86R1388 JSC-F

By: West S.B. No. 400

A BILL TO BE ENTITLED

AN ACT

relating to authorizing the possession, use, cultivation, distribution, transportation, and delivery of medical cannabis for medical use by patients with certain debilitating medical conditions and terminal illnesses and the licensing of dispensing organizations and cannabis testing facilities; authorizing a fee.

BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS:

ARTICLE 1. CHANGES TO CHAPTER 169, OCCUPATIONS CODE

SECTION 1.01. The heading to Chapter 169, Occupations Code, is amended to read as follows:

CHAPTER 169. AUTHORITY TO PRESCRIBE MEDICAL [LOW-THC] CANNABIS TO

CERTAIN PATIENTS FOR COMPASSIONATE USE

SECTION 1.02. Section 169.001, Occupations Code, is amended by amending Subdivisions (2), (3), and (4) and adding Subdivisions (2-a), (2-b), (3-a), and (6) to read as follows:

(2) "Debilitating epileptic condition" ["Intractable epilepsy"] means epilepsy or other neurological [a seizure] disorder, or the treatment of epilepsy or other neurological disorder that, as diagnosed by a board-certified neurologist, produces serious, debilitating, or life-threatening [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.

(2-a) "Debilitating medical condition" means cancer, glaucoma, a debilitating epileptic condition, acquired immune deficiency syndrome, amyotrophic lateral sclerosis, Crohn's disease, Parkinson's disease, Huntington's disease, or multiple sclerosis;

(2-b) "Higher concentration 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 more than 0.5 percent by weight of tetrahydrocannabinols and any concentration of cannabidiol.

(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 15 [10] percent by weight of cannabidiol.

(3-a) "Medical cannabis" means low-THC cannabis or higher concentration cannabis.

(4) "Medical use" means the ingestion by a means of administration other than by smoking of a prescribed amount of medical [low-THC] cannabis by a person for whom medical [low-THC] cannabis is prescribed under this chapter.

(6) "Terminal illness" means an advanced stage of a disease with an unfavorable prognosis that, without life-sustaining procedures, will soon result in death or a state of permanent unconsciousness from which recovery is unlikely.

SECTION 1.03. 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 debilitating medical condition [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 a debilitating medical condition [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.

SECTION 1.04. Chapter 169, Occupations Code, is amended by adding Section 169.0035 to read as follows:

Sec. 169.0035. PRESCRIPTION OF HIGHER CONCENTRATION CANNABIS TO PATIENTS WITH TERMINAL ILLNESS. A physician may prescribe higher concentration cannabis to a patient 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 a terminal illness;

(B) the physician determines the risk of the medical use of higher concentration cannabis by the patient is reasonable in light of the potential benefit for the patient; and

(C) a second physician has concurred with the determination under Paragraph (B), and the second physician's concurrence is recorded in the patient's medical record.

SECTION 1.05. Sections 169.004 and 169.005, Occupations Code, are amended to read as follows:

Sec. 169.004. MEDICAL [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 medical [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 nature of the patient's debilitating medical condition or terminal illness;

(4) whether the medical cannabis the physician prescribes to the patient is:

(A) low-THC cannabis; or

(B) higher concentration cannabis;

(5) the dosage prescribed to the patient;

(6) [(4)] the means of administration ordered for the patient; and

(7) [(5)] the total amount of medical [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 medical [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 medical [low-THC] cannabis;

(2) a plan for monitoring the patient's symptoms; and

(3) a plan for monitoring indicators of tolerance or reaction to medical [low-THC] cannabis.

SECTION 1.06. Section 169.002, Occupations Code, is repealed.

ARTICLE 2. CHANGES TO CHAPTER 487, HEALTH AND SAFETY CODE

SECTION 2.01. Section 487.001, Health and Safety Code, is amended to read as follows:

Sec. 487.001. DEFINITIONS. In this chapter:

(1) "Cannabis testing facility" means an independent entity licensed by the department under this chapter to analyze the safety and potency of medical cannabis.

(2) "Debilitating medical condition," "higher concentration cannabis," "low-THC cannabis," "medical cannabis," and "terminal illness" have the meanings assigned by Section 169.001, Occupations Code.

(3) "Department" means the Department of Public Safety.

(4) [(2)] "Director" means the public safety director of the department.

(5) [(3)] "Dispensing organization" means an organization licensed by the department to cultivate, process, and dispense medical [low-THC] cannabis to a patient for whom medical [low-THC] cannabis is prescribed under Chapter 169, Occupations Code.

[(4) "Low-THC cannabis" has the meaning assigned by Section 169.001, Occupations Code.]

SECTION 2.02. The heading to Section 487.053, Health and Safety Code, is amended to read as follows:

Sec. 487.053. LICENSING OF DISPENSING ORGANIZATIONS AND CANNABIS TESTING FACILITIES; REGISTRATION OF CERTAIN ASSOCIATED INDIVIDUALS.

SECTION 2.03. Section 487.053(a), Health and Safety Code, is amended to read as follows:

(a) The department shall:

(1) issue or renew a license under Subchapter C to operate as:

(A) a dispensing organization to each applicant who satisfies the requirements established under this chapter for licensure as a dispensing organization; and

(B) a cannabis testing facility to each applicant who satisfies the requirements established under this chapter for licensure as a cannabis testing facility; and

(2) register directors, managers, and employees under Subchapter D of each:

(A) dispensing organization; and

(B) cannabis testing facility.

SECTION 2.04. 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, and for each patient for whom the physician has registered as the prescriber:

(A) the patient's name;

(B) the patient's [and] date of birth;

(C) the nature of the patient's debilitating medical condition or terminal illness;

(D) whether the medical cannabis the physician prescribes to the patient is:

(i) low-THC cannabis; or

(ii) higher concentration cannabis;

(E) [of the patient,] the dosage prescribed;

(F) [,] the means of administration ordered;[,] and

(G) the total amount of medical [low-THC] cannabis required to fill the patient's prescription; and

(2) a record of each amount of medical [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 medical [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 medical [low-THC] cannabis is prescribed under Chapter 169, Occupations Code.

SECTION 2.05. Subchapter B, Chapter 487, Health and Safety Code, is amended by adding Sections 487.055 and 487.056 to read as follows:

Sec. 487.055. DESIGNATION OF CAREGIVER. (a) The department shall develop a form for a patient listed in the registry to designate one caregiver and one alternate caregiver. A caregiver is a person who has significant responsibility for managing the well-being of a registered patient.

(b) The form must require the patient to provide the full name, home address, and date of birth of the patient's caregiver and alternate caregiver.

(c) A patient may designate only one caregiver and one alternate caregiver.

(d) A patient may not designate as the patient's caregiver or alternate caregiver a person who:

(1) is younger than 21 years of age; or

(2) has been previously convicted of an offense punishable as a felony involving the manufacture, delivery, or possession of a controlled substance.

(e) Except as otherwise provided by Subsection (f), a person may be a caregiver or alternate caregiver for only one patient at a time.

(f) A person may be a caregiver or alternate caregiver for two patients simultaneously, provided that each patient is related to the caregiver within the fourth degree of consanguinity or affinity, as determined under Chapter 573, Government Code.

(g) The director shall adopt rules necessary to implement this section, including rules allowing a patient to change the patient's caregiver or alternate caregiver.

Sec. 487.056. LABELING REQUIREMENTS. The director by rule shall prescribe labeling requirements for medical cannabis. The requirements must provide that a label include:

(1) a product name;

(2) the name of the manufacturer;

(3) a batch identification number, batch date, batch size, and total quantity produced;

(4) a list of ingredients;

(5) an expiration date;

(6) the potency of the medical cannabis, as measured by the percent by weight of tetrahydrocannabinols, cannabidiols, and any other psychoactive substances or chemicals determined relevant by the department; and

(7) any additional labeling requirements as provided by department rule.

SECTION 2.06. The heading to Subchapter C, Chapter 487, Health and Safety Code, is amended to read as follows:

SUBCHAPTER C. LICENSING OF [LICENSE TO OPERATE AS] DISPENSING

ORGANIZATIONS AND CANNABIS TESTING FACILITIES [ORGANIZATION]

SECTION 2.07. Section 487.101, Health and Safety Code, is amended to read as follows:

Sec. 487.101. LICENSE REQUIRED. A person may not operate as a dispensing organization or a cannabis testing facility without the appropriate license issued by the department under this subchapter [chapter is required to operate a dispensing organization].

SECTION 2.08. Section 487.102, Health and Safety Code, is amended to read as follows:

Sec. 487.102. ELIGIBILITY FOR LICENSE TO OPERATE AS DISPENSING ORGANIZATION. 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 medical [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 medical [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.

SECTION 2.09. Subchapter C, Chapter 487, Health and Safety Code, is amended by adding Section 487.1021 to read as follows:

Sec. 487.1021. ELIGIBILITY FOR LICENSE TO OPERATE AS CANNABIS TESTING FACILITY. An applicant for a license to operate as a cannabis testing facility is eligible for the license if:

(1) as determined by the department, the applicant possesses:

(A) the ability to secure the resources and personnel necessary to operate as a cannabis testing facility; and

(B) 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 for the operation of a cannabis testing facility.

SECTION 2.10. Section 487.103, Health and Safety Code, is amended by adding Subsection (a-1) to read as follows:

(a-1) A person may apply for an initial or renewal license to operate as a cannabis testing facility by submitting a form prescribed by the department along with the application fee in an amount set by the director.

SECTION 2.11. Section 487.104(a), Health and Safety Code, is amended to read as follows:

(a) The department shall issue or renew a license under this subchapter [to operate as a dispensing organization] only if:

(1) the department determines the applicant meets the eligibility requirements described by Section 487.102 or 487.1021, as applicable; and

(2) issuance or renewal of the license is necessary to ensure reasonable statewide access to, and the availability of, medical [low-THC] cannabis for patients registered in the compassionate-use registry and for whom medical [low-THC] cannabis is prescribed under Chapter 169, Occupations Code.

SECTION 2.12. Sections 487.105(a) and (b), Health and Safety Code, are amended to read as follows:

(a) An applicant for the issuance or renewal of a license under this subchapter [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 license holder under this subchapter [dispensing organization licensee] hires a manager or employee for the organization or facility, the license holder [licensee] must provide the department with the name of the prospective manager or employee. The license holder [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.

SECTION 2.13. Sections 487.106 and 487.107, Health and Safety Code, are amended to read as follows:

Sec. 487.106. DUTY TO MAINTAIN ELIGIBILITY. Each license holder under this subchapter [A dispensing organization] must maintain compliance at all times with the eligibility requirements described by Section 487.102 or 487.1021, as applicable.

Sec. 487.107. DUTIES RELATING TO DISPENSING PRESCRIPTION. (a) Before dispensing medical [low-THC] cannabis to a person for whom the medical [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 medical [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 medical [low-THC] cannabis to a patient for whom the medical [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 medical [low-THC] cannabis dispensed and the date and time of dispensation.

SECTION 2.14. Sections 487.108(a), (b), and (c), Health and Safety Code, are amended to read as follows:

(a) The department may at any time suspend or revoke a license issued under this subchapter [chapter] if the department determines that the license holder [licensee] has not maintained the eligibility requirements described by Section 487.102 or 487.1021, as applicable, or has failed to comply with a duty imposed under this subchapter [chapter].

(b) The director shall give written notice to the license holder [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 subchapter [chapter], the director may seize or place under seal all medical [low-THC] cannabis and drug paraphernalia owned or possessed by the dispensing organization or cannabis testing facility. If the director orders the revocation of the license, a disposition may not be made of the seized or sealed medical [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 medical [low-THC] cannabis and drug paraphernalia may be forfeited to the state as provided under Subchapter E, Chapter 481.

SECTION 2.15. Section 487.151, Health and Safety Code, is amended by adding Subsection (a-1) to read as follows:

(a-1) An individual who is a director, manager, or employee of a cannabis testing facility must apply for and obtain a registration under this section.

SECTION 2.16. Section 487.201, Health and Safety Code, is amended to read as follows:

Sec. 487.201. COUNTIES AND MUNICIPALITIES MAY NOT PROHIBIT MEDICAL [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, testing, or possession of medical [low-THC] cannabis, as authorized by this chapter.

ARTICLE 3. CONFORMING CHANGES

SECTION 3.01. Section 161.001(c), Family Code, is amended to read as follows:

(c) A court may not make a finding under Subsection (b) and order termination of the parent-child relationship based on evidence that the parent:

(1) homeschooled the child;

(2) is economically disadvantaged;

(3) has been charged with a nonviolent misdemeanor offense other than:

(A) an offense under Title 5, Penal Code;

(B) an offense under Title 6, Penal Code; or

(C) an offense that involves family violence, as defined by Section 71.004 of this code;

(4) provided or administered medical [low-THC] cannabis to a child for whom the medical [low-THC] cannabis was prescribed under Chapter 169, Occupations Code; or

(5) declined immunization for the child for reasons of conscience, including a religious belief.

SECTION 3.02. Section 262.116(a), Family Code, is amended to read as follows:

(a) The Department of Family and Protective Services may not take possession of a child under this subchapter based on evidence that the parent:

(1) homeschooled the child;

(2) is economically disadvantaged;

(3) has been charged with a nonviolent misdemeanor offense other than:

(A) an offense under Title 5, Penal Code;

(B) an offense under Title 6, Penal Code; or

(C) an offense that involves family violence, as defined by Section 71.004 of this code;

(4) provided or administered medical [low-THC] cannabis to a child for whom the medical [low-THC] cannabis was prescribed under Chapter 169, Occupations Code; or

(5) declined immunization for the child for reasons of conscience, including a religious belief.

SECTION 3.03. 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 or cannabis testing facility licensed under Subchapter C, Chapter 487, that possesses medical [low-THC] cannabis.

SECTION 3.04. Sections 481.111(e) and (f), Health and Safety Code, are 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 medical [low-THC] cannabis if the person:

(1) for an offense involving possession only of marihuana or drug paraphernalia:

(A) [,] is a patient for whom medical [low-THC] cannabis is prescribed under Chapter 169, Occupations Code, [or] the patient's legal guardian, or the patient's designated caregiver or alternate caregiver; and

(B) [the person] possesses medical [low-THC] cannabis obtained under a valid prescription from a dispensing organization; or

(2) is a director, manager, or employee of a dispensing organization or cannabis testing facility and the person, solely in performing the person's regular duties at the organization or facility, acquires, possesses, produces, cultivates, dispenses, or disposes of:

(A) in reasonable quantities, any medical [low-THC] cannabis or raw materials used in or by-products created by the production or cultivation of medical [low-THC] cannabis; or

(B) any drug paraphernalia used in the acquisition, possession, production, cultivation, delivery, or disposal of medical [low-THC] cannabis.

(f) For purposes of Subsection (e):

(1) "Cannabis testing facility" and "dispensing organization" have the meanings ["Dispensing organization" has the meaning] assigned by Section 487.001.

(2) "Medical cannabis" ["Low-THC cannabis"] has the meaning assigned by Section 169.001, Occupations Code.

SECTION 3.05. Section 551.004, Occupations Code, is amended by amending Subsection (a) and adding Subsection (a-1) 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 medical [low-THC] cannabis, as authorized by a license issued under Subchapter C, Chapter 487, Health and Safety Code, to a patient listed in the compassionate-use registry established under that chapter; or

(6) a cannabis testing facility that analyzes the safety and potency of medical cannabis, as authorized by a license issued under Subchapter C, Chapter 487, Health and Safety Code.

(a-1) For purposes of Subsections (a)(5) and (6), "cannabis testing facility" and "dispensing organization" have the meanings assigned by Section 487.001, Health and Safety Code.

ARTICLE 4. STUDY AND REPORT

SECTION 4.01. In this article, "department" means the Department of Public Safety of the State of Texas.

SECTION 4.02. The department, in consultation with a nationally accredited research university, shall conduct a study regarding whether application and licensing fees for dispensing organizations and cannabis testing facilities are impediments to the entrance of new dispensing organizations and cannabis testing facilities into the market in this state.

SECTION 4.03. Not later than December 1, 2020, the department shall submit to the legislature a report on the conclusions from the study under this article, including any legislative recommendations.

ARTICLE 5. TRANSITIONS AND EFFECTIVE DATE

SECTION 5.01. Not later than October 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, as amended by this Act.

SECTION 5.02. (a) A license to operate as a dispensing organization issued under Chapter 487, Health and Safety Code, before the effective date of this Act continues to be valid after the effective date of this Act until that license expires.

(b) The registration of a director, manager, or employee of a dispensing organization under Subchapter D, Chapter 487, Health and Safety Code, continues to be valid after the effective date of this Act until that registration expires.

(c) Not later than March 1, 2020, the Department of Public Safety shall begin licensing cannabis testing facilities in accordance with Subchapter C, Chapter 487, Health and Safety Code, as amended by this Act, provided that the applicants for a license have met all requirements for approval under that subchapter.

SECTION 5.03. 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.