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AN ACT
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relating to the regulation of controlled substances; providing an |
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administrative penalty. |
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BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS: |
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SECTION 1. Subsection (a), Section 481.064, Health and |
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Safety Code, is amended to read as follows: |
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(a) The director may charge a nonrefundable fee of not more |
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than $25 before processing an application for annual registration |
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and may charge a late fee of not more than $50 for each application |
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for renewal the department receives after the date the registration |
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expires. The director by rule shall set the amounts [amount] of the |
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fees [fee] at the amounts [amount] that are [is] necessary to cover |
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the cost of administering and enforcing this subchapter. Except as |
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provided by Subsection (b), registrants shall pay the fees to the |
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director. Not later than 60 days before the date the registration |
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expires, the director shall send a renewal notice to the registrant |
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at the last known address of the registrant according to department |
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records. |
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SECTION 2. Section 481.074, Health and Safety Code, is |
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amended by amending Subsections (b), (d), and (k) and adding |
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Subsection (q) to read as follows: |
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(b) Except in an emergency as defined by rule of the |
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director or as provided by Subsection (o) or Section 481.075(j) or |
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(m), a person may not dispense or administer a controlled substance |
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listed in Schedule II without the written prescription of a |
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practitioner on an official prescription form that meets the |
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requirements of and is completed by the practitioner in accordance |
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with Section 481.075. In an emergency, a person may dispense or |
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administer a controlled substance listed in Schedule II on the oral |
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or telephonically communicated prescription of a practitioner. The |
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person who administers or dispenses the substance shall: |
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(1) if the person is a prescribing practitioner or a |
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pharmacist, promptly comply with Subsection (c); or |
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(2) if the person is not a prescribing practitioner or |
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a pharmacist, promptly write the oral or telephonically |
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communicated prescription and include in the written record of the |
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prescription the name, address, department registration number, |
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and Federal Drug Enforcement Administration number of the |
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prescribing practitioner, all information required to be provided |
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by a practitioner under Section 481.075(e)(1), and all information |
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required to be provided by a dispensing pharmacist under Section |
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481.075(e)(2). |
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(d) Except as specified in Subsections (e) and (f) [of this
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section], the director, by rule and in consultation with the Texas |
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Medical Board and the Texas State Board of Pharmacy, shall |
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establish the period after the date on which the prescription is |
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issued that a person may [not] fill a prescription for a controlled |
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substance listed in Schedule II [after the end of the seventh day
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after the date on which the prescription is issued]. A person may |
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not refill a prescription for a substance listed in Schedule II. |
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(k) A prescription for a controlled substance must show: |
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(1) the quantity of the substance prescribed: |
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(A) numerically, followed by the number written |
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as a word, if the prescription is written; or |
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(B) if the prescription is communicated orally or |
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telephonically, as transcribed by the receiving pharmacist; |
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(2) the date of issue; |
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(3) the name, [and] address, and date of birth or age |
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of the patient or, if the controlled substance is prescribed for an |
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animal, the species of the animal and the name and address of its |
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owner; |
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(4) the name and strength of the controlled substance |
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prescribed; |
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(5) the directions for use of the controlled |
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substance; |
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(6) the intended use of the substance prescribed |
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unless the practitioner determines the furnishing of this |
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information is not in the best interest of the patient; [and] |
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(7) the legibly printed or stamped name, address, |
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Federal Drug Enforcement Administration registration number, and |
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telephone number of the practitioner at the practitioner's usual |
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place of business; |
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(8) if the prescription is handwritten, the signature |
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of the prescribing practitioner; and |
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(9) if the prescribing practitioner is licensed in |
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this state, the practitioner's department registration number. |
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(q) Each dispensing pharmacist shall send all information |
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required by the director, including any information required to |
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complete the Schedule III through V prescription forms, to the |
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director by electronic transfer or another form approved by the |
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director not later than the 15th day after the last day of the month |
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in which the prescription is completely filled. |
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SECTION 3. Subsections (a) and (c), Section 481.076, Health |
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and Safety Code, are amended to read as follows: |
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(a) The director may not permit any person to have access to |
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information submitted to the director under Section 481.074(q) or |
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481.075 except: |
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(1) an investigator for the Texas [State Board of] |
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Medical Board [Examiners], the Texas State Board of Podiatric |
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Medical Examiners, the State Board of Dental Examiners, the State |
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Board of Veterinary Medical Examiners, or the Texas State Board of |
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Pharmacy; |
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(2) an authorized officer or member of the department |
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engaged in the administration, investigation, or enforcement of |
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this chapter or another law governing illicit drugs in this state or |
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another state; or |
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(3) if the director finds that proper need has been |
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shown to the director: |
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(A) a law enforcement or prosecutorial official |
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engaged in the administration, investigation, or enforcement of |
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this chapter or another law governing illicit drugs in this state or |
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another state; |
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(B) a pharmacist or practitioner who is a |
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physician, dentist, veterinarian, [or] podiatrist, or advanced |
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practice nurse or physician assistant described by Section |
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481.002(39)(D) and is inquiring about a [the] recent Schedule II, |
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III, IV, or V prescription history of a particular patient of the |
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practitioner; or |
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(C) a pharmacist or practitioner who is inquiring |
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about the person's own dispensing or prescribing activity. |
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(c) The director by rule shall design and implement a system |
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for submission of information to the director by electronic or |
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other means and for retrieval of information submitted to the |
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director under this section and Sections 481.074 and [Section] |
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481.075. The director shall use automated information security |
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techniques and devices to preclude improper access to the |
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information. The director shall submit the system design to the |
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Texas State Board of Pharmacy and the Texas [State Board of] Medical |
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Board [Examiners] for review and approval or comment a reasonable |
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time before implementation of the system and shall comply with the |
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comments of those agencies unless it is unreasonable to do so. |
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SECTION 4. Subsections (a), (b), (c), and (e), Section |
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481.0761, Health and Safety Code, are amended to read as follows: |
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(a) The director shall consult with the Texas State Board of |
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Pharmacy and by rule establish and revise as necessary a |
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standardized database format that may be used by a pharmacy to |
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transmit the information required by Sections 481.074(q) and |
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[Section] 481.075(i) to the director electronically or to deliver |
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the information on storage media, including disks, tapes, and |
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cassettes. |
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(b) The director shall consult with the [Texas] Department |
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of State Health Services, the Texas State Board of Pharmacy, and the |
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Texas [State Board of] Medical Board [Examiners] and by rule may: |
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(1) remove a controlled substance listed in Schedules |
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[Schedule] II through V from the official prescription program, if |
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the director determines that the burden imposed by the program |
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substantially outweighs the risk of diversion of the particular |
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controlled substance; or |
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(2) return a substance previously removed from |
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Schedules [Schedule] II through V to the official prescription |
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program, if the director determines that the risk of diversion |
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substantially outweighs the burden imposed by the program on the |
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particular controlled substance. |
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(c) The director by rule may: |
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(1) permit more than one prescription to be |
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administered or dispensed and recorded on one [official] |
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prescription form for a Schedule III through V controlled |
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substance; |
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(2) remove from or return to the official prescription |
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program any aspect of a practitioner's or pharmacist's hospital |
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practice, including administering or dispensing; |
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(3) waive or delay any requirement relating to the |
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time or manner of reporting; |
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(4) establish compatibility protocols for electronic |
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data transfer hardware, software, or format; |
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(5) establish a procedure to control the release of |
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information under Sections 481.074, 481.075, and 481.076; and |
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(6) establish a minimum level of prescription activity |
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below which a reporting activity may be modified or deleted. |
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(e) In adopting a rule relating to the electronic transfer |
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of information under this subchapter, the director shall consider |
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the economic impact of the rule on practitioners and pharmacists |
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and, to the extent permitted by law, act to minimize any negative |
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economic impact, including the imposition of costs related to |
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computer hardware or software or to the transfer of information. |
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The director may not adopt a rule relating to the electronic |
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transfer of information under this subchapter that imposes a fee in |
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addition to the fees [fee] authorized by Section 481.064. |
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SECTION 5. Chapter 481, Health and Safety Code, is amended |
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by adding Subchapter H to read as follows: |
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SUBCHAPTER H. ADMINISTRATIVE PENALTY |
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Sec. 481.301. IMPOSITION OF PENALTY. The department may |
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impose an administrative penalty on a person who violates Section |
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481.061, 481.066, 481.067, 481.069, 481.074, 481.075, 481.077, |
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481.0771, 481.078, 481.080, or 481.081 or a rule or order adopted |
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under any of those sections. |
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Sec. 481.302. AMOUNT OF PENALTY. (a) The amount of the |
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penalty may not exceed $1,000 for each violation, and each day a |
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violation continues or occurs is a separate violation for purposes |
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of imposing a penalty. The total amount of the penalty assessed for |
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a violation continuing or occurring on separate days under this |
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subsection may not exceed $20,000. |
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(b) The amount shall be based on: |
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(1) the seriousness of the violation, including the |
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nature, circumstances, extent, and gravity of the violation; |
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(2) the threat to health or safety caused by the |
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violation; |
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(3) the history of previous violations; |
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(4) the amount necessary to deter a future violation; |
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(5) whether the violator demonstrated good faith, |
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including when applicable whether the violator made good faith |
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efforts to correct the violation; and |
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(6) any other matter that justice may require. |
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Sec. 481.303. REPORT AND NOTICE OF VIOLATION AND PENALTY. |
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(a) If the department initially determines that a violation |
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occurred, the department shall give written notice of the report to |
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the person by certified mail, registered mail, personal delivery, |
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or another manner of delivery that records the person's receipt of |
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the notice. |
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(b) The notice must: |
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(1) include a brief summary of the alleged violation; |
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(2) state the amount of the recommended penalty; and |
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(3) inform the person of the person's right to a |
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hearing on the occurrence of the violation, the amount of the |
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penalty, or both. |
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Sec. 481.304. PENALTY TO BE PAID OR INFORMAL HEARING |
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REQUESTED. (a) Before the 21st day after the date the person |
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receives notice under Section 481.303, the person in writing may: |
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(1) accept the determination and recommended penalty; |
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or |
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(2) make a request for an informal hearing held by the |
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department on the occurrence of the violation, the amount of the |
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penalty, or both. |
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(b) At the conclusion of an informal hearing requested under |
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Subsection (a), the department may modify the amount of the |
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recommended penalty. |
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(c) If the person accepts the determination and recommended |
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penalty, including any modification of the amount, or if the person |
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fails to timely respond to the notice, the director by order shall |
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approve the determination and impose the recommended penalty. |
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Sec. 481.305. FORMAL HEARING. (a) The person may request |
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a formal hearing only after participating in an informal hearing. |
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(b) The request must be submitted in writing and received by |
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the department before the 21st day after the date the person is |
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notified of the decision from the informal hearing. |
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(c) If a timely request for a formal hearing is not |
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received, the director by order shall approve the determination |
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from the informal hearing and impose the recommended penalty. |
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(d) If the person timely requests a formal hearing, the |
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director shall refer the matter to the State Office of |
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Administrative Hearings, which shall promptly set a hearing date |
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and give written notice of the time and place of the hearing to the |
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director and to the person. An administrative law judge of the |
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State Office of Administrative Hearings shall conduct the hearing. |
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(e) The administrative law judge shall make findings of fact |
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and conclusions of law and promptly issue to the director a proposal |
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for a decision about the occurrence of the violation and the amount |
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of any proposed penalty. |
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(f) If a penalty is proposed under Subsection (e), the |
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administrative law judge shall include in the proposal for a |
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decision a finding setting out costs, fees, expenses, and |
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reasonable and necessary attorney's fees incurred by the state in |
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bringing the proceeding. The director may adopt the finding and |
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impose the costs, fees, and expenses on the person as part of the |
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final order entered in the proceeding. |
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Sec. 481.306. DECISION. (a) Based on the findings of |
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fact, conclusions of law, and proposal for a decision, the director |
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by order may: |
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(1) find that a violation occurred and impose a |
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penalty; or |
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(2) find that a violation did not occur. |
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(b) The notice of the director's order under Subsection (a) |
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that is sent to the person in the manner provided by Chapter 2001, |
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Government Code, must include a statement of the right of the person |
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to judicial review of the order. |
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Sec. 481.307. OPTIONS FOLLOWING DECISION: PAY OR APPEAL. |
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Before the 31st day after the date the order under Section 481.306 |
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that imposes an administrative penalty becomes final, the person |
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shall: |
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(1) pay the penalty; or |
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(2) file a petition for judicial review of the order |
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contesting the occurrence of the violation, the amount of the |
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penalty, or both. |
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Sec. 481.308. STAY OF ENFORCEMENT OF PENALTY. (a) Within |
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the period prescribed by Section 481.307, a person who files a |
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petition for judicial review may: |
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(1) stay enforcement of the penalty by: |
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(A) paying the penalty to the court for placement |
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in an escrow account; or |
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(B) giving the court a supersedeas bond approved |
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by the court that: |
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(i) is for the amount of the penalty; and |
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(ii) is effective until all judicial review |
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of the order is final; or |
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(2) request the court to stay enforcement of the |
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penalty by: |
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(A) filing with the court a sworn affidavit of |
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the person stating that the person is financially unable to pay the |
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penalty and is financially unable to give the supersedeas bond; and |
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(B) sending a copy of the affidavit to the |
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director by certified mail. |
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(b) Following receipt of a copy of an affidavit under |
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Subsection (a)(2), the director may file with the court, before the |
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sixth day after the date of receipt, a contest to the affidavit. |
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The court shall hold a hearing on the facts alleged in the affidavit |
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as soon as practicable and shall stay the enforcement of the penalty |
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on finding that the alleged facts are true. The person who files an |
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affidavit has the burden of proving that the person is financially |
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unable to pay the penalty or to give a supersedeas bond. |
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Sec. 481.309. COLLECTION OF PENALTY. (a) If the person |
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does not pay the penalty and the enforcement of the penalty is not |
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stayed, the penalty may be collected. |
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(b) The attorney general may sue to collect the penalty. |
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Sec. 481.310. DECISION BY COURT. (a) If the court |
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sustains the finding that a violation occurred, the court may |
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uphold or reduce the amount of the penalty and order the person to |
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pay the full or reduced amount of the penalty. |
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(b) If the court does not sustain the finding that a |
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violation occurred, the court shall order that a penalty is not |
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owed. |
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Sec. 481.311. REMITTANCE OF PENALTY AND INTEREST. (a) If |
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the person paid the penalty and if the amount of the penalty is |
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reduced or the penalty is not upheld by the court, the court shall |
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order, when the court's judgment becomes final, that the |
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appropriate amount plus accrued interest be remitted to the person |
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before the 31st day after the date that the judgment of the court |
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becomes final. |
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(b) The interest accrues at the rate charged on loans to |
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depository institutions by the New York Federal Reserve Bank. |
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(c) The interest shall be paid for the period beginning on |
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the date the penalty is paid and ending on the date the penalty is |
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remitted. |
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Sec. 481.312. RELEASE OF BOND. (a) If the person gave a |
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supersedeas bond and the penalty is not upheld by the court, the |
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court shall order, when the court's judgment becomes final, the |
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release of the bond. |
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(b) If the person gave a supersedeas bond and the amount of |
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the penalty is reduced, the court shall order the release of the |
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bond after the person pays the reduced amount. |
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Sec. 481.313. ADMINISTRATIVE PROCEDURE. A proceeding to |
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impose the penalty is considered to be a contested case under |
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Chapter 2001, Government Code. |
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Sec. 481.314. DISPOSITION OF PENALTY. The department shall |
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send any amount collected as a penalty under this subchapter to the |
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comptroller for deposit to the credit of the general revenue fund. |
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SECTION 6. Chapter 107, Occupations Code, is amended by |
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adding Subchapter E to read as follows: |
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SUBCHAPTER E. PAIN TREATMENT REVIEW COMMITTEE |
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Sec. 107.201. PAIN TREATMENT REVIEW COMMITTEE. (a) The |
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following individuals shall be appointed as a review committee on |
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pain treatment: |
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(1) the attorney general or the attorney general's |
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designee; |
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(2) a physician who practices at a public hospital in |
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this state; |
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(3) a physician who practices at a private hospital in |
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this state; |
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(4) a physician who practices in this state as a |
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psychiatrist specializing in the treatment of addictive diseases; |
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(5) a probate court judge licensed to practice law in |
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this state; |
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(6) a member of the governing board of the American |
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Cancer Society, Texas Division, or the member's designee; |
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(7) a member of the governing board of the Texas |
|
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Medical Association or the member's designee; |
|
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(8) a member of the governing board of the Texas Nurses |
|
|
Association or the member's designee; |
|
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(9) an officer of a public hospital in this state who |
|
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is a member of the governing board of the Texas Hospital Association |
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or the member's designee; |
|
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(10) an officer of a private hospital in this state who |
|
|
is a member of the governing board of the Texas Hospital Association |
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or the member's designee; and |
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(11) a public member who is a resident of this state. |
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(b) The lieutenant governor and the speaker of the house of |
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representatives shall each appoint five of the members described by |
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Subsections (a)(2) through (11). |
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(c) The following individuals serve on the committee as |
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nonvoting resource members and are appointed by the executive |
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director of the agency the member represents: |
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(1) a pharmacist member of the Texas State Board of |
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Pharmacy; |
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(2) a physician member of the Texas Medical Board; |
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(3) a nurse member of the Board of Nurse Examiners; |
|
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(4) a representative of the Department of Aging and |
|
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Disability Services; and |
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(5) a representative of the narcotics regulatory |
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programs of the Department of Public Safety. |
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(d) The committee shall study the relevant provisions in the |
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laws of this state that relate to the administration of |
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prescription medication, controlled substances, and the needs of |
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patients for effective pain control and management. The committee |
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shall examine how the following statutes affect public health |
|
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needs, the professional medical community, and persons affected by |
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acute, chronic, or end-of-life pain: |
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(1) this chapter; |
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(2) Subtitles B, E, I, and J of this title; and |
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(3) Chapter 481, Health and Safety Code. |
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|
(e) The committee shall meet at least once every three |
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months. |
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(f) Not later than September 1, 2008, the committee shall |
|
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report any changes recommended to the statutes examined under |
|
|
Subsection (d) to the lieutenant governor, the speaker of the house |
|
|
of representatives, and the appropriate standing committees in the |
|
|
senate and the house of representatives that have jurisdiction over |
|
|
the issues studied by the committee. |
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|
(g) This section expires July 1, 2009. |
|
|
SECTION 7. (a) An advisory committee is created to advise |
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the Department of Public Safety of the State of Texas on the |
|
|
implementation of this Act. |
|
|
(b) The advisory committee is composed of: |
|
|
(1) the public safety director of the Department of |
|
|
Public Safety of the State of Texas or the director's designee; |
|
|
(2) a physician appointed by the governor; |
|
|
(3) a pharmacist appointed by the governor; |
|
|
(4) a physician appointed by the lieutenant governor; |
|
|
(5) a pharmacist appointed by the lieutenant governor; |
|
|
(6) a physician appointed by the governor from a list |
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of names submitted by the speaker of the house of representatives; |
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|
(7) a pharmacist appointed by the governor from a list |
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|
of names submitted by the speaker of the house of representatives; |
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|
and |
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|
(8) one member from each of the following boards: |
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|
(A) Texas Medical Board; |
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|
(B) Texas State Board of Pharmacy; |
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|
(C) State Board of Dental Examiners; and |
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|
(D) Board of Nurse Examiners. |
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|
(c) The public safety director or the director's designee is |
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|
the presiding officer of the advisory committee. The committee |
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|
shall meet at the call of the presiding officer or at the request of |
|
|
any three members other than the presiding officer. |
|
|
(d) The advisory committee shall: |
|
|
(1) develop recommendations regarding the improvement |
|
|
of the official prescription program established by Section |
|
|
481.075, Health and Safety Code; |
|
|
(2) develop recommendations regarding the |
|
|
implementation of an electronic controlled substance monitoring |
|
|
system that would be used for prescriptions of controlled |
|
|
substances listed in Schedules II through V as established under |
|
|
Subchapter B, Chapter 481, Health and Safety Code; |
|
|
(3) develop recommendations as to which data should be |
|
|
provided to the Department of Public Safety of the State of Texas to |
|
|
support a controlled substance monitoring system recommended under |
|
|
Subdivision (2) of this subsection, including provider |
|
|
identification information; |
|
|
(4) monitor and develop recommendations regarding the |
|
|
implementation and enforcement of a controlled substance |
|
|
monitoring system recommended under Subdivision (2) of this |
|
|
subsection; |
|
|
(5) develop recommended procedures necessary for |
|
|
real-time point-of-service access for a practitioner authorized to |
|
|
prescribe or dispense controlled substances listed in Schedules II |
|
|
through V so that the practitioner may obtain: |
|
|
(A) the prescription history for a particular |
|
|
patient; or |
|
|
(B) the practitioner's own dispensing or |
|
|
prescribing activity; and |
|
|
(6) develop recommended procedures that should be |
|
|
followed by the Department of Public Safety of the State of Texas |
|
|
and the applicable licensing authority of this state, another |
|
|
state, or the United States when: |
|
|
(A) the department shares information related to |
|
|
diversion of controlled substances with a licensing authority for |
|
|
the purpose of licensing enforcement; or |
|
|
(B) a licensing authority shares information |
|
|
related to diversion of controlled substances with the department |
|
|
for the purpose of criminal enforcement. |
|
|
(e) The public safety director shall report the |
|
|
recommendations developed under Subsection (d) of this section to |
|
|
the governor, lieutenant governor, speaker of the house of |
|
|
representatives, and appropriate committees of the senate and the |
|
|
house not later than July 1, 2008. |
|
|
(f) This section expires and the advisory committee is |
|
|
abolished on September 1, 2009. |
|
|
SECTION 8. (a) The Department of Public Safety of the |
|
|
State of Texas, Texas Medical Board, Texas State Board of Pharmacy, |
|
|
State Board of Dental Examiners, and Board of Nurse Examiners shall |
|
|
submit to the presiding officers of the Senate Committee on Health |
|
|
and Human Services and the House Committee on Public Health a report |
|
|
that details the number and type of actions relating to the |
|
|
prosecution of violations of Chapter 481, Health and Safety Code, |
|
|
as amended by this Act. |
|
|
(b) Each agency shall submit its initial report under |
|
|
Subsection (a) of this section not later than November 1, 2007. |
|
|
Each agency shall submit an update of its initial report not later |
|
|
than May 1 and November 1 of each year. |
|
|
(c) This section expires November 1, 2011. |
|
|
SECTION 9. The public safety director of the Department of |
|
|
Public Safety of the State of Texas shall adopt any rules necessary |
|
|
to administer and enforce Subchapter H, Chapter 481, Health and |
|
|
Safety Code, as added by this Act, not later than September 1, 2007, |
|
|
except that if this section does not take effect before that date, |
|
|
the public safety director shall adopt the rules as soon as |
|
|
practicable after that date. |
|
|
SECTION 10. (a) Except as provided by Subsections (b), |
|
|
(c), and (d) of this section, this Act takes effect September 1, |
|
|
2007. |
|
|
(b) Section 9 of this Act takes effect immediately if this |
|
|
Act receives a vote of two-thirds of all the members elected to each |
|
|
house, as provided by Section 39, Article III, Texas Constitution. |
|
|
If this Act does not receive the vote necessary for immediate |
|
|
effect, Section 9 of this Act takes effect September 1, 2007. |
|
|
(c) Except as otherwise provided by Subsection (d) of this |
|
|
section, the changes in law made by this Act in amending Subsection |
|
|
(k), Section 481.074, and Section 481.076, Health and Safety Code, |
|
|
and in adding Subsection (q), Section 481.074 of that code, take |
|
|
effect September 1, 2008. The public safety director of the |
|
|
Department of Public Safety of the State of Texas shall adopt any |
|
|
rules necessary to administer and enforce the changes in law made by |
|
|
those provisions not later than September 1, 2008. |
|
|
(d) The change in law made by this Act in amending |
|
|
Subsections (b) and (k), Section 481.074, Health and Safety Code, |
|
|
to require the use of registration numbers issued by the Department |
|
|
of Public Safety of the State of Texas takes effect only after the |
|
|
department establishes a means by which pharmacies are able to |
|
|
electronically access and verify the accuracy of the registration |
|
|
numbers. |
|
|
|
|
|
|
|
|
|
| |
| |
| |
| |
______________________________ |
______________________________ |
| |
President of the Senate |
Speaker of the House |
| |
|
|
I hereby certify that S.B. No. 1879 passed the Senate on |
|
|
April 25, 2007, by the following vote: Yeas 28, Nays 1; |
|
|
May 24, 2007, Senate refused to concur in House amendments and |
|
|
requested appointment of Conference Committee; May 26, 2007, House |
|
|
granted request of the Senate; May 26, 2007, Senate adopted |
|
|
Conference Committee Report by the following vote: Yeas 30, |
|
|
Nays 0. |
|
|
|
| |
| |
______________________________ |
| |
Secretary of the Senate |
| |
|
|
I hereby certify that S.B. No. 1879 passed the House, with |
|
|
amendments, on May 23, 2007, by the following vote: Yeas 139, |
|
|
Nays 0, one present not voting; May 26, 2007, House granted request |
|
|
of the Senate for appointment of Conference Committee; |
|
|
May 27, 2007, House adopted Conference Committee Report by the |
|
|
following vote: Yeas 143, Nays 1, two present not voting. |
|
|
|
| |
| |
______________________________ |
| |
Chief Clerk of the House |
| |
|
|
|
| |
|
|
Approved: |
|
|
|
|
|
______________________________ |
|
|
Date |
|
|
|
|
|
|
|
|
______________________________ |
|
|
Governor |