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. All prescription drugs need a licence from a regulator to treat a specific condition. But licensed drugs can be prescribed for conditions they haven’t been tested for in a clinical trial. This is. An off-label prescription is when a doctor prescribes an FDA-approved medication for a purpose, dose, or method that the FDA hasn’t specifically reviewed and approved. This is surprisingly common: roughly 1 in 4 prescriptions in the United States are written for off-label uses. 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. 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. 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. In contrast, off-label use involves the use of a licensed medicine outside its authorised indication, route, dose or patient group. While often clinically justified, such prescribing carries additional legal, ethical and safety considerations for the prescriber. Off-label promotion happens when a drug or device manufacturer markets its product for a use the FDA never approved, and it is generally illegal under federal law. A drug may be used off-label when it was tested for the treatment of one disease and prescribed in an attempt to prevent or treat another, when it was tested at one dose and used at higher or lower doses, or when it was tested in an eight-week trial and prescribed for long-term use. 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?.