86R10694 SCL-D
By: Bettencourt S.B. No. 1765
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 1003.055(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 [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 3. 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 a stem cell treatment authorized under
this subchapter unless the treatment uses a drug that is considered
adulterated or misbranded under Chapter 431. For purposes of this
subsection, a governmental entity may not consider the drug to be
adulterated or misbranded solely on the basis that the United
States Food and Drug Administration has not approved the drug.
SECTION 4. 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) 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 5. This Act takes effect September 1, 2019.