Texas 2015 - 84th Regular

Texas Senate Bill SB339 Compare Versions

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1-By: Eltife, et al. S.B. No. 339
2- (Klick, Zerwas, Zedler, Coleman, Sheffield, et al.)
1+S.B. No. 339
32
43
5- A BILL TO BE ENTITLED
64 AN ACT
75 relating to the medical use of low-THC cannabis and the regulation
86 of related organizations and individuals; requiring a dispensing
97 organization to obtain a license to dispense low-THC cannabis and
108 any employee of a dispensing organization to obtain a registration;
119 authorizing fees.
1210 BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS:
1311 SECTION 1. Subtitle C, Title 6, Health and Safety Code, is
1412 amended by adding Chapter 487 to read as follows:
1513 CHAPTER 487. TEXAS COMPASSIONATE-USE ACT
1614 SUBCHAPTER A. GENERAL PROVISIONS
1715 Sec. 487.001. DEFINITIONS. In this chapter:
1816 (1) "Department" means the Department of Public
1917 Safety.
2018 (2) "Director" means the public safety director of the
2119 department.
2220 (3) "Dispensing organization" means an organization
2321 licensed by the department to cultivate, process, and dispense
2422 low-THC cannabis to a patient for whom low-THC cannabis is
2523 prescribed under Chapter 169, Occupations Code.
2624 (4) "Low-THC cannabis" has the meaning assigned by
2725 Section 169.001, Occupations Code.
2826 SUBCHAPTER B. DUTIES OF DEPARTMENT
2927 Sec. 487.051. DUTIES OF DEPARTMENT. The department shall
3028 administer this chapter.
3129 Sec. 487.052. RULES. The director shall adopt any rules
3230 necessary for the administration and enforcement of this chapter,
3331 including rules imposing fees under this chapter in amounts
3432 sufficient to cover the cost of administering this chapter.
3533 Sec. 487.053. LICENSING OF DISPENSING ORGANIZATIONS AND
3634 REGISTRATION OF CERTAIN ASSOCIATED INDIVIDUALS. (a) The
3735 department shall:
3836 (1) issue or renew a license to operate as a dispensing
3937 organization to each applicant who satisfies the requirements
4038 established under this chapter; and
4139 (2) register directors, managers, and employees of
4240 each dispensing organization.
4341 (b) The department shall enforce compliance of licensees
4442 and registrants and shall adopt procedures for suspending or
4543 revoking a license or registration issued under this chapter and
4644 for renewing a license or registration issued under this chapter.
4745 Sec. 487.054. COMPASSIONATE-USE REGISTRY. (a) The
4846 department shall establish and maintain a secure online
4947 compassionate-use registry that contains:
5048 (1) the name of each physician who registers as the
5149 prescriber for a patient under Section 169.004, Occupations Code,
5250 the name and date of birth of the patient, the dosage prescribed,
5351 the means of administration ordered, and the total amount of
5452 low-THC cannabis required to fill the patient's prescription; and
5553 (2) a record of each amount of low-THC cannabis
5654 dispensed by a dispensing organization to a patient under a
5755 prescription.
5856 (b) The department shall ensure the registry:
5957 (1) is designed to prevent more than one qualified
6058 physician from registering as the prescriber for a single patient;
6159 (2) is accessible to law enforcement agencies and
6260 dispensing organizations for the purpose of verifying whether a
6361 patient is one for whom low-THC cannabis is prescribed and whether
6462 the patient's prescriptions have been filled; and
6563 (3) allows a physician qualified to prescribe low-THC
6664 cannabis under Section 169.002, Occupations Code, to input safety
6765 and efficacy data derived from the treatment of patients for whom
6866 low-THC cannabis is prescribed under Chapter 169, Occupations Code.
6967 SUBCHAPTER C. LICENSE TO OPERATE AS DISPENSING ORGANIZATION
7068 Sec. 487.101. LICENSE REQUIRED. A license issued by the
7169 department under this chapter is required to operate a dispensing
7270 organization.
7371 Sec. 487.102. ELIGIBILITY FOR LICENSE. An applicant for a
7472 license to operate as a dispensing organization is eligible for the
7573 license if:
7674 (1) as determined by the department, the applicant
7775 possesses:
7876 (A) the technical and technological ability to
7977 cultivate and produce low-THC cannabis;
8078 (B) the ability to secure:
8179 (i) the resources and personnel necessary
8280 to operate as a dispensing organization; and
8381 (ii) premises reasonably located to allow
8482 patients listed on the compassionate-use registry access to the
8583 organization through existing infrastructure;
8684 (C) the ability to maintain accountability for
8785 the raw materials, the finished product, and any by-products used
8886 or produced in the cultivation or production of low-THC cannabis to
8987 prevent unlawful access to or unlawful diversion or possession of
9088 those materials, products, or by-products; and
9189 (D) the financial ability to maintain operations
9290 for not less than two years from the date of application;
9391 (2) each director, manager, or employee of the
9492 applicant is registered under Subchapter D; and
9593 (3) the applicant satisfies any additional criteria
9694 determined by the director to be necessary to safely implement this
9795 chapter.
9896 Sec. 487.103. APPLICATION. (a) A person may apply for an
9997 initial or renewal license to operate as a dispensing organization
10098 by submitting a form prescribed by the department along with the
10199 application fee in an amount set by the director.
102100 (b) The application must include the name and address of the
103101 applicant, the name and address of each of the applicant's
104102 directors, managers, and employees, and any other information
105103 considered necessary by the department to determine the applicant's
106104 eligibility for the license.
107105 Sec. 487.104. ISSUANCE, RENEWAL, OR DENIAL OF LICENSE.
108106 (a) The department shall issue or renew a license to operate as a
109107 dispensing organization only if:
110108 (1) the department determines the applicant meets the
111109 eligibility requirements described by Section 487.102; and
112110 (2) issuance or renewal of the license is necessary to
113111 ensure reasonable statewide access to, and the availability of,
114112 low-THC cannabis for patients registered in the compassionate-use
115113 registry and for whom low-THC cannabis is prescribed under Chapter
116114 169, Occupations Code.
117115 (b) If the department denies the issuance or renewal of a
118116 license under Subsection (a), the applicant is entitled to a
119117 hearing. The department shall give written notice of the grounds
120118 for denial to the applicant at least 30 days before the date of the
121119 hearing.
122120 (c) A license issued or renewed under this section expires
123121 on the second anniversary of the date of issuance or renewal, as
124122 applicable.
125123 Sec. 487.105. CRIMINAL HISTORY BACKGROUND CHECK. (a) An
126124 applicant for the issuance or renewal of a license to operate as a
127125 dispensing organization shall provide the department with the
128126 applicant's name and the name of each of the applicant's directors,
129127 managers, and employees.
130128 (b) Before a dispensing organization licensee hires a
131129 manager or employee for the organization, the licensee must provide
132130 the department with the name of the prospective manager or
133131 employee. The licensee may not transfer the license to another
134132 person before that prospective applicant and the applicant's
135133 directors, managers, and employees pass a criminal history
136134 background check and are registered as required by Subchapter D.
137135 (c) The department shall conduct a criminal history
138136 background check on each individual whose name is provided to the
139137 department under Subsection (a) or (b). The director by rule shall:
140138 (1) determine the manner by which an individual is
141139 required to submit a complete set of fingerprints to the department
142140 for purposes of a criminal history background check under this
143141 section; and
144142 (2) establish criteria for determining whether an
145143 individual passes the criminal history background check for the
146144 purposes of this section.
147145 (d) After conducting a criminal history background check
148146 under this section, the department shall notify the relevant
149147 applicant or organization and the individual who is the subject of
150148 the criminal history background check as to whether the individual
151149 passed the criminal history background check.
152150 Sec. 487.106. DUTY TO MAINTAIN ELIGIBILITY. A dispensing
153151 organization must maintain compliance at all times with the
154152 eligibility requirements described by Section 487.102.
155153 Sec. 487.107. DUTIES RELATING TO DISPENSING PRESCRIPTION.
156154 (a) Before dispensing low-THC cannabis to a person for whom the
157155 low-THC cannabis is prescribed under Chapter 169, Occupations Code,
158156 the dispensing organization must verify that the prescription
159157 presented:
160158 (1) is for a person listed as a patient in the
161159 compassionate-use registry;
162160 (2) matches the entry in the compassionate-use
163161 registry with respect to the total amount of low-THC cannabis
164162 required to fill the prescription; and
165163 (3) has not previously been filled by a dispensing
166164 organization as indicated by an entry in the compassionate-use
167165 registry.
168166 (b) After dispensing low-THC cannabis to a patient for whom
169167 the low-THC cannabis is prescribed under Chapter 169, Occupations
170168 Code, the dispensing organization shall record in the
171169 compassionate-use registry the form and quantity of low-THC
172170 cannabis dispensed and the date and time of dispensation.
173171 Sec. 487.108. LICENSE SUSPENSION OR REVOCATION. (a) The
174172 department may at any time suspend or revoke a license issued under
175173 this chapter if the department determines that the licensee has not
176174 maintained the eligibility requirements described by Section
177175 487.102 or has failed to comply with a duty imposed under this
178176 chapter.
179177 (b) The director shall give written notice to the dispensing
180178 organization of a license suspension or revocation under this
181179 section and the grounds for the suspension or revocation. The
182180 notice must be sent by certified mail, return receipt requested.
183181 (c) After suspending or revoking a license issued under this
184182 chapter, the director may seize or place under seal all low-THC
185183 cannabis and drug paraphernalia owned or possessed by the
186184 dispensing organization. If the director orders the revocation of
187185 the license, a disposition may not be made of the seized or sealed
188186 low-THC cannabis or drug paraphernalia until the time for
189187 administrative appeal of the order has elapsed or until all appeals
190188 have been concluded. When a revocation order becomes final, all
191189 low-THC cannabis and drug paraphernalia may be forfeited to the
192190 state as provided under Subchapter E, Chapter 481.
193191 (d) Chapter 2001, Government Code, applies to a proceeding
194192 under this section.
195193 SUBCHAPTER D. REGISTRATION OF CERTAIN INDIVIDUALS
196194 Sec. 487.151. REGISTRATION REQUIRED. (a) An individual
197195 who is a director, manager, or employee of a dispensing
198196 organization must apply for and obtain a registration under this
199197 section.
200198 (b) An applicant for a registration under this section must:
201199 (1) be at least 18 years of age;
202200 (2) submit a complete set of fingerprints to the
203201 department in the manner required by department rule; and
204202 (3) pass a fingerprint-based criminal history
205203 background check as required by Section 487.105.
206204 (c) A registration expires on the second anniversary of the
207205 date of the registration's issuance, unless suspended or revoked
208206 under rules adopted under this chapter.
209207 SUBCHAPTER E. DUTIES OF COUNTIES AND MUNICIPALITIES
210208 Sec. 487.201. COUNTIES AND MUNICIPALITIES MAY NOT PROHIBIT
211209 LOW-THC CANNABIS. A municipality, county, or other political
212210 subdivision may not enact, adopt, or enforce a rule, ordinance,
213211 order, resolution, or other regulation that prohibits the
214212 cultivation, production, dispensing, or possession of low-THC
215213 cannabis, as authorized by this chapter.
216214 SECTION 2. Section 481.062(a), Health and Safety Code, as
217215 amended by S.B. 219, Acts of the 84th Legislature, Regular Session,
218216 2015, is amended to read as follows:
219217 (a) The following persons are not required to register and
220218 may possess a controlled substance under this chapter:
221219 (1) an agent or employee of a registered manufacturer,
222220 distributor, analyzer, or dispenser of the controlled substance
223221 acting in the usual course of business or employment;
224222 (2) a common or contract carrier, a warehouseman, or
225223 an employee of a carrier or warehouseman whose possession of the
226224 controlled substance is in the usual course of business or
227225 employment;
228226 (3) an ultimate user or a person in possession of the
229227 controlled substance under a lawful order of a practitioner or in
230228 lawful possession of the controlled substance if it is listed in
231229 Schedule V;
232230 (4) an officer or employee of this state, another
233231 state, a political subdivision of this state or another state, or
234232 the United States who is lawfully engaged in the enforcement of a
235233 law relating to a controlled substance or drug or to a customs law
236234 and authorized to possess the controlled substance in the discharge
237235 of the person's official duties; [or]
238236 (5) if the substance is tetrahydrocannabinol or one of
239237 its derivatives:
240238 (A) a Department of State Health Services
241239 official, a medical school researcher, or a research program
242240 participant possessing the substance as authorized under
243241 Subchapter G; or
244242 (B) a practitioner or an ultimate user possessing
245243 the substance as a participant in a federally approved therapeutic
246244 research program that the commissioner has reviewed and found, in
247245 writing, to contain a medically responsible research protocol; or
248246 (6) a dispensing organization licensed under Chapter
249247 487 that possesses low-THC cannabis.
250248 SECTION 3. Section 481.111, Health and Safety Code, is
251249 amended by adding Subsections (e) and (f) to read as follows:
252250 (e) Sections 481.120, 481.121, 481.122, and 481.125 do not
253251 apply to a person who engages in the acquisition, possession,
254252 production, cultivation, delivery, or disposal of a raw material
255253 used in or by-product created by the production or cultivation of
256254 low-THC cannabis if the person:
257255 (1) for an offense involving possession only of
258256 marihuana or drug paraphernalia, is a patient for whom low-THC
259257 cannabis is prescribed under Chapter 169, Occupations Code, or the
260258 patient's legal guardian, and the person possesses low-THC cannabis
261259 obtained under a valid prescription from a dispensing organization;
262260 or
263261 (2) is a director, manager, or employee of a
264262 dispensing organization and the person, solely in performing the
265263 person's regular duties at the organization, acquires, possesses,
266264 produces, cultivates, dispenses, or disposes of:
267265 (A) in reasonable quantities, any low-THC
268266 cannabis or raw materials used in or by-products created by the
269267 production or cultivation of low-THC cannabis; or
270268 (B) any drug paraphernalia used in the
271269 acquisition, possession, production, cultivation, delivery, or
272270 disposal of low-THC cannabis.
273271 (f) For purposes of Subsection (e):
274272 (1) "Dispensing organization" has the meaning
275273 assigned by Section 487.001.
276274 (2) "Low-THC cannabis" has the meaning assigned by
277275 Section 169.001, Occupations Code.
278276 SECTION 4. Subtitle B, Title 3, Occupations Code, is
279277 amended by adding Chapter 169 to read as follows:
280278 CHAPTER 169. AUTHORITY TO PRESCRIBE LOW-THC CANNABIS TO CERTAIN
281279 PATIENTS FOR COMPASSIONATE USE
282280 Sec. 169.001. DEFINITIONS. In this chapter:
283281 (1) "Department" means the Department of Public
284282 Safety.
285283 (2) "Intractable epilepsy" means a seizure disorder in
286284 which the patient's seizures have been treated by two or more
287285 appropriately chosen and maximally titrated antiepileptic drugs
288286 that have failed to control the seizures.
289287 (3) "Low-THC cannabis" means the plant Cannabis sativa
290288 L., and any part of that plant or any compound, manufacture, salt,
291289 derivative, mixture, preparation, resin, or oil of that plant that
292290 contains:
293291 (A) not more than 0.5 percent by weight of
294292 tetrahydrocannabinols; and
295293 (B) not less than 10 percent by weight of
296294 cannabidiol.
297295 (4) "Medical use" means the ingestion by a means of
298296 administration other than by smoking of a prescribed amount of
299297 low-THC cannabis by a person for whom low-THC cannabis is
300298 prescribed under this chapter.
301299 (5) "Smoking" means burning or igniting a substance
302300 and inhaling the smoke.
303301 Sec. 169.002. PHYSICIAN QUALIFIED TO PRESCRIBE LOW-THC
304302 CANNABIS. (a) Only a physician qualified as provided by this
305303 section may prescribe low-THC cannabis in accordance with this
306304 chapter.
307305 (b) A physician is qualified to prescribe low-THC cannabis
308306 to a patient with intractable epilepsy if the physician:
309307 (1) is licensed under this subtitle;
310308 (2) dedicates a significant portion of clinical
311309 practice to the evaluation and treatment of epilepsy; and
312310 (3) is certified:
313311 (A) by the American Board of Psychiatry and
314312 Neurology in:
315313 (i) epilepsy; or
316314 (ii) neurology or neurology with special
317315 qualification in child neurology and is otherwise qualified for the
318316 examination for certification in epilepsy; or
319317 (B) in neurophysiology by:
320318 (i) the American Board of Psychiatry and
321319 Neurology; or
322320 (ii) the American Board of Clinical
323321 Neurophysiology.
324322 Sec. 169.003. PRESCRIPTION OF LOW-THC CANNABIS. A
325323 physician described by Section 169.002 may prescribe low-THC
326324 cannabis to alleviate a patient's seizures if:
327325 (1) the patient is a permanent resident of the state;
328326 (2) the physician complies with the registration
329327 requirements of Section 169.004; and
330328 (3) the physician certifies to the department that:
331329 (A) the patient is diagnosed with intractable
332330 epilepsy;
333331 (B) the physician determines the risk of the
334332 medical use of low-THC cannabis by the patient is reasonable in
335333 light of the potential benefit for the patient; and
336334 (C) a second physician qualified to prescribe
337335 low-THC cannabis under Section 169.002 has concurred with the
338336 determination under Paragraph (B), and the second physician's
339337 concurrence is recorded in the patient's medical record.
340338 Sec. 169.004. LOW-THC CANNABIS PRESCRIBER REGISTRATION.
341339 Before a physician qualified to prescribe low-THC cannabis under
342340 Section 169.002 may prescribe or renew a prescription for low-THC
343341 cannabis for a patient under this chapter, the physician must
344342 register as the prescriber for that patient in the
345343 compassionate-use registry maintained by the department under
346344 Section 487.054, Health and Safety Code. The physician's
347345 registration must indicate:
348346 (1) the physician's name;
349347 (2) the patient's name and date of birth;
350348 (3) the dosage prescribed to the patient;
351349 (4) the means of administration ordered for the
352350 patient; and
353351 (5) the total amount of low-THC cannabis required to
354352 fill the patient's prescription.
355353 Sec. 169.005. PATIENT TREATMENT PLAN. A physician
356354 described by Section 169.002 who prescribes low-THC cannabis for a
357355 patient's medical use under this chapter must maintain a patient
358356 treatment plan that indicates:
359357 (1) the dosage, means of administration, and planned
360358 duration of treatment for the low-THC cannabis;
361359 (2) a plan for monitoring the patient's symptoms; and
362360 (3) a plan for monitoring indicators of tolerance or
363361 reaction to low-THC cannabis.
364362 SECTION 5. Section 551.004(a), Occupations Code, is amended
365363 to read as follows:
366364 (a) This subtitle does not apply to:
367365 (1) a practitioner licensed by the appropriate state
368366 board who supplies a patient of the practitioner with a drug in a
369367 manner authorized by state or federal law and who does not operate a
370368 pharmacy for the retailing of prescription drugs;
371369 (2) a member of the faculty of a college of pharmacy
372370 recognized by the board who is a pharmacist and who performs the
373371 pharmacist's services only for the benefit of the college;
374372 (3) a person who procures prescription drugs for
375373 lawful research, teaching, or testing and not for resale; [or]
376374 (4) a home and community support services agency that
377375 possesses a dangerous drug as authorized by Section 142.0061,
378376 142.0062, or 142.0063, Health and Safety Code; or
379377 (5) a dispensing organization, as defined by Section
380378 487.001, Health and Safety Code, that cultivates, processes, and
381379 dispenses low-THC cannabis, as authorized by Chapter 487, Health
382380 and Safety Code, to a patient listed in the compassionate-use
383381 registry established under that chapter.
384382 SECTION 6. (a) Not later than December 1, 2015, the public
385383 safety director of the Department of Public Safety shall adopt
386384 rules as required to implement, administer, and enforce Chapter
387385 487, Health and Safety Code, as added by this Act, including rules
388386 to establish the compassionate-use registry required by that
389387 chapter.
390388 (b) Not later than September 1, 2017, the Department of
391389 Public Safety shall license at least three dispensing organizations
392390 in accordance with Section 487.053, Health and Safety Code, as
393391 added by this Act, provided at least three applicants for a license
394392 to operate as a dispensing organization have met the requirements
395393 for approval provided by Subchapter C, Chapter 487, Health and
396394 Safety Code, as added by this Act.
397395 SECTION 7. This Act takes effect immediately if it receives
398396 a vote of two-thirds of all the members elected to each house, as
399397 provided by Section 39, Article III, Texas Constitution. If this
400398 Act does not receive the vote necessary for immediate effect, this
401399 Act takes effect September 1, 2015.
400+ ______________________________ ______________________________
401+ President of the Senate Speaker of the House
402+ I hereby certify that S.B. No. 339 passed the Senate on
403+ May 7, 2015, by the following vote: Yeas 26, Nays 5.
404+ ______________________________
405+ Secretary of the Senate
406+ I hereby certify that S.B. No. 339 passed the House on
407+ May 19, 2015, by the following vote: Yeas 108, Nays 38, one
408+ present not voting.
409+ ______________________________
410+ Chief Clerk of the House
411+ Approved:
412+ ______________________________
413+ Date
414+ ______________________________
415+ Governor