Bill Text: TX HB3148 | 2019-2020 | 86th Legislature | Enrolled
Bill Title: Relating to the administration and oversight of investigational adult stem cell treatments administered to certain patients.
Spectrum: Slight Partisan Bill (Republican 5-3)
Status: (Passed) 2019-06-14 - Effective on 9/1/19 [HB3148 Detail]
Download: Texas-2019-HB3148-Enrolled.html
H.B. No. 3148 |
|
||
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 Sections 1003.0525 and 1003.0526 to read | ||
as follows: | ||
Sec. 1003.0525. ADMINISTRATION OF SUBCHAPTER. The | ||
department shall administer this subchapter. | ||
Sec. 1003.0526. INVESTIGATIONAL STEM CELL REGISTRY. The | ||
department shall establish and maintain an investigational stem | ||
cell registry that lists each physician who administers an | ||
investigational stem cell treatment under 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 [ |
||
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 [ |
||
|
||
(1) be affiliated with a medical school, as defined by | ||
Section 61.501, Education Code; [ |
||
(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 Texas Medical Board. | ||
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 [ |
||
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. The Department of State Health Services may not | ||
establish the investigational stem cell registry described by | ||
Section 1003.0526, Health and Safety Code, as added by this Act, | ||
until September 1, 2027. | ||
SECTION 7. This Act takes effect September 1, 2019. | ||
______________________________ | ______________________________ | |
President of the Senate | Speaker of the House | |
I certify that H.B. No. 3148 was passed by the House on May 9, | ||
2019, by the following vote: Yeas 141, Nays 0, 2 present, not | ||
voting; that the House refused to concur in Senate amendments to | ||
H.B. No. 3148 on May 23, 2019, and requested the appointment of a | ||
conference committee to consider the differences between the two | ||
houses; and that the House adopted the conference committee report | ||
on H.B. No. 3148 on May 26, 2019, by the following vote: Yeas 141, | ||
Nays 0, 3 present, not voting. | ||
______________________________ | ||
Chief Clerk of the House | ||
I certify that H.B. No. 3148 was passed by the Senate, with | ||
amendments, on May 21, 2019, by the following vote: Yeas 31, Nays | ||
0; at the request of the House, the Senate appointed a conference | ||
committee to consider the differences between the two houses; and | ||
that the Senate adopted the conference committee report on H.B. No. | ||
3148 on May 26, 2019, by the following vote: Yeas 31, Nays 0. | ||
______________________________ | ||
Secretary of the Senate | ||
APPROVED: __________________ | ||
Date | ||
__________________ | ||
Governor |