Texas 2019 - 86th Regular

Texas Senate Bill SB2416 Compare Versions

Only one version of the bill is available at this time.

Old	New	Differences
1	1	2019S0397-1 03/08/19
2	2	By: Campbell S.B. No. 2416
3	3
4	4
5	5	A BILL TO BE ENTITLED
6	6	AN ACT
7	7	relating to the medical use of low-THC cannabis and medical
8	8	research cannabis.
9	9	BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS:
10	10	SECTION 1. Section 481.062(a), Health and Safety Code, is
11	11	amended to read as follows:
12	12	(a) The following persons may possess a controlled
13	13	substance under this chapter without registering with the Federal
14	14	Drug Enforcement Administration:
15	15	(1) an agent or employee of a manufacturer,
16	16	distributor, analyzer, or dispenser of the controlled substance who
17	17	is registered with the Federal Drug Enforcement Administration and
18	18	acting in the usual course of business or employment;
19	19	(2) a common or contract carrier, a warehouseman, or
20	20	an employee of a carrier or warehouseman whose possession of the
21	21	controlled substance is in the usual course of business or
22	22	employment;
23	23	(3) an ultimate user or a person in possession of the
24	24	controlled substance under a lawful order of a practitioner or in
25	25	lawful possession of the controlled substance if it is listed in
26	26	Schedule V;
27	27	(4) an officer or employee of this state, another
28	28	state, a political subdivision of this state or another state, or
29	29	the United States who is lawfully engaged in the enforcement of a
30	30	law relating to a controlled substance or drug or to a customs law
31	31	and authorized to possess the controlled substance in the discharge
32	32	of the person's official duties;
33	33	(5) if the substance is tetrahydrocannabinol or one of
34	34	its derivatives:
35	35	(A) a Department of State Health Services
36	36	official, a medical school researcher, or a research program
37	37	participant possessing the substance as authorized under
38	38	Subchapter G; or
39	39	(B) a practitioner or an ultimate user possessing
40	40	the substance as a participant in a federally approved therapeutic
41	41	research program that the commissioner has reviewed and found, in
42	42	writing, to contain a medically responsible research protocol; or
43	43	(6) a dispensing organization licensed under Chapter
44	44	487 that possesses low-THC cannabis or medical research cannabis.
45	45	SECTION 2. Section 481.111(e), Health and Safety Code, is
46	46	amended to read as follows:
47	47	(e) Sections 481.120, 481.121, 481.122, and 481.125 do not
48	48	apply to a person who engages in the acquisition, possession,
49	49	production, cultivation, delivery, or disposal of a raw material
50	50	used in or by-product created by the production or cultivation of
51	51	low-THC cannabis or medical research cannabis if the person:
52	52	(1) for an offense involving possession only of
53	53	marihuana or drug paraphernalia, is a patient for whom low-THC
54	54	cannabis or medical research cannabis is prescribed under Chapter
55	55	169, Occupations Code, or the patient's legal guardian, and the
56	56	person possesses low-THC cannabis or medical research cannabis
57	57	obtained under a valid prescription from a dispensing organization;
58	58	or
59	59	(2) is a director, manager, or employee of a
60	60	dispensing organization and the person, solely in performing the
61	61	person's regular duties at the organization, acquires, possesses,
62	62	produces, cultivates, dispenses, or disposes of:
63	63	(A) in reasonable quantities, any low-THC
64	64	cannabis or medical research cannabis or raw materials used in or
65	65	by-products created by the production or cultivation of low-THC
66	66	cannabis or medical research cannabis; or
67	67	(B) any drug paraphernalia used in the
68	68	acquisition, possession, production, cultivation, delivery, or
69	69	disposal of low-THC cannabis or medical research cannabis.
70	70	SECTION 3. Section 481.111(f), Health and Safety Code, is
71	71	amended by adding Subdivision (3) to read as follows:
72	72	(3) "Medical research cannabis" has the meaning
73	73	assigned by Section 169.001, Occupations Code.
74	74	SECTION 4. Section 487.001, Health and Safety Code, is
75	75	amended by amending Subdivision (3) and adding Subdivision (5) to
76	76	read as follows:
77	77	(3) "Dispensing organization" means an organization
78	78	licensed by the department to cultivate, process, and dispense
79	79	low-THC cannabis or medical research cannabis to a patient for whom
80	80	low-THC cannabis or medical research cannabis is prescribed under
81	81	Chapter 169, Occupations Code.
82	82	(5) "Medical research cannabis" has the meaning
83	83	assigned by Section 169.001, Occupations Code.
84	84	SECTION 5. Section 487.054, Health and Safety Code, is
85	85	amended to read as follows:
86	86	Sec. 487.054. COMPASSIONATE-USE REGISTRY. (a) The
87	87	department shall establish and maintain a secure online
88	88	compassionate-use registry that contains:
89	89	(1) the name of each physician who registers as the
90	90	prescriber for a patient under Section 169.004, Occupations Code,
91	91	the name and date of birth of the patient, the dosage prescribed,
92	92	the means of administration ordered, and the total amount of
93	93	low-THC cannabis or medical research cannabis required to fill the
94	94	patient's prescription; and
95	95	(2) a record of each amount of low-THC cannabis or
96	96	medical research cannabis dispensed by a dispensing organization to
97	97	a patient under a prescription.
98	98	(b) The department shall ensure the registry:
99	99	(1) is designed to prevent more than one qualified
100	100	physician from registering as the prescriber for a single patient;
101	101	(2) is accessible to law enforcement agencies and
102	102	dispensing organizations for the purpose of verifying whether a
103	103	patient is one for whom low-THC cannabis or medical research
104	104	cannabis is prescribed and whether the patient's prescriptions have
105	105	been filled; and
106	106	(3) allows a physician qualified to prescribe low-THC
107	107	cannabis and medical research cannabis under Section 169.002,
108	108	Occupations Code, to input safety and efficacy data derived from
109	109	the treatment of patients for whom low-THC cannabis or medical
110	110	research cannabis is prescribed under Chapter 169, Occupations
111	111	Code.
112	112	SECTION 6. Section 487.102, Health and Safety Code, is
113	113	amended to read as follows:
114	114	Sec. 487.102. ELIGIBILITY FOR LICENSE. An applicant for a
115	115	license to operate as a dispensing organization is eligible for the
116	116	license if:
117	117	(1) as determined by the department, the applicant
118	118	possesses:
119	119	(A) the technical and technological ability to
120	120	cultivate and produce low-THC cannabis or medical research
121	121	cannabis;
122	122	(B) the ability to secure:
123	123	(i) the resources and personnel necessary
124	124	to operate as a dispensing organization; and
125	125	(ii) premises reasonably located to allow
126	126	patients listed on the compassionate-use registry access to the
127	127	organization through existing infrastructure;
128	128	(C) the ability to maintain accountability for
129	129	the raw materials, the finished product, and any by-products used
130	130	or produced in the cultivation or production of low-THC cannabis or
131	131	medical research cannabis to prevent unlawful access to or unlawful
132	132	diversion or possession of those materials, products, or
133	133	by-products; and
134	134	(D) the financial ability to maintain operations
135	135	for not less than two years from the date of application;
136	136	(2) each director, manager, or employee of the
137	137	applicant is registered under Subchapter D; and
138	138	(3) the applicant satisfies any additional criteria
139	139	determined by the director to be necessary to safely implement this
140	140	chapter.
141	141	SECTION 7. Section 487.104(a), Health and Safety Code, is
142	142	amended to read as follows:
143	143	(a) The department shall issue or renew a license to operate
144	144	as a dispensing organization only if:
145	145	(1) the department determines the applicant meets the
146	146	eligibility requirements described by Section 487.102; and
147	147	(2) issuance or renewal of the license is necessary to
148	148	ensure reasonable statewide access to, and the availability of,
149	149	low-THC cannabis or medical research cannabis for patients
150	150	registered in the compassionate-use registry and for whom low-THC
151	151	cannabis or medical research cannabis is prescribed under Chapter
152	152	169, Occupations Code.
153	153	SECTION 8. Section 487.107, Health and Safety Code, is
154	154	amended to read as follows:
155	155	Sec. 487.107. DUTIES RELATING TO DISPENSING PRESCRIPTION.
156	156	(a) Before dispensing low-THC cannabis or medical research
157	157	cannabis to a person for whom the low-THC cannabis or medical
158	158	research cannabis is prescribed under Chapter 169, Occupations
159	159	Code, the dispensing organization must verify that the prescription
160	160	presented:
161	161	(1) is for a person listed as a patient in the
162	162	compassionate-use registry;
163	163	(2) matches the entry in the compassionate-use
164	164	registry with respect to the total amount of low-THC cannabis or
165	165	medical research cannabis required to fill the prescription; and
166	166	(3) has not previously been filled by a dispensing
167	167	organization as indicated by an entry in the compassionate-use
168	168	registry.
169	169	(b) After dispensing low-THC cannabis or medical research
170	170	cannabis to a patient for whom the low-THC cannabis or medical
171	171	research cannabis is prescribed under Chapter 169, Occupations
172	172	Code, the dispensing organization shall record in the
173	173	compassionate-use registry the form and quantity of low-THC
174	174	cannabis or medical research cannabis dispensed and the date and
175	175	time of dispensation.
176	176	SECTION 9. Section 487.108(c), Health and Safety Code, is
177	177	amended to read as follows:
178	178	(c) After suspending or revoking a license issued under this
179	179	chapter, the director may seize or place under seal all low-THC
180	180	cannabis or medical research cannabis and drug paraphernalia owned
181	181	or possessed by the dispensing organization. If the director
182	182	orders the revocation of the license, a disposition may not be made
183	183	of the seized or sealed low-THC cannabis or medical research
184	184	cannabis or drug paraphernalia until the time for administrative
185	185	appeal of the order has elapsed or until all appeals have been
186	186	concluded. When a revocation order becomes final, all low-THC
187	187	cannabis or medical research cannabis and drug paraphernalia may be
188	188	forfeited to the state as provided under Subchapter E, Chapter 481.
189	189	SECTION 10. Section 487.201, Health and Safety Code, is
190	190	amended to read as follows:
191	191	Sec. 487.201. COUNTIES AND MUNICIPALITIES MAY NOT PROHIBIT
192	192	LOW-THC CANNABIS OR MEDICAL RESEARCH CANNABIS. A municipality,
193	193	county, or other political subdivision may not enact, adopt, or
194	194	enforce a rule, ordinance, order, resolution, or other regulation
195	195	that prohibits the cultivation, production, dispensing, or
196	196	possession of low-THC cannabis or medical research cannabis, as
197	197	authorized by this chapter.
198	198	SECTION 11. Chapter 487, Health and Safety Code, is amended
199	199	by adding Subchapter F to read as follows:
200	200	SUBCHAPTER F. COMPASSIONATE-USE RESEARCH AND REPORTING
201	201	Sec. 487.251. COMPASSIONATE-USE INSTITUTIONAL REVIEW
202	202	BOARDS. (a) One or more institutional review boards may be
203	203	established to:
204	204	(1) evaluate and approve proposed research programs to
205	205	study the medical use of cannabis; and
206	206	(2) oversee patient treatment undertaken as part of an
207	207	approved research program, including the certification of treating
208	208	physicians and the approval of cannabis products to be prescribed
209	209	and evaluated.
210	210	(b) An institutional review board must be affiliated with a
211	211	dispensing organization and a:
212	212	(1) medical school, as defined by Section 61.501,
213	213	Education Code; or
214	214	(2) hospital licensed under Chapter 241 that has at
215	215	least 150 beds.
216	216	(c) An institutional review board must submit written
217	217	reports that describe and assess the research findings of each
218	218	approved research program to:
219	219	(1) the department, not later than October 1 of each
220	220	year; and
221	221	(2) the legislature, not later than 90 days before
222	222	each regular legislative session.
223	223	(d) The Texas Medical Board may adopt rules as necessary to
224	224	implement this subchapter.
225	225	Sec. 487.252. PATIENT TREATMENT. (a) Patient treatment
226	226	provided as part of a research program under this subchapter may
227	227	only be administered by a physician certified by an institutional
228	228	review board to participate in the program. A certified physician
229	229	must remain in compliance with all applicable department and Texas
230	230	Medical Board rules and all applicable provisions of this chapter
231	231	and Chapter 169, Occupations Code.
232	232	(b) A patient participating in a research program under this
233	233	subchapter must be:
234	234	(1) a permanent resident of this state; and
235	235	(2) 21 years of age or older.
236	236	Sec. 487.253. INFORMED CONSENT. (a) Before receiving
237	237	treatment, each patient in a research program under this subchapter
238	238	must sign a written informed consent.
239	239	(b) If the patient lacks the mental capacity to provide
240	240	informed consent, a parent, guardian, or conservator may provide
241	241	informed consent on the patient's behalf.
242	242	(c) An institutional review board overseeing a research
243	243	program under this subchapter may adopt a form to be used for the
244	244	informed consent required by this section.
245	245	SECTION 12. The heading to Chapter 169, Occupations Code,
246	246	is amended to read as follows:
247	247	CHAPTER 169. AUTHORITY TO PRESCRIBE LOW-THC CANNABIS OR MEDICAL
248	248	RESEARCH CANNABIS TO CERTAIN PATIENTS FOR COMPASSIONATE USE
249	249	SECTION 13. Section 169.001, Occupations Code, is amended
250	250	by amending Subdivisions (3) and (4) and adding Subdivision (3-a)
251	251	to read as follows:
252	252	(3) "Low-THC cannabis" means a product derived from
253	253	the plant Cannabis sativa L.[, and any part of that plant or any
254	254	compound, manufacture, salt, derivative, mixture, preparation,
255	255	resin, or oil of that plant] that contains less than one[:
256	256	[(A) not more than 0.5] percent by weight of
257	257	tetrahydrocannabinols[; and
258	258	[(B) not less than 10 percent by weight of
259	259	cannabidiol].
260	260	(3-a) "Medical research cannabis" means a product
261	261	derived from the plant Cannabis sativa L. that is approved by an
262	262	institutional review board for use in a research program under
263	263	Chapter 487, Health and Safety Code.
264	264	(4) "Medical use" means the ingestion by a means of
265	265	administration other than by smoking of a prescribed amount of
266	266	low-THC cannabis or medical research cannabis by a person for whom
267	267	low-THC cannabis or medical research cannabis is prescribed under
268	268	this chapter.
269	269	SECTION 14. The heading to Section 169.002, Occupations
270	270	Code, is amended to read as follows:
271	271	Sec. 169.002. PHYSICIAN QUALIFIED TO PRESCRIBE LOW-THC
272	272	CANNABIS OR MEDICAL RESEARCH CANNABIS.
273	273	SECTION 15. Section 169.002(a), Occupations Code, is
274	274	amended to read as follows:
275	275	(a) A [Only a] physician licensed under [qualified as
276	276	provided by] this subtitle [section] may prescribe low-THC cannabis
277	277	and medical research cannabis in accordance with this chapter.
278	278	SECTION 16. Section 169.003, Occupations Code, is amended
279	279	to read as follows:
280	280	Sec. 169.003. PRESCRIPTION OF LOW-THC CANNABIS. A
281	281	physician described by Section 169.002 may prescribe low-THC
282	282	cannabis [to alleviate a patient's seizures] if:
283	283	(1) the patient is a permanent resident of the state;
284	284	(2) the physician complies with the registration
285	285	requirements of Section 169.004; and
286	286	(3) the physician certifies to the department that[:
287	287	[(A) the patient is diagnosed with intractable
288	288	epilepsy;
289	289	[(B)] the physician has determined that
290	290	[determines] the risk of the medical use of low-THC cannabis by the
291	291	patient is reasonable in light of the potential benefit for the
292	292	patient[; and
293	293	[(C) a second physician qualified to prescribe
294	294	low-THC cannabis under Section 169.002 has concurred with the
295	295	determination under Paragraph (B), and the second physician's
296	296	concurrence is recorded in the patient's medical record].
297	297	SECTION 17. Chapter 169, Occupations Code, is amended by
298	298	adding Section 169.0031 to read as follows:
299	299	Sec. 169.0031. PRESCRIPTION OF MEDICAL RESEARCH CANNABIS.
300	300	A physician described by Section 169.002 may prescribe medical
301	301	research cannabis if:
302	302	(1) the prescription is for treatment approved by an
303	303	institutional review board as part of a research program under
304	304	Chapter 487, Health and Safety Code;
305	305	(2) the patient is:
306	306	(A) a permanent resident of this state; and
307	307	(B) 21 years of age or older; and
308	308	(3) the physician:
309	309	(A) complies with the registration requirements
310	310	of Section 169.004;
311	311	(B) is certified by an institutional review board
312	312	as a treating physician in a research program under Chapter 487,
313	313	Health and Safety Code; and
314	314	(C) certifies to the department that the
315	315	physician has determined that the risk of the medical use of medical
316	316	research cannabis by the patient is reasonable in light of the
317	317	potential benefit for the patient.
318	318	SECTION 18. Section 169.004, Occupations Code, is amended
319	319	to read as follows:
320	320	Sec. 169.004. LOW-THC CANNABIS AND MEDICAL RESEARCH
321	321	CANNABIS PRESCRIBER REGISTRATION. (a) Before a physician
322	322	qualified to prescribe low-THC cannabis or medical research
323	323	cannabis under Section 169.002 may prescribe or renew a
324	324	prescription for low-THC cannabis or medical research cannabis for
325	325	a patient under this chapter, the physician must register as the
326	326	prescriber for that patient in the compassionate-use registry
327	327	maintained by the department under Section 487.054, Health and
328	328	Safety Code. The physician's registration must indicate:
329	329	(1) the physician's name;
330	330	(2) the patient's name and date of birth;
331	331	(3) the dosage prescribed to the patient;
332	332	(4) the means of administration ordered for the
333	333	patient; and
334	334	(5) the total amount of low-THC cannabis or medical
335	335	research cannabis required to fill the patient's prescription.
336	336	(b) The department may publish the name of a physician
337	337	registered under this section only if permission is expressly
338	338	granted by the physician.
339	339	SECTION 19. Section 169.005, Occupations Code, is amended
340	340	to read as follows:
341	341	Sec. 169.005. PATIENT TREATMENT PLAN. A physician
342	342	described by Section 169.002 who prescribes low-THC cannabis or
343	343	medical research cannabis for a patient's medical use under this
344	344	chapter must maintain a patient treatment plan that indicates:
345	345	(1) the dosage, means of administration, and planned
346	346	duration of treatment for the low-THC cannabis or medical research
347	347	cannabis;
348	348	(2) a plan for monitoring the patient's symptoms; and
349	349	(3) a plan for monitoring indicators of tolerance or
350	350	reaction to low-THC cannabis or medical research cannabis.
351	351	SECTION 20. Section 551.004(a), Occupations Code, is
352	352	amended to read as follows:
353	353	(a) This subtitle does not apply to:
354	354	(1) a practitioner licensed by the appropriate state
355	355	board who supplies a patient of the practitioner with a drug in a
356	356	manner authorized by state or federal law and who does not operate a
357	357	pharmacy for the retailing of prescription drugs;
358	358	(2) a member of the faculty of a college of pharmacy
359	359	recognized by the board who is a pharmacist and who performs the
360	360	pharmacist's services only for the benefit of the college;
361	361	(3) a person who procures prescription drugs for
362	362	lawful research, teaching, or testing and not for resale;
363	363	(4) a home and community support services agency that
364	364	possesses a dangerous drug as authorized by Section 142.0061,
365	365	142.0062, or 142.0063, Health and Safety Code; or
366	366	(5) a dispensing organization, as defined by Section
367	367	487.001, Health and Safety Code, that cultivates, processes, and
368	368	dispenses low-THC cannabis or medical research cannabis, as
369	369	authorized by Chapter 487, Health and Safety Code, to a patient
370	370	listed in the compassionate-use registry established under that
371	371	chapter.
372	372	SECTION 21. The following provisions of the Occupations
373	373	Code are repealed:
374	374	(1) Section 169.001(2); and
375	375	(2) Section 169.002(b).
376	376	SECTION 22. Not later than December 1, 2019, the public
377	377	safety director of the Department of Public Safety shall adopt
378	378	rules as required to implement, administer, and enforce Chapter
379	379	487, Health and Safety Code, and Chapter 169, Occupations Code, as
380	380	amended by this Act.
381	381	SECTION 23. This Act takes effect immediately if it
382	382	receives a vote of two-thirds of all the members elected to each
383	383	house, as provided by Section 39, Article III, Texas Constitution.
384	384	If this Act does not receive the vote necessary for immediate
385	385	effect, this Act takes effect September 1, 2019.