Relating to the medical use of low-THC cannabis under and the administration of the Texas Compassionate-Use Program; requiring registration.

89(R) HB 46 - Enrolled version - Bill Text

H.B. No. 46

AN ACT

relating to the medical use of low-THC cannabis under and the

administration of the Texas Compassionate-Use Program; requiring

registration.

BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS:

SECTION 1. Section 487.053(a), Health and Safety Code, is

amended to read as follows:

(a) The department shall:

(1) issue or renew a license to operate as a dispensing

organization to each applicant who satisfies the requirements

established under this chapter; and

(2) register directors,
owners,
managers,
members,

and employees of each dispensing organization.

SECTION 2. Section 487.054, Health and Safety Code, is

amended by adding Subsections (c) and (d) to read as follows:

(c)

Information within the registry regarding patient

identification, including the fact that a person is listed as a

patient in the registry, is confidential and may only be accessed by

the department, registered physicians, and dispensing

organizations for the purposes of this chapter.

Confidential

information under this subsection may not be disclosed except as

authorized under this chapter and is not subject to disclosure

under Chapter 552, Government Code.

(d)

Notwithstanding Subsection (c), on request by a

patient, the department may release patient information contained

in the registry to the patient or a person designated by the

patient.

SECTION 3. Section 487.101, Health and Safety Code, is

amended to read as follows:

Sec. 487.101. LICENSE REQUIRED.
(a)
A license issued by the

department under this chapter is required to operate a dispensing

organization.

(b)

A dispensing organization licensed under this chapter

is not required to apply for an additional license for the use of a

satellite location for secure storage of low-THC cannabis if:

(1)

the address of the satellite location was included

in the application; or

(2)

the dispensing organization obtains approval from

the department under Section 487.1035.

SECTION 4. Section 487.102, Health and Safety Code, is

amended to read as follows:

Sec. 487.102. ELIGIBILITY FOR LICENSE. An applicant for a

license to operate as a dispensing organization is eligible for the

license if:

(1) as determined by the department, the applicant

possesses:

(A) the technical and technological ability to

cultivate and produce low-THC cannabis;

(B) the ability to secure:

(i) the resources and personnel necessary

to operate as a dispensing organization; and

(ii) premises reasonably located to allow

patients listed on the compassionate-use registry access to the

organization through existing infrastructure;

(C) the ability to maintain accountability for

the raw materials, the finished product, and any by-products used

or produced in the cultivation or production of low-THC cannabis to

prevent unlawful access to or unlawful diversion or possession of

those materials, products, or by-products; and

(D) the financial ability to maintain operations

for not less than two years from the date of application;

(2) each director,
owner,
manager,
member,
or employee

of the applicant is registered under Subchapter D; and

(3) the applicant satisfies any additional criteria

determined by the director to be necessary to safely implement this

chapter.

SECTION 5. Section 487.103(b), Health and Safety Code, is

amended to read as follows:

(b) The application must include
:

(1)
the name and address of the applicant
;

(2)
[
,
] the name and address of each of the applicant's

directors,
owners,
managers,
members,
and employees
;

(3)

the address of any satellite location that will be

used by the applicant for secure storage of low-THC cannabis under

Section 487.1035;
[
,
] and

(4)
any other information considered necessary by the

department to determine the applicant's eligibility for the

license.

SECTION 6. Subchapter C, Chapter 487, Health and Safety

Code, is amended by adding Section 487.1035 to read as follows:

Sec.

487.1035.

SATELLITE LOCATIONS. (a) A dispensing

organization licensed under this chapter may operate one or more

satellite locations in addition to the organization's primary

location to securely store low-THC cannabis for distribution.

(b)

A satellite location must be approved by the department

before a dispensing organization may operate the location. A

dispensing organization may apply for approval in the form and

manner prescribed by the department.

(c)

The department must act on an application submitted

under Subsection (b) not later than the 180th day after the date the

application is submitted to the department.

(d)

The director shall adopt rules regarding the design and

security requirements for satellite locations.

(e)

A dispensing organization may not operate more than one

satellite location in a public health region designated under

Section 121.007 until the dispensing organization operates one

satellite location in each public health region.

(f)

A location previously approved by the department as a

patient pickup location before September 1, 2025, is considered to

be approved as a satellite location under Subsection (b) for

purposes of this section and is permitted to:

(1) operate as a patient pickup location; and

(2) securely store low-THC cannabis for distribution.

SECTION 7. Section 487.104, Health and Safety Code, is

amended by amending Subsection (b) and adding Subsections (b-1),

(d), (d-1), (e), and (f) to read as follows:

(b)
Except as provided by Subsection (b-1), if
[
If
] the

department denies the issuance or renewal of a license under

Subsection (a), the applicant is entitled to a hearing. Chapter

2001, Government Code, applies to a proceeding under this section.

(b-1)

If the department denies the issuance of a license

under this section to an applicant that has never held a license

under this section, the applicant is not entitled to a hearing.

(d)

The department shall issue 15 licenses under this

section to dispensing organizations in this state provided that the

department receives applications from a sufficient number of

applicants meeting the requirements for eligibility under this

subchapter.

(d-1)

The department shall issue initial licenses to

dispensing organizations under this section based on a competitive

evaluation of applicant qualifications relative to other

applicants.

(e)

The department shall issue and renew licenses under this

section in a manner that ensures adequate access to low-THC

cannabis for patients registered in the compassionate-use registry

in each public health region designated under Section 121.007.

(f)

The director shall adopt rules to establish a timeline

for reviewing and taking action on an application submitted under

this section.

SECTION 8. Subchapter C, Chapter 487, Health and Safety

Code, is amended by adding Section 487.1045 to read as follows:

Sec.

487.1045.

REQUIREMENT OF LICENSE HOLDER TO BEGIN AND

MAINTAIN OPERATIONS. (a) An applicant issued a license to operate a

dispensing organization must begin dispensing low-THC cannabis not

later than 24 months after the date the license is issued and

continue dispensing low-THC cannabis during the term of a license

issued under this subchapter.

(b) The director shall adopt rules to:

(1)

monitor whether a dispensing organization is using

a license issued under this subchapter to dispense low-THC

cannabis; and

(2)

revoke the license of a dispensing organization

that does not dispense low-THC cannabis within the time required by

this section or that discontinues dispensing low-THC cannabis

during the term of a license.

SECTION 9. Section 487.105, Health and Safety Code, is

amended by amending Subsections (a) and (b) and adding Subsection

(c-1) to read as follows:

(a) An applicant for the issuance or renewal of a license to

operate as a dispensing organization shall provide the department

with the applicant's name and the name of each of the applicant's

directors,
owners,
managers,
members,
and employees.

(b) Before a dispensing organization licensee hires a

manager or employee for the organization, the licensee must provide

the department with the name of the prospective manager or

employee. The licensee may not transfer the license to another

person before that prospective applicant and the applicant's

directors,
owners,
managers,
members,
and employees pass a criminal

history background check and are registered as required by

Subchapter D.

(c-1)

This section does not apply to a director, owner,

manager, member, or employee who does not exercise direct control

over the daily operations of the dispensing organization.

SECTION 10. Section 487.107, Health and Safety Code, is

amended by adding Subsection (c) to read as follows:

(c)

A dispensing organization may not dispense to a person

low-THC cannabis in a:

(1)

package or container that contains more than a

total of one gram of tetrahydrocannabinols; or

(2)

medical device for pulmonary inhalation that

contains more than one gram of tetrahydrocannabinols.

SECTION 11. Subchapter C, Chapter 487, Health and Safety

Code, is amended by adding Section 487.1071 to read as follows:

Sec.

487.1071.

CANNABINOIDS ELIGIBLE FOR DISPENSING. (a)

In this section, "phytocannabinoid" means a chemical substance:

(1)

created naturally by a plant of the species

Cannabis sativa L. that is separated from the plant by a mechanical

or chemical extraction process;

(2)

created naturally by a plant of the species

Cannabis sativa L. that binds to or interacts with the cannabinoid

receptors of the endocannabinoid system; or

(3)

produced by decarboxylation from a naturally

occurring cannabinoid acid without the use of a chemical catalyst.

(b)

A dispensing organization may not dispense a low-THC

cannabis product that contains a cannabinoid that is not a

phytocannabinoid.

SECTION 12. Section 487.151(a), Health and Safety Code, is

amended to read as follows:

(a) An individual who is a director,
owner,
manager,
member,

or employee of a dispensing organization must apply for and obtain a

registration under this section.

SECTION 13. Section 487.201, Health and Safety Code, is

amended to read as follows:

Sec. 487.201. COUNTIES AND MUNICIPALITIES MAY NOT PROHIBIT

LOW-THC CANNABIS. A municipality, county, or other political

subdivision may not enact, adopt, or enforce a rule, ordinance,

order, resolution, or other regulation that prohibits the

cultivation, production,
storage,
dispensing, or possession of

low-THC cannabis, as authorized by this chapter.

SECTION 14. Section 169.001, Occupations Code, is amended

to read as follows:

Sec. 169.001. DEFINITIONS. In this chapter:

(1)
"Chronic pain" means pain that is not relieved

with acute, post-surgical, post-procedure, or persistent

non-chronic pain treatment and is associated with a chronic

pathological process that causes continuous or intermittent severe

pain for more than 90 days and for which tetrahydrocannabinol is a

viable method of treatment.

(1-a)
"Department" means the Department of Public

Safety.

(1-b)

"Executive commissioner"

means the executive

commissioner of the Health and Human Services Commission.

(2)
[
(1-a)
] "Incurable neurodegenerative disease"

means a disease designated as an incurable neurodegenerative

disease by rule of the executive commissioner [
of the Health and

Human Services Commission
], adopted in consultation with the

National Institutes of Health.

(3) "Low-THC cannabis" means the plant Cannabis sativa

L., and any part of that plant or any compound, manufacture, salt,

derivative, mixture, preparation, resin, or oil of that plant that

contains not more than
10 milligrams
[
one percent by weight
] of

tetrahydrocannabinols
in each dosage unit
.

(4) "Medical use" means the ingestion
, absorption, or

insertion
by a means of administration other than by smoking of a

prescribed amount of low-THC cannabis by a person for whom low-THC

cannabis is prescribed under this chapter.

(5) "Smoking" means burning or igniting a substance

and inhaling the smoke.
The term does not include inhaling a

medication or other substance that is otherwise aerosolized or

vaporized for administration by pulmonary inhalation.

SECTION 15. Section 169.003, Occupations Code, is amended

to read as follows:

Sec. 169.003. PRESCRIPTION OF LOW-THC CANNABIS.
(a)
A

physician described by Section 169.002 may prescribe low-THC

cannabis to a patient if:

(1) the patient is a permanent resident of the state;

(2) the physician complies with the registration

requirements of Section 169.004; and

(3) the physician certifies to the department that:

(A) the patient is diagnosed with:

(i) epilepsy;

(ii) a seizure disorder;

(iii) multiple sclerosis;

(iv) spasticity;

(v) amyotrophic lateral sclerosis;

(vi) autism;

(vii) cancer;

(viii) an incurable neurodegenerative

disease;

(ix) post-traumatic stress disorder;

(x) a condition that causes chronic pain;

(xi) traumatic brain injury;

(xii)

Crohn's disease or other inflammatory

bowel disease;

(xiii)

a terminal illness or a condition

for which a patient is receiving hospice or palliative care;
or

(xiv)
[
(x)
] a medical condition that is

approved for a research program under Subchapter F, Chapter 487,

Health and Safety Code, and for which the patient is receiving

treatment under that program; and

(B) the physician determines the risk of the

medical use of low-THC cannabis by the patient is reasonable in

light of the potential benefit for the patient.

(b)

Each prescription issued by a physician to a patient for

low-THC cannabis:

(1)

may only provide for a 90-day supply of low-THC

cannabis based on the dosage prescribed to the patient; and

(2)

may provide up to four refills of a 90-day supply

of low-THC cannabis.

(c)

A physician may prescribe more than one package in a

90-day period.

(d)

A physician may submit to the Department of State Health

Services a request that the department report to the legislature

that low-THC cannabis may be beneficial to treat a specific medical

condition not listed in Subsection (a)(3)(A).

The request must be

accompanied by medical evidence such as peer-reviewed published

research demonstrating that low-THC cannabis may be beneficial to

treat that medical condition.

The executive commissioner by rule

shall prescribe the manner in which a physician may submit a request

under this subsection.

SECTION 16. Chapter 169, Occupations Code, is amended by

adding Section 169.006 to read as follows:

Sec.

169.006.

ADMINISTRATION OF LOW-THC CANNABIS BY

PULMONARY INHALATION.

(a) A physician may prescribe pulmonary

inhalation of an aerosol or vapor as a means of administration of

low-THC cannabis if the physician determines that based on the

patient's condition there is a medical necessity for that means of

administration.

(b)

The prescription under Subsection (a) must specify the

amount of tetrahydrocannabinols in each dosage unit to be

administered by pulmonary inhalation that is medically necessary

based on the patient's condition.

(c) The executive commissioner shall adopt rules:

(1)

related to medical devices for pulmonary

inhalation of low-THC cannabis; and

(2)

establishing a reasonable timeline for reviewing

and granting approval for medical devices for pulmonary inhalation.

SECTION 17. Not later than October 1, 2025:

(1) the director of the Department of Public Safety

shall adopt the rules necessary to implement the changes in law made

by this Act to Chapter 487, Health and Safety Code; and

(2) the executive commissioner of the Health and Human

Services Commission shall adopt the rules necessary to implement

Section 169.006, Occupations Code, as added by this Act.

SECTION 18. Provided that applicants for a license to

operate as a dispensing organization have met the requirements for

approval provided by Subchapter C, Chapter 487, Health and Safety

Code, as amended by this Act, the Department of Public Safety shall:

(1) not later than December 1, 2025, license at least

nine new dispensing organizations from applications submitted

before July 1, 2025; and

(2) not later than April 1, 2026, in addition to any

licenses issued by the Department of Public Safety under

Subdivision (1) of this section, license at least three new

dispensing organizations from applications submitted at any time.

SECTION 19. This Act takes effect September 1, 2025.

______________________________

______________________________

President of the Senate

Speaker of the House

I certify that H.B. No. 46 was passed by the House on May 13,

2025, by the following vote: Yeas 122, Nays 21, 2 present, not

voting; that the House refused to concur in Senate amendments to

H.B. No. 46 on May 30, 2025, and requested the appointment of a

conference committee to consider the differences between the two

houses; that the House adopted the conference committee report on

H.B. No. 46 on June 1, 2025, by the following vote: Yeas 138, Nays

1, 2 present, not voting; that the House adopted S.C.R. No. 56

authorizing certain corrections in H.B. No. 46 on June 1, 2025, by

the following vote: Yeas 137, Nays 0, 1 present, not voting; and

that the House adopted H.C.R. No. 171 authorizing certain

corrections in H.B. No. 46 on June 2, 2025, by the following vote:

Yeas 138, Nays 0, 1 present, not voting.

______________________________

Chief Clerk of the House

I certify that H.B. No. 46 was passed by the Senate, with

amendments, on May 27, 2025, by the following vote: Yeas 31, Nays

0; at the request of the House, the Senate appointed a conference

committee to consider the differences between the two houses; that

the Senate adopted the conference committee report on H.B. No. 46 on

June 1, 2025, by the following vote: Yeas 31, Nays 0; that the

Senate adopted S.C.R. No. 56 authorizing certain corrections in

H.B. No. 46 on June 1, 2025, by the following vote: Yeas 31, Nays 0;

and that the Senate adopted H.C.R. No. 171 authorizing certain

corrections in H.B. No. 46 on June 2, 2025, by the following vote:

Yeas 31, Nays 0.

______________________________

Secretary of the Senate

APPROVED: __________________

Date

__________________

Governor