Texas 2025 - 89th Regular

Texas House Bill HB5147 Compare Versions

Only one version of the bill is available at this time.

Old	New	Differences
1	1	89R12486 MCF-F
2	2	By: King H.B. No. 5147
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7	7	A BILL TO BE ENTITLED
8	8	AN ACT
9	9	relating to investigational stem cell treatment.
10	10	BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS:
11	11	SECTION 1. Section 1003.051(1), Health and Safety Code, is
12	12	amended to read as follows:
13	13	(1) "Investigational stem cell treatment" means an
14	14	adult stem cell treatment that:
15	15	(A) is under investigation in a clinical trial
16	16	and being administered to human participants in that trial; [and]
17	17	(B) has not yet been approved for general use by
18	18	the United States Food and Drug Administration; and
19	19	(C) uses only adult stem cells that satisfy
20	20	current good manufacturing practices adopted by the United States
21	21	Food and Drug Administration.
22	22	SECTION 2. Section 1003.054(c), Health and Safety Code, is
23	23	amended to read as follows:
24	24	(c) The executive commissioner by rule shall adopt a form
25	25	for the informed consent under this section. The form must provide
26	26	notice that:
27	27	(1) the department administers this subchapter; and
28	28	(2) the investigational stem cell treatment has not
29	29	been approved for general use by the United States Food and Drug
30	30	Administration.
31	31	SECTION 3. Sections 1003.055(a) and (d), Health and Safety
32	32	Code, are amended to read as follows:
33	33	(a) Treatment provided under this subchapter must be:
34	34	(1) administered directly by a physician certified
35	35	under Subsection (c);
36	36	(2) overseen by an institutional review board
37	37	described by Subsection (d); and
38	38	(3) provided [at]:
39	39	(A) at a hospital licensed under Chapter 241;
40	40	(B) at an ambulatory surgical center licensed
41	41	under Chapter 243; [or]
42	42	(C) at a medical school, as defined by Section
43	43	61.501, Education Code; or
44	44	(D) in an outpatient setting, as defined by
45	45	Section 162.101, Occupations Code, listed by a physician registered
46	46	under Section 162.104, Occupations Code, to provide level II
47	47	anesthesia services in that setting.
48	48	(d) An institutional review board that oversees
49	49	investigational stem cell treatments administered under this
50	50	subchapter must meet one of the following conditions:
51	51	(1) be affiliated with a medical school, as defined by
52	52	Section 61.501, Education Code;
53	53	(2) be affiliated with a hospital licensed under
54	54	Chapter 241 that has at least 150 beds;
55	55	(3) be accredited by the Association for the
56	56	Accreditation of Human Research Protection Programs;
57	57	(4) be registered by the United States Department of
58	58	Health and Human Services, Office for Human Research Protections,
59	59	in accordance with 21 C.F.R. Part 56; [or]
60	60	(5) be accredited by a national accreditation
61	61	organization acceptable to the Texas Medical Board; or
62	62	(6) be registered by the United States Department of
63	63	Health and Human Services, Office for Human Research Protections,
64	64	in accordance with 21 C.F.R. Part 56.
65	65	SECTION 4. Section 1003.059(b), Health and Safety Code, is
66	66	amended to read as follows:
67	67	(b) Each institutional review board overseeing an
68	68	investigational stem cell treatment under this subchapter shall
69	69	submit to the Texas Medical Board an annual report on any serious
70	70	adverse events related to the treatment and [to the Texas Medical
71	71	Board on] the review board's findings based on records kept under
72	72	Subsection (a). The report may not include any patient identifying
73	73	information [and must be made available to the public in both
74	74	written and electronic form].
75	75	SECTION 5. This Act takes effect September 1, 2025.