2
3
4
5
6
7 LONG TITLE
8 General Description:
9 This bill authorizes the production and medical use of psilocybin in the state.
10 Highlighted Provisions:
11 This bill:
12 ▸ defines terms;
13 ▸ authorizes the production of psilocybin and psilocybin products;
14 ▸ requires the Department of Agriculture and Food (UDAF) to regulate psilocybin
15 production establishments;
16 ▸ authorizes the Department of Health and Human Services (DHHS) to register
17 psilocybin medical providers and therapy providers;
18 ▸ allows an individual who is at least 21 years old to receive a psilocybin treatment
19 directly from a psilocybin therapy provider;
20 ▸ decriminalizes psilocybin possession under certain circumstances; and
21 ▸ modifies the uses of certain statutorily created funds overseen by UDAF and DHHS.
22 Money Appropriated in this Bill:
23 None
24 Other Special Clauses:
25 None
26 Utah Code Sections Affected:
27 AMENDS:
28 4-41a-104, as enacted by Laws of Utah 2018, Third Special Session, Chapter 1
29 26-61a-109, as last amended by Laws of Utah 2019, First Special Session, Chapter 5
30 30-3-10, as last amended by Laws of Utah 2019, First Special Session, Chapter 5
31 31A-22-1016, as enacted by Laws of Utah 2019, Chapter 341
32 58-31b-305, as last amended by Laws of Utah 2019, Chapter 447
33 58-60-205.5, as enacted by Laws of Utah 2010, Chapter 214
34 58-61-306, as enacted by Laws of Utah 1994, Chapter 32
35 58-67-304, as last amended by Laws of Utah 2020, Chapters 12, 339
36 58-68-304, as last amended by Laws of Utah 2020, Chapters 12, 339
37 58-70a-303, as last amended by Laws of Utah 2018, Third Special Session, Chapter 1
38 ENACTS:
39 4-41c-101, Utah Code Annotated 1953
40 4-41c-102, Utah Code Annotated 1953
41 4-41c-103, Utah Code Annotated 1953
42 4-41c-104, Utah Code Annotated 1953
43 4-41c-201, Utah Code Annotated 1953
44 4-41c-202, Utah Code Annotated 1953
45 4-41c-203, Utah Code Annotated 1953
46 4-41c-204, Utah Code Annotated 1953
47 4-41c-205, Utah Code Annotated 1953
48 4-41c-206, Utah Code Annotated 1953
49 4-41c-301, Utah Code Annotated 1953
50 4-41c-302, Utah Code Annotated 1953
51 4-41c-401, Utah Code Annotated 1953
52 4-41c-402, Utah Code Annotated 1953
53 4-41c-403, Utah Code Annotated 1953
54 4-41c-404, Utah Code Annotated 1953
55 4-41c-405, Utah Code Annotated 1953
56 4-41c-406, Utah Code Annotated 1953
57 4-41c-501, Utah Code Annotated 1953
58 4-41c-502, Utah Code Annotated 1953
59 4-41c-601, Utah Code Annotated 1953
60 4-41c-602, Utah Code Annotated 1953
61 4-41c-701, Utah Code Annotated 1953
62 26B-4-901, Utah Code Annotated 1953
63 26B-4-902, Utah Code Annotated 1953
64 26B-4-903, Utah Code Annotated 1953
65 26B-4-904, Utah Code Annotated 1953
66 26B-4-905, Utah Code Annotated 1953
67 26B-4-906, Utah Code Annotated 1953
68 26B-4-907, Utah Code Annotated 1953
69 26B-4-908, Utah Code Annotated 1953
70 26B-4-909, Utah Code Annotated 1953
71 26B-4-910, Utah Code Annotated 1953
72 26B-4-911, Utah Code Annotated 1953
73 26B-4-912, Utah Code Annotated 1953
74 26B-4-913, Utah Code Annotated 1953
75 26B-4-914, Utah Code Annotated 1953
76 26B-4-915, Utah Code Annotated 1953
77 26B-4-916, Utah Code Annotated 1953
78 58-37-3.1, Utah Code Annotated 1953
79
80 Be it enacted by the Legislature of the state of Utah:
81 Section 1. Section 4-41a-104 is amended to read:
82
83 4-41a-104. Qualified Production Enterprise Fund -- Creation -- Revenue
84 neutrality.
85 (1) There is created an enterprise fund known as the "Qualified Production Enterprise
86 Fund."
87 (2) The fund created in this section is funded from:
88 (a) money the department deposits into the fund under:
89 (i) this chapter; and
90 (ii) Chapter 41c, Psilocybin Production Act;
91 (b) appropriations the Legislature makes to the fund; and
92 (c) the interest described in Subsection (3).
93 (3) Interest earned on the Qualified Production Enterprise Fund shall be deposited into
94 the fund.
95 (4) The department may only use money in the fund to fund the department's
96 implementation of this chapter and Chapter 41c, Psilocybin Production Act.
97 (5) The department shall set fees authorized under this chapter and Chapter 41c,
98 Psilocybin Production Act in amounts that the department anticipates are necessary, in total, to
99 cover the department's cost to implement this chapter and Chapter 41c, Psilocybin Production
100 Act.
101 Section 2. Section 4-41c-101 is enacted to read:
102
103
104 4-41c-101. Definitions.
105 (1) "Active psilocybin" means the psychoactive chemical C12H17N2O4P.
106 (2) "Adulterant" means any poisonous or deleterious substance in a quantity that may
107 be injurious to health, including:
108 (a) pesticides;
109 (b) heavy metals;
110 (c) solvents;
111 (d) microbial life;
112 (e) toxins;
113 (f) foreign matter; and
114 (g) synthetics.
115 (3) "Community location" means a public or private elementary or secondary school, a
116 church, a public library, a public playground, or a public park.
117 (4) "Cultivation space" means, quantified in square feet, the horizontal area in which a
118 psilocybin cultivation facility cultivates psilocybin, including each level of horizontal area if
119 the psilocybin cultivation facility hangs, suspends, stacks, or otherwise positions plants above
120 other plants in multiple levels.
121 (5) "Family member" means a parent, step-parent, spouse, child, sibling, step-sibling,
122 uncle, aunt, nephew, niece, first cousin, mother-in-law, father-in-law, brother-in-law,
123 sister-in-law, son-in-law, daughter-in-law, grandparent, or grandchild.
124 (6) "Independent psilocybin testing laboratory" means a person that:
125 (a) conducts a chemical or other analysis of psilocybin or psilocybin product; or
126 (b) acquires, possesses, and transports psilocybin or psilocybin product with the intent
127 to conduct a chemical or other analysis of the psilocybin or psilocybin product.
128 (7) "Independent psilocybin testing laboratory agent" means an individual who holds a
129 valid psilocybin production establishment agent registration card with a psilocybin testing
130 laboratory designation.
131 (8) "Inventory control system" means a system described in Section 4-41b-103.
132 (9) "Licensing board" means the Psilocybin Production Establishment Licensing Board
133 created in Section 4-41c-101.
134 (10) "Patient" means an individual for whom a qualified medical psilocybin provider
135 recommends psilocybin.
136 (11) "Psilocybin" means any fresh mushroom containing psilocybin or psilocin.
137 (12) (a) "Psilocybin biomass" means any part of a psilocybin-containing fungus.
138 (b) "Psilocybin biomass" includes any part of the psilocybin-containing fungus that is:
139 (i) intended for sale; or
140 (ii) a psilocybin byproduct.
141 (13) "Psilocybin byproduct" means any portion of a psilocybin-containing fungus
142 which is not used or intended for sale.
143 (14) "Psilocybin cultivation facility" means a person that:
144 (a) possesses psilocybin;
145 (b) grows or intends to grow psilocybin; and
146 (c) sells or intends to sell psilocybin to a qualified therapy provider.
147 (15) "Psilocybin cultivation facility agent" means an individual who holds a valid
148 psilocybin production establishment agent registration card with a cultivation facility
149 designation.
150 (16) "Psilocybin product" means any portion of a psilocybin-containing mushroom
151 that:
152 (a) has been dried; and
153 (b) is intended for oral consumption by a patient.
154 (17) "Psilocybin production establishment" means a psilocybin cultivation facility or an
155 independent psilocybin testing laboratory.
156 (18) "Psilocybin production establishment agent registration card" means a registration
157 card that the department issues that:
158 (a) authorizes an individual to act as a psilocybin production establishment agent; and
159 (b) designates the type of psilocybin production establishment for which an individual
160 is authorized to act as an agent.
161 (19) "Qualified medical psilocybin provider" means the same as that term is defined in
162 Section 26B-4-901.
163 (20) "Qualified therapy provider" means the same as that term is defined in Section
164 26B-4-901.
165 (21) "Qualified therapy provider location" means the same as that term is defined in
166 Section 26B-4-901.
167 Section 3. Section 4-41c-102 is enacted to read:
168 4-41c-102. Inventory control system.
169 (1) Each psilocybin production establishment and qualified therapy provider shall
170 maintain an inventory control system that meets the requirements of this section.
171 (2) Each psilocybin production establishment and qualified therapy provider shall
172 ensure that the inventory control system:
173 (a) tracks psilocybin and psilocybin product using a unique identifier, in real time, from
174 the time psilocybin is ready to be harvested;
175 (b) maintains in real time a record of the amount of psilocybin or psilocybin product in
176 the possession of the establishment or provider;
177 (c) includes a video recording system that:
178 (i) tracks all handling and processing of psilocybin or psilocybin product in the
179 establishment or provider location;
180 (ii) is tamper proof; and
181 (iii) stores a video record for at least 45 days.
182 (3) A psilocybin production establishment or qualified therapy provider shall allow the
183 following to access the establishment's or provider's inventory control system at any time:
184 (a) the department;
185 (b) the Department of Health and Human Services; and
186 (c) a financial institution that the Division of Finance validates, in accordance with
187 Subsection (6).
188 (4) The department may establish compatibility standards for an inventory control
189 system by rule made in accordance with Title 63G, Chapter 3, Utah Administrative
190 Rulemaking Act.
191 (5) The department shall make rules in accordance with Title 63G, Chapter 3, Utah
192 Administrative Rulemaking Act, establishing requirements for aggregate or batch records
193 regarding the planting and propagation of psilocybin before being tracked in an inventory
194 control system described in this section.
195 (6) The Division of Finance shall, in consultation with the state treasurer:
196 (a) make rules, in accordance with Title 63G, Chapter 3, Utah Administrative
197 Rulemaking Act, to:
198 (i) establish a process for validating financial institutions for access to an inventory
199 control system in accordance with Subsections (2) and (7); and
200 (ii) establish qualifications for the validation described in Subsection (6)(a)(i);
201 (b) review an application received by the Division of Finance in accordance with the
202 process established under Subsection (6)(a);
203 (c) validate a financial institution that meets the qualifications described in Subsection
204 (6)(a); and
205 (d) provide a list of validated financial institutions to the department and the
206 Department of Health and Human Services.
207 (7) A financial institution that the Division of Finance validates under Subsection (6):
208 (a) may only access an inventory control system for the purpose of reconciling
209 transactions and other financial activity of the psilocybin production establishments that use
210 financial services that the financial institution provides;
211 (b) may only access information related to financial transactions; and
212 (c) may not access any identifying patient information.
213 Section 4. Section 4-41c-103 is enacted to read:
214 4-41c-103. Severability clause.
215 (1) If a final decision of a court of competent jurisdiction holds invalid any provision
216 of this chapter or the application of any provision of this chapter to any person or circumstance,
217 the remaining provisions of this chapter remain effective without the invalidated provision or
218 application.
219 (2) The provisions of this chapter are severable.
220 Section 5. Section 4-41c-104 is enacted to read:
221 4-41c-104. Notice to prospective and current public employees.
222 (1) Before giving a current employee an assignment or duty that arises from or directly
223 relates to an obligation under this chapter or hiring a prospective employee whose assignments
224 or duties would include an assignment or duty that arises from or directly relates to an
225 obligation under this chapter, a state employer or a political subdivision employer shall give the
226 employee a written notice stating that:
227 (a) the employee's or prospective employee's job duties may require the employee or
228 prospective employee to engage in conduct which is in violation of the criminal laws of the
229 United States; and
230 (b) in accepting a job or undertaking a duty described in this subsection, although the
231 employee or prospective employee is entitled to the protection of Title 67, Chapter 21, Utah
232 Protection of Public Employees Act, the employee may not object or refuse to carry out an
233 assignment or duty that may be a violation of the criminal laws of the United States with
234 respect to the manufacture, sale, or distribution of psilocybin.
235 (2) The Division of Human Resources Management shall create, revise, and publish
236 the form of the notice described in Subsection (1)(a).
237 (3) Notwithstanding Subsection 67-21-3(3), an employee who has signed the notice
238 described in Subsection (1) may not:
239 (a) claim in good faith that the employee's actions violate or potentially violate the laws
240 of the United States with respect to the manufacture, sale, or distribution of psilocybin; or
241 (b) refuse to carry out a directive that the employee reasonably believes violates the
242 criminal laws of the United States with respect to the manufacture, sale, or distribution of
243 psilocybin.
244 (4) An employer of an employee who has signed the notice described in Subsection
245 (1)(a) may not take retaliatory action as defined in Section 67-19a-101 against a current
246 employee who refuses to sign the notice described in Subsection (1)(a).
247 Section 6. Section 4-41c-201 is enacted to read:
248
249 4-41c-201. Psilocybin Production Establishment Licensing Board.
250 (1) There is created within the department the Psilocybin Production Establishment
251 Licensing Board.
252 (2) (a) The commissioner shall:
253 (i) appoint the members of the board;
254 (ii) submit the name of each individual that the commissioner appoints under
255 Subsection (2)(a) to the governor for confirmation or rejection; and
256 (iii) if the governor rejects an appointee that the commissioner submits under
257 Subsection (2)(b), appoint another individual in accordance with Subsection (2).
258 (b) Except as provided in Subsection (3)(c), the board shall consist of seven members
259 consisting of:
260 (i) one member of the public with knowledge of psilocybin;
261 (ii) one member with knowledge and experience in the pharmaceutical or nutraceutical
262 manufacturing industry;
263 (iii) one member representing law enforcement;
264 (iv) one member whom an organization representing patients recommends;
265 (v) one member who is a chemist or researcher with experience with psilocybin and
266 who is associated with a research university;
267 (vi) one member who has a background in psilocybin cultivation and processing; and
268 (vii) the commissioner or the commissioner's designee.
269 (c) The commissioner or the commissioner's designee shall serve as the chair of the
270 board.
271 (d) An individual is not eligible for appointment to be a member of the board if the
272 individual:
273 (i) has any commercial or ownership interest in a psilocybin production establishment;
274 (ii) has an owner, officer, director, or employee whose family member holds a license
275 or has an interest in a psilocybin production establishment; or
276 (iii) is employed or contracted to lobby on behalf of any psilocybin production
277 establishment.
278 (3) (a) Except as provided in Subsection (3)(b), a voting board member shall serve a
279 term of four years, beginning July 1 and ending June 30.
280 (b) Notwithstanding Subsection (3)(a), for the initial appointments to the board, the
281 commissioner shall stagger the length of the terms of board members to ensure that the
282 commissioner appoints two or three board members every two years.
283 (c) As a board member's term expires:
284 (i) the board member is eligible for reappointment; and
285 (ii) the commissioner shall make an appointment, in accordance with Subsection (2),
286 for the new term before the end of the member's term.
287 (d) When a vacancy occurs on the board for any reason other than the expiration of a
288 board member's term, the commissioner shall appoint a replacement to the vacant position, in
289 accordance with Subsection (2), for the unexpired term.
290 (e) In making appointments, the commissioner shall ensure that no two members of the
291 board are employed by or represent the same company or nonprofit organization.
292 (f) The commissioner may remove a board member for cause, neglect of duty,
293 inefficiency, or malfeasance.
294 (4) (a) Four members of the board constitute a quorum of the board.
295 (b) An action of the majority of the board members when a quorum is present
296 constitutes an action of the board.
297 (c) The department shall provide staff support to the board.
298 (d) A member of the board may not receive compensation or benefits for the member's
299 service, but may receive per diem and travel expenses in accordance with:
300 (i) Section 63A-3-106;
301 (ii) Section 63A-3-107; and
302 (iii) rules made by the Division of Finance in accordance with Sections 63A-3-106 and
303 63A-3-107.6.
304 (5) The board shall:
305 (a) meet as called by the chair to review psilocybin production establishment license
306 applications;
307 (b) review each license application for compliance with:
308 (i) this chapter; and
309 (ii) department rules;
310 (c) conduct a public hearing to consider a license application;
311 (d) approve the department's license application forms and checklists; and
312 (e) make a determination on each license application.
313 (6) The board shall hold a public hearing to review a psilocybin production
314 establishment's license if the establishment:
315 (a) changes ownership by an interest of at least 20%;
316 (b) changes or adds a location;
317 (c) upgrades to a different licensing tier under department rule; or
318 (d) as necessary based on the recommendation of the department.
319 (7) (a) The board shall meet annually in December to consider psilocybin production
320 establishment license renewal applications.
321 (b) During the meeting described in Subsection (7)(a):
322 (i) a representative from each applicant for renewal shall:
323 (A) attend in person or electronically; or
324 (B) submit information before the meeting, as the board may require, for the board's
325 consideration; and
326 (ii) the board shall consider, for each psilocybin cultivation facility seeking renewal,
327 information related to the license renewal, including:
328 (A) the amount of biomass the licensee produces during the current calendar year;
329 (B) the amount of biomass the licensee projects to produce during the following year;
330 (C) the current square footage of growing area the licensee uses; and
331 (D) the square footage of growing area the licensee projects to use in the following
332 year.
333 (c) The information a licensee or license applicant provides to the board for a license
334 determination constitutes a protected record under Subsection 63G-2-305(1) or (2) if the
335 applicant or licensee provides the board with the information regarding business confidentiality
336 required in Section 63G-2-309.
337 Section 7. Section 4-41c-202 is enacted to read:
338 4-41c-202. Psilocybin production establishment-- License.
339 (1) A person may not operate a psilocybin production establishment without a license
340 that the licensing board issues under this chapter.
341 (2) (a) Subject to this section and Section 4-41c-206, the department, through the
342 licensing board, shall issue licenses in accordance with Section 4-41c-201.
343 (b) In accordance with Title 63G, Chapter 3, Utah Administrative Rulemaking Act, the
344 department shall make rules to specify a transparent and efficient process to:
345 (i) solicit applications for a license under this section;
346 (ii) allow for comments and questions in the development of applications;
347 (iii) timely and objectively evaluate applications; and
348 (iv) hold public hearings that the department deems appropriate.
349 (c) The licensing board may not issue a license to operate a psilocybin production
350 establishment to an applicant who is not eligible for a license under this section.
351 (d) An applicant is eligible for a license under this section if the applicant submits to
352 the licensing board:
353 (i) subject to Subsection (2)(e) and in accordance with Subsection 4-41c-406(2)(a), the
354 following information regarding:
355 (A) for an independent psilocybin testing laboratory license, the proposed name and the
356 address where the laboratory will be located; or
357 (B) for a psilocybin cultivation facility license, the proposed name and no more than
358 two addresses for where the facility will be located;
359 (ii) the name and address of any individual who has:
360 (A) for a publicly traded company, a financial or voting interest of 2% or greater in the
361 proposed psilocybin production establishment;
362 (B) for a privately held company, a financial or voting interest in the proposed
363 psilocybin production establishment; or
364 (C) the power to direct the management or control of a proposed psilocybin production
365 establishment;
366 (iii) an operating plan that:
367 (A) complies with Section 4-41b-205;
368 (B) includes operating procedures that comply with this chapter and any law the
369 municipality or county in which the person is located adopts that is consistent with Section
370 4-41b-406; and
371 (C) the department or licensing board approves;
372 (iv) a statement that the applicant will obtain and maintain a performance bond that a
373 surety authorized to transact surety business in the state issues in an amount of at least:
374 (A) $100,000 for each psilocybin cultivation facility license for which the applicant
375 applies; or
376 (B) $50,000 for each independent psilocybin testing laboratory license for which the
377 applicant applies;
378 (v) an application fee in an amount that, subject to Subsection 4-41a-104(5), the
379 department sets in accordance with Section 63J-1-504; and
380 (vi) a description of any investigatory or adverse action taken by a licensing
381 jurisdiction, government agency, law enforcement agency, or court in any state for any
382 violation or detrimental conduct in relation to any of the applicant's psilocybin-related
383 operations or businesses.
384 (e) (i) A person may not locate a psilocybin production establishment:
385 (A) within 1,000 feet of a community location; or
386 (B) in or within 500 feet of a district that the relevant municipality or county has zoned
387 as primarily residential.
388 (ii) The proximity requirements described in Subsection (2)(e)(i) shall be measured
389 from the nearest entrance to the psilocybin production establishment by following the shortest
390 route of ordinary pedestrian travel to the property boundary of the community location or
391 residential area.
392 (iii) The licensing board may grant a waiver to reduce the proximity requirements in
393 Subsection (2)(e)(i) by up to 20% if the licensing board determines that it is not reasonably
394 feasible to the applicant to site the proposed psilocybin production establishment without the
395 waiver.
396 (iv) An applicant for a license under this section shall provide evidence of compliance
397 with the proximity requirements described in Subsection (2)(e).
398 (3) If the licensing board approves an application for a license under this section:
399 (a) the applicant shall pay the department an initial license fee in an amount that,
400 subject to Subsection 4-41a-104(5), the department sets in accordance with Section 63J-1-504;
401 and
402 (b) the department shall notify the Department of Public Safety of the license approval
403 and the names of each individual described in Subsection (2)(d)(ii).
404 (4) (a) A psilocybin production establishment shall obtain a separate license for each
405 location.
406 (b) A psilocybin production establishment may be located at the same location as a
407 cannabis production establishment if a separate license is obtained for each.
408 (5) If the licensing board receives more than one application for a psilocybin
409 production establishment within the same city or town, the licensing board shall consult with
410 the local land use authority before approving any of the applications pertaining to that city or
411 town.
412 (6) The licensing board may not issue a license to operate an independent psilocybin
413 testing laboratory to a person who:
414 (a) holds a license or has an ownership interest to operate a psilocybin cultivation
415 facility;
416 (b) has an owner, officer, director, or employee whose family member holds a license
417 or has an ownership interest in a psilocybin cultivation facility; or
418 (c) proposes to operate the independent psilocybin testing laboratory at the same
419 location as a psilocybin cultivation facility.
420 (7) The license board may not issue a license to operate a psilocybin production
421 establishment to an applicant if any individual described in Subsection (2)(d)(ii):
422 (a) has been convicted under state or federal law of:
423 (i) a felony; or
424 (ii) after December 3, 2018, a misdemeanor for drug distribution; or
425 (b) is younger than 21 years old.
426 (8) If an applicant for a psilocybin production establishment license under this section
427 holds a license under Title 4, Chapter 41a, Cannabis Production Establishments, the licensing
428 board may give preference to the applicant if:
429 (a) the applicant demonstrates that a decrease in psilocybin costs to patients is more
430 likely to result from efficiencies and economies of scale than from a more competitive
431 marketplace; and
432 (b) the licensing board finds other factors which also support granting the new license.
433 (9) The licensing board may revoke a license under this part:
434 (a) if the psilocybin production establishment does not begin operations within one
435 year after the day on which the licensing board issues the initial license;
436 (b) after the third of the same violation of this chapter in any of the licensees licensed
437 psilocybin production establishments;
438 (c) if any individual described in Subsection (2)(d)(ii) is convicted, while the license is
439 active, under state or federal law of:
440 (i) a felony; or
441 (ii) after December 3, 2018, a misdemeanor for drug distribution;
442 (d) if the licensee fails to provide the information described in Subsection (2)(d)(vi) at
443 the time of application, or fails to supplement the information described in Subsection
444 (2)(d)(vi) with any investigation or adverse action that occurs after the submission of the
445 application within 14 calendar days after the day on which the licensee receives notice of the
446 investigation or adverse action;
447 (e) if the psilocybin production establishment demonstrates a willful or reckless
448 disregard for the requirements of this chapter or the rules the department makes in accordance
449 with this chapter;
450 (f) if after a change of ownership described in Subsection (19), the board determines
451 that the psilocybin production establishment no longer meets the minimum standards for
452 licensure and operation of the psilocybin production establishment described in the chapter; or
453 (g) for an independent psilocybin testing laboratory, if the independent psilocybin
454 testing laboratory fails to substantially meet the performance standards described in
455 Subsections (16) and (17).
456 (10) If the municipality or county where the licensed psilocybin production
457 establishment will be located requires a local land use permit, a person who receives a
458 psilocybin production establishment license under this chapter shall submit to the licensing
459 board a copy of the licensee's approved land use permit within 120 days after the day on which
460 the licensing board issues the license.
461 (11) The department shall deposit the proceeds of a fee imposed under this section into
462 the Qualified Production Enterprise Fund.
463 (12) The department shall begin accepting applications under this part on July 1, 2024.
464 (13) The licensing board's authority to issue a license under this section is plenary and
465 is not subject to review.
466 (14) Notwithstanding Subsection (2)(b), the decision of the licensing board to award a
467 license to an applicant is not subject to:
468 (a) Title 63G, Chapter 6a, Part 16, Protests; or
469 (b) Title 63G, Chapter 6a, Part 17, Procurement Appeals Board.
470 (15) (a) Notwithstanding this section, the licensing board may not issue more than four
471 licenses to operate an independent psilocybin testing laboratory.
472 (b) The department may operate or partner with a research university to operate an
473 independent psilocybin testing laboratory.
474 (c) If the department operates or partners with a research university to operate an
475 independent psilocybin testing laboratory, the department may not cease operating or
476 partnering with a research university to operate the independent psilocybin testing laboratory
477 unless:
478 (i) the department issues at least two licenses to independent psilocybin laboratories;
479 and
480 (ii) the department has ensured that the licensed independent psilocybin testing
481 laboratories have sufficient capacity to provide the testing necessary to support the state's
482 medical psilocybin market.
483 (d) The department shall resume independent psilocybin testing laboratory operations
484 at any time if:
485 (i) the department at any time operated or partnered with a research university to
486 operate an independent psilocybin testing laboratory under Subsection (15)(b); and
487 (ii) (A) fewer than two licensed independent psilocybin testing laboratories are
488 operating; or
489 (B) as determined by the department, the licensed independent psilocybin testing
490 laboratories become unable to fully meet the market demand for testing.
491 (16) The department shall make rules, in accordance with Title 63G, Chapter 3, Utah
492 Administrative Rulemaking Act, to establish performance standards for the operation of an
493 independent psilocybin testing laboratory, including deadlines for testing completion.
494 (17) A license that the licensing board issues to an independent psilocybin testing
495 laboratory is contingent upon substantial satisfaction of the performance standards described in
496 Subsection (16), as determined by the board.
497 (18) A psilocybin production establishment license is not transferable or assignable.
498 (19) (a) If ownership of a psilocybin production establishment changes by 50% or
499 more, the psilocybin production establishment shall submit a new application described in
500 Subsection (2)(d).
501 (b) Within 30 days of the submission of the application under Subsection (19)(a), the
502 board shall:
503 (i) conduct the application review described in Subsection 4-41c-201(6); and
504 (ii) award a license to the psilocybin production establishment for the remainder of the
505 term of the psilocybin production establishment's license before the ownership change if the
506 psilocybin production establishment meets the minimum standards for licensure and operation
507 described in this chapter.
508 (c) If the board approves the license application under Subsection (19)(b),
509 notwithstanding Subsection (3), the psilocybin production establishment shall pay a license fee
510 that the department sets in accordance with Section 63J-1-504 in an amount that covers the
511 board's cost of conducting the application review.
512 Section 8. Section 4-41c-203 is enacted to read:
513 4-41c-203. Psilocybin production establishment owners and directors -- Criminal
514 background checks.
515 (1) Each applicant for a license as a psilocybin production establishment shall submit
516 to the department, at the time of application, from each individual who has a financial or voting
517 interest of 2% or greater in the applicant or who has the power to direct or cause the
518 management or control of the applicant:
519 (a) a fingerprint card in a form acceptable to the Department of Public Safety;
520 (b) a signed waiver in accordance with Subsection 53-10-108(4) acknowledging the
521 registration of the individual's fingerprints in the Federal Bureau of Investigation Next
522 Generation Identification System's Rap Back Service; and
523 (c) consent to a fingerprint background check by:
524 (i) the Utah Bureau of Criminal Identification; and
525 (ii) the Federal Bureau of Investigation.
526 (2) The Bureau of Criminal Identification shall:
527 (a) check the fingerprints the applicant submits under Subsection (1) against the
528 applicable state, regional, and national criminal records databases, including the Federal
529 Bureau of Investigation Next Generation Identification System;
530 (b) report the results of the background check to the department;
531 (c) maintain a separate file of fingerprints that applicants submit under Subsection (1)
532 for search by future submissions to the local and regional criminal records databases, including
533 latent prints;
534 (d) request that the fingerprints be retained in the Federal Bureau of Investigation Next
535 Generation Identification System's Rap Back Service for search by future submissions to
536 national criminal records databases, including the Next Generation Identification System and
537 latent prints; and
538 (e) establish a privacy risk mitigation strategy to ensure that the department only
539 receives notification for an individual with whom the department maintains an authorizing
540 relationship.
541 (3) The department shall:
542 (a) assess an individual who submits fingerprints under Subsection (1) a fee in an
543 amount that the department sets in accordance with Section 63J-1-504 for the services that the
544 Bureau of Criminal Identification or another authorized agency provides under this section; and
545 (b) remit the fee described in Subsection (3)(a) to the Bureau of Criminal
546 Identification.
547 Section 9. Section 4-41c-204 is enacted to read:
548 4-41c-204. Renewal.
549 The licensing board shall renew a license issued under Section 4-41c-201 every year if:
550 (1) the licensee meets the requirements of Section 4-41b-202 at the time of renewal;
551 (2) the board does not identify:
552 (a) a significant failure of compliance with this chapter or department rules in the
553 review described in Section 4-41c-201; or
554 (b) grounds for revocation described in Subsection 4-41c-202(9);
555 (3) the licensee pays the department a license renewal fee in an amount that, subject to
556 Subsection 4-41a-104(5), the department sets in accordance with Section 63J-1-504; and
557 (4) the department approves the new operating plan if the psilocybin production
558 establishment made changes to the operating plan described in Section 4-41b-205 that the
559 department or licensing board approved under Subsection 4-41b-202(2)(d)(iii).
560 Section 10. Section 4-41c-205 is enacted to read:
561 4-41c-205. Operating plan.
562 (1) A person applying for a psilocybin production establishment license or license
563 renewal shall submit to the department for the department's review a proposed operating plan
564 that complies with this section and that includes:
565 (a) a description of the physical characteristics of the proposed facility or, for a
566 psilocybin cultivation facility, no more than two facility locations, including a floor plan and an
567 architectural elevation;
568 (b) a description of the credentials and experience of:
569 (i) each officer, director, and owner of the proposed psilocybin production
570 establishment; and
571 (ii) any highly skilled or experienced prospective employee;
572 (c) the psilocybin production establishment's employee training standards;
573 (d) a security plan;
574 (e) a description of the psilocybin production establishment's inventory control system;
575 (f) storage protocols, to ensure that psilocybin is stored in a manner that is sanitary and
576 preserves the integrity of the psilocybin;
577 (g) for a psilocybin cultivation facility, the information described in Subsection (2);
578 and
579 (h) for an independent psilocybin testing laboratory, the information described in
580 Subsection (3).
581 (2) (a) A psilocybin cultivation facility shall ensure that the facility's operating plan
582 includes the facility's intended:
583 (i) psilocybin cultivation practices, including the facility's intended pesticide and
584 fertilizer use; and
585 (ii) subject to Subsection (2)(b), square footage under cultivation and anticipated
586 psilocybin yield.
587 (b) Except as provided in Subsection (2)(c), a psilocybin cultivation facility may not
588 use more than 5,000 total square feet of cultivation space.
589 (c) Each licensee may apply to the department for:
590 (i) a one-time permanent increase of up to 20% of the limitation of the psilocybin
591 cultivation facility's cultivation space; or
592 (ii) a short-term increase, not to exceed 12 months, of up to 40% of the limitation on
593 the psilocybin cultivation facility's cultivation space.
594 (d) After conducting a review equivalent to the review described in Subsection
595 4-41c-206(2), if the department determines that additional cultivation is needed, the department
596 may:
597 (i) grant the one-time, permanent increase described in Subsection (2)(c)(i); or
598 (ii) grant the short-term increase described in Subsection (2)(c)(ii).
599 (e) If a licensee describes an intended square footage under cultivation under
600 Subsection (2)(a)(ii) that is less than the limitation described in Subsection (2)(b), the licensee
601 may not cultivate more than the licensee's identified intended square footage under cultivation.
602 (f) The department may authorize a psilocybin cultivation facility to operate at no more
603 than two separate locations.
604 (g) If the department authorizes multiple locations under Subsection (2)(f), the two
605 psilocybin cultivation facility locations combined may not exceed the cultivation limitations
606 described in Subsection (2)(b).
607 (3) An independent psilocybin testing laboratory's operating plan shall include the
608 laboratory's intended:
609 (a) psilocybin and psilocybin product testing capacity;
610 (b) psilocybin and psilocybin product testing equipment; and
611 (c) testing methods, standards, practices, and procedures for testing psilocybin or
612 psilocybin product.
613 (4) Notwithstanding an applicant's proposed operating plan, a psilocybin production
614 establishment is subject to land use regulations, as described in Sections 10-9a-103 and
615 17-27a-103, regarding the availability of outdoor cultivation in an industrial zone.
616 Section 11. Section 4-41c-206 is enacted to read:
617 4-41c-206. Number of licenses for psilocybin cultivation facilities.
618 (1) Except as provided in Subsection (2), the licensing board shall issue at least five
619 but not more than eight licenses to operate a psilocybin cultivation facility.
620 (2) The licensing board may issue a number of licenses to operate a psilocybin
621 cultivation facility that, in addition to the licenses described in Subsection (1), does not cause
622 the total number of licenses to exceed 15 if the department determines, in consultation with the
623 Department of Health and Human Services and after an annual or more frequent analysis of the
624 current and anticipated market for psilocybin, that each additional license is necessary to
625 provide an adequate supply, quality, or variety of medical psilocybin to patients to whom
626 psilocybin is recommended.
627 (3) If the recipient of one of the initial licenses described in Subsection (1) ceases
628 operations for any reason or otherwise abandons the license, the licensing board may grant the
629 vacant license to another applicant based on an analysis as described in Subsection (2).
630 (4) If there are more qualified applicants than the number of available licenses of
631 psilocybin cultivation facilities under Subsections (1) and (2), the licensing board shall evaluate
632 the applicants and award the limited number of licenses described in Subsections (1) and (2) to
633 the applicants that best demonstrate:
634 (a) experience with establishing and successfully operating a business that involves:
635 (i) complying with a regulatory environment;
636 (ii) tracking inventory; and
637 (iii) training, evaluating, and monitoring employees;
638 (b) an operating plan that will best ensure the safety and security of patrons and the
639 community;
640 (c) positive connections to the local community; and
641 (d) the extent to which the applicant can increase efficiency and reduce the cost to
642 patients of medical psilocybin.
643 (5) The licensing board may conduct a face-to-face interview with an applicant for a
644 license that the department evaluates under Subsection (3).
645 Section 12. Section 4-41c-301 is enacted to read:
646
647 4-41c-301. Psilocybin production establishment agent -- Registration.
648 (1) An individual may not act as a psilocybin production establishment agent unless the
649 department registers the individual as a psilocybin production establishment agent, regardless
650 of whether the individual is a seasonal, temporary, or permanent employee.
651 (2) The following individuals, regardless of the individual's status as a qualified
652 medical psilocybin provider, may not serve as a psilocybin production establishment agent,
653 have a financial or voting interest of 2% or greater in a psilocybin production establishment, or
654 have the power to direct or cause the management or control of a psilocybin production
655 establishment:
656 (a) an advanced practice registered nurse licensed under Title 58, Chapter 31b, Nurse
657 Practice Act;
658 (b) a physician licensed under Title 58, Chapter 67, Utah Medical Practice Act, or Title
659 58, Chapter 68, Utah Osteopathic Medical Practice Act; or
660 (c) a physician assistant licensed under Title 58, Chapter 70a, Utah Physician Assistant
661 Act.
662 (3) An independent psilocybin testing laboratory agent may not act as an agent for a
663 psilocybin cultivation facility.
664 (4) (a) The department shall, within 15 business days after the day on which the
665 department receives a complete application from a psilocybin production establishment on
666 behalf of a prospective psilocybin production establishment agent, register and issue a
667 psilocybin production establishment agent registration card to the prospective agent if the
668 psilocybin production establishment:
669 (i) provides to the department:
670 (A) the prospective agent's name and address; and
671 (B) the submission required under Subsection (4)(b); and
672 (ii) pays a fee to the department in an amount that, subject to Subsection 4-41a-104(5),
673 the department sets in accordance with Section 63J-1-504.
674 (b) Each prospective agent described in Subsection (4)(a) shall:
675 (i) submit to the department:
676 (A) a fingerprint card in the form acceptable to the Department of Public Safety; and
677 (B) a signed waiver in accordance with Subsection 53-10-108(4) acknowledging the
678 registration of the prospective agent's fingerprints in the Federal Bureau of Investigation Next
679 Generation Identification System; and
680 (ii) consent to a fingerprint background check by:
681 (A) the Bureau of Criminal Identification; and
682 (B) the Federal Bureau of Investigation.
683 (c) The Bureau of Criminal Identification shall:
684 (i) check the fingerprints the prospective agent submits under Subsection (4)(b) against
685 the applicable state, regional, and national criminal records databases, including the Federal
686 Bureau of Investigation Next Generation Identification System;
687 (ii) report the results of the background check to the department;
688 (iii) maintain a separate file of fingerprints that prospective agents submit under
689 Subsection (4)(b) for search by future submissions to the local and regional criminal records
690 databases, including latent prints;
691 (iv) request that the fingerprints be retained in the Federal Bureau of Investigation Next
692 Generation Identification System's Rap Back Service for search by future submissions to
693 national criminal records databases, including the Next Generation Identification System and
694 latent prints; and
695 (v) establish a privacy risk mitigation strategy to ensure that the department only
696 receives notifications for an individual with whom the department maintains an authorizing
697 relationship.
698 (d) The department shall:
699 (i) assess an individual who submits fingerprints under Subsection (4)(b) a fee in an
700 amount that the department sets in accordance with Section 63J-1-504 for the services that the
701 Bureau of Criminal Identification or another authorized agency provides under this section; and
702 (ii) remit the fee described in Subsection (4)(d)(i) to the Bureau of Criminal
703 Identification.
704 (5) The department shall designate, on an individual's psilocybin production
705 establishment agent registration card the type of psilocybin production establishment for which
706 the individual is authorized to act as an agent.
707 (6) A psilocybin production establishment agent shall comply with:
708 (a) a certification standard that the department develops; or
709 (b) a certification standard that the department has reviewed and approved.
710 (7) The department shall ensure that the certification standard described in Subsection
711 (6) includes training:
712 (a) in Utah medical psilocybin law;
713 (b) for a psilocybin cultivation facility agent, in psilocybin cultivation best practices;
714 and
715 (c) for an independent psilocybin testing laboratory agent, in psilocybin testing best
716 practices.
717 (8) For an individual who holds or applies for a psilocybin production establishment
718 registration card:
719 (a) the department may revoke or refuse to issue the card if the individual violates the
720 requirements of this chapter; and
721 (b) the department shall revoke or refuse to issue the card if the individual is convicted
722 under state or federal law of:
723 (i) a felony; or
724 (ii) after December 3, 2018, a misdemeanor for drug distribution.
725 (9) (a) A psilocybin production establishment agent registration card expires two years
726 after the day on which the department issues the card.
727 (b) A psilocybin production establishment agent may renew the agent's registration
728 card if the agent:
729 (i) is eligible for a psilocybin production establishment registration card under this
730 section;
731 (ii) certifies to the department in a renewal application that the information in
732 Subsection (4)(a) is accurate or updates the information; and
733 (iii) pays to the department a renewal fee in an amount that:
734 (A) subject to Subsection 4-41a-104(5), the department sets in accordance with Section
735 63J-1-504; and
736 (B) may not exceed the cost of the relatively lower administrative burden of renewal in
737 comparison to the original application process.
738 Section 13. Section 4-41c-302 is enacted to read:
739 4-41c-302. Psilocybin production establishment agent registration card --
740 Rebuttable presumption.
741 (1) A psilocybin production establishment agent whom the department registers under
742 Section 4-41c-301 shall carry the individual's psilocybin production card with the agent at all
743 times when:
744 (a) the agent is on the premises of a psilocybin production establishment where the
745 agent is registered; or
746 (b) the agent is transporting psilocybin or psilocybin product between:
747 (i) two psilocybin production establishments; or
748 (ii) a psilocybin production establishment and a qualified therapy provider location.
749 (2) If a psilocybin processing facility agent possesses psilocybin or psilocybin product
750 and produces the registration card in the agent's possession in compliance with Subsection (1)
751 while handling, at a psilocybin production establishment, or transporting psilocybin or
752 psilocybin product in compliance with Subsection (1):
753 (a) there is a rebuttable presumption that the agent possesses the psilocybin or
754 psilocybin product legally; and
755 (b) a law enforcement officer does not have probable cause, based solely on the agent's
756 possession of the psilocybin or psilocybin product in compliance with Subsection (1), to
757 believe that the individual is engaging in illegal activity.
758 (3) (a) A psilocybin production establishment agent who fails to carry the agent's
759 psilocybin production establishment registration card in accordance with Subsection (1) is:
760 (i) for a first or second offense in a two-year period:
761 (A) guilty of an infraction; and
762 (B) subject to a $100 fine; or
763 (ii) for a third or subsequent offense in a two-year period:
764 (A) guilty of a class C misdemeanor; and
765 (B) subject to a $750 fine.
766 (b) The prosecuting entity shall notify the department and the relevant psilocybin
767 production establishment of each conviction under Subsection (3)(a).
768 (c) For each violation described in Subsection (3)(a)(ii), the department may assess the
769 relevant psilocybin production establishment a fine of up to $5,000, in accordance with a fine
770 schedule that the department establishes by rule in accordance with Title 63G, Chapter 3, Utah
771 Administrative Rulemaking Act.
772 (d) An individual who is guilty of a violation described in Subsection (3)(a) is not
773 guilty for a violation of Title 58, Chapter 37, Utah Controlled Substances Act, for the conduct
774 underlying the violation described in Subsection (3)(a).
775 Section 14. Section 4-41c-401 is enacted to read:
776
777 4-41c-401. Psilocybin production establishment -- General operating
778 requirements.
779 (1) (a) A psilocybin production establishment shall operate in accordance with the
780 operating plan described in Section 4-41c-205.
781 (b) A psilocybin production establishment shall notify the department before a change
782 in the psilocybin production establishment's operating plan.
783 (c) If a psilocybin production establishment changes the psilocybin production
784 establishment's operating plan, the psilocybin production establishment shall ensure that the
785 new operating plan complies with this chapter.
786 (d) The department shall establish by rule, in accordance with Title 63G, Chapter 3,
787 Utah Administrative Rulemaking Act, a process to:
788 (i) review a change notification described in Subsection (1)(b);
789 (ii) identify for the psilocybin production establishment each point of noncompliance
790 between the new operating plan and this chapter;
791 (iii) provide an opportunity for the psilocybin production establishment to address each
792 identified point of noncompliance; and
793 (iv) suspend or revoke a license if the psilocybin production establishment fails to cure
794 the noncompliance.
795 (2) A psilocybin production establishment shall operate:
796 (a) except as provided in Subsection (5), in a facility that is accessible only by an
797 individual with a valid psilocybin production establishment agent registration card issued under
798 Section 4-41c-301; and
799 (b) at the physical address provided to the department under Subsection
800 4-41c-202(d)(i).
801 (3) A psilocybin production establishment may not employ an individual who is
802 younger than 21 years old.
803 (4) A psilocybin production establishment may not employ an individual who has been
804 convicted, under state or federal law, of:
805 (a) a felony; or
806 (b) after December 3, 2018, a misdemeanor for drug distribution.
807 (5) A psilocybin production establishment may authorize an individual who is at least
808 18 years old and is not a psilocybin production establishment agent to access the psilocybin
809 production establishment if the psilocybin production establishment:
810 (a) tracks and monitors the individual at all times while the individual is at the
811 psilocybin production establishment; and
812 (b) maintains a record of the individual's access, including arrival and departure.
813 (6) A psilocybin production establishment shall operate in a facility that has:
814 (a) a single, secure public entrance; and
815 (b) a security system with a backup power source that:
816 (i) detects and records entry into the psilocybin production establishment;
817 (ii) provides notice of an unauthorized entry to law enforcement when the psilocybin
818 production establishment is closed; and
819 (iii) has a lock or equivalent restrictive security feature on any area where the
820 psilocybin production establishment stores psilocybin or a psilocybin product.
821 Section 15. Section 4-41c-402 is enacted to read:
822 4-41c-402. Inspections.
823 (1) The department may inspect the records and facility of a psilocybin production
824 establishment at any time during business hours to determine if the psilocybin production
825 establishment complies with this chapter.
826 (2) (a) An inspection under this section may include:
827 (i) inspection of a site, facility, vehicle, book, record, paper, document, data, and other
828 physical or electronic information;
829 (ii) questioning of any relevant individual;
830 (iii) observation of an independent psilocybin testing laboratory's methods, standards,
831 practices, and procedures;
832 (iv) the taking of a specimen of psilocybin or psilocybin product sufficient for testing
833 purposes; or
834 (v) inspection of equipment, an instrument, a tool, or machinery, including a container
835 or label.
836 (b) Notwithstanding Section 4-41c-404, an authorized department employee may
837 possess and transport a specimen of psilocybin or psilocybin product for testing described in
838 Subsection (2)(a).
839 (3) In making an inspection under this section, the department may freely access any
840 area and review and make copies of a book, record, paper, document, data, or other physical or
841 electrical information, including financial data, sales data, shipping data, pricing data, and
842 employee data.
843 (4) Failure to provide the department or the department's authorized agents immediate
844 access to the records and facilities during business hours in accordance with this section may
845 result in:
846 (a) the imposition of a civil monetary penalty that the department sets in accordance
847 with Title 63G, Chapter 3, Utah Administrative Rulemaking Act;
848 (b) license or registration suspension or revocation; or
849 (c) an immediate cessation of operations under a cease and desist order that the
850 department issues.
851 Section 16. Section 4-41c-403 is enacted to read:
852 4-41c-403. Advertising.
853 (1) Except as provided in this section, a psilocybin production establishment may not
854 advertise to the general public in any medium.
855 (2) A psilocybin production establishment may advertise an employment opportunity at
856 the psilocybin production establishment.
857 (3) A psilocybin production establishment may maintain a website that:
858 (a) contains information about the psilocybin production establishment and employees;
859 and
860 (b) does not advertise any medical psilocybin or psilocybin product.
861 (4) (a) Notwithstanding any municipal or county ordinance prohibiting signage, a
862 psilocybin production establishment may use signage on the outside of the psilocybin
863 production establishment that:
864 (i) includes, only in accordance with Subsection (4)(b), the psilocybin production
865 establishment's name, logo, and hours of operation; and
866 (ii) complies with local ordinances regulating signage.
867 (b) The department shall define standards for a psilocybin production establishment's
868 name and logo to ensure a medical rather than recreational disposition.
869 (5) (a) A psilocybin production establishment may hold an educational event for the
870 public or medical providers in accordance with this Subsection (5) and the rules described in
871 Subsection (5)(c).
872 (b) A psilocybin production establishment may not include in an educational event
873 described in Subsection (5)(a):
874 (i) any topic that conflicts with this chapter or Title 26, Chapter 61a, Utah Medical
875 Cannabis Act;
876 (ii) any gift or merchandise other than educational materials, as those terms are defined
877 by the department;
878 (iii) any statement, claim, or information that would violate the federal Food, Drug,
879 and Cosmetic Act, 21 U.S.C. Sec. 301, et seq.; or
880 (iv) a presenter other than the following:
881 (A) a psilocybin production establishment agent;
882 (B) a pharmacist licensed under Title 58, Chapter 17b, Pharmacy Practice Act;
883 (C) an advanced practice registered nurse licensed under Title 58, Chapter 31b, Nurse
884 Practice Act;
885 (D) a physician licensed under Title 58, Chapter 67, Utah Medical Practice Act, or
886 Title 58, Chapter 68, Utah Osteopathic Medical Practice Act;
887 (E) a physician assistant licensed under Title 58, Chapter 70a, Utah Physician Assistant
888 Act; or
889 (F) a state employee.
890 (c) The department shall make rules, in accordance with Title 63G, Chapter 3, Utah
891 Administrative Rulemaking Act, to define the elements of and restrictions on the educational
892 event described in Subsection (5)(a), including a minimum age of 21 years old for attendees.
893 Section 17. Section 4-41c-404 is enacted to read:
894 4-41c-404. Medical psilocybin transportation.
895 (1) Only the following individuals may transport psilocybin or a psilocybin product:
896 (a) a registered psilocybin production establishment agent;
897 (b) a qualified therapy provider; or
898 (c) a registered qualified therapy provider agent.
899 (2) An individual transporting psilocybin or psilocybin product under this chapter
900 shall:
901 (a) be employed by the person authorizing the transportation; and
902 (b) possess a transportation manifest that:
903 (i) includes a unique identifier that links the psilocybin or psilocybin product to a
904 relevant inventory control system;
905 (ii) includes origin and destination information for any psilocybin or psilocybin product
906 that the individual is transporting; and
907 (iii) identifies the departure and arrival times of the individual transporting the
908 psilocybin or psilocybin product.
909 (3) (a) It is unlawful for a registered psilocybin production establishment to make a
910 transport described in this section with a manifest that does not meet the requirements of this
911 section.
912 (b) Except as provided in Subsection (3)(d), an agent who violates Subsection (3)(a) is:
913 (i) guilty of an infraction; and
914 (ii) subject to a $100 fine.
915 (c) An individual who is guilty of a violation described in Subsection (3)(b) is not
916 guilty of a violation of Title 58, Chapter 37, Utah Controlled Substances Act, for the conduct
917 underlying the violation described in Subsection (3)(b).
918 (d) If the agent described in Subsection (2) is transporting more psilocybin or
919 psilocybin product than the manifest identifies, except for a de minimis administrative error:
920 (i) the penalty described in Subsection (3)(b) does not apply; and
921 (ii) the agent is subject to penalties under Title 58, Chapter 37, Utah Controlled
922 Substances Act.
923 (4) Nothing in this section prevents the department from taking administrative
924 enforcement action against a psilocybin production establishment or another person for failing
925 to make a transport in compliance with this section.
926 Section 18. Section 4-41c-405 is enacted to read:
927 4-41c-405. Excess and disposal.
928 (1) As used in the section, "psilocybin waste" means waste and unused material from
929 the cultivation and production of psilocybin or psilocybin product under this chapter.
930 (2) A psilocybin production establishment shall:
931 (a) render psilocybin waste unusable and unrecognizable before transporting it from the
932 psilocybin production establishment; and
933 (b) dispose of psilocybin waste in accordance with:
934 (i) federal and state laws, rules, and regulation related to hazardous waste;
935 (ii) the Resource Conservation and Recovery Act, 42 U.S.C. Sec. 6991 et seq.;
936 (iii) Title 19, Chapter 6, Part 5, Solid Waste Management Act; and
937 (iv) other regulations that the department makes in accordance with Title 63G, Chapter
938 3, Utah Administrative Rulemaking Act.
939 (3) An individual may not transport or dispose of medical psilocybin waste other than
940 as provided in this section.
941 Section 19. Section 4-41c-406 is enacted to read:
942 4-41c-406. Local control.
943 (1) As used in this section:
944 (a) "Land use decision" means the same as that term is defined in Sections 10-9a-103
945 and 17-27a-103.
946 (b) "Land use permit" means the same as that term is defined in Sections 10-9a-103
947 and 17-27a-103.
948 (c) "Land use regulation" means the same as that term is defined in Sections 10-9a-103
949 and 17-271-103.
950 (2) (a) If a municipality's or a county's zoning ordinances provide for an industrial
951 zone, the operation of a psilocybin production establishment shall be a permitted industrial use
952 in any industrial zone unless the municipality or county has designated by ordinance, before an
953 individual submits a land use permit application for a psilocybin production establishment, at
954 least one industrial zone in which the operation of a psilocybin production establishment is a
955 permitted use.
956 (b) If a municipality's or county's zoning ordinance provides for an agricultural zone,
957 the operation of a psilocybin production establishment shall be a permitted agricultural use in
958 any agricultural zone unless the municipality or county has designated by ordinance, before an
959 individual submits a land use permit application for a psilocybin production establishment, at
960 least one agricultural zone in which the operation of a psilocybin production establishment is a
961 permitted use.
962 (c) The operation of a psilocybin production establishment shall be a permitted use on
963 land that the municipality or county has not zoned.
964 (3) A municipality or county may not:
965 (a) on the sole basis that the applicant or psilocybin production establishment violates
966 federal law regarding the legal status of psilocybin, deny or revoke:
967 (i) a land use permit to operate a psilocybin production facility; or
968 (ii) a business license to operate a psilocybin production facility;
969 (b) require a certain distance between a psilocybin production establishment and:
970 (i) another psilocybin production establishment;
971 (ii) a retail tobacco specialty business, as that term is defined in Section 26-62-103; or
972 (iii) an outlet, as that term is defined in Section 32B-1-202; or
973 (c) in accordance with Subsections 10-9a-509(1) and 17-27a-508(1), enforce a land use
974 regulation against a psilocybin production establishment that was not in effect on the day on
975 which the psilocybin production establishment submitted a complete land use application.
976 (4) An applicant for a land use permit to operate a psilocybin production establishment
977 shall comply with the land use requirements and application process described in:
978 (a) Title 10, Chapter 9a, Municipal Land Use, Development, and Management Act; and
979 (b) Title 17, Chapter 27a, County Land Use, Development, and Management Act.
980 Section 20. Section 4-41c-501 is enacted to read:
981
982 4-41c-501. Growing and harvesting.
983 (1) A psilocybin cultivation facility shall use a unique identifier that is connected to the
984 facility's inventory control system to identify:
985 (a) each unique harvest of psilocybin;
986 (b) each batch of psilocybin that the facility transfers to an independent psilocybin
987 testing laboratory; and
988 (c) any excess, contaminated, or deteriorated psilocybin of which the psilocybin
989 cultivation facility disposes.
990 (2) A psilocybin cultivation facility shall identify psilocybin biomass as psilocybin
991 byproduct or psilocybin product before transferring the psilocybin biomass from the facility.
992 (3) A psilocybin cultivation facility shall destroy psilocybin cultivation byproduct in
993 accordance with Section 4-41-405.
994 Section 21. Section 4-41c-502 is enacted to read:
995 4-41c-502. Sales.
996 (1) A psilocybin cultivation facility may not sell a product other than, subject to this
997 chapter:
998 (a) a psilocybin product; or
999 (b) an educational material related to the medical use of psilocybin.
1000 (2) A psilocybin cultivation facility may only sell an item listed in Subsection (1) to:
1001 (a) a qualified therapy provider; or
1002 (b) a registered agent of a qualified therapy provider.
1003 Section 22. Section 4-41c-601 is enacted to read:
1004
1005 4-41c-601. Psilocybin and psilocybin product testing.
1006 (1) In accordance with Title 63G, Chapter 3, Utah Administrative Rulemaking Act, the
1007 department may make rules to:
1008 (a) determine required adulterant tests for psilocybin or psilocybin product;
1009 (b) determine the amount of any adulterant that is safe for human consumption; or
1010 (c) establish protocols for a recall of psilocybin or psilocybin product by a psilocybin
1011 production establishment.
1012 (2) The department may require testing for a toxin if:
1013 (a) the department receives information indicating the potential presence of a toxin; or
1014 (b) the department's inspector has reason to believe a toxin may be present based on the
1015 inspection of a facility.
1016 (3) A psilocybin production establishment may not transfer psilocybin or psilocybin
1017 product to a qualified therapy provider until an independent psilocybin testing laboratory tests a
1018 representative sample of the psilocybin or psilocybin product in accordance with department
1019 rule.
1020 (4) Before the sale of a psilocybin product, an independent psilocybin testing
1021 laboratory shall identify and quantify the amount of active psilocybin present in a psilocybin
1022 product.
1023 (5) The department shall establish by rule, in accordance with Title 63G, Chapter 3,
1024 Utah Administrative Rulemaking Act, the standards, methods, practices, and procedures for the
1025 testing of psilocybin and psilocybin products by independent psilocybin laboratories.
1026 (6) The department may require an independent psilocybin testing laboratory to
1027 participate in a proficiency evaluation that the department conducts or that an organization that
1028 the department approves conducts.
1029 Section 23. Section 4-41c-602 is enacted to read:
1030 4-41c-602. Reporting -- Inspections --Seizure by the department.
1031 (1) If an independent psilocybin testing laboratory determines that the results of a lab
1032 test indicate that a psilocybin or psilocybin product batch may be unsafe for human use:
1033 (a) the independent psilocybin testing laboratory shall report the results and the
1034 psilocybin product batch to:
1035 (i) the department; and
1036 (ii) the psilocybin cultivation facility from which the batch originated;
1037 (b) the department shall place a hold on the psilocybin or psilocybin products to:
1038 (i) investigate the cause of the defective batch; and
1039 (ii) make a determination; and
1040 (c) the psilocybin cultivation facility that grew the psilocybin may appeal the
1041 determination described in Subsection (1)(b)(ii) to the department.
1042 (2) If the department determines, under Subsection (1)(b)(ii) or following an appeal
1043 under Subsection (1)(c), that psilocybin or psilocybin product prepared by a psilocybin
1044 cultivation establishment is unsafe for human consumption, the department may seize,
1045 embargo, or destroy, in the same manner as the psilocybin production establishment under
1046 Section 4-41b-405, the psilocybin or psilocybin product batch.
1047 (3) If an independent psilocybin testing laboratory determines that the results of a lab
1048 test indicate that the active psilocybin content of psilocybin or a psilocybin product batch
1049 diverges more than 10% from the amount the label indicates, the psilocybin processing facility
1050 may not sell the psilocybin or psilocybin product batch unless the facility replaces the incorrect
1051 label with a label that correctly indicates the active psilocybin content.
1052 Section 24. Section 4-41c-701 is enacted to read:
1053
1054 4-41c-701. Enforcement -- Fine -- Citation.
1055 (1) If a person that is a psilocybin production establishment or a psilocybin production
1056 establishment agent violates this chapter, the department may:
1057 (a) revoke the person's license or psilocybin production establishment agent
1058 registration card;
1059 (b) decline to renew the person's license or psilocybin production establishment agent
1060 registration card; or
1061 (c) assess the person an administrative penalty that the department establishes by rule
1062 in accordance with Title 63G, Chapter 3, Utah Administrative Rulemaking Act.
1063 (2) The department shall deposit an administrative penalty imposed under this section
1064 into the General Fund.
1065 (3) (a) The department may take an action described in Subsection (3)(b) if the
1066 department concludes upon investigation that, for a person that is a psilocybin production
1067 establishment or psilocybin production establishment agent:
1068 (i) the person has violated the provisions of this chapter, a rule made under this
1069 chapter, or an order issued under this chapter; or
1070 (ii) the person produced a psilocybin or psilocybin product batch that contains a
1071 substance, other than active psilocybin, that poses a significant threat to human health.
1072 (b) If the department makes the determination about a person described in Subsection
1073 (3)(a), the department shall:
1074 (i) issue the person a written administrative citation;
1075 (ii) attempt to negotiate a stipulated settlement;
1076 (iii) seize, embargo, or destroy the psilocybin or psilocybin product batch;
1077 (iv) order the person to cease and desist from the action that creates a violation; and
1078 (v) direct the person to appear before an adjudicative proceeding conducted under Title
1079 63G, Chapter 4, Administrative Procedures Act.
1080 (4) The department may, for a person subject to an uncontested citation, a stipulated
1081 settlement, or a finding of a violation in an adjudicative proceeding under this section, for a
1082 fine amount not already specified in law, assess the person, who is not an individual, a fine of
1083 up to $5,000 per violation, in accordance with a fine schedule that the department establishes
1084 by rule in accordance with Title 63G, Chapter 3, Utah Administrative Rulemaking Act.
1085 (5) The department may not revoke a psilocybin production establishment's license
1086 without first directing the psilocybin production establishment to appear before an adjudicative
1087 proceeding conducted under Title 63G, Chapter 4, Administrative Procedures Act.
1088 (6) If within 20 calendar days after the day on which a department serves a citation for
1089 a violation of this chapter the person that is the subject of the citation fails to request a hearing
1090 to contest the citation, the citation becomes the department's final order.
1091 (7) The department may, for a person who fails to comply with a citation under this
1092 section:
1093 (a) refuse to issue or renew the person's license or psilocybin production establishment
1094 agent registration card; or
1095 (b) suspend, revoke, or place on probation the person's license or psilocybin production
1096 establishment agent registration card.
1097 (8) (a) Except where a criminal penalty is expressly provided for a specific violation of
1098 this chapter, if an individual:
1099 (i) violates a provision of this chapter, the individual is:
1100 (A) guilty of an infraction; and
1101 (B) subject to a $100 fine; or
1102 (ii) intentionally or knowingly violates a provision of this chapter or violates this
1103 chapter three or more times, the individual is:
1104 (A) guilty of a class B misdemeanor; and
1105 (B) subject to a $1,000 fine.
1106 (b) An individual who is guilty of a violation described in Subsection (8)(a) is not
1107 guilty of a violation of Title 58, Chapter 37, Utah Controlled Substances Act, for the conduct
1108 underlying the violation described in Subsection (8)(a).
1109 (9) Nothing in this section prohibits the department from referring potential criminal
1110 activity to law enforcement.
1111 Section 25. Section 26-61a-109 is amended to read:
1112 26-61a-109. Qualified Patient Enterprise Fund -- Creation -- Revenue neutrality.
1113 (1) There is created an enterprise fund known as the "Qualified Patient Enterprise
1114 Fund."
1115 (2) The fund created in this section is funded from:
1116 (a) money the department deposits into the fund:
1117 (i) under this chapter; and
1118 (ii) under Title 26B, Chapter 4, Part 9, Utah Medical Psilocybin Act.
1119 (b) appropriations the Legislature makes to the fund; and
1120 (c) the interest described in Subsection (3).
1121 (3) Interest earned on the fund shall be deposited into the fund.
1122 (4) The department may only use money in the fund to fund the department's
1123 responsibilities under this chapter and Title 26B, Chapter 4, Part 9, Utah Medical Psilocybin
1124 Act.
1125 (5) The department shall set fees authorized under this chapter and Title 26B, Chapter
1126 4, Part 9, Utah Medical Psilocybin Act in amounts that the department anticipates are
1127 necessary, in total, to cover the department's cost to implement this chapter and Title 26B,
1128 Chapter 4, Part 9, Utah Medical Psilocybin Act.
1129 Section 26. Section 26B-4-901 is enacted to read:
1130
1131 26B-4-901. Definitions.
1132 As used in this part:
1133 (1) "Adverse event" means:
1134 (a) an injury or suspected injury to a patient that results in an escalation of care, harm
1135 to a patient, or rescue of a patient; and
1136 (b) occurs:
1137 (i) during a psilocybin administration session; or
1138 (ii) within 24 hours from when the administration session ended.
1139 (2) "Community location" means the same as that term is defined in Section 4-41c-101.
1140 (3) "Controlled substance database" means the controlled substance database created in
1141 Section 58-37f-201.
1142 (4) "Inventory Control System" means the same as that term is defined in Section
1143 4-41c-101.
1144 (5) "Patient" means the same as that term is defined in Section 4-41c-101.
1145 (6) "Payment provider" means an entity that contracts with a psilocybin production
1146 establishment to facilitate transfer of funds between the establishment and another business or
1147 individual.
1148 (7) "Psilocybin" means the same as that term is defined in Section 4-41c-101.
1149 (8) "Psilocybin administration session" means the time period from when a qualified
1150 medical provider administers psilocybin to a patient to the time the patient leaves the qualified
1151 therapy provider location.
1152 (9) "Psilocybin cultivation facility" means the same as that term is defined in Section
1153 4-41c-101.
1154 (10) "Psilocybin product" means the same as that term is defined in Section 4-41c-101.
1155 (11) "Psilocybin production establishment" means the same as that term is defined in
1156 Section 4-41c-101.
1157 (12) "Psilocybin production establishment agent" means the same as that term is
1158 defined in Section 4-41c-101.
1159 (13) "Psilocybin production establishment registration card" means the same as that
1160 term is defined in Section 4-41c-101.
1161 (14) "Qualified medical psilocybin provider" means an individual:
1162 (a) who meets the recommending qualifications; and
1163 (b) whom the department registers to recommend treatment with psilocybin under
1164 Section 26B-4-904.
1165 (15) "Qualified therapy provider" means an individual:
1166 (a) who meets the therapy provider qualifications; and
1167 (b) whom the department registers to administer treatment with psilocybin under
1168 Section 26B-4-911.
1169 (16) "Qualified therapy provider location" means a facility that:
1170 (a) is located at the address listed under Subsection 26B-4-911(2)(b);
1171 (b) has a single, secure public entrance;
1172 (c) has a security system with a backup power source that:
1173 (i) detects and records entry into the psilocybin production establishment; and
1174 (ii) provides notice of an unauthorized entry to law enforcement when the psilocybin
1175 production establishment is closed; and
1176 (d) has a lock or equivalent restrictive security feature on any area where the qualified
1177 therapy provider location stores psilocybin or psilocybin product.
1178 (17) "Qualified Patient Enterprise Fund" means the fund created in Section
1179 26-61a-109.
1180 (18) "Qualifying condition" means a condition described in Section 26B-4-903.
1181 (19) "Therapy provider qualifications" means that an individual is licensed as any of
1182 the following:
1183 (a) a clinical social worker, certified social worker, or social service worker under Title
1184 58, Chapter 60, Part 2, Social Work Licensing Act;
1185 (b) a clinical mental health counselor under Title 58, Chapter 60, Part 4, Clinical
1186 Mental Health Counselor Licensing Act;
1187 (c) licensed advanced substance use disorder counselor or a certified advanced
1188 substance use disorder counselor under Title 58, Chapter 60, Part 5, Substance Use Disorder
1189 Counselor Act;
1190 (d) an advanced practice registered nurse licensed under Title 58, Chapter 31b, Nurse
1191 Practice Act;
1192 (e) a psychologist licensed under Title 58, Chapter 61, Psychologist Licensing Act;
1193 (f) a physician licensed under Title 58, Chapter 67, Utah Medical Practice Act, or Title
1194 58, Chapter 68, Utah Osteopathic Medical Practice Act; or
1195 (g) a physician assistant licensed under Title 58, Chapter 70a, Utah Physician Assistant
1196 Act.
1197 (20) "Recommend" or "recommendation" means, for a qualified medical psilocybin
1198 provider, the act of suggesting the use of medical psilocybin treatment.
1199 (21) "Recommending qualifications" means that an individual is licensed:
1200 (a) to prescribe a controlled substance under Title 58, Chapter 37, Utah Controlled
1201 Substances Act; and
1202 (b) as any of the following:
1203 (i) an advanced practice registered nurse licensed under Title 58, Chapter 31b, Nurse
1204 Practice Act;
1205 (ii) a physician licensed under Title 58, Chapter 67, Utah Medical Practice Act, or Title
1206 58, Chapter 68, Utah Osteopathic Medical Practice Act; or
1207 (iii) a physician assistant licensed under Title 58, Chapter 70a, Utah Physician
1208 Assistant Act.
1209 Section 27. Section 26B-4-902 is enacted to read:
1210 26B-4-902. Electronic verification system.
1211 (1) The department, the Department of Agriculture and Food, the Department of Public
1212 Safety, and the Division of Technology Services shall:
1213 (a) enter into a memorandum of understanding in order to determine the function and
1214 operation of the state electronic verification system in accordance with Subsection (2);
1215 (b) coordinate with the Division of Purchasing, under Title 63G, Chapter 6a, Utah
1216 Procurement Code, to develop a request for proposals for a third-party provider to develop and
1217 maintain the state electronic verification system in coordination with the Division of
1218 Technology Services; and
1219 (c) select a third-party provider who:
1220 (i) meets the requirements contained in the request for proposals issued under
1221 Subsection (1)(b); and
1222 (ii) may not have any commercial or ownership interest in a psilocybin production
1223 establishment.
1224 (2) The department, the Department of Agriculture and Food, and the Division of
1225 Technology Services shall ensure that, on or before July 1, 2024, the state electronic
1226 verification system described in Subsection (1):
1227 (a) allows a qualified medical psilocybin provider, or an employee described in
1228 Subsection (3) acting on behalf of the qualified medical psilocybin provider:
1229 (i) to access dispensing information regarding a patient:
1230 (A) with whom the qualified medical psilocybin provider has a provider-patient
1231 relationship; and
1232 (B) for whom the qualified medical psilocybin provider has recommended or is
1233 considering recommending psilocybin;
1234 (ii) to electronically recommend or renew a recommendation for psilcobyin or a
1235 psilocybin product in accordance with Subsection 26B-4-909(4)(b); and
1236 (iii) to connect with an inventory control system that a psilocybin production
1237 establishment uses to track in real time and archive purchases of any psilocybin or psilocybin
1238 product including:
1239 (A) the date and time each recommendation was filled;
1240 (B) the quantity and type of psilocybin or psilocybin product;
1241 (C) any psilocybin production establishment associated with the psilocybin or
1242 psilocybin product;
1243 (D) the name of the qualified therapy provider or qualified therapy provider agent who
1244 took receipt of the psilocybin or psilocybin product; and
1245 (E) the personally identifiable information of the patient for whom the psilocybin was
1246 recommended; and
1247 (iv) to connect with any commercially available inventory control system that a
1248 psilocybin production establishment utilizes in accordance with Section 4-41c-102 to use data
1249 that the Department of Agriculture and Food requires by rule, in accordance with Title 63G,
1250 Chapter 3, Utah Administrative Rulemaking Act, from the inventory tracking system that a
1251 licensee uses to track and confirm compliance;
1252 (b) provides access to:
1253 (i) the department to the extent necessary to carry out the department's functions and
1254 responsibilities under this title;
1255 (ii) the Department of Agriculture and Food to the extent necessary to carry out the
1256 functions and responsibilities of the Department of Agriculture and Food under Title 4, Chapter
1257 41c, Psilocybin Production Act; and
1258 (iii) the Division of Professional Licensing to the extent necessary to carry out the
1259 functions and responsibilities related to the participation of the following in the
1260 recommendation of medical psilocybin:
1261 (A) an advanced practice registered nurse licensed under Title 58, Chapter 31b, Nurse
1262 Practice Act;
1263 (B) a physician licensed under Title 58, Chapter 67, Utah Medical Practice Act, or
1264 Title 58, Chapter 68, Utah Osteopathic Medical Practice Act; or
1265 (C) a physician assistant licensed under Title 58, Chapter 70a, Utah Physician Assistant
1266 Act;
1267 (c) provides access to state or local law enforcement after obtaining a warrant; and
1268 (d) creates a record each time a person accesses the system that identifies the person
1269 who accesses the system and the individual whose records the person accesses.
1270 (3) (a) An employee of a qualified medical psilocybin provider may access the
1271 electronic verification system for a purpose described in Subsection (2)(a) on behalf of the
1272 qualified medical psilocybin provider if:
1273 (i) the qualified medical psilocybin provider has designated the employee as an
1274 individual authorized to access the electronic verification system on behalf of the qualified
1275 medical provider;
1276 (ii) the qualified medical psilocybin provider provides written notice to the department
1277 of the employee's identity and the designation described in Subsection (3)(a)(i); and
1278 (iii) the department grants to the employee access to the electronic verification system.
1279 (b) An employee of a business that employs a qualified medical psilocybin provider
1280 may access the electronic verification system for a purpose described in Subsection (2)(a) on
1281 behalf of the qualified medical psilocybin provider if:
1282 (i) the qualified medical psilocybin provider has designated the employee as an
1283 individual authorized to access the electronic verification system on behalf of the qualified
1284 medical provider;
1285 (ii) the qualified medical provider and the employing business jointly provide written
1286 notice to the department of the employee's identity and the designation described in Subsection
1287 (3)(b)(i); and
1288 (iii) the department grants to the employee access to the electronic verification system.
1289 (4) Beginning July 1, 2024, a provider who meets the recommending qualifications
1290 may access information in the electronic verification system regarding a patient the prescribing
1291 provider treats.
1292 (5) The department may release limited data that the system collects for the purpose of:
1293 (a) conducting medical and other department approved research;
1294 (b) providing the report required by Section 26B-4-914; and
1295 (c) other official department purposes.
1296 (6) The department shall make rules, in accordance with Title 63G, Chapter 3, Utah
1297 Administrative Rulemaking Act, to establish:
1298 (a) the limitations on access to the data in the electronic verification system, as
1299 described in this section; and
1300 (b) standards and procedures to ensure accurate identification of an individual
1301 requesting information or receiving information in this section.
1302 (7) (a) Any person who knowingly and intentionally releases any information in the
1303 state electronic verification system in violation of this section is guilty of a third degree felony.
1304 (b) Any person who negligently or recklessly releases any information in the state
1305 electronic verification system in violation of this section is guilty of a class C misdemeanor.
1306 (8) (a) Any person who obtains or attempts to obtain information from the state
1307 electronic verification system by misrepresentation or fraud is guilty of a third degree felony.
1308 (b) Any person who obtains or attempts to obtain information from the state electronic
1309 verification system for a purpose other than a purpose this part authorizes is guilty of a third
1310 degree felony.
1311 (9) (a) Except as provided in Subsection (9)(e), a person may not knowingly and
1312 intentionally use, release, publish, or otherwise make available to any other person information
1313 obtained from the state electronic verification system for any purpose other than a purpose
1314 specified in this section.
1315 (b) Each separate violation of this Subsection (9) is:
1316 (i) a third degree felony; and
1317 (ii) subject to a civil penalty not to exceed $5,000.
1318 (c) The department shall determine a civil violation of this Subsection (9) in
1319 accordance with Title 63G, Chapter 4, Administrative Procedures Act.
1320 (d) Civil penalties assessed under this Subsection (9) shall be deposited into the
1321 General Fund.
1322 (e) This Subsection (9) does not prohibit a person who obtains information from the
1323 state electronic verification system under Subsection (2)(a) or (d) from:
1324 (i) including the information in the person's medical chart or file for access by a person
1325 authorized to review the medical chart or file;
1326 (ii) providing the information to a person in accordance with the requirements of the
1327 Health Insurance Portability and Accountability Act of 1996; or
1328 (iii) discussing or sharing that information about the patient with the patient.
1329 Section 28. Section 26B-4-903 is enacted to read:
1330 26B-4-903. Qualifying condition.
1331 (1) By designating a particular condition under Subsection (2) for which the use of
1332 medical psilocybin to treat symptoms is decriminalized, the Legislature does not conclusively
1333 state that:
1334 (a) current scientific evidence clearly supports the efficacy of a medical psilocybin
1335 treatment for the condition; or
1336 (b) a medical psilocybin treatment will treat, cure, or positively affect the condition.
1337 (2) For the purposes of this part, each of the following conditions is a qualifying
1338 condition:
1339 (a) depression;
1340 (b) anxiety, if the patient has tried at least one other treatment which has not proven
1341 effective;
1342 (c) post-traumatic stress disorder, if the patient has tried at least one other treatment
1343 which has not proven effective; and
1344 (d) a condition where the individual is receiving hospice care.
1345 Section 29. Section 26B-4-904 is enacted to read:
1346 26B-4-904. Qualified medical psilocybin provider registration -- Continuing
1347 education -- Treatment recommendation.
1348 (1) Except as provided in Subsection (2), an individual may not recommend a medical
1349 psilocybin treatment unless the department registers the individual as a qualified medical
1350 psilocybin provider in accordance with this section.
1351 (2) (a) The department shall, within 15 days after the day on which the department
1352 receives an application from an individual, register and issue a qualified medical psilocybin
1353 provider registration card to the individual if the individual:
1354 (i) provides to the department the individual's name and address;
1355 (ii) provides to the department a report detailing the individual's completion of the
1356 applicable continuing education requirements described in Subsection (3);
1357 (iii) provides to the department evidence that the individual meets the recommending
1358 qualifications;
1359 (iv) for an applicant on or after January 1, 2025, provides to the department the
1360 information described in Subsection (9)(a); and
1361 (v) pays the department an amount that:
1362 (A) the department sets, in accordance with Section 63J-1-504; and
1363 (B) does not exceed $300 for an initial registration.
1364 (b) The department may not register an individual as a qualified medical psilocybin
1365 provider if the individual is an owner, officer, director, board member, employee, or agent of a
1366 psilocybin production establishment.
1367 (3) (a) An individual shall complete the continuing education described in this
1368 Subsection (3) in the following amounts:
1369 (i) before registration, 16 hours; and
1370 (ii) for renewing a registration, four hours every two years.
1371 (b) In accordance with Subsection (3)(a), a qualified medical psilocybin provider shall:
1372 (i) complete continuing education:
1373 (A) regarding topics described in Subsection (3)(d); and
1374 (B) offered by the department under Subsection (3)(c) or an accredited or approved
1375 continuing education provider that the department recognizes as offering continuing education
1376 appropriate for the recommendation of psilocybin to patients; and
1377 (ii) make a continuing education report to the department in accordance with a process
1378 that the department establishes by rule, in accordance with Title 63G, Chapter 3, Utah
1379 Administrative Rulemaking Act, and in collaboration with the Division of Professional
1380 Licensing and the applicable licensing board for a health care provider who meets the
1381 recommending qualifications.
1382 (c) The department may, in consultation with the Division of Professional Licensing,
1383 develop the continuing education described in this Subsection (3).
1384 (d) The continuing education described in this Subsection (3) may discuss:
1385 (i) the provisions of this part;
1386 (ii) general information about psilocybin under federal and state law;
1387 (iii) the latest scientific research on medical psilocybin, including risks and benefits;
1388 (iv) best practices for recommending the form and dosage of psilocybin based on the
1389 qualifying condition;
1390 (v) systems and receptors affected by psilocybin;
1391 (vi) mechanisms of action;
1392 (vii) drug interactions;
1393 (viii) qualifying conditions;
1394 (ix) diagnostic criteria;
1395 (x) contraindications;
1396 (xi) side effects and their mitigation;
1397 (xii) administrative set and setting, including physical patient safety;
1398 (xiii) integration;
1399 (xiv) potential outcomes;
1400 (xv) ethical considerations; and
1401 (xvi) discharge safety planning.
1402 (4) (a) A qualified medical psilocybin provider may only recommend psilocybin to an
1403 individual under this part in the course of a provider-patient relationship after the qualified
1404 medical psilocybin provider has:
1405 (i) completed and documented in the patient's medical record a thorough assessment of
1406 the patient's condition and medical history based on the appropriate standard of care for the
1407 patient's condition;
1408 (ii) verified that the patient has a qualifying condition; and
1409 (iii) verified that the patient is at least 21 years old.
1410 (b) To recommend a psilocybin treatment or to renew a recommendation, a qualified
1411 medical psilocybin provider:
1412 (i) shall meet with the patient face-to-face if the qualified medical psilocybin provider
1413 has not recommended a psilocybin treatment to the patient in the past; or
1414 (ii) may use telehealth services, if the qualified medical psilocybin provider
1415 recommended a medical psilocybin treatment to the patient in the past.
1416 (5) (a) Except as provided in Subsection (5)(b), an individual may not advertise that the
1417 individual recommends medical psilocybin treatment.
1418 (b) Notwithstanding Subsection (5)(a) and subject to Section 26B-4-910, a qualified
1419 medical psilocybin provider or clinic or office that employs a qualified medical psilocybin
1420 provider may advertise the following:
1421 (i) the provider's or clinic's name and logo;
1422 (ii) a qualifying condition that the individual treats;
1423 (iii) that the individual is registered as a qualified medical psilocybin provider and
1424 recommends medical psilocybin; or
1425 (iv) a scientific study regarding medical psilocybin use.
1426 (6) (a) A qualified medical psilocybin provider registration card expires two years after
1427 the day on which the department issues the card.
1428 (b) The department shall renew a qualified medical psilocybin provider's registration
1429 card if the psilocybin provider:
1430 (i) applies for renewal;
1431 (ii) is eligible for a qualified medical psilocybin provider registration card under this
1432 section, including maintaining an unrestricted license under the recommending qualifications;
1433 (iii) certifies to the department in a renewal application that the information in
1434 Subsection (2)(a) is accurate or updates the information;
1435 (iv) submits a report detailing the completion of the continuing education requirements
1436 described in Subsection (3); and
1437 (v) pays the department a fee in an amount that:
1438 (A) the department sets, in accordance with Section 63J-1-504; and
1439 (B) does not exceed $50 for a registration renewal.
1440 (7) The department may revoke the registration of a qualified medical psilocybin
1441 provider who fails to maintain compliance with the requirements of this section.
1442 (8) A qualified medical psilocybin provider may not receive any compensation or
1443 benefit for the qualified medical psilocybin provider's medical psilocybin treatment
1444 recommendation from a psilocybin production establishment or an owner, officer, director,
1445 board member, employee, or agent of a psilocybin production establishment.
1446 (9) (a) On or before January 1 of each year, a qualified medical provider shall report to
1447 the department, in a manner designated by the department:
1448 (i) if applicable, that the qualified medical psilocybin provider or the entity that
1449 employs the qualified medical psilocybin provider represents online or on printed material that
1450 the qualified medical psilocybin provider is a qualified medical psilocybin provider or offers
1451 medical psilocybin recommendations to patients; and
1452 (ii) the fee amount that the qualified medical psilocybin provider or the entity that
1453 employs the qualified medical psilocybin provider charges a patient for a medical psilocybin
1454 recommendation, either as an actual cash rate or, if the psilocybin provider or entity bills
1455 insurance, an average cash rate.
1456 (b) The department shall:
1457 (i) ensure that the following information related to qualified medical psilocybin
1458 providers and entities described in Subsection (9)(a)(i) is available on the department's website
1459 or on the health care price transparency tool under Subsection (9)(b)(ii):
1460 (A) the name of the qualified medical psilocybin provider and, if applicable, the name
1461 of the entity that employs the qualified medical psilocybin provider;
1462 (B) the address of the qualified medical psilocybin provider's office or, if applicable,
1463 the entity that employs the qualified medical psilocybin provider; and
1464 (C) the fee amount described in Subsection (9)(a)(ii); and
1465 (ii) share data collected under this Subsection (9) with the state auditory for use in the
1466 health care price transparency tool described in Section 67-3-11.
1467 Section 30. Section 26B-4-905 is enacted to read:
1468 26B-4-905. Standard of care -- Provider not liable -- No private right of action.
1469 (1) A qualified medical psilocybin provider or a qualified therapy provider described in
1470 Subsection (2) is not subject to the following solely for violating a federal law or regulation
1471 that would otherwise prohibit recommending, prescribing, possessing, or dispensing psilocybin
1472 or a psilocybin product:
1473 (a) civil or criminal liability; or
1474 (b) licensure sanctions under Title 58, Occupations and Professions.
1475 (2) A qualified medical psilocybin provider or a qualified therapy provider is eligible
1476 for the protections described in Subsection (1) if the qualified medical provider or qualified
1477 therapy provider recommends or provides treatment with psilocybin or a psilocybin product to
1478 a patient in accordance with this part.
1479 (3) Nothing in this section or part reduces or in any way negates the duty of a qualified
1480 medical psilocybin provider or qualified therapy provider to use reasonable and ordinary care
1481 in the treatment of a patient.
1482 Section 31. Section 26B-4-906 is enacted to read:
1483 26B-4-906. Nondiscrimination for medical care or government employment --
1484 Notice to prospective and current public employees -- No effect on private employers.
1485 (1) For purposes of medical care, including an organ or tissue transplant, a patient's use
1486 of psilocybin, in accordance with this part:
1487 (a) is the equivalent of authorized use of any other medication used at the discretion of
1488 a physician; and
1489 (b) does not constitute the use of an illicit substance or otherwise disqualify an
1490 individual from needed medical care.
1491 (2) (a) Notwithstanding any other provision of law and except as provided in
1492 Subsection (2)(b), the state or any political subdivision shall treat:
1493 (i) an employee's use of medical psilocybin in accordance with this part or Section
1494 58-37-3.7 in the same way the state or political subdivision treats employee use of any
1495 prescribed controlled substance; and
1496 (ii) an employee's medical psilocybin recommendation from a qualified medical
1497 psilocybin provider in the same way the state or political subdivision treats an employee's
1498 prescription for any prescribed controlled substance.
1499 (b) A state or political subdivision employee who has a valid medical psilocybin
1500 recommendation is not subject to retaliatory action, as that term is defined in Section
1501 67-19a-101, for failing a drug test due to psilocybin or psilocin without evidence that the
1502 employee was impaired or otherwise adversely affected in the employee's job performance due
1503 to the use of medical psilocybin.
1504 (c) Subsections (2)(a) and (b) do not apply:
1505 (i) where the application of Subsections (2)(a) or (b) would jeopardize federal funding,
1506 a federal security clearance, or any other federal background determination required for the
1507 employee's position;
1508 (ii) if the employee's position is dependent on a license or peace officer certification
1509 that is subject to federal regulations, including 18 U.S.C. Sec. 922(g)(3); or
1510 (iii) if an employee described in Subsections 34A-2-102(1)(h)(ii) through (vi) uses
1511 medical psilocybin during the 12 hours immediately preceding the employee's shift or during
1512 the employee's shift.
1513 (3) (a) (i) A state employer or a political subdivision employer shall take the action
1514 described in Subsection (3)(a)(ii) before:
1515 (A) giving to a current employee an assignment or duty that arises from or directly
1516 relates to an obligation under this part; or
1517 (B) hiring a prospective employee whose assignments or duties would include an
1518 assignment or duty that arises from or directly relates to an obligation under this part.
1519 (ii) The employer described in Subsection (3)(a)(i) shall give the employee or
1520 prospective employee described in Subsection (3)(a)(i) a written notice that notifies the
1521 employee or prospective employee:
1522 (A) that the employee's or prospective employee's job duties may require the employee
1523 or prospective employee to engage in conduct which is in violation of the criminal laws of the
1524 United States; and
1525 (B) that in accepting a job or undertaking a duty described in Subsection (3)(a)(i),
1526 although the employee or prospective employee is entitled to the protection of Title 67, Chapter
1527 21, Utah Protection of Public Employees Act, the employee may not object or refuse to carry
1528 out an assignment or duty that may be a violation of the criminal laws of the United States with
1529 respect to the manufacture, sale, or distribution of psilocybin.
1530 (b) The Division of Human Resources Management shall create, revise, and publish
1531 the form of the notice described in Subsection (3)(a).
1532 (c) Notwithstanding Subsection 67-21-3(3), an employee who has signed the notice
1533 described in Subsection (3)(a) may not:
1534 (i) claim in good faith that the employee's actions violate or potentially violate the laws
1535 of the United States with respect to the manufacture, sale, or distribution of psilocybin; or
1536 (ii) refuse to carry out a directive that the employee reasonably believes violates the
1537 criminal laws of the United States with respect to the manufacture, sale, or distribution of
1538 psilocybin.
1539 (d) An employer may not take retaliatory action as defined in Section 67-19a-101
1540 against a current employee who refuses to sign the notice described in Subsection (3)(a).
1541 (4) Nothing in this section affects the ability of a private employer to have policies
1542 restricting the use of medical psilocybin by applicants or employees.
1543 Section 32. Section 26B-4-907 is enacted to read:
1544 26B-4-907. No insurance requirement.
1545 Nothing in this part requires an insurer, a third-party administrator, or an employer to
1546 pay or reimburse for psilocybin or psilocybin product.
1547 Section 33. Section 26B-4-908 is enacted to read:
1548 26B-4-908. Approved drugs.
1549 Nothing in this part restricts or otherwise affects the prescription, distribution, or
1550 dispensing of a product that the United States Food and Drug Administration has approved.
1551 Section 34. Section 26B-4-909 is enacted to read:
1552 26B-4-909. Severability.
1553 (1) If any provision of this part or the application of any of the provisions of this part to
1554 any person or circumstance is held invalid by a final decision of a court of competent
1555 jurisdiction, the remaining provisions of this part remain effective without the invalidated
1556 provision or application.
1557 (2) The provisions of this part are severable.
1558 Section 35. Section 26B-4-910 is enacted to read:
1559 26B-4-910. Advertising.
1560 (1) Except as provided in this part, a person may not advertise regarding the
1561 recommendation, sale, dispensing, or transportation of medical psilocybin.
1562 (2) Notwithstanding any authorization to advertise medical psilocybin under this part,
1563 the person advertising may not advertise:
1564 (a) using promotional discounts or incentives; or
1565 (b) an assurance regarding an outcome related to medical psilocybin treatment.
1566 (3) Notwithstanding Subsection (1):
1567 (a) a nonprofit organization that offers financial assistance for medical psilocybin
1568 treatment to low-income patients may advertise the organization's assistance if the
1569 advertisement does not relate to a specific qualified therapy provider; and
1570 (b) a qualified therapy provider may provide information regarding subsidies for the
1571 cost of medical psilocybin treatment to patients who affirmatively accept receipt of the subsidy
1572 information.
1573 (4) To ensure that the name and logo of a licensee under this part have a medical rather
1574 than a recreational disposition, the name and logo of the licensee:
1575 (a) may include terms and images associated with a medical disposition, including
1576 "medical," "medicinal," "medicine," "apothecary," "wellness," "therapeutic," "health," "care,"
1577 "natural," "psilocybin," "clinic," "compassionate," "relief," "treatment," and "patient;"
1578 (b) may not include:
1579 (i) any term, statement, design representation, picture, or illustration that is associated
1580 with a recreational disposition that appeals to children; or
1581 (ii) an emphasis on psychoactivity.
1582 (5) The department shall define standards for advertising authorized under this part,
1583 including names and logos in accordance with Subsection (4), to ensure a medical rather than
1584 recreational disposition.
1585 Section 36. Section 26B-4-911 is enacted to read:
1586 26B-4-911. Qualified therapy provider registration -- Continuing education --
1587 Psilocybin administration.
1588 (1) An individual may not administer a medical psilocybin treatment unless the
1589 department registers the individual as a qualified therapy provider in accordance with this
1590 section.
1591 (2) The department shall, within 15 days after the day on which the department
1592 receives an application from an individual, register and issue a qualified therapy provider
1593 registration card to the individual if the individual:
1594 (a) provides to the department the individual's name;
1595 (b) provides the address of the clinic at which the individual will be administering
1596 psilocybin to patients;
1597 (c) provides to the department a report detailing the individual's completion of the
1598 applicable continuing education requirements described in Subsection (3);
1599 (d) certifies to the department that the individual has installed and maintains an
1600 inventory control system;
1601 (e) provides to the department evidence that the individual meets the therapy provider
1602 qualifications;
1603 (f) pays the department an amount that:
1604 (i) the department sets in accordance with Section 63J-1-504; and
1605 (ii) does not exceed $300 for an initial registration; and
1606 (g) provides to the department an emergency transport plan for patients who experience
1607 a medical emergency during the course of treatment.
1608 (3) (a) An individual shall complete the continuing education described in this
1609 Subsection (3) in the following amounts:
1610 (i) for initial registration, 16 hours; and
1611 (ii) for renewing a registration, four hours every two years.
1612 (b) In accordance with Subsection (3)(a), a qualified therapy provider shall:
1613 (i) complete continuing education:
1614 (A) regarding topics described in Subsection (3)(d); and
1615 (B) offered by the department under Subsection (3)(c) or an accredited or approved
1616 continuing education provider that the department recognizes as offering continuing education
1617 appropriate for the administration of psilocybin to patients; and
1618 (ii) make a continuing education report to the department in accordance with a process
1619 that the department establishes by rule, in accordance with Title 63G, Chapter 3, Utah
1620 Administrative Rulemaking Act, and in collaboration with the Division of Professional
1621 Licensing and relevant licensing boards.
1622 (c) The department may, in consultation with the Division of Professional Licensing,
1623 develop the continuing education described in this Subsection (3).
1624 (d) The continuing education described in this Subsection (3) may discuss:
1625 (i) the provisions of this part;
1626 (ii) general information about psilocybin under federal and state law;
1627 (iii) the latest scientific research on medical psilocybin including risks and benefits;
1628 (iv) best practices for recommending the form and dosage of psilocybin based on the
1629 qualifying condition;
1630 (v) systems and receptors affected by psilocybin;
1631 (vi) mechanisms of action;
1632 (vii) drug interactions;
1633 (viii) qualifying conditions;
1634 (ix) diagnostic criteria;
1635 (x) contraindications;
1636 (xi) side effects and mitigation of side effects;
1637 (xii) administrative set and setting, including physical patient safety;
1638 (xiii) integration;
1639 (xiv) potential outcomes;
1640 (xv) ethical considerations; and
1641 (xvi) discharge safety planning.
1642 (4) A qualified therapy provider may only administer psilocybin to an individual under
1643 this part:
1644 (a) pursuant to a recommendation issued by a qualified medical psilocybin provider
1645 under Section 26B-4-904;
1646 (b) after obtaining and reviewing the patient's mental health history;
1647 (c) after providing the patient with a safety data sheet created by the department which
1648 outlines the potential risks of psilocybin use;
1649 (d) if there are unexpired rescue medications on site as determined by the department
1650 in accordance with Title 63G, Chapter 3, Utah Administrative Rulemaking Act;
1651 (e) if either:
1652 (i) the administration session is video recorded and the video recording is preserved for
1653 one year; or
1654 (ii) the patient gives written, informed consent waiving the video recording
1655 requirement; and
1656 (f) if the qualified therapy provider has a contractual relationship with a licensed
1657 physician who remains on-call during the course of the administration session in case a patient
1658 requires non-emergency medical intervention.
1659 (5) A qualified therapy provider may only administer psilocybin or a psilocybin
1660 product in a qualified therapy provider location.
1661 (6) (a) Except as provided in Subsection (6)(b), an individual may not advertise that the
1662 individual administers medical psilocybin treatment.
1663 (b) Notwithstanding Subsection (6)(a) and subject to Section 26B-4-910, a qualified
1664 therapy provider or clinic or office that employs a qualified therapy provider may advertise the
1665 following:
1666 (i) the provider's or clinic's name and logo;
1667 (ii) a qualifying condition that the individual treats;
1668 (iii) that the individual is registered as a qualified therapy provider and administers
1669 medical psilocybin; or
1670 (iv) a scientific study regarding medical psilocybin use.
1671 (7) (a) A qualified therapy provider registration card expires two years after the day on
1672 which the department issues the card.
1673 (b) The department shall renew a qualified therapy provider's registration card if the
1674 provider:
1675 (i) applies for renewal;
1676 (ii) is eligible for a qualified therapy provider registration card under this section,
1677 including maintaining an unrestricted license;
1678 (iii) certifies to the department in a renewal application that the information in
1679 Subsection (2) is accurate or updates the information;
1680 (iv) submits a report detailing the completion of the continuing education requirements
1681 described in Subsection (3); and
1682 (v) pays the department a fee in an amount that:
1683 (A) the department sets, in accordance with Section 63J-1-504; and
1684 (B) does not exceed $50 for a registration renewal.
1685 (8) Within seven days of the day on which an adverse event occurs, a qualified therapy
1686 provider shall submit to the department a report containing:
1687 (a) the age and sex of the patient;
1688 (b) the patient's pre-existing health conditions, if any;
1689 (c) the qualifying condition for which psilocybin was administered;
1690 (d) the amount of psilocybin administered to the patient;
1691 (e) factors which contributed to the adverse event;
1692 (f) the nature and severity of the adverse event; and
1693 (g) the ultimate outcome of the adverse event.
1694 (9) The department may revoke the registration of a qualified therapy provider who
1695 fails to maintain compliance with the requirements of this section.
1696 Section 37. Section 26B-4-912 is enacted to read:
1697 26B-4-912. Qualified therapy provider agents -- Registration.
1698 (1) An individual may not serve as the agent of a qualified therapy provider unless the
1699 department registers the individual as a qualified therapy provider agent.
1700 (2) (a) The department shall, within 15 days after the day on which the department
1701 receives a complete application from a prospective qualified therapy provider agent, register
1702 and issue a qualified therapy provider agent card to the prospective agent if the prospective
1703 agent:
1704 (i) provides to the department:
1705 (A) the prospective agent's name and address; and
1706 (B) the submission required under Subsection (2)(b); and
1707 (ii) pays a fee to the department in an amount that, subject to Subsection
1708 26-61a-109(5), the department sets in accordance with Section 63J-1-504.
1709 (b) Each prospective agent described in Subsection (2)(a) shall:
1710 (i) submit to the department:
1711 (A) a fingerprint card in a form acceptable to the Department of Public Safety; and
1712 (B) a signed waiver in accordance with Subsection 53-10-108(4) acknowledging the
1713 registration of the prospective agent's fingerprints in the Federal Bureau of Investigation Next
1714 Generation Identification System's Rap Back Service; and
1715 (ii) consent to a fingerprint background check by:
1716 (A) the Bureau of Criminal Identification; and
1717 (B) the Federal Bureau of Investigation.
1718 (c) The Bureau of Criminal Identification shall:
1719 (i) check the fingerprints the prospective agent submits under Subsection (2)(b) against
1720 the applicable state, regional, and national criminal records databases, including the Federal
1721 Bureau of Investigation Next Generation Identification System;
1722 (ii) report the results of the background check to the department;
1723 (iii) maintain a separate file of fingerprints that prospective agents submit under
1724 Subsection (2)(b) for search by future submissions to the local and regional criminal records
1725 databases, including latent prints;
1726 (iv) request that the fingerprints be retained in the Federal Bureau of Investigation Next
1727 Generation Identification System's Rap Back Service for search by future submissions to
1728 national criminal records databases, including the Next Generation Identification System and
1729 latent prints; and
1730 (v) establish a privacy risk mitigation strategy to ensure that the department only
1731 receives notifications for an individual with whom the department maintains an authorizing
1732 relationship.
1733 (d) The department shall:
1734 (i) assess an individual who submits fingerprints under Subsection (2)(b) a fee in an
1735 amount that the department sets in accordance with Section 63J-1-504 for the services that the
1736 Bureau of Criminal Identification or another authorized agency provides under this section; and
1737 (ii) remit the fee described in Subsection (2)(d)(i) to the Bureau of Criminal
1738 Identification.
1739 (3) A qualified therapy provider agent shall comply with:
1740 (a) a certification standard that the department develops; or
1741 (b) a certification standard that the department has reviewed and approved.
1742 (4) The department shall ensure that the certification standard described in Subsection
1743 (3) includes training in Utah medical psilocybin law.
1744 (5) For an individual who holds or applies for a qualified therapy provider agent card:
1745 (a) the department may revoke or refuse to issue the card if the individual violates the
1746 requirements of this part; and
1747 (b) the department shall revoke or refuse to issue the card if the individual is convicted
1748 under state or federal law of:
1749 (i) felony; or
1750 (ii) after December 3, 2018, a misdemeanor for drug distribution.
1751 (6) A qualified therapy provider agent registration card expires two years after the day
1752 on which the department issues the card.
1753 (7) The department may renew a qualified therapy provider agent registration card if
1754 the agent:
1755 (a) is eligible for a qualified therapy provider agent registration card under this section;
1756 (b) certifies to the department in a renewal application that the information in
1757 Subsection (2)(a) is accurate or updates the information; and
1758 (c) pays to the department a renewal fee in an amount that:
1759 (i) subject to Section 26-61a-109, the department sets in accordance with Section
1760 63J-1-504; and
1761 (ii) may not exceed the cost of the relatively lower administrative burden of renewal in
1762 comparison to the original application process.
1763 Section 38. Section 26B-4-913 is enacted to read:
1764 26B-4-913. Qualified therapy provider registration card and agent registration
1765 card -- Rebuttable presumption.
1766 (1) An individual who is registered as a qualified therapy provider or qualified therapy
1767 provider agent shall carry the individual's applicable registration card issued by the department
1768 under this part at all times when the individual:
1769 (a) is transporting psilocybin product between a psilocybin production establishment
1770 and a qualified therapy provider location; or
1771 (b) handling a psilocybin product.
1772 (2) If an individual possesses psilocybin or a psilocybin product and produces the
1773 registration card in the individual's possession while handling or transporting psilocybin in
1774 compliance with Subsection (1):
1775 (a) there is a rebuttable presumption that the individual possesses the psilocybin
1776 product legally; and
1777 (b) a law enforcement officer does not have probable cause, based solely on the
1778 possession of psilocybin or psilocybin product to believe the individual is engaging in illegal
1779 activity.
1780 (3) (a) An individual described in Subsection (1) who fails to carry the registration card
1781 in accordance with Subsection (1) is:
1782 (i) for a first or second offense in a two-year period:
1783 (A) guilty of an infraction; and
1784 (B) subject to a $100 fine; or
1785 (ii) for a third or subsequent offense in a two-year period:
1786 (A) guilty of a class C misdemeanor; and
1787 (B) subject to a $750 fine.
1788 (b) For each conviction under Subsection (3)(a), the prosecuting entity shall:
1789 (i) notify the department; and
1790 (ii) for a conviction involving a qualified therapy provider agent, notify the relevant
1791 qualified therapy provider.
1792 (c) For each violation described in Subsection (3)(a)(ii) committed by a qualified
1793 therapy provider agent, the department may assess the relevant qualified therapy provider a fine
1794 of up to $2,500, in accordance with a fine schedule that the department establishes by rule in
1795 accordance with Title 63G, Chapter 3, Utah Administrative Rulemaking Act.
1796 (d) An individual who is guilty of a violation described in Subsection (3)(a) is not
1797 guilty of a violation of Title 58, Chapter 37, Utah Controlled Substances Act, for the conduct
1798 underlying the violation described in Subsection (3)(a).
1799 Section 39. Section 26B-4-914 is enacted to read:
1800 26B-4-914. Enforcement -- Fine -- Citation.
1801 (1) (a) The department may, for a qualified therapy provider's violation of this chapter
1802 or an applicable administrative rule:
1803 (i) revoke the qualified therapy provider's registration;
1804 (ii) refuse to renew the qualified therapy provider's registration; or
1805 (iii) assess the qualified therapy provider an administrative penalty.
1806 (b) The department may, for a qualified therapy provider agent's violation of this part:
1807 (i) revoke the qualified therapy provider agent registration card;
1808 (ii) refuse to renew the qualified therapy provider agent registration card; or
1809 (iii) assess the qualified therapy provider agent an administrative penalty.
1810 (2) The department shall deposit an administrative penalty imposed under this section
1811 into the General Fund.
1812 (3) For a person subject to an uncontested citation, a stipulated settlement, or a finding
1813 of violation in an adjudicative proceeding under this section, the department may:
1814 (a) for a fine amount not already specified in law, assess the person a fine of up to
1815 $5,000 per violation, in accordance with a fine schedule that the department establishes by rule
1816 in accordance with Title 63G, Chapter 3, Utah Administrative Rulemaking Act; or
1817 (b) order the person to cease and desist from the action that creates a violation.
1818 (4) The department may not revoke a qualified therapy provider's registration without
1819 first directing the qualified therapy provider to appear before an adjudicative proceeding
1820 conducted under Title 63G, Chapter 4, Administrative Procedures Act.
1821 (5) If, within 20 calendar days after the day on which the department issues a citation
1822 for a violation of this part, the person that is the subject of the citation fails to request a hearing
1823 to contest the citation, the citation becomes the department's final order.
1824 (6) The department may, for a person who fails to comply with a citation under this
1825 section:
1826 (a) refuse to issue or renew the person's license or agent registration card; or
1827 (b) suspend, revoke, or place on probation the person's license or agent registration
1828 card.
1829 (7) (a) Except where a criminal penalty is expressly provided for a specific violation of
1830 this part, if an individual violates a provision of this part, the individual is:
1831 (i) guilty of an infraction; and
1832 (ii) subject to a $100 fine.
1833 (b) An individual who is guilty of a violation described in Subsection (7)(a) is not
1834 guilty of a violation of Title 58, Chapter 37, Utah Controlled Substances Act, for the conduct
1835 underlying the violation described in Subsection (7)(a).
1836 Section 40. Section 26B-4-915 is enacted to read:
1837 26B-4-915. Report.
1838 (1) On or before November 1, 2024, and each year thereafter, the department shall
1839 submit a report to the Health and Human Services Interim Committee on:
1840 (a) the number of patients for whom psilocybin has been recommended;
1841 (b) the age and county of patients;
1842 (c) the number of qualified medical psilocybin providers;
1843 (d) the number of license applications and renewal license applications received;
1844 (e) the number of licenses the department has issued in each county;
1845 (f) the number of licenses the department has revoked;
1846 (g) the expenses incurred and revenues generated from the medical psilocybin
1847 program; and
1848 (h) the number and nature of adverse events reported.
1849 (2) The department may not include personally identifying information in the report
1850 described in this section.
1851 Section 41. Section 26B-4-916 is enacted to read:
1852 26B-4-916. Religious Freedom Restoration Act.
1853 Nothing in this chapter shall be construed as limiting any right or privilege a person
1854 possesses under the Religious Freedom Restoration Act, 42 U.S.C. Sec. 2000bb et. seq.
1855 Section 42. Section 30-3-10 is amended to read:
1856 30-3-10. Custody of a child -- Custody factors.
1857 (1) If a married couple having one or more minor children are separated, or the married
1858 couple's marriage is declared void or dissolved, the court shall enter, and has continuing
1859 jurisdiction to modify, an order of custody and parent-time.
1860 (2) In determining any form of custody and parent-time under Subsection (1), the court
1861 shall consider the best interest of the child and may consider among other factors the court
1862 finds relevant, the following for each parent:
1863 (a) evidence of domestic violence, neglect, physical abuse, sexual abuse, or emotional
1864 abuse, involving the child, the parent, or a household member of the parent;
1865 (b) the parent's demonstrated understanding of, responsiveness to, and ability to meet
1866 the developmental needs of the child, including the child's:
1867 (i) physical needs;
1868 (ii) emotional needs;
1869 (iii) educational needs;
1870 (iv) medical needs; and
1871 (v) any special needs;
1872 (c) the parent's capacity and willingness to function as a parent, including:
1873 (i) parenting skills;
1874 (ii) co-parenting skills, including:
1875 (A) ability to appropriately communicate with the other parent;
1876 (B) ability to encourage the sharing of love and affection; and
1877 (C) willingness to allow frequent and continuous contact between the child and the
1878 other parent, except that, if the court determines that the parent is acting to protect the child
1879 from domestic violence, neglect, or abuse, the parent's protective actions may be taken into
1880 consideration; and
1881 (iii) ability to provide personal care rather than surrogate care;
1882 (d) in accordance with Subsection (10), the past conduct and demonstrated moral
1883 character of the parent;
1884 (e) the emotional stability of the parent;
1885 (f) the parent's inability to function as a parent because of drug abuse, excessive
1886 drinking, or other causes;
1887 (g) whether the parent has intentionally exposed the child to pornography or material
1888 harmful to minors, as "material" and "harmful to minors" are defined in Section 76-10-1201;
1889 (h) the parent's reasons for having relinquished custody or parent-time in the past;
1890 (i) duration and depth of desire for custody or parent-time;
1891 (j) the parent's religious compatibility with the child;
1892 (k) the parent's financial responsibility;
1893 (l) the child's interaction and relationship with step-parents, extended family members
1894 of other individuals who may significantly affect the child's best interests;
1895 (m) who has been the primary caretaker of the child;
1896 (n) previous parenting arrangements in which the child has been happy and
1897 well-adjusted in the home, school, and community;
1898 (o) the relative benefit of keeping siblings together;
1899 (p) the stated wishes and concerns of the child, taking into consideration the child's
1900 cognitive ability and emotional maturity;
1901 (q) the relative strength of the child's bond with the parent, meaning the depth, quality,
1902 and nature of the relationship between the parent and the child; and
1903 (r) any other factor the court finds relevant.
1904 (3) There is a rebuttable presumption that joint legal custody, as defined in Section
1905 30-3-10.1, is in the best interest of the child, except in cases when there is:
1906 (a) evidence of domestic violence, neglect, physical abuse, sexual abuse, or emotional
1907 abuse involving the child, a parent, or a household member of the parent;
1908 (b) special physical or mental needs of a parent or child, making joint legal custody
1909 unreasonable;
1910 (c) physical distance between the residences of the parents, making joint decision
1911 making impractical in certain circumstances; or
1912 (d) any other factor the court considers relevant including those listed in this section
1913 and Section 30-3-10.2.
1914 (4) (a) The person who desires joint legal custody shall file a proposed parenting plan
1915 in accordance with Sections 30-3-10.8 and 30-3-10.9.
1916 (b) A presumption for joint legal custody may be rebutted by a showing by a
1917 preponderance of the evidence that it is not in the best interest of the child.
1918 (5) (a) A child may not be required by either party to testify unless the trier of fact
1919 determines that extenuating circumstances exist that would necessitate the testimony of the
1920 child be heard and there is no other reasonable method to present the child's testimony.
1921 (b) (i) The court may inquire of the child's and take into consideration the child's
1922 desires regarding future custody or parent-time schedules, but the expressed desires are not
1923 controlling and the court may determine the child's custody or parent-time otherwise.
1924 (ii) The desires of a child 14 years [
1925 but is not the single controlling factor.
1926 (c) (i) If an interview with a child is conducted by the court pursuant to Subsection
1927 (5)(b), the interview shall be conducted by the judge in camera.
1928 (ii) The prior consent of the parties may be obtained but is not necessary if the court
1929 finds that an interview with a child is the only method to ascertain the child's desires regarding
1930 custody.
1931 (6) (a) Except as provided in Subsection (6)(b), a court may not discriminate against a
1932 parent due to a disability, as defined in Section 57-21-2, in awarding custody or determining
1933 whether a substantial change has occurred for the purpose of modifying an award of custody.
1934 (b) The court may not consider the disability of a parent as a factor in awarding custody
1935 or modifying an award of custody based on a determination of a substantial change in
1936 circumstances, unless the court makes specific findings that:
1937 (i) the disability significantly or substantially inhibits the parent's ability to provide for
1938 the physical and emotional needs of the child at issue; and
1939 (ii) the parent with a disability lacks sufficient human, monetary, or other resources
1940 available to supplement the parent's ability to provide for the physical and emotional needs of
1941 the child at issue.
1942 (c) Nothing in this section may be construed to apply to adoption proceedings under
1943 Title 78B, Chapter 6, Part 1, Utah Adoption Act.
1944 (7) This section does not establish a preference for either parent solely because of the
1945 gender of the parent.
1946 (8) This section establishes neither a preference nor a presumption for or against joint
1947 physical custody or sole physical custody, but allows the court and the family the widest
1948 discretion to choose a parenting plan that is in the best interest of the child.
1949 (9) When an issue before the court involves custodial responsibility in the event of a
1950 deployment of one or both parents who are servicemembers, and the servicemember has not yet
1951 been notified of deployment, the court shall resolve the issue based on the standards in Sections
1952 78B-20-306 through 78B-20-309.
1953 (10) In considering the past conduct and demonstrated moral standards of each party
1954 under Subsection (2)(d) or any other factor a court finds relevant, the court may not:
1955 (a) consider or treat a parent's lawful possession or use of cannabis in a medicinal
1956 dosage form, a cannabis product in a medicinal dosage form, or a medical cannabis device, in
1957 accordance with Title 4, Chapter 41a, Cannabis Production Establishments, Title 26, Chapter
1958 61a, Utah Medical Cannabis Act, or Subsection 58-37-3.7(2) or (3) any differently than the
1959 court would consider or treat the lawful possession or use of any prescribed controlled
1960 substance; [
1961 (b) discriminate against a parent because of the parent's status as a:
1962 (i) cannabis production establishment agent, as that term is defined in Section
1963 4-41a-102;
1964 (ii) medical cannabis pharmacy agent, as that term is defined in Section 26-61a-102;
1965 (iii) medical cannabis courier agent, as that term is defined in Section 26-61a-102; or
1966 (iv) medical cannabis cardholder in accordance with Title 26, Chapter 61a, Utah
1967 Medical Cannabis Act[
1968 (c) consider or treat a parent's lawful possession or use of psilocybin or psilocybin
1969 product in accordance with Title 4, Chapter 41c, Psilocybin Production Act, and Title 26B,
1970 Chapter 4, Part 9, Utah Medical Psilocybin Act, any differently than the court would consider
1971 the lawful possession or use of any prescribed substance.
1972 Section 43. Section 31A-22-1016 is amended to read:
1973 31A-22-1016. Workers' compensation coverage for medical cannabis operations.
1974 A licensed and admitted workers' compensation insurer may issue coverage to:
1975 (1) a cannabis production establishment as defined in Section 4-41a-102; [
1976 (2) a medical cannabis pharmacy as defined in Section 26-61a-102[
1977 (3) a psilocybin production establishment as defined in Section 4-41c-101.
1978 Section 44. Section 58-31b-305 is amended to read:
1979 58-31b-305. Term of license -- Expiration -- Renewal.
1980 (1) (a) The division shall issue each license or certification under this chapter in
1981 accordance with a two-year renewal cycle established by rule.
1982 (b) The division may by rule extend or shorten a renewal period by as much as one year
1983 to stagger the renewal cycles the division administers.
1984 (2) The division shall renew the license of a licensee who, at the time of renewal:
1985 (a) completes and submits an application for renewal in a form prescribed by the
1986 division;
1987 (b) pays a renewal fee established by the division under Section 63J-1-504;
1988 (c) views a suicide prevention video described in Section 58-1-601 and submits proof
1989 in the form required by the division; and
1990 (d) meets continuing competency requirements as established by rule.
1991 (3) In addition to the renewal requirements under Subsection (2), a person licensed as
1992 an advanced practice registered nurse shall be currently certified by a program approved by the
1993 division in collaboration with the board and submit evidence satisfactory to the division of that
1994 qualification or if licensed prior to July 1, 1992, meet the requirements established by rule.
1995 (4) In addition to the requirements described in Subsections (2) and (3), an advanced
1996 practice registered nurse licensee specializing in psychiatric mental health nursing who, as of
1997 the day on which the division originally issued the licensee's license had not completed the
1998 division's clinical practice requirements in psychiatric and mental health nursing, shall, to
1999 qualify for renewal:
2000 (a) if renewing less than two years after the day on which the division originally issued
2001 the license, demonstrate satisfactory progress toward completing the clinical practice
2002 requirements; or
2003 (b) have completed the clinical practice requirements.
2004 (5) Each license or certification automatically expires on the expiration date shown on
2005 the license or certification unless renewed in accordance with Section 58-1-308.
2006 (6) The division shall accept and apply toward an hour requirement that the division
2007 establishes under Subsection (2)(d) continuing education that an advanced practice registered
2008 nurse completes in accordance with Section 26-61a-106, 26B-4-904, or 26B-4-911.
2009 Section 45. Section 58-37-3.1 is enacted to read:
2010 58-37-3.1. Exemption for possession or distribution of psilocybin or psilocybin
2011 product.
2012 (1) As used in this section, "psilocybin" means any mushroom containing psilocybin
2013 whether fresh or dried.
2014 (2) Notwithstanding any other provision of law, an individual is not guilty for a
2015 violation of this title for the following conduct if the individual engages in the conduct in
2016 accordance with Title 4, Chapter 41c, Psilocybin Production Act, or Title 26B, Chapter 4, Part
2017 9, Utah Medical Psilocybin Act:
2018 (a) possessing, ingesting, producing, manufacturing, dispensing, distributing, selling,
2019 or offering to sell psilocybin or a psilocybin product; or
2020 (b) possessing psilocybin or a psilocybin product with the intent to engage in conduct
2021 described in Subsection (2)(a).
2022 (3) An individual who is assessed a penalty or convicted of a crime under Title 4,
2023 Chapter 41c, Psilocybin Production Act, or Title 26B, Chapter 4, Part 9, Utah Medical
2024 Psilocybin Act, is not, based on the conduct underlying that penalty or conviction, subject to a
2025 penalty described in this chapter for:
2026 (a) the possession, manufacture, sale, or offer for sale of psilocybin or a psilocybin
2027 product; or
2028 (b) the possession, manufacture, sale, or offer for sale of drug paraphernalia.
2029 Section 46. Section 58-60-205.5 is amended to read:
2030 58-60-205.5. Continuing education.
2031 (1) As a condition for renewal of a license under this part, a social service worker
2032 licensee shall, during each two-year licensure cycle, complete qualified continuing professional
2033 education, as defined by rule made in accordance with Title 63G, Chapter 3, Utah
2034 Administrative Rulemaking Act.
2035 (2) The division shall accept and apply toward the professional education established
2036 under Subsection (1) any hours completed in accordance with Section 26B-4-911.
2037 Section 47. Section 58-61-306 is amended to read:
2038 58-61-306. Continuing education.
2039 (1) By rule made under Section 58-1-203, the division may establish a continuing
2040 education requirement as a condition for renewal of a license under this chapter upon finding
2041 continuing education is necessary to reasonably protect the public health, safety, or welfare.
2042 (2) The division shall accept and apply toward the professional education established
2043 under Subsection (1) any hours completed in accordance with Section 26B-4-911.
2044 Section 48. Section 58-67-304 is amended to read:
2045 58-67-304. License renewal requirements.
2046 (1) As a condition precedent for license renewal, each licensee shall, during each
2047 two-year licensure cycle or other cycle defined by division rule:
2048 (a) complete qualified continuing professional education requirements in accordance
2049 with the number of hours and standards defined by division rule made in collaboration with the
2050 board;
2051 (b) appoint a contact person for access to medical records and an alternate contact
2052 person for access to medical records in accordance with Subsection 58-67-302(1)(i);
2053 (c) if the licensee practices medicine in a location with no other persons licensed under
2054 this chapter, provide some method of notice to the licensee's patients of the identity and
2055 location of the contact person and alternate contact person for the licensee; and
2056 (d) if the licensee is an associate physician licensed under Section 58-67-302.8,
2057 successfully complete the educational methods and programs described in Subsection
2058 58-67-807(4).
2059 (2) If a renewal period is extended or shortened under Section 58-67-303, the
2060 continuing education hours required for license renewal under this section are increased or
2061 decreased proportionally.
2062 (3) An application to renew a license under this chapter shall:
2063 (a) require a physician to answer the following question: "Do you perform elective
2064 abortions in Utah in a location other than a hospital?"; and
2065 (b) immediately following the question, contain the following statement: "For purposes
2066 of the immediately preceding question, elective abortion means an abortion other than one of
2067 the following: removal of a dead fetus, removal of an ectopic pregnancy, an abortion that is
2068 necessary to avert the death of a woman, an abortion that is necessary to avert a serious risk of
2069 substantial and irreversible impairment of a major bodily function of a woman, an abortion of a
2070 fetus that has a defect that is uniformly diagnosable and uniformly lethal, or an abortion where
2071 the woman is pregnant as a result of rape or incest."
2072 (4) In order to assist the Department of Health in fulfilling its responsibilities relating
2073 to the licensing of an abortion clinic and the enforcement of Title 76, Chapter 7, Part 3,
2074 Abortion, if a physician responds positively to the question described in Subsection (3)(a), the
2075 division shall, within 30 days after the day on which it renews the physician's license under this
2076 chapter, inform the Department of Health in writing:
2077 (a) of the name and business address of the physician; and
2078 (b) that the physician responded positively to the question described in Subsection
2079 (3)(a).
2080 (5) The division shall accept and apply toward the hour requirement in Subsection
2081 (1)(a) any continuing education that a physician completes in accordance with [
2082
2083 Section 49. Section 58-68-304 is amended to read:
2084 58-68-304. License renewal requirements.
2085 (1) As a condition precedent for license renewal, each licensee shall, during each
2086 two-year licensure cycle or other cycle defined by division rule:
2087 (a) complete qualified continuing professional education requirements in accordance
2088 with the number of hours and standards defined by division rule in collaboration with the
2089 board;
2090 (b) appoint a contact person for access to medical records and an alternate contact
2091 person for access to medical records in accordance with Subsection 58-68-302(1)(i);
2092 (c) if the licensee practices osteopathic medicine in a location with no other persons
2093 licensed under this chapter, provide some method of notice to the licensee's patients of the
2094 identity and location of the contact person and alternate contact person for access to medical
2095 records for the licensee in accordance with Subsection 58-68-302(1)(j); and
2096 (d) if the licensee is an associate physician licensed under Section 58-68-302.5,
2097 successfully complete the educational methods and programs described in Subsection
2098 58-68-807(4).
2099 (2) If a renewal period is extended or shortened under Section 58-68-303, the
2100 continuing education hours required for license renewal under this section are increased or
2101 decreased proportionally.
2102 (3) An application to renew a license under this chapter shall:
2103 (a) require a physician to answer the following question: "Do you perform elective
2104 abortions in Utah in a location other than a hospital?"; and
2105 (b) immediately following the question, contain the following statement: "For purposes
2106 of the immediately preceding question, elective abortion means an abortion other than one of
2107 the following: removal of a dead fetus, removal of an ectopic pregnancy, an abortion that is
2108 necessary to avert the death of a woman, an abortion that is necessary to avert a serious risk of
2109 substantial and irreversible impairment of a major bodily function of a woman, an abortion of a
2110 fetus that has a defect that is uniformly diagnosable and uniformly lethal, or an abortion where
2111 the woman is pregnant as a result of rape or incest."
2112 (4) In order to assist the Department of Health in fulfilling its responsibilities relating
2113 to the licensing of an abortion clinic, if a physician responds positively to the question
2114 described in Subsection (3)(a), the division shall, within 30 days after the day on which it
2115 renews the physician's license under this chapter, inform the Department of Health in writing:
2116 (a) of the name and business address of the physician; and
2117 (b) that the physician responded positively to the question described in Subsection
2118 (3)(a).
2119 (5) The division shall accept and apply toward the hour requirement in Subsection
2120 (1)(a) any continuing education that a physician completes in accordance with [
2121
2122 Section 50. Section 58-70a-303 is amended to read:
2123 58-70a-303. Term of license -- Expiration -- Renewal.
2124 (1) (a) The division shall issue each license under this chapter in accordance with a
2125 two-year renewal cycle established by division rule.
2126 (b) The division may by rule extend or shorten a renewal period by as much as one year
2127 to stagger the renewal cycles it administers.
2128 (2) At the time of renewal, the licensee shall show compliance with continuing
2129 education renewal requirements.
2130 (3) Each license issued under this chapter expires on the expiration date shown on the
2131 license unless renewed in accordance with Section 58-1-308.
2132 (4) The division shall accept and apply toward an hour requirement that the division
2133 establishes under Subsection (2) continuing education that a physician assistant completes in
2134 accordance with Section 26-61a-106, 26B-4-904, or 26B-4-911.