2019S0397-1 03/08/19
By: Campbell S.B. No. 2416
A BILL TO BE ENTITLED
AN ACT
relating to the medical use of low-THC cannabis and medical
research cannabis.
BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS:
SECTION 1. 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 dispensing organization licensed under Chapter
487 that possesses low-THC cannabis or medical research cannabis.
SECTION 2. Section 481.111(e), Health and Safety Code, is
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 or medical research cannabis if the person:
(1) for an offense involving possession only of
marihuana or drug paraphernalia, is a patient for whom low-THC
cannabis or medical research cannabis is prescribed under Chapter
169, Occupations Code, or the patient's legal guardian, and the
person possesses low-THC cannabis or medical research 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 medical research cannabis or raw materials used in or
by-products created by the production or cultivation of low-THC
cannabis or medical research cannabis; or
(B) any drug paraphernalia used in the
acquisition, possession, production, cultivation, delivery, or
disposal of low-THC cannabis or medical research cannabis.
SECTION 3. Section 481.111(f), Health and Safety Code, is
amended by adding Subdivision (3) to read as follows:
(3) "Medical research cannabis" has the meaning
assigned by Section 169.001, Occupations Code.
SECTION 4. Section 487.001, Health and Safety Code, is
amended by amending Subdivision (3) and adding Subdivision (5) to
read as follows:
(3) "Dispensing organization" means an organization
licensed by the department to cultivate, process, and dispense
low-THC cannabis or medical research cannabis to a patient for whom
low-THC cannabis or medical research cannabis is prescribed under
Chapter 169, Occupations Code.
(5) "Medical research cannabis" has the meaning
assigned by Section 169.001, Occupations Code.
SECTION 5. 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 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 total amount of
low-THC cannabis or medical research cannabis required to fill the
patient's prescription; and
(2) a record of each amount of low-THC cannabis or
medical research 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 or medical research
cannabis is prescribed and whether the patient's prescriptions have
been filled; and
(3) allows a physician qualified to prescribe low-THC
cannabis and medical research cannabis under Section 169.002,
Occupations Code, to input safety and efficacy data derived from
the treatment of patients for whom low-THC cannabis or medical
research cannabis is prescribed under Chapter 169, Occupations
Code.
SECTION 6. Section 487.102, Health and Safety Code, is
amended to read as follows:
Sec. 487.102. ELIGIBILITY FOR LICENSE. An applicant for a
license to operate as a dispensing organization is eligible for the
license if:
(1) as determined by the department, the applicant
possesses:
(A) the technical and technological ability to
cultivate and produce low-THC cannabis or medical research
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 or
medical research 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.
SECTION 7. 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 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 or medical research cannabis for patients
registered in the compassionate-use registry and for whom low-THC
cannabis or medical research cannabis is prescribed under Chapter
169, Occupations Code.
SECTION 8. Section 487.107, Health and Safety Code, is
amended to read as follows:
Sec. 487.107. DUTIES RELATING TO DISPENSING PRESCRIPTION.
(a) Before dispensing low-THC cannabis or medical research
cannabis to a person for whom the low-THC cannabis or medical
research 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 or
medical research 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 or medical research
cannabis to a patient for whom the low-THC cannabis or medical
research 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 or medical research cannabis dispensed and the date and
time of dispensation.
SECTION 9. Section 487.108(c), Health and Safety Code, is
amended to read as follows:
(c) After suspending or revoking a license issued under this
chapter, the director may seize or place under seal all low-THC
cannabis or medical research 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 medical research
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 or medical research cannabis and drug paraphernalia may be
forfeited to the state as provided under Subchapter E, Chapter 481.
SECTION 10. 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 OR MEDICAL RESEARCH 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 or medical research cannabis, as
authorized by this chapter.
SECTION 11. Chapter 487, Health and Safety Code, is amended
by adding Subchapter F to read as follows:
SUBCHAPTER F. COMPASSIONATE-USE RESEARCH AND REPORTING
Sec. 487.251. COMPASSIONATE-USE INSTITUTIONAL REVIEW
BOARDS. (a) One or more institutional review boards may be
established to:
(1) evaluate and approve proposed research programs to
study the medical use of cannabis; and
(2) oversee patient treatment undertaken as part of an
approved research program, including the certification of treating
physicians and the approval of cannabis products to be prescribed
and evaluated.
(b) An institutional review board must be affiliated with a
dispensing organization and a:
(1) medical school, as defined by Section 61.501,
Education Code; or
(2) hospital licensed under Chapter 241 that has at
least 150 beds.
(c) An institutional review board must submit written
reports that describe and assess the research findings of each
approved research program to:
(1) the department, not later than October 1 of each
year; and
(2) the legislature, not later than 90 days before
each regular legislative session.
(d) The Texas Medical Board may adopt rules as necessary to
implement this subchapter.
Sec. 487.252. PATIENT TREATMENT. (a) Patient treatment
provided as part of a research program under this subchapter may
only be administered by a physician certified by an institutional
review board to participate in the program. A certified physician
must remain in compliance with all applicable department and Texas
Medical Board rules and all applicable provisions of this chapter
and Chapter 169, Occupations Code.
(b) A patient participating in a research program under this
subchapter must be:
(1) a permanent resident of this state; and
(2) 21 years of age or older.
Sec. 487.253. INFORMED CONSENT. (a) Before receiving
treatment, each patient in a research program under this subchapter
must sign a written informed consent.
(b) If the patient lacks the mental capacity to provide
informed consent, a parent, guardian, or conservator may provide
informed consent on the patient's behalf.
(c) An institutional review board overseeing a research
program under this subchapter may adopt a form to be used for the
informed consent required by this section.
SECTION 12. The heading to Chapter 169, Occupations Code,
is amended to read as follows:
CHAPTER 169. AUTHORITY TO PRESCRIBE LOW-THC CANNABIS OR MEDICAL
RESEARCH CANNABIS TO CERTAIN PATIENTS FOR COMPASSIONATE USE
SECTION 13. Section 169.001, Occupations Code, is amended
by amending Subdivisions (3) and (4) and adding Subdivision (3-a)
to read as follows:
(3) "Low-THC cannabis" means a product derived from
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 less than one[:
[(A) not more than 0.5] percent by weight of
tetrahydrocannabinols[; and
[(B) not less than 10 percent by weight of
cannabidiol].
(3-a) "Medical research cannabis" means a product
derived from the plant Cannabis sativa L. that is approved by an
institutional review board for use in a research program under
Chapter 487, Health and Safety Code.
(4) "Medical use" means the ingestion by a means of
administration other than by smoking of a prescribed amount of
low-THC cannabis or medical research cannabis by a person for whom
low-THC cannabis or medical research cannabis is prescribed under
this chapter.
SECTION 14. The heading to Section 169.002, Occupations
Code, is amended to read as follows:
Sec. 169.002. PHYSICIAN QUALIFIED TO PRESCRIBE LOW-THC
CANNABIS OR MEDICAL RESEARCH CANNABIS.
SECTION 15. Section 169.002(a), Occupations Code, is
amended to read as follows:
(a) A [Only a] physician licensed under [qualified as
provided by] this subtitle [section] may prescribe low-THC cannabis
and medical research cannabis in accordance with this chapter.
SECTION 16. Section 169.003, Occupations Code, is amended
to read as follows:
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 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
[(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].
SECTION 17. Chapter 169, Occupations Code, is amended by
adding Section 169.0031 to read as follows:
Sec. 169.0031. PRESCRIPTION OF MEDICAL RESEARCH CANNABIS.
A physician described by Section 169.002 may prescribe medical
research cannabis if:
(1) the prescription is for treatment approved by an
institutional review board as part of a research program under
Chapter 487, Health and Safety Code;
(2) the patient is:
(A) a permanent resident of this state; and
(B) 21 years of age or older; and
(3) the physician:
(A) complies with the registration requirements
of Section 169.004;
(B) is certified by an institutional review board
as a treating physician in a research program under Chapter 487,
Health and Safety Code; and
(C) certifies to the department that the
physician has determined that the risk of the medical use of medical
research cannabis by the patient is reasonable in light of the
potential benefit for the patient.
SECTION 18. Section 169.004, Occupations Code, is amended
to read as follows:
Sec. 169.004. LOW-THC CANNABIS AND MEDICAL RESEARCH
CANNABIS PRESCRIBER REGISTRATION. (a) Before a physician
qualified to prescribe low-THC cannabis or medical research
cannabis under Section 169.002 may prescribe or renew a
prescription for low-THC cannabis or medical research 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 or medical
research cannabis required to fill the patient's prescription.
(b) The department may publish the name of a physician
registered under this section only if permission is expressly
granted by the physician.
SECTION 19. 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 prescribes low-THC cannabis or
medical research 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 or medical research
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 or medical research cannabis.
SECTION 20. 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 dispensing organization, as defined by Section
487.001, Health and Safety Code, that cultivates, processes, and
dispenses low-THC cannabis or medical research cannabis, as
authorized by Chapter 487, Health and Safety Code, to a patient
listed in the compassionate-use registry established under that
chapter.
SECTION 21. The following provisions of the Occupations
Code are repealed:
(1) Section 169.001(2); and
(2) Section 169.002(b).
SECTION 22. 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, and Chapter 169, Occupations Code, as
amended by this Act.
SECTION 23. 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.