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10.1164/rccm.200206-507OC

Finally, Section 396 of the FDCA expressly authorizes off-label use: Nothing in this chapter shall be construed to limit or interfere with the authority of a health care practitioner to prescribe or administer any legally marketed device to a patient for any condition or disease within a legitimate health care practitioner-patient relationship. Because physicians lawfully may prescribe off-label, there also is no question that pharmacies lawfully may fill the orders they receive

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