Are "off-labels" legal?
A doctor prescribes a beta-blocker to calm a patient's muscle tremors, even though the Food and Drug Administration (FDA) has only approved the drug for use in lowering blood pressure. A physician recommends that a patient wear a nicotine patch as a treatment for colitis. A pediatrician prescribes a drug that has been approved for adult use only. Such "off-label" prescriptions are increasingly common--and legal.
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Detroit College of Law, Michigan State University, East Lansing, USA.
D017277:Drug Approval / Q000331:legislation & jurisprudence; D004348:Drug Labeling; D004363:Drug Utilization / Q000331:legislation & jurisprudence*; D010818:Practice Patterns, Physicians' / Q000331:legislation & jurisprudence; D014481:United States; D014486:United States Food and Drug Administration