(a) The purpose of this chapter is to recognize that physicians should be allowed a reasonable and responsible degree of latitude in the kinds of therapies they offer their patients. The Board has determined that use of investigational agents constitutes the practice of medicine and is thus subject to all applicable statutory and regulatory provisions of the Medical Practice Act and Board Rules unless otherwise specifically stated. Section 198.4 of this chapter (relating to Use of Investigational Drugs, Biological Products, or Devices for Patients with Terminal Illnesses) sets forth specific requirements applicable only to terminal patients being treated with investigational drugs, biological products or devices.
(b) Subchapter B of this title (relating to Investigational Stem Cell Treatments for Patients with Certain Severe Chronic Diseases or Terminal Illnesses) sets forth separate requirements applicable only to the use of investigational stem cell treatments.

Source Note: The provisions of this §198.1 adopted to be effective July 8, 2012, 37 TexReg 4929; amended to be effective March 15, 2016, 41 TexReg 1840; amended to be effective July 19, 2018, 43 TexReg 4754