House File 636 - Introduced HOUSE FILE 636 BY SHIPLEY A BILL FOR An Act creating the psilocybin services Act, and providing 1 penalties. 2 BE IT ENACTED BY THE GENERAL ASSEMBLY OF THE STATE OF IOWA: 3 TLSB 2408HH (6) 89 pf/rh
H.F. 636 Section 1. Section 124.204, subsection 4, paragraph s, Code 1 2021, is amended to read as follows: 2 s. Psilocybin , except as otherwise provided in subsection 3 8A . 4 Sec. 2. Section 124.204, Code 2021, is amended by adding the 5 following new subsection: 6 NEW SUBSECTION . 8A. Psilocybin. Nothing in this chapter 7 shall apply to psilocybin when manufactured, planted, 8 cultivated, grown, harvested, produced, prepared, propagated, 9 compounded, converted, processed, handled, transported, 10 delivered, marketed, distributed, possessed, administered, 11 consumed, tested, or otherwise used in accordance and 12 compliance with chapter 124F. 13 Sec. 3. Section 124.401, Code 2021, is amended by adding the 14 following new subsection: 15 NEW SUBSECTION . 7. Notwithstanding any other provision 16 in this section to the contrary, a person may manufacture, 17 plant, cultivate, grow, harvest, produce, prepare, propagate, 18 compound, convert, process, handle, transport, deliver, market, 19 distribute, possess, administer, consume, test, or otherwise 20 use psilocybin in accordance and compliance with chapter 124F. 21 Sec. 4. NEW SECTION . 124F.1 Short title. 22 This Act shall be known and may be cited as the “Psilocybin 23 Services Act” . 24 Sec. 5. NEW SECTION . 124F.2 Definitions. 25 As used in this chapter, unless the context otherwise 26 requires: 27 1. “Administration session” means a session held at 28 a psilocybin service center at which a client purchases, 29 consumes, and experiences the effects of a psilocybin product 30 under the supervision of a psilocybin service facilitator. 31 2. “Client” means a person who is provided psilocybin 32 services under this chapter. 33 3. “Department” means the department of public health. 34 4. “Entheogenic plants and fungi” means any plant or 35 -1- LSB 2408HH (6) 89 pf/rh 1/ 39
H.F. 636 fungus of any species in which ibogaine, dimethyltryptamine, 1 mescaline, peyote, psilocybin, or psilocin occurs naturally in 2 any form that would cause such plant or fungus to be named or 3 described as a controlled substance under chapter 124. 4 5. “Integration session” means a meeting between a client 5 and a psilocybin service facilitator that may occur after the 6 client completes an administration session. 7 6. “Legal entity” means a corporation, limited liability 8 company, limited partnership, or other entity that is 9 registered with the office of the secretary of state. 10 7. “Licensee” means a person who holds a license issued 11 under this chapter. 12 8. “Licensee representative” means an owner, director, 13 officer, manager, employee, agent, or other representative of 14 a licensee, to the extent that such person is serving in a 15 representative capacity. 16 9. “Manufacture” or “manufacturing” means the manufacture, 17 planting, cultivation, growing, harvesting, production, 18 preparation, propagation, compounding, conversion, or 19 processing of a psilocybin product, either directly or 20 indirectly by extraction from substances of natural origin, 21 or independently by means of chemical synthesis, or by a 22 combination of extraction and chemical synthesis. The term 23 includes any packaging or repackaging of the psilocybin product 24 or labeling or relabeling of the psilocybin product package. 25 10. “One-year program development period” means the period 26 beginning on January 1, 2022, and ending no later than December 27 31, 2022. 28 11. “Premises” includes all of the following areas of a 29 location licensed under this chapter: 30 a. All public and private enclosed areas that are used 31 in the business operated at the location, including offices, 32 kitchens, restrooms, and storerooms. 33 b. All areas outside a building that the department has 34 specifically licensed for the manufacturing of psilocybin 35 -2- LSB 2408HH (6) 89 pf/rh 2/ 39
H.F. 636 products or the operation of a psilocybin service center. 1 c. For a location that the department has specifically 2 licensed for the operation of a psilocybin service center 3 outside a building, that portion of the location used to 4 operate the center and provide psilocybin services to clients. 5 d. The term does not include a primary residence. 6 12. “Preparation session” means a meeting between a client 7 and a psilocybin service facilitator that must occur before the 8 client participates in an administration session. 9 13. “Psilocybin” means a hallucinogenic compound obtained 10 from P. cubensis mushrooms. 11 14. “Psilocybin product manufacturing facility” means a 12 facility that manufactures psilocybin products in this state. 13 15. “Psilocybin products” means psilocybin-producing fungi 14 and mixtures or substances containing a detectable amount of 15 psilocybin. The term does not include psilocybin services. 16 16. “Psilocybin service center” means a center where 17 administration sessions are held and other psilocybin services 18 may be provided. 19 17. “Psilocybin service facilitator” means a person who 20 facilitates the provision of psilocybin services to a client. 21 18. “Psilocybin services” means services provided to a 22 client before, during, or after the client’s consumption of 23 a psilocybin product, including a preparation session, an 24 administration session, and an integration session. 25 19. “Psilocybin testing laboratory” means a laboratory that 26 conducts tests on psilocybin products in accordance with this 27 chapter. 28 Sec. 6. NEW SECTION . 124F.3 Purposes. 29 The purposes of this chapter include all of the following: 30 1. To educate the public about the safe and effective use of 31 psilocybin in treating mental health conditions. 32 2. To reduce the prevalence of mental illness among adults 33 in the state and improve the physical, mental, and social 34 well-being of all people in the state. 35 -3- LSB 2408HH (6) 89 pf/rh 3/ 39
H.F. 636 3. To develop a long-term strategic plan for ensuring that 1 psilocybin services will become and remain a safe, accessible, 2 and affordable therapeutic option for all persons twenty-one 3 years of age or older for whom psilocybin may be appropriate. 4 4. To protect the public health, safety, and welfare by 5 prioritizing the state’s limited law enforcement resources in 6 the most effective, consistent, and rational way. 7 5. To allow persons licensed under this chapter to legally 8 manufacture psilocybin products and provide psilocybin services 9 to persons twenty-one years of age or older in accordance with 10 this chapter. 11 6. To establish a comprehensive regulatory framework 12 regarding psilocybin products and psilocybin services. 13 7. To prevent the distribution of psilocybin products to 14 persons who are not allowed to possess psilocybin products 15 under this chapter, including persons who are younger than 16 twenty-one years of age. 17 8. To prevent the diversion of psilocybin products from this 18 state to other states. 19 Sec. 7. NEW SECTION . 124F.4 Department authority and 20 duties. 21 1. The department shall do all of the following during the 22 one-year program development period: 23 a. Examine, publish, and distribute to the public available 24 medical, psychological, and scientific studies, research, 25 and other information relating to the safety and efficacy of 26 psilocybin in treating mental health conditions. 27 b. Adopt rules pursuant to chapter 17A for the 28 implementation of a comprehensive regulatory framework 29 authorizing persons twenty-one years of age or older to be 30 provided psilocybin services in this state. 31 c. Establish an advisory board for the purpose of advising 32 and making recommendations to the department regarding the use 33 of psilocybin for mental health treatment. 34 2. Unless otherwise provided by law, the department shall 35 -4- LSB 2408HH (6) 89 pf/rh 4/ 39
H.F. 636 not issue any licenses or permits during the one-year program 1 development period. 2 3. Beginning November 30, 2022, and periodically 3 thereafter, the department shall publish on its internet 4 website information received from the psilocybin advisory board 5 and available medical, psychological, and scientific studies, 6 research, and any other information relating to the safety and 7 efficacy of psilocybin in treating mental health conditions, 8 including but not limited to addiction, depression, anxiety 9 disorders, and end-of-life psychological distress. 10 4. After the one-year program development period, beginning 11 no later than January 1, 2023, the duties of the department 12 shall include all of the following: 13 a. Regulating the possession, manufacturing, 14 transportation, delivery, sale, and purchase of psilocybin 15 products and the provision of psilocybin services in this state 16 in accordance with this chapter. 17 b. Issuing, renewing, suspending, revoking, or refusing 18 to issue or renew licenses for the manufacturing or sale of 19 psilocybin products or the provision of psilocybin services 20 or other licenses related to the consumption of psilocybin 21 products, and allowing the transfer of a license between 22 persons. 23 c. Issuing, renewing, suspending, revoking, or refusing to 24 issue or renew permits for licensee representatives. 25 d. Regulating the use of psilocybin products and psilocybin 26 services for other purposes as deemed necessary or appropriate 27 by the department. 28 e. Adopting, amending, or repealing rules pursuant to 29 chapter 17A as necessary to administer this chapter including 30 rules that the department considers necessary to protect the 31 public health, safety, and welfare. 32 f. Exercising the department’s authority to administer 33 this chapter or any other law that authorizes the department 34 to regulate psilocybin products and psilocybin services, which 35 -5- LSB 2408HH (6) 89 pf/rh 5/ 39
H.F. 636 includes all of the following: 1 (1) Issuing subpoenas. 2 (2) Compelling the attendance of witnesses. 3 (3) Administering oaths. 4 (4) Certifying official acts. 5 (5) Taking depositions. 6 (6) Compelling the production of books, payrolls, accounts, 7 papers, records, documents, and testimony. 8 (7) Adopting rules regulating the advertisement of 9 psilocybin products to the public. 10 (8) Adopting rules prohibiting the advertisement of 11 psilocybin services in a manner that does any of the following: 12 (a) Is appealing to minors. 13 (b) Promotes excessive use. 14 (c) Promotes illegal activity. 15 (d) Violates the code of professional conduct for 16 psilocybin service facilitators. 17 (e) Otherwise poses a significant risk to the public health, 18 safety, and welfare. 19 g. Purchasing, possessing, seizing, transferring to a 20 licensee, or disposing of psilocybin products as necessary for 21 the department to ensure compliance with and to enforce this 22 chapter. 23 5. The department shall not do any of the following: 24 a. Require that a psilocybin product be manufactured by 25 means of chemical synthesis. 26 b. Require a client to be diagnosed with or have any 27 particular medical condition before being provided psilocybin 28 services. 29 Sec. 8. NEW SECTION . 124F.5 Psilocybin advisory board —— 30 membership, duties. 31 1. The psilocybin advisory board is created within 32 the department for the purpose of advising and making 33 recommendations to the department regarding the use of 34 psilocybin for mental health treatment. 35 -6- LSB 2408HH (6) 89 pf/rh 6/ 39
H.F. 636 2. a. The board shall include the following ex-officio, 1 nonvoting members: 2 (1) The state medical director, or the medical director’s 3 designee. 4 (2) The secretary of agriculture, or the secretary’s 5 designee. 6 (3) The attorney general or the attorney general’s 7 designee. 8 (4) The director of public safety, or the director’s 9 designee. 10 (5) The director of the department of human services, or the 11 director’s designee. 12 b. The board shall include all of the following voting 13 members appointed by the governor, subject to sections 69.16, 14 69.16A, and 69.16C, and subject to confirmation by the senate: 15 (1) A state employee employed by the department of public 16 health to administer the medical cannabidiol program pursuant 17 to chapter 124E. 18 (2) A licensed attorney with experience with laws and 19 regulations relating to controlled substances. 20 (3) A state employee who has technical and policy expertise 21 in the field of public health. 22 (4) A person who is a member of, or who represents, a 23 federally recognized Indian tribe in this state. 24 (5) A person who represents providers who deliver health 25 care services directly to the public. 26 (6) A psychologist licensed under chapter 154B who has 27 professional experience diagnosing or treating mental, 28 emotional, or behavioral health conditions. 29 (7) A physician licensed under chapter 148. 30 (8) A person who practices naturopathy. 31 (9) A person who is an expert in the field of public health 32 and is employed by a postsecondary institution in the state. 33 (10) A person who has professional experience conducting 34 scientific research regarding the use of psychedelic compounds 35 -7- LSB 2408HH (6) 89 pf/rh 7/ 39
H.F. 636 in clinical therapy. 1 (11) A person who has experience in the field of mycology. 2 (12) A person who has experience in the field of 3 ethnobotany. 4 (13) A person who has experience in the field of 5 psychopharmacology. 6 (14) A person who has experience in the field of psilocybin 7 harm reduction. 8 (15) Two members selected at large. 9 3. Voting members shall serve for four-year terms beginning 10 and ending as provided in section 69.19. Vacancies shall be 11 filled by the governor for the duration of the unexpired terms. 12 A majority of the voting members of the board shall constitute 13 a quorum. The affirmative vote of a majority of the quorum is 14 necessary for any action taken by the board. The board shall 15 elect one of the members to serve as chairperson. 16 4. During the one-year program development period, the 17 board shall meet at least bimonthly at a time and place 18 determined by the chairperson or a majority of the voting 19 members of the board. After the one-year program development 20 period, the board shall meet at least quarterly at a time and 21 place determined by the chairperson or a majority of the voting 22 members of the board. The board may also meet at other times 23 and places at the call of the chairperson or a majority of the 24 voting members of the board. 25 5. The advisory board shall do all of the following: 26 a. Advise the department regarding the administration of 27 this chapter. 28 b. Make recommendations to the department on available 29 medical, psychological, and scientific studies, research, 30 and other information relating to the safety and efficacy of 31 psilocybin in treating mental health conditions, including but 32 not limited to addiction, depression, anxiety disorders, and 33 end-of-life psychological distress. 34 c. Make recommendations to the department regarding the 35 -8- LSB 2408HH (6) 89 pf/rh 8/ 39
H.F. 636 requirements, specifications, and guidelines for providing 1 psilocybin services to a client, including all of the 2 following: 3 (1) The requirements, specifications, and guidelines for 4 holding and verifying the completion of a preparation session, 5 an administration session, and an integration session. 6 (2) The contents of the client information form that a 7 client must complete and sign before the client participates in 8 a preparation session, including all of the following: 9 (a) Information that must be solicited from the client 10 to determine whether it is appropriate for the client to 11 participate in the preparation session, which may identify risk 12 factors and contraindications. 13 (b) Information that must be solicited from the client to 14 assist the psilocybin service center and the psilocybin service 15 facilitator in meeting any public health and safety standards 16 and industry best practices during the administration session. 17 (c) Health and safety warnings and other disclosures that 18 must be made to the client before the client participates in 19 the administration session. 20 (3) Make recommendations to the department on public health 21 and safety standards and industry best practices for each type 22 of licensee and licensee representative under this chapter. 23 (4) Make recommendations to the department on the 24 formulation of a code of professional conduct for psilocybin 25 service facilitators, including a code of ethics. 26 (5) Make recommendations to the department on the education 27 and training that psilocybin service facilitators must 28 complete, including all of the following: 29 (a) Facilitation skills that are affirming, nonjudgmental, 30 and nondirective. 31 (b) Skills to support clients during an administration 32 session, including specialized skills for client safety and 33 clients who may have a mental health condition. 34 (c) The optimal environment in which psilocybin services 35 -9- LSB 2408HH (6) 89 pf/rh 9/ 39
H.F. 636 must occur. 1 (d) Social and cultural considerations. 2 (e) Whether such education and training should be made 3 available through online resources. 4 (6) Make recommendations to the department on the 5 examinations that psilocybin service facilitators and licensee 6 representatives must pass to obtain and maintain a license or 7 permit. 8 (7) Make recommendations to the department on public health 9 and safety standards and industry best practices for holding 10 and completing an administration session, including whether 11 group administration sessions will be made available and 12 whether clients will be able to access common or outside areas 13 on the premises of the psilocybin service center at which the 14 administration session is held. 15 (8) Make recommendations to the department as to whether 16 and how psilocybin service centers and psilocybin service 17 facilitators may safely and effectively provide administration 18 sessions using telehealth. 19 (9) Make recommendations to the department regarding 20 the circumstances under which an administration session is 21 considered complete. 22 (10) Make recommendations to the department regarding the 23 transportation needs of the client after the completion of an 24 administration session. 25 (11) Develop a long-term strategic plan for ensuring that 26 psilocybin services are and will remain a safe, accessible, and 27 affordable therapeutic option for all persons twenty-one years 28 of age or older for whom psilocybin may be appropriate. 29 (12) Make recommendations to the department about 30 technologies that can be used and implemented by the department 31 to track product information, client data, and outcomes of 32 clients during and after receiving psilocybin services. 33 (13) Monitor and study federal laws, regulations, and 34 policies relating to psilocybin. 35 -10- LSB 2408HH (6) 89 pf/rh 10/ 39
H.F. 636 6. The advisory board shall submit its initial findings 1 and recommendations to the governor and the general assembly 2 by August 31, 2022, and shall periodically thereafter submit 3 findings and recommendations to the governor and the general 4 assembly regarding improvements in the program. 5 Sec. 9. NEW SECTION . 124F.6 Applications for licensure. 6 1. By February 1, 2023, the department shall begin receiving 7 applications for the licensing of all of the following: 8 a. Psilocybin product manufacturing facilities. 9 b. Psilocybin service centers. 10 c. Psilocybin service facilitators. 11 d. Psilocybin testing laboratories. 12 2. An applicant for a license or renewal of a license shall 13 apply to the department in a form prescribed by department 14 by rule. The application shall include the name and address 15 of the applicant, the location of the premises that will be 16 operated under the license, and any other pertinent information 17 required by the department. 18 3. The department shall not issue or renew a license until 19 the applicant has complied with this section. 20 4. The department shall approve or deny an application for 21 licensure under this section in a timely manner. 22 5. The department shall not issue a license for premises 23 that do not have defined boundaries. The premises are not 24 required to be enclosed by a wall, fence, or other structure. 25 However, the department may require the premises to be enclosed 26 as a condition of issuing or renewing a license. 27 6. The department shall not issue a license to a mobile 28 premises. 29 7. A license issued under this section serves the purpose 30 of exempting the licensee from the criminal laws of this state 31 for the possession, transportation, delivery, manufacturing, 32 or sale of psilocybin products to the extent that the person 33 complies with all state laws and rules applicable to a 34 licensee. 35 -11- LSB 2408HH (6) 89 pf/rh 11/ 39
H.F. 636 8. The department may reject any application that is not 1 submitted in the form prescribed by the department. 2 9. An applicant may appeal any action taken by the 3 department pursuant to this section in a proceeding under 4 chapter 17A. 5 10. A license issued under this section: 6 a. Is a personal privilege. 7 b. Is renewable except for a cause that would be grounds for 8 refusal to issue the license. 9 c. Is revocable or may be subject to suspension. 10 d. Except for a license issued to a psilocybin service 11 facilitator, is transferable from the premises for which the 12 license was originally issued to another premises. 13 e. If the license was issued to a person, expires upon the 14 death of the licensee, except as otherwise provided in this 15 section. 16 f. Does not constitute property. 17 g. Is not alienable. 18 h. Is not subject to attachment or execution. 19 i. Does not descend by the laws of testate or intestate 20 succession. 21 11. The department may require an applicant for a license 22 or a licensee to submit to the department, in a form and manner 23 prescribed by the department, a sworn statement showing both 24 of the following: 25 a. The name and address of each person who has a financial 26 interest in the business operating or to be operated under the 27 license. 28 b. The nature and extent of the financial interest of each 29 person who has a financial interest in the business operating 30 or to be operated under the license. 31 12. The department may refuse to issue, or may suspend, 32 revoke, or refuse to renew, a license issued under this chapter 33 if the department determines that a person who has a financial 34 interest in the business operating or to be operated under 35 -12- LSB 2408HH (6) 89 pf/rh 12/ 39
H.F. 636 the license committed or failed to commit an act that would 1 constitute grounds for the department to refuse to issue, or to 2 suspend, revoke, or refuse to renew, the license if the person 3 were the licensee or applicant for the license. 4 13. A person including a legal entity that directly or 5 indirectly owns, controls, or holds with power to vote five 6 percent or more of the voting shares of a psilocybin product 7 manufacturing facility or psilocybin service center shall not 8 acquire direct or indirect ownership or control of any voting 9 shares or other form of ownership of any other psilocybin 10 product manufacturing facility or psilocybin service center. 11 14. Before receiving a license for a psilocybin product 12 manufacturing facility or psilocybin service center, an 13 applicant shall request a land use compatibility statement 14 from the city or county in which the applicant will operate. 15 The land use compatibility statement must demonstrate that 16 the requested license is for a land use that is allowable as 17 a permitted or conditional use within the applicable zoning 18 designation where the land is located. The department shall 19 not issue a license if the land use compatibility statement 20 shows that the proposed land use is prohibited in the 21 applicable zone. 22 15. Except as otherwise provided by law, a city or county 23 that receives a request for a land use compatibility statement 24 shall act on such request within twenty-one days after receipt 25 of the request, if the land use is allowable as an outright 26 permitted use, or twenty-one days after final local permit 27 approval, if the land use is allowable as a conditional use. 28 16. A city or county that receives a request for a land use 29 compatibility statement is not required to act on that request 30 during the period that the department suspends licensing for 31 the premises. 32 17. The department may require the fingerprints of any 33 person listed on an application. However, the department shall 34 require the fingerprints of all of the following: 35 -13- LSB 2408HH (6) 89 pf/rh 13/ 39
H.F. 636 a. Each general partner of the limited partnership, if the 1 applicant is a limited partnership. 2 b. Each manager of the limited liability company, if the 3 applicant is a manager-managed limited liability company. 4 c. Each voting member of the limited liability company, if 5 the applicant is a member-managed limited liability company. 6 d. Each director and officer of the corporation, if the 7 applicant is a corporation. 8 e. Any person who holds a financial interest, whether direct 9 or indirect, in a psilocybin product manufacturing facility or 10 psilocybin service center. 11 f. Any licensee representative. 12 18. An applicant shall be subject to a background screening 13 under this section. Any arrest record identified shall be 14 reported to the department. 15 Sec. 10. NEW SECTION . 124F.7 Psilocybin product 16 manufacturing license. 17 1. The manufacture of psilocybin products is subject to 18 regulation by the department. Any psilocybin products used 19 by a psilocybin service center shall be manufactured by a 20 psilocybin product manufacturing facility licensed under this 21 chapter. A psilocybin product manufacturing facility shall 22 have a psilocybin product manufacturing facility license issued 23 by the department for the premises at which the psilocybin 24 products will be manufactured. 25 2. To hold a psilocybin product manufacturing facility 26 license, a psilocybin product manufacturing facility shall do 27 all of the following: 28 a. Apply for a license in the manner described in this 29 chapter. 30 b. Provide proof that the applicant is owned and controlled 31 by a person or persons who are twenty-one years of age or 32 older. 33 c. Provide proof that the applicant’s psilocybin product 34 manufacturing facility is located in an area zoned for 35 -14- LSB 2408HH (6) 89 pf/rh 14/ 39
H.F. 636 industrial or agricultural use. 1 (1) For purposes of this paragraph, the department shall 2 adopt rules pursuant to chapter 17A that designate different 3 types of psilocybin product manufacturing activities and 4 provide for endorsement by the department for such activities. 5 A psilocybin product manufacturing facility shall only engage 6 in a type of psilocybin product manufacturing activity if the 7 psilocybin product manufacturing facility has received an 8 endorsement from the department for that type of psilocybin 9 product manufacturing activity. 10 (2) An applicant shall request an endorsement upon 11 submission of an initial application but the applicant or 12 licensee may request a subsequent endorsement at any time after 13 licensure. 14 (3) Only one application is required regardless of how many 15 endorsements an applicant or licensee requests or at what point 16 in the licensing process the request is made. 17 (4) A psilocybin product manufacturing facility licensee 18 may hold multiple endorsements. 19 (5) The department may deny a psilocybin product 20 manufacturing facility’s request for an endorsement or revoke 21 an existing endorsement if the psilocybin product manufacturing 22 facility cannot or does not meet the requirements for the 23 endorsement. 24 Sec. 11. NEW SECTION . 124F.8 Psilocybin service center 25 license. 26 1. The operation of a psilocybin service center is subject 27 to regulation by the department. A psilocybin service center 28 is not a health care facility subject to chapter 135C. 29 2. A psilocybin service center shall receive a psilocybin 30 service center license issued by the department for the 31 premises at which psilocybin services will be provided. To 32 hold such a license under this section, a psilocybin service 33 center shall do all of the following: 34 a. Apply for a license in the manner described in this 35 -15- LSB 2408HH (6) 89 pf/rh 15/ 39
H.F. 636 chapter. 1 b. Provide proof that the applicant is owned and controlled 2 by a person or persons who are twenty-one years of age or 3 older. 4 c. Provide proof that the psilocybin service center is not 5 located in any of the following areas: 6 (1) An area zoned exclusively for residential use. 7 (2) An area located within five hundred feet of the real 8 property that comprises a public or private elementary school, 9 middle school, or high school. If a school that has not 10 previously been attended by children is established within 11 five hundred feet of a premises for which a license has been 12 issued, the psilocybin service center located at that premises 13 may remain at that location, unless the department revokes the 14 license of the psilocybin service center for cause. 15 3. The department shall adopt rules pursuant to chapter 17A 16 that require all of the following: 17 a. A psilocybin service center to annually renew a license 18 issued under this chapter. 19 b. Any psilocybin products sold or used by a psilocybin 20 service center to be tested in accordance with this chapter. 21 c. A psilocybin service center to meet any public health 22 and safety standards and industry best practices established 23 by department rule. 24 Sec. 12. NEW SECTION . 124F.9 Psilocybin service facilitator 25 license. 26 1. A psilocybin service facilitator is subject to 27 regulation by the department. 28 2. A psilocybin service facilitator shall maintain a 29 facilitator license issued by the department. 30 3. To hold a facilitator license issued under this chapter, 31 a psilocybin service facilitator must do all of the following: 32 a. Apply for a license in the manner described in this 33 chapter. 34 b. Provide proof that the applicant is twenty-one years of 35 -16- LSB 2408HH (6) 89 pf/rh 16/ 39
H.F. 636 age or older. 1 c. Submit evidence of completion of the required education 2 and training as approved by the department. 3 d. Submit evidence of passing an examination approved, 4 administered, or recognized by the department. 5 e. Annually renew a license issued under this chapter. 6 f. Meet any public health and safety standards and industry 7 best practices established by department rule. 8 4. A psilocybin service facilitator shall only be an 9 employee, manager, director, officer, partner, member, 10 shareholder, or direct or indirect owner of one psilocybin 11 service center. 12 5. A license issued to a psilocybin service facilitator 13 under this chapter is not limited to any single premises. 14 6. The department shall do all of the following: 15 a. Establish the qualifications, training, and education 16 requirements for applicants for a psilocybin service 17 facilitator license with an emphasis on all of the following: 18 (1) Facilitation skills that are affirming, nonjudgmental, 19 and nondirective. 20 (2) Support skills for clients during an administration 21 session, including specialized skills for client safety and for 22 clients who may have a mental health condition. 23 (3) The environment in which psilocybin services should 24 occur. 25 (4) Social and cultural considerations. 26 b. Formulate a code of professional conduct for psilocybin 27 service facilitators, including a code of ethics. 28 c. Establish standards of practice and professional 29 responsibility for persons licensed by the department to 30 facilitate psilocybin services. 31 d. Develop or select examinations for licensure as a 32 psilocybin service facilitator. 33 e. Provide for waivers of examinations as appropriate. 34 f. Appoint representatives to conduct or supervise 35 -17- LSB 2408HH (6) 89 pf/rh 17/ 39
H.F. 636 examinations of applicants. 1 g. Require background screenings of all applicants for a 2 psilocybin service facilitator license. 3 h. Approve courses that psilocybin service facilitators 4 must complete. To obtain approval of a course, the provider 5 of a course must submit a curriculum outline to the department 6 and the department of education for review. The outline 7 must include the approved courses, total number of hours of 8 instruction, total number of hours of lectures in theory, and 9 total number of hours of instruction in the application of 10 practical skills. 11 i. Offer an examination for psilocybin service facilitator 12 applicants at least twice annually. An applicant who fails any 13 section of the examination may retake the failed section of the 14 examination in accordance with rules adopted by the department. 15 Sec. 13. NEW SECTION . 124F.10 Psilocybin testing laboratory 16 license. 17 1. A laboratory that conducts testing of psilocybin 18 products as required by this section shall maintain a license 19 to operate at the premises at which the psilocybin products are 20 tested. 21 2. The department shall adopt rules pursuant to chapter 17A 22 to establish all of the following: 23 a. Qualifications for a psilocybin testing laboratory 24 license, including accreditation of the applicant for licensure 25 by the department. 26 b. Processes for applying for and renewing a license. 27 c. A procedure for an initial license and biennial renewal 28 of such license. The department shall renew the license 29 biennially if the psilocybin testing laboratory meets the 30 requirements in this chapter. 31 3. The department may inspect premises licensed under this 32 section to ensure compliance. 33 4. The department may refuse to issue or renew, or may 34 suspend or revoke, a psilocybin testing laboratory license for 35 -18- LSB 2408HH (6) 89 pf/rh 18/ 39
H.F. 636 a violation of this chapter. 1 Sec. 14. NEW SECTION . 124F.11 Licensee representative 2 permit. 3 1. A licensee representative shall maintain a valid permit 4 issued by the department under this chapter if the licensee 5 representative participates in any of the following: 6 a. Provision of psilocybin services at the premises. 7 b. Possession, manufacturing, transportation, delivery, or 8 selling of psilocybin products at the premises. 9 c. Recording of the possession, manufacturing, 10 transportation, delivery, or selling of psilocybin products at 11 the premises. 12 2. By February 1, 2023, the department shall begin receiving 13 applications and issuing licensee representative permits 14 to qualified applicants. The department shall adopt rules 15 pursuant to chapter 17A establishing all of the following: 16 a. Qualifications for performing activities as described in 17 this section. 18 b. The duration of a permit issued under this section. 19 c. Procedures for applying for and renewing a permit. 20 d. The successful completion of a course, made available by 21 or through the department, which provides training on all of 22 the following: 23 (1) Confirming client identification. 24 (2) Detecting client intoxication. 25 (3) Handling psilocybin products. 26 (4) If applicable, the manufacturing of psilocybin 27 products. 28 (5) If applicable, the testing of psilocybin products. 29 (6) The requirements of this chapter. 30 (7) Any matter deemed necessary by the department to protect 31 the public health, safety, and welfare. 32 3. A licensee shall verify that a person has a valid permit 33 as a licensee representative issued by the department before 34 allowing the person to perform any activity specified in 35 -19- LSB 2408HH (6) 89 pf/rh 19/ 39
H.F. 636 subsection 1 at the premises. 1 4. The department shall not require a person applying for 2 a licensee representative permit to successfully complete 3 a course more than once unless subsequent completion is a 4 condition of rescinding a suspension of a permit issued under 5 this chapter or to issue a new permit following revocation of a 6 permit. 7 Sec. 15. NEW SECTION . 124F.12 Refusal to issue a license 8 or permit —— grounds for revocation, suspension, or restriction 9 of a license or permit. 10 1. The department may refuse to issue a license or, if 11 applicable, a permit to an applicant if the department finds 12 that any of the following applies to the applicant: 13 a. The applicant is younger than twenty-one years of age. 14 b. The applicant has not completed any of the education or 15 training requirements required for issuance of the license or 16 permit. 17 c. The applicant has not passed an examination required for 18 issuance of the license or permit. 19 d. The applicant has made false or fraudulent statements or 20 representations in the application. 21 e. The applicant is incompetent or physically unable to 22 manage the premises proposed to be licensed. 23 f. The applicant has been convicted of violating a federal 24 law, state law, or local ordinance if the conviction is 25 substantially related to the qualifications and ability of the 26 applicant to lawfully carry out activities under the license 27 or permit. 28 g. The applicant does not have a good record of compliance 29 with the requirements of this chapter. 30 h. The applicant is not the legitimate owner of the premises 31 proposed to be licensed or has not disclosed that other 32 persons have ownership interests in the premises proposed to 33 be licensed. 34 i. The applicant has not demonstrated financial 35 -20- LSB 2408HH (6) 89 pf/rh 20/ 39
H.F. 636 responsibility sufficient to adequately meet the requirements 1 of the premises proposed to be licensed. 2 j. The applicant is unable to understand the laws of this 3 state relating to psilocybin products, psilocybin services, or 4 the rules adopted by the department relating to such products 5 and services. 6 2. The department may revoke, suspend, or restrict a 7 license or, if applicable, a permit issued under this chapter 8 or require a licensee or licensee representative to undergo 9 training if the department finds or has reasonable grounds to 10 believe that the licensee or licensee representative: 11 a. Has violated the requirements of this chapter including 12 any code of professional conduct or code of ethics. 13 b. Has made any false or fraudulent statement or 14 representation to the department in order to induce or prevent 15 action by the department. 16 c. Is insolvent or incompetent or physically unable to 17 manage the premises of the licensee. 18 d. Has misrepresented to a person or the public any 19 psilocybin products sold by the licensee or licensee 20 representative. 21 e. Since the issuance of the license or, if applicable, the 22 permit, has been convicted of a felony, of violating any law of 23 this state relating to psilocybin products, or of any violation 24 of any municipal ordinance committed on the premises. 25 f. Any other reason that, at the discretion of the 26 department, warrants revoking, suspending, or restricting the 27 license or, if applicable, the permit to protect the public 28 health, safety, and welfare. 29 Sec. 16. NEW SECTION . 124F.13 Operation of a psilocybin 30 product manufacturing facility. 31 1. A licensed psilocybin product manufacturing facility 32 shall not manufacture psilocybin products outdoors. 33 2. The department shall adopt rules pursuant to chapter 17A 34 restricting the quantities of psilocybin products manufactured 35 -21- LSB 2408HH (6) 89 pf/rh 21/ 39
H.F. 636 at a premises. In determining the restrictions, the department 1 shall take into consideration the demand for psilocybin 2 services in the state, the number of psilocybin product 3 manufacturing facilities applying for licenses, the number of 4 licensed psilocybin product manufacturing facilities in the 5 state, and whether the availability of psilocybin products 6 in the state is commensurate with the demand for psilocybin 7 services. 8 3. A psilocybin product shall not be sold or offered for 9 sale within this state unless the psilocybin product complies 10 with the minimum standards adopted by the department by rule. 11 The department may prohibit the sale of a psilocybin product 12 by a psilocybin product manufacturing facility or psilocybin 13 service center for a reasonable period of time for the purpose 14 of determining whether the psilocybin product complies with the 15 minimum standards. 16 4. As necessary to protect the public health, safety, and 17 welfare, the department shall require a licensed psilocybin 18 product manufacturing facility to test psilocybin products 19 before selling or transferring the psilocybin products. 20 5. The department may conduct random testing of psilocybin 21 products for the purpose of determining whether a licensed 22 psilocybin product manufacturing facility is in compliance with 23 this chapter. 24 6. The department shall not require a psilocybin product 25 to undergo the same test more than once, unless the psilocybin 26 product is processed into a different type of psilocybin 27 product or fundamentally altered. 28 7. The testing of psilocybin products shall be conducted by 29 a licensed psilocybin testing laboratory. 30 8. In requiring testing, the department shall consider the 31 cost of a potential testing procedure and how that cost will 32 affect the overall cost of psilocybin products to the client. 33 9. The department shall not adopt rules under this section 34 that are more restrictive than are reasonably necessary to 35 -22- LSB 2408HH (6) 89 pf/rh 22/ 39
H.F. 636 protect the public health, safety, and welfare. 1 Sec. 17. NEW SECTION . 124F.14 Labeling and packaging of 2 psilocybin products. 3 1. a. The department may adopt rules pursuant to chapter 4 17A to require a licensee to submit a label intended for use 5 on a psilocybin product for preapproval by the department 6 before the licensee may sell or transfer a psilocybin product 7 bearing the label. The rules shall also establish standards 8 for the labeling of psilocybin products, including all of the 9 following: 10 (1) Ensuring that psilocybin products have labeling that 11 communicates all of the following to the consumer: 12 (a) Health and safety warnings. 13 (b) If applicable, the activation time of the psilocybin 14 product. 15 (c) The potency of the psilocybin product. 16 (d) If applicable, the dosage of the psilocybin product and 17 the number of doses included in the psilocybin product package. 18 (e) The content of the psilocybin product. 19 (2) Labeling that is in accordance with applicable state 20 food labeling requirements for the same type of food product 21 or potable liquid when the food product or potable liquid does 22 not contain psilocybin. 23 (3) Requiring that all psilocybin products sold or 24 transferred by a licensed psilocybin product manufacturing 25 facility are labeled in accordance with this section. 26 (4) Establishing different labeling standards for different 27 varieties and types of psilocybin products. 28 b. In establishing labeling requirements, the department 29 shall consider the cost of a potential labeling requirement 30 and how that cost will affect the overall cost of psilocybin 31 products to the client. 32 2. The department may adopt rules pursuant to chapter 33 17A to require a licensee to submit packaging intended for a 34 psilocybin product for preapproval by the department before 35 -23- LSB 2408HH (6) 89 pf/rh 23/ 39
H.F. 636 the licensee may sell or transfer a psilocybin product in the 1 packaging. As necessary to protect the public health, safety, 2 and welfare, the rules shall also establish standards for the 3 packaging of psilocybin products that ensure that psilocybin 4 products are not marketed in a manner that is untruthful or 5 misleading or otherwise creates a significant risk of harm 6 to the public health, safety, and welfare. In adopting the 7 packaging standards, the department: 8 a. May establish different packaging standards for different 9 varieties and types of psilocybin products. 10 b. May consider the effect on the environment of requiring 11 certain packaging of psilocybin products. 12 c. Shall consider the cost of a potential requirement 13 and how that cost will affect the overall cost of psilocybin 14 products to the client. 15 d. Shall not adopt rules that are more restrictive than are 16 reasonably necessary to protect the public health, safety, and 17 welfare. 18 3. A licensee shall not use or allow the use of a mark 19 or label on the package of a psilocybin product that is held 20 for sale if the mark or label does not precisely and clearly 21 indicate the nature of the package’s contents or if the mark 22 or label in any way might deceive a person about the nature, 23 composition, quantity, age, or quality of the package’s 24 contents. 25 4. The department may prohibit a licensee from selling 26 a psilocybin product that in the department’s judgment is 27 deceptively labeled or contains injurious or adulterated 28 ingredients. 29 5. The department shall adopt rules pursuant to chapter 17A 30 establishing the maximum concentration of psilocybin that is 31 allowed in a single dose of a psilocybin product and the number 32 of doses that are allowed in a psilocybin product package. 33 The department shall require all psilocybin products sold or 34 transferred by a psilocybin product manufacturing facility or 35 -24- LSB 2408HH (6) 89 pf/rh 24/ 39
H.F. 636 psilocybin service center to meet the concentration, packaging, 1 and labeling standards adopted by the department. 2 Sec. 18. NEW SECTION . 124F.15 Operating a psilocybin 3 testing laboratory. 4 1. The department shall adopt rules pursuant to chapter 17A 5 for psilocybin testing laboratories that include all of the 6 following: 7 a. Security standards. 8 b. Minimum standards for licensee representatives. 9 c. Sample collection method and process standards. 10 d. Proficiency testing for psilocybin products for potency 11 and contaminants unsafe for human consumption, as determined by 12 rule of the department. 13 e. Reporting content, format, and frequency. 14 f. Audits and onsite inspections. 15 g. Quality assurance. 16 h. Equipment and methodology. 17 i. Chain of custody. 18 j. Any other standard the department deems necessary to 19 protect the public health, safety, and welfare. 20 2. The department shall establish standards for testing 21 psilocybin products and identify appropriate tests for 22 psilocybin products, depending on the type of psilocybin 23 product and the manner in which the psilocybin product was 24 manufactured, that are necessary to protect the public health, 25 safety, and welfare. The standards may include testing for all 26 of the following: 27 a. Microbiological contaminants. 28 b. Pesticides. 29 c. Other contaminants. 30 d. Solvents or residual solvents. 31 e. Psilocybin concentration. 32 3. The department shall also establish procedures for 33 determining batch sizes and for sampling psilocybin products, 34 including different minimum procedures and standards for 35 -25- LSB 2408HH (6) 89 pf/rh 25/ 39
H.F. 636 different varieties of psilocybin products. 1 4. In addition to the testing standards, the department may 2 require psilocybin products to be tested in accordance with any 3 applicable law or department rule related to the production and 4 processing of food products, potable liquids, or commodities. 5 5. A psilocybin testing laboratory may acquire psilocybin 6 products only from a psilocybin product manufacturing 7 facility or a psilocybin service center. A psilocybin testing 8 laboratory shall not sell, distribute, or transfer psilocybin 9 products received from a psilocybin product manufacturing 10 facility or psilocybin service center, except that a psilocybin 11 testing laboratory may transfer a sample of a psilocybin 12 product to another psilocybin testing laboratory in this state. 13 6. A psilocybin testing laboratory shall properly dispose 14 of all samples it receives, unless transferred to another 15 psilocybin testing laboratory in this state, after all 16 necessary tests have been conducted and any required storage 17 period has elapsed, as established by department rule. 18 7. A psilocybin testing laboratory shall use the computer 19 software tracking system designated by the department under 20 this chapter. 21 Sec. 19. NEW SECTION . 124F.16 Operating a psilocybin 22 service center. 23 1. The department shall adopt rules pursuant to chapter 17A 24 establishing the requirements, specifications, and guidelines 25 for the operation of a psilocybin service center including all 26 of the following: 27 a. Having a client complete, sign, and deliver a client 28 information form to a psilocybin service center and a 29 psilocybin service facilitator. 30 b. Providing preparation sessions to a client. 31 c. Holding and verifying the completion of a preparation 32 session. 33 d. Providing administration sessions to a client. 34 e. Holding and verifying the completion of an administration 35 -26- LSB 2408HH (6) 89 pf/rh 26/ 39
H.F. 636 session. 1 f. Providing integration sessions to a client. 2 g. Holding and verifying the completion of an integration 3 session. 4 2. a. Before a client participates in a preparation 5 session, the client shall complete and sign a client 6 information form, in a form and manner prescribed by the 7 department by rule. 8 b. A copy of the completed and signed client information 9 form shall be delivered to both the psilocybin service 10 center at which the preparation session will be held and the 11 psilocybin service facilitator who will conduct the preparation 12 session. 13 c. The client information form shall provide for all of the 14 following: 15 (1) Solicit from the client such information as may 16 be necessary to enable a psilocybin service center and a 17 psilocybin service facilitator to determine whether the 18 client should participate in an administration session, 19 including information that may identify risk factors and 20 contraindications, and if applicable, assist the psilocybin 21 service center and the psilocybin service facilitator in 22 meeting any public health and safety standards and industry 23 best practices during the administration session. 24 (2) Health and safety warnings and other disclosures as 25 prescribed by the department by rule. 26 d. (1) If a client information form is offered as evidence 27 in any administrative or criminal proceeding involving a 28 licensee or licensee representative for the sale or service 29 of a psilocybin product to a client, the licensee or licensee 30 representative shall not be guilty of any offense prohibiting a 31 person from selling or serving a psilocybin product to a client 32 unless it is demonstrated that a reasonable person would have 33 determined that the responses provided by the client on the 34 client information form were incorrect or altered. 35 -27- LSB 2408HH (6) 89 pf/rh 27/ 39
H.F. 636 (2) A licensee or licensee representative shall be 1 entitled to rely upon all statements, declarations, and 2 representations made by a client in a client information form 3 unless it is demonstrated that a reasonable person would have 4 determined that one or more of the statements, declarations, or 5 representations made by the client in the client information 6 form were incorrect or altered, or unless the licensee or 7 licensee representative violated any provision relating to the 8 client information form. 9 3. Except as otherwise provided by law, a licensee or 10 licensee representative is not liable by virtue of any untrue 11 statements, declarations, or representations relied upon in 12 good faith by the licensee or licensee representative. 13 4. a. Before a client participates in an administration 14 session, the client shall attend a preparation session with a 15 psilocybin service facilitator. 16 b. A preparation session shall be held at a psilocybin 17 service center. However, the department may adopt rules to 18 allow preparation sessions to be conducted using telehealth. 19 c. If a preparation session is completed in accordance with 20 all applicable requirements, specifications, and guidelines, 21 as determined by the department, the psilocybin service 22 facilitator shall certify, in a form and manner prescribed 23 by the department, that the client completed the preparation 24 session. 25 5. a. After a client completes and signs a client 26 information form and completes a preparation session, the 27 client may participate in an administration session, which 28 shall be held at a psilocybin service center. However, the 29 department may adopt rules to allow administration sessions to 30 be conducted using telehealth. 31 b. If an administration session is completed in accordance 32 with all applicable requirements, specifications, and 33 guidelines, as determined by the department, the psilocybin 34 service facilitator shall certify, in a form and manner 35 -28- LSB 2408HH (6) 89 pf/rh 28/ 39
H.F. 636 prescribed by the department, that the client completed the 1 administration session. 2 6. A psilocybin service facilitator shall not consume a 3 psilocybin product during an administration session that the 4 psilocybin service facilitator is supervising. 5 7. a. After a client completes an administration session, 6 the psilocybin service facilitator who supervised the 7 administration session shall offer the client an opportunity 8 to participate in an integration session. The client is not 9 obligated to participate in an integration session. 10 b. An integration session shall be held at a psilocybin 11 service center. However, the department may adopt rules to 12 allow integration sessions to be conducted using telehealth. 13 c. If an integration session is completed in accordance with 14 all applicable requirements, specifications, and guidelines, 15 as determined by the department, the psilocybin service 16 facilitator shall certify, in a form and manner prescribed 17 by the department, that the client completed the integration 18 session. 19 8. A licensee or licensee representative may refuse to 20 provide psilocybin services or cease providing psilocybin 21 services to a client at the licensee’s or licensee 22 representative’s discretion. However, a psilocybin service 23 center or a psilocybin service facilitator shall not 24 cease providing psilocybin services to a client during 25 an administration session after the client has consumed a 26 psilocybin product, except in the case of an emergency or as 27 provided for by the department by rule. 28 9. A licensee representative or a psilocybin service 29 facilitator shall not disclose any information that may be used 30 to identify a client or any communication made by a client 31 during the course of providing psilocybin services or selling 32 psilocybin products to the client, unless any of the following 33 applies: 34 a. The client, or the client’s legal guardian or 35 -29- LSB 2408HH (6) 89 pf/rh 29/ 39
H.F. 636 representative, provides consent to the disclosure. 1 b. The client initiates legal action or makes a complaint 2 against the psilocybin service center, the psilocybin service 3 facilitator, or a licensee representative. 4 c. The communication reveals the intent to commit a crime 5 resulting in harm to the client or others. 6 d. The communication reveals that a minor may have been a 7 victim of a crime or physical, sexual, or emotional abuse or 8 neglect. 9 e. In response to an inquiry by the department made during 10 the course of an investigation into the conduct of a psilocybin 11 service center, a psilocybin service facilitator, or a licensee 12 representative. 13 Sec. 20. NEW SECTION . 124F.17 Inspection of records and 14 premises —— notice. 15 1. The department may request a review of the records of a 16 licensee for the purpose of determining compliance with this 17 chapter. The department shall provide a licensee with notice 18 forty-eight hours prior to inspecting the licensee’s records. 19 The department shall not require the records of a licensee to 20 be maintained on the licensee’s premises. 21 2. The department may at any time inspect the premises of a 22 licensee for compliance with this chapter. 23 Sec. 21. NEW SECTION . 124F.18 Prohibitions. 24 1. A person shall not make false representations or 25 statements to the department in order to induce or prevent 26 action by the department. 27 2. A licensee shall not maintain a noisy, lewd, disorderly, 28 or unsanitary premises or supply adulterated or otherwise 29 harmful psilocybin products. 30 3. A licensee shall not misrepresent to a person or to the 31 public any psilocybin products. 32 Sec. 22. NEW SECTION . 124F.19 General liability insurance. 33 As necessary to protect the public health, safety, and 34 welfare, the department may require a licensee to maintain 35 -30- LSB 2408HH (6) 89 pf/rh 30/ 39
H.F. 636 general liability insurance coverage in an amount that the 1 department determines is reasonably affordable and available 2 for the purpose of protecting the licensee against damages 3 resulting from a cause of action related to activities carried 4 out in accordance with the particular license held by the 5 licensee. 6 Sec. 23. NEW SECTION . 124F.20 Investigation and enforcement 7 —— disciplinary action. 8 1. The department may proceed with any investigation of, 9 or any action or disciplinary proceeding against, a licensee 10 or licensee representative or revise or render void an order 11 suspending or revoking a license or permit. In cases involving 12 the proposed denial of a license or permit, the applicant for 13 licensure or permitting shall not withdraw the application. 14 2. In addition to any other disciplinary action that may be 15 available to the department, the department shall immediately 16 restrict, suspend, or refuse to renew a license or permit 17 issued under this chapter if circumstances create probable 18 cause for the department to determine that a licensee or 19 licensee representative has purchased or received a psilocybin 20 product from an unlicensed source or that a licensee or 21 licensee representative has stored, manufactured, transported, 22 delivered, sold, or transferred a psilocybin product in a 23 manner that is prohibited by the license or permit. 24 Sec. 24. NEW SECTION . 124F.21 Enforceability of contracts. 25 A contract is not unenforceable on the basis that 26 possessing, manufacturing, transporting, delivering, 27 distributing, dispensing, selling, or using psilocybin products 28 is prohibited by federal law. 29 Sec. 25. NEW SECTION . 124F.22 Protections for licensee 30 representatives. 31 It is an unlawful employment practice for a licensee to 32 discharge, demote, suspend, or in any manner discriminate 33 or retaliate against a licensee representative with regard 34 to promotion, compensation, or other terms, conditions, 35 -31- LSB 2408HH (6) 89 pf/rh 31/ 39
H.F. 636 or privileges of employment on the basis that the licensee 1 representative has in good faith reported information to 2 the department that the licensee representative believes is 3 evidence of a violation of this chapter. 4 Sec. 26. NEW SECTION . 124F.23 Rights of deceased, 5 insolvent, or bankrupt persons or licensees. 6 The department may, by rule or order, provide for the 7 manner and conditions under which psilocybin products left 8 by a deceased, insolvent, or bankrupt person or licensee 9 are subject to a security interest, may be foreclosed, sold 10 under execution, or otherwise disposed of. The business 11 of a deceased, insolvent, or bankrupt person or licensee 12 may be operated for a reasonable period after the death, 13 insolvency, or bankruptcy. An obligor may continue to operate 14 at a premises for a reasonable period after default on the 15 indebtedness by the debtor. 16 Sec. 27. NEW SECTION . 124F.24 Tracking system for 17 psilocybin products. 18 1. The department shall develop and maintain a computer 19 software tracking system to track the transfer of psilocybin 20 products between premises. 21 2. The purposes of the computer software tracking system 22 include all of the following: 23 a. Preventing the diversion of psilocybin products to other 24 states. 25 b. Preventing persons from substituting or tampering with 26 psilocybin products. 27 c. Ensuring an accurate accounting of the production, 28 processing, and sale of psilocybin products. 29 d. Ensuring that test results from a psilocybin testing 30 laboratory are accurately reported. 31 e. Ensuring compliance with this chapter and any other 32 law of this state that authorizes the department to regulate 33 psilocybin. 34 3. At a minimum, the tracking system shall be capable of 35 -32- LSB 2408HH (6) 89 pf/rh 32/ 39
H.F. 636 tracking all of the following: 1 a. The manufacturing of psilocybin products. 2 b. The sale of psilocybin products by a psilocybin service 3 center to a client. 4 c. The sale and purchase of psilocybin products between 5 licensees. 6 d. The transfer of psilocybin products between premises. 7 e. Any other information that the department determines 8 is reasonably necessary to accomplish the department’s duties 9 under this chapter. 10 Sec. 28. NEW SECTION . 124F.25 Sale or delivery of 11 psilocybin products —— penalties. 12 1. A licensee or licensee representative shall not sell 13 or deliver a psilocybin product to a person younger than 14 twenty-one years of age in this state. 15 2. Prior to selling or delivering a psilocybin product to 16 a person in this state, a licensee or licensee representative 17 shall require the person to produce one of the following forms 18 of identification: 19 a. A valid driver’s license issued by this state or another 20 state. 21 b. A valid United States passport. 22 c. A valid military identification card. 23 d. A valid identification card issued by a federally 24 recognized Indian tribe. 25 e. Any other valid identification card issued by a state or 26 territory of the United States that bears a picture, name, date 27 of birth, and physical description of the person. 28 3. A person shall not produce a form of identification that 29 misrepresents the person or the person’s age. 30 4. A person who violates this section commits a simple 31 misdemeanor. 32 5. If a form of identification is offered as evidence in 33 any administrative or criminal proceeding involving a licensee 34 or licensee representative for the sale or delivery of a 35 -33- LSB 2408HH (6) 89 pf/rh 33/ 39
H.F. 636 psilocybin product to a person younger than twenty-one years 1 of age, the licensee or licensee representative shall not be 2 guilty of any offense prohibiting the sale or delivery of a 3 psilocybin product to a person younger than twenty-one years of 4 age unless it is demonstrated that a reasonable person would 5 have determined that the form of identification exhibited by 6 the person younger than twenty-one years of age was altered or 7 that the form of identification exhibited by the person younger 8 than twenty-one years of age did not accurately describe the 9 person to whom the psilocybin product was sold or delivered. 10 Sec. 29. NEW SECTION . 124F.26 Tax on the sale of psilocybin 11 products. 12 1. An additional tax shall not be imposed upon the sale 13 of psilocybin products which exceeds the sales tax rate. 14 The sales tax shall be collected by a psilocybin product 15 manufacturing facility at the point of sale of a psilocybin 16 product or by a psilocybin service center when a psilocybin 17 product is sold. 18 2. A psilocybin service center shall not discount a 19 psilocybin product or offer a psilocybin product at no cost if 20 the sale of the psilocybin product is made in conjunction with 21 the sale of any other item or service. 22 Sec. 30. NEW SECTION . 124F.27 Delivery of psilocybin 23 products. 24 1. A psilocybin product manufacturing facility that is 25 licensed under this chapter may deliver psilocybin products 26 only to or on a premises. 27 2. A psilocybin service center and a psilocybin service 28 facilitator that is licensed under this chapter may do any of 29 the following: 30 a. Deliver psilocybin products only to or on a premises. 31 b. Receive psilocybin products only from a psilocybin 32 product manufacturing facility or a psilocybin service center. 33 3. The sale of psilocybin products to a client by a 34 psilocybin service center or a psilocybin service facilitator 35 -34- LSB 2408HH (6) 89 pf/rh 34/ 39
H.F. 636 shall be restricted to the premises. 1 4. Notwithstanding subsection 2, the department may 2 adopt rules to allow for delivery of psilocybin products to a 3 client’s residence. 4 Sec. 31. NEW SECTION . 124F.28 Persons younger than 5 twenty-one years of age on premises. 6 1. Except as authorized by the department by rule, or as 7 necessary in the case of an emergency, a person younger than 8 twenty-one years of age shall not enter or attempt to enter any 9 portion of the premises of a psilocybin product manufacturing 10 facility or psilocybin service center. A person who violates 11 this section commits an aggravated misdemeanor. 12 2. Subsection 1 does not apply to a person younger than 13 twenty-one years of age who is any of the following: 14 a. Temporarily at the premises to make a service, 15 maintenance, or repair call or for other purposes independent 16 of the operations of the premises. 17 b. Acting under the direction of the department or state or 18 local law enforcement agencies for the purpose of investigating 19 possible violations of laws prohibiting sales of psilocybin 20 products to persons younger than twenty-one years of age. 21 c. Acting under the direction of a licensee for the purpose 22 of investigating possible violations of laws prohibiting sales 23 of psilocybin products to persons younger than twenty-one years 24 of age by licensee representatives. 25 3. a. A person younger than twenty-one years of age is not 26 in violation of, and is immune from prosecution under, this 27 section if the person meets any of the following criteria: 28 (1) The person contacted emergency medical services or a law 29 enforcement agency in order to obtain medical assistance for 30 another person who was in need of medical assistance because 31 that person consumed a psilocybin product. 32 (2) The person was in need of medical assistance because 33 the person consumed a psilocybin product and the evidence of 34 the violation was obtained as a result of the person seeking or 35 -35- LSB 2408HH (6) 89 pf/rh 35/ 39
H.F. 636 obtaining such medical assistance. 1 b. Paragraph “a” shall not exclude the use of evidence 2 obtained as a result of a person seeking or obtaining medical 3 assistance in proceedings for crimes or offenses other than a 4 violation of this section. 5 Sec. 32. NEW SECTION . 124F.29 Investigations, arrests, 6 prosecutions, and convictions for offenses involving psilocybin 7 —— duty to notify. 8 1. The department of public safety shall make the 9 investigation and arrest of persons eighteen years of age 10 or older engaged in noncommercial planting, cultivating, 11 purchasing, transporting, distributing, engaging in practices 12 with, or possessing entheogenic plants and fungi one of its 13 lowest enforcement priorities. 14 2. The attorney general shall cease prosecution of 15 residents of the state for noncommercial planting, cultivating, 16 purchasing, transporting, distributing, engaging in practices 17 with, or possessing entheogenic plants and fungi. 18 3. A law enforcement officer may enforce this section and 19 assist the department in detecting violations of this section 20 and apprehending offenders. A law enforcement officer who has 21 notice, knowledge, or reasonable suspicion of a violation of 22 this section shall immediately notify the department. 23 4. The district courts, district attorneys, and municipal 24 authorities shall, immediately upon the conviction of a 25 licensee or licensee representative for a violation of this 26 section or any other law, notify the department of such 27 conviction. 28 Sec. 33. NEW SECTION . 124F.30 Immunity. 29 An agent or employee of the department shall not incur civil 30 liability and is considered an employee of the state for the 31 purposes of chapter 669 in performing any duty in accordance 32 with this chapter or any other law requiring the department to 33 perform any duty related to psilocybin products. 34 Sec. 34. NEW SECTION . 124F.31 Preemption. 35 -36- LSB 2408HH (6) 89 pf/rh 36/ 39
H.F. 636 The provisions of this chapter are intended to operate 1 uniformly throughout the state and shall expressly preempt the 2 regulation of psilocybin products and services in the state and 3 supersede any municipal or county ordinance on the subject. 4 Sec. 35. NEW SECTION . 124F.32 Application of chapter —— 5 severability. 6 1. This chapter shall not be construed to do any of the 7 following: 8 a. Require a federal or state government medical assistance 9 program or private health insurer to reimburse a person for 10 costs associated with the use of psilocybin products. 11 b. Amend or affect state or federal law pertaining to 12 employment matters. 13 c. Amend or affect state or federal law pertaining to 14 landlord-tenant matters. 15 d. Prohibit a recipient of a federal grant or an applicant 16 for a federal grant from prohibiting the possession, 17 manufacturing, transportation, delivery, sale, or use of 18 psilocybin products to the extent necessary to satisfy federal 19 requirements for the grant. 20 e. Prohibit a party to a federal contract or a person 21 applying to be a party to a federal contract from prohibiting 22 the possession, manufacturing, transportation, delivery, sale, 23 or use of psilocybin products to the extent necessary to comply 24 with the terms and conditions of the contract or to satisfy 25 federal requirements for the contract. 26 f. Require a person to violate a federal law. 27 2. If any provision of this chapter or its application to 28 any person or circumstance is held invalid, the invalidity does 29 not affect other provisions or applications of the chapter 30 which can be given effect without the invalid provision or 31 application, and to this end the provisions of this chapter are 32 severable. 33 EXPLANATION 34 The inclusion of this explanation does not constitute agreement with 35 -37- LSB 2408HH (6) 89 pf/rh 37/ 39
H.F. 636 the explanation’s substance by the members of the general assembly. 1 This bill relates to psilocybin, including the creation 2 of the psilocybin services Act, to, in part, provide for 3 administration of psilocybin products to individuals 21 years 4 of age and older in the state. Psilocybin is defined as a 5 hallucinogenic compound obtained from P. cubensis mushrooms. 6 The bill provides definitions used in the bill and the 7 purposes of the bill. The bill provides for a one-year program 8 development period beginning January 1, 2022, and ending not 9 later than December 31, 2022; requires the department of public 10 health (DPH) to prescribe forms and adopt rules necessary for 11 the administration of the Code chapter no later than January 12 1, 2023; and requires DPH to begin receiving applications for 13 licensure of the various entities involved under the bill by 14 February 1, 2023. 15 The bill establishes the duties of DPH including licensing 16 the entities required to be licensed to perform the various 17 activities under the Code chapter; determination of the 18 qualifications, education, training, and examination 19 requirements of these entities; labeling and packaging 20 requirements for psilocybin products; penalties; and 21 enforcement. The bill also creates a psilocybin advisory board 22 tasked with making recommendations to DPH and providing general 23 oversight of the provisions of the bill. 24 The bill includes application and licensing provisions for 25 psilocybin product manufacturing facilities, psilocybin service 26 centers, psilocybin service facilitators, and psilocybin 27 testing laboratories; provisions for the permitting of licensee 28 representatives; and provisions relating to the operation of 29 the various entities. A licensee or licensee representative 30 who sells or delivers a psilocybin product to a person under 31 21 years of age is guilty of a simple misdemeanor. A simple 32 misdemeanor is punishable by confinement for no more than 30 33 days and a fine of at least $105 but not more than $855. 34 The bill also provides for application of the Code chapter 35 -38- LSB 2408HH (6) 89 pf/rh 38/ 39
H.F. 636 and a severability provision. 1 The bill also exempts psilocybin from the application of 2 Code chapter 124 (controlled substances) when manufactured, 3 planted, cultivated, grown, harvested, produced, prepared, 4 propagated, compounded, converted, processed, handled, 5 transported, delivered, marketed, distributed, possessed, 6 administered, consumed, tested, or otherwise used in accordance 7 and compliance with the bill. 8 -39- LSB 2408HH (6) 89 pf/rh 39/ 39