House File 978 - Reprinted HOUSE FILE 978 BY COMMITTEE ON WAYS AND MEANS (SUCCESSOR TO HF 620) (As Amended and Passed by the House April 21, 2025 ) A BILL FOR An Act relating to the production and administration of 1 psilocybin, and providing penalties. 2 BE IT ENACTED BY THE GENERAL ASSEMBLY OF THE STATE OF IOWA: 3 HF 978 (2) 91 ss/ko/md
H.F. 978 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- HF 978 (2) 91 ss/ko/md 1/ 35
H.F. 978 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- HF 978 (2) 91 ss/ko/md 2/ 35
H.F. 978 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.22 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- HF 978 (2) 91 ss/ko/md 3/ 35
H.F. 978 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- HF 978 (2) 91 ss/ko/md 4/ 35
H.F. 978 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- HF 978 (2) 91 ss/ko/md 5/ 35
H.F. 978 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- HF 978 (2) 91 ss/ko/md 6/ 35
H.F. 978 establishment changes location or as necessary based on the 1 recommendation of the department. 2 4. The board is not subject to dissolution pursuant to 3 section 4A.5. 4 Sec. 6. NEW SECTION . 124F.5 Psilocybin production 5 establishment license. 6 1. A person shall not operate a psilocybin production 7 establishment unless the person holds a psilocybin production 8 establishment license issued by the licensing board pursuant to 9 this chapter. 10 2. The department shall adopt rules pursuant to chapter 17A 11 to develop a process for soliciting and evaluating applications 12 for a psilocybin production establishment license. 13 3. An applicant for a psilocybin production establishment 14 license shall submit all of the following: 15 a. (1) The proposed name of the establishment and the 16 address where the establishment will be located, except as 17 provided in subparagraph (2). 18 (2) The board may issue a provisional license to an 19 applicant who submits an application that does not include 20 the address at which the establishment will be located. The 21 department shall convert a provisional license to a license if 22 the provisional licensee submits documentation confirming that 23 the provisional licensee has purchased or leased a location 24 meeting the requirements of subsection 4 and section 124F.15. 25 b. The name and address of any individual who has any of the 26 following: 27 (1) For a privately held company, a financial or voting 28 interest in the proposed psilocybin production establishment. 29 (2) The power to direct the management or control of the 30 proposed psilocybin production establishment. 31 c. An operating plan, approved by the department, that 32 complies with section 124F.8 and any laws that the municipality 33 or county in which the person is located adopts regarding the 34 operation of psilocybin production establishments. 35 -7- HF 978 (2) 91 ss/ko/md 7/ 35
H.F. 978 d. A statement that the applicant will obtain and maintain 1 a performance bond that a surety authorized to transact surety 2 business in this state issues in an amount of at least one 3 hundred thousand dollars for each psilocybin cultivation 4 facility license, or at least fifty thousand dollars for each 5 independent psilocybin testing laboratory license. 6 e. An application fee in an amount determined by the 7 department. 8 f. A description of any investigatory or adverse action 9 taken by a licensing jurisdiction, government agency, law 10 enforcement agency, or court in any state for any violation 11 or detrimental conduct in relation to any of the applicants 12 psilocybin-related operations or businesses. 13 4. A psilocybin production establishment shall not be 14 located within one thousand feet of a community location or 15 in or within five hundred feet of an area that is zoned as 16 primarily residential. The board may grant a waiver to reduce 17 the proximity requirements in this subsection by up to twenty 18 percent if the board determines that it is not reasonably 19 feasible for the applicant to site the proposed psilocybin 20 production establishment without the waiver. 21 5. Upon the approval of an application for a license under 22 this section, the applicant shall pay to the department the 23 initial licensing fee, as determined by the department by rule, 24 and the department shall inform the department of public safety 25 of the license approval. 26 6. A psilocybin production establishment may be located 27 at the same location as a medical cannabidiol manufacturer 28 licensed pursuant to section 124E.6 if a separate license is 29 obtained for each. 30 7. If the licensing board receives more than one application 31 for a psilocybin production establishment within the same city 32 or town, the licensing board shall consult with the local 33 land use authority before approving any of the applications 34 pertaining to that city or town. 35 -8- HF 978 (2) 91 ss/ko/md 8/ 35
H.F. 978 8. The licensing board shall not issue a license to operate 1 an independent psilocybin testing laboratory to any of the 2 following persons: 3 a. A person who holds a license or has an ownership interest 4 to operate a psilocybin cultivation facility. 5 b. A person who has an owner, officer, director, or employee 6 whose family member holds a license or has an ownership 7 interest in a psilocybin cultivation facility. 8 c. A person who has an ownership interest in a psilocybin 9 cultivation facility. 10 9. The licensing board shall not issue a license to operate 11 a psilocybin production establishment to an applicant if an 12 individual described in subsection 3, paragraph b , has been 13 convicted of a misdemeanor for drug distribution, or convicted 14 of a felony, or is younger than twenty-one years old. 15 10. The licensing board may, at the discretion of the 16 licensing board, grant preference to an applicant who currently 17 holds a medical cannabidiol manufacturer license issued 18 pursuant to section 124E.6. 19 11. The licensing board may revoke a license issued pursuant 20 to this section if any of the following apply: 21 a. The psilocybin production establishment does not 22 begin operations within one year after the date on which the 23 licensing board issues the initial license. 24 b. An individual psilocybin production establishment 25 operated by the licensee has violated the same provision of 26 this chapter three times. 27 c. An individual described in subsection 3, paragraph b , 28 is convicted of a misdemeanor for drug distribution, or is 29 convicted of a felony. 30 d. The licensee fails to cooperate with an investigation 31 of the psilocybin production establishment conducted by the 32 licensing board. 33 e. The psilocybin production establishment demonstrates 34 a willful or reckless disregard for the requirements of this 35 -9- HF 978 (2) 91 ss/ko/md 9/ 35
H.F. 978 chapter or the rules of the department. 1 f. The licensing board determines that the psilocybin 2 production establishment no longer meets the minimum standards 3 for licensure and operation of the psilocybin production 4 establishment. 5 g. For an independent psilocybin testing laboratory, 6 the independent psilocybin testing laboratory fails to 7 substantially meet the performance standards adopted by the 8 department by rule. 9 12. If the municipality or county where the licensed 10 psilocybin production establishment will be located requires 11 a local land use permit, a person who is issued a psilocybin 12 production establishment license under this chapter shall 13 submit to the licensing board a copy of the licensees approved 14 land use permit within one hundred twenty days after the date 15 on which the licensing board issues the license. 16 13. The department shall deposit fees imposed under this 17 section into the general fund of the state. 18 14. The department shall begin accepting applications under 19 this chapter on July 1, 2026. 20 15. The licensing boards authority to issue a license under 21 this section shall be plenary and not subject to review. 22 16. The licensing board shall not issue more than four 23 licenses to operate an independent psilocybin testing 24 laboratory. 25 17. The department may operate or partner with a research 26 university to operate an independent psilocybin testing 27 laboratory. 28 18. A psilocybin production establishment license shall not 29 be transferable or assignable. 30 Sec. 7. NEW SECTION . 124F.6 Psilocybin production 31 establishment owners and directors criminal background checks. 32 1. The division of criminal investigation of the department 33 of public safety shall conduct a thorough investigation of 34 each applicant for a psilocybin production establishment 35 -10- HF 978 (2) 91 ss/ko/md 10/ 35
H.F. 978 license as in a substantially similar manner as provided in 1 section 124E.19. The division shall report the results of the 2 investigation to the department. 3 2. The department shall collect a fee from the applicant, 4 determined by the department by rule, to cover the costs of the 5 investigation by the division of criminal investigation of the 6 department of public safety. The department shall remit the 7 fee to the division. 8 Sec. 8. NEW SECTION . 124F.7 License renewal. 9 The director of the department shall renew a license issued 10 pursuant to section 124F.5 on an annual basis if all of the 11 following apply: 12 1. The licensee meets all of the requirements for initial 13 licensure. 14 2. The director of the department does not identify a 15 significant failure of compliance with this chapter or grounds 16 for revocation. 17 3. The licensee pays a renewal fee as determined by the 18 department by rule. 19 Sec. 9. NEW SECTION . 124F.8 Operating plan. 20 A person applying for a psilocybin production establishment 21 license or license renewal shall submit to the department for 22 the departments review a proposed operating plan that includes 23 all of the following: 24 1. A description of the physical characteristics of the 25 proposed facility or, for a psilocybin cultivation facility, no 26 more than two facility locations, including a floor plan and an 27 architectural elevation. 28 2. A description of the credentials and experience of 29 each officer, director, and owner of the proposed psilocybin 30 production establishment, and of any highly skilled or 31 experienced prospective employee. 32 3. The psilocybin production establishments employee 33 training standards. 34 4. A security plan. 35 -11- HF 978 (2) 91 ss/ko/md 11/ 35
H.F. 978 5. A description of the psilocybin production 1 establishments inventory control system. 2 6. Storage protocols to ensure that psilocybin is stored in 3 a manner that is sanitary and preserves the integrity of the 4 psilocybin. 5 7. For a psilocybin cultivation facility: 6 a. Psilocybin cultivation practices, including the 7 facilitys intended pesticide and fertilizer use. 8 b. Square footage under cultivation and anticipated 9 psilocybin yield. 10 8. For an independent psilocybin testing laboratory: 11 a. Psilocybin and psilocybin product testing capacity. 12 b. Psilocybin and psilocybin product testing equipment. 13 c. Testing methods, standards, practices, and procedures for 14 testing psilocybin or psilocybin product. 15 Sec. 10. NEW SECTION . 124F.9 Psilocybin production 16 establishment agent registration. 17 1. An individual shall not act as a psilocybin production 18 establishment agent unless the department registers the 19 individual as a psilocybin production establishment agent, 20 regardless of whether the individual is a seasonal, temporary, 21 or permanent employee. 22 2. None of the following individuals shall serve as a 23 psilocybin production establishment agent or have the power 24 to direct or cause the management or control of a psilocybin 25 production establishment: 26 a. An advanced registered nurse practitioner licensed under 27 chapter 152 or an advanced practice registered nurse under 28 chapter 152E. 29 b. An individual licensed under chapter 148 to practice 30 medicine and surgery or osteopathic medicine and surgery. 31 c. A physician assistant licensed under chapter 148C. 32 3. An independent psilocybin testing laboratory agent may 33 not act as a psilocybin cultivation facility agent. 34 4. The department shall, within fifteen business days 35 -12- HF 978 (2) 91 ss/ko/md 12/ 35
H.F. 978 from the date on which the department receives a complete 1 application from a psilocybin production establishment on 2 behalf of a prospective psilocybin production establishment 3 agent, register and issue a psilocybin production establishment 4 agent registration card to the prospective psilocybin 5 production establishment agent who successfully passes a 6 criminal background investigation as provided in section 124F.6 7 if the psilocybin production establishment does all of the 8 following: 9 a. Provides to the department the prospective psilocybin 10 production establishment agents name and address. 11 b. Pays a fee to the department in an amount determined by 12 the department by rule. 13 5. The department shall designate, on an individuals 14 psilocybin production establishment agent registration card, 15 the type of psilocybin production establishment for which the 16 individual is authorized to act as an agent. 17 6. a. A psilocybin production establishment agent shall 18 comply with either a certification standard developed by the 19 department by rule, or a certification standard that the 20 department has reviewed and approved. 21 b. A certification standard described in paragraph a shall 22 include training in all of the following: 23 (1) Iowa medical psilocybin law. 24 (2) For a psilocybin cultivation facility agent, psilocybin 25 cultivation best practices. 26 (3) For an independent psilocybin testing laboratory agent, 27 psilocybin laboratory testing best practices. 28 7. A psilocybin production establishment agent registration 29 card shall expire two years from the date the department issued 30 the card. A psilocybin production establishment agent may 31 renew the agents registration card if the agent is still 32 eligible to hold a psilocybin production establishment agent 33 registration card and pays a fee determined by the department 34 by rule. 35 -13- HF 978 (2) 91 ss/ko/md 13/ 35
H.F. 978 8. a. A psilocybin production establishment agent shall 1 carry the individuals psilocybin production card with the 2 agent at all times when the agent is on the premises of 3 a psilocybin production establishment where the agent is 4 registered, or when the agent is transporting psilocybin or 5 psilocybin product. 6 b. If a psilocybin production establishment agent possesses 7 psilocybin or psilocybin product and produces the registration 8 card while handling or transporting psilocybin or psilocybin 9 product, there is a rebuttable presumption that the agent 10 possesses the psilocybin or psilocybin product legally and 11 a law enforcement officer does not have probable cause, 12 based solely on the agents possession of the psilocybin or 13 psilocybin product, to believe that the individual is engaging 14 in illegal activity. 15 c. A psilocybin production establishment agent who fails to 16 carry the individuals psilocybin production card as required 17 by paragraph a is guilty of the following offenses: 18 (1) For a first offense, or second offense within a two-year 19 period, a simple misdemeanor punishable by a fine of one 20 hundred dollars. 21 (2) For a third or subsequent offense within a two-year 22 period, a simple misdemeanor punishable as provided by law. 23 d. For each violation of paragraph c , the department may 24 assess the relevant psilocybin production establishment a fine 25 of up to five thousand dollars. 26 Sec. 11. NEW SECTION . 124F.10 Psilocybin production 27 establishment general operation requirements. 28 1. A psilocybin production establishment shall operate in 29 accordance with the operating plan submitted by the psilocybin 30 production establishment pursuant to section 124F.8. A 31 psilocybin production establishment shall notify the department 32 prior to implementing a change to the establishments operating 33 plan. The department shall inform the establishment of any 34 deficiencies in the new operating plan. 35 -14- HF 978 (2) 91 ss/ko/md 14/ 35
H.F. 978 2. a. Except as provided in paragraph b , a psilocybin 1 production establishment shall operate in a facility that 2 is accessible only by an individual with a valid psilocybin 3 production establishment agent registration card. 4 b. A psilocybin production establishment may authorize 5 an individual who is at least eighteen years of age and who 6 is not a psilocybin production establishment agent to access 7 the psilocybin production establishment if the psilocybin 8 production establishment tracks and monitors the individual at 9 all times while the individual is at the psilocybin production 10 establishment, and maintains a record of the individuals 11 access, including arrival and departure. 12 3. A psilocybin production establishment shall not employ 13 an individual who is younger than twenty-one years of age or 14 who has been convicted of a misdemeanor for drug distribution, 15 or convicted of a felony. 16 4. A psilocybin production establishment shall operate in a 17 facility that has all of the following: 18 a. A single, secure public entrance. 19 b. A security system with a backup power source that does 20 all of the following: 21 (1) Detects and records entry into the psilocybin 22 production establishment. 23 (2) Provides notice of an unauthorized entry to law 24 enforcement when the psilocybin production establishment is 25 closed. 26 (3) Secures any area where the psilocybin production 27 establishment stores psilocybin or a psilocybin product. 28 Sec. 12. NEW SECTION . 124F.11 Inspections. 29 1. The department may inspect the records and facility of a 30 psilocybin production establishment at any time during business 31 hours to determine if the psilocybin production establishment 32 complies with this chapter. 33 2. An inspection under this section may include all of the 34 following: 35 -15- HF 978 (2) 91 ss/ko/md 15/ 35
H.F. 978 a. Inspection of a site, facility, vehicle, book, record, 1 paper, document, data, and other physical or electronic 2 information. 3 b. Questioning of any relevant individual. 4 c. Observation of an independent psilocybin testing 5 laboratorys methods, standards, practices, and procedures. 6 d. The sampling of a specimen of psilocybin or psilocybin 7 product sufficient for testing purposes. 8 e. Inspection of equipment, an instrument, a tool, or 9 machinery, including a container or label. 10 3. In conducting an inspection under this section, the 11 department may review and make copies of a book, record, paper, 12 document, data, or other physical or electrical information, 13 including financial data, sales data, shipping data, pricing 14 data, and employee data. 15 4. The department may impose a fee, or a license or 16 registration suspension or revocation, if a psilocybin 17 production establishment fails to comply with this section. 18 Sec. 13. NEW SECTION . 124F.12 Advertising. 19 1. A psilocybin production establishment shall not 20 advertise to the general public in any medium, except that a 21 psilocybin production establishment may advertise an employment 22 opportunity at the psilocybin production establishment. 23 2. The department shall adopt rules pursuant to chapter 17A 24 for standards relating to advertising by a qualified medical 25 psilocybin provider or qualified therapy provider. The rules 26 shall ensure that advertising by a qualified medical psilocybin 27 provider or qualified therapy provider does not imply that the 28 psilocybin may be used for recreational purposes. 29 Sec. 14. NEW SECTION . 124F.13 Psilocybin transportation. 30 1. No individual other than the following may transport 31 psilocybin or a psilocybin product: 32 a. A registered psilocybin production establishment agent. 33 b. A qualified therapy provider. 34 c. A registered qualified therapy provider agent. 35 -16- HF 978 (2) 91 ss/ko/md 16/ 35
H.F. 978 d. An agent of the department conducting an inspection 1 pursuant to section 124F.11. 2 2. An individual transporting psilocybin or psilocybin 3 product shall be employed by the individual authorizing the 4 transportation and possess a manifest that includes all of the 5 following: 6 a. A unique identifier that links the psilocybin or 7 psilocybin product to a relevant inventory control system. 8 b. The origin and destination information for any psilocybin 9 or psilocybin product that the person is transporting. 10 c. The departure and arrival times of the individual 11 transporting the psilocybin or psilocybin product. 12 3. A registered psilocybin production establishment 13 agent transporting psilocybin or psilocybin product without 14 a manifest as provided in subsection 2 is guilty of a simple 15 misdemeanor punishable by a fine of one hundred dollars. 16 However, if the registered psilocybin production establishment 17 agent is carrying more psilocybin or psilocybin product than is 18 indicated on the manifest, other than a de minimis amount, the 19 registered psilocybin production establishment agent is subject 20 to penalties as provided in chapter 124. 21 4. This section shall not prohibit the department from 22 taking administrative enforcement action against a psilocybin 23 production establishment or another person for failing to make 24 a transport in compliance with this section. 25 Sec. 15. NEW SECTION . 124F.14 Psilocybin excess and 26 disposal. 27 1. As used in this section, psilocybin waste means waste 28 and unused material from the cultivation and production of 29 psilocybin or psilocybin product under this chapter. 30 2. A psilocybin production establishment shall do all of the 31 following: 32 a. Render psilocybin waste unusable and unrecognizable 33 before transporting it from the psilocybin production 34 establishment. 35 -17- HF 978 (2) 91 ss/ko/md 17/ 35
H.F. 978 b. Dispose of the psilocybin waste in compliance with all 1 applicable state and federal laws. 2 3. A person shall not transport or dispose of psilocybin 3 waste other than as provided in this section. 4 Sec. 16. NEW SECTION . 124F.15 Psilocybin production 5 establishment local control. 6 1. A local government shall allow a psilocybin production 7 establishment to operate in any zone designated for industrial 8 use unless the local government has designated by ordinance 9 at least one industrial zone for the operation of psilocybin 10 production establishments before a person submits an 11 application for the establishment of a psilocybin production 12 establishment to the local government. 13 2. A local government shall allow a psilocybin production 14 establishment to operate in any zone designated for 15 agricultural use unless the local government has designated by 16 ordinance at least one agricultural zone for the operation of 17 psilocybin production establishments before a person submits an 18 application for the establishment of a psilocybin production 19 establishment to the local government. 20 3. A psilocybin production establishment may operate on 21 land that a local government has not zoned. 22 4. A local government shall not do any of the following: 23 a. Revoke from, or refuse to issue a license or permit to, 24 a psilocybin production establishment on the sole basis that 25 the applicant or psilocybin production establishment violates 26 federal law regarding the legal status of psilocybin. 27 b. Require a certain distance between a psilocybin 28 production establishment and another psilocybin production 29 establishment or a retail tobacco store as defined in section 30 142D.2. 31 c. Enforce an ordinance against a psilocybin production 32 establishment that was not in effect on the date the psilocybin 33 production establishment submitted a complete application to 34 the local government. 35 -18- HF 978 (2) 91 ss/ko/md 18/ 35
H.F. 978 Sec. 17. NEW SECTION . 124F.16 Psilocybin cultivation 1 facility growing and harvesting. 2 1. A psilocybin cultivation facility shall use a unique 3 identifier that is connected to the facilitys inventory 4 control system to identify all of the following: 5 a. Each unique harvest of psilocybin. 6 b. Each batch of psilocybin that the facility transfers to 7 an independent psilocybin testing laboratory. 8 c. Any psilocybin waste, as defined in section 124F.14, of 9 which the psilocybin cultivation facility disposes. 10 2. A psilocybin cultivation facility shall identify 11 psilocybin biomass as psilocybin byproduct or psilocybin 12 product before transferring the psilocybin biomass from the 13 facility. 14 3. A psilocybin cultivation facility shall destroy 15 psilocybin cultivation byproduct as provided in section 16 124F.15. 17 Sec. 18. NEW SECTION . 124F.17 Psilocybin cultivation 18 facility sales. 19 1. A psilocybin cultivation facility shall not sell a 20 product other than a psilocybin product or educational material 21 related to the medical use of psilocybin. 22 2. A psilocybin cultivation facility shall not sell a 23 product to a person other than a qualified therapy provider or 24 a registered agent of a qualified therapy provider. 25 Sec. 19. NEW SECTION . 124F.18 Psilocybin cultivation 26 facility labeling. 27 1. A psilocybin cultivation facility shall label a 28 psilocybin or psilocybin product with the amount of active 29 psilocybin in the psilocybin or psilocybin product. 30 2. The department may adopt rules pursuant to chapter 17A to 31 establish labeling requirements for a psilocybin product. 32 Sec. 20. NEW SECTION . 124F.19 Independent psilocybin 33 testing laboratory psilocybin and psilocybin product testing. 34 1. The department shall adopt rules pursuant to chapter 17A 35 -19- HF 978 (2) 91 ss/ko/md 19/ 35
H.F. 978 to do all of the following: 1 a. Identify the adulterant analyses required to be performed 2 on psilocybin or psilocybin product. 3 b. Determine the level of each adulterant that is safe for 4 human consumption. 5 c. Establish protocols for a recall of psilocybin or 6 psilocybin product by a psilocybin production establishment. 7 2. The department may require an independent psilocybin 8 testing laboratory to test for a toxin if the department 9 receives information indicating the potential presence of a 10 toxin, or the departments inspector has reason to believe a 11 toxin may be present based on the inspection of a facility. 12 3. A psilocybin production establishment may not transfer 13 psilocybin or psilocybin product to a qualified therapy 14 provider until an independent psilocybin testing laboratory 15 tests a representative sample of the psilocybin or psilocybin 16 product as provided by the department by rule. 17 4. Before the sale of a psilocybin product, an independent 18 psilocybin testing laboratory shall identify and quantify the 19 amount of active psilocybin present in the psilocybin product. 20 5. The department shall adopt rules pursuant to chapter 21 17A for standards, methods, practices, and procedures for the 22 testing of psilocybin and psilocybin products by an independent 23 psilocybin laboratory. 24 6. The department may require an independent psilocybin 25 testing laboratory to participate in a proficiency evaluation 26 that the department conducts, or that an organization that the 27 department approves conducts. 28 Sec. 21. NEW SECTION . 124F.20 Independent psilocybin 29 testing laboratory inspections. 30 1. If an independent psilocybin testing laboratory 31 determines that the results of a laboratory test indicate that 32 a psilocybin or psilocybin product batch may be unsafe for 33 human use: 34 a. The independent psilocybin testing laboratory shall 35 -20- HF 978 (2) 91 ss/ko/md 20/ 35
H.F. 978 report the laboratory test results and the psilocybin or 1 psilocybin product batch to the department and the psilocybin 2 cultivation facility from which the batch originated. 3 b. The department shall place a hold on the psilocybin or 4 psilocybin products to conduct a root cause analysis of the 5 defective batch and make a determination as to the root cause. 6 The psilocybin cultivation facility that grew the psilocybin 7 may appeal the determination of the department. 8 2. If the department determines that psilocybin or 9 psilocybin product prepared by a psilocybin cultivation 10 establishment is unsafe for human consumption, the department 11 may seize, embargo, or destroy the psilocybin or psilocybin 12 product batch as provided in section 124F.14. 13 3. If an independent psilocybin testing laboratory 14 determines that the results of a lab test indicate that the 15 active psilocybin content of psilocybin or a psilocybin product 16 batch diverges more than ten percent from the amount the label 17 indicates, the psilocybin cultivation facility shall not sell 18 the psilocybin or psilocybin product batch unless the facility 19 replaces the incorrect label with a label that correctly 20 indicates the active psilocybin content. 21 Sec. 22. NEW SECTION . 124F.21 Psilocybin electronic 22 verification system. 23 1. The department, in consultation with the department of 24 agriculture and land stewardship and the department of public 25 safety, shall adopt rules pursuant to chapter 17A for the 26 creation and operation of an electronic verification system 27 that, at minimum, does all of the following: 28 a. Allows a qualified medical psilocybin provider to access 29 dispensing information regarding a patient of the qualified 30 medical psilocybin provider, electronically recommend or renew 31 a recommendation for psilocybin or a psilocybin product, 32 connect with an inventory control system that a psilocybin 33 production establishment uses to track in real time and archive 34 purchases of any psilocybin or psilocybin product, and connect 35 -21- HF 978 (2) 91 ss/ko/md 21/ 35
H.F. 978 with an inventory control system that a psilocybin production 1 establishment utilizes. 2 b. Allows access by all of the following: 3 (1) The department to the extent necessary to carry out the 4 departments functions and responsibilities. 5 (2) The department of inspections, appeals, and licensing 6 to carry out the functions and responsibilities related to 7 the participation of qualified medical psilocybin providers 8 and qualified therapy providers in the recommendation and 9 administration of psilocybin. 10 c. Creates a record each time a person accesses the system 11 that identifies the person who accessed the system and the 12 individual whose records the person accessed. 13 d. Keeps a current record of the total number of individuals 14 who have a psilocybin recommendation issued pursuant to section 15 124F.23. 16 2. The department may release limited data from the 17 electronic verification system for the purposes of conducting 18 research, issuing required reports, or for other official 19 department purposes. 20 3. a. A person who knowingly and intentionally releases any 21 information from the state electronic verification system in 22 violation of this section is guilty of a class D felony. 23 b. A person who negligently or recklessly releases any 24 information from the state electronic verification system in 25 violation of this section is guilty of a serious misdemeanor. 26 4. a. A person who obtains or attempts to obtain 27 information from the state electronic verification system by 28 misrepresentation or fraud is guilty of a class D felony. 29 b. A person who obtains or attempts to obtain information 30 from the state electronic verification system for a purpose 31 other than a purpose authorized in this chapter is guilty of a 32 class D felony. 33 5. a. Except as provided in paragraph b , a person who 34 knowingly and intentionally uses, releases, publishes, or 35 -22- HF 978 (2) 91 ss/ko/md 22/ 35
H.F. 978 otherwise makes available to any other person information 1 obtained from the state electronic verification system for 2 any purpose other than a purpose specified in this section is 3 guilty of a class D felony. 4 b. This subsection shall not prohibit a person who 5 rightfully obtains information from the state electronic 6 verification system from including the information in 7 the persons medical chart or file for access by a person 8 authorized to review the medical chart or file, providing the 9 information to a person in accordance with the requirements of 10 the federal Health Insurance Portability and Accountability Act 11 of 1996, Pub. L. No. 104-191, or discussing or sharing that 12 information about the patient with the patient. 13 Sec. 23. NEW SECTION . 124F.22 Qualified medical psilocybin 14 provider registration continuing education treatment 15 recommendation. 16 1. An individual shall not recommend a medical psilocybin 17 treatment unless the department registers the individual as a 18 qualified medical psilocybin provider under this section. 19 2. The department shall, within fifteen days after the date 20 the department receives an application from an individual, 21 register and issue a qualified medical psilocybin provider 22 registration card to the individual if the individual does all 23 of the following: 24 a. Provides to the department the individuals name and 25 address. 26 b. Provides to the department a report detailing the 27 individuals completion of the applicable continuing education 28 requirements described in subsection 3. 29 c. Provides to the department evidence that the individual 30 holds a license that qualifies the individual as a qualified 31 medical psilocybin provider. 32 d. Pays an application fee as determined by the department 33 by rule. 34 e. For an applicant on or after January 1, 2026, provides 35 -23- HF 978 (2) 91 ss/ko/md 23/ 35
H.F. 978 the information required by subsection 9. 1 3. a. An individual applying for initial registration 2 or renewal of a registration shall complete a continuing 3 education program as determined by the department by rule. The 4 continuing education program shall be offered by the department 5 or a continuing education provider approved by the department. 6 The continuing education program shall address all of the 7 following: 8 (1) This chapter. 9 (2) General information about psilocybin under federal and 10 state law. 11 (3) The latest scientific research on medical psilocybin, 12 including risks and benefits. 13 (4) Best practices for recommending the form and dosage of 14 psilocybin. 15 (5) Systems and receptors affected by psilocybin. 16 (6) Mechanisms of action. 17 (7) Drug interactions. 18 (8) Diagnostic criteria. 19 (9) Contraindications. 20 (10) Side effects and mitigation of side effects. 21 (11) Administrative set and setting, including physical 22 patient safety. 23 (12) Integration. 24 (13) Potential outcomes. 25 (14) Ethical considerations. 26 (15) Discharge safety planning. 27 b. An applicant for initial registration shall complete 28 sixteen hours of continuing education. A qualified medical 29 psilocybin provider shall complete four hours of continuing 30 education every two years. 31 4. A qualified medical psilocybin provider shall not 32 recommend psilocybin to a patient, or renew a recommendation 33 for psilocybin, unless the qualified medical psilocybin 34 provider has done all of the following: 35 -24- HF 978 (2) 91 ss/ko/md 24/ 35
H.F. 978 a. Completed and documented in the patients medical record 1 a thorough assessment of the patients condition and medical 2 history based on the appropriate standard of care. 3 b. Verified that the patient is at least twenty-one years 4 old. 5 c. Met with the patient face to face if the qualified 6 medical psilocybin provider has not recommended a psilocybin 7 treatment to the patient in the past. 8 5. a. Except as provided in paragraph b , an individual 9 shall not advertise that the individual recommends medical 10 psilocybin treatment. 11 b. A qualified medical psilocybin provider, or a clinic or 12 office that employs a qualified medical psilocybin provider, 13 may advertise the following: 14 (1) The providers or clinics name and logo. 15 (2) That the individual is registered as a qualified medical 16 psilocybin provider and recommends medical psilocybin. 17 (3) A scientific study regarding medical psilocybin use. 18 6. a. A qualified medical psilocybin provider registration 19 card shall expire two years from the date the department issued 20 the card. 21 b. The department shall adopt rules pursuant to chapter 17A 22 for the renewal of a medical psilocybin provider registration 23 card. 24 7. The department may revoke a medical psilocybin provider 25 registration card if a qualified medical psilocybin provider 26 fails to maintain compliance with this section. 27 8. A qualified medical psilocybin provider shall not 28 receive any compensation or benefit for the qualified 29 medical psilocybin providers medical psilocybin treatment 30 recommendation from a psilocybin production establishment or an 31 owner, officer, director, board member, employee, or agent of a 32 psilocybin production establishment. 33 9. On or before January 1 of each year, a qualified medical 34 provider shall report to the department all of the following: 35 -25- HF 978 (2) 91 ss/ko/md 25/ 35
H.F. 978 a. That the qualified medical psilocybin provider, or the 1 entity that employs the qualified medical psilocybin provider, 2 represents online or in printed material that the qualified 3 medical psilocybin provider is a qualified medical psilocybin 4 provider or offers medical psilocybin recommendations to 5 patients, if applicable. 6 b. The fee amount that the qualified medical psilocybin 7 provider, or the entity that employs the qualified medical 8 psilocybin provider, charges a patient for a medical psilocybin 9 recommendation, either as an actual cash rate or, if the 10 psilocybin provider or entity bills insurance, an average cash 11 rate. 12 Sec. 24. NEW SECTION . 124F.23 Standard of care provider 13 not liable no private right of action. 14 1. A qualified medical psilocybin provider or a qualified 15 therapy provider who recommends or administers psilocybin in 16 compliance with this chapter shall not be subject to a civil or 17 criminal penalty, or license discipline, solely for violating 18 a federal law or regulation that prohibits recommending, 19 prescribing, possessing, or dispensing psilocybin or a 20 psilocybin product. 21 2. This chapter shall not be construed to reduce or 22 negate the duty of a qualified medical psilocybin provider or 23 qualified therapy provider to use reasonable and ordinary care 24 in the treatment of a patient. 25 Sec. 25. NEW SECTION . 124F.24 Nondiscrimination for use 26 of psilocybin. 27 1. For purposes of medical care, including an organ or 28 tissue transplant, a patients use of psilocybin as provided in 29 this chapter is the equivalent of authorized use of any other 30 medication used at the discretion of a physician, and does 31 not constitute the use of an illicit substance or otherwise 32 disqualify an individual from needed medical care. 33 2. a. Except as provided in paragraph b , the state or a 34 political subdivision of the state shall treat an employees 35 -26- HF 978 (2) 91 ss/ko/md 26/ 35
H.F. 978 use of medical psilocybin as provided in this chapter in 1 the same way the state or political subdivision treats an 2 employees use of any prescribed controlled substance, and an 3 employees medical psilocybin recommendation from a qualified 4 medical psilocybin provider in the same way the state or 5 political subdivision treats an employees prescription for any 6 prescribed controlled substance. 7 b. A state or political subdivision employee who has a valid 8 medical psilocybin registration shall not be subject to adverse 9 action for failing a drug test due to psilocybin or psilocin 10 without evidence that the employee was impaired or otherwise 11 adversely affected in the employees job performance due to the 12 use of medical psilocybin. This paragraph shall not apply in 13 any of the following circumstances: 14 (1) The employees use of psilocybin jeopardizes federal 15 funding, a federal security clearance, or any other federal 16 background determination required for the employees position. 17 (2) The employees position is dependent on a license 18 or peace officer certification that is subject to federal 19 regulations, including 18 U.S.C. 922(g)(3). 20 (3) An employee who uses medical psilocybin during the 21 twelve hours immediately preceding the employees shift or 22 during the employees shift. 23 3. An agency of this state or a political subdivision 24 thereof, including any law enforcement agency, shall not 25 remove or initiate proceedings to remove a child under the age 26 of eighteen from the home of a parent based solely upon the 27 parents possession or use of psilocybin as authorized under 28 this chapter. 29 Sec. 26. NEW SECTION . 124F.25 Insurance coverage 30 requirement. 31 This chapter shall not be construed to require an insurer, 32 a third-party administrator, or an employer to pay for or 33 reimburse an employee for psilocybin or psilocybin product. 34 Sec. 27. NEW SECTION . 124F.26 Approved drugs. 35 -27- HF 978 (2) 91 ss/ko/md 27/ 35
H.F. 978 This chapter shall not be construed to restrict or otherwise 1 affect the prescription, distribution, or dispensing of a 2 product that the United States food and drug administration has 3 approved. 4 Sec. 28. NEW SECTION . 124F.27 Qualified therapy 5 provider registration continuing education psilocybin 6 administration. 7 1. An individual shall not administer a medical psilocybin 8 treatment unless the department registers the individual as 9 a qualified medical psilocybin therapist as provided in this 10 section. 11 2. The department shall, within fifteen days after the date 12 the department receives an application from an individual, 13 register and issue a qualified medical psilocybin therapist 14 registration card to the individual if the individual does all 15 of the following: 16 a. Provides to the department the individuals name and 17 address. 18 b. Provides to the department the address of the clinic 19 at which the individual will be administering psilocybin to 20 patients. 21 c. Provides to the department a report detailing the 22 individuals completion of the applicable continuing education 23 requirements described in subsection 3. 24 d. Certifies to the department that the individual has 25 installed and maintains an inventory control system. 26 e. Provides to the department evidence that the individual 27 holds a license that qualifies the individual as a qualified 28 medical psilocybin provider. 29 f. Pays an application fee as determined by the department 30 by rule. 31 g. Provides to the department an emergency transport plan 32 for patients who experience a medical emergency during the 33 course of treatment. 34 3. a. An individual applying for initial registration 35 -28- HF 978 (2) 91 ss/ko/md 28/ 35
H.F. 978 or renewal of a registration shall complete a continuing 1 education program as determined by the department by rule. The 2 continuing education program shall be offered by the department 3 or a continuing education provider approved by the department. 4 The continuing education program shall address all of the 5 following: 6 (1) This chapter. 7 (2) General information about psilocybin under federal and 8 state law. 9 (3) The latest scientific research on medical psilocybin, 10 including risks and benefits. 11 (4) Best practices for recommending the form and dosage of 12 psilocybin. 13 (5) Systems and receptors affected by psilocybin. 14 (6) Mechanisms of action. 15 (7) Drug interactions. 16 (8) Diagnostic criteria. 17 (9) Contraindications. 18 (10) Side effects and mitigation of side effects. 19 (11) Administrative set and setting, including physical 20 patient safety. 21 (12) Integration. 22 (13) Potential outcomes. 23 (14) Ethical considerations. 24 (15) Discharge safety planning. 25 b. An applicant for initial registration shall complete 26 eighty hours of continuing education. A qualified therapy 27 provider shall complete four hours of continuing education 28 every two years. 29 4. A qualified therapy provider shall only administer 30 psilocybin to a patient when all of the following requirements 31 are met: 32 a. The patient has a recommendation issued by a qualified 33 medical psilocybin provider. 34 b. The qualified medical therapy provider has obtained and 35 -29- HF 978 (2) 91 ss/ko/md 29/ 35
H.F. 978 reviewed the patients mental health history. 1 c. The qualified therapy provider has provided the patient 2 with a safety data sheet created by the department which 3 outlines the potential risks of psilocybin use. 4 d. There are unexpired rescue medications on site, as 5 determined by the department by rule. 6 e. The administration session is video-recorded and the 7 video recording is preserved for one year from the date of the 8 session, or the patient gives written, informed consent waiving 9 the video-recording requirement. 10 f. The qualified therapy provider has a contractual 11 relationship with a licensed physician and surgeon or 12 osteopathic physician and surgeon who remains on call during 13 the course of the administration session in case the patient 14 requires nonemergency medical intervention. 15 5. A qualified therapy provider shall only administer 16 psilocybin or a psilocybin product in a qualified therapy 17 provider location. 18 6. a. Except as provided in paragraph b , an individual 19 shall not advertise that the individual administers medical 20 psilocybin treatment. 21 b. A qualified therapy provider or clinic or office 22 that employs a qualified therapy provider may advertise the 23 following: 24 (1) The providers or clinics name and logo. 25 (2) That the individual is registered as a qualified therapy 26 provider and administers medical psilocybin. 27 (3) A scientific study regarding medical psilocybin use. 28 7. a. A qualified therapy provider registration card 29 expires two years from the date the department issues the card. 30 b. The department shall adopt rules pursuant to chapter 17A 31 for the renewal of a qualified therapy provider registration 32 card. 33 8. Within seven days of the date on which an adverse event 34 occurs, a qualified therapy provider shall submit to the 35 -30- HF 978 (2) 91 ss/ko/md 30/ 35
H.F. 978 department a report containing all of the following: 1 a. The age and sex of the patient. 2 b. The patients preexisting health conditions, if any. 3 c. The amount of psilocybin administered to the patient. 4 d. Factors which contributed to the adverse event. 5 e. The nature and severity of the adverse event. 6 f. The ultimate outcome of the adverse event. 7 9. The department may revoke a qualified therapy provider 8 registration card if a qualified therapy provider fails to 9 maintain compliance with this section. 10 Sec. 29. NEW SECTION . 124F.28 Qualified therapy provider 11 agent registration. 12 1. An individual shall not act as a qualified therapy 13 provider agent unless the department registers the individual 14 as a qualified therapy provider agent, regardless of whether 15 the individual is a seasonal, temporary, or permanent employee. 16 2. The department shall, within fifteen business days 17 after the date the department receives a complete application 18 from a qualified therapy provider agent, register and issue 19 a qualified therapy provider agent registration card to the 20 prospective agent who successfully passes a criminal background 21 investigation as provided in section 124F.6 if the prospective 22 agent does all of the following: 23 a. Provides to the department the prospective agents name 24 and address. 25 b. Pays a fee to the department in an amount determined by 26 the department by rule. 27 3. a. A qualified therapy provider agent shall comply with 28 either a certification standard developed by the department 29 by rule, or a certification standard that the department has 30 reviewed and approved. 31 b. A certification standard described in paragraph a shall 32 include training in Iowa medical psilocybin law. 33 4. A qualified therapy provider agent registration card 34 shall expire two years from the date the department issued the 35 -31- HF 978 (2) 91 ss/ko/md 31/ 35
H.F. 978 card. A qualified therapy provider agent may renew the agents 1 registration card if the agent is still eligible to hold a 2 qualified therapy provider agent registration card and pays a 3 fee determined by the department by rule. 4 5. a. A qualified therapy provider agent shall carry the 5 individuals qualified therapy provider agent card with the 6 agent at all times when the agent is handling psilocybin or 7 psilocybin product. 8 b. If a qualified therapy provider agent possesses 9 psilocybin or psilocybin product and produces the registration 10 card in the agents possession, there is a rebuttable 11 presumption that the agent possesses the psilocybin or 12 psilocybin product legally and a law enforcement officer does 13 not have probable cause, based solely on the agents possession 14 of the psilocybin or psilocybin product, to believe that the 15 individual is engaging in illegal activity. 16 c. A qualified therapy provider agent who fails to carry 17 the individuals qualified therapy provider agent card with the 18 agent as required by paragraph a is guilty of the following 19 offenses: 20 (1) For a first offense, or a second offense within a 21 two-year period, a simple misdemeanor punishable by a fine of 22 one hundred dollars. 23 (2) For a third offense, or a subsequent offense within a 24 two-year period, a simple misdemeanor. 25 d. For each violation of paragraph c , the department may 26 assess the relevant qualified therapy provider a fine of up to 27 two thousand five hundred dollars. 28 Sec. 30. NEW SECTION . 124F.29 Reports. 29 1. a. On or before November 1, 2025, and by November 1 of 30 each year thereafter, the department shall submit a report to 31 the general assembly including all of the following: 32 (1) The number of patients for whom psilocybin has been 33 recommended. 34 (2) The age and county of patients. 35 -32- HF 978 (2) 91 ss/ko/md 32/ 35
H.F. 978 (3) The number of qualified medical psilocybin providers. 1 (4) The number of license applications and renewal 2 applications received. 3 (5) The number of licenses the department has issued in each 4 county. 5 (6) The number of licenses the department has revoked. 6 (7) The expenses incurred and revenues generated from the 7 medical psilocybin program. 8 (8) The number and nature of adverse events reported. 9 b. The department shall not include personally identifying 10 information in the report submitted pursuant to paragraph a . 11 2. The department shall submit a report to the general 12 assembly regarding the efficacy of medical psilocybin, 13 including recommendations, by June 1, 2028. 14 Sec. 31. NEW SECTION . 124F.30 Enforcement. 15 1. If a person that is licensed or registered under this 16 chapter violates a provision of this chapter or rules adopted 17 by the department pursuant to this chapter, or fails to 18 comply with an enforcement action taken under this chapter, 19 the department may do any of the following, subject to the 20 requirements of this section: 21 a. Revoke the persons license or registration card. 22 b. Decline to renew the persons license or registration 23 card. 24 c. Assess an administrative fee, as determined by the 25 department by rule. 26 2. If the department finds that a person produced a 27 psilocybin or psilocybin product batch that contains a 28 substance, other than active psilocybin, that poses a 29 significant threat to human health the department shall do all 30 of the following: 31 a. Issue the person a written administrative citation. 32 b. Attempt to negotiate a stipulated settlement. 33 c. Seize, embargo, or destroy the psilocybin or psilocybin 34 product batch. 35 -33- HF 978 (2) 91 ss/ko/md 33/ 35
H.F. 978 d. Order the person to cease and desist from the action that 1 creates a violation. 2 3. The department may, for a person subject to an 3 uncontested citation, a stipulated settlement, or a finding of 4 a violation in an adjudicative proceeding under this section, 5 if a fine is not already specified by law, assess a person who 6 is not an individual a fine of up to five thousand dollars per 7 violation. 8 4. The department shall not revoke a license or registration 9 issued under this chapter without first conducting a contested 10 case proceeding pursuant to chapter 17A. 11 5. Except where a criminal penalty is expressly provided for 12 a specific violation of this chapter, the following criminal 13 penalties apply: 14 a. Except as provided in paragraph b , an individual who 15 violates a provision of this chapter is guilty of a simple 16 misdemeanor punishable by a fine of one hundred dollars. 17 b. An individual who intentionally or knowingly violates 18 a provision of this chapter, or violates a provision of this 19 chapter three or more times, is guilty of a serious misdemeanor 20 punishable by a fine of one thousand dollars. 21 Sec. 32. NEW SECTION . 124F.31 Psilocybin and psilocybin 22 products consumable goods rules. 23 The department shall adopt rules pursuant to chapter 17A 24 to allow for the production and sale of consumable goods 25 containing psilocybin and psilocybin product. 26 Sec. 33. NEW SECTION . 124F.32 Contracts enforceable. 27 It is the public policy of this state that contracts related 28 to the production, sale, and administration of psilocybin 29 pursuant to this chapter shall be enforceable. It is the 30 public policy of this state that no contract entered into 31 by a psilocybin production establishment, qualified medical 32 psilocybin provider, or qualified therapy provider, or 33 its employees or agents as permitted pursuant to a valid 34 registration, or by an entity who allows property to be used 35 -34- HF 978 (2) 91 ss/ko/md 34/ 35
H.F. 978 by an establishment, qualified medical psilocybin provider, 1 or qualified therapy provider, its employees, or its agents 2 as permitted pursuant to a valid registration, shall be 3 unenforceable on the basis that cultivating, obtaining, 4 manufacturing, distributing, dispensing, transporting, selling, 5 possessing, or using psilocybin is prohibited by federal law. 6 Sec. 34. PSYCHEDELIC COMPOUNDS STUDY. The department 7 of health and human services shall conduct a study regarding 8 the use of psychedelic compounds other than psilocybin in the 9 treatment of medical conditions. The department shall submit 10 a report to the general assembly, including the departments 11 findings and recommendations, by January 1, 2026. 12 -35- HF 978 (2) 91 ss/ko/md 35/ 35