House File 620 - Introduced HOUSE FILE 620 BY WILLS A BILL FOR An Act relating to the production of psilocybin and the 1 administration of psilocybin to persons with post-traumatic 2 stress disorder, and providing penalties. 3 BE IT ENACTED BY THE GENERAL ASSEMBLY OF THE STATE OF IOWA: 4 TLSB 1463HH (6) 91 ss/ko
H.F. 620 Section 1. Section 124.401, subsection 5, Code 2025, is 1 amended by adding the following new paragraph: 2 NEW PARAGRAPH . g. A person may knowingly or intentionally 3 recommend, possess, use, dispense, deliver, transport, or 4 administer psilocybin if the recommendation, possession, use, 5 dispensing, delivery, transporting, or administering is in 6 accordance with the provisions of chapter 124F. 7 Sec. 2. NEW SECTION . 124F.1 Definitions. 8 For the purposes of this chapter, unless the context 9 otherwise requires: 10 1. Active psilocybin means the psychoactive chemical with 11 the chemical abstracts service registry number 520-52-5. 12 2. Adulterant means a poisonous or deleterious substance 13 in a quantity that may be injurious to health. 14 3. Adverse event means an injury or suspected injury to 15 a patient that results in an escalation of care, harm to a 16 patient, or rescue of a patient and occurs during a psilocybin 17 administration session or within twenty-four hours from when 18 the administration session ended. 19 4. Community location means a public or private elementary 20 or secondary school, a church, a public library, a public 21 playground, or a public park. 22 5. Cultivation space means, quantified in square feet, 23 the horizontal area in which a psilocybin cultivation facility 24 cultivates psilocybin, including each level of horizontal area 25 if the psilocybin cultivation facility hangs, suspends, stacks, 26 or otherwise positions plants above other plants in multiple 27 levels. 28 6. Department means the department of health and human 29 services. 30 7. Family member means a parent, stepparent, spouse, 31 child, sibling, stepsibling, uncle, aunt, nephew, niece, 32 first cousin, mother-in-law, father-in-law, brother-in-law, 33 sister-in-law, son-in-law, daughter-in-law, grandparent, or 34 grandchild. 35 -1- LSB 1463HH (6) 91 ss/ko 1/ 45
H.F. 620 8. Independent psilocybin testing laboratory means a person 1 that does any of the following: 2 a. Conducts a chemical or other analysis of psilocybin or a 3 psilocybin product. 4 b. Acquires, possesses, and transports psilocybin or a 5 psilocybin product with the intent to conduct a chemical or 6 other analysis of the psilocybin or psilocybin product. 7 9. Independent psilocybin testing laboratory agent 8 means an individual who holds a valid psilocybin production 9 establishment agent registration card with a psilocybin testing 10 laboratory designation. 11 10. Inventory control system means a system described in 12 section 124F.2. 13 11. Licensing board means the psilocybin production 14 establishment licensing board created pursuant to section 15 124F.4. 16 12. Patient means an individual for whom a qualified 17 medical psilocybin provider recommends psilocybin. 18 13. Payment provider means an entity that contracts with 19 a psilocybin production establishment to facilitate transfer 20 of funds between the establishment and another business or 21 individual. 22 14. Psilocybin means a fresh mushroom containing 23 psilocybin or psilocin. 24 15. Psilocybin administration session means the time 25 period from when a qualified medical provider administers 26 psilocybin to a patient to the time the patient leaves the 27 qualified therapy provider location. 28 16. Psilocybin biomass means any part of a 29 psilocybin-containing fungus. 30 17. Psilocybin byproduct means any part of a 31 psilocybin-containing mushroom which is not used or intended 32 for sale. 33 18. Psilocybin cultivation facility means a person that 34 possesses psilocybin, grows or intends to grow psilocybin, and 35 -2- LSB 1463HH (6) 91 ss/ko 2/ 45
H.F. 620 sells or intends to sell psilocybin to a qualified therapy 1 provider. 2 19. Psilocybin cultivation facility agent means 3 an individual who holds a valid psilocybin production 4 establishment agent registration card with a cultivation 5 facility designation. 6 20. Psilocybin product means any portion of a 7 psilocybin-containing mushroom that has been dried and is 8 intended for oral consumption by a patient. 9 21. Psilocybin production establishment or establishment 10 means a psilocybin cultivation facility or an independent 11 psilocybin testing laboratory. 12 22. Psilocybin production establishment agent registration 13 card means a registration card issued by the department that 14 authorizes an individual to act as a psilocybin production 15 establishment agent, and that designates the type of psilocybin 16 production establishment for which an individual is authorized 17 to act as an agent. 18 23. Qualified medical psilocybin provider means a 19 physician and surgeon or osteopathic physician and surgeon 20 licensed pursuant to chapter 148, a physician assistant 21 licensed pursuant to chapter 148C, an advanced registered 22 nurse practitioner licensed under chapter 152, or an advanced 23 practice registered nurse under chapter 152E, who is registered 24 by the department under section 124F.24 to recommend treatment 25 with psilocybin. 26 24. Qualified therapy provider means a physician and 27 surgeon or osteopathic physician and surgeon licensed pursuant 28 to chapter 148, a physician assistant licensed pursuant 29 to chapter 148C, an advanced registered nurse practitioner 30 licensed under chapter 152, an advanced practice registered 31 nurse under chapter 152E, a psychologist licensed pursuant 32 to chapter 154B, or a social worker licensed pursuant to 33 chapter 154C who is registered by the department to administer 34 treatment with psilocybin. 35 -3- LSB 1463HH (6) 91 ss/ko 3/ 45
H.F. 620 25. Qualified therapy provider agent means an individual 1 who holds a valid qualified therapy provider agent registration 2 card. 3 26. Qualified therapy provider agent registration card 4 means a registration card issued by the department that 5 authorizes an individual to act as a qualified therapy provider 6 agent. 7 27. Qualified therapy provider location or provider 8 location means a facility with all of the following: 9 a. A single, secure public entrance. 10 b. A security system with a backup power source that detects 11 and records entry and provides notice of an unauthorized entry 12 to law enforcement when the facility is closed. 13 c. A lock or equivalent restrictive security feature on any 14 area where the psilocybin or psilocybin product is stored at 15 the facility. 16 Sec. 3. NEW SECTION . 124F.2 Inventory control system. 17 1. Each psilocybin production establishment and qualified 18 therapy provider shall maintain an inventory control system 19 that meets all of the requirements of this section. 20 2. An inventory control system shall do all of the 21 following: 22 a. Track, in real time, psilocybin and psilocybin product 23 using a unique identifier from the time psilocybin is ready to 24 be harvested. 25 b. Maintain in real time a record of the amount of 26 psilocybin or psilocybin product in the possession of the 27 establishment or provider. 28 c. Include a video recording system that is tamper proof and 29 does all of the following: 30 (1) Tracks all handling and processing of psilocybin or 31 psilocybin product in the establishment or provider location. 32 (2) Stores each video record for at least forty-five days. 33 3. A psilocybin production establishment or qualified 34 therapy provider shall allow the department, or a financial 35 -4- LSB 1463HH (6) 91 ss/ko 4/ 45
H.F. 620 institution designated by the department, to validate 1 transactions to access the inventory control system at any 2 time. 3 4. The department shall adopt rules pursuant to chapter 4 17A to implement this section, and the rules shall include 5 requirements for aggregate or batch records regarding the 6 planting and propagation of psilocybin before being tracked, 7 and which may include compatibility standards for inventory 8 control systems. 9 Sec. 4. NEW SECTION . 124F.3 Notice to prospective and 10 current public employees. 11 Prior to giving a current employee an assignment or duty that 12 arises from or directly relates to an obligation under this 13 chapter, or hiring a prospective employee whose assignments or 14 duties would include an assignment or duty that arises from or 15 directly relates to an obligation under this chapter, a state 16 employer or a political subdivision employer shall give the 17 employee or prospective employee a written notice that the 18 employees or prospective employees job duties may require the 19 employee or prospective employee to engage in conduct which is 20 in violation of the criminal laws of the United States. 21 Sec. 5. NEW SECTION . 124F.4 Psilocybin production 22 establishment licensing board. 23 1. a. There is created within the department the psilocybin 24 production establishment licensing board. The board shall 25 consist of the following members, appointed by the director of 26 the department: 27 (1) One member of the public with knowledge of psilocybin. 28 (2) One member with knowledge and experience in the 29 pharmaceutical or nutraceutical manufacturing industry. 30 (3) One member representing law enforcement. 31 (4) One member who is a chemist or researcher with 32 experience in manufacturing and who is associated with a 33 research university. 34 (5) One member who has a background in fungus or mushroom 35 -5- LSB 1463HH (6) 91 ss/ko 5/ 45
H.F. 620 cultivation and processing. 1 (6) The director or the directors designee, who shall serve 2 as the chairperson of the board and as a nonvoting member, 3 except to cast a deciding vote in the event of a tie. 4 b. A person is ineligible for appointment to the board if 5 any of the following apply: 6 (1) The person has any commercial or ownership interest in a 7 psilocybin production establishment. 8 (2) The person is associated with a business that has an 9 owner, officer, director, or employee whose family member 10 holds a license or has an interest in a psilocybin production 11 establishment. 12 (3) The person is employed or contracted to lobby on behalf 13 of a psilocybin production establishment. 14 c. The director shall ensure that no two members of the 15 board are employed by or represent the same business or 16 nonprofit organization. 17 d. Members of the board shall serve a term of four years, 18 except that initial members of the board shall be appointed 19 for staggered terms such that the director appoints two or 20 three board members every two years. The director shall fill a 21 vacancy on the board for the balance of the unexpired term. 22 e. The director may remove a member of the board for cause, 23 neglect of duty, inefficiency, or malfeasance. 24 f. Members of the board shall serve without compensation but 25 may be reimbursed for actual expenses. 26 2. The board shall meet as called by the chairperson to do 27 all of the following: 28 a. Review each license application for compliance with this 29 chapter and rules adopted by the department. 30 b. Conduct a public hearing to consider a license 31 application. 32 c. Make a determination on a license application. 33 3. The board shall hold a public hearing to review 34 a psilocybin production establishments license if the 35 -6- LSB 1463HH (6) 91 ss/ko 6/ 45
H.F. 620 establishment changes ownership interest by more than twenty 1 percent, changes location, or as necessary based on the 2 recommendation of the department. 3 4. The board shall meet annually in December to consider 4 psilocybin production establishment license renewal 5 applications. A representative from each applicant for renewal 6 shall attend the meeting. The board shall consider the amount 7 of biomass the applicant produces, the amount of biomass the 8 applicant projects to produce, the current square footage of 9 growing area the applicant uses, and the square footage of 10 growing area the applicant projects to use. 11 5. The board is not subject to dissolution pursuant to 12 section 4A.5. 13 Sec. 6. NEW SECTION . 124F.5 Psilocybin production 14 establishment license. 15 1. A person shall not operate a psilocybin production 16 establishment unless the person holds a psilocybin production 17 establishment license issued by the licensing board pursuant to 18 this chapter. 19 2. The department shall adopt rules pursuant to chapter 17A 20 to develop a process for soliciting and evaluating applications 21 for a psilocybin production establishment license. 22 3. An applicant for a psilocybin production establishment 23 license shall submit all of the following: 24 a. The proposed name of the establishment and the address 25 where the establishment will be located. 26 b. The name and address of any individual who has any of the 27 following: 28 (1) For a publicly traded company, a financial or voting 29 interest of two percent or greater in the proposed psilocybin 30 production establishment. 31 (2) For a privately held company, a financial or voting 32 interest in the proposed psilocybin production establishment. 33 (3) The power to direct the management or control of the 34 proposed psilocybin production establishment. 35 -7- LSB 1463HH (6) 91 ss/ko 7/ 45
H.F. 620 c. An operating plan, approved by the department, that 1 complies with section 124F.8 and any laws that the municipality 2 or county in which the person is located adopts regarding the 3 operation of psilocybin production establishments. 4 d. A statement that the applicant will obtain and maintain 5 a performance bond that a surety authorized to transact surety 6 business in this state issues in an amount of at least one 7 hundred thousand dollars for each psilocybin cultivation 8 facility license, or at least fifty thousand dollars for each 9 independent psilocybin testing laboratory license. 10 e. An application fee in an amount determined by the 11 department. 12 f. A description of any investigatory or adverse action 13 taken by a licensing jurisdiction, government agency, law 14 enforcement agency, or court in any state for any violation 15 or detrimental conduct in relation to any of the applicants 16 psilocybin-related operations or businesses. 17 4. A psilocybin production establishment shall not be 18 located within one thousand feet of a community location or 19 in or within five hundred feet of an area that is zoned as 20 primarily residential. The board may grant a waiver to reduce 21 the proximity requirements in this subsection by up to twenty 22 percent if the board determines that it is not reasonably 23 feasible for the applicant to site the proposed psilocybin 24 production establishment without the waiver. 25 5. Upon the approval of an application for a license under 26 this section, the applicant shall pay to the department the 27 initial licensing fee, as determined by the department by rule, 28 and the department shall inform the department of public safety 29 of the license approval. 30 6. A psilocybin production establishment may be located 31 at the same location as a medical cannabidiol manufacturer 32 licensed pursuant to section 124E.6 if a separate license is 33 obtained for each. 34 7. If the licensing board receives more than one application 35 -8- LSB 1463HH (6) 91 ss/ko 8/ 45
H.F. 620 for a psilocybin production establishment within the same city 1 or town, the licensing board shall consult with the local 2 land use authority before approving any of the applications 3 pertaining to that city or town. 4 8. The licensing board shall not issue a license to operate 5 an independent psilocybin testing laboratory to any of the 6 following persons: 7 a. A person who holds a license or has an ownership interest 8 to operate a psilocybin cultivation facility. 9 b. A person who has an owner, officer, director, or employee 10 whose family member holds a license or has an ownership 11 interest in a psilocybin cultivation facility. 12 c. A person who has an ownership interest in a psilocybin 13 cultivation facility. 14 9. The licensing board shall not issue a license to operate 15 a psilocybin production establishment to an applicant if an 16 individual described in subsection 3, paragraph b , has been 17 convicted of a misdemeanor for drug distribution, or convicted 18 of a felony, or is younger than twenty-one years old. 19 10. The licensing board may, at the discretion of the 20 licensing board, grant preference to an applicant who currently 21 holds a medical cannabidiol manufacturer license issued 22 pursuant to section 124E.6. 23 11. The licensing board may revoke a license issued pursuant 24 to this section if any of the following apply: 25 a. The psilocybin production establishment does not 26 begin operations within one year after the date on which the 27 licensing board issues the initial license. 28 b. An individual psilocybin production establishment 29 operated by the licensee has violated the same provision of 30 this chapter three times. 31 c. An individual described in subsection 3, paragraph b , 32 is convicted of a misdemeanor for drug distribution, or is 33 convicted of a felony. 34 d. The licensee fails to cooperate with an investigation 35 -9- LSB 1463HH (6) 91 ss/ko 9/ 45
H.F. 620 of the psilocybin production establishment conducted by the 1 licensing board. 2 e. The psilocybin production establishment demonstrates 3 a willful or reckless disregard for the requirements of this 4 chapter or the rules of the department. 5 f. The licensing board determines that the psilocybin 6 production establishment no longer meets the minimum standards 7 for licensure and operation of the psilocybin production 8 establishment. 9 g. For an independent psilocybin testing laboratory, 10 the independent psilocybin testing laboratory fails to 11 substantially meet the performance standards adopted by the 12 department by rule. 13 12. If the municipality or county where the licensed 14 psilocybin production establishment will be located requires 15 a local land use permit, a person who is issued a psilocybin 16 production establishment license under this chapter shall 17 submit to the licensing board a copy of the licensees approved 18 land use permit within one hundred twenty days after the date 19 on which the licensing board issues the license. 20 13. The department shall deposit fees imposed under this 21 section into the general fund of the state. 22 14. The department shall begin accepting applications under 23 this chapter on July 1, 2026. 24 15. The licensing boards authority to issue a license under 25 this section shall be plenary and not subject to review. 26 16. The licensing board shall not issue more than four 27 licenses to operate an independent psilocybin testing 28 laboratory. 29 17. The department may operate or partner with a research 30 university to operate an independent psilocybin testing 31 laboratory. 32 18. A psilocybin production establishment license shall not 33 be transferable or assignable. 34 19. If ownership of a psilocybin production establishment 35 -10- LSB 1463HH (6) 91 ss/ko 10/ 45
H.F. 620 changes by fifty percent or more, the psilocybin production 1 establishment shall submit a new application pursuant to this 2 section. 3 Sec. 7. NEW SECTION . 124F.6 Psilocybin production 4 establishment owners and directors criminal background checks. 5 1. The division of criminal investigation of the department 6 of public safety shall conduct a thorough investigation of 7 each applicant for a psilocybin production establishment 8 license as in a substantially similar manner as provided in 9 section 124E.19. The division shall report the results of the 10 investigation to the department. 11 2. The department shall collect a fee from the applicant, 12 determined by the department by rule, to cover the costs of the 13 investigation by the division of criminal investigation of the 14 department of public safety. The department shall remit the 15 fee to the division. 16 Sec. 8. NEW SECTION . 124F.7 License renewal. 17 The licensing board shall renew a license issued pursuant 18 to section 124F.5 on an annual basis if all of the following 19 apply: 20 1. The licensee meets all of the requirements for initial 21 licensure. 22 2. The licensing board does not identify a significant 23 failure of compliance with this chapter or grounds for 24 revocation. 25 3. The licensee pays a renewal fee as determined by the 26 department by rule. 27 Sec. 9. NEW SECTION . 124F.8 Operating plan. 28 A person applying for a psilocybin production establishment 29 license or license renewal shall submit to the department for 30 the departments review a proposed operating plan that includes 31 all of the following: 32 1. A description of the physical characteristics of the 33 proposed facility or, for a psilocybin cultivation facility, no 34 more than two facility locations, including a floor plan and an 35 -11- LSB 1463HH (6) 91 ss/ko 11/ 45
H.F. 620 architectural elevation. 1 2. A description of the credentials and experience of 2 each officer, director, and owner of the proposed psilocybin 3 production establishment, and of any highly skilled or 4 experienced prospective employee. 5 3. The psilocybin production establishments employee 6 training standards. 7 4. A security plan. 8 5. A description of the psilocybin production 9 establishments inventory control system. 10 6. Storage protocols to ensure that psilocybin is stored in 11 a manner that is sanitary and preserves the integrity of the 12 psilocybin. 13 7. For a psilocybin cultivation facility: 14 a. Psilocybin cultivation practices, including the 15 facilitys intended pesticide and fertilizer use. 16 b. Square footage under cultivation and anticipated 17 psilocybin yield. 18 8. For an independent psilocybin testing laboratory: 19 a. Psilocybin and psilocybin product testing capacity. 20 b. Psilocybin and psilocybin product testing equipment. 21 c. Testing methods, standards, practices, and procedures for 22 testing psilocybin or psilocybin product. 23 Sec. 10. NEW SECTION . 124F.9 Psilocybin cultivation 24 facilities number of licenses. 25 The licensing board shall not issue more than two licenses to 26 operate a psilocybin cultivation facility. If the recipient 27 of a license ceases operations for any reason, or otherwise 28 abandons the license, the board may grant the abandoned license 29 to another applicant. 30 Sec. 11. NEW SECTION . 124F.10 Psilocybin production 31 establishment agent registration. 32 1. An individual shall not act as a psilocybin production 33 establishment agent unless the department registers the 34 individual as a psilocybin production establishment agent, 35 -12- LSB 1463HH (6) 91 ss/ko 12/ 45
H.F. 620 regardless of whether the individual is a seasonal, temporary, 1 or permanent employee. 2 2. None of the following individuals shall serve as a 3 psilocybin production establishment agent, have a financial 4 or voting interest of two percent or greater in a psilocybin 5 production establishment, or have the power to direct or 6 cause the management or control of a psilocybin production 7 establishment: 8 a. An advanced registered nurse practitioner licensed under 9 chapter 152 or an advanced practice registered nurse under 10 chapter 152E. 11 b. An individual licensed under chapter 148 to practice 12 medicine and surgery or osteopathic medicine and surgery. 13 c. A physician assistant licensed under chapter 148C. 14 3. An independent psilocybin testing laboratory agent may 15 not act as a psilocybin cultivation facility agent. 16 4. The department shall, within fifteen business days 17 from the date on which the department receives a complete 18 application from a psilocybin production establishment on 19 behalf of a prospective psilocybin production establishment 20 agent, register and issue a psilocybin production establishment 21 agent registration card to the prospective psilocybin 22 production establishment agent who successfully passes a 23 criminal background investigation as provided in section 124F.6 24 if the psilocybin production establishment does all of the 25 following: 26 a. Provides to the department the prospective psilocybin 27 production establishment agents name and address. 28 b. Pays a fee to the department in an amount determined by 29 the department by rule. 30 5. The department shall designate, on an individuals 31 psilocybin production establishment agent registration card, 32 the type of psilocybin production establishment for which the 33 individual is authorized to act as an agent. 34 6. a. A psilocybin production establishment agent shall 35 -13- LSB 1463HH (6) 91 ss/ko 13/ 45
H.F. 620 comply with either a certification standard developed by the 1 department by rule, or a certification standard that the 2 department has reviewed and approved. 3 b. A certification standard described in paragraph a shall 4 include training in all of the following: 5 (1) Iowa medical psilocybin law. 6 (2) For a psilocybin cultivation facility agent, psilocybin 7 cultivation best practices. 8 (3) For an independent psilocybin testing laboratory agent, 9 psilocybin laboratory testing best practices. 10 7. A psilocybin production establishment agent registration 11 card shall expire two years from the date the department issued 12 the card. A psilocybin production establishment agent may 13 renew the agents registration card if the agent is still 14 eligible to hold a psilocybin production establishment agent 15 registration card and pays a fee determined by the department 16 by rule. 17 8. a. A psilocybin production establishment agent shall 18 carry the individuals psilocybin production card with the 19 agent at all times when the agent is on the premises of 20 a psilocybin production establishment where the agent is 21 registered, or when the agent is transporting psilocybin or 22 psilocybin product. 23 b. If a psilocybin production establishment agent possesses 24 psilocybin or psilocybin product and produces the registration 25 card while handling or transporting psilocybin or psilocybin 26 product, there is a rebuttable presumption that the agent 27 possesses the psilocybin or psilocybin product legally and 28 a law enforcement officer does not have probable cause, 29 based solely on the agents possession of the psilocybin or 30 psilocybin product, to believe that the individual is engaging 31 in illegal activity. 32 c. A psilocybin production establishment agent who fails to 33 carry the individuals psilocybin production card as required 34 by paragraph a is guilty of the following offenses: 35 -14- LSB 1463HH (6) 91 ss/ko 14/ 45
H.F. 620 (1) For a first offense, or second offense within a two-year 1 period, a simple misdemeanor punishable by a fine of one 2 hundred dollars. 3 (2) For a third or subsequent offense within a two-year 4 period, a simple misdemeanor punishable as provided by law. 5 d. For each violation of paragraph c , the department may 6 assess the relevant psilocybin production establishment a fine 7 of up to five thousand dollars. 8 Sec. 12. NEW SECTION . 124F.11 Psilocybin production 9 establishment general operation requirements. 10 1. A psilocybin production establishment shall operate in 11 accordance with the operating plan submitted by the psilocybin 12 production establishment pursuant to section 124F.8. A 13 psilocybin production establishment shall notify the department 14 prior to implementing a change to the establishments operating 15 plan. The department shall inform the establishment of any 16 deficiencies in the new operating plan. 17 2. a. Except as provided in paragraph b , a psilocybin 18 production establishment shall operate in a facility that 19 is accessible only by an individual with a valid psilocybin 20 production establishment agent registration card. 21 b. A psilocybin production establishment may authorize 22 an individual who is at least eighteen years of age and who 23 is not a psilocybin production establishment agent to access 24 the psilocybin production establishment if the psilocybin 25 production establishment tracks and monitors the individual at 26 all times while the individual is at the psilocybin production 27 establishment, and maintains a record of the individuals 28 access, including arrival and departure. 29 3. A psilocybin production establishment shall not employ 30 an individual who is younger than twenty-one years of age or 31 who has been convicted of a misdemeanor for drug distribution, 32 or convicted of a felony. 33 4. A psilocybin production establishment shall operate in a 34 facility that has all of the following: 35 -15- LSB 1463HH (6) 91 ss/ko 15/ 45
H.F. 620 a. A single, secure public entrance. 1 b. A security system with a backup power source that does 2 all of the following: 3 (1) Detects and records entry into the psilocybin 4 production establishment. 5 (2) Provides notice of an unauthorized entry to law 6 enforcement when the psilocybin production establishment is 7 closed. 8 (3) Secures any area where the psilocybin production 9 establishment stores psilocybin or a psilocybin product. 10 Sec. 13. NEW SECTION . 124F.12 Inspections. 11 1. The department may inspect the records and facility of a 12 psilocybin production establishment at any time during business 13 hours to determine if the psilocybin production establishment 14 complies with this chapter. 15 2. An inspection under this section may include all of the 16 following: 17 a. Inspection of a site, facility, vehicle, book, record, 18 paper, document, data, and other physical or electronic 19 information. 20 b. Questioning of any relevant individual. 21 c. Observation of an independent psilocybin testing 22 laboratorys methods, standards, practices, and procedures. 23 d. The sampling of a specimen of psilocybin or psilocybin 24 product sufficient for testing purposes. 25 e. Inspection of equipment, an instrument, a tool, or 26 machinery, including a container or label. 27 3. In conducting an inspection under this section, the 28 department may review and make copies of a book, record, paper, 29 document, data, or other physical or electrical information, 30 including financial data, sales data, shipping data, pricing 31 data, and employee data. 32 4. The department may impose a fee, or a license or 33 registration suspension or revocation, if a psilocybin 34 production establishment fails to comply with this section. 35 -16- LSB 1463HH (6) 91 ss/ko 16/ 45
H.F. 620 Sec. 14. NEW SECTION . 124F.13 Advertising. 1 1. A psilocybin production establishment shall not 2 advertise to the general public in any medium, except that a 3 psilocybin production establishment may advertise an employment 4 opportunity at the psilocybin production establishment. 5 2. The department shall adopt rules pursuant to chapter 17A 6 for standards relating to advertising by a qualified medical 7 psilocybin provider or qualified therapy provider. The rules 8 shall ensure that advertising by a qualified medical psilocybin 9 provider or qualified therapy provider does not imply that the 10 psilocybin may be used for recreational purposes. 11 Sec. 15. NEW SECTION . 124F.14 Psilocybin transportation. 12 1. No individual other than the following may transport 13 psilocybin or a psilocybin product: 14 a. A registered psilocybin production establishment agent. 15 b. A qualified therapy provider. 16 c. A registered qualified therapy provider agent. 17 d. An agent of the department conducting an inspection 18 pursuant to section 124F.12. 19 2. An individual transporting psilocybin or psilocybin 20 product shall be employed by the individual authorizing the 21 transportation and possess a manifest that includes all of the 22 following: 23 a. A unique identifier that links the psilocybin or 24 psilocybin product to a relevant inventory control system. 25 b. The origin and destination information for any psilocybin 26 or psilocybin product that the person is transporting. 27 c. The departure and arrival times of the individual 28 transporting the psilocybin or psilocybin product. 29 3. A registered psilocybin production establishment 30 agent transporting psilocybin or psilocybin product without 31 a manifest as provided in subsection 2 is guilty of a simple 32 misdemeanor punishable by a fine of one hundred dollars. 33 However, if the registered psilocybin production establishment 34 agent is carrying more psilocybin or psilocybin product than is 35 -17- LSB 1463HH (6) 91 ss/ko 17/ 45
H.F. 620 indicated on the manifest, other than a de minimis amount, the 1 registered psilocybin production establishment agent is subject 2 to penalties as provided in chapter 124. 3 4. This section shall not prohibit the department from 4 taking administrative enforcement action against a psilocybin 5 production establishment or another person for failing to make 6 a transport in compliance with this section. 7 Sec. 16. NEW SECTION . 124F.15 Psilocybin excess and 8 disposal. 9 1. As used in this section, psilocybin waste means waste 10 and unused material from the cultivation and production of 11 psilocybin or psilocybin product under this chapter. 12 2. A psilocybin production establishment shall do all of the 13 following: 14 a. Render psilocybin waste unusable and unrecognizable 15 before transporting it from the psilocybin production 16 establishment. 17 b. Dispose of the psilocybin waste in compliance with all 18 applicable state and federal laws. 19 3. A person shall not transport or dispose of psilocybin 20 waste other than as provided in this section. 21 Sec. 17. NEW SECTION . 124F.16 Psilocybin production 22 establishment local control. 23 1. A local government shall allow a psilocybin production 24 establishment to operate in any zone designated for industrial 25 use unless the local government has designated by ordinance 26 at least one industrial zone for the operation of psilocybin 27 production establishments before a person submits an 28 application for the establishment of a psilocybin production 29 establishment to the local government. 30 2. A local government shall allow a psilocybin production 31 establishment to operate in any zone designated for 32 agricultural use unless the local government has designated by 33 ordinance at least one agricultural zone for the operation of 34 psilocybin production establishments before a person submits an 35 -18- LSB 1463HH (6) 91 ss/ko 18/ 45
H.F. 620 application for the establishment of a psilocybin production 1 establishment to the local government. 2 3. A psilocybin production establishment may operate on 3 land that a local government has not zoned. 4 4. A local government shall not do any of the following: 5 a. Revoke from, or refuse to issue a license or permit to, 6 a psilocybin production establishment on the sole basis that 7 the applicant or psilocybin production establishment violates 8 federal law regarding the legal status of psilocybin. 9 b. Require a certain distance between a psilocybin 10 production establishment and another psilocybin production 11 establishment or a retail tobacco store as defined in section 12 142D.2. 13 c. Enforce an ordinance against a psilocybin production 14 establishment that was not in effect on the date the psilocybin 15 production establishment submitted a complete application to 16 the local government. 17 Sec. 18. NEW SECTION . 124F.17 Psilocybin cultivation 18 facility growing and harvesting. 19 1. A psilocybin cultivation facility shall use a unique 20 identifier that is connected to the facilitys inventory 21 control system to identify all of the following: 22 a. Each unique harvest of psilocybin. 23 b. Each batch of psilocybin that the facility transfers to 24 an independent psilocybin testing laboratory. 25 c. Any psilocybin waste, as defined in section 124F.15, of 26 which the psilocybin cultivation facility disposes. 27 2. A psilocybin cultivation facility shall identify 28 psilocybin biomass as psilocybin byproduct or psilocybin 29 product before transferring the psilocybin biomass from the 30 facility. 31 3. A psilocybin cultivation facility shall destroy 32 psilocybin cultivation byproduct as provided in section 33 124F.15. 34 Sec. 19. NEW SECTION . 124F.18 Psilocybin cultivation 35 -19- LSB 1463HH (6) 91 ss/ko 19/ 45
H.F. 620 facility sales. 1 1. A psilocybin cultivation facility shall not sell a 2 product other than a psilocybin product or educational material 3 related to the medical use of psilocybin. 4 2. A psilocybin cultivation facility shall not sell a 5 product to a person other than a qualified therapy provider or 6 a registered agent of a qualified therapy provider. 7 Sec. 20. NEW SECTION . 124F.19 Psilocybin cultivation 8 facility labeling. 9 1. A psilocybin cultivation facility shall label a 10 psilocybin or psilocybin product with the amount of active 11 psilocybin in the psilocybin or psilocybin product. 12 2. The department may adopt rules pursuant to chapter 17A to 13 establish labeling requirements for a psilocybin product. 14 Sec. 21. NEW SECTION . 124F.20 Independent psilocybin 15 testing laboratory psilocybin and psilocybin product testing. 16 1. The department shall adopt rules pursuant to chapter 17A 17 to do all of the following: 18 a. Identify the adulterant analyses required to be performed 19 on psilocybin or psilocybin product. 20 b. Determine the level of each adulterant that is safe for 21 human consumption. 22 c. Establish protocols for a recall of psilocybin or 23 psilocybin product by a psilocybin production establishment. 24 2. The department may require an independent psilocybin 25 testing laboratory to test for a toxin if the department 26 receives information indicating the potential presence of a 27 toxin, or the departments inspector has reason to believe a 28 toxin may be present based on the inspection of a facility. 29 3. A psilocybin production establishment may not transfer 30 psilocybin or psilocybin product to a qualified therapy 31 provider until an independent psilocybin testing laboratory 32 tests a representative sample of the psilocybin or psilocybin 33 product as provided by the department by rule. 34 4. Before the sale of a psilocybin product, an independent 35 -20- LSB 1463HH (6) 91 ss/ko 20/ 45
H.F. 620 psilocybin testing laboratory shall identify and quantify the 1 amount of active psilocybin present in the psilocybin product. 2 5. The department shall adopt rules pursuant to chapter 3 17A for standards, methods, practices, and procedures for the 4 testing of psilocybin and psilocybin products by an independent 5 psilocybin laboratory. 6 6. The department may require an independent psilocybin 7 testing laboratory to participate in a proficiency evaluation 8 that the department conducts, or that an organization that the 9 department approves conducts. 10 Sec. 22. NEW SECTION . 124F.21 Independent psilocybin 11 testing laboratory inspections. 12 1. If an independent psilocybin testing laboratory 13 determines that the results of a laboratory test indicate that 14 a psilocybin or psilocybin product batch may be unsafe for 15 human use: 16 a. The independent psilocybin testing laboratory shall 17 report the laboratory test results and the psilocybin or 18 psilocybin product batch to the department and the psilocybin 19 cultivation facility from which the batch originated. 20 b. The department shall place a hold on the psilocybin or 21 psilocybin products to conduct a root cause analysis of the 22 defective batch and make a determination as to the root cause. 23 The psilocybin cultivation facility that grew the psilocybin 24 may appeal the determination of the department. 25 2. If the department determines that psilocybin or 26 psilocybin product prepared by a psilocybin cultivation 27 establishment is unsafe for human consumption, the department 28 may seize, embargo, or destroy the psilocybin or psilocybin 29 product batch as provided in section 124F.15. 30 3. If an independent psilocybin testing laboratory 31 determines that the results of a lab test indicate that the 32 active psilocybin content of psilocybin or a psilocybin product 33 batch diverges more than ten percent from the amount the label 34 indicates, the psilocybin cultivation facility shall not sell 35 -21- LSB 1463HH (6) 91 ss/ko 21/ 45
H.F. 620 the psilocybin or psilocybin product batch unless the facility 1 replaces the incorrect label with a label that correctly 2 indicates the active psilocybin content. 3 Sec. 23. NEW SECTION . 124F.22 Psilocybin electronic 4 verification system. 5 1. The department, in consultation with the department of 6 agriculture and land stewardship and the department of public 7 safety, shall adopt rules pursuant to chapter 17A for the 8 creation and operation of an electronic verification system 9 that, at minimum, does all of the following: 10 a. Allows a qualified medical psilocybin provider to access 11 dispensing information regarding a patient of the qualified 12 medical psilocybin provider, electronically recommend or renew 13 a recommendation for psilocybin or a psilocybin product, 14 connect with an inventory control system that a psilocybin 15 production establishment uses to track in real time and archive 16 purchases of any psilocybin or psilocybin product, and connect 17 with an inventory control system that a psilocybin production 18 establishment utilizes. 19 b. Allows access by all of the following: 20 (1) The department to the extent necessary to carry out the 21 departments functions and responsibilities. 22 (2) The department of inspections, appeals, and licensing 23 to carry out the functions and responsibilities related to 24 the participation of qualified medical psilocybin providers 25 and qualified therapy providers in the recommendation and 26 administration of psilocybin. 27 c. Creates a record each time a person accesses the system 28 that identifies the person who accessed the system and the 29 individual whose records the person accessed. 30 d. Keeps a current record of the total number of individuals 31 who have a psilocybin recommendation issued pursuant to section 32 124F.23. 33 2. The department may release limited data from the 34 electronic verification system for the purposes of conducting 35 -22- LSB 1463HH (6) 91 ss/ko 22/ 45
H.F. 620 research, issuing required reports, or for other official 1 department purposes. 2 3. a. A person who knowingly and intentionally releases any 3 information from the state electronic verification system in 4 violation of this section is guilty of a class D felony. 5 b. A person who negligently or recklessly releases any 6 information from the state electronic verification system in 7 violation of this section is guilty of a serious misdemeanor. 8 4. a. A person who obtains or attempts to obtain 9 information from the state electronic verification system by 10 misrepresentation or fraud is guilty of a class D felony. 11 b. A person who obtains or attempts to obtain information 12 from the state electronic verification system for a purpose 13 other than a purpose authorized in this chapter is guilty of a 14 class D felony. 15 5. a. Except as provided in paragraph b , a person who 16 knowingly and intentionally uses, releases, publishes, or 17 otherwise makes available to any other person information 18 obtained from the state electronic verification system for 19 any purpose other than a purpose specified in this section is 20 guilty of a class D felony. 21 b. This subsection shall not prohibit a person who 22 rightfully obtains information from the state electronic 23 verification system from including the information in 24 the persons medical chart or file for access by a person 25 authorized to review the medical chart or file, providing the 26 information to a person in accordance with the requirements of 27 the federal Health Insurance Portability and Accountability Act 28 of 1996, Pub. L. No. 104-191, or discussing or sharing that 29 information about the patient with the patient. 30 Sec. 24. NEW SECTION . 124F.23 Psilocybin recommendation 31 limitations expiration. 32 1. No more than five thousand individuals shall 33 simultaneously hold a psilocybin recommendation from a 34 qualified medical psilocybin provider. 35 -23- LSB 1463HH (6) 91 ss/ko 23/ 45
H.F. 620 2. An individuals psilocybin recommendation expires if the 1 individual has not received treatment from a qualified therapy 2 provider with psilocybin or a psilocybin product by the later 3 of one year from the date the qualified medical psilocybin 4 provider provided the recommendation, or one year from the date 5 of the individuals most recent administration of psilocybin or 6 a psilocybin product by a qualified therapy provider. 7 Sec. 25. NEW SECTION . 124F.24 Qualified medical psilocybin 8 provider registration continuing education treatment 9 recommendation. 10 1. An individual shall not recommend a medical psilocybin 11 treatment unless the department registers the individual as a 12 qualified medical psilocybin provider under this section. 13 2. The department shall, within fifteen days after the date 14 the department receives an application from an individual, 15 register and issue a qualified medical psilocybin provider 16 registration card to the individual if the individual does all 17 of the following: 18 a. Provides to the department the individuals name and 19 address. 20 b. Provides to the department a report detailing the 21 individuals completion of the applicable continuing education 22 requirements described in subsection 3. 23 c. Provides to the department evidence that the individual 24 holds a license that qualifies the individual as a qualified 25 medical psilocybin provider. 26 d. Pays an application fee as determined by the department 27 by rule. 28 e. For an applicant on or after January 1, 2026, provides 29 the information required by subsection 9. 30 3. a. An individual applying for initial registration 31 or renewal of a registration shall complete a continuing 32 education program as determined by the department by rule. The 33 continuing education program shall be offered by the department 34 or a continuing education provider approved by the department. 35 -24- LSB 1463HH (6) 91 ss/ko 24/ 45
H.F. 620 The continuing education program shall address all of the 1 following: 2 (1) This chapter. 3 (2) General information about psilocybin under federal and 4 state law. 5 (3) The latest scientific research on medical psilocybin, 6 including risks and benefits. 7 (4) Best practices for recommending the form and dosage of 8 psilocybin. 9 (5) Systems and receptors affected by psilocybin. 10 (6) Mechanisms of action. 11 (7) Drug interactions. 12 (8) Diagnostic criteria. 13 (9) Contraindications. 14 (10) Side effects and mitigation of side effects. 15 (11) Administrative set and setting, including physical 16 patient safety. 17 (12) Integration. 18 (13) Potential outcomes. 19 (14) Ethical considerations. 20 (15) Discharge safety planning. 21 b. An applicant for initial registration shall complete 22 sixteen hours of continuing education. A qualified medical 23 psilocybin provider shall complete four hours of continuing 24 education every two years. 25 4. A qualified medical psilocybin provider shall not 26 recommend psilocybin to a patient, or renew a recommendation 27 for psilocybin, unless the qualified medical psilocybin 28 provider has done all of the following: 29 a. Completed and documented in the patients medical record 30 a thorough assessment of the patients condition and medical 31 history based on the appropriate standard of care. 32 b. Verified that the patient has post-traumatic stress 33 disorder. 34 c. Verified that the patient is at least twenty-one years 35 -25- LSB 1463HH (6) 91 ss/ko 25/ 45
H.F. 620 old. 1 d. Met with the patient face to face if the qualified 2 medical psilocybin provider has not recommended a psilocybin 3 treatment to the patient in the past. 4 5. a. Except as provided in paragraph b , an individual 5 shall not advertise that the individual recommends medical 6 psilocybin treatment. 7 b. A qualified medical psilocybin provider, or a clinic or 8 office that employs a qualified medical psilocybin provider, 9 may advertise the following: 10 (1) The providers or clinics name and logo. 11 (2) That the individual treats post-traumatic stress 12 disorder. 13 (3) That the individual is registered as a qualified medical 14 psilocybin provider and recommends medical psilocybin. 15 (4) A scientific study regarding medical psilocybin use. 16 6. a. A qualified medical psilocybin provider registration 17 card shall expire two years from the date the department issued 18 the card. 19 b. The department shall adopt rules pursuant to chapter 17A 20 for the renewal of a medical psilocybin provider registration 21 card. 22 7. The department may revoke a medical psilocybin provider 23 registration card if a qualified medical psilocybin provider 24 fails to maintain compliance with this section. 25 8. A qualified medical psilocybin provider shall not 26 receive any compensation or benefit for the qualified 27 medical psilocybin providers medical psilocybin treatment 28 recommendation from a psilocybin production establishment or an 29 owner, officer, director, board member, employee, or agent of a 30 psilocybin production establishment. 31 9. On or before January 1 of each year, a qualified medical 32 provider shall report to the department all of the following: 33 a. That the qualified medical psilocybin provider, or the 34 entity that employs the qualified medical psilocybin provider, 35 -26- LSB 1463HH (6) 91 ss/ko 26/ 45
H.F. 620 represents online or in printed material that the qualified 1 medical psilocybin provider is a qualified medical psilocybin 2 provider or offers medical psilocybin recommendations to 3 patients, if applicable. 4 b. The fee amount that the qualified medical psilocybin 5 provider, or the entity that employs the qualified medical 6 psilocybin provider, charges a patient for a medical psilocybin 7 recommendation, either as an actual cash rate or, if the 8 psilocybin provider or entity bills insurance, an average cash 9 rate. 10 Sec. 26. NEW SECTION . 124F.25 Standard of care provider 11 not liable no private right of action. 12 1. A qualified medical psilocybin provider or a qualified 13 therapy provider who recommends or administers psilocybin in 14 compliance with this chapter shall not be subject to a civil or 15 criminal penalty, or license discipline, solely for violating 16 a federal law or regulation that prohibits recommending, 17 prescribing, possessing, or dispensing psilocybin or a 18 psilocybin product. 19 2. This chapter shall not be construed to reduce or 20 negate the duty of a qualified medical psilocybin provider or 21 qualified therapy provider to use reasonable and ordinary care 22 in the treatment of a patient. 23 Sec. 27. NEW SECTION . 124F.26 Nondiscrimination for medical 24 care or government employment. 25 1. For purposes of medical care, including an organ or 26 tissue transplant, a patients use of psilocybin as provided in 27 this chapter is the equivalent of authorized use of any other 28 medication used at the discretion of a physician, and does 29 not constitute the use of an illicit substance or otherwise 30 disqualify an individual from needed medical care. 31 2. a. Except as provided in paragraph b , the state or a 32 political subdivision of the state shall treat an employees 33 use of medical psilocybin as provided in this chapter in 34 the same way the state or political subdivision treats an 35 -27- LSB 1463HH (6) 91 ss/ko 27/ 45
H.F. 620 employees use of any prescribed controlled substance, and an 1 employees medical psilocybin recommendation from a qualified 2 medical psilocybin provider in the same way the state or 3 political subdivision treats an employees prescription for any 4 prescribed controlled substance. 5 b. A state or political subdivision employee who has a valid 6 medical psilocybin registration shall not be subject to adverse 7 action for failing a drug test due to psilocybin or psilocin 8 without evidence that the employee was impaired or otherwise 9 adversely affected in the employees job performance due to the 10 use of medical psilocybin. This paragraph shall not apply in 11 any of the following circumstances: 12 (1) The employees use of psilocybin jeopardizes federal 13 funding, a federal security clearance, or any other federal 14 background determination required for the employees position. 15 (2) The employees position is dependent on a license 16 or peace officer certification that is subject to federal 17 regulations, including 18 U.S.C. 922(g)(3). 18 (3) An employee who uses medical psilocybin during the 19 twelve hours immediately preceding the employees shift or 20 during the employees shift. 21 Sec. 28. NEW SECTION . 124F.27 Insurance coverage 22 requirement. 23 This chapter shall not be construed to require an insurer, 24 a third-party administrator, or an employer to pay for or 25 reimburse an employee for psilocybin or psilocybin product. 26 Sec. 29. NEW SECTION . 124F.28 Approved drugs. 27 This chapter shall not be construed to restrict or otherwise 28 affect the prescription, distribution, or dispensing of a 29 product that the United States food and drug administration has 30 approved. 31 Sec. 30. NEW SECTION . 124F.29 Qualified therapy 32 provider registration continuing education psilocybin 33 administration. 34 1. An individual shall not administer a medical psilocybin 35 -28- LSB 1463HH (6) 91 ss/ko 28/ 45
H.F. 620 treatment unless the department registers the individual as 1 a qualified medical psilocybin therapist as provided in this 2 section. 3 2. The department shall, within fifteen days after the date 4 the department receives an application from an individual, 5 register and issue a qualified medical psilocybin therapist 6 registration card to the individual if the individual does all 7 of the following: 8 a. Provides to the department the individuals name and 9 address. 10 b. Provides to the department the address of the clinic 11 at which the individual will be administering psilocybin to 12 patients. 13 c. Provides to the department a report detailing the 14 individuals completion of the applicable continuing education 15 requirements described in subsection 3. 16 d. Certifies to the department that the individual has 17 installed and maintains an inventory control system. 18 e. Provides to the department evidence that the individual 19 holds a license that qualifies the individual as a qualified 20 medical psilocybin provider. 21 f. Pays an application fee as determined by the department 22 by rule. 23 g. Provides to the department an emergency transport plan 24 for patients who experience a medical emergency during the 25 course of treatment. 26 3. a. An individual applying for initial registration 27 or renewal of a registration shall complete a continuing 28 education program as determined by the department by rule. The 29 continuing education program shall be offered by the department 30 or a continuing education provider approved by the department. 31 The continuing education program shall address all of the 32 following: 33 (1) This chapter. 34 (2) General information about psilocybin under federal and 35 -29- LSB 1463HH (6) 91 ss/ko 29/ 45
H.F. 620 state law. 1 (3) The latest scientific research on medical psilocybin, 2 including risks and benefits. 3 (4) Best practices for recommending the form and dosage of 4 psilocybin. 5 (5) Systems and receptors affected by psilocybin. 6 (6) Mechanisms of action. 7 (7) Drug interactions. 8 (8) Diagnostic criteria. 9 (9) Contraindications. 10 (10) Side effects and mitigation of side effects. 11 (11) Administrative set and setting, including physical 12 patient safety. 13 (12) Integration. 14 (13) Potential outcomes. 15 (14) Ethical considerations. 16 (15) Discharge safety planning. 17 b. An applicant for initial registration shall complete 18 eighty hours of continuing education. A qualified therapy 19 provider shall complete four hours of continuing education 20 every two years. 21 4. A qualified therapy provider shall only administer 22 psilocybin to a patient when all of the following requirements 23 are met: 24 a. The patient has a recommendation issued by a qualified 25 medical psilocybin provider. 26 b. The qualified medical therapy provider has obtained and 27 reviewed the patients mental health history. 28 c. The qualified therapy provider has provided the patient 29 with a safety data sheet created by the department which 30 outlines the potential risks of psilocybin use. 31 d. There are unexpired rescue medications on site, as 32 determined by the department by rule. 33 e. The administration session is video-recorded and the 34 video recording is preserved for one year from the date of the 35 -30- LSB 1463HH (6) 91 ss/ko 30/ 45
H.F. 620 session, or the patient gives written, informed consent waiving 1 the video-recording requirement. 2 f. The qualified therapy provider has a contractual 3 relationship with a licensed physician and surgeon or 4 osteopathic physician and surgeon who remains on call during 5 the course of the administration session in case the patient 6 requires nonemergency medical intervention. 7 5. A qualified therapy provider shall only administer 8 psilocybin or a psilocybin product in a qualified therapy 9 provider location. 10 6. a. Except as provided in paragraph b , an individual 11 shall not advertise that the individual administers medical 12 psilocybin treatment. 13 b. A qualified therapy provider or clinic or office 14 that employs a qualified therapy provider may advertise the 15 following: 16 (1) The providers or clinics name and logo. 17 (2) That the individual treats post-traumatic stress 18 disorder. 19 (3) That the individual is registered as a qualified therapy 20 provider and administers medical psilocybin. 21 (4) A scientific study regarding medical psilocybin use. 22 7. a. A qualified therapy provider registration card 23 expires two years from the date the department issues the card. 24 b. The department shall adopt rules pursuant to chapter 17A 25 for the renewal of a qualified therapy provider registration 26 card. 27 8. Within seven days of the date on which an adverse event 28 occurs, a qualified therapy provider shall submit to the 29 department a report containing all of the following: 30 a. The age and sex of the patient. 31 b. The patients preexisting health conditions, if any. 32 c. The amount of psilocybin administered to the patient. 33 d. Factors which contributed to the adverse event. 34 e. The nature and severity of the adverse event. 35 -31- LSB 1463HH (6) 91 ss/ko 31/ 45
H.F. 620 f. The ultimate outcome of the adverse event. 1 9. The department may revoke a qualified therapy provider 2 registration card if a qualified therapy provider fails to 3 maintain compliance with this section. 4 Sec. 31. NEW SECTION . 124F.30 Qualified therapy provider 5 agent registration. 6 1. An individual shall not act as a qualified therapy 7 provider agent unless the department registers the individual 8 as a qualified therapy provider agent, regardless of whether 9 the individual is a seasonal, temporary, or permanent employee. 10 2. The department shall, within fifteen business days 11 after the date the department receives a complete application 12 from a qualified therapy provider agent, register and issue 13 a qualified therapy provider agent registration card to the 14 prospective agent who successfully passes a criminal background 15 investigation as provided in section 124F.6 if the prospective 16 agent does all of the following: 17 a. Provides to the department the prospective agents name 18 and address. 19 b. Pays a fee to the department in an amount determined by 20 the department by rule. 21 3. a. A qualified therapy provider agent shall comply with 22 either a certification standard developed by the department 23 by rule, or a certification standard that the department has 24 reviewed and approved. 25 b. A certification standard described in paragraph a shall 26 include training in Iowa medical psilocybin law. 27 4. A qualified therapy provider agent registration card 28 shall expire two years from the date the department issued the 29 card. A qualified therapy provider agent may renew the agents 30 registration card if the agent is still eligible to hold a 31 qualified therapy provider agent registration card and pays a 32 fee determined by the department by rule. 33 5. a. A qualified therapy provider agent shall carry the 34 individuals qualified therapy provider agent card with the 35 -32- LSB 1463HH (6) 91 ss/ko 32/ 45
H.F. 620 agent at all times when the agent is handling psilocybin or 1 psilocybin product. 2 b. If a qualified therapy provider agent possesses 3 psilocybin or psilocybin product and produces the registration 4 card in the agents possession, there is a rebuttable 5 presumption that the agent possesses the psilocybin or 6 psilocybin product legally and a law enforcement officer does 7 not have probable cause, based solely on the agents possession 8 of the psilocybin or psilocybin product, to believe that the 9 individual is engaging in illegal activity. 10 c. A qualified therapy provider agent who fails to carry 11 the individuals qualified therapy provider agent card with the 12 agent as required by paragraph a is guilty of the following 13 offenses: 14 (1) For a first offense, or a second offense within a 15 two-year period, a simple misdemeanor punishable by a fine of 16 one hundred dollars. 17 (2) For a third offense, or a subsequent offense within a 18 two-year period, a simple misdemeanor. 19 d. For each violation of paragraph c , the department may 20 assess the relevant qualified therapy provider a fine of up to 21 two thousand five hundred dollars. 22 Sec. 32. NEW SECTION . 124F.31 Reports. 23 1. a. On or before November 1, 2025, and by November 1 of 24 each year thereafter, the department shall submit a report to 25 the general assembly including all of the following: 26 (1) The number of patients for whom psilocybin has been 27 recommended. 28 (2) The age and county of patients. 29 (3) The number of qualified medical psilocybin providers. 30 (4) The number of license applications and renewal 31 applications received. 32 (5) The number of licenses the department has issued in each 33 county. 34 (6) The number of licenses the department has revoked. 35 -33- LSB 1463HH (6) 91 ss/ko 33/ 45
H.F. 620 (7) The expenses incurred and revenues generated from the 1 medical psilocybin program. 2 (8) The number and nature of adverse events reported. 3 b. The department shall not include personally identifying 4 information in the report submitted pursuant to paragraph a . 5 2. The department shall submit a report to the general 6 assembly regarding the efficacy of medical psilocybin, 7 including recommendations, by June 1, 2028. 8 Sec. 33. NEW SECTION . 124F.32 Enforcement. 9 1. If a person that is licensed or registered under this 10 chapter violates a provision of this chapter or rules adopted 11 by the department pursuant to this chapter, or fails to 12 comply with an enforcement action taken under this chapter, 13 the department may do any of the following, subject to the 14 requirements of this section: 15 a. Revoke the persons license or registration card. 16 b. Decline to renew the persons license or registration 17 card. 18 c. Assess an administrative fee, as determined by the 19 department by rule. 20 2. If the department finds that a person produced a 21 psilocybin or psilocybin product batch that contains a 22 substance, other than active psilocybin, that poses a 23 significant threat to human health the department shall do all 24 of the following: 25 a. Issue the person a written administrative citation. 26 b. Attempt to negotiate a stipulated settlement. 27 c. Seize, embargo, or destroy the psilocybin or psilocybin 28 product batch. 29 d. Order the person to cease and desist from the action that 30 creates a violation. 31 3. The department may, for a person subject to an 32 uncontested citation, a stipulated settlement, or a finding of 33 a violation in an adjudicative proceeding under this section, 34 if a fine is not already specified by law, assess a person who 35 -34- LSB 1463HH (6) 91 ss/ko 34/ 45
H.F. 620 is not an individual a fine of up to five thousand dollars per 1 violation. 2 4. The department shall not revoke a license or registration 3 issued under this chapter without first conducting a contested 4 case proceeding pursuant to chapter 17A. 5 5. Except where a criminal penalty is expressly provided for 6 a specific violation of this chapter, the following criminal 7 penalties apply: 8 a. Except as provided in paragraph b , an individual who 9 violates a provision of this chapter is guilty of a simple 10 misdemeanor punishable by a fine of one hundred dollars. 11 b. An individual who intentionally or knowingly violates 12 a provision of this chapter, or violates a provision of this 13 chapter three or more times, is guilty of a serious misdemeanor 14 punishable by a fine of one thousand dollars. 15 EXPLANATION 16 The inclusion of this explanation does not constitute agreement with 17 the explanations substance by the members of the general assembly. 18 This bill relates to the production of psilocybin and 19 administration of psilocybin to persons with post-traumatic 20 stress disorder. The bill requires a psilocybin production 21 establishment or a qualified therapy provider location, 22 defined in the bill, to include an inventory control system 23 that tracks psilocybin product, defined in the bill, in 24 real time; maintains access records; and includes a video 25 recording system. The bill requires a psilocybin production 26 establishment or qualified therapy provider location to allow 27 the department of health and human services (department) to 28 access the inventory control system at any time. 29 The bill requires a state employer or political subdivision 30 employer to inform an employee or prospective employee prior to 31 assigning a duty related to the administration of the bill that 32 the employees or prospective employees job duties may require 33 the employee or prospective employee to engage in conduct in 34 violation of the criminal laws of the United States. 35 -35- LSB 1463HH (6) 91 ss/ko 35/ 45
H.F. 620 The bill creates within the department the psilocybin 1 production establishment licensing board (board), with members 2 appointed by the director of the department. The board shall 3 consist of a member of the public with knowledge of psilocybin, 4 a member with knowledge and experience in the pharmaceutical 5 or nutraceutical manufacturing industry, a member representing 6 law enforcement, a member who is a chemist or researcher with 7 experience in manufacturing and who is associated with a 8 research university, a member who has a background in fungus or 9 mushroom cultivation and processing, and the director of the 10 department or the directors designee, who shall serve as the 11 chairperson of the board and a nonvoting member, except in the 12 case of a tied vote. The bill prohibits a person from serving 13 on the board if the person has certain financial interests 14 related to psilocybin. Members of the board shall serve a 15 term of four years, except that initial members of the board 16 shall be appointed for staggered terms such that the director 17 appoints two or three board members every two years. The 18 director shall fill vacancies in the board for the balance of 19 the unexpired term. Members of the board shall serve without 20 compensation, although they may be reimbursed for actual 21 expenses, and the director may remove a member of the board 22 for cause, neglect of duty, inefficiency, or malfeasance. The 23 board is not subject to automatic dissolution pursuant to Code 24 section 4A.5 (boards and governmental entities dissolution). 25 The board shall meet as called by the chairperson to review 26 psilocybin license applications, conduct public hearings on 27 applications, and make determinations on license applications. 28 The bill requires the board to meet if a psilocybin production 29 establishment undergoes certain changes and annually to 30 consider license renewal applications. The bill prohibits a 31 person from operating a psilocybin production establishment 32 unless the person holds a license issued by the board. The 33 bill requires the department to adopt rules for solicitation 34 and evaluation of license applications. The bill also 35 -36- LSB 1463HH (6) 91 ss/ko 36/ 45
H.F. 620 requires an applicant for a license to submit the proposed 1 name and address of the establishment, the names and addresses 2 of certain persons associated with the establishment, an 3 operating plan, a statement that the applicant will obtain 4 a performance bond, an application fee, and a description 5 of any investigatory or adverse action previously taken 6 against the applicant in relation to any of the applicants 7 psilocybin-related operations or businesses. The bill 8 prohibits a psilocybin production establishment from operating 9 within 1,000 feet of a community location, defined in the bill, 10 or 500 feet of an area that is zoned as primarily residential. 11 The bill allows the board to waive these limitations by up to 12 20 percent. 13 Upon approval of an application for a license, the bill 14 requires the applicant to pay an initial licensing fee and the 15 department to inform the department of public safety. The bill 16 allows a psilocybin production establishment to be located 17 at the same location as a medical cannabidiol producer and 18 the board may grant preference to an applicant who currently 19 holds a medical cannabidiol producer license. If the board 20 receives more than one application for a psilocybin production 21 establishment license in the same city or town, the board 22 shall consult with the local land use authority prior to 23 issuing a license. The bill prohibits the board from issuing 24 a license to certain persons. The bill allows the board to 25 revoke a license for certain violations. Fees collected by 26 the department shall be deposited into the general fund of the 27 state. 28 If the municipality or county where the psilocybin 29 production establishment will be located requires a land use 30 permit, the bill requires a licensee to submit a copy of an 31 approved land use permit within 120 days of issuance of the 32 license. The bill prohibits the board from issuing more than 33 four licenses to operate an independent psilocybin testing 34 laboratory and allows the board to operate an independent 35 -37- LSB 1463HH (6) 91 ss/ko 37/ 45
H.F. 620 psilocybin testing laboratory. A psilocybin production 1 establishment is not transferable or assignable, and the 2 boards authority to issue a license is plenary and not 3 subject to review. The bill requires the division of criminal 4 investigation of the department of public safety to conduct 5 a thorough investigation of each applicant for a psilocybin 6 production establishment license. The bill requires the board 7 to begin accepting license applications on July 1, 2026. The 8 board shall renew a license if the licensee continues to meet 9 the requirements for initial licensure, the board does not 10 identify a significant failure of compliance or grounds for 11 revocation, and the licensee pays a renewal fee. 12 The bill requires a person applying for a psilocybin 13 production establishment license or license renewal to submit a 14 proposed operating plan, including certain information about 15 the facility, the facilitys officers and employees, a security 16 plan, a description of the inventory control system, and 17 storage protocols. The bill requires psilocybin cultivation 18 facilities and psilocybin testing laboratories to submit 19 additional information particular to the type of psilocybin 20 production establishment. 21 The bill prohibits a person from acting as a psilocybin 22 production establishment or qualified therapy provider agent 23 unless the person is registered as a psilocybin production 24 establishment agent with the board. The bill prohibits certain 25 persons from acting as a psilocybin production establishment 26 agent. The bill requires the board to issue a psilocybin 27 production establishment agent registration to a person if 28 the psilocybin production establishment that will employ 29 the agent submits an application and pays a fee on behalf 30 of the person. The prospective agent shall also undergo a 31 criminal background investigation. A psilocybin production 32 establishment agent shall comply with a certification standard 33 adopted by the board. A psilocybin production establishment 34 agent registration is valid for two years and may be renewed. 35 -38- LSB 1463HH (6) 91 ss/ko 38/ 45
H.F. 620 The bill requires a psilocybin production establishment agent 1 to carry the agents registration card at all times while on 2 the premises of the psilocybin production establishment or when 3 transporting psilocybin. There is a rebuttable presumption a 4 person carrying a psilocybin production establishment agent 5 registration card while in possession of psilocybin possesses 6 the psilocybin legally. A psilocybin production establishment 7 agent who fails to carry a psilocybin production establishment 8 agent registration card while required to do so is guilty of a 9 simple misdemeanor punishable by a fine of $100 for a first or 10 second offense in a two-year period and a simple misdemeanor 11 punishable as provided by law for a third or subsequent offense 12 in a two-year period. A simple misdemeanor is punishable by 13 confinement for no more than 30 days and a fine of at least 14 $105 but not more than $855. The board may fine a psilocybin 15 production establishment or qualified therapy provider that 16 employs a psilocybin production establishment agent a fine for 17 each violation. 18 The bill requires a psilocybin production establishment 19 to operate in accordance with the operating plan submitted 20 by the psilocybin production establishment and to inform the 21 department prior to implementing any changes to the plan. 22 The bill requires a psilocybin production establishment to 23 operate in a facility that is accessible only by an individual 24 with a valid psilocybin production establishment registration 25 card, except that a psilocybin production establishment may 26 authorize a person who is at least 18 years of age who is 27 not a psilocybin production establishment agent to access 28 the psilocybin production establishment if the psilocybin 29 production establishment tracks and monitors the individual at 30 all times. A psilocybin production establishment shall not 31 employ a person who is under 21 years of age or who has been 32 convicted of a misdemeanor for drug distribution or any felony. 33 The bill requires a psilocybin production establishment to have 34 a single, secure public entrance and a security system with a 35 -39- LSB 1463HH (6) 91 ss/ko 39/ 45
H.F. 620 backup power source. 1 The bill allows the department to inspect the facility and 2 records of a psilocybin production establishment at any time 3 during business hours. The bill grants certain investigational 4 powers to the department and allows the department to impose 5 a fee or suspend or revoke a license or registration for 6 failing to comply with an inspection. The bill prohibits a 7 psilocybin production establishment from advertising to the 8 general public, except to advertise an employment opportunity. 9 The bill requires the department to adopt rules for standards 10 relating to advertisement by qualified medical psilocybin 11 providers and qualified medical psilocybin therapists, defined 12 in the bill. 13 The bill prohibits a person other than a psilocybin 14 production establishment agent, qualified therapy provider, 15 qualified therapy provider agent, or an agent of the department 16 conducting an inspection from transporting psilocybin. A 17 person transporting psilocybin must possess a manifest 18 including details about the psilocybin the person has been 19 authorized to transport. A psilocybin production establishment 20 agent who transports psilocybin without a manifest is guilty 21 of a simple misdemeanor punishable by a fine of $100. A 22 psilocybin production establishment who transports an amount of 23 psilocybin in excess of the amount indicated in the manifest 24 is subject to penalties as provided in Code chapter 124 25 (controlled substances). The bill requires a person disposing 26 of psilocybin waste to render the psilocybin waste unusable 27 and unrecognizable and to dispose of it in compliance with 28 applicable state and federal law. 29 The bill requires a local government to allow a psilocybin 30 production establishment to operate in any zone designated for 31 industrial or agricultural use, unless the local government has 32 designated at least one industrial or agricultural zone for the 33 operation of a psilocybin production establishment prior to the 34 receipt of an application for the establishment of a psilocybin 35 -40- LSB 1463HH (6) 91 ss/ko 40/ 45
H.F. 620 production establishment by the local government. The bill 1 allows a psilocybin production establishment to operate on land 2 that has not been zoned. The bill prohibits local governments 3 from imposing certain restrictions on the establishment of a 4 psilocybin production establishment. 5 The bill requires a psilocybin cultivation facility to 6 use unique identifiers to identify certain classifications 7 of psilocybin. The bill prohibits a psilocybin cultivation 8 facility from selling any product other than a psilocybin 9 product or educational material related to psilocybin and from 10 selling to a person other than a qualified therapy provider or 11 a registered agent of a qualified therapy provider. The bill 12 includes certain labeling requirements for psilocybin products. 13 The bill requires the department to adopt rules for the 14 testing of psilocybin by an independent psilocybin testing 15 laboratory. The bill allows the department to require an 16 independent psilocybin testing laboratory to test for a toxin 17 if the department receives information about the presence 18 of the toxin. The bill prohibits a psilocybin production 19 establishment from transferring psilocybin to a qualified 20 therapy provider until a sample of the psilocybin has been 21 tested by an independent psilocybin testing laboratory. The 22 bill allows the department to require an independent psilocybin 23 testing laboratory to participate in a proficiency evaluation. 24 If an independent psilocybin testing laboratory determines that 25 a psilocybin product is unsafe for human use, the bill requires 26 the independent psilocybin testing laboratory to inform the 27 department and the psilocybin cultivation facility from which 28 the batch originated, and the department shall place a hold on 29 the sale and use of the psilocybin product until the department 30 completes an investigation. 31 The bill requires the department, in consultation with the 32 departments of agriculture and public safety, to adopt rules 33 for the creation and operation of an electronic verification 34 system. The electronic verification system shall, at a 35 -41- LSB 1463HH (6) 91 ss/ko 41/ 45
H.F. 620 minimum, allow a medical psilocybin provider to engage in 1 patient management; allow access by the department and the 2 department of inspections, appeals, and licensing; create a 3 record each time a person accesses the system; and keeps a 4 current record of the total number of individuals who have a 5 psilocybin recommendation. The bill allows the department to 6 release limited data from the electronic verification system 7 for research, reporting, and official department purposes. A 8 person who knowingly and intentionally releases information 9 from the electronic verification system in violation of the 10 bill is guilty of class D felony. A class D felony is 11 punishable by confinement for no more than five years and a 12 fine of at least $1,025 but not more than $10,245. A person 13 who negligently or recklessly releases information from the 14 electronic verification system in violation of the bill is 15 guilty of a serious misdemeanor. A serious misdemeanor is 16 punishable by confinement for no more than one year and a 17 fine of at least $430 but not more than $2,560. A person who 18 unlawfully obtains or attempts to obtain information from the 19 electronic verification system is guilty of a class D felony. 20 The bill limits the number of psilocybin recommendations 21 in the state to 5,000 patients. An individuals psilocybin 22 recommendation expires if the individual has not received 23 treatment from a qualified therapy provider with psilocybin 24 or a psilocybin product by the later of one year from the 25 day a qualified medical psilocybin provider provided the 26 recommendation or one year from the day of the individuals 27 most recent administration of psilocybin or a psilocybin 28 product by a qualified therapy provider. The bill prohibits 29 a person from recommending the use of psilocybin unless the 30 person is a qualified medical psilocybin provider, defined in 31 the bill as a physician and surgeon or osteopathic physician 32 and surgeon, a physician assistant, an advanced registered 33 nurse practitioner, or an advanced practice registered nurse 34 who is registered by the department to recommend treatment 35 -42- LSB 1463HH (6) 91 ss/ko 42/ 45
H.F. 620 with psilocybin. The bill requires the department to issue a 1 qualified medical psilocybin provider registration card to an 2 individual if the individual submits an application, provides 3 a report detailing the completion of continuing education 4 requirements regarding the use of psilocybin listed in the 5 bill, provides evidence that the person holds an appropriate 6 license, and pays an application fee. 7 The bill prohibits a qualified medical psilocybin provider 8 from recommending the use of psilocybin unless the qualified 9 medical psilocybin provider completes a thorough assessment 10 of the patients condition and history, verifies that the 11 patient has post-traumatic stress disorder, verifies that the 12 patient is at least 21 years old, and meets with the patient 13 in person if the qualified medical psilocybin provider has not 14 previously recommended a psilocybin treatment to the patient. 15 The bill places restrictions on advertisements by qualified 16 medical psilocybin providers. A qualified medical psilocybin 17 provider registration card expires after two years and may be 18 renewed. The bill allows the department to revoke a qualified 19 medical psilocybin provider registration card for failure 20 to comply with the bill. The bill prohibits a qualified 21 medical psilocybin provider from receiving compensation from 22 certain persons involved in the production of psilocybin. A 23 qualified medical psilocybin provider shall not be subject to a 24 professional, civil, or criminal penalty solely for violating 25 a federal law or regulation that would prohibit recommending, 26 prescribing, possessing, or dispensing psilocybin. 27 The bill prohibits discrimination against a person in 28 the provision of medical care, including organ or tissue 29 transplantation, on the basis of the usage of psilocybin as 30 provided in the bill. The bill also prohibits the state or a 31 political subdivision of the state from discriminating against 32 an employee on the basis of the employees use of psilocybin 33 as provided in the bill except under certain circumstances, as 34 provided in the bill. 35 -43- LSB 1463HH (6) 91 ss/ko 43/ 45
H.F. 620 The bill does not require an insurer, a third-party 1 administrator, or an employer to pay or reimburse for 2 psilocybin. The bill does not restrict the prescription, 3 distribution, or dispensing of a product that the United States 4 food and drug administration has approved. 5 The bill prohibits a person from administering a psilocybin 6 treatment unless the department registers the person as a 7 qualified medical psilocybin therapist, defined in the bill as 8 a physician and surgeon or osteopathic physician and surgeon, a 9 physician assistant, an advanced registered nurse practitioner, 10 an advanced practice registered nurse, a psychologist, or a 11 social worker. The department shall register a person as a 12 qualified medical psilocybin therapist if the person submits 13 an application, provides the address of the clinic where 14 psilocybin will be administered, provides a report detailing 15 the completion of continuing education requirements regarding 16 the use of psilocybin listed in the bill, certifies that the 17 individual has an inventory control system, provides evidence 18 that person has an appropriate license, pays an application 19 fee, and provides an emergency transport plan. A qualified 20 medical psilocybin therapist shall not administer psilocybin 21 to a patient unless the patient has a recommendation issued 22 by a qualified medical psilocybin provider, the qualified 23 medical psilocybin therapist has reviewed the patients mental 24 health history, the qualified medical psilocybin therapist 25 has provided the patient with a safety sheet created by the 26 department, there are unexpired rescue medications on site, the 27 administration session is video-recorded, and the qualified 28 medical psilocybin therapist has a contractual relationship 29 with a licensed physician and surgeon or osteopathic physician 30 and surgeon who remains on call during the course of the 31 administration session in case a patient requires nonemergency 32 medical intervention. 33 A qualified therapy provider shall only administer 34 psilocybin in a qualified therapy provider location. The bill 35 -44- LSB 1463HH (6) 91 ss/ko 44/ 45
H.F. 620 places limits on advertising by qualified therapy providers. A 1 qualified therapy provider registration expires after two years 2 and may be renewed. The bill requires a qualified therapy 3 provider to submit a report to the department within seven days 4 after the occurrence of an adverse event, defined in the bill. 5 The bill allows the department to revoke a qualified therapy 6 provider registration if a qualified therapy provider fails to 7 maintain compliance with the requirements of the bill. 8 The bill requires the department to submit a report to the 9 general assembly on or before November 1, 2025, and annually by 10 November 1 thereafter, regarding participation in the medical 11 psilocybin program. The bill also requires the department to 12 submit a report regarding the medical efficacy of psilocybin 13 to the general assembly, including recommendations, by June 1, 14 2028. 15 The bill grants the department enforcement authority for the 16 enforcement of the bill, including by disciplining licenses 17 and registrations, imposing fees, and seizing and destroying 18 psilocybin. The department shall not revoke a license or 19 registration issued pursuant to the bill without first 20 conducting a contested case proceeding. 21 A person who violates a provision of the bill for which 22 another penalty is not provided is guilty of a simple 23 misdemeanor punishable by a fine of $100, except that a person 24 who intentionally or knowingly violates a provision of the bill 25 for which no other penalty is provided three or more times is 26 guilty of a serious misdemeanor punishable by a fine of $1,000. 27 -45- LSB 1463HH (6) 91 ss/ko 45/ 45