58-17-100.   Definitions. Terms used in §§ 58-17-100 to 58-17-106, inclusive, mean:

             (1)      "FDA," the federal Food and Drug Administration;

             (2)      "Health insurer," any person who provides health insurance in this state. The term includes a licensed insurance company, a prepaid hospital or medical service plan, a health maintenance organization, a multiple employer welfare arrangement, or any person providing a plan of health insurance subject to state insurance regulation;

             (3)      "Life threatening," either or both of the following:

             (a)      A disease or condition where the likelihood of death is high, unless the course of the disease is interrupted; or

             (b)      A disease or condition with potentially fatal outcomes where the end point of clinical intervention is survival;

             (4)      "Medical literature," a published scientific study in a journal or other publication in which original manuscripts have been published only after critical review for scientific accuracy, validity, and reliability by unbiased independent experts and a determination by the International Committee of Medical Journal Editors that it meets the Uniform Requirements for Manuscripts submitted to biomedical journals. The term, medical literature, does not include a publication or a supplement to a publication that is sponsored to a significant extent by a pharmaceutical manufacturing company or health carrier;

             (5)      "Standard reference compendia," one of the following:

             (a)      The United States Pharmacopeia Drug Information;

             (b)      DRUGDEX; or

             (c)      The American Hospital Formulary Service Drug Information;

             (6)      "Off-label," the use of an FDA approved drug for an indication that is not included in the approved labeling;

             (7)      "Drug," any substance prescribed by a licensed health care provider acting within the scope of the provider's license and that is intended for use in the diagnosis, mitigation, treatment, or prevention of disease and is taken by mouth; injected into a muscle, the skin, a blood vessel, or cavity of the body; applied to the skin; or otherwise assimilated by the body. The term, drug, includes only those substances that are approved by the FDA for at least one indication.

Source: SL 2000, ch 242, § 1.

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