(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).

Source Note: The provisions of this §198.2 adopted to be effective July 8, 2012, 37 TexReg 4929; amended to be effective July 19, 2018, 43 TexReg 4754