P.R. Laws tit. 26, § 9983
(a) Standard reference compendia.— Means:
(1) The American Hospital Formulary Service-Drug Information;
(2) The American Medical Association Drug Evaluation; or
(3) The United States Pharmacopoeia-Drug Information.
(b) FDA.— Means the United States Food and Drug Administration.
(c) Peer-reviewed medical literature.— Means a published scientific study in a journal or other publication in which original manuscripts have been published only after having been critically reviewed by unbiased independent experts, and that has been determined by the International Committee of Medical Journal Editors to have met the Uniform Requirements for Manuscripts submitted to biomedical journals. Peer-reviewed medical literature does not include publications or supplements to publications that are sponsored to a significant extent by a pharmaceutical manufacturing company or a health insurance organization or issuer.
(d) Drug or Drugs.— Means any substance prescribed by a licensed healthcare provider 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.
History —Aug. 29, 2011, No. 194, added as § 52.030 on Aug. 23, 2012, No. 203, § 8, eff. 90 days after Aug. 23, 2012.