SECTION 198.2. Definitions

(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