84R21487 GCB-F
By: Klick, Zerwas, Zedler, Coleman, H.B. No. 892
Sheffield, et al.
Substitute the following for H.B. No. 892:
By: Crownover C.S.H.B. No. 892
A BILL TO BE ENTITLED
AN ACT
relating to the medical use of low-THC cannabis and the regulation
of related organizations and individuals; requiring a dispensing
organization to obtain a license to dispense low-THC cannabis and
any employee of a dispensing organization to obtain a registration;
authorizing fees.
BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS:
SECTION 1. Subtitle C, Title 6, Health and Safety Code, is
amended by adding Chapter 487 to read as follows:
CHAPTER 487. TEXAS COMPASSIONATE-USE ACT
SUBCHAPTER A. GENERAL PROVISIONS
Sec. 487.001. DEFINITIONS. In this chapter:
(1) "Department" means the Department of Public
Safety.
(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) "Low-THC cannabis" has the meaning assigned by
Section 169.001, Occupations Code.
SUBCHAPTER B. DUTIES OF DEPARTMENT
Sec. 487.051. DUTIES OF DEPARTMENT. The department shall
administer this chapter.
Sec. 487.052. RULES. The director shall adopt any rules
necessary for the administration and enforcement of this chapter,
including rules imposing fees under this chapter in amounts
sufficient to cover the cost of administering this chapter.
Sec. 487.053. LICENSING OF DISPENSING ORGANIZATIONS AND
REGISTRATION OF CERTAIN ASSOCIATED INDIVIDUALS. (a) The
department shall:
(1) issue or renew a license to operate as a dispensing
organization to each applicant who satisfies the requirements
established under this chapter; and
(2) register directors, managers, and employees of
each dispensing organization.
(b) The department shall enforce compliance of licensees
and registrants and shall adopt procedures for suspending or
revoking a license or registration issued under this chapter and
for renewing a license or registration issued under this chapter.
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 the
prescriber for a patient under Section 169.003, Occupations Code,
the name and date of birth of the patient, the dosage prescribed,
the means of administration ordered, and the total amount of
low-THC cannabis required to fill the patient's prescription; and
(2) 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 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 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
low-THC cannabis is prescribed under Chapter 169, Occupations Code.
SUBCHAPTER C. LICENSE TO OPERATE AS DISPENSING ORGANIZATION
Sec. 487.101. LICENSE REQUIRED. A license issued by the
department under this chapter is required to operate a dispensing
organization.
Sec. 487.102. ELIGIBILITY FOR LICENSE. An applicant for a
license to operate as a dispensing organization is eligible for the
license if:
(1) as determined by the department, the applicant
possesses:
(A) the technical and technological ability to
cultivate and produce low-THC cannabis;
(B) the ability to secure:
(i) the resources and personnel necessary
to operate as a dispensing organization; and
(ii) premises reasonably located to allow
patients listed on the compassionate-use registry access to the
organization through existing infrastructure;
(C) the ability to maintain accountability for
the raw materials, the finished product, and any by-products used
or produced in the cultivation or production of low-THC cannabis to
prevent unlawful access to or unlawful diversion or possession of
those materials, products, or by-products; and
(D) the financial ability to maintain operations
for not less than two years from the date of application;
(2) each director, 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.
Sec. 487.103. APPLICATION. (a) A person may apply for an
initial or renewal license to operate as a dispensing organization
by submitting a form prescribed by the department along with the
application fee in an amount set by the director.
(b) The application must include the name and address of the
applicant, the name and address of each of the applicant's
directors, managers, and employees, and any other information
considered necessary by the department to determine the applicant's
eligibility for the license.
Sec. 487.104. ISSUANCE, RENEWAL, OR DENIAL OF LICENSE. (a)
The department shall issue or renew a license to operate as a
dispensing organization only if:
(1) the department determines the applicant meets the
eligibility requirements described by Section 487.102; and
(2) issuance or renewal of the license is necessary to
ensure reasonable statewide access to, and the availability of,
low-THC cannabis for patients registered in the compassionate-use
registry and for whom low-THC cannabis is prescribed under Chapter
169, Occupations Code.
(b) If the department denies the issuance or renewal of a
license under Subsection (a), the applicant is entitled to a
hearing. The department shall give written notice of the grounds
for denial to the applicant at least 30 days before the date of the
hearing.
(c) A license issued or renewed under this section expires
on the second anniversary of the date of issuance or renewal, as
applicable.
Sec. 487.105. CRIMINAL HISTORY BACKGROUND CHECK. (a) An
applicant for the issuance or renewal of a license to operate as a
dispensing organization shall provide the department with the
applicant's name and the name of each of the applicant's directors,
managers, and employees.
(b) Before a dispensing organization licensee hires a
manager or employee for the organization, the licensee must provide
the department with the name of the prospective manager or
employee. The licensee may not transfer the license to another
person before that prospective applicant and the applicant's
directors, managers, and employees pass a criminal history
background check and are registered as required by Subchapter D.
(c) The department shall conduct a criminal history
background check on each individual whose name is provided to the
department under Subsection (a) or (b). The director by rule shall:
(1) determine the manner by which an individual is
required to submit a complete set of fingerprints to the department
for purposes of a criminal history background check under this
section; and
(2) establish criteria for determining whether an
individual passes the criminal history background check for the
purposes of this section.
(d) After conducting a criminal history background check
under this section, the department shall notify the relevant
applicant or organization and the individual who is the subject of
the criminal history background check as to whether the individual
passed the criminal history background check.
Sec. 487.106. DUTY TO MAINTAIN ELIGIBILITY. A dispensing
organization must maintain compliance at all times with the
eligibility requirements described by Section 487.102.
Sec. 487.107. DUTIES RELATING TO DISPENSING PRESCRIPTION.
(a) Before dispensing low-THC cannabis to a person for whom the
low-THC cannabis is prescribed under Chapter 169, Occupations Code,
the dispensing organization must verify that the 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 low-THC cannabis
required to fill the prescription; and
(3) has not previously been filled by a dispensing
organization as indicated by an entry in the compassionate-use
registry.
(b) After dispensing low-THC cannabis to a patient for whom
the low-THC cannabis is prescribed under Chapter 169, Occupations
Code, the dispensing organization shall record in the
compassionate-use registry the form and quantity of low-THC
cannabis dispensed and the date and time of dispensation.
Sec. 487.108. LICENSE SUSPENSION OR REVOCATION. (a) The
department may at any time suspend or revoke a license issued under
this chapter if the department determines that the licensee has not
maintained the eligibility requirements described by Section
487.102 or has failed to comply with a duty imposed under this
chapter.
(b) The director shall give written notice to the 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
chapter, the director may seize or place under seal all low-THC
cannabis and drug paraphernalia owned or possessed by the
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.
(d) Chapter 2001, Government Code, applies to a proceeding
under this section.
SUBCHAPTER D. REGISTRATION OF CERTAIN INDIVIDUALS
Sec. 487.151. REGISTRATION REQUIRED. (a) An individual
who is a director, manager, or employee of a dispensing
organization must apply for and obtain a registration under this
section.
(b) An applicant for a registration under this section must:
(1) be at least 18 years of age;
(2) submit a complete set of fingerprints to the
department in the manner required by department rule; and
(3) pass a fingerprint-based criminal history
background check as required by Section 487.105.
(c) A registration expires on the second anniversary of the
date of the registration's issuance, unless suspended or revoked
under rules adopted under this chapter.
SUBCHAPTER E. DUTIES OF COUNTIES AND MUNICIPALITIES
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, or possession of low-THC
cannabis, as authorized by this chapter.
SECTION 2. Section 481.062(a), Health and Safety Code, as
amended by S.B. 219, Acts of the 84th Legislature, Regular Session,
2015, is amended to read as follows:
(a) The following persons are not required to register and
may possess a controlled substance under this chapter:
(1) an agent or employee of a registered manufacturer,
distributor, analyzer, or dispenser of the controlled substance
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; [or]
(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 dispensing organization licensed under Chapter
487 that possesses low-THC cannabis.
SECTION 3. Section 481.111, Health and Safety Code, is
amended by adding Subsections (e) and (f) 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 low-THC
cannabis is prescribed under Chapter 169, Occupations Code, or the
patient's legal guardian, and the person possesses low-THC cannabis
obtained under a valid prescription from a dispensing organization;
or
(2) is a director, manager, or employee of a
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 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) "Dispensing organization" has the meaning
assigned by Section 487.001.
(2) "Low-THC cannabis" has the meaning assigned by
Section 169.001, Occupations Code.
SECTION 4. Subtitle B, Title 3, Occupations Code, is
amended by adding Chapter 169 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) "Department" means the Department of Public
Safety.
(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.
(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 low-THC cannabis is
prescribed under this chapter.
(5) "Smoking" means burning or igniting a substance
and inhaling the smoke.
Sec. 169.002. PHYSICIAN QUALIFIED TO PRESCRIBE LOW-THC
CANNABIS. (a) Only a physician qualified as provided by this
section may prescribe low-THC cannabis in accordance with this
chapter.
(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 described by Section 169.002 may prescribe low-THC
cannabis to alleviate a patient's seizures if:
(1) the patient is a permanent resident of the state;
(2) the physician complies with the registration
requirements of Section 169.004; and
(3) the physician certifies to the department that:
(A) the patient is diagnosed with intractable
epilepsy;
(B) the physician determines the risk of the
medical use of low-THC cannabis by the patient is reasonable in
light of the potential benefit for the patient; and
(C) a second physician qualified to prescribe
low-THC cannabis under Section 169.002 has concurred with the
determination under Paragraph (B), and the second physician's
concurrence is recorded in the patient's medical record.
Sec. 169.004. LOW-THC CANNABIS PRESCRIBER REGISTRATION.
Before a physician qualified to prescribe low-THC cannabis under
Section 169.002 may prescribe or renew a prescription for 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;
(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.
SECTION 5. 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; [or]
(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 Chapter 487, Health
and Safety Code, to a patient listed in the compassionate-use
registry established under that chapter.
SECTION 6. (a) Not later than December 1, 2015, 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 added by this Act, including rules
to establish the compassionate-use registry required by that
chapter.
(b) Not later than September 1, 2017, the Department of
Public Safety shall license at least three dispensing organizations
in accordance with Section 487.053, Health and Safety Code, as
added by this Act, provided at least three 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 added by this Act.
SECTION 7. 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, 2015.