Off-label Uses of Prescription Drugs

SECTION 27-55-1

§ 27-55-1 Definitions. [Effective until January 1, 2017.].

For the purpose of this chapter, the following words and terms have the following meanings:

(1) "FDA" means the Federal Food and Drug Administration;

(2) "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, which insures or reimburses for diagnostic, therapeutic or preventive services to a determined population on the basis of a periodic premium;

(3) "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;

(4) "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;

(5) "Drug" means the primary anti-cancer or antineoplastic agent or agents.

History of Section.
(P.L. 1994, ch. 339, § 1.)