§ 27-55-1. Definitions.
For the purpose of this chapter, the following words and terms have the following
meanings:
(1) "Drug� or "drugs� means any substance prescribed by a licensed healthcare provider
acting within the scope of the provider's license that is intended for use in the
diagnosis, mitigation, treatment, or prevention of disease that 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 includes only those substances
that are approved by the FDA for at least one indication.
(2) "FDA� means the federal Food and Drug Administration.
(3) "Health insurer� means all persons, firms, corporations, or other organizations offering
and assuring health services on a prepaid or primarily expense-incurred basis including,
but not limited to, policies of accident or sickness insurance, as defined in chapter
18 of this title, nonprofit hospital or medical service plans, whether organized under
chapter 19 or 20 of this title or under any public law or by special act of the general
assembly, health maintenance organizations, and any other entity that insures or reimburses
for diagnostic, therapeutic, or preventive services to a determined population on
the basis of a periodic premium.
(4) "Medical literature� means published scientific studies published in at least two
(2) articles from major peer-reviewed medical journals that present data supporting
the proposed off-label use, or uses, as generally safe and effective unless there
is clear and convincing contradictory evidence presented in a major peer-reviewed
medical journal.
(5) "Peer-reviewed medical journals� means a published study in a journal or other publication
in which original manuscripts have been critically reviewed for scientific accuracy,
validity, and reliability by unbiased independent experts, and that has been determined
by the International Committee of Medical Journal Editors to have met its Uniform
Requirements for Manuscripts Submitted to Biomedical Journals. It does not include
publications or supplements to publications that are sponsored to a significant extent
by a pharmaceutical manufacturing company or any health insurer, healthcare center,
hospital service corporation, medical service corporation, or fraternal benefit society
that delivers, issues for delivery, renews, amends, or continues a health insurance
policy in this state.
(6) "Standard reference compendia� means: (i) The United States Pharmacopoeia drug information,
(ii) The American Medical Association drug evaluations, or (iii) The American Hospital
Formulary Service drug information.