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A BILL TO BE ENTITLED
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AN ACT
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relating to the medical use of low-THC cannabis and the regulation |
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of related organizations and individuals; requiring a dispensing |
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organization to obtain a license to dispense low-THC cannabis and |
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any employee of a dispensing organization to obtain a registration; |
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authorizing fees. |
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BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS: |
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SECTION 1. Subtitle C, Title 6, Health and Safety Code, is |
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amended by adding Chapter 487 to read as follows: |
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CHAPTER 487. TEXAS COMPASSIONATE-USE ACT |
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SUBCHAPTER A. GENERAL PROVISIONS |
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Sec. 487.001. DEFINITIONS. In this chapter: |
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(1) "Department" means the Department of Public |
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Safety. |
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(2) "Director" means the public safety director of the |
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department. |
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(3) "Dispensing organization" means a nonprofit |
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organization licensed by the department to cultivate, process, and |
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dispense low-THC cannabis to a patient for whom low-THC cannabis is |
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prescribed under Chapter 169, Occupations Code. |
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(4) "Low-THC cannabis" has the meaning assigned by |
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Section 169.001, Occupations Code. |
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(5) "Nonprofit organization" means any organization |
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exempt from taxation under Section 501(a) of the Internal Revenue |
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Code of 1986 as an organization described in Section 501(c) of that |
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code. |
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SUBCHAPTER B. DUTIES OF DEPARTMENT |
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Sec. 487.051. DUTIES OF DEPARTMENT. The department shall |
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administer this chapter. |
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Sec. 487.052. RULES. The director shall adopt any rules |
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necessary for the administration and enforcement of this chapter, |
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including rules imposing fees under this chapter in amounts |
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sufficient to cover the cost of administering this chapter. |
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Sec. 487.053. LICENSING OF DISPENSING ORGANIZATIONS AND |
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REGISTRATION OF CERTAIN ASSOCIATED INDIVIDUALS. (a) The |
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department shall: |
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(1) issue or renew a license to operate as a dispensing |
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organization to each applicant who satisfies the requirements |
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established under this chapter; and |
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(2) register directors, managers, and employees of |
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each dispensing organization. |
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(b) The department shall enforce compliance of licensees |
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and registrants and shall adopt procedures for suspending or |
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revoking a license or registration issued under this chapter and |
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for renewing a license or registration issued under this chapter. |
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Sec. 487.054. COMPASSIONATE-USE REGISTRY. (a) The |
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department shall establish and maintain a secure online |
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compassionate-use registry that contains: |
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(1) the name of each physician who registers as the |
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prescriber for a patient under Section 169.003, Occupations Code, |
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the name and date of birth of the patient, the dosage prescribed, |
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|
the means of administration ordered, and the total amount of |
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|
low-THC cannabis required to fill the patient's prescription; and |
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(2) a record of each amount of low-THC cannabis |
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dispensed by a dispensing organization to a patient under a |
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prescription. |
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(b) The department shall ensure the registry: |
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(1) is designed to: |
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(A) allow a physician qualified to prescribe |
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low-THC cannabis under Section 169.002, Occupations Code, or |
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dispensing organization to record information in the registry; and |
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(B) prevent more than one qualified physician |
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from registering as the prescriber for a single patient; and |
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(2) is accessible to law enforcement agencies and |
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dispensing organizations for the purpose of verifying whether a |
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patient is one for whom low-THC cannabis is prescribed and whether |
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the patient's prescriptions have been filled. |
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SUBCHAPTER C. LICENSE TO OPERATE AS DISPENSING ORGANIZATION |
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Sec. 487.101. LICENSE REQUIRED. A license issued by the |
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department under this chapter is required to operate a dispensing |
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organization. |
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Sec. 487.102. ELIGIBILITY FOR LICENSE. An applicant for a |
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license to operate as a dispensing organization is eligible for the |
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license if: |
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(1) the applicant is a nonprofit organization; |
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(2) as determined by the department, the applicant |
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possesses: |
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(A) the technical and technological ability to |
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cultivate and produce low-THC cannabis; |
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(B) the ability to secure: |
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(i) the resources and personnel necessary |
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to operate as a dispensing organization; and |
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(ii) premises reasonably located to allow |
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patients listed on the compassionate-use registry access to the |
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organization through existing infrastructure; |
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(C) the ability to maintain accountability for |
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the raw materials, the finished product, and any by-products used |
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or produced in the cultivation or production of low-THC cannabis to |
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prevent unlawful access to or unlawful diversion or possession of |
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|
those materials, products, or by-products; and |
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(D) the financial ability to maintain operations |
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for not less than two years from the date of application; |
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(3) each director, manager, or employee of the |
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applicant is registered under Subchapter D; and |
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(4) the applicant satisfies any additional criteria |
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determined by the director to be necessary to safely implement this |
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chapter. |
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Sec. 487.103. APPLICATION. (a) A nonprofit organization |
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may apply for an initial or renewal license to operate as a |
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dispensing organization by submitting a form prescribed by the |
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department along with the application fee in an amount set by the |
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director. |
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(b) The application must include the name and address of the |
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applicant, the name and address of each director, manager, and |
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employee, and any other information considered necessary by the |
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department to determine the applicant's eligibility for the |
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license. |
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Sec. 487.104. ISSUANCE, RENEWAL, OR DENIAL OF LICENSE. (a) |
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The department shall issue or renew a license to operate as a |
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dispensing organization only if: |
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(1) the department determines the applicant meets the |
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eligibility requirements described by Section 487.102; and |
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(2) issuance or renewal of the license is necessary to |
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ensure reasonable statewide access to, and the availability of, |
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low-THC cannabis for patients registered in the compassionate-use |
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registry and for whom low-THC cannabis is prescribed under Chapter |
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169, Occupations Code. |
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(b) If the department denies the issuance or renewal of a |
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license under Subsection (a), the applicant is entitled to a |
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hearing. The department shall give written notice of the grounds |
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for denial to the applicant at least 30 days before the hearing. |
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(c) A license issued or renewed under this section expires |
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on the second anniversary of the date of issuance or renewal, as |
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applicable. |
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Sec. 487.105. CRIMINAL HISTORY BACKGROUND CHECK. (a) An |
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applicant for the issuance or renewal of a license to operate as a |
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dispensing organization shall provide the department with the name |
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of each of the applicant's directors, managers, and employees. |
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(b) Before a dispensing organization licensee hires a |
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manager or employee for the organization, the licensee must provide |
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the department with the name of the prospective manager or |
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employee. The licensee may not transfer the license to another |
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nonprofit organization before that prospective organization and |
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its directors, managers, and employees pass a criminal background |
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check and are registered as required by Subchapter D. |
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(c) The department shall conduct a criminal history |
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|
background check on each individual whose name is provided to the |
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department under Subsection (a) or (b). The director by rule shall: |
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(1) determine the manner by which an individual is |
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|
required to submit a complete set of fingerprints to the department |
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|
for purposes of a criminal history background check under this |
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|
section; and |
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(2) establish criteria for determining whether an |
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individual passes the criminal history background check for the |
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purposes of this section. |
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(d) After conducting a criminal history background check |
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under this section, the department shall notify the relevant |
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applicant or organization and the individual who is the subject of |
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the criminal history background check as to whether the individual |
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passed the criminal history background check. |
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Sec. 487.106. DUTY TO MAINTAIN ELIGIBILITY. A dispensing |
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organization must maintain compliance at all times with the |
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eligibility requirements described by Section 487.102. |
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Sec. 487.107. DUTIES RELATING TO DISPENSING PRESCRIPTION. |
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(a) Before dispensing low-THC cannabis to a person for whom the |
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low-THC cannabis is prescribed under Chapter 169, Occupations Code, |
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the dispensing organization must verify that the prescription |
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|
presented: |
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(1) is for a person listed as a patient in the |
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|
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. |
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(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. |
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Sec. 487.108. LICENSE SUSPENSION OR REVOCATION. (a) The |
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|
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. |
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(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. |
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|
(c) After suspending or revoking a license issued under this |
|
|
chapter, the director may seize or place under seal all low-THC |
|
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cannabis and drug paraphernalia owned or possessed by the |
|
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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 |
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|
state as provided under Subchapter E, Chapter 481. |
|
|
(d) Chapter 2001, Government Code, applies to a proceeding |
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under this section. |
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SUBCHAPTER D. REGISTRATION OF CERTAIN INDIVIDUALS |
|
|
Sec. 487.151. REGISTRATION REQUIRED. (a) An individual |
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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. |
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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, 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) an [a Texas Department of Health] official of |
|
|
the Department of State Health Services, 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. |
|
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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 has provided two or more |
|
|
different treatments approved by the United States Food and Drug |
|
|
Administration and the provided treatments have not alleviated the |
|
|
patient's seizures; |
|
|
(C) no other treatment options approved by the |
|
|
United States Food and Drug Administration are available or |
|
|
appropriate for the patient; |
|
|
(D) 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 |
|
|
(E) if the patient is younger than 18 years of |
|
|
age: |
|
|
(i) a second physician qualified to |
|
|
prescribe low-THC cannabis under Section 169.002 has concurred with |
|
|
the determination under Paragraph (D); and |
|
|
(ii) 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 January 1, 2018, 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. |
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SECTION 7. This Act takes effect immediately if it receives |
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a vote of two-thirds of all the members elected to each house, as |
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provided by Section 39, Article III, Texas Constitution. If this |
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Act does not receive the vote necessary for immediate effect, this |
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Act takes effect September 1, 2015. |