85R22838 JSC-F

By: Lucio III, Isaac, White, Simmons, H.B. No. 2107

Sheffield, et al.

Substitute the following for H.B. No. 2107:

By: Cortez C.S.H.B. No. 2107

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 the licensing of dispensing organizations and cannabis testing facilities; authorizing fees.

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

SECTION 1. Section 481.062(a), Health and Safety Code, is amended to read as follows:

(a) The following persons may possess a controlled substance under this chapter without registering with the Federal Drug Enforcement Administration:

(1) an agent or employee of a manufacturer, distributor, analyzer, or dispenser of the controlled substance who is registered with the Federal Drug Enforcement Administration and acting in the usual course of business or employment;

(2) a common or contract carrier, a warehouseman, or an employee of a carrier or warehouseman whose possession of the controlled substance is in the usual course of business or employment;

(3) an ultimate user or a person in possession of the controlled substance under a lawful order of a practitioner or in lawful possession of the controlled substance if it is listed in Schedule V;

(4) an officer or employee of this state, another state, a political subdivision of this state or another state, or the United States who is lawfully engaged in the enforcement of a law relating to a controlled substance or drug or to a customs law and authorized to possess the controlled substance in the discharge of the person's official duties;

(5) if the substance is tetrahydrocannabinol or one of its derivatives:

(A) a Department of State Health Services official, a medical school researcher, or a research program participant possessing the substance as authorized under Subchapter G; or

(B) a practitioner or an ultimate user possessing the substance as a participant in a federally approved therapeutic research program that the commissioner has reviewed and found, in writing, to contain a medically responsible research protocol; or

(6) a dispensing organization or cannabis testing facility licensed under Subchapter C, Chapter 487, that possesses medical [low-THC] cannabis.

SECTION 2. 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, is a patient for whom medical use [low-THC cannabis] is recommended [prescribed] under Chapter 169, Occupations Code, [or the patient's legal guardian,] and the person possesses no more than the allowable amount of medical [low-THC] cannabis, as determined under Section 487.002 [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" and "medical use" have the meanings ["Low-THC cannabis" has the meaning] assigned by Section 169.001, Occupations Code.

SECTION 3. 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," "medical cannabis," and "medical use" 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 use [low-THC cannabis] is recommended [prescribed] under Chapter 169, Occupations Code.

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

SECTION 4. Subchapter A, Chapter 487, Health and Safety Code, is amended by adding Section 487.002 to read as follows:

Sec. 487.002. ALLOWABLE AMOUNT OF MEDICAL CANNABIS. (a) The allowable amount of medical cannabis for a person for whom medical use is recommended under Chapter 169, Occupations Code, is:

(1) not more than 2.5 ounces of medical cannabis;

(2) if applicable, a greater amount specified in accordance with department rules by a recommending physician under Chapter 169, Occupations Code, and included with the patient's registration on the compassionate-use registry established under Section 487.054; or

(3) an amount of oils or products infused with medical cannabis such that the quantity of tetrahydrocannabinols and cannabidiol in the oil or product does not exceed the quantity of those substances contained in the amount of medical cannabis under Subdivision (1) or (2), as applicable.

(b) Oils and products infused with medical cannabis must be labeled in accordance with department rules to indicate the quantity of tetrahydrocannabinols and cannabidiol contained in the oil or product for purposes of determining compliance with this section.

SECTION 5. Section 487.052, Health and Safety Code, is amended to read as follows:

Sec. 487.052. RULES. (a) The director shall adopt any rules necessary for the administration and enforcement of this chapter.

(b) The director shall adopt [, including] rules imposing fees under this chapter in amounts sufficient to cover the cost of administering this chapter.

(c) The director shall adopt rules in accordance with Section 487.002 governing the allowable amount of medical cannabis a physician may recommend for a patient for whom medical use is recommended under Chapter 169, Occupations Code.

(d) The director by rule shall adopt labeling requirements for medical cannabis. In adopting labeling requirements, the director shall ensure each oil and product infused with medical cannabis is labeled with the quantity of tetrahydrocannabinols and cannabidiol contained in the oil or product.

SECTION 6. 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 7. 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 8. 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 physician recommending medical use [prescriber] for a patient under Section 169.004, Occupations Code, and 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) if applicable, the allowable amount of cannabis specified by a recommending physician for the patient under Chapter 169, Occupations Code [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 physician recommending medical use [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 use is recommended under Chapter 169, Occupations Code [low-THC cannabis is prescribed and whether the patient's prescriptions have been filled]; and

(3) allows a physician recommending medical use [qualified to prescribe low-THC cannabis] under Chapter 169 [Section 169.002], Occupations Code, to input safety and efficacy data derived from the treatment of patients for whom medical use [low-THC cannabis] is recommended [prescribed under Chapter 169, Occupations Code].

SECTION 9. 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 10. 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 11. 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 12. 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 13. Section 487.103(a), Health and Safety Code, is amended to read as follows:

(a) A person may apply for an initial or renewal license under this subchapter [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.

SECTION 14. 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 recommended [prescribed] under Chapter 169, Occupations Code.

SECTION 15. 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 16. 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 MEDICAL CANNABIS [PRESCRIPTION]. (a) Before dispensing medical [low-THC] cannabis to a person for whom medical use is recommended [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 is 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 medical [low-THC] cannabis to a patient for whom medical use is recommended [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 the medical [low-THC] cannabis dispensed and the date and time of dispensation.

SECTION 17. 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 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 18. 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 19. 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.

SECTION 20. Chapter 169, Occupations Code, is amended to read as follows:

CHAPTER 169. AUTHORITY TO RECOMMEND MEDICAL USE OF [PRESCRIBE

LOW-THC] CANNABIS TO CERTAIN PATIENTS FOR COMPASSIONATE USE

Sec. 169.001. DEFINITIONS. In this chapter:

(1) "Debilitating medical condition" means:

(A) cancer, glaucoma, positive status for human immunodeficiency virus, acquired immune deficiency syndrome, amyotrophic lateral sclerosis, Crohn's disease, ulcerative colitis, agitation of Alzheimer's disease, post-traumatic stress disorder, autism, sickle cell anemia, Parkinson's disease, muscular dystrophy, or Huntington's disease;

(B) a chronic medical condition that produces, or the treatment of a chronic medical condition that produces:

(i) cachexia or wasting syndrome;

(ii) severe debilitating pain;

(iii) severe nausea;

(iv) seizures, including those characteristic of epilepsy; or

(v) severe and persistent muscle spasms, including those characteristic of multiple sclerosis; or

(C) any other medical condition approved as a debilitating medical condition by department rule or any symptom caused by the treatment of a medical condition that is approved as a debilitating medical condition by department rule.

(2) "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) "Medical ["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 recommended [prescribed] amount of medical [low-THC] cannabis by a person for whom medical use [low-THC cannabis] is recommended [prescribed] under this chapter.

(5) "Smoking" means burning or igniting a substance and inhaling the smoke.

Sec. 169.002. RECOMMENDATION OF MEDICAL USE [PHYSICIAN QUALIFIED TO PRESCRIBE LOW-THC CANNABIS]. (a) A [Only a] physician [qualified as provided by this section] may recommend medical use [prescribe low-THC cannabis] in accordance with this chapter for a patient with a debilitating medical condition.

(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 who recommends medical use for a patient must [described by Section 169.002 may prescribe low-THC cannabis to alleviate a patient's seizures if]:

(1) comply [the patient is a permanent resident of the state;

[(2) the physician complies] with the registration requirements of Section 169.004; and

(2) certify [(3) the physician certifies] to the department that:

(A) the patient is diagnosed with a debilitating medical condition [intractable epilepsy]; and

(B) the physician has determined that [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. RECOMMENDING PHYSICIAN [LOW-THC CANNABIS PRESCRIBER] REGISTRATION. Before a physician [qualified to prescribe low-THC cannabis under Section 169.002] may recommend medical use [prescribe or renew a prescription for low-THC cannabis] for a patient under this chapter, the physician must register as the recommending physician [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; and

(3) the allowable [dosage prescribed to the patient;

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

[(5) the total] amount of medical [low-THC] cannabis recommended for the patient, if the physician recommends an allowable amount greater than the amount provided by Section 487.002(a)(1), Health and Safety Code [required to fill the patient's prescription].

Sec. 169.005. PATIENT TREATMENT PLAN. A physician [described by Section 169.002] who recommends medical use [prescribes low-THC cannabis] for a patient [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

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

SECTION 21. 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 (b), "cannabis testing facility" and "dispensing organization" have the meanings assigned by Section 487.001, Health and Safety Code.

SECTION 22. Not later than October 1, 2017, 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 23. (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, 2018, 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 24. 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, 2017.