Investigational drugs, biological products, or devices which meet the criteria enumerated in §198.2, of this title (relating to Definitions) and have successfully completed phase one of a clinical trial and remain under investigation in the clinical trial shall be administered and provided to patients with terminal illnesses in accordance with applicable law, including Chapter 489 of the Texas Health and Safety Code.

Source Note: The provisions of this §198.4 adopted to be effective March 15, 2016, 41 TexReg 1840; amended to be effective July 19, 2018, 43 TexReg 4754