Texas Administrative Code
Title 22 - EXAMINING BOARDS
Part 9 - TEXAS MEDICAL BOARD
Chapter 198 - STANDARDS FOR USE OF INVESTIGATIONAL AGENTS
Subchapter A - STANDARDS FOR USE OF INVESTIGATIONAL DRUGS, BIOLOGICAL PRODUCTS, OR DEVICES
Section 198.2 - Definitions
Universal Citation: 22 TX Admin Code ยง 198.2
Current through Reg. 49, No. 38; September 20, 2024
(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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