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A BILL TO BE ENTITLED
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AN ACT
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relating to the establishment of a laser and intense pulsed light |
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device registry; providing a civil penalty. |
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BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS: |
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SECTION 1. Chapter 401, Health and Safety Code, is amended |
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by adding Subchapter M to read as follows: |
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SUBCHAPTER M. LASER OR SIMILAR MEDICAL DEVICE REGISTRY |
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Sec. 401.501. DEFINITIONS. In this subchapter: |
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(1) "Laser or similar medical device" means a laser or |
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intense pulsed light device defined as a prescription device under |
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21 C.F.R. Section 801.109 and approved by the United States Food and |
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Drug Administration for use in general and plastic surgery and |
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dermatology, including hair removal. |
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(2) "Practitioner" has the meaning assigned by Section |
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483.001. |
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Sec. 401.502. RESTRICTED POSSESSION OF LASER OR SIMILAR |
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MEDICAL DEVICE. A person may not purchase or possess a laser or |
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similar medical device unless the person is a practitioner who, |
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under the practitioner's prescriptive authority in this state, may |
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use a laser or similar medical device in the provision of medical, |
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dental, podiatric, optometric, or veterinary care. |
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Sec. 401.503. NOTIFICATION OF POSSESSION OF LASER OR |
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SIMILAR MEDICAL DEVICE. (a) A practitioner who purchases or takes |
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possession of a laser or similar medical device shall notify the |
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department not later than the seventh day after the date the |
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practitioner takes possession of the laser or device. |
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(b) The notification required under Subsection (a) must be |
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on the form prescribed by the department and must include: |
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(1) the name, address, and telephone number of the |
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practitioner who took possession of the laser or similar medical |
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device and the date the practitioner took possession of the laser or |
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device; |
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(2) the type of laser or device; |
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(3) the address of the premises where the laser or |
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device is used; and |
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(4) the name of each practitioner who uses the laser or |
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device. |
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(c) A practitioner who has possession of a laser or similar |
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medical device shall notify the department of any change in the |
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information provided to the department under Subsection (b) not |
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later than the seventh day after the date of the change. |
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Sec. 401.504. ESTABLISHMENT OF REGISTRY. The department |
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shall establish a central registry of laser or similar medical |
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devices and include in the registry the information submitted to |
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the department under Section 401.503. |
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Sec. 401.505. INSPECTION; RECORDS. (a) The department may |
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exercise the general inspection authority granted to the department |
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under Section 401.063 to determine whether a person is complying |
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with this chapter and department rules. |
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(b) A practitioner required to submit notification under |
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Section 401.503 shall retain a copy of all maintenance records and |
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records relating to the use, receipt, storage, transfer, or |
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disposal of the laser or similar medical device as provided by |
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department rules. |
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Sec. 401.506. RULES. The executive commissioner of the |
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Health and Human Services Commission shall adopt rules necessary to |
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implement this subchapter, including rules on inspections and on |
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maintenance of records. |
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Sec. 401.507. CIVIL PENALTY. (a) A person who violates |
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this subchapter or any rule adopted under this subchapter is liable |
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to this state for a civil penalty of $1,000 for each violation. |
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Each day a violation continues constitutes a separate violation. |
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(b) The amount of the penalty shall be based on: |
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(1) the seriousness of the violation; |
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(2) the history of previous violations; |
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(3) the amount necessary to deter a future violation; |
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and |
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(4) any other matter that justice may require. |
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(c) The department or the attorney general may sue to |
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collect a civil penalty under this section. In the suit the state |
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may recover the reasonable expenses incurred in obtaining the |
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penalty, including investigation and court costs, reasonable |
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attorney's fees, witness fees, and other expenses. |
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SECTION 2. (a) Not later than November 1, 2009, the |
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executive commissioner of the Health and Human Services Commission |
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shall adopt the rules required by Subchapter M, Chapter 401, Health |
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and Safety Code, as added by this Act. |
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(b) Not later than December 31, 2009, the Department of |
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State Health Services shall prescribe the form required under |
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Section 401.503, Health and Safety Code, as added by this Act, and |
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establish the registry required by Section 401.504, Health and |
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Safety Code, as added by this Act. |
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SECTION 3. Notwithstanding Subchapter M, Chapter 401, |
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Health and Safety Code, as added by this Act, a practitioner is not |
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required to submit the notification required by Section 401.503, |
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Health and Safety Code, as added by this Act, before January 1, |
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2010. |
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SECTION 4. This Act takes effect September 1, 2009. |