Bill Text: TX SB339 | 2015-2016 | 84th Legislature | Enrolled
Bill Title: 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.
Spectrum: Bipartisan Bill
Status: (Passed) 2015-06-01 - Effective immediately [SB339 Detail]
Download: Texas-2015-SB339-Enrolled.html
S.B. No. 339 |
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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 169.004, 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 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; [ |
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(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; [ |
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(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. | ||
______________________________ | ______________________________ | |
President of the Senate | Speaker of the House | |
I hereby certify that S.B. No. 339 passed the Senate on | ||
May 7, 2015, by the following vote: Yeas 26, Nays 5. | ||
______________________________ | ||
Secretary of the Senate | ||
I hereby certify that S.B. No. 339 passed the House on | ||
May 19, 2015, by the following vote: Yeas 108, Nays 38, one | ||
present not voting. | ||
______________________________ | ||
Chief Clerk of the House | ||
Approved: | ||
______________________________ | ||
Date | ||
______________________________ | ||
Governor |