| (a) The following words and terms, when used in this
section, shall have the following meanings, unless the context clearly
indicates otherwise.
(1) Investigational drug, biological product, or device--A
drug, biological product, or device that is not approved or licensed
by the Food and Drug Administration (FDA) for use in humans and remains
under investigation in a clinical trial. Investigational drugs, biological
products, and devices may be used for the purposes of prevention,
treatment, diagnosis or for relieving symptoms of a disease. An investigational
drug, biological product or device shall not include:
(A) a drug, biological product, device, diagnostic
product or treatment regimen approved by the FDA, but used for off-label
purposes;
(B) a drug, biological product, device, diagnostic
product or treatment regimen which is already approved for use by
an existing Institutional Review Board (IRB);
(C) products processed or manufactured as human cell,
tissue or cellular-or-tissue-based product ("HCT/P") pursuant to Sections
351 and 361 of the Public Health Service Act ("PHSA") (42 U.S.C. 264);
or
(D) a drug, device or biological product pursuant to
the federal Food Drug and Cosmetic Act (FDCA).
(2) Terminal illness--An advanced stage of a disease
with an unfavorable prognosis that, without life-sustaining procedures,
will soon result in death or a state of permanent unconsciousness
from which recovery is unlikely.
(b) These definitions do not apply to Subchapter B
of this title (relating to Investigational Stem Cell Treatments for
Patients with Certain Severe Chronic Diseases or Terminal Illnesses).
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