Texas 2019 - 86th Regular

Texas House Bill HB1365 Compare Versions

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1+86R26458 GCB-D
12 By: Lucio III, Zerwas, Thompson of Harris, H.B. No. 1365
23 Anchia, Larson, et al.
4+ Substitute the following for H.B. No. 1365:
5+ By: Zedler C.S.H.B. No. 1365
36
47
58 A BILL TO BE ENTITLED
69 AN ACT
710 relating to authorizing the possession, use, cultivation,
811 processing, distribution, transportation, research, testing, and
912 delivery of low-THC cannabis for medical use by patients with
1013 certain debilitating medical conditions and the licensing of
1114 cannabis dispensing organizations, cannabis research
1215 organizations, and cannabis testing facilities; establishing the
1316 cannabis therapeutic research review board; authorizing fees.
1417 BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS:
1518 SECTION 1. Subchapter A, Chapter 37, Education Code, is
1619 amended by adding Section 37.0015 to read as follows:
1720 Sec. 37.0015. LOW-THC CANNABIS. Notwithstanding any other
1821 provision of this chapter, a student for whom low-THC cannabis was
1922 prescribed under Chapter 169, Occupations Code, may not be subject
2023 to suspension, expulsion, placement in a disciplinary alternative
2124 education program, or any other form of discipline solely because
2225 the student possessed, used, or was under the influence of the
2326 low-THC cannabis.
2427 SECTION 2. Section 481.062(a), Health and Safety Code, is
2528 amended to read as follows:
2629 (a) The following persons may possess a controlled
2730 substance under this chapter without registering with the Federal
2831 Drug Enforcement Administration:
2932 (1) an agent or employee of a manufacturer,
3033 distributor, analyzer, or dispenser of the controlled substance who
3134 is registered with the Federal Drug Enforcement Administration and
3235 acting in the usual course of business or employment;
3336 (2) a common or contract carrier, a warehouseman, or
3437 an employee of a carrier or warehouseman whose possession of the
3538 controlled substance is in the usual course of business or
3639 employment;
3740 (3) an ultimate user or a person in possession of the
3841 controlled substance under a lawful order of a practitioner or in
3942 lawful possession of the controlled substance if it is listed in
4043 Schedule V;
4144 (4) an officer or employee of this state, another
4245 state, a political subdivision of this state or another state, or
4346 the United States who is lawfully engaged in the enforcement of a
4447 law relating to a controlled substance or drug or to a customs law
4548 and authorized to possess the controlled substance in the discharge
4649 of the person's official duties;
4750 (5) if the substance is tetrahydrocannabinol or one of
4851 its derivatives:
4952 (A) a Health and Human Services Commission
5053 [Department of State Health Services] official, a medical school
5154 researcher, or a research program participant possessing the
5255 substance as authorized under Subchapter G; or
5356 (B) a practitioner or an ultimate user possessing
5457 the substance as a participant in a federally approved therapeutic
5558 research program that the commissioner has reviewed and found, in
5659 writing, to contain a medically responsible research protocol; or
5760 (6) a dispensing organization, cannabis research
5861 organization, or cannabis testing facility licensed under
5962 Subchapter C, Chapter 487, that possesses low-THC cannabis.
6063 SECTION 3. Sections 481.111(e) and (f), Health and Safety
6164 Code, are amended to read as follows:
6265 (e) Sections 481.120, 481.121, 481.122, and 481.125 do not
6366 apply to a person who engages in the acquisition, possession,
6467 production, cultivation, delivery, or disposal of a raw material
6568 used in or by-product created by the production or cultivation of
6669 low-THC cannabis if the person:
6770 (1) for an offense involving possession only of
6871 marihuana or drug paraphernalia, is a patient for whom medical use
6972 [low-THC cannabis] is prescribed under Chapter 169, Occupations
7073 Code, or the patient's legal guardian, and the person possesses no
7174 more than the allowable amount of low-THC cannabis, as determined
7275 under Section 487.002 [obtained under a valid prescription from a
7376 dispensing organization]; or
7477 (2) is a director, manager, or employee of a
7578 dispensing organization, cannabis research organization, or
7679 cannabis testing facility and the person, solely in performing the
7780 person's regular duties at the organization or facility, acquires,
7881 possesses, produces, cultivates, dispenses, or disposes of:
7982 (A) in reasonable quantities, any low-THC
8083 cannabis or raw materials used in or by-products created by the
8184 production or cultivation of low-THC cannabis; or
8285 (B) any drug paraphernalia used in the
8386 acquisition, possession, production, cultivation, delivery, or
8487 disposal of low-THC cannabis.
8588 (f) For purposes of Subsection (e):
8689 (1) "Cannabis testing facility," "cannabis research
8790 organization," and "dispensing organization" have the meanings
8891 ["Dispensing organization" has the meaning] assigned by Section
8992 487.001.
9093 (2) "Low-THC cannabis" and "medical use" have the
9194 meanings ["Low-THC cannabis" has the meaning] assigned by Section
9295 169.001, Occupations Code.
9396 SECTION 4. Subchapter G, Chapter 481, Health and Safety
9497 Code, is amended to read as follows:
9598 SUBCHAPTER G. CANNABIS THERAPEUTIC RESEARCH PROGRAM
9699 Sec. 481.201. RESEARCH PROGRAM; REVIEW BOARD. (a) A
97100 cannabis therapeutic research review board is established to
98101 administer the cannabis therapeutic research program under this
99102 subchapter. The executive commissioner shall assist the review
100103 board as provided by this subchapter [may establish a controlled
101104 substance therapeutic research program for the supervised use of
102105 tetrahydrocannabinols for medical and research purposes to be
103106 conducted in accordance with this chapter].
104107 (b) [If the executive commissioner establishes the program,
105108 the executive commissioner shall create a research program review
106109 board.] The review board members are appointed by the governor
107110 [executive commissioner] and serve staggered six-year terms. The
108111 terms of one-third of the members expire August 31 of each
109112 odd-numbered year [at the will of the executive commissioner].
110113 (c) The review board shall be composed of the following 12
111114 members:
112115 (1) a licensed physician certified by the American
113116 Board of Ophthalmology;
114117 (2) a licensed physician certified by the American
115118 Board of Internal Medicine and certified in the subspecialty of
116119 medical oncology;
117120 (3) a licensed physician certified by the American
118121 Board of Psychiatry;
119122 (4) a licensed physician certified by the American
120123 Board of Surgery;
121124 (5) a licensed physician certified by the American
122125 Board of Radiology; [and]
123126 (6) a licensed attorney with experience in law
124127 pertaining to the practice of medicine;
125128 (7) a licensed physician certified by the American
126129 Board of Family Medicine;
127130 (8) a licensed physician certified by the American
128131 Osteopathic Association;
129132 (9) a licensed physician specializing in pain
130133 management certified by the American Board of Anesthesiology, the
131134 American Board of Psychiatry, the American Board of Neurology, or
132135 the American Board of Physical Medicine and Rehabilitation;
133136 (10) a licensed advanced practice registered nurse
134137 specializing in palliative care certified by the Hospice and
135138 Palliative Credentialing Center or a licensed physician
136139 specializing in palliative care certified by a member board of the
137140 American Board of Medical Specialties, the American Osteopathic
138141 Association, or the Hospice Medical Director Certification Board;
139142 and
140143 (11) two licensed physicians certified by the American
141144 Board of Psychiatry and Neurology.
142145 (d) The review board may create and appoint one or more
143146 advisory committees composed of patients, law enforcement
144147 officers, other medical professionals, and other persons who are
145148 knowledgeable about low-THC cannabis cultivation, processing, and
146149 regulation.
147150 (e) Members serve without compensation but are entitled to
148151 reimbursement for actual and necessary expenses incurred in
149152 performing official duties.
150153 Sec. 481.202. REVIEW BOARD POWERS AND DUTIES. (a) The
151154 review board shall review research proposals submitted [and medical
152155 case histories of persons recommended for participation in a
153156 research program] and determine which research programs and persons
154157 are most suitable for the therapy and research purposes of the
155158 program. The review board shall approve the research programs[,
156159 certify program participants,] and conduct periodic reviews of the
157160 research and participants.
158161 (b) Research programs may be conducted with a medical
159162 school, as defined by Section 61.501, Education Code, a hospital
160163 licensed under Chapter 241, or a general academic teaching
161164 institution, as defined by Section 61.003, Education Code, and may
162165 investigate the safety and efficacy of low-THC cannabis and other
163166 public health outcomes [The review board, after approval of the
164167 executive commissioner, may seek authorization to expand the
165168 research program to include diseases not covered by this
166169 subchapter].
167170 (c) The review board shall maintain a record of all persons
168171 in charge of approved research programs and of all persons who
169172 participate in the program as researchers or as patients. The
170173 record must indicate whether a patient is registered under Chapter
171174 487.
172175 (d) The review board shall encourage multiple research
173176 goals, including:
174177 (1) objective scientific research into the safety and
175178 efficacy of low-THC cannabis;
176179 (2) developing medical guidelines for the appropriate
177180 administration of low-THC cannabis, to assist physicians and
178181 patients in evaluating the risks and benefits of low-THC cannabis,
179182 and to provide a scientific basis for future policies;
180183 (3) developing quality control, purity, and labeling
181184 standards for low-THC cannabis;
182185 (4) developing best practices for the safe and
183186 efficient cultivation of low-THC cannabis; and
184187 (5) analysis of genetic and healing properties of
185188 different varieties of cannabis. [The executive commissioner may
186189 terminate the distribution of tetrahydrocannabinols and their
187190 derivatives to a research program as the executive commissioner
188191 determines necessary.]
189192 (e) The review board shall require written reports that
190193 describe and assess the research findings by each approved research
191194 program, including research findings relating to the safety and
192195 efficacy of low-THC cannabis. In consultation with the Department
193196 of Public Safety, the review board shall report on the quality,
194197 diversity, and availability of low-THC cannabis. The review board
195198 shall submit a report on the status and findings of the research
196199 programs to the department not later than October 1 of each year.
197200 (f) The review board shall determine the formulations and
198201 dosages, including ratios of cannabinoids, that are medically
199202 appropriate for patients with particular debilitating medical
200203 conditions under Chapter 169, Occupations Code.
201204 (g) The review board may establish training criteria for the
202205 qualification of a physician under Section 169.002, Occupations
203206 Code.
204- (h) The review board shall conduct a continuing study of the
207+ (h) If after review of published, peer-reviewed medical
208+ literature and research results under this subchapter, the review
209+ board determines that the likely benefit of medical use in the
210+ treatment or alleviation of a medical condition or symptom
211+ outweighs any likely harm to patients, that condition or symptom
212+ qualifies as a debilitating medical condition under Chapter 169,
213+ Occupations Code.
214+ (i) The review board shall conduct a continuing study of the
205215 laws relating to cannabis to facilitate statewide access to safe
206216 and effective low-THC cannabis and report the board's findings and
207217 recommendations to the legislature not later than the 90th day
208218 before the first day of each regular legislative session.
209- (i) The review board may accept donations for research under
219+ (j) The review board may accept donations for research under
210220 this chapter and provide grants for research into low-THC cannabis
211221 use and health outcomes and scientific public education outreach to
212222 educate youth on the risks of using cannabis for nonmedical
213223 purposes or without the supervision of a health care provider.
214224 Sec. 481.203. PATIENT PARTICIPATION. (a) A person may not
215225 be considered for participation as a recipient of low-THC cannabis
216226 [tetrahydrocannabinols and their derivatives] through a research
217227 program unless the person is recommended to a person in charge of an
218228 approved research program and the review board by a physician who is
219229 licensed by the Texas Medical Board and is attending the person.
220230 (b) A physician may [not] recommend a person for the
221231 research program if [unless] the person[:
222232 [(1) has glaucoma or cancer;
223233 [(2) is not responding to conventional treatment for
224234 glaucoma or cancer or is experiencing severe side effects from
225235 treatment; and
226236 [(3)] has a condition, symptoms, or side effects [from
227237 treatment] that may be alleviated by medical use of low-THC
228238 cannabis and the risk of the medical use of low-THC cannabis is
229239 reasonable in light of the potential benefit for the patient
230240 [tetrahydrocannabinols or their derivatives].
231241 (c) Each patient in a research program must provide informed
232242 consent in writing. If the patient lacks the mental or legal
233243 capacity to provide informed consent, a parent, guardian, or
234244 conservator may provide informed consent on the patient's behalf.
235245 Sec. 481.204. ACQUISITION AND DISTRIBUTION OF LOW-THC
236246 CANNABIS [CONTROLLED SUBSTANCES]. (a) The executive commissioner
237247 shall acquire low-THC cannabis [the tetrahydrocannabinols and
238248 their derivatives] for use in the research program by contracting
239249 with the National Institute on Drug Abuse to receive
240250 tetrahydrocannabinols and their derivatives that are safe for human
241251 consumption according to the regulations adopted by the institute,
242252 the United States Food and Drug Administration, and the Federal
243253 Drug Enforcement Administration.
244254 (b) The executive commissioner shall supervise the
245255 distribution of low-THC cannabis [the tetrahydrocannabinols and
246256 their derivatives] to program participants. The low-THC cannabis
247257 [tetrahydrocannabinols and derivatives of tetrahydrocannabinols]
248258 may be distributed only by the person in charge of the research
249259 program to physicians caring for program participant patients,
250260 under rules adopted by the executive commissioner in such a manner
251261 as to prevent unauthorized diversion of the substances and in
252262 compliance with all requirements of the Federal Drug Enforcement
253263 Administration. The physician is responsible for dispensing the
254264 substances to patients.
255265 (c) Notwithstanding Subsections (a) and (b), a research
256266 program may use and patients may acquire low-THC cannabis produced
257267 by license holders under Chapter 487.
258268 Sec. 481.205. RULES; REPORTS. (a) The executive
259269 commissioner shall adopt rules necessary for implementing the
260270 research program.
261271 (b) The [If the executive commissioner establishes a
262272 program under this subchapter, the] commissioner shall publish a
263273 report not later than January 1 of each odd-numbered year on the
264274 medical effectiveness of the use of low-THC cannabis
265275 [tetrahydrocannabinols and their derivatives] and any other
266276 medical findings of the research program.
267277 SECTION 5. Section 487.001, Health and Safety Code, is
268278 amended to read as follows:
269279 Sec. 487.001. DEFINITIONS. In this chapter:
270280 (1) "Cannabis research organization" means an
271281 organization licensed by the department to conduct medical,
272282 scientific, or agricultural research on low-THC cannabis.
273283 (2) "Cannabis testing facility" means an independent
274284 entity licensed by the department under this chapter to analyze the
275285 content, safety, and potency of low-THC cannabis.
276286 (3) "Caregiver" means a person who has significant
277287 responsibility for managing the well-being of a registered patient.
278288 (4) "Debilitating medical condition" has the meaning
279289 assigned by Section 169.001, Occupations Code.
280290 (5) "Department" means the Department of Public
281291 Safety.
282292 (6) [(2)] "Director" means the public safety director
283293 of the department.
284294 (7) [(3)] "Dispensing organization" means an
285295 organization licensed by the department to cultivate, process, and
286296 dispense low-THC cannabis to a patient for whom low-THC cannabis is
287297 prescribed under Chapter 169, Occupations Code.
288298 (8) [(4)] "Low-THC cannabis" has the meaning assigned
289299 by Section 169.001, Occupations Code.
290300 (9) "Medical use" has the meaning assigned by Section
291301 169.001, Occupations Code.
292302 SECTION 6. Subchapter A, Chapter 487, Health and Safety
293303 Code, is amended by adding Section 487.002 to read as follows:
294304 Sec. 487.002. ALLOWABLE AMOUNT OF LOW-THC CANNABIS. (a)
295305 The allowable amount of low-THC cannabis for a person for whom
296306 medical use is recommended under Chapter 169, Occupations Code, is
297307 a 30-day supply of the recommended dosage for a particular patient
298308 stated in terms of grams for low-THC cannabis in the form of dried
299309 flower and in terms of milligrams of tetrahydrocannabinols
300310 contained in oils or other products infused with low-THC cannabis.
301311 (b) Oils or other products infused with low-THC cannabis
302312 must be labeled in accordance with department rules to indicate the
303313 quantity of each cannabinoid and terpene contained in the oil or
304314 product for purposes of determining compliance with this section.
305315 SECTION 7. Chapter 487, Health and Safety Code, is amended
306316 by adding Subchapter A-1 to read as follows:
307317 SUBCHAPTER A-1. PROTECTIONS RELATED TO MEDICAL USE OF CANNABIS
308318 Sec. 487.021. PROTECTION FROM LEGAL ACTION. (a) This
309319 section applies to a person who is:
310320 (1) a patient for whom medical use is prescribed under
311321 Chapter 169, Occupations Code, or the parent or caregiver of a
312322 patient;
313323 (2) a dispensing organization;
314324 (3) a cannabis research organization;
315325 (4) a cannabis testing facility; or
316326 (5) a director, manager, or employee of a dispensing
317327 organization, cannabis research organization, or cannabis testing
318328 facility who is registered with the department under Section
319329 487.053.
320330 (b) Notwithstanding any other law, a person described by
321331 Subsection (a) is not subject to arrest, prosecution, or penalty in
322332 any manner, or denial of any right or privilege, including any civil
323333 penalty or disciplinary action by a court or occupational or
324334 professional licensing board or bureau, for conduct involving
325335 medical use that is authorized under this chapter, Subchapter G,
326336 Chapter 481, department rule, or Chapter 169, Occupations Code.
327337 Sec. 487.022. NO PRESUMPTION OF CHILD ABUSE, NEGLECT, OR
328338 ENDANGERMENT. A person described by Section 487.021(a) may not be
329339 presumed to have engaged in conduct constituting child abuse,
330340 neglect, or endangerment solely because the person engaged in
331341 conduct involving medical use that is authorized under this
332342 chapter, Subchapter G, Chapter 481, department rule, or Chapter
333343 169, Occupations Code.
334344 Sec. 487.023. NO DENIAL OF PARENTAL RIGHTS. The fact that a
335345 person described by Section 487.021(a) engages in conduct
336346 authorized under this chapter, Subchapter G, Chapter 481,
337347 department rule, or Chapter 169, Occupations Code, does not in
338348 itself constitute grounds for denying, limiting, or restricting
339349 conservatorship or possession of or access to a child under Title 5,
340350 Family Code.
341351 Sec. 487.024. NO SEIZURE OR FORFEITURE. Property used in
342352 the cultivation, research, testing, processing, distribution,
343353 transportation, and delivery of low-THC cannabis for medical use
344354 that is authorized under this chapter, Subchapter G, Chapter 481,
345355 department rule, or Chapter 169, Occupations Code, is not
346356 contraband for purposes of Chapter 59, Code of Criminal Procedure,
347357 and is not subject to seizure or forfeiture under that chapter or
348358 other law solely for the use of the property in those authorized
349359 activities.
350360 Sec. 487.025. NO PROSECUTION FOR PROVISION OF
351361 PARAPHERNALIA. A person is not subject to arrest, prosecution, or
352362 the imposition of any sentence or penalty for the delivery,
353363 possession with intent to deliver, or manufacture of any item that
354364 meets the definition of drug paraphernalia, as defined by Section
355365 481.002, if that item is delivered, possessed with intent to
356366 deliver, or manufactured for the sole purpose of providing that
357367 item to:
358368 (1) a person for whom medical use is recommended under
359369 Chapter 169, Occupations Code;
360370 (2) a licensed cannabis research organization; or
361371 (3) a licensed cannabis testing facility.
362372 SECTION 8. Section 487.052, Health and Safety Code, is
363373 amended to read as follows:
364374 Sec. 487.052. RULES. (a) The director shall adopt any
365375 rules necessary for the administration and enforcement of this
366376 chapter.
367377 (b) The director shall adopt [, including] rules imposing
368378 reasonable fees under this chapter in amounts sufficient to cover
369379 the cost of administering this chapter and Subchapter G, Chapter
370380 481. The department may also use fees to establish a cannabis
371381 testing and quality control fund for the costs of equipment to test
372382 cannabis, cannabis products, and other substances for the purpose
373383 of assisting law enforcement to enforce this subtitle.
374384 (c) The director by rule shall adopt labeling requirements
375385 for low-THC cannabis. In adopting labeling requirements, the
376386 director shall ensure each oil and product infused with low-THC
377387 cannabis is labeled with the quantity of each cannabinoid and
378388 terpene contained in the oil or product.
379389 (d) In consultation with the cannabis therapeutic research
380390 review board under Chapter 481, the director shall adopt necessary
381391 rules to allow the department to monitor the safety and efficacy of
382392 low-THC cannabis and oils or products infused with low-THC
383393 cannabis, including rules:
384394 (1) requiring accurate reporting to consumers by
385395 testing facilities regarding the content of low-THC cannabis and
386396 oils or products infused with low-THC cannabis; and
387397 (2) providing for random testing by the department to
388398 ensure compliance with labeling and reporting requirements.
389399 (e) In consultation with the cannabis therapeutic research
390400 review board under Chapter 481, the director may collect data from
391401 dispensing organizations, cannabis research organizations,
392402 cannabis testing facilities, and health care providers as necessary
393403 to enable the department to monitor the safety and efficacy of
394404 low-THC cannabis and oils or products infused with low-THC
395405 cannabis. The director may adopt rules for the data collection
396406 under this subsection.
397407 SECTION 9. The heading to Section 487.053, Health and
398408 Safety Code, is amended to read as follows:
399409 Sec. 487.053. LICENSING OF DISPENSING ORGANIZATIONS,
400410 CANNABIS RESEARCH ORGANIZATIONS, AND CANNABIS TESTING FACILITIES;
401411 REGISTRATION OF CERTAIN ASSOCIATED INDIVIDUALS.
402412 SECTION 10. Section 487.053(a), Health and Safety Code, is
403413 amended to read as follows:
404414 (a) The department shall:
405415 (1) issue or renew a license under Subchapter C to
406416 operate as:
407417 (A) a dispensing organization to each applicant
408418 who satisfies the requirements established under this chapter for
409419 licensure as a dispensing organization;
410420 (B) a cannabis research organization to each
411421 applicant who satisfies the requirements established under this
412422 chapter for licensure as a cannabis research organization; and
413423 (C) a cannabis testing facility to each applicant
414424 who satisfies the requirements established under this chapter for
415425 licensure as a cannabis testing facility; and
416426 (2) register directors, managers, and employees under
417427 Subchapter D of each:
418428 (A) dispensing organization;
419429 (B) cannabis research organization; and
420430 (C) cannabis testing facility.
421431 SECTION 11. Section 487.054, Health and Safety Code, is
422432 amended to read as follows:
423433 Sec. 487.054. COMPASSIONATE-USE REGISTRY. (a) The
424434 department shall establish and maintain a secure online
425435 compassionate-use registry that contains:
426436 (1) the name of each physician who registers as a
427437 physician prescribing low-THC cannabis for medical use [the
428438 prescriber] for a patient under Section 169.004, Occupations Code,
429439 the name and date of birth of the patient, the dosage prescribed,
430440 the means of administration ordered, and the debilitating medical
431441 condition for which medical use is prescribed for the patient
432442 [total amount of low-THC cannabis required to fill the patient's
433443 prescription]; and
434444 (2) the allowable amount of low-THC cannabis specified
435445 by a prescribing physician for the patient under Chapter 169,
436446 Occupations Code [a record of each amount of low-THC cannabis
437447 dispensed by a dispensing organization to a patient under a
438448 prescription].
439449 (b) The department shall ensure the registry:
440450 (1) is designed to prevent more than one [qualified]
441451 physician from registering as the prescribing physician
442452 [prescriber] for a single patient;
443453 (2) is accessible to law enforcement agencies and
444454 dispensing organizations for the purpose of verifying whether a
445455 patient is one for whom low-THC cannabis is prescribed [and whether
446456 the patient's prescriptions have been filled]; and
447457 (3) allows a physician prescribing [qualified to
448458 prescribe] low-THC cannabis under Chapter 169 [Section 169.002],
449459 Occupations Code, to input safety and efficacy data derived from
450460 the treatment of patients for whom medical use of low-THC cannabis
451461 is prescribed under Chapter 169, Occupations Code.
452462 SECTION 12. Subchapter B, Chapter 487, Health and Safety
453463 Code, is amended by adding Section 487.055 to read as follows:
454464 Sec. 487.055. DESIGNATION OF CAREGIVERS. (a) The
455465 department shall develop a form for a patient listed in the registry
456466 to designate one caregiver and one alternate caregiver.
457467 (b) The form must require the patient to provide the full
458468 name, home address, and date of birth of the patient's caregiver and
459469 alternate caregiver.
460470 (c) A patient may not designate as the patient's caregiver
461471 or alternate caregiver a person who has been previously convicted
462472 of an offense punishable as a felony involving the manufacture,
463473 delivery, or possession of a controlled substance.
464474 (d) A person may be a caregiver or alternate caregiver for
465475 only one patient at a time unless:
466476 (1) each patient is related to the caregiver within
467477 the fourth degree of consanguinity or affinity, as determined in
468478 the manner described by Chapter 573, Government Code; or
469479 (2) the caregiver is employed by a home health care
470480 agency or other service and provides assistance to multiple
471481 patients who are registered low-THC cannabis patients as part of
472482 the caregiver's job duties.
473483 (e) The director shall adopt rules necessary to implement
474484 this section, including rules allowing a patient to change the
475485 patient's caregiver or alternate caregiver and to provide
476486 identification cards for registered caregivers.
477487 SECTION 13. The heading to Subchapter C, Chapter 487,
478488 Health and Safety Code, is amended to read as follows:
479489 SUBCHAPTER C. LICENSING OF [LICENSE TO OPERATE AS] DISPENSING
480490 ORGANIZATIONS, CANNABIS RESEARCH ORGANIZATIONS, AND CANNABIS
481491 TESTING FACILITIES [ORGANIZATION]
482492 SECTION 14. Section 487.101, Health and Safety Code, is
483493 amended to read as follows:
484494 Sec. 487.101. LICENSE REQUIRED. A person may not operate as
485495 a dispensing organization, a cannabis research organization, or a
486496 cannabis testing facility without the appropriate license issued by
487497 the department under this subchapter [chapter is required to
488498 operate a dispensing organization].
489499 SECTION 15. Section 487.102, Health and Safety Code, is
490500 amended to read as follows:
491501 Sec. 487.102. ELIGIBILITY FOR LICENSE TO OPERATE AS
492502 DISPENSING ORGANIZATION. (a) An applicant for a license to operate
493503 as a dispensing organization is eligible for the license if:
494504 (1) as determined by the department, the applicant
495505 possesses:
496506 (A) the technical and technological ability to
497507 cultivate and produce low-THC cannabis;
498508 (B) the ability to secure:
499509 (i) the resources and personnel necessary
500510 to operate as a dispensing organization; and
501511 (ii) premises reasonably located to allow
502512 patients listed on the compassionate-use registry access to the
503513 organization through existing infrastructure;
504514 (C) the ability to maintain accountability for
505515 the raw materials, the finished product, and any by-products used
506516 or produced in the cultivation or production of low-THC cannabis to
507517 prevent unlawful access to or unlawful diversion or possession of
508518 those materials, products, or by-products; and
509519 (D) the financial ability to maintain operations
510520 for not less than two years from the date of application;
511521 (2) each director, manager, or employee of the
512522 applicant is registered under Subchapter D; and
513523 (3) the applicant satisfies any additional criteria
514524 determined by the director to be necessary to safely implement this
515525 chapter.
516526 (b) A dispensing organization may operate three additional
517527 retail dispensing locations under a single license issued by the
518528 department under this chapter on application to the department. If
519529 the department determines that additional locations are necessary
520530 to meet patient access needs, then a licensee may operate more than
521531 four dispensing locations. The department may set a fee for an
522532 application for each additional location in accordance with Section
523533 487.103.
524534 SECTION 16. Subchapter C, Chapter 487, Health and Safety
525535 Code, is amended by adding Sections 487.1021 and 487.1022 to read as
526536 follows:
527537 Sec. 487.1021. ELIGIBILITY FOR LICENSE TO OPERATE AS
528538 CANNABIS RESEARCH ORGANIZATION. (a) An applicant for a license to
529539 operate as a cannabis research organization is eligible for the
530540 license if:
531541 (1) as determined by the department, the applicant
532542 possesses:
533543 (A) the ability to secure the resources and
534544 personnel necessary to operate as a cannabis research organization;
535545 and
536546 (B) the financial ability to maintain operations
537547 for not less than two years from the date of application;
538548 (2) each director, manager, or employee of the
539549 applicant is registered under Subchapter D;
540550 (3) for medical or scientific research, the applicant
541551 has submitted a research proposal to the cannabis therapeutic
542552 research review board as described in Subchapter G, Chapter 481;
543553 and
544554 (4) the applicant satisfies any additional criteria
545555 determined by the director to be necessary for the operation of a
546556 cannabis research organization.
547557 (b) If the applicant is affiliated with a medical school, as
548558 defined by Section 61.501, Education Code, a hospital licensed
549559 under Chapter 241, or a general academic teaching institution, as
550560 defined by Section 61.003, Education Code, the department shall
551561 presume the requirements of Subsection (a)(1) are met.
552562 Sec. 487.1022. ELIGIBILITY FOR LICENSE TO OPERATE AS
553563 CANNABIS TESTING FACILITY. An applicant for a license to operate as
554564 a cannabis testing facility is eligible for the license if:
555565 (1) as determined by the department, the applicant
556566 possesses:
557567 (A) the ability to secure the resources and
558568 personnel necessary to operate as a cannabis testing facility; and
559569 (B) the financial ability to maintain operations
560570 for not less than two years from the date of application;
561571 (2) the applicant is accredited by an accreditation
562572 body in accordance with International Organization for
563573 Standardization ISO/IEC 17025 or a successor standard;
564574 (3) each director, manager, or employee of the
565575 applicant is registered under Subchapter D; and
566576 (4) the applicant satisfies any additional criteria
567577 determined by the director to be necessary for the operation of a
568578 cannabis testing facility.
569579 SECTION 17. Section 487.103, Health and Safety Code, is
570580 amended by adding Subsections (a-1) and (a-2) to read as follows:
571581 (a-1) A person may apply for an initial or renewal license
572582 to operate as a cannabis research organization by submitting a form
573583 prescribed by the department along with the application fee in an
574584 amount set by the director that may not exceed $500.
575585 (a-2) A person may apply for an initial or renewal license
576586 to operate as a cannabis testing facility by submitting a form
577587 prescribed by the department along with the application fee in an
578588 amount set by the director.
579589 SECTION 18. Section 487.104(a), Health and Safety Code, is
580590 amended to read as follows:
581591 (a) The department shall issue or renew a license under this
582592 subchapter [to operate as a dispensing organization] only if:
583593 (1) the department determines the applicant meets the
584594 eligibility requirements described by Section 487.102, 487.1021,
585595 or 487.1022, as applicable; and
586596 (2) in the case of a dispensing organization, issuance
587597 [or renewal] of the license is necessary to ensure reasonable
588598 statewide access to, and the availability of, low-THC cannabis and
589599 the medically appropriate formulations determined under Section
590600 481.202(f) for patients registered in the compassionate-use
591601 registry and for whom low-THC cannabis is prescribed under Chapter
592602 169, Occupations Code.
593603 SECTION 19. Sections 487.105(a) and (b), Health and Safety
594604 Code, are amended to read as follows:
595605 (a) An applicant for the issuance or renewal of a license
596606 under this subchapter [to operate as a dispensing organization]
597607 shall provide the department with the applicant's name and the name
598608 of each of the applicant's directors, managers, and employees.
599609 (b) Before a license holder under this subchapter
600610 [dispensing organization licensee] hires a manager or employee for
601611 the organization or facility, the license holder [licensee] must
602612 provide the department with the name of the prospective manager or
603613 employee. The license holder [licensee] may not transfer the
604614 license to another person before that prospective applicant and the
605615 applicant's directors, managers, and employees pass a criminal
606616 history background check and are registered as required by
607617 Subchapter D.
608618 SECTION 20. Section 487.106, Health and Safety Code, is
609619 amended to read as follows:
610620 Sec. 487.106. DUTY TO MAINTAIN ELIGIBILITY. Each license
611621 holder under this subchapter [A dispensing organization] must
612622 maintain compliance at all times with the eligibility requirements
613623 described by Section 487.102, 487.1021, or 487.1022, as applicable.
614624 SECTION 21. Section 487.107, Health and Safety Code, is
615625 amended by adding Subsection (c) to read as follows:
616626 (c) On request of the department, a dispensing organization
617627 must provide to the department a sample suitable for testing of
618628 low-THC cannabis dispensed by the organization.
619629 SECTION 22. Sections 487.108(a), (b), and (c), Health and
620630 Safety Code, are amended to read as follows:
621631 (a) The department may at any time suspend or revoke a
622632 license issued under this subchapter [chapter] if the department
623633 determines that the license holder [licensee] has not maintained
624634 the eligibility requirements described by Section 487.102,
625635 487.1021, or 487.1022, as applicable, or has failed to comply with a
626636 duty imposed under this chapter.
627637 (b) The director shall give written notice to the license
628638 holder [dispensing organization] of a license suspension or
629639 revocation under this section and the grounds for the suspension or
630640 revocation. The notice must be sent by certified mail, return
631641 receipt requested.
632642 (c) After suspending or revoking a license issued under this
633643 subchapter [chapter], the director may seize or place under seal
634644 all low-THC cannabis and drug paraphernalia owned or possessed by
635645 the license holder [dispensing organization]. If the director
636646 orders the revocation of the license, a disposition may not be made
637647 of the seized or sealed low-THC cannabis or drug paraphernalia
638648 until the time for administrative appeal of the order has elapsed or
639649 until all appeals have been concluded. When a revocation order
640650 becomes final, all low-THC cannabis and drug paraphernalia may be
641651 forfeited to the state as provided under Subchapter E, Chapter 481.
642652 SECTION 23. Section 487.151(a), Health and Safety Code, is
643653 amended to read as follows:
644654 (a) An individual who is a director, manager, or employee of
645655 a license holder under Subchapter C [dispensing organization] must
646656 apply for and obtain a registration under this section.
647657 SECTION 24. Section 487.201, Health and Safety Code, is
648658 amended to read as follows:
649659 Sec. 487.201. COUNTIES AND MUNICIPALITIES MAY NOT PROHIBIT
650660 LOW-THC CANNABIS. A municipality, county, or other political
651661 subdivision may not enact, adopt, or enforce a rule, ordinance,
652662 order, resolution, or other regulation that prohibits the
653663 cultivation, production, dispensing, research, testing, or
654664 possession of low-THC cannabis, as authorized by this chapter.
655665 SECTION 25. Chapter 169, Occupations Code, is amended to
656666 read as follows:
657667 CHAPTER 169. AUTHORITY TO PRESCRIBE LOW-THC CANNABIS TO CERTAIN
658668 PATIENTS FOR COMPASSIONATE USE
659669 Sec. 169.001. DEFINITIONS. In this chapter:
660670 (1) "Bona fide physician-patient relationship" means
661671 a treatment or counseling relationship between a physician and
662672 patient in which all of the following are present:
663673 (A) the physician has reviewed the patient's
664674 relevant medical records and completed a full assessment of the
665675 patient's medical history and current medical condition, including
666676 a relevant, in-person, medical evaluation of the patient;
667677 (B) the physician has created and maintained
668678 records of the patient's condition in accordance with medically
669679 accepted standards;
670680 (C) the physician has a reasonable expectation
671681 that the physician will provide follow-up care to the patient to
672682 monitor the efficacy of the use of low-THC cannabis as a treatment
673683 of the patient's debilitating medical condition; and
674684 (D) if the patient has given permission, the
675685 physician has notified the patient's primary care physician of the
676686 patient's debilitating medical condition and certification for the
677687 medical use of low-THC cannabis to treat that condition.
678688 (2) "Debilitating medical condition" means:
679689 (A) cancer, autism, post-traumatic stress
680690 disorder, neurological conditions including agitation of
681691 Alzheimer's disease, Parkinson's disease, Huntington's disease,
682692 amyotrophic lateral sclerosis, and Tourette syndrome, Crohn's
683693 disease, ulcerative colitis, muscular dystrophy, or multiple
684- sclerosis; or
694+ sclerosis;
685695 (B) a medical condition that produces, or the
686696 treatment of a medical condition that produces:
687697 (i) endocannabinoid deficiency syndrome;
688698 (ii) cachexia or wasting syndrome;
689699 (iii) neuropathy;
690700 (iv) visceral, neuropathic, somatic, or
691701 severe intractable pain;
692702 (v) severe nausea;
693703 (vi) seizures, including those
694704 characteristic of epilepsy;
695705 (vii) severe and persistent muscle spasms,
696706 including those characteristic of multiple sclerosis; or
697- (viii) tic disorders.
707+ (viii) tic disorders; or
708+ (C) any other medical condition or any symptom
709+ caused by the treatment of a medical condition approved as a
710+ debilitating medical condition by the cannabis therapeutic
711+ research review board under Section 481.202(h).
698712 (3) "Department" means the Department of Public
699713 Safety.
700714 (4) [(2) "Intractable epilepsy" means a seizure
701715 disorder in which the patient's seizures have been treated by two or
702716 more appropriately chosen and maximally titrated antiepileptic
703717 drugs that have failed to control the seizures.
704718 [(3)] "Low-THC cannabis" means the plant Cannabis
705719 sativa L., and any part of that plant or any compound, manufacture,
706720 salt, derivative, mixture, preparation, resin, or oil of that plant
707721 that contains[:
708722 [(A)] not more than 0.5 percent by weight of
709723 tetrahydrocannabinols[; and
710724 [(B) not less than 10 percent by weight of
711725 cannabidiol]. Notwithstanding other law, low-THC cannabis includes
712726 any medical formulation or dosage approved under Section
713727 481.202(f).
714728 (5) [(4)] "Medical use" means the ingestion by a means
715729 of administration other than by smoking of a prescribed amount of
716730 low-THC cannabis by a person for whom medical use [low-THC
717731 cannabis] is prescribed under this chapter.
718732 (6) "Prescribe" means the act of a physician to
719733 authorize low-THC cannabis to be dispensed to a patient.
720734 (7) "Prescription" means an order by a physician,
721735 provided on a secure online form designated by the department, that
722736 specifies:
723737 (A) the date of the order's issue;
724738 (B) the name and date of birth of the patient;
725739 (C) the dosage, any cannabinoid ratios, and
726740 quantity prescribed to the patient;
727741 (D) directions for the use and means of
728742 administration of the low-THC cannabis; and
729743 (E) an amount of low-THC cannabis needed by the
730744 patient for a 30-day period.
731745 (8) "Serious adverse event" means an adverse event
732746 that:
733747 (A) results in death;
734748 (B) results in an illness requiring
735749 hospitalization;
736750 (C) is considered life-threatening; or
737751 (D) results in a persistent or significant
738752 disability, incapacity, or medically important condition.
739753 (9) [(5)] "Smoking" means burning or igniting a
740754 substance and inhaling the smoke. The term does not include
741755 vaporizing.
742756 (10) "Vaporizing" means heating a substance to a
743757 temperature below the combustion point of the substance so that the
744758 vapor may be inhaled.
745759 Sec. 169.002. PHYSICIAN AUTHORIZED [QUALIFIED] TO
746760 PRESCRIBE LOW-THC CANNABIS. (a) A [Only a] physician [qualified as
747761 provided by this section] may prescribe low-THC cannabis in
748762 accordance with this chapter for a patient with a debilitating
749- medical condition, provided that:
750- (1) the physician has obtained the proper medical
751- knowledge concerning medical use as treatment for a patient's
752- particular debilitating medical condition through a course of
753- instruction provided for that purpose, continuing medical
754- education relating to medical use, or self-study;
755- (2) the physician has determined that the risk of
756- medical use by the patient is reasonable in light of the potential
757- benefit for the patient; and
758- (3) a second physician licensed in this state has
759- concurred with the physician's determination under Subdivision (2)
760- and the second physician's concurrence is recorded in the patient's
761- medical record.
763+ medical condition, provided that the physician has obtained the
764+ proper medical knowledge concerning medical use as treatment for a
765+ patient's particular debilitating medical condition through a
766+ course of instruction provided for that purpose, continuing medical
767+ education relating to medical use, or self-study.
762768 (b) [A physician is qualified to prescribe low-THC cannabis
763769 to a patient with intractable epilepsy if the physician:
764770 [(1) is licensed under this subtitle;
765771 [(2) dedicates a significant portion of clinical
766772 practice to the evaluation and treatment of epilepsy; and
767773 [(3) is certified:
768774 [(A) by the American Board of Psychiatry and
769775 Neurology in:
770776 [(i) epilepsy; or
771777 [(ii) neurology or neurology with special
772778 qualification in child neurology and is otherwise qualified for the
773779 examination for certification in epilepsy; or
774780 [(B) in neurophysiology by:
775781 [(i) the American Board of Psychiatry and
776782 Neurology; or
777783 [(ii) the American Board of Clinical
778784 Neurophysiology.
779785 [Sec. 169.003. PRESCRIPTION OF LOW-THC CANNABIS.] A
780786 physician who prescribes low-THC cannabis under this chapter must
781787 [described by Section 169.002 may prescribe low-THC cannabis to
782788 alleviate a patient's seizures if]:
783789 (1) comply [the patient is a permanent resident of the
784790 state;
785791 [(2) the physician complies] with the registration
786792 requirements of Section 169.004; and
787793 (2) certify [(3) the physician certifies] to the
788794 department that:
789795 (A) there is a bona fide physician-patient
790796 relationship;
791797 (B) the patient is diagnosed with a debilitating
792798 medical condition [intractable epilepsy];
793799 (C) [(B)] the physician has determined that
794800 [determines] the risk of [the] medical use [of low-THC cannabis] by
795801 the patient is reasonable in light of the potential benefit for the
796- patient; [and]
797- (D) the physician has obtained the proper medical
798- knowledge required by Subsection (a); and
799- (E) [(C)] a second physician licensed in this
800- state [qualified to prescribe low-THC cannabis under Section
801- 169.002] has concurred with the physician's determination under
802- Paragraph (C) [(B)], and the second physician's concurrence is
803- recorded in the patient's medical record.
802+ patient; and
803+ (D) [(C)] the physician has obtained the proper
804+ medical knowledge required by Subsection (a) [a second physician
805+ qualified to prescribe low-THC cannabis under Section 169.002 has
806+ concurred with the determination under Paragraph (B), and the
807+ second physician's concurrence is recorded in the patient's medical
808+ record].
804809 Sec. 169.004. PHYSICIAN [LOW-THC CANNABIS PRESCRIBER]
805810 REGISTRATION OF PRESCRIPTION. (a) Before a physician [qualified
806811 to prescribe low-THC cannabis under Section 169.002] may prescribe
807812 low-THC cannabis for medical use [prescribe or renew a prescription
808813 for low-THC cannabis] for a patient under this chapter, the
809814 physician must register as the prescribing physician [prescriber
810815 for that patient] in the compassionate-use registry maintained by
811816 the department under Section 487.054, Health and Safety Code.
812817 (b) Before a physician may prescribe low-THC cannabis for a
813818 particular patient, the physician must add that prescription for
814819 the patient to the physician's registration information.
815820 (c) The department may publish the name of a physician
816821 registered under this section only if permission is expressly
817822 granted by the physician. The physician's name is confidential and
818823 is not subject to disclosure under Chapter 552, Government Code.
819824 [The physician's registration must indicate:
820825 [(1) the physician's name;
821826 [(2) the patient's name and date of birth;
822827 [(3) the dosage prescribed to the patient;
823828 [(4) the means of administration ordered for the
824829 patient; and
825830 [(5) the total amount of low-THC cannabis required to
826831 fill the patient's prescription.]
827832 Sec. 169.005. PATIENT TREATMENT PLAN. A physician
828833 [described by Section 169.002] who prescribes low-THC cannabis for
829834 a patient's medical use under this chapter must maintain a patient
830835 treatment plan that indicates:
831836 (1) the dosage, means of administration, and planned
832837 duration of treatment for the low-THC cannabis;
833838 (2) a plan for monitoring the patient's symptoms; and
834839 (3) a plan for monitoring indicators of tolerance or
835840 reaction to low-THC cannabis, including any adverse events.
836841 Sec. 169.006. ADVERSE EVENT REPORTING. A physician must
837842 record any adverse event in the patient's medical records and shall
838843 report any serious adverse event to the cannabis therapeutic
839844 research review board.
840845 Sec. 169.007. PHYSICIAN'S STATEMENT; PARTICIPATION IN
841846 PROGRAMS. A physician may not be denied any right or privilege or
842847 be subject to any disciplinary action solely for:
843848 (1) making a written or oral statement that, in the
844849 physician's professional opinion, the potential benefits of the use
845850 of cannabis would likely outweigh the health risks; or
846851 (2) participation in programs under Subchapter G,
847852 Chapter 481, or Chapter 487, Health and Safety Code.
848853 SECTION 26. Section 551.004, Occupations Code, is amended
849854 by amending Subsection (a) and adding Subsection (a-1) to read as
850855 follows:
851856 (a) This subtitle does not apply to:
852857 (1) a practitioner licensed by the appropriate state
853858 board who supplies a patient of the practitioner with a drug in a
854859 manner authorized by state or federal law and who does not operate a
855860 pharmacy for the retailing of prescription drugs;
856861 (2) a member of the faculty of a college of pharmacy
857862 recognized by the board who is a pharmacist and who performs the
858863 pharmacist's services only for the benefit of the college;
859864 (3) a person who procures prescription drugs for
860865 lawful research, teaching, or testing and not for resale;
861866 (4) a home and community support services agency that
862867 possesses a dangerous drug as authorized by Section 142.0061,
863868 142.0062, or 142.0063, Health and Safety Code; [or]
864869 (5) a dispensing organization[, as defined by Section
865870 487.001, Health and Safety Code,] that cultivates, processes, and
866871 dispenses low-THC cannabis, as authorized by a license issued under
867872 Subchapter C, Chapter 487, Health and Safety Code, to a patient
868873 listed in the compassionate-use registry established under that
869874 chapter;
870875 (6) a cannabis research organization that researches
871876 the cultivation, analysis, and medical use of low-THC cannabis, as
872877 authorized by a license issued under Subchapter C, Chapter 487,
873878 Health and Safety Code; or
874879 (7) a cannabis testing facility that analyzes the
875880 content, safety, and potency of low-THC cannabis, as authorized by
876881 a license issued under Subchapter C, Chapter 487, Health and Safety
877882 Code.
878883 (a-1) For purposes of Subsections (a)(5), (6), and (7),
879884 "cannabis research organization," "cannabis testing facility," and
880885 "dispensing organization" have the meanings assigned by Section
881886 487.001, Health and Safety Code.
882887 SECTION 27. Not later than December 1, 2019, the public
883888 safety director of the Department of Public Safety shall adopt
884889 rules as required to implement, administer, and enforce Chapter
885890 487, Health and Safety Code, as amended by this Act.
886891 SECTION 28. (a) A license to operate as a dispensing
887892 organization issued under Chapter 487, Health and Safety Code,
888893 before the effective date of this Act continues to be valid after
889894 the effective date of this Act until that license expires.
890895 (b) The registration of a director, manager, or employee of
891896 a dispensing organization under Subchapter D, Chapter 487, Health
892897 and Safety Code, continues to be valid after the effective date of
893898 this Act until that registration expires.
894899 (c) Not later than September 1, 2020, the Department of
895900 Public Safety shall license at least 12 dispensing organizations in
896901 accordance with Section 487.053, Health and Safety Code, as amended
897902 by this Act, including those already licensed as of the effective
898903 date of this Act, provided at least 12 applicants for a license to
899904 operate as a dispensing organization have met the requirements for
900905 approval provided by Subchapter C, Chapter 487, Health and Safety
901906 Code, as amended by this Act.
902907 (d) As of the effective date of this Act, the duties of the
903908 review board established under Subchapter G, Chapter 481, Health
904909 and Safety Code, are transferred to the review board composed of the
905910 members appointed under Section 481.201, Health and Safety Code, as
906911 amended by this Act. The governor shall appoint the additional
907912 members provided for by amendments made to that section by this Act,
908913 as soon as practicable and not later than October 1, 2019.
909914 (e) Not later than March 1, 2020, the Department of Public
910915 Safety shall begin licensing cannabis research organizations and
911916 cannabis testing facilities in accordance with Subchapter C,
912917 Chapter 487, Health and Safety Code, as amended by this Act,
913918 provided that the applicants for a license have met all
914919 requirements for approval under that subchapter.
915920 SECTION 29. This Act takes effect immediately if it
916921 receives a vote of two-thirds of all the members elected to each
917922 house, as provided by Section 39, Article III, Texas Constitution.
918923 If this Act does not receive the vote necessary for immediate
919924 effect, this Act takes effect September 1, 2019.