaning of OFF-LABEL is of, relating to, or being a drug used to treat a condition for which it has not been officially approved. How to use off-label in a sentence. Off-label prescribing is when a physician gives you a drug that the U.S. Food and Drug Administration (FDA) has approved to treat a condition different than your condition. This practice is legal and common. In fact, one in five prescriptions written today are for off-label use. When a doctor prescribes a drug off-label, they are prescribing it for a different condition or at a different dosage than the FDA has approved.