Bill Text: TX SB2416 | 2019-2020 | 86th Legislature | Introduced
Bill Title: Relating to the medical use of low-THC cannabis and medical research cannabis.
Spectrum: Partisan Bill (Republican 2-0)
Status: (Introduced - Dead) 2019-03-21 - Referred to Health & Human Services [SB2416 Detail]
Download: Texas-2019-SB2416-Introduced.html
2019S0397-1 03/08/19 | ||
By: Campbell | S.B. No. 2416 |
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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.[ |
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tetrahydrocannabinols[ |
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(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 [ |
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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 [ |
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(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[ |
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patient is reasonable in light of the potential benefit for the | ||
patient[ |
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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. |