Bill Text: TX HB3284 | 2019-2020 | 86th Legislature | Introduced
NOTE: There are more recent revisions of this legislation. Read Latest Draft
Bill Title: Relating to the prescribing and dispensing of controlled substances under the Texas Controlled Substances Act; authorizing a fee; providing for administrative penalties; creating criminal offenses.
Spectrum: Moderate Partisan Bill (Republican 6-1)
Status: (Passed) 2019-06-14 - Effective on 9/1/19 [HB3284 Detail]
Download: Texas-2019-HB3284-Introduced.html
Bill Title: Relating to the prescribing and dispensing of controlled substances under the Texas Controlled Substances Act; authorizing a fee; providing for administrative penalties; creating criminal offenses.
Spectrum: Moderate Partisan Bill (Republican 6-1)
Status: (Passed) 2019-06-14 - Effective on 9/1/19 [HB3284 Detail]
Download: Texas-2019-HB3284-Introduced.html
86R11548 JSC-D | ||
By: Sheffield | H.B. No. 3284 |
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relating to prescribing and dispensing controlled substances and | ||
monitoring the prescribing and dispensing of controlled substances | ||
under the Texas Controlled Substances Act; providing for | ||
administrative penalties. | ||
BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS: | ||
SECTION 1. Subchapter C, Chapter 481, Health and Safety | ||
Code, is amended by adding Sections 481.0751 and 481.0755 to read as | ||
follows: | ||
Sec. 481.0751. DISPENSING VETERINARIANS. (a) This section | ||
applies to a veterinarian who holds a registration issued by the | ||
Federal Drug Enforcement Administration and dispenses Schedule II, | ||
III, IV, or V controlled substances directly to the owner or handler | ||
of an animal. | ||
(b) Not later than the 30th day after the date the | ||
veterinarian dispenses a controlled substance, the veterinarian | ||
shall submit to the board: | ||
(1) the name, strength, and quantity of the substance | ||
dispensed; | ||
(2) the date the substance was dispensed; | ||
(3) the name of the animal; | ||
(4) the species, gender, and actual or estimated date | ||
of birth of the animal; | ||
(5) the name and address of the animal's owner; and | ||
(6) the name, address, Federal Drug Enforcement | ||
Administration number, and telephone number of the veterinarian at | ||
the veterinarian's usual place of business. | ||
(c) A veterinarian shall retain a record of the information | ||
submitted to the board under Subsection (b) for a period of not less | ||
than two years after the date the substance is dispensed. | ||
(d) Failure to comply with this section is grounds for | ||
disciplinary action by the State Board of Veterinary Medical | ||
Examiners. | ||
Sec. 481.0755. WRITTEN, ORAL, AND TELEPHONICALLY | ||
COMMUNICATED PRESCRIPTIONS. (a) Notwithstanding Sections | ||
481.073, 481.074, and 481.075, a person prescribing or dispensing a | ||
controlled substance must use the electronic prescription record | ||
and may not use a written, oral, or telephonically communicated | ||
prescription. | ||
(b) A prescriber may issue a written, oral, or | ||
telephonically communicated prescription for a controlled | ||
substance as authorized under this subchapter only if the | ||
prescription is issued: | ||
(1) by a veterinarian; | ||
(2) in circumstances in which electronic prescribing | ||
is not available due to temporary technological or electronic | ||
failure, as prescribed by board rule; | ||
(3) by a practitioner to be dispensed by a pharmacy | ||
located outside this state, as prescribed by board rule; | ||
(4) when the prescriber and dispenser are the same | ||
entity; | ||
(5) in circumstances in which necessary elements are | ||
not supported by the most recent electronic prescription drug | ||
software; | ||
(6) for a drug for which the United States Food and | ||
Drug Administration requires additional information in the | ||
prescription that is not possible with electronic prescribing; | ||
(7) for a non-patient-specific prescription pursuant | ||
to a standing order, approved protocol for drug therapy, | ||
collaborative drug management, or comprehensive medication | ||
management, in response to a public health emergency or in other | ||
circumstances in which the practitioner may issue a | ||
non-patient-specific prescription; | ||
(8) for a drug under a research protocol; | ||
(9) by a practitioner who has received a waiver under | ||
Subsection (c) from the requirement to use electronic prescribing; | ||
or | ||
(10) under circumstances in which the practitioner has | ||
the present ability to submit an electronic prescription but | ||
reasonably determines that it would be impractical for the patient | ||
to obtain the drugs prescribed under the electronic prescription in | ||
a timely manner and that a delay would adversely impact the | ||
patient's medical condition. | ||
(c) The board shall adopt rules establishing a process by | ||
which a practitioner may request and receive a waiver under | ||
Subsection (b)(9), not to exceed one year, from the requirement to | ||
use electronic prescribing. The board shall adopt rules | ||
establishing the eligibility for a waiver, including: | ||
(1) economic hardship; | ||
(2) technological limitations not reasonably within | ||
the control of the practitioner; or | ||
(3) other exceptional circumstances demonstrated by | ||
the practitioner. | ||
(d) A written, oral, or telephonically communicated | ||
prescription must comply with the applicable requirements | ||
prescribed by Sections 481.074 and 481.075. | ||
(e) A dispensing pharmacist who receives a controlled | ||
substance prescription in a manner other than electronically is not | ||
required to verify that the prescription is exempt from the | ||
requirement that it be submitted electronically. | ||
(f) The board shall enforce this section. | ||
SECTION 2. Sections 481.076(a), (f), (g), and (h), Health | ||
and Safety Code, are amended to read as follows: | ||
(a) The board may not permit any person to have access to | ||
information submitted to the board under Section 481.074(q) or | ||
481.075 except: | ||
(1) the board, the Texas Medical Board, the Texas | ||
Department of Licensing and Regulation, with respect to the | ||
regulation of podiatrists [ |
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Veterinary Medical Examiners, the Texas Board of Nursing, or the | ||
Texas Optometry Board for the purpose of: | ||
(A) investigating a specific license holder; or | ||
(B) monitoring for potentially harmful | ||
prescribing or dispensing patterns or practices under Section | ||
481.0762; | ||
(2) an [ |
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investigation, or enforcement of this chapter or another law | ||
governing illicit drugs in this state or another state; | ||
(3) the department or other [ |
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enforcement or prosecutorial official engaged in the | ||
administration, investigation, or enforcement of this chapter or | ||
another law governing illicit drugs in this state or another state, | ||
if the board is provided a warrant, subpoena, or other court order | ||
compelling the disclosure; | ||
(4) a medical examiner conducting an investigation; | ||
(5) provided that accessing the information is | ||
authorized under the Health Insurance Portability and | ||
Accountability Act of 1996 (Pub. L. No. 104-191) and regulations | ||
adopted under that Act: | ||
(A) a pharmacist or a pharmacy technician, as | ||
defined by Section 551.003, Occupations Code, acting at the | ||
direction of a pharmacist; or | ||
(B) a practitioner who: | ||
(i) is a physician, dentist, veterinarian, | ||
podiatrist, optometrist, or advanced practice nurse or is a | ||
physician assistant described by Section 481.002(39)(D) or an | ||
employee or other agent of a practitioner acting at the direction of | ||
a practitioner; and | ||
(ii) is inquiring about a recent Schedule | ||
II, III, IV, or V prescription history of a particular patient of | ||
the practitioner; | ||
(6) a pharmacist or practitioner who is inquiring | ||
about the person's own dispensing or prescribing activity; [ |
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(7) one or more states or an association of states with | ||
which the board has an interoperability agreement, as provided by | ||
Subsection (j); or | ||
(8) a health care facility certified by the federal | ||
Centers for Medicare and Medicaid Services. | ||
(f) If the board accesses [ |
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information under Subsection (a)(2) relating to a person licensed | ||
or regulated by an agency listed in Subsection (a)(1), the board | ||
[ |
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the disposition of the matter before taking action against the | ||
person, unless the board [ |
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reasonably likely to interfere with an administrative or criminal | ||
investigation or prosecution. | ||
(g) If the board provides [ |
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information under Subsection (a)(3) relating to a person licensed | ||
or regulated by an agency listed in Subsection (a)(1), the board | ||
[ |
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information not later than the 10th working day after the date the | ||
information is disclosed. | ||
(h) If the board [ |
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agency under Subsection (f), the board [ |
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agency of the disclosure of the information and the reason for | ||
withholding notification when the board [ |
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notification is no longer likely to interfere with an | ||
administrative or criminal investigation or prosecution. | ||
SECTION 3. Subchapter C, Chapter 481, Health and Safety | ||
Code, is amended by adding Sections 481.07635, 481.07655, and | ||
481.0768 to read as follows: | ||
Sec. 481.07635. PRESCRIPTIONS OF OPIOIDS. (a) In this | ||
section, "acute pain" means pain with abrupt onset that is caused by | ||
an injury or other process that is not ongoing. | ||
(b) For the initial treatment of acute pain, a prescriber | ||
may not issue a prescription for an opioid in an amount that exceeds | ||
a 14-day supply. | ||
Sec. 481.07655. LIMITATION OF LIABILITY. (a) A prescriber | ||
or dispenser is not liable in a civil action for damages arising | ||
from the failure to access prescription drug information as | ||
required or authorized by Section 481.0764 or failure to submit the | ||
information to the board as required under Section 481.074(q) or | ||
481.075, unless the failure constitutes gross negligence or wilful | ||
misconduct and the prescriber or dispenser would be liable to the | ||
claimant under other law. | ||
(b) This section does not establish a standard of care. | ||
Sec. 481.0768. ADMINISTRATIVE PENALTY: DISCLOSURE OR USE | ||
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 | ||
periodically update the administrative penalties, or any | ||
applicable disciplinary guidelines concerning the penalties, | ||
assessed by that agency for conduct that violates Subsection (a). | ||
(c) The agency shall set the penalties in an amount | ||
sufficient to deter the conduct. | ||
SECTION 4. 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, | ||
481.076, 481.0761, 481.0762, 481.0763, 481.07635, 481.0764, | ||
481.0765, 481.07655, [ |
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adopt rules to administer Sections 481.073, 481.074, 481.075, | ||
481.0751, 481.0755, 481.076, 481.0761, 481.0762, 481.0763, | ||
481.07635, 481.0764, 481.0765, 481.07655, [ |
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481.0768. | ||
SECTION 5. 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 [ |
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(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 6. 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; [ |
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(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 7. 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, 481.0751, 481.0755, 481.076, 481.0761, | ||
481.0762, 481.0763, 481.07635, 481.0764, 481.0765, 481.07655, | ||
[ |
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SECTION 8. 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) Section 481.073, 481.074, [ |
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481.0755, 481.076, 481.0761, 481.0762, 481.0763, 481.07635, | ||
481.0764, 481.0765, 481.07655, 481.0766, or 481.0768, 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 9. Sections 481.076(a-3), (a-4), and (a-5), Health | ||
and Safety Code, are repealed. | ||
SECTION 10. 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 11. Section 481.0751, Health and Safety Code, as | ||
added by this Act, applies only to a controlled substance dispensed | ||
on or after the effective date of this Act. | ||
SECTION 12. Sections 481.0755, 481.07635, and 481.07655, | ||
Health and Safety Code, as added by this Act, apply only to a | ||
prescription issued on or after the effective date of this Act. | ||
SECTION 13. 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 14. This Act takes effect September 1, 2019. |