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A BILL TO BE ENTITLED
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AN ACT
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relating to prescribing and dispensing controlled substances and |
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monitoring the prescribing and dispensing of controlled substances |
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under the Texas Controlled Substances Act; authorizing a fee; |
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providing for administrative penalties; creating criminal |
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offenses. |
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BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS: |
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SECTION 1. Subchapter C, Chapter 481, Health and Safety |
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Code, is amended by adding Section 481.0755 to read as follows: |
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Sec. 481.0755. WRITTEN, ORAL, AND TELEPHONICALLY |
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COMMUNICATED PRESCRIPTIONS. (a) Notwithstanding Sections |
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481.073, 481.074, and 481.075, a person prescribing or dispensing a |
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controlled substance must use the electronic prescription record |
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and may not use a written, oral, or telephonically communicated |
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prescription. |
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(b) A prescriber may issue a written, oral, or |
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telephonically communicated prescription for a controlled |
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substance as authorized under this subchapter only if the |
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prescription is issued: |
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(1) by a veterinarian; |
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(2) in circumstances in which electronic prescribing |
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is not available due to temporary technological or electronic |
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failure, as prescribed by board rule; |
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(3) by a practitioner to be dispensed by a pharmacy |
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located outside this state, as prescribed by board rule; |
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(4) when the prescriber and dispenser are the same |
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entity; |
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(5) in circumstances in which necessary elements are |
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not supported by the most recent electronic prescription drug |
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software; |
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(6) for a drug for which the United States Food and |
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Drug Administration requires additional information in the |
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prescription that is not possible with electronic prescribing; |
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(7) for a non-patient-specific prescription pursuant |
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to a standing order, approved protocol for drug therapy, |
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collaborative drug management, or comprehensive medication |
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management, in response to a public health emergency or in other |
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circumstances in which the practitioner may issue a |
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non-patient-specific prescription; |
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(8) for a drug under a research protocol; |
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(9) by a prescriber who is employed by or is practicing |
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a health care profession at a health-related institution, as |
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defined by Section 62.161, Education Code, as added by Chapter 448 |
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(H.B. 7), Acts of the 84th Legislature, 2015; |
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(10) by a practitioner who has received a waiver under |
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Subsection (c) from the requirement to use electronic prescribing; |
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or |
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(11) under circumstances in which the practitioner has |
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the present ability to submit an electronic prescription but |
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reasonably determines that it would be impractical for the patient |
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to obtain the drugs prescribed under the electronic prescription in |
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a timely manner and that a delay would adversely impact the |
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patient's medical condition. |
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(c) The board shall adopt rules establishing a process by |
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which a practitioner may request and receive a waiver under |
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Subsection (b)(10), not to exceed one year, from the requirement to |
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use electronic prescribing. The board shall adopt rules |
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establishing the eligibility for a waiver, including: |
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(1) economic hardship; |
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(2) technological limitations not reasonably within |
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the control of the practitioner; or |
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(3) other exceptional circumstances demonstrated by |
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the practitioner. |
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(d) A written, oral, or telephonically communicated |
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prescription must comply with the applicable requirements |
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prescribed by Sections 481.074 and 481.075. |
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(e) A dispensing pharmacist who receives a controlled |
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substance prescription in a manner other than electronically is not |
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required to verify that the prescription is exempt from the |
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requirement that it be submitted electronically. |
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(f) The board shall enforce this section. |
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SECTION 2. Section 481.076, Health and Safety Code, is |
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amended by amending Subsections (a), (f), (g), and (h) and adding |
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Subsection (a-6) to read as follows: |
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(a) The board may not permit any person to have access to |
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information submitted to the board under Section 481.074(q) or |
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481.075 except: |
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(1) the board, the Texas Medical Board, the Texas |
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Department of Licensing and Regulation, with respect to the |
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regulation of podiatrists [State Board of Podiatric Medical
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Examiners], the State Board of Dental Examiners, the State Board of |
|
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Veterinary Medical Examiners, the Texas Board of Nursing, or the |
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Texas Optometry Board for the purpose of: |
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(A) investigating a specific license holder; or |
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(B) monitoring for potentially harmful |
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prescribing or dispensing patterns or practices under Section |
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481.0762; |
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(2) an [authorized officer or member of the department
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or] authorized employee of the board engaged in the administration, |
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investigation, or enforcement of this chapter or another law |
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governing illicit drugs in this state or another state; |
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(3) the department or other [on behalf of a] law |
|
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enforcement or prosecutorial official engaged in the |
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administration, investigation, or enforcement of this chapter or |
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another law governing illicit drugs in this state or another state, |
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if the board is provided a warrant, subpoena, or other court order |
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compelling the disclosure; |
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(4) a medical examiner conducting an investigation; |
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(5) provided that accessing the information is |
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authorized under the Health Insurance Portability and |
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|
Accountability Act of 1996 (Pub. L. No. 104-191) and regulations |
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|
adopted under that Act: |
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(A) a pharmacist or a pharmacy technician, as |
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|
defined by Section 551.003, Occupations Code, acting at the |
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direction of a pharmacist; or |
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(B) a practitioner who: |
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(i) is a physician, dentist, veterinarian, |
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podiatrist, optometrist, or advanced practice nurse or is a |
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physician assistant described by Section 481.002(39)(D) or an |
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employee or other agent of a practitioner acting at the direction of |
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a practitioner; and |
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(ii) is inquiring about a recent Schedule |
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|
II, III, IV, or V prescription history of a particular patient of |
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the practitioner; |
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(6) a pharmacist or practitioner who is inquiring |
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about the person's own dispensing or prescribing activity; [or] |
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(7) one or more states or an association of states with |
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which the board has an interoperability agreement, as provided by |
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Subsection (j); |
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(8) a health care facility certified by the federal |
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Centers for Medicare and Medicaid Services; or |
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(9) the patient, the patient's parent or legal |
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|
guardian, if the patient is a minor, or the patient's legal |
|
|
guardian, if the patient is an incapacitated person, as defined by |
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Section 1002.017(2), Estates Code, inquiring about the patient's |
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prescription record, including persons who have accessed that |
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record. |
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(a-6) A patient, the patient's parent or legal guardian, if |
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the patient is a minor, or the patient's legal guardian, if the |
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patient is an incapacitated person, as defined by Section |
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1002.017(2), Estates Code, is entitled to a copy of the patient's |
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prescription record as provided by Subsection (a)(9), including a |
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list of persons who have accessed that record, if a completed |
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patient data request form and any supporting documentation required |
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by the board is submitted to the board. The board may charge a |
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reasonable fee for providing the copy. The board shall adopt rules |
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to implement this subsection, including rules prescribing the |
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patient data request form, listing the documentation required for |
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receiving a copy of the prescription record, and setting the fee. |
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(f) If the board accesses [director permits access to] |
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information under Subsection (a)(2) relating to a person licensed |
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or regulated by an agency listed in Subsection (a)(1), the board |
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[director] shall notify and cooperate with that agency regarding |
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the disposition of the matter before taking action against the |
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person, unless the board [director] determines that notification is |
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reasonably likely to interfere with an administrative or criminal |
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investigation or prosecution. |
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(g) If the board provides [director permits] access to |
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information under Subsection (a)(3) relating to a person licensed |
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or regulated by an agency listed in Subsection (a)(1), the board |
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[director] shall notify that agency of the disclosure of the |
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information not later than the 10th working day after the date the |
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information is disclosed. |
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(h) If the board [director] withholds notification to an |
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agency under Subsection (f), the board [director] shall notify the |
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agency of the disclosure of the information and the reason for |
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withholding notification when the board [director] determines that |
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notification is no longer likely to interfere with an |
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administrative or criminal investigation or prosecution. |
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SECTION 3. Section 481.0766, Health and Safety Code, is |
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amended by adding Subsection (c) to read as follows: |
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(c) The board shall make the information reported under |
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Subsection (a) available to the State Board of Veterinary Medical |
|
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Examiners for the purpose of routine inspections and |
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investigations. |
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SECTION 4. Subchapter C, Chapter 481, Health and Safety |
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|
Code, is amended by adding Sections 481.0767, 481.0768, and |
|
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481.0769 to read as follows: |
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Sec. 481.0767. ADVISORY COMMITTEE. (a) The board shall |
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establish an advisory committee to make recommendations regarding |
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information submitted to the board and access to that information |
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under Sections 481.074, 481.075, 481.076, and 481.0761, including |
|
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recommendations for: |
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(1) operational improvements to the electronic system |
|
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that stores the information, including implementing best practices |
|
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and improvements that address system weaknesses and workflow |
|
|
challenges; |
|
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(2) resolutions to identified data concerns; |
|
|
(3) methods to improve data accuracy, integrity, and |
|
|
security and to reduce technical difficulties; and |
|
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(4) the addition of any new data set or service to the |
|
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information submitted to the board or the access to that |
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information. |
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(b) The board shall appoint the following members to the |
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advisory committee: |
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(1) a physician licensed in this state who practices |
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in pain management; |
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(2) a physician licensed in this state who practices |
|
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in family medicine; |
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(3) a physician licensed in this state who performs |
|
|
surgery; |
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(4) a physician licensed in this state who practices |
|
|
in emergency medicine at a hospital; |
|
|
(5) a physician licensed in this state who practices |
|
|
in psychiatry; |
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(6) an oral and maxillofacial surgeon; |
|
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(7) a physician assistant or advanced practice |
|
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registered nurse to whom a physician has delegated the authority to |
|
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prescribe or order a drug; |
|
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(8) a pharmacist working at a chain pharmacy; |
|
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(9) a pharmacist working at an independent pharmacy; |
|
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(10) an academic pharmacist; and |
|
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(11) two representatives of the health information |
|
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technology industry, at least one of whom is a representative of a |
|
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company whose primary line of business is electronic medical |
|
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records. |
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(c) Members of the advisory committee serve three-year |
|
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terms. Each member shall serve until the member's replacement has |
|
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been appointed. |
|
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(d) The advisory committee shall annually elect a presiding |
|
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officer from its members. |
|
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(e) The advisory committee shall meet at least two times a |
|
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year and at the call of the presiding officer or the board. |
|
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(f) A member of the advisory committee serves without |
|
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compensation but may be reimbursed by the board for actual expenses |
|
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incurred in performing the duties of the advisory committee. |
|
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Sec. 481.0768. ADMINISTRATIVE PENALTY: DISCLOSURE OR USE |
|
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OF INFORMATION. (a) A person authorized to receive information |
|
|
under Section 481.076(a) may not disclose or use the information in |
|
|
a manner not authorized by this subchapter or other law. |
|
|
(b) A regulatory agency that issues a license, |
|
|
certification, or registration to a prescriber or dispenser shall |
|
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periodically update the administrative penalties, or any |
|
|
applicable disciplinary guidelines concerning the penalties, |
|
|
assessed by that agency for conduct that violates Subsection (a). |
|
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(c) The agency shall set the penalties in an amount |
|
|
sufficient to deter the conduct. |
|
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Sec. 481.0769. CRIMINAL OFFENSES RELATED TO PRESCRIPTION |
|
|
INFORMATION. (a) A person authorized to receive information under |
|
|
Section 481.076(a) commits an offense if the person discloses or |
|
|
uses the information in a manner not authorized by this subchapter |
|
|
or other law. |
|
|
(b) A person requesting information under Section |
|
|
481.076(a-6) commits an offense if the person makes a material |
|
|
misrepresentation or fails to disclose a material fact in the |
|
|
request for information under that subsection. |
|
|
(c) An offense under Subsection (a) is a Class A |
|
|
misdemeanor. |
|
|
(d) An offense under Subsection (b) is a Class C |
|
|
misdemeanor. |
|
|
SECTION 5. Section 801.307, Occupations Code, is amended by |
|
|
adding Subsection (a-1) to read as follows: |
|
|
(a-1) The board by rule shall require a veterinarian to |
|
|
complete two hours of continuing education related to opioid abuse |
|
|
and controlled substance diversion, inventory, and security every |
|
|
two years to renew a license to practice veterinary medicine. |
|
|
SECTION 6. Section 481.003(a), Health and Safety Code, is |
|
|
amended to read as follows: |
|
|
(a) The director may adopt rules to administer and enforce |
|
|
this chapter, other than Sections 481.073, 481.074, 481.075, |
|
|
481.0755, 481.076, 481.0761, 481.0762, 481.0763, 481.0764, |
|
|
481.0765, [and] 481.0766, 481.0767, 481.0768, and 481.0769. The |
|
|
board may adopt rules to administer Sections 481.073, 481.074, |
|
|
481.075, 481.0755, 481.076, 481.0761, 481.0762, 481.0763, |
|
|
481.0764, 481.0765, [and] 481.0766, 481.0767, 481.0768, and |
|
|
481.0769. |
|
|
SECTION 7. Section 481.128(a), Health and Safety Code, is |
|
|
amended to read as follows: |
|
|
(a) A registrant or dispenser commits an offense if the |
|
|
registrant or dispenser knowingly: |
|
|
(1) distributes, delivers, administers, or dispenses |
|
|
a controlled substance in violation of Subchapter C [Sections
|
|
|
481.070-481.075]; |
|
|
(2) manufactures a controlled substance not |
|
|
authorized by the person's Federal Drug Enforcement Administration |
|
|
registration or distributes or dispenses a controlled substance not |
|
|
authorized by the person's registration to another registrant or |
|
|
other person; |
|
|
(3) refuses or fails to make, keep, or furnish a |
|
|
record, report, notification, order form, statement, invoice, or |
|
|
information required by this chapter; |
|
|
(4) prints, manufactures, possesses, or produces an |
|
|
official prescription form without the approval of the board; |
|
|
(5) delivers or possesses a counterfeit official |
|
|
prescription form; |
|
|
(6) refuses an entry into a premise for an inspection |
|
|
authorized by this chapter; |
|
|
(7) refuses or fails to return an official |
|
|
prescription form as required by Section 481.075(k); |
|
|
(8) refuses or fails to make, keep, or furnish a |
|
|
record, report, notification, order form, statement, invoice, or |
|
|
information required by a rule adopted by the director or the board; |
|
|
or |
|
|
(9) refuses or fails to maintain security required by |
|
|
this chapter or a rule adopted under this chapter. |
|
|
SECTION 8. Section 481.129(a), Health and Safety Code, is |
|
|
amended to read as follows: |
|
|
(a) A person commits an offense if the person knowingly: |
|
|
(1) distributes as a registrant or dispenser a |
|
|
controlled substance listed in Schedule I or II, unless the person |
|
|
distributes the controlled substance as authorized under the |
|
|
federal Controlled Substances Act (21 U.S.C. Section 801 et seq.); |
|
|
(2) uses in the course of manufacturing, prescribing, |
|
|
or distributing a controlled substance a Federal Drug Enforcement |
|
|
Administration registration number that is fictitious, revoked, |
|
|
suspended, or issued to another person; |
|
|
(3) issues a prescription bearing a forged or |
|
|
fictitious signature; |
|
|
(4) uses a prescription issued to another person to |
|
|
prescribe a Schedule II controlled substance; |
|
|
(5) possesses, obtains, or attempts to possess or |
|
|
obtain a controlled substance or an increased quantity of a |
|
|
controlled substance: |
|
|
(A) by misrepresentation, fraud, forgery, |
|
|
deception, or subterfuge; |
|
|
(B) through use of a fraudulent prescription |
|
|
form; [or] |
|
|
(C) through use of a fraudulent oral or |
|
|
telephonically communicated prescription; or |
|
|
(D) through the use of a fraudulent electronic |
|
|
prescription; or |
|
|
(6) furnishes false or fraudulent material |
|
|
information in or omits material information from an application, |
|
|
report, record, or other document required to be kept or filed under |
|
|
this chapter. |
|
|
SECTION 9. Section 554.051(a-1), Occupations Code, is |
|
|
amended to read as follows: |
|
|
(a-1) The board may adopt rules to administer Sections |
|
|
481.073, 481.074, 481.075, 481.0755, 481.076, 481.0761, 481.0762, |
|
|
481.0763, 481.0764, 481.0765, [and] 481.0766, 481.0767, 481.0768, |
|
|
and 481.0769, Health and Safety Code. |
|
|
SECTION 10. Section 565.003, Occupations Code, is amended |
|
|
to read as follows: |
|
|
Sec. 565.003. ADDITIONAL GROUNDS FOR DISCIPLINE REGARDING |
|
|
APPLICANT FOR OR HOLDER OF NONRESIDENT PHARMACY LICENSE. Unless |
|
|
compliance would violate the pharmacy or drug statutes or rules in |
|
|
the state in which the pharmacy is located, the board may discipline |
|
|
an applicant for or the holder of a nonresident pharmacy license if |
|
|
the board finds that the applicant or license holder has failed to |
|
|
comply with: |
|
|
(1) Subchapter C, Chapter 481 [Section 481.074 or
|
|
|
481.075], Health and Safety Code; |
|
|
(2) Texas substitution requirements regarding: |
|
|
(A) the practitioner's directions concerning |
|
|
generic substitution; |
|
|
(B) the patient's right to refuse generic |
|
|
substitution; or |
|
|
(C) notification to the patient of the patient's |
|
|
right to refuse substitution; |
|
|
(3) any board rule relating to providing drug |
|
|
information to the patient or the patient's agent in written form or |
|
|
by telephone; or |
|
|
(4) any board rule adopted under Section 554.051(a) |
|
|
and determined by the board to be applicable under Section |
|
|
554.051(b). |
|
|
SECTION 11. Sections 481.076(a-3), (a-4), and (a-5), Health |
|
|
and Safety Code, are repealed. |
|
|
SECTION 12. To the extent of any conflict, this Act prevails |
|
|
over another Act of the 86th Legislature, Regular Session, 2019, |
|
|
relating to nonsubstantive additions to and corrections in enacted |
|
|
codes. |
|
|
SECTION 13. Notwithstanding Section 24, Chapter 485 (H.B. |
|
|
2561), Acts of the 85th Legislature, Regular Session, 2017, Section |
|
|
481.0764(a), Health and Safety Code, as added by that Act, applies |
|
|
only to: |
|
|
(1) a prescriber, other than a veterinarian, who |
|
|
issues a prescription for a controlled substance on or after March |
|
|
1, 2020; or |
|
|
(2) a person authorized by law to dispense a |
|
|
controlled substance, other than a veterinarian, who dispenses a |
|
|
controlled substance on or after March 1, 2020. |
|
|
SECTION 14. Section 481.0755, Health and Safety Code, as |
|
|
added by this Act, applies only to a prescription issued on or after |
|
|
the effective date of this Act. |
|
|
SECTION 15. Section 481.0768(a), Health and Safety Code, as |
|
|
added by this Act, applies only to conduct that occurs on or after |
|
|
the effective date of this Act. |
|
|
SECTION 16. Section 801.307(a-1), Occupations Code, as |
|
|
added by this Act, applies only to the renewal of a license to |
|
|
practice veterinary medicine on or after September 1, 2020. The |
|
|
renewal of a license before that date is governed by the law in |
|
|
effect immediately before the effective date of this Act, and the |
|
|
former law is continued in effect for that purpose. |
|
|
SECTION 17. This Act takes effect September 1, 2019. |
|
|
|
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|
* * * * * |