217.5401 Definitions for KRS 217.5401 to 217.5408.
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/ky/chapter-217/217-5401A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
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 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;
(2)"Device" has the same meaning as in KRS 217.015;
(3)"Drug" has 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 assistant;
(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 United States Food and Drug
Administration-approved clinical trial;
(8)"Terminal illness" means a progressive disease or a medical or surgical 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.