Doctors Can Dispense Drugs Without A Pharmacy License

The text as introduced · 2,762 words

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.