81R3595 YDB-D
By: Zerwas H.B. No. 2029
A BILL TO BE ENTITLED
AN ACT
relating to the establishment of a laser and intense pulsed light
device registry; providing a civil penalty.
BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS:
SECTION 1. Chapter 401, Health and Safety Code, is amended
by adding Subchapter M to read as follows:
SUBCHAPTER M. LASER OR SIMILAR MEDICAL DEVICE REGISTRY
Sec. 401.501. DEFINITIONS. In this subchapter:
(1) "Laser or similar medical device" means a laser or
intense pulsed light device defined as a prescription device under
21 C.F.R. Section 801.109 and approved by the United States Food and
Drug Administration for use in general and plastic surgery and
dermatology, including hair removal.
(2) "Practitioner" has the meaning assigned by Section
483.001.
Sec. 401.502. RESTRICTED POSSESSION OF LASER OR SIMILAR
MEDICAL DEVICE. A person may not purchase or possess a laser or
similar medical device unless the person is a practitioner who,
under the practitioner's prescriptive authority in this state, may
use a laser or similar medical device in the provision of medical,
dental, podiatric, optometric, or veterinary care.
Sec. 401.503. NOTIFICATION OF POSSESSION OF LASER OR
SIMILAR MEDICAL DEVICE. (a) A practitioner who purchases or takes
possession of a laser or similar medical device shall notify the
department not later than the seventh day after the date the
practitioner takes possession of the laser or device.
(b) The notification required under Subsection (a) must be
on the form prescribed by the department and must include:
(1) the name, address, and telephone number of the
practitioner who took possession of the laser or similar medical
device and the date the practitioner took possession of the laser or
device;
(2) the type of laser or device;
(3) the address of the premises where the laser or
device is used; and
(4) the name of each practitioner who uses the laser or
device.
(c) A practitioner who has possession of a laser or similar
medical device shall notify the department of any change in the
information provided to the department under Subsection (b) not
later than the seventh day after the date of the change.
Sec. 401.504. ESTABLISHMENT OF REGISTRY. The department
shall establish a central registry of laser or similar medical
devices and include in the registry the information submitted to
the department under Section 401.503.
Sec. 401.505. INSPECTION; RECORDS. (a) The department may
exercise the general inspection authority granted to the department
under Section 401.063 to determine whether a person is complying
with this chapter and department rules.
(b) A practitioner required to submit notification under
Section 401.503 shall retain a copy of all maintenance records and
records relating to the use, receipt, storage, transfer, or
disposal of the laser or similar medical device as provided by
department rules.
Sec. 401.506. RULES. The executive commissioner of the
Health and Human Services Commission shall adopt rules necessary to
implement this subchapter, including rules on inspections and on
maintenance of records.
Sec. 401.507. CIVIL PENALTY. (a) A person who violates
this subchapter or any rule adopted under this subchapter is liable
to this state for a civil penalty of $1,000 for each violation.
Each day a violation continues constitutes a separate violation.
(b) The amount of the penalty shall be based on:
(1) the seriousness of the violation;
(2) the history of previous violations;
(3) the amount necessary to deter a future violation;
and
(4) any other matter that justice may require.
(c) The department or the attorney general may sue to
collect a civil penalty under this section. In the suit the state
may recover the reasonable expenses incurred in obtaining the
penalty, including investigation and court costs, reasonable
attorney's fees, witness fees, and other expenses.
SECTION 2. (a) Not later than November 1, 2009, the
executive commissioner of the Health and Human Services Commission
shall adopt the rules required by Subchapter M, Chapter 401, Health
and Safety Code, as added by this Act.
(b) Not later than December 31, 2009, the Department of
State Health Services shall prescribe the form required under
Section 401.503, Health and Safety Code, as added by this Act, and
establish the registry required by Section 401.504, Health and
Safety Code, as added by this Act.
SECTION 3. Notwithstanding Subchapter M, Chapter 401,
Health and Safety Code, as added by this Act, a practitioner is not
required to submit the notification required by Section 401.503,
Health and Safety Code, as added by this Act, before January 1,
2010.
SECTION 4. This Act takes effect September 1, 2009.