As used in KRS 217.5401 to 217.5408:

1. (1)
2. (2)
3. (3)
4. (4)
5. (5)
6. (6)
7. (7)

8. (8) "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 product, 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; "Device" has the same meaning as in KRS 217.015; "Drug" has the same meaning as in KRS 217.015; "Eligible patient" means an individual who meets the requirements of KRS 217.5403; "Health care provider" means a licensed physician, a licensed advanced practice registered nurse, or a licensed physician assistant; "Health facility" has the same meaning as in KRS 216B.015; "Investigational drug, biological product, or device" means a drug, biological product, or device that:

   1. (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
   2. (b) Remains under investigation in a United States Food and Drug Administration-approved clinical trial; "Terminal illness" means a progressive disease or a medical or surgical condition that:
   3. (a) Entails significant functional impairment;
   4. (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
9. (9)
10. (c) Without life-sustaining procedures, will result in death; and "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.