A patient shall be eligible for treatment with an investigational drug, biological product, or device if the patient has: (1) A terminal illness that is attested to by the patient's treating health care provider; (2) Considered all other treatment options currently approved by the United States Food and Drug Administration; (3) Received a recommendation from the patient's treating health care provider for an investigational drug, biological product, or device; (4) Given written informed consent for the use of the investigational drug, biological product, or device; and (5) Documentation from the treating health care provider that the patient meets the requirements of this section.
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