86R21292 SCL-D
 
  By: Parker, Springer, Zerwas, Lucio III H.B. No. 3148
 
  Substitute the following for H.B. No. 3148:
 
  By:  Zedler C.S.H.B. No. 3148
 
 
 
A BILL TO BE ENTITLED
 
AN ACT
  relating to the administration and oversight of investigational
  adult stem cell treatments administered to certain patients.
         BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS:
         SECTION 1.  Subchapter B, Chapter 1003, Health and Safety
  Code, is amended by adding Section 1003.0525 to read as follows:
         Sec. 1003.0525.  ADMINISTRATION OF SUBCHAPTER. The
  department shall administer this subchapter.
         SECTION 2.  Section 1003.054(c), Health and Safety Code, is
  amended to read as follows:
         (c)  The executive commissioner by rule shall [may] adopt a
  form for the informed consent under this section. The form must
  provide notice that the department administers this subchapter.
         SECTION 3.  Section 1003.055(d), Health and Safety Code, is
  amended to read as follows:
         (d)  An institutional review board that oversees
  investigational stem cell treatments administered under this
  subchapter must meet one of the following conditions [be affiliated
  with]:
               (1)  be affiliated with a medical school, as defined by
  Section 61.501, Education Code; [or]
               (2)  be affiliated with a hospital licensed under
  Chapter 241 that has at least 150 beds;
               (3)  be accredited by the Association for the
  Accreditation of Human Research Protection Programs;
               (4)  be registered by the United States Department of
  Health and Human Services, Office for Human Research Protections,
  in accordance with 21 C.F.R. Part 56; or
               (5)  be accredited by a national accreditation
  organization acceptable to the department.
         SECTION 4.  Section 1003.058(b), Health and Safety Code, is
  amended to read as follows:
         (b)  A governmental entity or an officer, employee, or agent
  of a governmental entity may not interfere with an eligible
  patient's access to or use of an investigational [a] stem cell
  treatment authorized under this subchapter unless the treatment
  uses an adult stem cell product that is considered an adulterated or
  misbranded drug under Chapter 431. For purposes of this
  subsection, a governmental entity may not consider the adult stem
  cell product to be an adulterated or misbranded drug solely on the
  basis that the United States Food and Drug Administration has not
  approved the adult stem cell product.
         SECTION 5.  Subchapter B, Chapter 1003, Health and Safety
  Code, is amended by adding Section 1003.060 to read as follows:
         Sec. 1003.060.  CONSTRUCTION OF SUBCHAPTER. This subchapter
  may not be construed to:
               (1)  prohibit a physician from using adult stem cells
  for their intended homologous use if the stem cells are:
                     (A)  produced by a manufacturer registered by the
  United States Food and Drug Administration; and
                     (B)  commercially available; or
               (2)  require an institutional review board to oversee
  treatment using adult stem cells registered by the United States
  Food and Drug Administration for their intended homologous use.
         SECTION 6.  This Act takes effect September 1, 2019.