Texas 2021 - 87th Regular

Texas House Bill HB3137 Compare Versions

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11 By: Larson H.B. No. 3137
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44 A BILL TO BE ENTITLED
55 AN ACT
66 relating to a medical cannabis research program.
77 BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS:
88 SECTION 1. Section 481.062(a), Health and Safety Code, is
99 amended to read as follows:
1010 (a) The following persons may possess a controlled
1111 substance under this chapter without registering with the Federal
1212 Drug Enforcement Administration:
1313 (1) an agent or employee of a manufacturer,
1414 distributor, analyzer, or dispenser of the controlled substance who
1515 is registered with the Federal Drug Enforcement Administration and
1616 acting in the usual course of business or employment;
1717 (2) a common or contract carrier, a warehouseman, or
1818 an employee of a carrier or warehouseman whose possession of the
1919 controlled substance is in the usual course of business or
2020 employment;
2121 (3) an ultimate user or a person in possession of the
2222 controlled substance under a lawful order of a practitioner or in
2323 lawful possession of the controlled substance if it is listed in
2424 Schedule V;
2525 (4) an officer or employee of this state, another
2626 state, a political subdivision of this state or another state, or
2727 the United States who is lawfully engaged in the enforcement of a
2828 law relating to a controlled substance or drug or to a customs law
2929 and authorized to possess the controlled substance in the discharge
3030 of the person's official duties;
3131 (5) if the substance is tetrahydrocannabinol or one of
3232 its derivatives:
3333 (A) a Department of State Health Services
3434 official, a medical school researcher, or a research program
3535 participant possessing the substance as authorized under
3636 Subchapter G or G-1, including all persons permitted or otherwise
3737 authorized to possess cannabis under Subchapter G-1; or
3838 (B) a practitioner or an ultimate user possessing
3939 the substance as a participant in a federally approved therapeutic
4040 research program that the commissioner has reviewed and found, in
4141 writing, to contain a medically responsible research protocol; or
4242 (6) a dispensing organization licensed under Chapter
4343 487 that possesses low-THC cannabis.
4444 SECTION 2. Chapter 481, Health and Safety Code, is amended
4545 by adding Subchapter G-1 to read as follows:
4646 SUBCHAPTER G-1. MEDICAL CANNABIS RESEARCH PROGRAM
4747 Sec. 481.251. DEFINITION. In this subchapter, "commission"
4848 means the Health and Human Services Commission.
4949 Sec. 481.252. MEDICAL CANNABIS RESEARCH PROGRAM. (a) Not
5050 later than January 31, 2022, the executive commissioner by rule
5151 shall establish a medical cannabis research program to be conducted
5252 by health-related institutions of higher education in this state.
5353 (b) In adopting rules under this section, the executive
5454 commissioner may provide:
5555 (1) procedures for a health-related institution of
5656 higher education in this state to apply to the commission for a
5757 permit to conduct medical cannabis research under the program
5858 established by this subchapter; and
5959 (2) criteria for granting a permit to a health-related
6060 institution of higher education to conduct medical cannabis
6161 research.
6262 Sec. 481.253. INSTITUTIONAL REVIEW BOARD. (a) Before
6363 applying for a permit under this subchapter, a health-related
6464 institution of higher education shall establish an institutional
6565 review board to review or approve the initiation of and conduct
6666 periodic review of research programs to ensure the legal protection
6767 of the rights and welfare of human research subjects.
6868 (b) The institution may designate an existing board,
6969 committee, or other group as the institutional review board
7070 required under this section.
7171 Sec. 481.254. COMPASSIONATE-USE RESEARCH. (a) A
7272 health-related institution of higher education may apply for a
7373 permit to research:
7474 (1) the efficacy of medical cannabis product
7575 formulations and product forms;
7676 (2) medical conditions that might benefit from
7777 treatment with medical cannabis and are approved by the
7878 health-related institution's institutional review board, including
7979 those not listed in Section 169.003, Occupations Code; and
8080 (3) any other research matter approved by the
8181 institution's institutional review board.
8282 (b) In applying for a permit, the health-related
8383 institution of higher education shall disclose any private sector
8484 organization contractors under Section 481.255 and shall disclose
8585 additional contractors as additional contractors are formed.
8686 Sec. 481.255. CONTRACTORS. (a) A health-related
8787 institution of higher education granted a permit under this
8888 subchapter shall be authorized to contract with one or more private
8989 sector organizations to fulfill the terms of the permit, including
9090 contracting for the production and distribution of medical
9191 cannabis.
9292 (b) A private sector organization is eligible to contract
9393 with a health-related institution of higher education under this
9494 subchapter if the organization:
9595 (1) meets all requirements for a dispensing
9696 organization under Chapter 487, except that the participant is not
9797 required to pay a licensing or application fee;
9898 (2) demonstrates capability to provide funding to
9999 support medical cannabis research activities at a health-related
100100 institution of higher education;
101101 (3) demonstrates capability to establish and operate a
102102 production and distribution system sufficient to support research
103103 program needs; and
104104 (4) is not a dispensing organization licensed under
105105 Chapter 487, owned or controlled by any direct or indirect owner of
106106 a licensed dispensing organization, or otherwise affiliated with a
107107 licensed dispensing organization.
108108 (c) The commission shall approve contractors between
109109 health-related institutions of higher education and private sector
110110 organizations authorized under this subchapter.
111111 Sec. 481.256. PATIENT TREATMENT. (a) Patient treatment
112112 provided as part of an approved research program under this
113113 subchapter may be administered only by a medical practitioner
114114 meeting standards approved by the institution's institutional
115115 review board.
116116 (b) A patient participating in a research program under this
117117 subchapter must be a permanent resident of this state.
118118 Sec. 481.257. INFORMED CONSENT. (a) Before receiving
119119 treatment under an approved research program, each patient must
120120 sign a written informed consent form.
121121 (b) If a patient is a minor or lacks the mental capacity to
122122 provide informed consent, a parent, guardian, or conservator may
123123 provide informed consent on the patient's behalf.
124124 (c) The executive commissioner shall adopt a form to be used
125125 for the informed consent required by this section.
126126 Sec. 481.258. LICENSURE AS DISPENSING ORGANIZATION. A
127127 private sector organization contracting with a health-related
128128 institution of higher education under this subchapter shall be
129129 eligible for licensure as a dispensing organization under Chapter
130130 487, or any other law that authorizes cultivating, processing, and
131131 dispensing cannabis, on or after the second anniversary of the date
132132 the organization entered into a contract with a health-related
133133 institution of higher education related to a research program
134134 authorized under this subchapter, provided that the organization's
135135 operations comply with applicable state law.
136136 SECTION 3. This Act takes effect September 1, 2021.