Bill Text: TX HB1365 | 2019-2020 | 86th Legislature | Engrossed

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Bill Title: Relating to authorizing the possession, use, cultivation, processing, distribution, transportation, research, testing, and delivery of low-THC cannabis for medical use by patients with certain debilitating medical conditions and the licensing of cannabis dispensing organizations, cannabis research organizations, and cannabis testing facilities; establishing the cannabis therapeutic research review board; authorizing fees.

Spectrum: Slight Partisan Bill (Democrat 53-23)

Status: (Engrossed - Dead) 2019-05-15 - Referred to Health & Human Services [HB1365 Detail]

Download: Texas-2019-HB1365-Engrossed.html

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By: Lucio III, Zerwas, Thompson of Harris, H.B. No. 1365
Anchia, Larson, et al.

A BILL TO BE ENTITLED
AN ACT
relating to authorizing the possession, use, cultivation,
processing, distribution, transportation, research, testing, and
delivery of low-THC cannabis for medical use by patients with
certain debilitating medical conditions and the licensing of
cannabis dispensing organizations, cannabis research
organizations, and cannabis testing facilities; establishing the
cannabis therapeutic research review board; authorizing fees.
BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS:
SECTION 1. Subchapter A, Chapter 37, Education Code, is
amended by adding Section 37.0015 to read as follows:
Sec. 37.0015. LOW-THC CANNABIS. Notwithstanding any other
provision of this chapter, a student for whom low-THC cannabis was
prescribed under Chapter 169, Occupations Code, may not be subject
to suspension, expulsion, placement in a disciplinary alternative
education program, or any other form of discipline solely because
the student possessed, used, or was under the influence of the
low-THC cannabis.
SECTION 2. Section 481.062(a), Health and Safety Code, is
amended to read as follows:
(a) The following persons may possess a controlled
substance under this chapter without registering with the Federal
Drug Enforcement Administration:
(1) an agent or employee of a manufacturer,
distributor, analyzer, or dispenser of the controlled substance who
is registered with the Federal Drug Enforcement Administration and
acting in the usual course of business or employment;
(2) a common or contract carrier, a warehouseman, or
an employee of a carrier or warehouseman whose possession of the
controlled substance is in the usual course of business or
employment;
(3) an ultimate user or a person in possession of the
controlled substance under a lawful order of a practitioner or in
lawful possession of the controlled substance if it is listed in
Schedule V;
(4) an officer or employee of this state, another
state, a political subdivision of this state or another state, or
the United States who is lawfully engaged in the enforcement of a
law relating to a controlled substance or drug or to a customs law
and authorized to possess the controlled substance in the discharge
of the person's official duties;
(5) if the substance is tetrahydrocannabinol or one of
its derivatives:
(A) a Health and Human Services Commission
[Department of State Health Services] official, a medical school
researcher, or a research program participant possessing the
substance as authorized under Subchapter G; or
(B) a practitioner or an ultimate user possessing
the substance as a participant in a federally approved therapeutic
research program that the commissioner has reviewed and found, in
writing, to contain a medically responsible research protocol; or
(6) a dispensing organization, cannabis research
organization, or cannabis testing facility licensed under
Subchapter C, Chapter 487, that possesses low-THC cannabis.
SECTION 3. Sections 481.111(e) and (f), Health and Safety
Code, are amended to read as follows:
(e) Sections 481.120, 481.121, 481.122, and 481.125 do not
apply to a person who engages in the acquisition, possession,
production, cultivation, delivery, or disposal of a raw material
used in or by-product created by the production or cultivation of
low-THC cannabis if the person:
(1) for an offense involving possession only of
marihuana or drug paraphernalia, is a patient for whom medical use
[low-THC cannabis] is prescribed under Chapter 169, Occupations
Code, or the patient's legal guardian, and the person possesses no
more than the allowable amount of low-THC cannabis, as determined
under Section 487.002 [obtained under a valid prescription from a
dispensing organization]; or
(2) is a director, manager, or employee of a
dispensing organization, cannabis research organization, or
cannabis testing facility and the person, solely in performing the
person's regular duties at the organization or facility, acquires,
possesses, produces, cultivates, dispenses, or disposes of:
(A) in reasonable quantities, any low-THC
cannabis or raw materials used in or by-products created by the
production or cultivation of low-THC cannabis; or
(B) any drug paraphernalia used in the
acquisition, possession, production, cultivation, delivery, or
disposal of low-THC cannabis.
(f) For purposes of Subsection (e):
(1) "Cannabis testing facility," "cannabis research
organization," and "dispensing organization" have the meanings
["Dispensing organization" has the meaning] assigned by Section
487.001.
(2) "Low-THC cannabis" and "medical use" have the
meanings ["Low-THC cannabis" has the meaning] assigned by Section
169.001, Occupations Code.
SECTION 4. Subchapter G, Chapter 481, Health and Safety
Code, is amended to read as follows:
SUBCHAPTER G. CANNABIS THERAPEUTIC RESEARCH PROGRAM
Sec. 481.201. RESEARCH PROGRAM; REVIEW BOARD. (a) A
cannabis therapeutic research review board is established to
administer the cannabis therapeutic research program under this
subchapter. The executive commissioner shall assist the review
board as provided by this subchapter [may establish a controlled
substance therapeutic research program for the supervised use of
tetrahydrocannabinols for medical and research purposes to be
conducted in accordance with this chapter].
(b) [If the executive commissioner establishes the program,
the executive commissioner shall create a research program review
board.] The review board members are appointed by the governor
[executive commissioner] and serve staggered six-year terms. The
terms of one-third of the members expire August 31 of each
odd-numbered year [at the will of the executive commissioner].
(c) The review board shall be composed of the following 12
members:
(1) a licensed physician certified by the American
Board of Ophthalmology;
(2) a licensed physician certified by the American
Board of Internal Medicine and certified in the subspecialty of
medical oncology;
(3) a licensed physician certified by the American
Board of Psychiatry;
(4) a licensed physician certified by the American
Board of Surgery;
(5) a licensed physician certified by the American
Board of Radiology; [and]
(6) a licensed attorney with experience in law
pertaining to the practice of medicine;
(7) a licensed physician certified by the American
Board of Family Medicine;
(8) a licensed physician certified by the American
Osteopathic Association;
(9) a licensed physician specializing in pain
management certified by the American Board of Anesthesiology, the
American Board of Psychiatry, the American Board of Neurology, or
the American Board of Physical Medicine and Rehabilitation;
(10) a licensed advanced practice registered nurse
specializing in palliative care certified by the Hospice and
Palliative Credentialing Center or a licensed physician
specializing in palliative care certified by a member board of the
American Board of Medical Specialties, the American Osteopathic
Association, or the Hospice Medical Director Certification Board;
and
(11) two licensed physicians certified by the American
Board of Psychiatry and Neurology.
(d) The review board may create and appoint one or more
advisory committees composed of patients, law enforcement
officers, other medical professionals, and other persons who are
knowledgeable about low-THC cannabis cultivation, processing, and
regulation.
(e) Members serve without compensation but are entitled to
reimbursement for actual and necessary expenses incurred in
performing official duties.
Sec. 481.202. REVIEW BOARD POWERS AND DUTIES. (a) The
review board shall review research proposals submitted [and medical
case histories of persons recommended for participation in a
research program] and determine which research programs and persons
are most suitable for the therapy and research purposes of the
program. The review board shall approve the research programs[,
certify program participants,] and conduct periodic reviews of the
research and participants.
(b) Research programs may be conducted with a medical
school, as defined by Section 61.501, Education Code, a hospital
licensed under Chapter 241, or a general academic teaching
institution, as defined by Section 61.003, Education Code, and may
investigate the safety and efficacy of low-THC cannabis and other
public health outcomes [The review board, after approval of the
executive commissioner, may seek authorization to expand the
research program to include diseases not covered by this
subchapter].
(c) The review board shall maintain a record of all persons
in charge of approved research programs and of all persons who
participate in the program as researchers or as patients. The
record must indicate whether a patient is registered under Chapter
487.
(d) The review board shall encourage multiple research
goals, including:
(1) objective scientific research into the safety and
efficacy of low-THC cannabis;
(2) developing medical guidelines for the appropriate
administration of low-THC cannabis, to assist physicians and
patients in evaluating the risks and benefits of low-THC cannabis,
and to provide a scientific basis for future policies;
(3) developing quality control, purity, and labeling
standards for low-THC cannabis;
(4) developing best practices for the safe and
efficient cultivation of low-THC cannabis; and
(5) analysis of genetic and healing properties of
different varieties of cannabis. [The executive commissioner may
terminate the distribution of tetrahydrocannabinols and their
derivatives to a research program as the executive commissioner
determines necessary.]
(e) The review board shall require written reports that
describe and assess the research findings by each approved research
program, including research findings relating to the safety and
efficacy of low-THC cannabis. In consultation with the Department
of Public Safety, the review board shall report on the quality,
diversity, and availability of low-THC cannabis. The review board
shall submit a report on the status and findings of the research
programs to the department not later than October 1 of each year.
(f) The review board shall determine the formulations and
dosages, including ratios of cannabinoids, that are medically
appropriate for patients with particular debilitating medical
conditions under Chapter 169, Occupations Code.
(g) The review board may establish training criteria for the
qualification of a physician under Section 169.002, Occupations
Code.
(h) The review board shall conduct a continuing study of the
laws relating to cannabis to facilitate statewide access to safe
and effective low-THC cannabis and report the board's findings and
recommendations to the legislature not later than the 90th day
before the first day of each regular legislative session.
(i) The review board may accept donations for research under
this chapter and provide grants for research into low-THC cannabis
use and health outcomes and scientific public education outreach to
educate youth on the risks of using cannabis for nonmedical
purposes or without the supervision of a health care provider.
Sec. 481.203. PATIENT PARTICIPATION. (a) A person may not
be considered for participation as a recipient of low-THC cannabis
[tetrahydrocannabinols and their derivatives] through a research
program unless the person is recommended to a person in charge of an
approved research program and the review board by a physician who is
licensed by the Texas Medical Board and is attending the person.
(b) A physician may [not] recommend a person for the
research program if [unless] the person[:
[(1) has glaucoma or cancer;
[(2) is not responding to conventional treatment for
glaucoma or cancer or is experiencing severe side effects from
treatment; and
[(3)] has a condition, symptoms, or side effects [from
treatment] that may be alleviated by medical use of low-THC
cannabis and the risk of the medical use of low-THC cannabis is
reasonable in light of the potential benefit for the patient
[tetrahydrocannabinols or their derivatives].
(c) Each patient in a research program must provide informed
consent in writing. If the patient lacks the mental or legal
capacity to provide informed consent, a parent, guardian, or
conservator may provide informed consent on the patient's behalf.
Sec. 481.204. ACQUISITION AND DISTRIBUTION OF LOW-THC
CANNABIS [CONTROLLED SUBSTANCES]. (a) The executive commissioner
shall acquire low-THC cannabis [the tetrahydrocannabinols and
their derivatives] for use in the research program by contracting
with the National Institute on Drug Abuse to receive
tetrahydrocannabinols and their derivatives that are safe for human
consumption according to the regulations adopted by the institute,
the United States Food and Drug Administration, and the Federal
Drug Enforcement Administration.
(b) The executive commissioner shall supervise the
distribution of low-THC cannabis [the tetrahydrocannabinols and
their derivatives] to program participants. The low-THC cannabis
[tetrahydrocannabinols and derivatives of tetrahydrocannabinols]
may be distributed only by the person in charge of the research
program to physicians caring for program participant patients,
under rules adopted by the executive commissioner in such a manner
as to prevent unauthorized diversion of the substances and in
compliance with all requirements of the Federal Drug Enforcement
Administration. The physician is responsible for dispensing the
substances to patients.
(c) Notwithstanding Subsections (a) and (b), a research
program may use and patients may acquire low-THC cannabis produced
by license holders under Chapter 487.
Sec. 481.205. RULES; REPORTS. (a) The executive
commissioner shall adopt rules necessary for implementing the
research program.
(b) The [If the executive commissioner establishes a
program under this subchapter, the] commissioner shall publish a
report not later than January 1 of each odd-numbered year on the
medical effectiveness of the use of low-THC cannabis
[tetrahydrocannabinols and their derivatives] and any other
medical findings of the research program.
SECTION 5. Section 487.001, Health and Safety Code, is
amended to read as follows:
Sec. 487.001. DEFINITIONS. In this chapter:
(1) "Cannabis research organization" means an
organization licensed by the department to conduct medical,
scientific, or agricultural research on low-THC cannabis.
(2) "Cannabis testing facility" means an independent
entity licensed by the department under this chapter to analyze the
content, safety, and potency of low-THC cannabis.
(3) "Caregiver" means a person who has significant
responsibility for managing the well-being of a registered patient.
(4) "Debilitating medical condition" has the meaning
assigned by Section 169.001, Occupations Code.
(5) "Department" means the Department of Public
Safety.
(6) [(2)] "Director" means the public safety director
of the department.
(7) [(3)] "Dispensing organization" means an
organization licensed by the department to cultivate, process, and
dispense low-THC cannabis to a patient for whom low-THC cannabis is
prescribed under Chapter 169, Occupations Code.
(8) [(4)] "Low-THC cannabis" has the meaning assigned
by Section 169.001, Occupations Code.
(9) "Medical use" has the meaning assigned by Section
169.001, Occupations Code.
SECTION 6. Subchapter A, Chapter 487, Health and Safety
Code, is amended by adding Section 487.002 to read as follows:
Sec. 487.002. ALLOWABLE AMOUNT OF LOW-THC CANNABIS. (a)
The allowable amount of low-THC cannabis for a person for whom
medical use is recommended under Chapter 169, Occupations Code, is
a 30-day supply of the recommended dosage for a particular patient
stated in terms of grams for low-THC cannabis in the form of dried
flower and in terms of milligrams of tetrahydrocannabinols
contained in oils or other products infused with low-THC cannabis.
(b) Oils or other products infused with low-THC cannabis
must be labeled in accordance with department rules to indicate the
quantity of each cannabinoid and terpene contained in the oil or
product for purposes of determining compliance with this section.
SECTION 7. Chapter 487, Health and Safety Code, is amended
by adding Subchapter A-1 to read as follows:
SUBCHAPTER A-1. PROTECTIONS RELATED TO MEDICAL USE OF CANNABIS
Sec. 487.021. PROTECTION FROM LEGAL ACTION. (a) This
section applies to a person who is:
(1) a patient for whom medical use is prescribed under
Chapter 169, Occupations Code, or the parent or caregiver of a
patient;
(2) a dispensing organization;
(3) a cannabis research organization;
(4) a cannabis testing facility; or
(5) a director, manager, or employee of a dispensing
organization, cannabis research organization, or cannabis testing
facility who is registered with the department under Section
487.053.
(b) Notwithstanding any other law, a person described by
Subsection (a) is not subject to arrest, prosecution, or penalty in
any manner, or denial of any right or privilege, including any civil
penalty or disciplinary action by a court or occupational or
professional licensing board or bureau, for conduct involving
medical use that is authorized under this chapter, Subchapter G,
Chapter 481, department rule, or Chapter 169, Occupations Code.
Sec. 487.022. NO PRESUMPTION OF CHILD ABUSE, NEGLECT, OR
ENDANGERMENT. A person described by Section 487.021(a) may not be
presumed to have engaged in conduct constituting child abuse,
neglect, or endangerment solely because the person engaged in
conduct involving medical use that is authorized under this
chapter, Subchapter G, Chapter 481, department rule, or Chapter
169, Occupations Code.
Sec. 487.023. NO DENIAL OF PARENTAL RIGHTS. The fact that a
person described by Section 487.021(a) engages in conduct
authorized under this chapter, Subchapter G, Chapter 481,
department rule, or Chapter 169, Occupations Code, does not in
itself constitute grounds for denying, limiting, or restricting
conservatorship or possession of or access to a child under Title 5,
Family Code.
Sec. 487.024. NO SEIZURE OR FORFEITURE. Property used in
the cultivation, research, testing, processing, distribution,
transportation, and delivery of low-THC cannabis for medical use
that is authorized under this chapter, Subchapter G, Chapter 481,
department rule, or Chapter 169, Occupations Code, is not
contraband for purposes of Chapter 59, Code of Criminal Procedure,
and is not subject to seizure or forfeiture under that chapter or
other law solely for the use of the property in those authorized
activities.
Sec. 487.025. NO PROSECUTION FOR PROVISION OF
PARAPHERNALIA. A person is not subject to arrest, prosecution, or
the imposition of any sentence or penalty for the delivery,
possession with intent to deliver, or manufacture of any item that
meets the definition of drug paraphernalia, as defined by Section
481.002, if that item is delivered, possessed with intent to
deliver, or manufactured for the sole purpose of providing that
item to:
(1) a person for whom medical use is recommended under
Chapter 169, Occupations Code;
(2) a licensed cannabis research organization; or
(3) a licensed cannabis testing facility.
SECTION 8. Section 487.052, Health and Safety Code, is
amended to read as follows:
Sec. 487.052. RULES. (a) The director shall adopt any
rules necessary for the administration and enforcement of this
chapter.
(b) The director shall adopt [, including] rules imposing
reasonable fees under this chapter in amounts sufficient to cover
the cost of administering this chapter and Subchapter G, Chapter
481. The department may also use fees to establish a cannabis
testing and quality control fund for the costs of equipment to test
cannabis, cannabis products, and other substances for the purpose
of assisting law enforcement to enforce this subtitle.
(c) The director by rule shall adopt labeling requirements
for low-THC cannabis. In adopting labeling requirements, the
director shall ensure each oil and product infused with low-THC
cannabis is labeled with the quantity of each cannabinoid and
terpene contained in the oil or product.
(d) In consultation with the cannabis therapeutic research
review board under Chapter 481, the director shall adopt necessary
rules to allow the department to monitor the safety and efficacy of
low-THC cannabis and oils or products infused with low-THC
cannabis, including rules:
(1) requiring accurate reporting to consumers by
testing facilities regarding the content of low-THC cannabis and
oils or products infused with low-THC cannabis; and
(2) providing for random testing by the department to
ensure compliance with labeling and reporting requirements.
(e) In consultation with the cannabis therapeutic research
review board under Chapter 481, the director may collect data from
dispensing organizations, cannabis research organizations,
cannabis testing facilities, and health care providers as necessary
to enable the department to monitor the safety and efficacy of
low-THC cannabis and oils or products infused with low-THC
cannabis. The director may adopt rules for the data collection
under this subsection.
SECTION 9. The heading to Section 487.053, Health and
Safety Code, is amended to read as follows:
Sec. 487.053. LICENSING OF DISPENSING ORGANIZATIONS,
CANNABIS RESEARCH ORGANIZATIONS, AND CANNABIS TESTING FACILITIES;
REGISTRATION OF CERTAIN ASSOCIATED INDIVIDUALS.
SECTION 10. Section 487.053(a), Health and Safety Code, is
amended to read as follows:
(a) The department shall:
(1) issue or renew a license under Subchapter C to
operate as:
(A) a dispensing organization to each applicant
who satisfies the requirements established under this chapter for
licensure as a dispensing organization;
(B) a cannabis research organization to each
applicant who satisfies the requirements established under this
chapter for licensure as a cannabis research organization; and
(C) a cannabis testing facility to each applicant
who satisfies the requirements established under this chapter for
licensure as a cannabis testing facility; and
(2) register directors, managers, and employees under
Subchapter D of each:
(A) dispensing organization;
(B) cannabis research organization; and
(C) cannabis testing facility.
SECTION 11. Section 487.054, Health and Safety Code, is
amended to read as follows:
Sec. 487.054. COMPASSIONATE-USE REGISTRY. (a) The
department shall establish and maintain a secure online
compassionate-use registry that contains:
(1) the name of each physician who registers as a
physician prescribing low-THC cannabis for medical use [the
prescriber] for a patient under Section 169.004, Occupations Code,
the name and date of birth of the patient, the dosage prescribed,
the means of administration ordered, and the debilitating medical
condition for which medical use is prescribed for the patient
[total amount of low-THC cannabis required to fill the patient's
prescription]; and
(2) the allowable amount of low-THC cannabis specified
by a prescribing physician for the patient under Chapter 169,
Occupations Code [a record of each amount of low-THC cannabis
dispensed by a dispensing organization to a patient under a
prescription].
(b) The department shall ensure the registry:
(1) is designed to prevent more than one [qualified]
physician from registering as the prescribing physician
[prescriber] for a single patient;
(2) is accessible to law enforcement agencies and
dispensing organizations for the purpose of verifying whether a
patient is one for whom low-THC cannabis is prescribed [and whether
the patient's prescriptions have been filled]; and
(3) allows a physician prescribing [qualified to
prescribe] low-THC cannabis under Chapter 169 [Section 169.002],
Occupations Code, to input safety and efficacy data derived from
the treatment of patients for whom medical use of low-THC cannabis
is prescribed under Chapter 169, Occupations Code.
SECTION 12. Subchapter B, Chapter 487, Health and Safety
Code, is amended by adding Section 487.055 to read as follows:
Sec. 487.055. DESIGNATION OF CAREGIVERS. (a) The
department shall develop a form for a patient listed in the registry
to designate one caregiver and one alternate caregiver.
(b) The form must require the patient to provide the full
name, home address, and date of birth of the patient's caregiver and
alternate caregiver.
(c) A patient may not designate as the patient's caregiver
or alternate caregiver a person who has been previously convicted
of an offense punishable as a felony involving the manufacture,
delivery, or possession of a controlled substance.
(d) A person may be a caregiver or alternate caregiver for
only one patient at a time unless:
(1) each patient is related to the caregiver within
the fourth degree of consanguinity or affinity, as determined in
the manner described by Chapter 573, Government Code; or
(2) the caregiver is employed by a home health care
agency or other service and provides assistance to multiple
patients who are registered low-THC cannabis patients as part of
the caregiver's job duties.
(e) The director shall adopt rules necessary to implement
this section, including rules allowing a patient to change the
patient's caregiver or alternate caregiver and to provide
identification cards for registered caregivers.
SECTION 13. The heading to Subchapter C, Chapter 487,
Health and Safety Code, is amended to read as follows:
SUBCHAPTER C. LICENSING OF [LICENSE TO OPERATE AS] DISPENSING
ORGANIZATIONS, CANNABIS RESEARCH ORGANIZATIONS, AND CANNABIS
TESTING FACILITIES [ORGANIZATION]
SECTION 14. Section 487.101, Health and Safety Code, is
amended to read as follows:
Sec. 487.101. LICENSE REQUIRED. A person may not operate as
a dispensing organization, a cannabis research organization, or a
cannabis testing facility without the appropriate license issued by
the department under this subchapter [chapter is required to
operate a dispensing organization].
SECTION 15. Section 487.102, Health and Safety Code, is
amended to read as follows:
Sec. 487.102. ELIGIBILITY FOR LICENSE TO OPERATE AS
DISPENSING ORGANIZATION. (a) 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, manager, 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.
(b) A dispensing organization may operate three additional
retail dispensing locations under a single license issued by the
department under this chapter on application to the department. If
the department determines that additional locations are necessary
to meet patient access needs, then a licensee may operate more than
four dispensing locations. The department may set a fee for an
application for each additional location in accordance with Section
487.103.
SECTION 16. Subchapter C, Chapter 487, Health and Safety
Code, is amended by adding Sections 487.1021 and 487.1022 to read as
follows:
Sec. 487.1021. ELIGIBILITY FOR LICENSE TO OPERATE AS
CANNABIS RESEARCH ORGANIZATION. (a) An applicant for a license to
operate as a cannabis research organization is eligible for the
license if:
(1) as determined by the department, the applicant
possesses:
(A) the ability to secure the resources and
personnel necessary to operate as a cannabis research organization;
and
(B) the financial ability to maintain operations
for not less than two years from the date of application;
(2) each director, manager, or employee of the
applicant is registered under Subchapter D;
(3) for medical or scientific research, the applicant
has submitted a research proposal to the cannabis therapeutic
research review board as described in Subchapter G, Chapter 481;
and
(4) the applicant satisfies any additional criteria
determined by the director to be necessary for the operation of a
cannabis research organization.
(b) If the applicant is affiliated with a medical school, as
defined by Section 61.501, Education Code, a hospital licensed
under Chapter 241, or a general academic teaching institution, as
defined by Section 61.003, Education Code, the department shall
presume the requirements of Subsection (a)(1) are met.
Sec. 487.1022. ELIGIBILITY FOR LICENSE TO OPERATE AS
CANNABIS TESTING FACILITY. An applicant for a license to operate as
a cannabis testing facility is eligible for the license if:
(1) as determined by the department, the applicant
possesses:
(A) the ability to secure the resources and
personnel necessary to operate as a cannabis testing facility; and
(B) the financial ability to maintain operations
for not less than two years from the date of application;
(2) the applicant is accredited by an accreditation
body in accordance with International Organization for
Standardization ISO/IEC 17025 or a successor standard;
(3) each director, manager, or employee of the
applicant is registered under Subchapter D; and
(4) the applicant satisfies any additional criteria
determined by the director to be necessary for the operation of a
cannabis testing facility.
SECTION 17. Section 487.103, Health and Safety Code, is
amended by adding Subsections (a-1) and (a-2) to read as follows:
(a-1) A person may apply for an initial or renewal license
to operate as a cannabis research organization by submitting a form
prescribed by the department along with the application fee in an
amount set by the director that may not exceed $500.
(a-2) A person may apply for an initial or renewal license
to operate as a cannabis testing facility by submitting a form
prescribed by the department along with the application fee in an
amount set by the director.
SECTION 18. Section 487.104(a), Health and Safety Code, is
amended to read as follows:
(a) The department shall issue or renew a license under this
subchapter [to operate as a dispensing organization] only if:
(1) the department determines the applicant meets the
eligibility requirements described by Section 487.102, 487.1021,
or 487.1022, as applicable; and
(2) in the case of a dispensing organization, issuance
[or renewal] of the license is necessary to ensure reasonable
statewide access to, and the availability of, low-THC cannabis and
the medically appropriate formulations determined under Section
481.202(f) for patients registered in the compassionate-use
registry and for whom low-THC cannabis is prescribed under Chapter
169, Occupations Code.
SECTION 19. Sections 487.105(a) and (b), Health and Safety
Code, are amended to read as follows:
(a) An applicant for the issuance or renewal of a license
under this subchapter [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, managers, and employees.
(b) Before a license holder under this subchapter
[dispensing organization licensee] hires a manager or employee for
the organization or facility, the license holder [licensee] must
provide the department with the name of the prospective manager or
employee. The license holder [licensee] may not transfer the
license to another person before that prospective applicant and the
applicant's directors, managers, and employees pass a criminal
history background check and are registered as required by
Subchapter D.
SECTION 20. Section 487.106, Health and Safety Code, is
amended to read as follows:
Sec. 487.106. DUTY TO MAINTAIN ELIGIBILITY. Each license
holder under this subchapter [A dispensing organization] must
maintain compliance at all times with the eligibility requirements
described by Section 487.102, 487.1021, or 487.1022, as applicable.
SECTION 21. Section 487.107, Health and Safety Code, is
amended by adding Subsection (c) to read as follows:
(c) On request of the department, a dispensing organization
must provide to the department a sample suitable for testing of
low-THC cannabis dispensed by the organization.
SECTION 22. Sections 487.108(a), (b), and (c), Health and
Safety Code, are amended to read as follows:
(a) The department may at any time suspend or revoke a
license issued under this subchapter [chapter] if the department
determines that the license holder [licensee] has not maintained
the eligibility requirements described by Section 487.102,
487.1021, or 487.1022, as applicable, or has failed to comply with a
duty imposed under this chapter.
(b) The director shall give written notice to the license
holder [dispensing organization] of a license suspension or
revocation under this section and the grounds for the suspension or
revocation. The notice must be sent by certified mail, return
receipt requested.
(c) After suspending or revoking a license issued under this
subchapter [chapter], the director may seize or place under seal
all low-THC cannabis and drug paraphernalia owned or possessed by
the license holder [dispensing organization]. If the director
orders the revocation of the license, a disposition may not be made
of the seized or sealed low-THC cannabis or drug paraphernalia
until the time for administrative appeal of the order has elapsed or
until all appeals have been concluded. When a revocation order
becomes final, all low-THC cannabis and drug paraphernalia may be
forfeited to the state as provided under Subchapter E, Chapter 481.
SECTION 23. Section 487.151(a), Health and Safety Code, is
amended to read as follows:
(a) An individual who is a director, manager, or employee of
a license holder under Subchapter C [dispensing organization] must
apply for and obtain a registration under this section.
SECTION 24. 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, dispensing, research, testing, or
possession of low-THC cannabis, as authorized by this chapter.
SECTION 25. Chapter 169, Occupations Code, is amended to
read as follows:
CHAPTER 169. AUTHORITY TO PRESCRIBE LOW-THC CANNABIS TO CERTAIN
PATIENTS FOR COMPASSIONATE USE
Sec. 169.001. DEFINITIONS. In this chapter:
(1) "Bona fide physician-patient relationship" means
a treatment or counseling relationship between a physician and
patient in which all of the following are present:
(A) the physician has reviewed the patient's
relevant medical records and completed a full assessment of the
patient's medical history and current medical condition, including
a relevant, in-person, medical evaluation of the patient;
(B) the physician has created and maintained
records of the patient's condition in accordance with medically
accepted standards;
(C) the physician has a reasonable expectation
that the physician will provide follow-up care to the patient to
monitor the efficacy of the use of low-THC cannabis as a treatment
of the patient's debilitating medical condition; and
(D) if the patient has given permission, the
physician has notified the patient's primary care physician of the
patient's debilitating medical condition and certification for the
medical use of low-THC cannabis to treat that condition.
(2) "Debilitating medical condition" means:
(A) cancer, autism, post-traumatic stress
disorder, neurological conditions including agitation of
Alzheimer's disease, Parkinson's disease, Huntington's disease,
amyotrophic lateral sclerosis, and Tourette syndrome, Crohn's
disease, ulcerative colitis, muscular dystrophy, or multiple
sclerosis; or
(B) a medical condition that produces, or the
treatment of a medical condition that produces:
(i) endocannabinoid deficiency syndrome;
(ii) cachexia or wasting syndrome;
(iii) neuropathy;
(iv) visceral, neuropathic, somatic, or
severe intractable pain;
(v) severe nausea;
(vi) seizures, including those
characteristic of epilepsy;
(vii) severe and persistent muscle spasms,
including those characteristic of multiple sclerosis; or
(viii) tic disorders.
(3) "Department" means the Department of Public
Safety.
(4) [(2) "Intractable epilepsy" means a seizure
disorder in which the patient's seizures have been treated by two or
more appropriately chosen and maximally titrated antiepileptic
drugs that have failed to control the seizures.
[(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[:
[(A)] not more than 0.5 percent by weight of
tetrahydrocannabinols[; and
[(B) not less than 10 percent by weight of
cannabidiol]. Notwithstanding other law, low-THC cannabis includes
any medical formulation or dosage approved under Section
481.202(f).
(5) [(4)] "Medical use" means the ingestion by a means
of administration other than by smoking of a prescribed amount of
low-THC cannabis by a person for whom medical use [low-THC
cannabis] is prescribed under this chapter.
(6) "Prescribe" means the act of a physician to
authorize low-THC cannabis to be dispensed to a patient.
(7) "Prescription" means an order by a physician,
provided on a secure online form designated by the department, that
specifies:
(A) the date of the order's issue;
(B) the name and date of birth of the patient;
(C) the dosage, any cannabinoid ratios, and
quantity prescribed to the patient;
(D) directions for the use and means of
administration of the low-THC cannabis; and
(E) an amount of low-THC cannabis needed by the
patient for a 30-day period.
(8) "Serious adverse event" means an adverse event
that:
(A) results in death;
(B) results in an illness requiring
hospitalization;
(C) is considered life-threatening; or
(D) results in a persistent or significant
disability, incapacity, or medically important condition.
(9) [(5)] "Smoking" means burning or igniting a
substance and inhaling the smoke. The term does not include
vaporizing.
(10) "Vaporizing" means heating a substance to a
temperature below the combustion point of the substance so that the
vapor may be inhaled.
Sec. 169.002. PHYSICIAN AUTHORIZED [QUALIFIED] TO
PRESCRIBE LOW-THC CANNABIS. (a) A [Only a] physician [qualified as
provided by this section] may prescribe low-THC cannabis in
accordance with this chapter for a patient with a debilitating
medical condition, provided that:
(1) the physician has obtained the proper medical
knowledge concerning medical use as treatment for a patient's
particular debilitating medical condition through a course of
instruction provided for that purpose, continuing medical
education relating to medical use, or self-study;
(2) the physician has determined that the risk of
medical use by the patient is reasonable in light of the potential
benefit for the patient; and
(3) a second physician licensed in this state has
concurred with the physician's determination under Subdivision (2)
and the second physician's concurrence is recorded in the patient's
medical record.
(b) [A physician is qualified to prescribe low-THC cannabis
to a patient with intractable epilepsy if the physician:
[(1) is licensed under this subtitle;
[(2) dedicates a significant portion of clinical
practice to the evaluation and treatment of epilepsy; and
[(3) is certified:
[(A) by the American Board of Psychiatry and
Neurology in:
[(i) epilepsy; or
[(ii) neurology or neurology with special
qualification in child neurology and is otherwise qualified for the
examination for certification in epilepsy; or
[(B) in neurophysiology by:
[(i) the American Board of Psychiatry and
Neurology; or
[(ii) the American Board of Clinical
Neurophysiology.
[Sec. 169.003. PRESCRIPTION OF LOW-THC CANNABIS.] A
physician who prescribes low-THC cannabis under this chapter must
[described by Section 169.002 may prescribe low-THC cannabis to
alleviate a patient's seizures if]:
(1) comply [the patient is a permanent resident of the
state;
[(2) the physician complies] with the registration
requirements of Section 169.004; and
(2) certify [(3) the physician certifies] to the
department that:
(A) there is a bona fide physician-patient
relationship;
(B) the patient is diagnosed with a debilitating
medical condition [intractable epilepsy];
(C) [(B)] the physician has determined that
[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; [and]
(D) the physician has obtained the proper medical
knowledge required by Subsection (a); and
(E) [(C)] a second physician licensed in this
state [qualified to prescribe low-THC cannabis under Section
169.002] has concurred with the physician's determination under
Paragraph (C) [(B)], and the second physician's concurrence is
recorded in the patient's medical record.
Sec. 169.004. PHYSICIAN [LOW-THC CANNABIS PRESCRIBER]
REGISTRATION OF PRESCRIPTION. (a) Before a physician [qualified
to prescribe low-THC cannabis under Section 169.002] may prescribe
low-THC cannabis for medical use [prescribe or renew a prescription
for low-THC cannabis] for a patient under this chapter, the
physician must register as the prescribing physician [prescriber
for that patient] in the compassionate-use registry maintained by
the department under Section 487.054, Health and Safety Code.
(b) Before a physician may prescribe low-THC cannabis for a
particular patient, the physician must add that prescription for
the patient to the physician's registration information.
(c) The department may publish the name of a physician
registered under this section only if permission is expressly
granted by the physician. The physician's name is confidential and
is not subject to disclosure under Chapter 552, Government Code.
[The physician's registration must indicate:
[(1) the physician's name;
[(2) the patient's name and date of birth;
[(3) the dosage prescribed to the patient;
[(4) the means of administration ordered for the
patient; and
[(5) the total amount of low-THC cannabis required to
fill the patient's prescription.]
Sec. 169.005. PATIENT TREATMENT PLAN. A physician
[described by Section 169.002] who prescribes low-THC cannabis for
a patient's medical use under this chapter must maintain a patient
treatment plan that indicates:
(1) the dosage, means of administration, and planned
duration of treatment for the low-THC cannabis;
(2) a plan for monitoring the patient's symptoms; and
(3) a plan for monitoring indicators of tolerance or
reaction to low-THC cannabis, including any adverse events.
Sec. 169.006. ADVERSE EVENT REPORTING. A physician must
record any adverse event in the patient's medical records and shall
report any serious adverse event to the cannabis therapeutic
research review board.
Sec. 169.007. PHYSICIAN'S STATEMENT; PARTICIPATION IN
PROGRAMS. A physician may not be denied any right or privilege or
be subject to any disciplinary action solely for:
(1) making a written or oral statement that, in the
physician's professional opinion, the potential benefits of the use
of cannabis would likely outweigh the health risks; or
(2) participation in programs under Subchapter G,
Chapter 481, or Chapter 487, Health and Safety Code.
SECTION 26. Section 551.004, Occupations Code, is amended
by amending Subsection (a) and adding Subsection (a-1) to read as
follows:
(a) This subtitle does not apply to:
(1) a practitioner licensed by the appropriate state
board who supplies a patient of the practitioner with a drug in a
manner authorized by state or federal law and who does not operate a
pharmacy for the retailing of prescription drugs;
(2) a member of the faculty of a college of pharmacy
recognized by the board who is a pharmacist and who performs the
pharmacist's services only for the benefit of the college;
(3) a person who procures prescription drugs for
lawful research, teaching, or testing and not for resale;
(4) a home and community support services agency that
possesses a dangerous drug as authorized by Section 142.0061,
142.0062, or 142.0063, Health and Safety Code; [or]
(5) a dispensing organization[, as defined by Section
487.001, Health and Safety Code,] that cultivates, processes, and
dispenses low-THC cannabis, as authorized by a license issued under
Subchapter C, Chapter 487, Health and Safety Code, to a patient
listed in the compassionate-use registry established under that
chapter;
(6) a cannabis research organization that researches
the cultivation, analysis, and medical use of low-THC cannabis, as
authorized by a license issued under Subchapter C, Chapter 487,
Health and Safety Code; or
(7) a cannabis testing facility that analyzes the
content, safety, and potency of low-THC cannabis, as authorized by
a license issued under Subchapter C, Chapter 487, Health and Safety
Code.
(a-1) For purposes of Subsections (a)(5), (6), and (7),
"cannabis research organization," "cannabis testing facility," and
"dispensing organization" have the meanings assigned by Section
487.001, Health and Safety Code.
SECTION 27. Not later than December 1, 2019, the public
safety director of the Department of Public Safety shall adopt
rules as required to implement, administer, and enforce Chapter
487, Health and Safety Code, as amended by this Act.
SECTION 28. (a) A license to operate as a dispensing
organization issued under Chapter 487, Health and Safety Code,
before the effective date of this Act continues to be valid after
the effective date of this Act until that license expires.
(b) The registration of a director, manager, or employee of
a dispensing organization under Subchapter D, Chapter 487, Health
and Safety Code, continues to be valid after the effective date of
this Act until that registration expires.
(c) Not later than September 1, 2020, the Department of
Public Safety shall license at least 12 dispensing organizations in
accordance with Section 487.053, Health and Safety Code, as amended
by this Act, including those already licensed as of the effective
date of this Act, provided at least 12 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.
(d) As of the effective date of this Act, the duties of the
review board established under Subchapter G, Chapter 481, Health
and Safety Code, are transferred to the review board composed of the
members appointed under Section 481.201, Health and Safety Code, as
amended by this Act. The governor shall appoint the additional
members provided for by amendments made to that section by this Act,
as soon as practicable and not later than October 1, 2019.
(e) Not later than March 1, 2020, the Department of Public
Safety shall begin licensing cannabis research organizations and
cannabis testing facilities in accordance with Subchapter C,
Chapter 487, Health and Safety Code, as amended by this Act,
provided that the applicants for a license have met all
requirements for approval under that subchapter.
SECTION 29. This Act takes effect immediately if it
receives a vote of two-thirds of all the members elected to each
house, as provided by Section 39, Article III, Texas Constitution.
If this Act does not receive the vote necessary for immediate
effect, this Act takes effect September 1, 2019.