By: Frank H.B. No. 4051
A BILL TO BE ENTITLED
AN ACT
relating to the authority of certain healthcare providers to order
and provide or dispense limited prescription drugs.
BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS:
SECTION 1. Section 483.001(11), Health and Safety Code, is
amended to read as follows:
(11) "Practice of pharmacy" has the meaning assigned
by Section 551.003, Occupations Code [means:
[(A) provision of those acts or services
necessary to provide pharmaceutical care;
[(B) interpretation and evaluation of
prescription drug orders or medication orders;
[(C) participation in drug and device selection
as authorized by law, drug administration, drug regimen review, or
drug or drug-related research;
[(D) provision of patient counseling;
[(E) responsibility for:
[(i) dispensing of prescription drug orders
or distribution of medication orders in the patient's best
interest;
[(ii) compounding and labeling of drugs and
devices, except labeling by a manufacturer, repackager, or
distributor of nonprescription drugs and commercially packaged
prescription drugs and devices;
[(iii) proper and safe storage of drugs and
devices; or
[(iv) maintenance of proper records for
drugs and devices. In this subdivision, "device" has the meaning
assigned by Subtitle J, Title 3, Occupations Code; or
[(F) performance of a specific act of drug
therapy management for a patient delegated to a pharmacist by a
written protocol from a physician licensed by the state under
Subtitle B, Title 3, Occupations Code].
SECTION 2. Section 151.002, Occupations Code, is amended by
adding Subdivisions (3-a) and (13-a) to read as follows:
(3-a) "Dispense" has the meaning assigned by Section
551.003.
(13-a) "Provision" means the supply of one or more
unit doses of a drug, medicine, or dangerous drug.
SECTION 3. The heading to Section 157.002, Occupations
Code, is amended to read as follows:
Sec. 157.002. GENERAL DELEGATION OF ADMINISTRATION, [AND]
PROVISION, AND DISPENSING OF DANGEROUS DRUGS.
SECTION 4. Sections 157.002(a), (b), (e), and (g),
Occupations Code, are amended to read as follows:
(a) In this section, "administering" [:
[(1) "Administering"] means the direct application of
a drug to the body of a patient by injection, inhalation, ingestion,
or any other means.
[(2) "Provision" means the supply of one or more unit
doses of a drug, medicine, or dangerous drug.]
(b) A physician may delegate to any qualified and properly
trained person acting under the physician's supervision the act of
administering [or providing] dangerous drugs in the physician's
office, as ordered by the physician, that are used or required to
meet the immediate needs of the physician's patients or the act of
providing or dispensing dangerous drugs as ordered by the physician
to the physician's patients. The administration, [or] provision,
or dispensing of the dangerous drugs must be performed in
compliance with laws relating to the practice of medicine and state
and federal laws relating to those dangerous drugs.
(e) The administration, [or] provision, or dispensing of
the drugs may be delegated through a physician's order, a standing
medical order, a standing delegation order, or another order
defined by the board.
(g) A drug or medicine provided or dispensed under
Subsection (b) or (c) must be:
(1) supplied in a child-resistant container unless the
patient request it not be in a child-resistant container or the
product is exempt from requirements of the Poison Prevention
Packaging Act of 1970;
(2) dispensed in a container with a label on the container
that contains the name of the drug, the date the prescription is
dispensed, the name of the prescribing practitioner, the quantity
dispensed, dosage and route of administration, date after which the
prescription should not be used or beyond-use-date, and appropriate
ancillary instructions such as storage instructions or cautionary
statements printed in an easily readable font size;
(3) stored prior to dispensing in a location with a
temperature range compatible with the proper storage of each drug,
including refrigeration where required, and secured against theft
or diversion of prescription drugs and locked to prohibit
unauthorized access when the physician is not on-site; and
(4) dispensed with written consumer information or written
directions to obtain written information online that provides the
therapeutic use of the drug and the names of generically equivalent
drugs.
(h) A physician dispensing a drug under this subchapter
must:
(1) complete a drug utilization review prior to dispensing
for therapeutic duplication, drug-to-disease contraindications,
drug-to-drug interactions, correct dosage, and drug-to-allergy
interactions;
(2) maintain records of dispensed medications including
patient information, prescription details and dispensing
information including the dispensing physicians name and office
address where drugs were dispensed from;
(3) counsel the patient on proper use of a prescription drug
or device; and
(4) perform a final check on all prescriptions filled onsite
for the accuracy and completeness of the prescription.
[supplied in a suitable container labeled in compliance with
applicable drug laws. A qualified and trained person, acting under
the supervision of a physician, may specify at the time of the
provision or dispensing of the drug the inclusion on the container
of the date of the provision or dispensing and the patient's name
and address.]
SECTION 5. The heading to Chapter 158, Occupations Code, is
amended to read as follows:
CHAPTER 158. AUTHORITY OF PHYSICIAN TO PROVIDE OR DISPENSE CERTAIN
DRUGS AND SUPPLIES
SECTION 6. Sections 158.001(a) and (c), Occupations Code,
are amended to read as follows:
(a) A physician licensed under this subtitle may provide
[supply] a patient with any drug, remedy, or clinical supply
necessary to meet the patient's immediate needs.
(c) This chapter does not prohibit a physician from
providing [supplying] to a patient, free of charge, a drug provided
to the physician by a drug manufacturer for an indigent
pharmaceutical program if, in the physician's opinion, it is
advantageous to the patient, in adhering to a course of treatment
prescribed by the physician, to receive the drug.
SECTION 7. Section 158.002(a), Occupations Code, is amended
to read as follows:
(a) This chapter does not prohibit a physician from
providing [supplying] a pharmaceutical sample to a patient free of
charge if, in the physician's opinion, it is advantageous to the
patient, in adhering to a course of treatment prescribed by the
physician, to receive the sample.
SECTION 8. The heading to Section 158.003, Occupations
Code, is amended to read as follows:
Sec. 158.003. DISPENSING OF DANGEROUS DRUGS TO CERTAIN
PATIENTS IN CERTAIN RURAL AREAS.
SECTION 9. Section 158.003, Occupations Code, is amended by
adding Subsection (a-1) to read as follows:
(a-1) This section applies only to a physician providing
care under workers' compensation insurance coverage, as defined by
Section 401.011, Labor Code.
SECTION 10. Chapter 158, Occupations Code, is amended by
adding Section 158.004 to read as follows:
Sec. 158.004. PROVISION AND DISPENSING OF DANGEROUS DRUGS.
(a) In this section, "reimbursement for cost" means an additional
charge, separate from that imposed for the physician's professional
services, that includes the cost of a drug product and all other
actual costs to the physician incidental to providing dispensing
service. The term does not include a separate fee imposed for the
act of dispensing a drug itself.
(b) This section does not apply to a physician providing
care under workers' compensation insurance coverage, as defined by
Section 401.011, Labor Code.
(c) A physician may:
(1) provide or dispense dangerous drugs to the
physician's patients; and
(2) be reimbursed for the cost of providing or
dispensing those drugs without obtaining a license under Chapter
558.
(d) A physician may not provide or dispense under this
section a controlled substance listed in Schedules II through V as
established under Subchapter B, Chapter 481, Health and Safety
Code.
(e) A physician who provides or dispenses dangerous drugs
under this section shall oversee compliance with the laws of this
state and federal law relating to those dangerous drugs.
(f) Before providing or dispensing dangerous drugs under
this section, a physician must notify the patient that the
prescription for the dangerous drug may be filled at a pharmacy.
With respect to dangerous drugs provided or dispensed in a
physician's office, the notification requirement of this
subsection may be satisfied by a written notice placed
conspicuously in the office.
(g) Not later than the 30th day after the date a physician
first provides or dispenses dangerous drugs under this section, the
physician shall notify the Texas State Board of Pharmacy and the
board that the physician is providing or dispensing dangerous drugs
under this section. The Texas State Board of Pharmacy and the board
shall jointly adopt a form by which a physician may provide
notification as required by this subsection.
(h) A physician who notifies the board under Subsection (g)
that the physician is providing or dispensing dangerous drugs under
this section and who intends to continue to provide or dispense
dangerous drugs under this section shall include notice of that
intent in any subsequent registration permit renewal application
submitted to the board. The board by rule shall prescribe the form
of a registration permit renewal application in accordance with
this subsection.
SECTION 11. Section 551.003(31) and (33), Occupations Code,
is amended to read as follows:
(31) "Pharmacy" means a facility at which a
prescription drug or medication order is received, processed, or
dispensed under this subtitle, Chapter 481 or 483, Health and
Safety Code, or the Comprehensive Drug Abuse Prevention and Control
Act of 1970 (21 U.S.C. Section 801 et seq.). The term does not
include:
(A) a narcotic drug treatment program that is
regulated under Chapter 466, Health and Safety Code; or
(B) a location where:
(i) a physician provides or dispenses a
dangerous drug under Section 158.003 or 158.004; or
(ii) a person provides or dispenses a
dangerous drug under a physician's supervision in accordance with
Section 157.002(b).
(33) "Practice of pharmacy" means:
(A) providing an act or service necessary to
provide pharmaceutical care;
(B) interpreting or evaluating a prescription
drug order or medication order;
(C) participating in drug or device selection as
authorized by law, and participating in drug administration, drug
regimen review, or drug or drug-related research;
(D) providing patient counseling;
(E) being responsible for:
(i) dispensing a prescription drug order or
distributing a medication order;
(ii) compounding or labeling a drug or
device, other than labeling by a manufacturer, repackager, or
distributor of a nonprescription drug or commercially packaged
prescription drug or device;
(iii) properly and safely storing a drug or
device; or
(iv) maintaining proper records for a drug
or device;
(F) performing for a patient a specific act of
drug therapy management delegated to a pharmacist by a written
protocol from a physician licensed in this state in compliance with
Subtitle B; [or]
(G) administering an immunization or vaccination
under a physician's written protocol; or
(H) ordering or furnishing a prescription drug to
treat an acute condition in accordance with Section 562.058.
SECTION 12. Section 551.004, Occupations Code, is amended
by adding Subsection (a-1) and amending Subsection (b) to read as
follows:
(a-1) For purposes of Subsection (a)(1), "retailing of
prescription drugs" does not include the collection of a
reimbursement for cost, as defined by Section 158.003(a) or
158.004(a).
(b) This subtitle does not prevent:
(1) a practitioner from:
(A) administering a drug to a patient of the
practitioner; or
(B) providing or dispensing dangerous drugs
under Section 158.003 or 158.004; or
(2) a person from providing or dispensing a dangerous
drug under a physician's supervision in accordance with Section
157.002(b).
SECTION 13. Section 558.001, Occupations Code, is amended
by amending Subsection (c) and adding Subsection (d) to read as
follows:
(c) Except as provided by Subsection (d), a [A] person may
not dispense or distribute prescription drugs unless the person:
(1) is a pharmacist; or
(2) is otherwise authorized by this subtitle to
dispense or distribute prescription drugs.
(d) A physician or person acting under the physician's
supervision may provide or dispense dangerous drugs in accordance
with Section 157.002(b), 158.003, or 158.004.
SECTION 14. Subchapter B, Chapter 562, Occupations Code, is
amended by adding Section 562.058 to read as follows:
Sec. 562.058. ORDERING AND FURNISHING CERTAIN PRESCRIPTION
DRUGS. (a) In this section:
(1) "Acute condition" means a condition or disease
that begins abruptly, intensifies rapidly, and is generally not
long-lasting.
(2) "Waived clinical laboratory test" means a clinical
laboratory test that is classified as waived under federal
regulations issued under the Clinical Laboratory Improvement
Amendments of 1988 (42 U.S.C. Section 263a).
(b) Notwithstanding any other law, a pharmacist may order
and furnish to a patient a prescription drug to treat an acute
condition that is:
(1) identified through performance of one of the following
tests, if the test is a waived clinical laboratory test:
(A) a rapid strep test or rapid antigen detection test
used in the identification of group A streptococcus (GAS);
(B) a rapid influenza diagnostic test used in the
identification of influenza types A and B; or
(C) a rapid diagnostic test for SARS-CoV-2 or a
related virus used in the identification of COVID-19 or a related
illness[.]; or
(2) for treatment of minor, uncomplicated infections,
including lice, skin conditions, such as ringworm and athlete's
foot, and urinary tract infections.
(c) The board shall adopt rules to permit a pharmacist to
order and furnish a prescription drug under this section to a
patient.
(d) A pharmacist who orders and furnishes a prescription
drug under this section must provide notice to the patient's
primary care physician, as identified by the patient if the patient
has a primary care physician, not later than the 14th day after the
date the drug is ordered and furnished by the pharmacist.
(e) The board by rule shall establish requirements to ensure
that a pharmacist possesses the necessary skill and training to
order and furnish prescription drugs under this section.
SECTION 15. The heading to Chapter 563, Occupations Code,
is amended to read as follows:
CHAPTER 563. [PRESCRIPTION REQUIREMENTS;] DELEGATION OF
ADMINISTRATION, [AND] PROVISION, AND DISPENSING OF DANGEROUS DRUGS
SECTION 16. Sections 563.051(a) and (c), Occupations Code,
are amended to read as follows:
(a) A physician may delegate to any qualified and properly
trained person acting under the physician's supervision the act of
administering [or providing] dangerous drugs in the physician's
office, as ordered by the physician, that are used or required to
meet the immediate needs of the physician's patients or the act of
providing or dispensing dangerous drugs, as ordered by the
physician, to the physician's patients. The administration, [or]
provision, or dispensing of the dangerous drugs must be performed
in compliance with laws relating to the practice of medicine and
state and federal laws relating to those dangerous drugs.
(c) The administration, [or] provision, or dispensing of
the drugs may be delegated through a physician's order, a standing
medical order, a standing delegation order, or another order
defined by the Texas Medical [State] Board [of Medical Examiners].
SECTION 17. Section 563.052, Occupations Code, is amended
to read as follows:
Sec. 563.052. SUITABLE CONTAINER REQUIRED. A drug or
medicine provided or dispensed under this subchapter must be
provided or dispensed [supplied] in a suitable container labeled in
compliance with applicable drug laws. A qualified and trained
person, acting under the supervision of a physician, may specify at
the time of the provision or dispensing of the drug the inclusion on
the container of the date of the provision or dispensing and the
patient's name and address.
SECTION 18. The heading to Section 563.053, Occupations
Code, is amended to read as follows:
Sec. 563.053. DISPENSING OF DANGEROUS DRUGS TO CERTAIN
PATIENTS IN CERTAIN RURAL AREAS.
SECTION 19. Section 563.053, Occupations Code, is amended
by adding Subsection (a-1) to read as follows:
(a-1) This section applies only to a physician providing
care under workers' compensation insurance coverage, as defined by
Section 401.011, Labor Code.
SECTION 20. The heading to Subchapter B, Chapter 563,
Occupations Code, is repealed.
SECTION 21. Not later than January 1, 2026, the Texas State
Board of Pharmacy shall adopt the rules required under Section
562.058, Occupations Code, as added by this Act.
SECTION 22. Not later than January 1, 2026, the Texas
Medical Board shall adopt the rules required under Section 558.001,
Occupations Code, as added by this Act.
SECTION 23. This Act takes effect September 1, 2025.