217.5403 Eligibility requirements for treatment with investigational drug,
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/ky/217-5403A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
biological product, or device. 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.