87R9471 JSC-F
By: Menéndez S.B. No. 2040
A BILL TO BE ENTITLED
AN ACT
relating to authorizing the possession, use, cultivation,
distribution, delivery, sale, and research of medical cannabis for
medical use by patients with certain medical conditions and the
licensing of medical cannabis organizations; authorizing fees.
BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS:
ARTICLE 1. FINDINGS AND PURPOSE
SECTION 1.01. LEGISLATIVE FINDINGS; PURPOSE. The
legislature finds that:
(1) scientific evidence suggests that medical
cannabis is one potential therapy that may mitigate suffering,
enhance quality of life, and offer potential treatment of certain
medical conditions;
(2) Texas patients should have reasonable statewide
access to medical cannabis subject to safeguards for public health
and safety;
(3) a seriously ill patient who engages in medical use
of cannabis on a treating practitioner's advice should not be
arrested, incarcerated, or otherwise punished for violation of drug
laws;
(4) where patients are suffering from certain medical
conditions, they and their physicians should have a right to try
medical cannabis as an alternative medicine through a safe and
regulated program; and
(5) Texas has a wealth of esteemed research
institutions from medical to agricultural that can greatly
contribute to the advancement of research on the safe cultivation,
manufacturing, and use of medical cannabis.
ARTICLE 2. MEDICAL CANNABIS RESEARCH PROGRAM
SECTION 2.01. Subtitle A, Title 6, Health and Safety Code,
is amended by adding Chapter 444 to read as follows:
CHAPTER 444. MEDICAL CANNABIS RESEARCH PROGRAM
SUBCHAPTER A. GENERAL PROVISIONS
Sec. 444.001. SHORT TITLE. This chapter may be cited as the
Medical Cannabis Research Act.
Sec. 444.002. DEFINITIONS. In this chapter:
(1) "Advisory board" means the medical cannabis
research advisory board established under this chapter.
(2) "License" means a medical cannabis research
license issued by the department under Subchapter C.
(3) "License holder" means a person who holds a
medical cannabis research license.
(4) "Medical cannabis" has the meaning assigned by
Section 169.001, Occupations Code.
SUBCHAPTER B. MEDICAL CANNABIS RESEARCH ADVISORY BOARD
Sec. 444.051. ESTABLISHMENT OF ADVISORY BOARD. (a) A
medical cannabis research advisory board is established to perform
functions and duties under this chapter.
(b) The executive commissioner shall assist the advisory
board as provided by this chapter.
Sec. 444.052. MEMBERSHIP. (a) The advisory board members
are appointed by the governor and serve staggered six-year terms,
with the terms of one-third of the members expiring on August 31 of
each odd-numbered year.
(b) The advisory board shall be composed of the following 12
members:
(1) a licensed physician certified by the American
Board of Internal Medicine and certified in the subspecialty of
medical oncology;
(2) a licensed physician certified by the American
Board of Psychiatry;
(3) a licensed physician certified by the American
Board of Surgery;
(4) a licensed physician certified by the American
Board of Psychiatry and Neurology;
(5) a licensed physician certified by the American
Board of Family Medicine;
(6) a licensed physician certified in neurology with a
special qualification in child neurology;
(7) a licensed physician specializing in pain
management certified by the American Board of Anesthesiology, the
American Board of Neurology, or the American Board of Physical
Medicine and Rehabilitation;
(8) a licensed pharmacist;
(9) 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;
(10) a representative from a Texas medical specialty
organization;
(11) a licensed attorney with experience in law
pertaining to the practice of medicine and cannabis regulation; and
(12) a person who represents medical cannabis patient
interests.
(c) At least two members of the advisory board must be
affiliated with an institution of higher education or private or
independent institution of higher education involved in relevant
research, such as a medical unit, general academic teaching
institution, or other agency of higher education, as defined by
Section 61.003, Education Code.
(d) The governor shall select a presiding officer from the
membership of the advisory board.
(e) The advisory board shall meet at least quarterly at the
call of the presiding officer.
(f) The advisory board may create and appoint one or more
advisory committees composed of patients, law enforcement
officers, researchers, other medical professionals, and other
persons who are knowledgeable about the medical use of cannabis.
(g) Members serve without compensation but are entitled to
reimbursement for actual and necessary expenses incurred in
performing official duties.
Sec. 444.053. DUTIES OF ADVISORY BOARD; REPORT. (a) The
advisory board shall assist the department in evaluating proposals
submitted as part of a license application under Section 444.104.
(b) The advisory board shall conduct a continuing study of
the laws relating to medical cannabis to facilitate statewide
access to safe and effective medical cannabis.
(c) The advisory board shall prepare a report of the board's
findings and recommendations under Subsection (b) and submit the
report to the legislature not later than September 1 of each
even-numbered year.
(d) The advisory board shall consult with the Department of
Public Safety under Section 487.0521(b) on rules monitoring the
safety and efficacy of medical cannabis or medical cannabis
products.
SUBCHAPTER C. MEDICAL CANNABIS RESEARCH LICENSE
Sec. 444.101. ISSUANCE OF LICENSE. The department shall
issue a medical cannabis research license to a person that
authorizes the person to possess, manufacture, cultivate, or
dispense medical cannabis for the limited research purposes
described by Section 444.102.
Sec. 444.102. PURPOSE OF LICENSE. A medical cannabis
research license may be issued for the following limited research
purposes:
(1) conducting objective scientific research into the
safety and efficacy of medical cannabis or other public health
outcomes related to medical cannabis;
(2) developing medical guidelines for the appropriate
administration of medical cannabis to assist physicians and
patients in evaluating the risks and benefits of medical cannabis
and to provide a scientific basis for future policies;
(3) developing quality control, purity, and labeling
standards for medical cannabis;
(4) developing best practices for the safe and
efficient cultivation of medical cannabis;
(5) analyzing genetic and healing properties of
different varieties of cannabis;
(6) conducting genomic, horticultural, or
agricultural research; and
(7) conducting research on cannabis-affiliated
products or systems.
Sec. 444.103. APPLICATION FOR LICENSE. (a) As part of the
application process for a license, an applicant shall submit to the
department and the advisory board a description of the research
that the applicant intends to conduct. The department shall grant
the license if:
(1) the department determines that the application
meets the criteria described by Sections 444.102 and 487.102; and
(2) the advisory board recommends the application for
approval under Section 444.104(b).
(b) The department may not grant a license if the advisory
board does not recommend the application for approval.
Sec. 444.104. REVIEW BY ADVISORY BOARD. (a) The advisory
board shall review each applicant's research project to assess the
following:
(1) the quality, study design, value, or impact of the
project;
(2) whether the research supports the purposes in
Section 444.102;
(3) whether the applicant has the appropriate
personnel, expertise, facilities, infrastructure, funding, and
approvals in place to successfully conduct the project; and
(4) whether the amount of cannabis to be grown by the
applicant is consistent with the scope and goals of the project.
(b) If the advisory board determines that the research
project does meet the requirements of this subchapter and assesses
the criteria to be adequate, the advisory board may recommend that a
license be granted to the applicant for the project.
Sec. 444.105. CONTRACTS. A license holder may contract to
perform research in conjunction with another license holder, a
medical school, as defined by Section 61.501, Education Code, a
hospital licensed under Chapter 241, or an institution of higher
education or private or independent institution of higher education
involved in relevant research, such as a general academic teaching
institution, medical unit, or other agency of higher education, as
defined by Section 61.003, Education Code.
Sec. 444.106. TRANSFER OF CANNABIS TO OTHER LICENSE
HOLDERS. Unless otherwise authorized by the department, a license
holder may only transfer, by sale or donation, cannabis grown or
processed within the license holder's operation to other license
holders or program participants as authorized by department rule.
Sec. 444.107. LIMITATION OF LIABILITY. The growing,
cultivating, possessing, or transferring, by sale or donation, of
cannabis in accordance with this subchapter and the rules adopted
under this subchapter, by a license holder may not be the basis of
criminal or civil liability.
Sec. 444.108. FEES. The executive commissioner shall set
license and renewal fees in an amount sufficient to administer this
chapter.
Sec. 444.109. RULES. The executive commissioner shall, in
consultation with the advisory board and the Public Safety
Commission, adopt rules to implement this chapter, including:
(1) license application requirements;
(2) license renewal requirements, including the
consideration or addition of additional projects by a license
holder;
(3) conditions for license revocation;
(4) security measures to ensure cannabis is not
diverted to purposes other than research;
(5) license holder reporting requirements;
(6) conditions under which cannabis grown by licensed
cannabis cultivators and other product types from licensed cannabis
processors may be donated to license holders; and
(7) additional rules considered necessary by the
executive commissioner.
ARTICLE 3. CHANGES TO TEXAS COMPASSIONATE USE PROGRAM
SECTION 3.01. Section 487.001, Health and Safety Code, is
amended to read as follows:
Sec. 487.001. DEFINITIONS. In this chapter:
(1) "Caregiver" means a person who has a significant
responsibility for managing the well-being of a registered patient
whether a private party or employee of a long-term care facility,
other health care organization, or public institution.
(2) "Department" means the Department of Public
Safety.
(3) [(2)] "Director" means the public safety director
of the department.
[(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.]
(4) "Medical [Low-THC] cannabis" has the meaning
assigned by Section 169.001, Occupations Code.
(5) "Medical cannabis organization" means any
organization that cultivates, processes, manufactures,
distributes, researches, tests, dispenses, or conducts other
business regarding medical cannabis as authorized by a license
issued by the department under this chapter to provide medical
cannabis to patients for whom medical cannabis is recommended under
Chapter 169, Occupations Code.
(6) "Medical cannabis product" means a product, other
than cannabis itself, which contains or is derived from cannabis.
The term does not include products derived from hemp as defined by
Section 121.001, Agriculture Code.
(7) "Medical use" has the meaning assigned by Section
169.001, Occupations Code.
SECTION 3.02. 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 MEDICAL CANNABIS. (a)
The allowable amount of medical cannabis for a person for whom
medical use is recommended under Chapter 169, Occupations Code, is
an amount of cannabis in any form approved by the physician
possessed by a qualified patient or collectively possessed by a
qualified patient and the qualified patient's caregiver that is no
more than reasonably necessary to ensure the uninterrupted
availability of cannabis for a period of three months based on the
individual patient's recommended amount of medical cannabis and
that is obtained solely from a medical cannabis organization.
(b) Medical cannabis and medical cannabis products must be
packaged and labeled in accordance with department rules before
sale to a medical cannabis dispensary to indicate the quantity of
each cannabinoid and terpene contained in the product for purposes
of determining compliance with this section and protecting patient
health and safety.
SECTION 3.03. 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 recommended
under Chapter 169, Occupations Code, or the parent or caregiver of a
patient;
(2) a medical cannabis organization;
(3) a director, manager, or employee of a medical
cannabis organization who is registered with the department under
Section 487.053;
(4) a medical cannabis research license holder under
Chapter 444; or
(5) a person participating as a researcher or patient
in an approved research program under Subchapter G, Chapter 481.
(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, Chapter 444,
Subchapter G, Chapter 481, Chapter 169, Occupations Code, or
department rule.
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, Chapter 444, Subchapter G, Chapter 481, Chapter 169,
Occupations Code, or department rule.
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, Chapter 444, Subchapter G, Chapter
481, Chapter 169, Occupations Code, or department rule, 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 medical cannabis for medical use
that is authorized under this chapter, Chapter 444, Subchapter G,
Chapter 481, Chapter 169, Occupations Code, or department rule, 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 patient for whom medical use is recommended
under Chapter 169, Occupations Code, or the parent or caregiver of a
patient;
(2) a medical cannabis organization;
(3) a director, manager, or employee of a medical
cannabis organization who is registered with the department under
Section 487.053;
(4) a medical cannabis research license holder under
Chapter 444; or
(5) a person participating as a researcher or patient
in an approved research program under Subchapter G, Chapter 481.
Sec. 487.026. NO PUNISHMENT FOR STUDENT PATIENTS AND THEIR
CAREGIVERS. Notwithstanding any other law, a school or university
student for whom medical cannabis was recommended 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 received a valid recommendation for medical cannabis, nor
may a school health care professional be subject to any discipline
solely for assisting a student in the administration of medical
cannabis.
SECTION 3.04. Section 487.052, Health and Safety Code, is
amended to read as follows:
Sec. 487.052. RULES; FEES. (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. The department shall also
use revenue from fees to establish a cannabis testing and quality
control fund for the purpose of assisting law enforcement,
including accredited crime laboratories, to purchase instruments,
establish methods, and obtain resources needed to conduct forensic
analysis necessary to enforce this subtitle and to protect the
health and safety of medical cannabis patients and the public.
(c) The fees adopted under Subsection (b) may not exceed:
(1) $5,000 for application fees;
(2) $100 for registration fees under Subchapter D; and
(3) reasonable amounts for the issuance or renewal of
each class of license.
(d) The director may not adopt rules establishing a total
limit on the number of medical cannabis organization licenses by
class that may be granted nor set the price of or production
quantity of medical cannabis.
SECTION 3.05. Subchapter B, Chapter 487, Health and Safety
Code, is amended by adding Sections 487.0521 and 487.0522 to read as
follows:
Sec. 487.0521. SAFETY. (a) The director by rule shall
adopt packaging and labeling requirements for medical cannabis to
ensure patients are informed and protected. In adopting packaging
and labeling requirements, the director shall ensure that:
(1) each medical cannabis package is labeled with the
cannabinoid potency and terpenoid profile of medical cannabis or
medical cannabis product as determined by an independent testing
laboratory;
(2) each medical cannabis product and medical cannabis
package is labeled with the required warnings as determined by the
department; and
(3) the packaging and label of medical cannabis or a
medical cannabis product do not contain any false or misleading
statements and are not designed to appeal to children.
(b) In consultation with the medical cannabis research
advisory board under Chapter 444, the director shall adopt
necessary rules to allow the department to monitor the safety and
efficacy of medical cannabis or medical cannabis products,
including rules:
(1) requiring accurate reporting to consumers
regarding the content of medical cannabis or medical cannabis
products;
(2) providing for random testing by the department or
the department's designee to ensure compliance with labeling and
reporting requirements; and
(3) providing for health and safety regulations and
standards for the manufacture and cultivation of medical cannabis
and medical cannabis products.
(c) The director may collect data from medical cannabis
organizations and health care providers as necessary to enable the
department to monitor the safety and efficacy of medical cannabis.
The director may adopt rules for the data collection under this
subsection.
Sec. 487.0522. INVENTORY TRACKING REQUIREMENTS. (a) The
department shall establish and maintain a medical cannabis
inventory system that oversees the tracking, tracing, testing, and
quality control and quality assurance certification of medical
cannabis and medical cannabis products.
(b) The department may contract with other entities to
establish and maintain all or part of the medical cannabis
inventory system on behalf of the department.
(c) A medical cannabis organization shall use the medical
cannabis inventory system approved by the department to keep
records throughout the cannabis supply chain, including for every
transaction between license holders and between license holders and
patients. A medical cannabis organization may use its own
recordkeeping system provided the medical cannabis organization's
system can integrate with the department's system as required under
this chapter and rules. The records shall include, at a minimum:
(1) the name, license number, and assigned
identification number of the licensee that cultivated,
manufactured, tested, or sold the product;
(2) the address and phone number of the licensee that
cultivated, manufactured, tested, or sold the product;
(3) the type and weight of medical cannabis or medical
cannabis product transferred or received during the transaction;
(4) the batch number of the medical cannabis or
medical cannabis product used;
(5) the date of the transaction;
(6) the total spent in dollars;
(7) all point-of-sale records;
(8) the amount of any medical cannabis waste, in
pounds; and
(9) any additional information as may be reasonably
required by the department.
(d) Until the department establishes the medical cannabis
inventory program, each licensee shall use its own inventory
program that meets the requirements of this section.
(e) Each medical cannabis organization has a continuing
responsibility to maintain records on site that are readily
available to the department regardless of the functionality of the
statewide inventory program including, at a minimum, the criteria
established by this section and any requirements established by
rule.
(f) The department shall adopt rules necessary for the
implementation and enforcement of this section, including rules
ensuring:
(1) the department has 24-hour access to the inventory
program; and
(2) all inventory tracking records containing patient
information comply with Chapter 181 and the Health Insurance
Portability and Accountability Act of 1996 (42 U.S.C. Section 1320d
et seq.).
SECTION 3.06. The heading to Section 487.053, Health and
Safety Code, is amended to read as follows:
Sec. 487.053. LICENSING OF CANNABIS [DISPENSING]
ORGANIZATIONS AND REGISTRATION OF CERTAIN ASSOCIATED INDIVIDUALS.
SECTION 3.07. 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 medical cannabis [dispensing] organization to each
applicant who satisfies the requirements established under this
chapter for licensure under that class of medical cannabis
organization; [and]
(2) register directors, managers, and employees under
Subchapter D of each medical cannabis [dispensing] organization;
(3) issue a permit for additional locations to a
dispensing cannabis licensee on application if the licensee is in
compliance with all eligibility requirements and the proposed
location complies with any local zoning requirements and will
assist with ensuring reasonable statewide access;
(4) to ensure reasonable statewide access, issue no
less than the following number of licenses or permits for each type
of medical cannabis organization provided the department receives
an adequate number of qualified applications:
(A) dispensing cannabis organization licenses
and permits, based on population within each of the 11 public health
regions established by the Health and Human Services Commission, as
follows:
(i) 9 in public health region 1;
(ii) 6 in public health region 2;
(iii) 82 in public health region 3;
(iv) 12 in public health region 4;
(v) 8 in public health region 5;
(vi) 75 in public health region 6;
(vii) 37 in public health region 7;
(viii) 31 in public health region 8;
(ix) 7 in public health region 9;
(x) 9 in public health region 10; and
(xi) 24 in public health region 11;
(B) one cultivation cannabis organization
license for every four dispensing cannabis organization licenses;
(C) one processing cannabis organization license
for every three dispensing cannabis organization licenses; and
(D) the number of testing cannabis organization
licenses necessary to meet demand;
(5) once the number of registered medical cannabis
patients reaches 100,000, issue no less than 24 additional
dispensing cannabis organization licenses and permits and other
medical cannabis organization license types under Subdivision (4);
and
(6) for each additional 100,000 patients, issue no
less than 24 additional dispensing cannabis organization licenses
and permits and other medical cannabis organization license types
under Subdivision (4).
SECTION 3.08. 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 recommending medical cannabis and for each patient for
whom the physician has registered:
(A) [the prescriber for a patient under Section
169.004, Occupations Code,] the patient's name, and any caregivers'
names, if applicable;
(B) the patient's [and] date of birth;
(C) the nature of the patient's eligible medical
condition;
(D) [of the patient,] the dosage recommended;
(E) [prescribed,] the means of administration
ordered; [,] and
(F) the total amount of medical [low-THC]
cannabis required to fill the patient's recommendation
[prescription]; and
(2) a record of each amount of medical [low-THC]
cannabis dispensed by a medical cannabis [dispensing] organization
to a patient under a recommendation [prescription].
(b) The department shall ensure the registry:
(1) is designed to prevent more than one qualified
physician from registering as the recommending physician
[prescriber] for a single patient;
(2) is accessible to law enforcement agencies and
medical cannabis [dispensing] organizations licensed to dispense
medical cannabis for the purpose of verifying whether a patient is
one for whom medical [low-THC] cannabis is recommended [prescribed]
and whether the patient's recommendations [prescriptions] have
been filled; [and]
(3) allows a physician [qualified to prescribe low-THC
cannabis under Section 169.002, Occupations Code,] to input safety
and efficacy data derived from the treatment of patients for whom
medical [low-THC] cannabis is recommended [prescribed] under
Chapter 169, Occupations Code, including any severe adverse effects
due to the medical use of medical cannabis; and
(4) ensures that all application records and
information are sealed to protect the privacy of patients.
(c) The handling of any records maintained in the registry
must comply with all relevant state and federal privacy laws,
including, but not limited to, Chapter 181.
SECTION 3.09. 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 caregivers whether an individual, health care
facility, or public institution. Caregivers may possess medical
cannabis and medical cannabis products up to the sum of the
possession limits for the patient or patients under the caregiver's
care.
(b) The form must require the patient to provide the full
name, home address, and date of birth of the patient's caregiver or,
in the case of an organization, the organization's name and
address.
(c) The director shall adopt rules necessary to implement
this section, including rules to provide identification cards for
registered caregivers.
SECTION 3.10. The heading to Subchapter C, Chapter 487,
Health and Safety Code, is amended to read as follows:
SUBCHAPTER C. LICENSE TO OPERATE AS MEDICAL CANNABIS [DISPENSING]
ORGANIZATION
SECTION 3.11. 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 medical
cannabis [dispensing] organization.
(b) The director by rule shall adopt application and
licensing requirements and privileges of each medical cannabis
organization license type.
(c) Medical cannabis organization license types shall
include the following:
(1) cultivating cannabis organization that cultivates
medical cannabis for sale and distribution to other medical
cannabis organizations and may process and package cannabis for
individual sale so long as the cannabis is not subjected to any
chemical alteration;
(2) processing cannabis organization that extracts
medical cannabis and manufactures, prepares, and packages medical
cannabis products for sale and distribution to other medical
cannabis organizations;
(3) dispensing cannabis organization that sells
medical cannabis and medical cannabis products to patients;
(4) independent testing cannabis organizations that
test medical cannabis and medical cannabis products for potency,
safety, and efficacy; and
(5) any other class of medical cannabis organization
that the department finds warranted to safely and securely ensure
reasonable statewide access of medical cannabis for medical use.
SECTION 3.12. 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 medical cannabis [dispensing] organization
is eligible for the license if:
(1) as determined by the department, the applicant
possesses:
(A) the technical and technological ability
appropriate for that class of license [to cultivate and produce
low-THC cannabis];
(B) the ability to secure:
(i) the resources and personnel necessary
to operate as a medical cannabis [dispensing] organization; and
(ii) for distribution or
dispensing 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 medical [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; and
(E) any specific qualifications for licensure
for each class of license the department promulgates by rule under
this chapter that are demonstrably related to the operations
authorized and duties imposed under that class of license to safely
and securely provide medical cannabis for medical use to patients;
(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; and
(4) each director, manager, employee, and any other
relevant individual, as determined by department rule, passes a
criminal history background check the department approves as
reliable and expedient to ensure applicants comply with eligibility
requirements established by the department by rule.
SECTION 3.13. Subchapter C, Chapter 487, Health and Safety
Code, is amended by adding Section 487.1021 to read as follows:
Sec. 487.1021. ELIGIBILITY FOR LICENSE TO OPERATE AS AN
INDEPENDENT CANNABIS TESTING ORGANIZATION. In addition to the
criteria described by Section 487.102, an applicant for a license
to operate as an independent cannabis testing organization is
eligible for the license if:
(1) the applicant submits proof of accreditation by an
independent accreditation body in accordance with the
International Organization for Standardization ISO/IEC 17025 or a
comparable or successor standard;
(2) the applicant submits proof that it does not share
ownership interest or joint management with any medical cannabis
organization whose product the applicant may test except for less
than 10 percent ownership in publicly traded companies; and
(3) the applicant satisfies any additional criteria
determined by the director to be necessary for the operation of a
cannabis testing facility.
SECTION 3.14. Section 487.103(a), Health and Safety Code,
is amended to read as follows:
(a) A person may apply for an initial or renewal license to
operate as a medical cannabis [dispensing] organization by
submitting a form prescribed by the department along with the
application fee in an amount set by the director for that class of
license.
SECTION 3.15. Section 487.104(a), Health and Safety Code,
is amended to read as follows:
(a) The department shall issue or renew a license to operate
as a medical cannabis [dispensing] organization [only] if:
(1) the department determines the applicant meets the
eligibility requirements described by Section 487.102 or 487.1021,
as applicable; and
(2) issuance or renewal of the license would assist
[is necessary to ensure] reasonable statewide access to, and the
availability of, medical [low-THC] cannabis for patients
registered in the compassionate-use registry and for whom medical
[low-THC] cannabis is recommended [prescribed] under Chapter 169,
Occupations Code.
SECTION 3.16. 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 medical cannabis [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, managers, and employees pass a criminal
history background check and any other requirements established by
the department by rule, and are registered as required by
Subchapter D.
SECTION 3.17. Section 487.106, Health and Safety Code, is
amended to read as follows:
Sec. 487.106. DUTY TO MAINTAIN ELIGIBILITY. (a) Each
license holder under this subchapter [A dispensing organization]
must maintain compliance at all times with the eligibility
requirements described by Section 487.102 or 487.1021, as
applicable.
(b) On request of the department, a license holder must
provide to the department a reasonably sized sample suitable for
testing of medical cannabis.
SECTION 3.18. Section 487.107, Health and Safety Code, is
amended to read as follows:
Sec. 487.107. DUTIES RELATING TO DISPENSING
[PRESCRIPTION]. (a) Before dispensing medical [low-THC] cannabis
to a person for whom the medical [low-THC] cannabis is recommended
[prescribed] under Chapter 169, Occupations Code, the medical
cannabis [dispensing] organization must verify that the
recommendation [prescription] presented:
(1) is for a person listed as a patient in the
compassionate-use registry;
(2) matches the entry in the compassionate-use
registry with respect to the total amount of medical [low-THC]
cannabis required to fill the recommendation [prescription]; and
(3) has not previously been filled by a medical
cannabis [dispensing] organization as indicated by an entry in the
compassionate-use registry.
(b) After dispensing medical [low-THC] cannabis to a
patient for whom the medical [low-THC] cannabis is recommended
[prescribed] under Chapter 169, Occupations Code, the medical
cannabis [dispensing] organization shall record in the
compassionate-use registry the form and quantity of medical
[low-THC] cannabis dispensed and the date and time of dispensation.
SECTION 3.19. 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 or
487.1021, 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 medical [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 medical [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 medical [low-THC] cannabis and
drug paraphernalia may be forfeited to the state as provided under
Subchapter E, Chapter 481.
SECTION 3.20. 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 3.21. Section 487.201, Health and Safety Code, is
amended to read as follows:
Sec. 487.201. COUNTIES AND MUNICIPALITIES MAY NOT PROHIBIT
MEDICAL [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, researching, testing, or
possession of medical [low-THC] cannabis, as authorized by this
chapter.
ARTICLE 4. PHYSICIAN RECOMMENDATIONS OF MEDICAL CANNABIS
SECTION 4.01. The heading to Chapter 169, Occupations Code,
is amended to read as follows:
CHAPTER 169. AUTHORITY TO RECOMMEND [PRESCRIBE] MEDICAL [LOW-THC]
CANNABIS TO CERTAIN PATIENTS FOR COMPASSIONATE USE
SECTION 4.02. Section 169.001, Occupations Code, is amended
to read as follows:
Sec. 169.001. DEFINITIONS. In this chapter:
(1) "Department" means the Department of Public
Safety.
[(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.]
(2) [(3)] "Medical [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. The term does not include hemp as
defined by Section 121.001, Agriculture Code [that contains not
more than 0.5 percent by weight of tetrahydrocannabinols].
(3) [(4)] "Medical use" means the administration of
medical cannabis to a registered patient for treatment of an
eligible medical condition or symptoms as recommended by a
physician [ingestion 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.
(4) "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.
[(5) "Smoking" means burning or igniting a substance
and inhaling the smoke.
[(6) "Terminal cancer" means cancer that meets the
criteria for a terminal illness, as defined by Section 1003.051,
Health and Safety Code.]
SECTION 4.03. Chapter 169, Occupations Code, is amended by
adding Section 169.0012 to read as follows:
Sec. 169.0012. BONA FIDE PHYSICIAN-PATIENT RELATIONSHIP.
For purposes of this chapter, a bona fide physician-patient
relationship exists when there is a treatment or counseling
relationship between a physician and patient in which all of the
following are present:
(1) 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
medical evaluation of the patient;
(2) the physician has created and continues to
maintain records of the patient's condition in accordance with
medically accepted standards;
(3) 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 medical cannabis as a treatment of the
patient's medical condition; and
(4) if the patient has given permission, the physician
has notified the patient's primary care physician of the patient's
medical condition and certification for the medical use of medical
cannabis to treat that condition.
SECTION 4.04. Section 169.002, Occupations Code, is amended
to read as follows:
Sec. 169.002. PHYSICIAN QUALIFIED TO RECOMMEND MEDICAL
[PRESCRIBE LOW-THC] CANNABIS [TO PATIENTS WITH CERTAIN MEDICAL
CONDITIONS]. (a) Only a physician qualified with respect to a
patient's particular medical condition [as provided by this
section] may recommend medical [prescribe low-THC] cannabis in
accordance with this chapter to treat the applicable medical
condition.
(b) A physician is qualified to recommend medical
[prescribe low-THC] cannabis with respect to a patient's particular
medical condition if the physician:
(1) is licensed under this subtitle;
(2) has a bona fide physician-patient relationship
with the patient [is board certified in a medical specialty
relevant to the treatment of the patient's particular medical
condition by a specialty board approved by the American Board of
Medical Specialties or the Bureau of Osteopathic Specialists]; and
(3) dedicates a significant portion of clinical
practice to the evaluation and treatment of the patient's
particular medical condition.
SECTION 4.05. Section 169.003, Occupations Code, is amended
to read as follows:
Sec. 169.003. RECOMMENDATION [PRESCRIPTION] OF MEDICAL
[LOW-THC] CANNABIS. A physician described by Section 169.002 may
recommend medical [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) there is a bona fide physician-patient
relationship;
(B) the patient has a diagnosis or symptoms such
that, in the physician's professional judgment and review of past
treatments, the patient is likely to receive therapeutic or
palliative benefit from medical cannabis [is diagnosed with:
[(i) epilepsy;
[(ii) a seizure disorder;
[(iii) multiple sclerosis;
[(iv) spasticity;
[(v) amyotrophic lateral sclerosis;
[(vi) autism;
[(vii) terminal cancer; or
[(viii) an incurable neurodegenerative
disease]; and
(C) [(B)] the physician determines the risk of
the medical use of medical [low-THC] cannabis by the patient is
reasonable in light of the potential benefit for the patient.
SECTION 4.06. The heading to Section 169.004, Occupations
Code, is amended to read as follows:
Sec. 169.004. MEDICAL [LOW-THC] CANNABIS RECOMMENDATION
[PRESCRIBER] REGISTRATION.
SECTION 4.07. Section 169.004(a), Occupations Code, is
amended to read as follows:
(a) Before a physician [qualified to prescribe low-THC
cannabis under Section 169.002] may recommend [prescribe] or renew
a recommendation [prescription] for medical [low-THC] cannabis for
a patient under this chapter, the physician must register [as the
prescriber for that patient] in the compassionate-use registry
maintained by the department under Section 487.054, Health and
Safety Code. The physician's registration must indicate:
(1) the physician's name; and
(2) for each patient:
(A) the patient's name and date of birth;
(B) the nature of the patient's diagnosis or
symptom being treated by medical cannabis;
(C) [(3)] the dosage prescribed to the patient;
(D) [(4)] the means of administration ordered
for the patient;
(E) [and
[(5)] the total amount of medical [low-THC]
cannabis required to fill the patient's recommendation; and
(F) any severe adverse events the patient may
experience due to the medical use of medical cannabis
[prescription].
SECTION 4.08. Section 169.005, Occupations Code, is amended
to read as follows:
Sec. 169.005. PATIENT TREATMENT PLAN. A physician
described by Section 169.002 who recommends medical [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 medical [low-THC] cannabis;
(2) a plan for monitoring the patient's symptoms; and
(3) a plan for monitoring indicators of tolerance or
reaction to medical [low-THC] cannabis.
SECTION 4.09. Section 169.0011, Occupations Code, is
repealed.
ARTICLE 5. CONFORMING AMENDMENTS
SECTION 5.01. Section 161.001(c), Family Code, is amended
to read as follows:
(c) A court may not make a finding under Subsection (b) and
order termination of the parent-child relationship based on
evidence that the parent:
(1) homeschooled the child;
(2) is economically disadvantaged;
(3) has been charged with a nonviolent misdemeanor
offense other than:
(A) an offense under Title 5, Penal Code;
(B) an offense under Title 6, Penal Code; or
(C) an offense that involves family violence, as
defined by Section 71.004 of this code;
(4) provided or administered medical [low-THC]
cannabis to a child for whom the medical [low-THC] cannabis was
prescribed under Chapter 169, Occupations Code; or
(5) declined immunization for the child for reasons of
conscience, including a religious belief.
SECTION 5.02. Section 262.116(a), Family Code, is amended
to read as follows:
(a) The Department of Family and Protective Services may not
take possession of a child under this subchapter based on evidence
that the parent:
(1) homeschooled the child;
(2) is economically disadvantaged;
(3) has been charged with a nonviolent misdemeanor
offense other than:
(A) an offense under Title 5, Penal Code;
(B) an offense under Title 6, Penal Code; or
(C) an offense that involves family violence, as
defined by Section 71.004 of this code;
(4) provided or administered medical [low-THC]
cannabis to a child for whom the medical [low-THC] cannabis was
recommended [prescribed] under Chapter 169, Occupations Code; or
(5) declined immunization for the child for reasons of
conscience, including a religious belief.
SECTION 5.03. Section 411.0891(a), Government Code, is
amended to read as follows:
(a) Subject to Section 411.087, the department is
authorized to obtain and use criminal history record information
maintained by the Federal Bureau of Investigation or the department
that relates to a person who:
(1) is an applicant for or holds a registration issued
by the director under Subchapter C, Chapter 481, Health and Safety
Code, that authorizes the person to manufacture, distribute,
analyze, or conduct research with a controlled substance;
(2) is an applicant for or holds a registration issued
by the department under Chapter 487, Health and Safety Code, to be a
director, manager, or employee of a medical cannabis [dispensing]
organization, as defined by Section 487.001, Health and Safety
Code;
(3) is an applicant for or holds an authorization
issued by the department under Section 521.2476, Transportation
Code, to do business in this state as a vendor of ignition interlock
devices;
(4) is an applicant for or holds certification by the
department as an inspection station or an inspector under
Subchapter G, Chapter 548, Transportation Code, holds an inspection
station or inspector certificate issued under that subchapter, or
is the owner of an inspection station operating under that chapter;
or
(5) is an applicant for or holds a certificate of
registration issued by the department under Chapter 1956,
Occupations Code, to act as a metal recycling entity.
SECTION 5.04. Section 443.202(a), Health and Safety Code,
is amended to read as follows:
(a) This section does not apply to medical [low-THC]
cannabis regulated under Chapter 487.
SECTION 5.05. Section 443.2025(a), Health and Safety Code,
is amended to read as follows:
(a) This section does not apply to medical [low-THC]
cannabis regulated under Chapter 487.
SECTION 5.06. 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 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 medical cannabis [dispensing] organization
licensed under Subchapter C, Chapter 487, or a medical cannabis
research organization licensed under Chapter 444, that possesses
medical [low-THC] cannabis.
SECTION 5.07. 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
medical [low-THC] cannabis if the person:
(1) for an offense involving possession only of
marihuana or drug paraphernalia:
(A) [,] is a patient for whom medical [low-THC]
cannabis is prescribed under Chapter 169, Occupations Code, or the
patient's legal guardian or caregiver; [,] and
(B) [the person] possesses medical [low-THC]
cannabis obtained under a valid recommendation [prescription] from
a medical cannabis [dispensing] organization; or
(2) is a director, manager, or employee of a medical
cannabis [dispensing] organization and the person, solely in
performing the person's regular duties at the organization,
acquires, possesses, produces, cultivates, dispenses, or disposes
of:
(A) in reasonable quantities, any medical
[low-THC] cannabis or raw materials used in or by-products created
by the production or cultivation of medical [low-THC] cannabis; or
(B) any drug paraphernalia used in the
acquisition, possession, production, cultivation, delivery, or
disposal of medical [low-THC] cannabis.
(f) For purposes of Subsection (e):
(1) ["Dispensing organization" has the meaning
assigned by Section 487.001.
[(2)] "Medical [Low-THC] cannabis" has the meaning
assigned by Section 169.001, Occupations Code.
(2) "Medical cannabis organization" has the meaning
assigned by Section 487.001.
(3) "Medical use" has the meaning assigned by Section
169.001, Occupations Code.
SECTION 5.08. Section 551.004(a), Occupations Code, is
amended 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 medical cannabis [dispensing] organization, as
defined by Section 487.001, Health and Safety Code, that
cultivates, processes, tests, and dispenses medical [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; or
(6) a medical cannabis research organization licensed
under Chapter 444, Health and Safety Code, that cultivates,
processes, researches, tests, and dispenses medical cannabis as
authorized by the license.
ARTICLE 6. TRANSITIONS AND EFFECTIVE DATE
SECTION 6.01. Not later than December 31, 2021, the
Department of Public Safety and the executive commissioner of the
Health and Human Services Commission shall adopt rules as required
to implement, administer, and enforce this Act.
SECTION 6.02. (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.
SECTION 6.03. (a) Not later than April 1, 2022, the
Department of Public Safety shall license cannabis cultivation
organizations 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.
(b) Not later than June 1, 2022, the Department of Public
Safety shall license other classes of medical cannabis
organizations 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.
(c) The governor shall appoint members to the medical
cannabis research advisory board as required under Chapter 444,
Health and Safety Code, as added by this Act, as soon as practicable
and not later than September 1, 2021.
SECTION 6.04. This Act takes effect September 1, 2021.