86R11548 JSC-D
By: Sheffield H.B. No. 3284
A BILL TO BE ENTITLED
AN ACT
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 [State Board of Podiatric Medical
Examiners], the State Board of Dental Examiners, the State Board of
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 [authorized officer or member of the department
or] authorized employee of the board engaged in the administration,
investigation, or enforcement of this chapter or another law
governing illicit drugs in this state or another state;
(3) the department or other [on behalf of a] law
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; [or]
(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 [director permits access to]
information under Subsection (a)(2) relating to a person licensed
or regulated by an agency listed in Subsection (a)(1), the board
[director] shall notify and cooperate with that agency regarding
the disposition of the matter before taking action against the
person, unless the board [director] determines that notification is
reasonably likely to interfere with an administrative or criminal
investigation or prosecution.
(g) If the board provides [director permits] access to
information under Subsection (a)(3) relating to a person licensed
or regulated by an agency listed in Subsection (a)(1), the board
[director] shall notify that agency of the disclosure of the
information not later than the 10th working day after the date the
information is disclosed.
(h) If the board [director] withholds notification to an
agency under Subsection (f), the board [director] shall notify the
agency of the disclosure of the information and the reason for
withholding notification when the board [director] determines that
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, [and] 481.0766, and 481.0768. 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, [and] 481.0766, and
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 [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 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; [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 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,
[and] 481.0766, and 481.0768, Health and Safety Code.
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, [or] 481.075, 481.0751,
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.