Texas 2009 - 81st Regular

Texas House Bill HB2029 Compare Versions

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

Old	New	Differences
1	1	81R3595 YDB-D
2	2	By: Zerwas H.B. No. 2029
3	3
4	4
5	5	A BILL TO BE ENTITLED
6	6	AN ACT
7	7	relating to the establishment of a laser and intense pulsed light
8	8	device registry; providing a civil penalty.
9	9	BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS:
10	10	SECTION 1. Chapter 401, Health and Safety Code, is amended
11	11	by adding Subchapter M to read as follows:
12	12	SUBCHAPTER M. LASER OR SIMILAR MEDICAL DEVICE REGISTRY
13	13	Sec. 401.501. DEFINITIONS. In this subchapter:
14	14	(1) "Laser or similar medical device" means a laser or
15	15	intense pulsed light device defined as a prescription device under
16	16	21 C.F.R. Section 801.109 and approved by the United States Food and
17	17	Drug Administration for use in general and plastic surgery and
18	18	dermatology, including hair removal.
19	19	(2) "Practitioner" has the meaning assigned by Section
20	20	483.001.
21	21	Sec. 401.502. RESTRICTED POSSESSION OF LASER OR SIMILAR
22	22	MEDICAL DEVICE. A person may not purchase or possess a laser or
23	23	similar medical device unless the person is a practitioner who,
24	24	under the practitioner's prescriptive authority in this state, may
25	25	use a laser or similar medical device in the provision of medical,
26	26	dental, podiatric, optometric, or veterinary care.
27	27	Sec. 401.503. NOTIFICATION OF POSSESSION OF LASER OR
28	28	SIMILAR MEDICAL DEVICE. (a) A practitioner who purchases or takes
29	29	possession of a laser or similar medical device shall notify the
30	30	department not later than the seventh day after the date the
31	31	practitioner takes possession of the laser or device.
32	32	(b) The notification required under Subsection (a) must be
33	33	on the form prescribed by the department and must include:
34	34	(1) the name, address, and telephone number of the
35	35	practitioner who took possession of the laser or similar medical
36	36	device and the date the practitioner took possession of the laser or
37	37	device;
38	38	(2) the type of laser or device;
39	39	(3) the address of the premises where the laser or
40	40	device is used; and
41	41	(4) the name of each practitioner who uses the laser or
42	42	device.
43	43	(c) A practitioner who has possession of a laser or similar
44	44	medical device shall notify the department of any change in the
45	45	information provided to the department under Subsection (b) not
46	46	later than the seventh day after the date of the change.
47	47	Sec. 401.504. ESTABLISHMENT OF REGISTRY. The department
48	48	shall establish a central registry of laser or similar medical
49	49	devices and include in the registry the information submitted to
50	50	the department under Section 401.503.
51	51	Sec. 401.505. INSPECTION; RECORDS. (a) The department may
52	52	exercise the general inspection authority granted to the department
53	53	under Section 401.063 to determine whether a person is complying
54	54	with this chapter and department rules.
55	55	(b) A practitioner required to submit notification under
56	56	Section 401.503 shall retain a copy of all maintenance records and
57	57	records relating to the use, receipt, storage, transfer, or
58	58	disposal of the laser or similar medical device as provided by
59	59	department rules.
60	60	Sec. 401.506. RULES. The executive commissioner of the
61	61	Health and Human Services Commission shall adopt rules necessary to
62	62	implement this subchapter, including rules on inspections and on
63	63	maintenance of records.
64	64	Sec. 401.507. CIVIL PENALTY. (a) A person who violates
65	65	this subchapter or any rule adopted under this subchapter is liable
66	66	to this state for a civil penalty of $1,000 for each violation.
67	67	Each day a violation continues constitutes a separate violation.
68	68	(b) The amount of the penalty shall be based on:
69	69	(1) the seriousness of the violation;
70	70	(2) the history of previous violations;
71	71	(3) the amount necessary to deter a future violation;
72	72	and
73	73	(4) any other matter that justice may require.
74	74	(c) The department or the attorney general may sue to
75	75	collect a civil penalty under this section. In the suit the state
76	76	may recover the reasonable expenses incurred in obtaining the
77	77	penalty, including investigation and court costs, reasonable
78	78	attorney's fees, witness fees, and other expenses.
79	79	SECTION 2. (a) Not later than November 1, 2009, the
80	80	executive commissioner of the Health and Human Services Commission
81	81	shall adopt the rules required by Subchapter M, Chapter 401, Health
82	82	and Safety Code, as added by this Act.
83	83	(b) Not later than December 31, 2009, the Department of
84	84	State Health Services shall prescribe the form required under
85	85	Section 401.503, Health and Safety Code, as added by this Act, and
86	86	establish the registry required by Section 401.504, Health and
87	87	Safety Code, as added by this Act.
88	88	SECTION 3. Notwithstanding Subchapter M, Chapter 401,
89	89	Health and Safety Code, as added by this Act, a practitioner is not
90	90	required to submit the notification required by Section 401.503,
91	91	Health and Safety Code, as added by this Act, before January 1,
92	92	2010.
93	93	SECTION 4. This Act takes effect September 1, 2009.