Pharmaceutical inserts: legal consequences.
Although the legal status of the pharmaceutical package insert is uncertain, a physician who prescribes a drug use or dosage that does not appear on the insert can best protect himself in case of a malpractice suit by documenting the scientific rationale for the FDA-unapproved use and by obtaining the patient's informed consent.
D004348:Drug Labeling / Q000592:standards*; D011307:Drug Prescriptions / Q000592:standards*; D007258:Informed Consent; D008318:Malpractice; D010819:Physician's Role; D012380:Role; D014481:United States; D014486:United States Food and Drug Administration