217.5401 Definitions for KRS 217.5401 to 217.5408. As used in KRS 217.5401 to 217.5408: (1) 'Biological product' means a virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or derivative, protein other than a chemically synthesized polypeptide, allergenic product or analogous produc t, or arsphenamine or derivative of arsphenamine or any other trivalent organic arsenic compound, applicable to the prevention, treatment, or cure of a disease or condition of human beings; (2) 'Device' has the same meaning as in KRS 217.015; (3) 'Drug' ha s the same meaning as in KRS 217.015; (4) 'Eligible patient' means an individual who meets the requirements of KRS 217.5403; (5) 'Health care provider' means a licensed physician, a licensed advanced practice registered nurse, or a licensed physician assis tant; (6) 'Health facility' has the same meaning as in KRS 216B.015; (7) 'Investigational drug, biological product, or device' means a drug, biological product, or device that: (a) Has successfully completed Phase I of a clinical trial but has not yet been approved for general use by the United States Food and Drug Administration; and (b) Remains under investigation in a t: (a) Has successfully completed Phase I of a clinical trial but has not yet been approved for general use by the United States Food and Drug Administration; and (b) Remains under investigation in a United States Food and Drug Administration -approved clinical trial; (8) 'Terminal illness' means a progressive disease or a medical or sur gical condition that: (a) Entails significant functional impairment; (b) Is not considered by a treating health care provider to be reversible even with administration of a treatment currently approved by the United States Food and Drug Administration; and (c) Without life -sustaining procedures, will result in death; and (9) 'Written informed consent' means a written document that meets the requirements of KRS 217.5404. Effective: June 29, 2017 History: Created 2017 Ky. Acts ch. 65, sec. 1, effective June 29, 2017.
Kentucky Legal Code