The practice whereby a doctor prescribes a drug or combination of drugs for a condition that has not been specifically approved by the Food and Drug Administration (FDA). Once a drug has been approved for one purpose, doctors are generally free to prescribe it to treat any condition. About half of all prescriptions are for off-label use.
In the United States, the Food and Drug Administration (FDA) grants approval to drugs for specific purposes, durations, and dosages based on findings from clinical trials. Nevertheless, physicians are legally permitted to prescribe these drugs for other uses not approved by the FDA, known as “off-label” uses. However, pharmaceutical companies are prohibited from advertising drugs for off-label applications.