HF 2085 (LSB 5087YH (3) 91)

HOUSE FILE 2085

BY  WILLS

A BILL FOR

An Act relating to the production and administration of psilocybin and providing penalties.
BE IT ENACTED BY THE GENERAL ASSEMBLY OF THE STATE OF IOWA:

    Section 1.  Section 124.401, subsection 5, Code 2026, is amended by adding the following new paragraph:
   NEW PARAGRAPH.  g.  A person may knowingly or intentionally recommend, possess, use, dispense, deliver, transport, or administer psilocybin if the recommendation, possession, use, dispensing, delivery, transporting, or administering is in accordance with the provisions of chapter 124F.
    Sec. 2.  NEW SECTION.  124F.1  Definitions.
   For the purposes of this chapter, unless the context otherwise requires:
   1.  “Active psilocybin” means the psychoactive chemical with the chemical abstracts service registry number 520-52-5.
   2.  “Adulterant” means a poisonous or deleterious substance in a quantity that may be injurious to health.
   3.  “Adverse event” means an injury or suspected injury to a patient that results in an escalation of care, harm to a patient, or rescue of a patient and occurs during a psilocybin administration session or within twenty-four hours from when the administration session ended.
   4.  “Community location” means a public or private elementary or secondary school, a church, a public library, a public playground, or a public park.
   5.  “Cultivation space” means, quantified in square feet, the horizontal area in which a psilocybin cultivation facility cultivates psilocybin, including each level of horizontal area if the psilocybin cultivation facility hangs, suspends, stacks, or otherwise positions plants above other plants in multiple levels.
   6.  “Department” means the department of health and human services.
   7.  “Family member” means a parent, stepparent, spouse, child, sibling, stepsibling, uncle, aunt, nephew, niece, first cousin, mother-in-law, father-in-law, brother-in-law, sister-in-law, son-in-law, daughter-in-law, grandparent, or grandchild.
   8.  “Independent psilocybin testing laboratory” means a person that does any of the following:
   a.  Conducts a chemical or other analysis of psilocybin or a psilocybin product.
   b.  Acquires, possesses, and transports psilocybin or a psilocybin product with the intent to conduct a chemical or other analysis of the psilocybin or psilocybin product.
   9.  “Independent psilocybin testing laboratory agent” means an individual who holds a valid psilocybin production establishment agent registration card with a psilocybin testing laboratory designation.
   10.  “Inventory control system” means a system described in section 124F.2.
   11.  “Licensing board” means the psilocybin production establishment licensing board created pursuant to section 124F.4.
   12.  “Patient” means an individual for whom a qualified medical psilocybin provider recommends psilocybin.
   13.  “Payment provider” means an entity that contracts with a psilocybin production establishment to facilitate transfer of funds between the establishment and another business or individual.
   14.  “Psilocybin” means a fresh mushroom containing psilocybin or psilocin.
   15.  “Psilocybin administration session” means the time period from when a qualified medical provider administers psilocybin to a patient to the time the patient leaves the qualified therapy provider location.
   16.  “Psilocybin biomass” means any part of a psilocybin-containing fungus.
   17.  “Psilocybin byproduct” means any part of a psilocybin-containing mushroom which is not used or intended for sale.
   18.  “Psilocybin cultivation facility” means a person that possesses psilocybin, grows or intends to grow psilocybin, and sells or intends to sell psilocybin to a qualified therapy provider.
   19.  “Psilocybin cultivation facility agent” means an individual who holds a valid psilocybin production establishment agent registration card with a cultivation facility designation.
   20.  “Psilocybin product” means any portion of a psilocybin-containing mushroom that has been dried and is intended for oral consumption by a patient.
   21.  “Psilocybin production establishment” or “establishment” means a psilocybin cultivation facility or an independent psilocybin testing laboratory.
   22.  “Psilocybin production establishment agent registration card” means a registration card issued by the department that authorizes an individual to act as a psilocybin production establishment agent, and that designates the type of psilocybin production establishment for which an individual is authorized to act as an agent.
   23.  “Qualified medical psilocybin provider” means a physician and surgeon or osteopathic physician and surgeon licensed pursuant to chapter 148, a physician assistant licensed pursuant to chapter 148C, an advanced registered nurse practitioner licensed under chapter 152, or an advanced practice registered nurse under chapter 152E, who is registered by the department under section 124F.22 to recommend treatment with psilocybin.
   24.  “Qualified therapy provider” means a physician and surgeon or osteopathic physician and surgeon licensed pursuant to chapter 148, a physician assistant licensed pursuant to chapter 148C, an advanced registered nurse practitioner licensed under chapter 152, an advanced practice registered nurse under chapter 152E, a psychologist licensed pursuant to chapter 154B, or a social worker licensed pursuant to chapter 154C who is registered by the department to administer treatment with psilocybin.
   25.  “Qualified therapy provider agent” means an individual who holds a valid qualified therapy provider agent registration card.
   26.  “Qualified therapy provider agent registration card” means a registration card issued by the department that authorizes an individual to act as a qualified therapy provider agent.
   27.  “Qualified therapy provider location” or “provider location” means a facility with all of the following:
   a.  A single, secure public entrance.
   b.  A security system with a backup power source that detects and records entry and provides notice of an unauthorized entry to law enforcement when the facility is closed.
   c.  A lock or equivalent restrictive security feature on any area where the psilocybin or psilocybin product is stored at the facility.
    Sec. 3.  NEW SECTION.  124F.2  Inventory control system.
   1.  Each psilocybin production establishment and qualified therapy provider shall maintain an inventory control system that meets all of the requirements of this section.
   2.  An inventory control system shall do all of the following:
   a.  Track, in real time, psilocybin and psilocybin product using a unique identifier from the time psilocybin is ready to be harvested.
   b.  Maintain in real time a record of the amount of psilocybin or psilocybin product in the possession of the establishment or provider.
   c.  Include a video recording system that is tamper proof and does all of the following:
   (1)  Tracks all handling and processing of psilocybin or psilocybin product in the establishment or provider location.
   (2)  Stores each video record for at least forty-five days.
   3.  A psilocybin production establishment or qualified therapy provider shall allow the department, or a financial institution designated by the department, to validate transactions to access the inventory control system at any time.
   4.  The department shall adopt rules pursuant to chapter 17A to implement this section, and the rules shall include requirements for aggregate or batch records regarding the planting and propagation of psilocybin before being tracked, and which may include compatibility standards for inventory control systems.
    Sec. 4.  NEW SECTION.  124F.3  Notice to prospective and current public employees.
   Prior to giving a current employee an assignment or duty that arises from or directly relates to an obligation under this chapter, or hiring a prospective employee whose assignments or duties would include an assignment or duty that arises from or directly relates to an obligation under this chapter, a state employer or a political subdivision employer shall give the employee or prospective employee a written notice that the employee’s or prospective employee’s job duties may require the employee or prospective employee to engage in conduct which is in violation of the criminal laws of the United States.
    Sec. 5.  NEW SECTION.  124F.4  Psilocybin production establishment licensing board.
   1.  a.  There is created within the department the psilocybin production establishment licensing board. The board shall consist of the following members, appointed by the director of the department:
   (1)  One member of the public with knowledge of psilocybin.
   (2)  One member with knowledge and experience in the pharmaceutical or nutraceutical manufacturing industry.
   (3)  One member representing law enforcement.
   (4)  One member who is a chemist or researcher with experience in manufacturing and who is associated with a research university.
   (5)  One member who has a background in fungus or mushroom cultivation and processing.
   (6)  The director or the director’s designee, who shall serve as the chairperson of the board and as a nonvoting member, except to cast a deciding vote in the event of a tie.
   b.  A person is ineligible for appointment to the board if any of the following apply:
   (1)  The person has any commercial or ownership interest in a psilocybin production establishment.
   (2)  The person is associated with a business that has an owner, officer, director, or employee whose family member holds a license or has an interest in a psilocybin production establishment.
   (3)  The person is employed or contracted to lobby on behalf of a psilocybin production establishment.
   c.  The director shall ensure that no two members of the board are employed by or represent the same business or nonprofit organization.
   d.  Members of the board shall serve a term of four years, except that initial members of the board shall be appointed for staggered terms such that the director appoints two or three board members every two years. The director shall fill a vacancy on the board for the balance of the unexpired term.
   e.  The director may remove a member of the board for cause, neglect of duty, inefficiency, or malfeasance.
   f.  Members of the board shall serve without compensation but may be reimbursed for actual expenses.
   2.  The board shall meet as called by the chairperson to do all of the following:
   a.  Review each license application for compliance with this chapter and rules adopted by the department.
   b.  Conduct a public hearing to consider a license application.
   c.  Make a determination on a license application.
   3.  The board shall hold a public hearing to review a psilocybin production establishment’s license if the establishment changes location or as necessary based on the recommendation of the department.
   4.  The board is not subject to dissolution pursuant to section 4A.5.
    Sec. 6.  NEW SECTION.  124F.5  Psilocybin production establishment —— license.
   1.  A person shall not operate a psilocybin production establishment unless the person holds a psilocybin production establishment license issued by the licensing board pursuant to this chapter.
   2.  The department shall adopt rules pursuant to chapter 17A to develop a process for soliciting and evaluating applications for a psilocybin production establishment license.
   3.  An applicant for a psilocybin production establishment license shall submit all of the following:
   a.  (1)  The proposed name of the establishment and the address where the establishment will be located, except as provided in subparagraph (2).
   (2)  The board may issue a provisional license to an applicant who submits an application that does not include the address at which the establishment will be located. The department shall convert a provisional license to a license if the provisional licensee submits documentation confirming that the provisional licensee has purchased or leased a location meeting the requirements of subsection 4 and section 124F.15.
   b.  The name and address of any individual who has any of the following:
   (1)  For a privately held company, a financial or voting interest in the proposed psilocybin production establishment.
   (2)  The power to direct the management or control of the proposed psilocybin production establishment.
   c.  An operating plan, approved by the department, that complies with section 124F.8 and any laws that the municipality or county in which the person is located adopts regarding the operation of psilocybin production establishments.
   d.  A statement that the applicant will obtain and maintain a performance bond that a surety authorized to transact surety business in this state issues in an amount of at least one hundred thousand dollars for each psilocybin cultivation facility license, or at least fifty thousand dollars for each independent psilocybin testing laboratory license.
   e.  An application fee in an amount determined by the department.
   f.  A description of any investigatory or adverse action taken by a licensing jurisdiction, government agency, law enforcement agency, or court in any state for any violation or detrimental conduct in relation to any of the applicant’s psilocybin-related operations or businesses.
   4.  A psilocybin production establishment shall not be located within one thousand feet of a community location or in or within five hundred feet of an area that is zoned as primarily residential. The board may grant a waiver to reduce the proximity requirements in this subsection by up to twenty percent if the board determines that it is not reasonably feasible for the applicant to site the proposed psilocybin production establishment without the waiver.
   5.  Upon the approval of an application for a license under this section, the applicant shall pay to the department the initial licensing fee, as determined by the department by rule, and the department shall inform the department of public safety of the license approval.
   6.  A psilocybin production establishment may be located at the same location as a medical cannabidiol manufacturer licensed pursuant to section 124E.6 if a separate license is obtained for each.
   7.  If the licensing board receives more than one application for a psilocybin production establishment within the same city or town, the licensing board shall consult with the local land use authority before approving any of the applications pertaining to that city or town.
   8.  The licensing board shall not issue a license to operate an independent psilocybin testing laboratory to any of the following persons:
   a.  A person who holds a license or has an ownership interest to operate a psilocybin cultivation facility.
   b.  A person who has an owner, officer, director, or employee whose family member holds a license or has an ownership interest in a psilocybin cultivation facility.
   c.  A person who has an ownership interest in a psilocybin cultivation facility.
   9.  The licensing board shall not issue a license to operate a psilocybin production establishment to an applicant if an individual described in subsection 3, paragraph “b”, has been convicted of a misdemeanor for drug distribution, or convicted of a felony, or is younger than twenty-one years old.
   10.  The licensing board may, at the discretion of the licensing board, grant preference to an applicant who currently holds a medical cannabidiol manufacturer license issued pursuant to section 124E.6.
   11.  The licensing board may revoke a license issued pursuant to this section if any of the following apply:
   a.  The psilocybin production establishment does not begin operations within one year after the date on which the licensing board issues the initial license.
   b.  An individual psilocybin production establishment operated by the licensee has violated the same provision of this chapter three times.
   c.  An individual described in subsection 3, paragraph “b”, is convicted of a misdemeanor for drug distribution, or is convicted of a felony.
   d.  The licensee fails to cooperate with an investigation of the psilocybin production establishment conducted by the licensing board.
   e.  The psilocybin production establishment demonstrates a willful or reckless disregard for the requirements of this chapter or the rules of the department.
   f.  The licensing board determines that the psilocybin production establishment no longer meets the minimum standards for licensure and operation of the psilocybin production establishment.
   g.  For an independent psilocybin testing laboratory, the independent psilocybin testing laboratory fails to substantially meet the performance standards adopted by the department by rule.
   12.  If the municipality or county where the licensed psilocybin production establishment will be located requires a local land use permit, a person who is issued a psilocybin production establishment license under this chapter shall submit to the licensing board a copy of the licensee’s approved land use permit within one hundred twenty days after the date on which the licensing board issues the license.
   13.  The department shall deposit fees imposed under this section into the general fund of the state.
   14.  The department shall begin accepting applications under this chapter on July 1, 2026.
   15.  The licensing board’s authority to issue a license under this section shall be plenary and not subject to review.
   16.  The licensing board shall not issue more than four licenses to operate an independent psilocybin testing laboratory.
   17.  The department may operate or partner with a research university to operate an independent psilocybin testing laboratory.
   18.  A psilocybin production establishment license shall not be transferable or assignable.
    Sec. 7.  NEW SECTION.  124F.6  Psilocybin production establishment owners and directors —— criminal background checks.
   1.  The division of criminal investigation of the department of public safety shall conduct a thorough investigation of each applicant for a psilocybin production establishment license as in a substantially similar manner as provided in section 124E.19. The division shall report the results of the investigation to the department.
   2.  The department shall collect a fee from the applicant, determined by the department by rule, to cover the costs of the investigation by the division of criminal investigation of the department of public safety. The department shall remit the fee to the division.
    Sec. 8.  NEW SECTION.  124F.7  License renewal.
   The director of the department shall renew a license issued pursuant to section 124F.5 on an annual basis if all of the following apply:
   1.  The licensee meets all of the requirements for initial licensure.
   2.  The director of the department does not identify a significant failure of compliance with this chapter or grounds for revocation.
   3.  The licensee pays a renewal fee as determined by the department by rule.
    Sec. 9.  NEW SECTION.  124F.8  Operating plan.
   A person applying for a psilocybin production establishment license or license renewal shall submit to the department for the department’s review a proposed operating plan that includes all of the following:
   1.  A description of the physical characteristics of the proposed facility or, for a psilocybin cultivation facility, no more than two facility locations, including a floor plan and an architectural elevation.
   2.  A description of the credentials and experience of each officer, director, and owner of the proposed psilocybin production establishment, and of any highly skilled or experienced prospective employee.
   3.  The psilocybin production establishment’s employee training standards.
   4.  A security plan.
   5.  A description of the psilocybin production establishment’s inventory control system.
   6.  Storage protocols to ensure that psilocybin is stored in a manner that is sanitary and preserves the integrity of the psilocybin.
   7.  For a psilocybin cultivation facility:
   a.  Psilocybin cultivation practices, including the facility’s intended pesticide and fertilizer use.
   b.  Square footage under cultivation and anticipated psilocybin yield.
   8.  For an independent psilocybin testing laboratory:
   a.  Psilocybin and psilocybin product testing capacity.
   b.  Psilocybin and psilocybin product testing equipment.
   c.  Testing methods, standards, practices, and procedures for testing psilocybin or psilocybin product.
    Sec. 10.  NEW SECTION.  124F.9  Psilocybin production establishment agent —— registration.
   1.  An individual shall not act as a psilocybin production establishment agent unless the department registers the individual as a psilocybin production establishment agent, regardless of whether the individual is a seasonal, temporary, or permanent employee.
   2.  None of the following individuals shall serve as a psilocybin production establishment agent or have the power to direct or cause the management or control of a psilocybin production establishment:
   a.  An advanced registered nurse practitioner licensed under chapter 152 or an advanced practice registered nurse under chapter 152E.
   b.  An individual licensed under chapter 148 to practice medicine and surgery or osteopathic medicine and surgery.
   c.  A physician assistant licensed under chapter 148C.
   3.  An independent psilocybin testing laboratory agent may not act as a psilocybin cultivation facility agent.
   4.  The department shall, within fifteen business days from the date on which the department receives a complete application from a psilocybin production establishment on behalf of a prospective psilocybin production establishment agent, register and issue a psilocybin production establishment agent registration card to the prospective psilocybin production establishment agent who successfully passes a criminal background investigation as provided in section 124F.6 if the psilocybin production establishment does all of the following:
   a.  Provides to the department the prospective psilocybin production establishment agent’s name and address.
   b.  Pays a fee to the department in an amount determined by the department by rule.
   5.  The department shall designate, on an individual’s psilocybin production establishment agent registration card, the type of psilocybin production establishment for which the individual is authorized to act as an agent.
   6.  a.  A psilocybin production establishment agent shall comply with either a certification standard developed by the department by rule, or a certification standard that the department has reviewed and approved.
   b.  A certification standard described in paragraph “a” shall include training in all of the following:
   (1)  Iowa medical psilocybin law.
   (2)  For a psilocybin cultivation facility agent, psilocybin cultivation best practices.
   (3)  For an independent psilocybin testing laboratory agent, psilocybin laboratory testing best practices.
   7.  A psilocybin production establishment agent registration card shall expire two years from the date the department issued the card. A psilocybin production establishment agent may renew the agent’s registration card if the agent is still eligible to hold a psilocybin production establishment agent registration card and pays a fee determined by the department by rule.
   8.  a.  A psilocybin production establishment agent shall carry the individual’s psilocybin production card with the agent at all times when the agent is on the premises of a psilocybin production establishment where the agent is registered, or when the agent is transporting psilocybin or psilocybin product.
   b.  If a psilocybin production establishment agent possesses psilocybin or psilocybin product and produces the registration card while handling or transporting psilocybin or psilocybin product, there is a rebuttable presumption that the agent possesses the psilocybin or psilocybin product legally and a law enforcement officer does not have probable cause, based solely on the agent’s possession of the psilocybin or psilocybin product, to believe that the individual is engaging in illegal activity.
   c.  A psilocybin production establishment agent who fails to carry the individual’s psilocybin production card as required by paragraph “a” is guilty of the following offenses:
   (1)  For a first offense, or second offense within a two-year period, a simple misdemeanor punishable by a fine of one hundred dollars.
   (2)  For a third or subsequent offense within a two-year period, a simple misdemeanor punishable as provided by law.
   d.  For each violation of paragraph “c”, the department may assess the relevant psilocybin production establishment a fine of up to five thousand dollars.
    Sec. 11.  NEW SECTION.  124F.10  Psilocybin production establishment —— general operation requirements.
   1.  A psilocybin production establishment shall operate in accordance with the operating plan submitted by the psilocybin production establishment pursuant to section 124F.8. A psilocybin production establishment shall notify the department prior to implementing a change to the establishment’s operating plan. The department shall inform the establishment of any deficiencies in the new operating plan.
   2.  a.  Except as provided in paragraph “b”, a psilocybin production establishment shall operate in a facility that is accessible only by an individual with a valid psilocybin production establishment agent registration card.
   b.  A psilocybin production establishment may authorize an individual who is at least eighteen years of age and who is not a psilocybin production establishment agent to access the psilocybin production establishment if the psilocybin production establishment tracks and monitors the individual at all times while the individual is at the psilocybin production establishment, and maintains a record of the individual’s access, including arrival and departure.
   3.  A psilocybin production establishment shall not employ an individual who is younger than twenty-one years of age or who has been convicted of a misdemeanor for drug distribution, or convicted of a felony.
   4.  A psilocybin production establishment shall operate in a facility that has all of the following:
   a.  A single, secure public entrance.
   b.  A security system with a backup power source that does all of the following:
   (1)  Detects and records entry into the psilocybin production establishment.
   (2)  Provides notice of an unauthorized entry to law enforcement when the psilocybin production establishment is closed.
   (3)  Secures any area where the psilocybin production establishment stores psilocybin or a psilocybin product.
    Sec. 12.  NEW SECTION.  124F.11  Inspections.
   1.  The department may inspect the records and facility of a psilocybin production establishment at any time during business hours to determine if the psilocybin production establishment complies with this chapter.
   2.  An inspection under this section may include all of the following:
   a.  Inspection of a site, facility, vehicle, book, record, paper, document, data, and other physical or electronic information.
   b.  Questioning of any relevant individual.
   c.  Observation of an independent psilocybin testing laboratory’s methods, standards, practices, and procedures.
   d.  The sampling of a specimen of psilocybin or psilocybin product sufficient for testing purposes.
   e.  Inspection of equipment, an instrument, a tool, or machinery, including a container or label.
   3.  In conducting an inspection under this section, the department may review and make copies of a book, record, paper, document, data, or other physical or electrical information, including financial data, sales data, shipping data, pricing data, and employee data.
   4.  The department may impose a fee, or a license or registration suspension or revocation, if a psilocybin production establishment fails to comply with this section.
    Sec. 13.  NEW SECTION.  124F.12  Advertising.
   1.  A psilocybin production establishment shall not advertise to the general public in any medium, except that a psilocybin production establishment may advertise an employment opportunity at the psilocybin production establishment.
   2.  The department shall adopt rules pursuant to chapter 17A for standards relating to advertising by a qualified medical psilocybin provider or qualified therapy provider. The rules shall ensure that advertising by a qualified medical psilocybin provider or qualified therapy provider does not imply that the psilocybin may be used for recreational purposes.
    Sec. 14.  NEW SECTION.  124F.13  Psilocybin transportation.
   1.  No individual other than the following may transport psilocybin or a psilocybin product:
   a.  A registered psilocybin production establishment agent.
   b.  A qualified therapy provider.
   c.  A registered qualified therapy provider agent.
   d.  An agent of the department conducting an inspection pursuant to section 124F.11.
   2.  An individual transporting psilocybin or psilocybin product shall be employed by the individual authorizing the transportation and possess a manifest that includes all of the following:
   a.  A unique identifier that links the psilocybin or psilocybin product to a relevant inventory control system.
   b.  The origin and destination information for any psilocybin or psilocybin product that the person is transporting.
   c.  The departure and arrival times of the individual transporting the psilocybin or psilocybin product.
   3.  A registered psilocybin production establishment agent transporting psilocybin or psilocybin product without a manifest as provided in subsection 2 is guilty of a simple misdemeanor punishable by a fine of one hundred dollars. However, if the registered psilocybin production establishment agent is carrying more psilocybin or psilocybin product than is indicated on the manifest, other than a de minimis amount, the registered psilocybin production establishment agent is subject to penalties as provided in chapter 124.
   4.  This section shall not prohibit the department from taking administrative enforcement action against a psilocybin production establishment or another person for failing to make a transport in compliance with this section.
    Sec. 15.  NEW SECTION.  124F.14  Psilocybin —— excess and disposal.
   1.  As used in this section, “psilocybin waste” means waste and unused material from the cultivation and production of psilocybin or psilocybin product under this chapter.
   2.  A psilocybin production establishment shall do all of the following:
   a.  Render psilocybin waste unusable and unrecognizable before transporting it from the psilocybin production establishment.
   b.  Dispose of the psilocybin waste in compliance with all applicable state and federal laws.
   3.  A person shall not transport or dispose of psilocybin waste other than as provided in this section.
    Sec. 16.  NEW SECTION.  124F.15  Psilocybin production establishment —— local control.
   1.  A local government shall allow a psilocybin production establishment to operate in any zone designated for industrial use unless the local government has designated by ordinance at least one industrial zone for the operation of psilocybin production establishments before a person submits an application for the establishment of a psilocybin production establishment to the local government.
   2.  A local government shall allow a psilocybin production establishment to operate in any zone designated for agricultural use unless the local government has designated by ordinance at least one agricultural zone for the operation of psilocybin production establishments before a person submits an application for the establishment of a psilocybin production establishment to the local government.
   3.  A psilocybin production establishment may operate on land that a local government has not zoned.
   4.  A local government shall not do any of the following:
   a.  Revoke from, or refuse to issue a license or permit to, a psilocybin production establishment on the sole basis that the applicant or psilocybin production establishment violates federal law regarding the legal status of psilocybin.
   b.  Require a certain distance between a psilocybin production establishment and another psilocybin production establishment or a retail tobacco store as defined in section 142D.2.
   c.  Enforce an ordinance against a psilocybin production establishment that was not in effect on the date the psilocybin production establishment submitted a complete application to the local government.
    Sec. 17.  NEW SECTION.  124F.16  Psilocybin cultivation facility —— growing and harvesting.
   1.  A psilocybin cultivation facility shall use a unique identifier that is connected to the facility’s inventory control system to identify all of the following:
   a.  Each unique harvest of psilocybin.
   b.  Each batch of psilocybin that the facility transfers to an independent psilocybin testing laboratory.
   c.  Any psilocybin waste, as defined in section 124F.14, of which the psilocybin cultivation facility disposes.
   2.  A psilocybin cultivation facility shall identify psilocybin biomass as psilocybin byproduct or psilocybin product before transferring the psilocybin biomass from the facility.
   3.  A psilocybin cultivation facility shall destroy psilocybin cultivation byproduct as provided in section 124F.15.
    Sec. 18.  NEW SECTION.  124F.17  Psilocybin cultivation facility —— sales.
   1.  A psilocybin cultivation facility shall not sell a product other than a psilocybin product or educational material related to the medical use of psilocybin.
   2.  A psilocybin cultivation facility shall not sell a product to a person other than a qualified therapy provider or a registered agent of a qualified therapy provider.
    Sec. 19.  NEW SECTION.  124F.18  Psilocybin cultivation facility —— labeling.
   1.  A psilocybin cultivation facility shall label a psilocybin or psilocybin product with the amount of active psilocybin in the psilocybin or psilocybin product.
   2.  The department may adopt rules pursuant to chapter 17A to establish labeling requirements for a psilocybin product.
    Sec. 20.  NEW SECTION.  124F.19  Independent psilocybin testing laboratory —— psilocybin and psilocybin product testing.
   1.  The department shall adopt rules pursuant to chapter 17A to do all of the following:
   a.  Identify the adulterant analyses required to be performed on psilocybin or psilocybin product.
   b.  Determine the level of each adulterant that is safe for human consumption.
   c.  Establish protocols for a recall of psilocybin or psilocybin product by a psilocybin production establishment.
   2.  The department may require an independent psilocybin testing laboratory to test for a toxin if the department receives information indicating the potential presence of a toxin, or the department’s inspector has reason to believe a toxin may be present based on the inspection of a facility.
   3.  A psilocybin production establishment may not transfer psilocybin or psilocybin product to a qualified therapy provider until an independent psilocybin testing laboratory tests a representative sample of the psilocybin or psilocybin product as provided by the department by rule.
   4.  Before the sale of a psilocybin product, an independent psilocybin testing laboratory shall identify and quantify the amount of active psilocybin present in the psilocybin product.
   5.  The department shall adopt rules pursuant to chapter 17A for standards, methods, practices, and procedures for the testing of psilocybin and psilocybin products by an independent psilocybin laboratory.
   6.  The department may require an independent psilocybin testing laboratory to participate in a proficiency evaluation that the department conducts, or that an organization that the department approves conducts.
    Sec. 21.  NEW SECTION.  124F.20  Independent psilocybin testing laboratory —— inspections.
   1.  If an independent psilocybin testing laboratory determines that the results of a laboratory test indicate that a psilocybin or psilocybin product batch may be unsafe for human use:
   a.  The independent psilocybin testing laboratory shall report the laboratory test results and the psilocybin or psilocybin product batch to the department and the psilocybin cultivation facility from which the batch originated.
   b.  The department shall place a hold on the psilocybin or psilocybin products to conduct a root cause analysis of the defective batch and make a determination as to the root cause. The psilocybin cultivation facility that grew the psilocybin may appeal the determination of the department.
   2.  If the department determines that psilocybin or psilocybin product prepared by a psilocybin cultivation establishment is unsafe for human consumption, the department may seize, embargo, or destroy the psilocybin or psilocybin product batch as provided in section 124F.14.
   3.  If an independent psilocybin testing laboratory determines that the results of a lab test indicate that the active psilocybin content of psilocybin or a psilocybin product batch diverges more than ten percent from the amount the label indicates, the psilocybin cultivation facility shall not sell the psilocybin or psilocybin product batch unless the facility replaces the incorrect label with a label that correctly indicates the active psilocybin content.
    Sec. 22.  NEW SECTION.  124F.21  Psilocybin electronic verification system.
   1.  The department, in consultation with the department of agriculture and land stewardship and the department of public safety, shall adopt rules pursuant to chapter 17A for the creation and operation of an electronic verification system that, at minimum, does all of the following:
   a.  Allows a qualified medical psilocybin provider to access dispensing information regarding a patient of the qualified medical psilocybin provider, electronically recommend or renew a recommendation for psilocybin or a psilocybin product, connect with an inventory control system that a psilocybin production establishment uses to track in real time and archive purchases of any psilocybin or psilocybin product, and connect with an inventory control system that a psilocybin production establishment utilizes.
   b.  Allows access by all of the following:
   (1)  The department to the extent necessary to carry out the department’s functions and responsibilities.
   (2)  The department of inspections, appeals, and licensing to carry out the functions and responsibilities related to the participation of qualified medical psilocybin providers and qualified therapy providers in the recommendation and administration of psilocybin.
   c.  Creates a record each time a person accesses the system that identifies the person who accessed the system and the individual whose records the person accessed.
   d.  Keeps a current record of the total number of individuals who have a psilocybin recommendation issued pursuant to section 124F.23.
   2.  The department may release limited data from the electronic verification system for the purposes of conducting research, issuing required reports, or for other official department purposes.
   3.  a.  A person who knowingly and intentionally releases any information from the state electronic verification system in violation of this section is guilty of a class “D” felony.
   b.  A person who negligently or recklessly releases any information from the state electronic verification system in violation of this section is guilty of a serious misdemeanor.
   4.  a.  A person who obtains or attempts to obtain information from the state electronic verification system by misrepresentation or fraud is guilty of a class “D” felony.
   b.  A person who obtains or attempts to obtain information from the state electronic verification system for a purpose other than a purpose authorized in this chapter is guilty of a class “D” felony.
   5.  a.  Except as provided in paragraph “b”, a person who knowingly and intentionally uses, releases, publishes, or otherwise makes available to any other person information obtained from the state electronic verification system for any purpose other than a purpose specified in this section is guilty of a class “D” felony.
   b.  This subsection shall not prohibit a person who rightfully obtains information from the state electronic verification system from including the information in the person’s medical chart or file for access by a person authorized to review the medical chart or file, providing the information to a person in accordance with the requirements of the federal Health Insurance Portability and Accountability Act of 1996, Pub. L. No. 104-191, or discussing or sharing that information about the patient with the patient.
    Sec. 23.  NEW SECTION.  124F.22  Qualified medical psilocybin provider registration —— continuing education —— treatment recommendation.
   1.  An individual shall not recommend a medical psilocybin treatment unless the department registers the individual as a qualified medical psilocybin provider under this section.
   2.  The department shall, within fifteen days after the date the department receives an application from an individual, register and issue a qualified medical psilocybin provider registration card to the individual if the individual does all of the following:
   a.  Provides to the department the individual’s name and address.
   b.  Provides to the department a report detailing the individual’s completion of the applicable continuing education requirements described in subsection 3.
   c.  Provides to the department evidence that the individual holds a license that qualifies the individual as a qualified medical psilocybin provider.
   d.  Pays an application fee as determined by the department by rule.
   e.  For an applicant on or after January 1, 2026, provides the information required by subsection 9.
   3.  a.  An individual applying for initial registration or renewal of a registration shall complete a continuing education program as determined by the department by rule. The continuing education program shall be offered by the department or a continuing education provider approved by the department. The continuing education program shall address all of the following:
   (1)  This chapter.
   (2)  General information about psilocybin under federal and state law.
   (3)  The latest scientific research on medical psilocybin, including risks and benefits.
   (4)  Best practices for recommending the form and dosage of psilocybin.
   (5)  Systems and receptors affected by psilocybin.
   (6)  Mechanisms of action.
   (7)  Drug interactions.
   (8)  Diagnostic criteria.
   (9)  Contraindications.
   (10)  Side effects and mitigation of side effects.
   (11)  Administrative set and setting, including physical patient safety.
   (12)  Integration.
   (13)  Potential outcomes.
   (14)  Ethical considerations.
   (15)  Discharge safety planning.
   b.  An applicant for initial registration shall complete sixteen hours of continuing education. A qualified medical psilocybin provider shall complete four hours of continuing education every two years.
   4.  A qualified medical psilocybin provider shall not recommend psilocybin to a patient, or renew a recommendation for psilocybin, unless the qualified medical psilocybin provider has done all of the following:
   a.  Completed and documented in the patient’s medical record a thorough assessment of the patient’s condition and medical history based on the appropriate standard of care.
   b.  Verified that the patient is at least twenty-one years old.
   c.  Met with the patient face to face if the qualified medical psilocybin provider has not recommended a psilocybin treatment to the patient in the past.
   5.  a.  Except as provided in paragraph “b”, an individual shall not advertise that the individual recommends medical psilocybin treatment.
   b.  A qualified medical psilocybin provider, or a clinic or office that employs a qualified medical psilocybin provider, may advertise the following:
   (1)  The provider’s or clinic’s name and logo.
   (2)  That the individual is registered as a qualified medical psilocybin provider and recommends medical psilocybin.
   (3)  A scientific study regarding medical psilocybin use.
   6.  a.  A qualified medical psilocybin provider registration card shall expire two years from the date the department issued the card.
   b.  The department shall adopt rules pursuant to chapter 17A for the renewal of a medical psilocybin provider registration card.
   7.  The department may revoke a medical psilocybin provider registration card if a qualified medical psilocybin provider fails to maintain compliance with this section.
   8.  A qualified medical psilocybin provider shall not receive any compensation or benefit for the qualified medical psilocybin provider’s medical psilocybin treatment recommendation from a psilocybin production establishment or an owner, officer, director, board member, employee, or agent of a psilocybin production establishment.
   9.  On or before January 1 of each year, a qualified medical provider shall report to the department all of the following:
   a.  That the qualified medical psilocybin provider, or the entity that employs the qualified medical psilocybin provider, represents online or in printed material that the qualified medical psilocybin provider is a qualified medical psilocybin provider or offers medical psilocybin recommendations to patients, if applicable.
   b.  The fee amount that the qualified medical psilocybin provider, or the entity that employs the qualified medical psilocybin provider, charges a patient for a medical psilocybin recommendation, either as an actual cash rate or, if the psilocybin provider or entity bills insurance, an average cash rate.
    Sec. 24.  NEW SECTION.  124F.23  Standard of care —— provider not liable —— no private right of action.
   1.  A qualified medical psilocybin provider or a qualified therapy provider who recommends or administers psilocybin in compliance with this chapter shall not be subject to a civil or criminal penalty, or license discipline, solely for violating a federal law or regulation that prohibits recommending, prescribing, possessing, or dispensing psilocybin or a psilocybin product.
   2.  This chapter shall not be construed to reduce or negate the duty of a qualified medical psilocybin provider or qualified therapy provider to use reasonable and ordinary care in the treatment of a patient.
    Sec. 25.  NEW SECTION.  124F.24  Nondiscrimination for use of psilocybin.
   1.  For purposes of medical care, including an organ or tissue transplant, a patient’s use of psilocybin as provided in this chapter is the equivalent of authorized use of any other medication used at the discretion of a physician, and does not constitute the use of an illicit substance or otherwise disqualify an individual from needed medical care.
   2.  a.  Except as provided in paragraph “b”, the state or a political subdivision of the state shall treat an employee’s use of medical psilocybin as provided in this chapter in the same way the state or political subdivision treats an employee’s use of any prescribed controlled substance, and an employee’s medical psilocybin recommendation from a qualified medical psilocybin provider in the same way the state or political subdivision treats an employee’s prescription for any prescribed controlled substance.
   b.  A state or political subdivision employee who has a valid medical psilocybin registration shall not be subject to adverse action for failing a drug test due to psilocybin or psilocin without evidence that the employee was impaired or otherwise adversely affected in the employee’s job performance due to the use of medical psilocybin. This paragraph shall not apply in any of the following circumstances:
   (1)  The employee’s use of psilocybin jeopardizes federal funding, a federal security clearance, or any other federal background determination required for the employee’s position.
   (2)  The employee’s position is dependent on a license or peace officer certification that is subject to federal regulations, including 18 U.S.C. §922(g)(3).
   (3)  An employee who uses medical psilocybin during the twelve hours immediately preceding the employee’s shift or during the employee’s shift.
   3.  An agency of this state or a political subdivision thereof, including any law enforcement agency, shall not remove or initiate proceedings to remove a child under the age of eighteen from the home of a parent based solely upon the parent’s possession or use of psilocybin as authorized under this chapter.
    Sec. 26.  NEW SECTION.  124F.25  Insurance —— coverage requirement.
   This chapter shall not be construed to require an insurer, a third-party administrator, or an employer to pay for or reimburse an employee for psilocybin or psilocybin product.
    Sec. 27.  NEW SECTION.  124F.26  Approved drugs.
   This chapter shall not be construed to restrict or otherwise affect the prescription, distribution, or dispensing of a product that the United States food and drug administration has approved.
    Sec. 28.  NEW SECTION.  124F.27  Qualified therapy provider registration —— continuing education —— psilocybin administration.
   1.  An individual shall not administer a medical psilocybin treatment unless the department registers the individual as a qualified medical psilocybin therapist as provided in this section.
   2.  The department shall, within fifteen days after the date the department receives an application from an individual, register and issue a qualified medical psilocybin therapist registration card to the individual if the individual does all of the following:
   a.  Provides to the department the individual’s name and address.
   b.  Provides to the department the address of the clinic at which the individual will be administering psilocybin to patients.
   c.  Provides to the department a report detailing the individual’s completion of the applicable continuing education requirements described in subsection 3.
   d.  Certifies to the department that the individual has installed and maintains an inventory control system.
   e.  Provides to the department evidence that the individual holds a license that qualifies the individual as a qualified medical psilocybin provider.
   f.  Pays an application fee as determined by the department by rule.
   g.  Provides to the department an emergency transport plan for patients who experience a medical emergency during the course of treatment.
   3.  a.  An individual applying for initial registration or renewal of a registration shall complete a continuing education program as determined by the department by rule. The continuing education program shall be offered by the department or a continuing education provider approved by the department. The continuing education program shall address all of the following:
   (1)  This chapter.
   (2)  General information about psilocybin under federal and state law.
   (3)  The latest scientific research on medical psilocybin, including risks and benefits.
   (4)  Best practices for recommending the form and dosage of psilocybin.
   (5)  Systems and receptors affected by psilocybin.
   (6)  Mechanisms of action.
   (7)  Drug interactions.
   (8)  Diagnostic criteria.
   (9)  Contraindications.
   (10)  Side effects and mitigation of side effects.
   (11)  Administrative set and setting, including physical patient safety.
   (12)  Integration.
   (13)  Potential outcomes.
   (14)  Ethical considerations.
   (15)  Discharge safety planning.
   b.  An applicant for initial registration shall complete eighty hours of continuing education. A qualified therapy provider shall complete four hours of continuing education every two years.
   4.  A qualified therapy provider shall only administer psilocybin to a patient when all of the following requirements are met:
   a.  The patient has a recommendation issued by a qualified medical psilocybin provider.
   b.  The qualified medical therapy provider has obtained and reviewed the patient’s mental health history.
   c.  The qualified therapy provider has provided the patient with a safety data sheet created by the department which outlines the potential risks of psilocybin use.
   d.  There are unexpired rescue medications on site, as determined by the department by rule.
   e.  The administration session is video-recorded and the video recording is preserved for one year from the date of the session, or the patient gives written, informed consent waiving the video-recording requirement.
   f.  The qualified therapy provider has a contractual relationship with a licensed physician and surgeon or osteopathic physician and surgeon who remains on call during the course of the administration session in case the patient requires nonemergency medical intervention.
   5.  A qualified therapy provider shall only administer psilocybin or a psilocybin product in a qualified therapy provider location.
   6.  a.  Except as provided in paragraph “b”, an individual shall not advertise that the individual administers medical psilocybin treatment.
   b.  A qualified therapy provider or clinic or office that employs a qualified therapy provider may advertise the following:
   (1)  The provider’s or clinic’s name and logo.
   (2)  That the individual is registered as a qualified therapy provider and administers medical psilocybin.
   (3)  A scientific study regarding medical psilocybin use.
   7.  a.  A qualified therapy provider registration card expires two years from the date the department issues the card.
   b.  The department shall adopt rules pursuant to chapter 17A for the renewal of a qualified therapy provider registration card.
   8.  Within seven days of the date on which an adverse event occurs, a qualified therapy provider shall submit to the department a report containing all of the following:
   a.  The age and sex of the patient.
   b.  The patient’s preexisting health conditions, if any.
   c.  The amount of psilocybin administered to the patient.
   d.  Factors which contributed to the adverse event.
   e.  The nature and severity of the adverse event.
   f.  The ultimate outcome of the adverse event.
   9.  The department may revoke a qualified therapy provider registration card if a qualified therapy provider fails to maintain compliance with this section.
    Sec. 29.  NEW SECTION.  124F.28  Qualified therapy provider agent —— registration.
   1.  An individual shall not act as a qualified therapy provider agent unless the department registers the individual as a qualified therapy provider agent, regardless of whether the individual is a seasonal, temporary, or permanent employee.
   2.  The department shall, within fifteen business days after the date the department receives a complete application from a qualified therapy provider agent, register and issue a qualified therapy provider agent registration card to the prospective agent who successfully passes a criminal background investigation as provided in section 124F.6 if the prospective agent does all of the following:
   a.  Provides to the department the prospective agent’s name and address.
   b.  Pays a fee to the department in an amount determined by the department by rule.
   3.  a.  A qualified therapy provider agent shall comply with either a certification standard developed by the department by rule, or a certification standard that the department has reviewed and approved.
   b.  A certification standard described in paragraph “a” shall include training in Iowa medical psilocybin law.
   4.  A qualified therapy provider agent registration card shall expire two years from the date the department issued the card. A qualified therapy provider agent may renew the agent’s registration card if the agent is still eligible to hold a qualified therapy provider agent registration card and pays a fee determined by the department by rule.
   5.  a.  A qualified therapy provider agent shall carry the individual’s qualified therapy provider agent card with the agent at all times when the agent is handling psilocybin or psilocybin product.
   b.  If a qualified therapy provider agent possesses psilocybin or psilocybin product and produces the registration card in the agent’s possession, there is a rebuttable presumption that the agent possesses the psilocybin or psilocybin product legally and a law enforcement officer does not have probable cause, based solely on the agent’s possession of the psilocybin or psilocybin product, to believe that the individual is engaging in illegal activity.
   c.  A qualified therapy provider agent who fails to carry the individual’s qualified therapy provider agent card with the agent as required by paragraph “a” is guilty of the following offenses:
   (1)  For a first offense, or a second offense within a two-year period, a simple misdemeanor punishable by a fine of one hundred dollars.
   (2)  For a third offense, or a subsequent offense within a two-year period, a simple misdemeanor.
   d.  For each violation of paragraph “c”, the department may assess the relevant qualified therapy provider a fine of up to two thousand five hundred dollars.
    Sec. 30.  NEW SECTION.  124F.29  Reports.
   1.  a.  On or before November 1, 2026, and by November 1 of each year thereafter, the department shall submit a report to the general assembly including all of the following:
   (1)  The number of patients for whom psilocybin has been recommended.
   (2)  The age and county of patients.
   (3)  The number of qualified medical psilocybin providers.
   (4)  The number of license applications and renewal applications received.
   (5)  The number of licenses the department has issued in each county.
   (6)  The number of licenses the department has revoked.
   (7)  The expenses incurred and revenues generated from the medical psilocybin program.
   (8)  The number and nature of adverse events reported.
   b.  The department shall not include personally identifying information in the report submitted pursuant to paragraph “a”.
   2.  The department shall submit a report to the general assembly regarding the efficacy of medical psilocybin, including recommendations, by June 1, 2028.
    Sec. 31.  NEW SECTION.  124F.30  Enforcement.
   1.  If a person that is licensed or registered under this chapter violates a provision of this chapter or rules adopted by the department pursuant to this chapter, or fails to comply with an enforcement action taken under this chapter, the department may do any of the following, subject to the requirements of this section:
   a.  Revoke the person’s license or registration card.
   b.  Decline to renew the person’s license or registration card.
   c.  Assess an administrative fee, as determined by the department by rule.
   2.  If the department finds that a person produced a psilocybin or psilocybin product batch that contains a substance, other than active psilocybin, that poses a significant threat to human health the department shall do all of the following:
   a.  Issue the person a written administrative citation.
   b.  Attempt to negotiate a stipulated settlement.
   c.  Seize, embargo, or destroy the psilocybin or psilocybin product batch.
   d.  Order the person to cease and desist from the action that creates a violation.
   3.  The department may, for a person subject to an uncontested citation, a stipulated settlement, or a finding of a violation in an adjudicative proceeding under this section, if a fine is not already specified by law, assess a person who is not an individual a fine of up to five thousand dollars per violation.
   4.  The department shall not revoke a license or registration issued under this chapter without first conducting a contested case proceeding pursuant to chapter 17A.
   5.  Except where a criminal penalty is expressly provided for a specific violation of this chapter, the following criminal penalties apply:
   a.  Except as provided in paragraph “b”, an individual who violates a provision of this chapter is guilty of a simple misdemeanor punishable by a fine of one hundred dollars.
   b.  An individual who intentionally or knowingly violates a provision of this chapter, or violates a provision of this chapter three or more times, is guilty of a serious misdemeanor punishable by a fine of one thousand dollars.
    Sec. 32.  NEW SECTION.  124F.31  Psilocybin and psilocybin products —— consumable goods —— rules.
   The department shall adopt rules pursuant to chapter 17A to allow for the production and sale of consumable goods containing psilocybin and psilocybin product.
    Sec. 33.  NEW SECTION.  124F.32  Contracts enforceable.
   It is the public policy of this state that contracts related to the production, sale, and administration of psilocybin pursuant to this chapter shall be enforceable. It is the public policy of this state that no contract entered into by a psilocybin production establishment, qualified medical psilocybin provider, or qualified therapy provider, or its employees or agents as permitted pursuant to a valid registration, or by an entity who allows property to be used by an establishment, qualified medical psilocybin provider, or qualified therapy provider, its employees, or its agents as permitted pursuant to a valid registration, shall be unenforceable on the basis that cultivating, obtaining, manufacturing, distributing, dispensing, transporting, selling, possessing, or using psilocybin is prohibited by federal law.
    Sec. 34.  PSYCHEDELIC COMPOUNDS —— STUDY.  The department of health and human services shall conduct a study regarding the use of psychedelic compounds other than psilocybin in the treatment of medical conditions. The department shall submit a report to the general assembly, including the department’s findings and recommendations, by January 1, 2027.
EXPLANATION
The inclusion of this explanation does not constitute agreement with
the explanation’s substance by the members of the general assembly.
   This bill relates to the production and administration of psilocybin. The bill requires a psilocybin production establishment or a qualified therapy provider location, defined in the bill, to include an inventory control system that tracks psilocybin product, defined in the bill, in real time; maintains access records; and includes a video recording system. The bill requires a psilocybin production establishment or qualified therapy provider location to allow the department of health and human services (department) to access the inventory control system at any time.
   The bill requires a state employer or political subdivision employer to inform an employee or prospective employee prior to assigning a duty related to the administration of the bill that the employee’s or prospective employee’s job duties may require the employee or prospective employee to engage in conduct in violation of the criminal laws of the United States.
   The bill creates within the department the psilocybin production establishment licensing board (board), with members appointed by the director of the department. The board shall consist of a member of the public with knowledge of psilocybin, a member with knowledge and experience in the pharmaceutical or nutraceutical manufacturing industry, a member representing law enforcement, a member who is a chemist or researcher with experience in manufacturing and who is associated with a research university, a member who has a background in fungus or mushroom cultivation and processing, and the director of the department or the director’s designee, who shall serve as the chairperson of the board and a nonvoting member, except in the case of a tied vote. The bill prohibits a person from serving on the board if the person has certain financial interests related to psilocybin. Members of the board shall serve a term of four years, except that initial members of the board shall be appointed for staggered terms such that the director appoints two or three board members every two years. The director shall fill vacancies in the board for the balance of the unexpired term. Members of the board shall serve without compensation, although they may be reimbursed for actual expenses, and the director may remove a member of the board for cause, neglect of duty, inefficiency, or malfeasance. The board is not subject to automatic dissolution pursuant to Code section 4A.5 (boards and governmental entities —— dissolution).
   The board shall meet as called by the chairperson to review psilocybin license applications, conduct public hearings on applications, and make determinations on license applications. The bill requires the board to meet if a psilocybin production establishment undergoes certain changes. The bill prohibits a person from operating a psilocybin production establishment unless the person holds a license issued by the board. The bill requires the department to adopt rules for solicitation and evaluation of license applications. The bill also requires an applicant for a license to submit the proposed name and address of the establishment, the names and addresses of certain persons associated with the establishment, an operating plan, a statement that the applicant will obtain a performance bond, an application fee, and a description of any investigatory or adverse action previously taken against the applicant in relation to any of the applicant’s psilocybin-related operations or businesses. The bill allows the board to issue a provisional license to an applicant who submits an application that does not include an address at which the establishment will be located. The bill prohibits a psilocybin production establishment from operating within 1,000 feet of a community location, defined in the bill, or 500 feet of an area that is zoned as primarily residential. The bill allows the board to waive these limitations by up to 20 percent.
   Upon approval of an application for a license, the bill requires the applicant to pay an initial licensing fee and the department to inform the department of public safety. The bill allows a psilocybin production establishment to be located at the same location as a medical cannabidiol producer and the board may grant preference to an applicant who currently holds a medical cannabidiol producer license. If the board receives more than one application for a psilocybin production establishment license in the same city or town, the board shall consult with the local land use authority prior to issuing a license. The bill prohibits the board from issuing a license to certain persons. The bill allows the board to revoke a license for certain violations. Fees collected by the department shall be deposited into the general fund of the state.
   If the municipality or county where the psilocybin production establishment will be located requires a land use permit, the bill requires a licensee to submit a copy of an approved land use permit within 120 days of issuance of the license. The bill prohibits the board from issuing more than four licenses to operate an independent psilocybin testing laboratory and allows the board to operate an independent psilocybin testing laboratory. A psilocybin production establishment is not transferable or assignable, and the board’s authority to issue a license is plenary and not subject to review. The bill requires the division of criminal investigation of the department of public safety to conduct a thorough investigation of each applicant for a psilocybin production establishment license. The bill requires the board to begin accepting license applications on July 1, 2027. The director of the department shall renew a license if the licensee continues to meet the requirements for initial licensure, the director does not identify a significant failure of compliance or grounds for revocation, and the licensee pays a renewal fee.
   The bill requires a person applying for a psilocybin production establishment license or license renewal to submit a proposed operating plan, including certain information about the facility, the facility’s officers and employees, a security plan, a description of the inventory control system, and storage protocols. The bill requires psilocybin cultivation facilities and psilocybin testing laboratories to submit additional information particular to the type of psilocybin production establishment.
   The bill prohibits a person from acting as a psilocybin production establishment or qualified therapy provider agent unless the person is registered as a psilocybin production establishment agent with the board. The bill prohibits certain persons from acting as a psilocybin production establishment agent. The bill requires the board to issue a psilocybin production establishment agent registration to a person if the psilocybin production establishment that will employ the agent submits an application and pays a fee on behalf of the person. The prospective agent shall also undergo a criminal background investigation. A psilocybin production establishment agent shall comply with a certification standard adopted by the board. A psilocybin production establishment agent registration is valid for two years and may be renewed. The bill requires a psilocybin production establishment agent to carry the agent’s registration card at all times while on the premises of the psilocybin production establishment or when transporting psilocybin. There is a rebuttable presumption a person carrying a psilocybin production establishment agent registration card while in possession of psilocybin possesses the psilocybin legally. A psilocybin production establishment agent who fails to carry a psilocybin production establishment agent registration card while required to do so is guilty of a simple misdemeanor punishable by a fine of $100 for a first or second offense in a two-year period and a simple misdemeanor punishable as provided by law for a third or subsequent offense in a two-year period. A simple misdemeanor is punishable by confinement for no more than 30 days and a fine of at least $105 but not more than $855. The board may fine a psilocybin production establishment or qualified therapy provider that employs a psilocybin production establishment agent a fine for each violation.
   The bill requires a psilocybin production establishment to operate in accordance with the operating plan submitted by the psilocybin production establishment and to inform the department prior to implementing any changes to the plan. The bill requires a psilocybin production establishment to operate in a facility that is accessible only by an individual with a valid psilocybin production establishment registration card, except that a psilocybin production establishment may authorize a person who is at least 18 years of age who is not a psilocybin production establishment agent to access the psilocybin production establishment if the psilocybin production establishment tracks and monitors the individual at all times. A psilocybin production establishment shall not employ a person who is under 21 years of age or who has been convicted of a misdemeanor for drug distribution or any felony. The bill requires a psilocybin production establishment to have a single, secure public entrance and a security system with a backup power source.
   The bill allows the department to inspect the facility and records of a psilocybin production establishment at any time during business hours. The bill grants certain investigational powers to the department and allows the department to impose a fee or suspend or revoke a license or registration for failing to comply with an inspection. The bill prohibits a psilocybin production establishment from advertising to the general public, except to advertise an employment opportunity. The bill requires the department to adopt rules for standards relating to advertisement by qualified medical psilocybin providers and qualified medical psilocybin therapists, defined in the bill.
   The bill prohibits a person other than a psilocybin production establishment agent, qualified therapy provider, qualified therapy provider agent, or an agent of the department conducting an inspection from transporting psilocybin. A person transporting psilocybin must possess a manifest including details about the psilocybin the person has been authorized to transport. A psilocybin production establishment agent who transports psilocybin without a manifest is guilty of a simple misdemeanor punishable by a fine of $100. A psilocybin production establishment who transports an amount of psilocybin in excess of the amount indicated in the manifest is subject to penalties as provided in Code chapter 124 (controlled substances). The bill requires a person disposing of psilocybin waste to render the psilocybin waste unusable and unrecognizable and to dispose of it in compliance with applicable state and federal law.
   The bill requires a local government to allow a psilocybin production establishment to operate in any zone designated for industrial or agricultural use, unless the local government has designated at least one industrial or agricultural zone for the operation of a psilocybin production establishment prior to the receipt of an application for the establishment of a psilocybin production establishment by the local government. The bill allows a psilocybin production establishment to operate on land that has not been zoned. The bill prohibits local governments from imposing certain restrictions on the establishment of a psilocybin production establishment.
   The bill requires a psilocybin cultivation facility to use unique identifiers to identify certain classifications of psilocybin. The bill prohibits a psilocybin cultivation facility from selling any product other than a psilocybin product or educational material related to psilocybin and from selling to a person other than a qualified therapy provider or a registered agent of a qualified therapy provider. The bill includes certain labeling requirements for psilocybin products.
   The bill requires the department to adopt rules for the testing of psilocybin by an independent psilocybin testing laboratory. The bill allows the department to require an independent psilocybin testing laboratory to test for a toxin if the department receives information about the presence of the toxin. The bill prohibits a psilocybin production establishment from transferring psilocybin to a qualified therapy provider until a sample of the psilocybin has been tested by an independent psilocybin testing laboratory. The bill allows the department to require an independent psilocybin testing laboratory to participate in a proficiency evaluation. If an independent psilocybin testing laboratory determines that a psilocybin product is unsafe for human use, the bill requires the independent psilocybin testing laboratory to inform the department and the psilocybin cultivation facility from which the batch originated, and the department shall place a hold on the sale and use of the psilocybin product until the department completes an investigation.
   The bill requires the department, in consultation with the departments of agriculture and public safety, to adopt rules for the creation and operation of an electronic verification system. The electronic verification system shall, at a minimum, allow a medical psilocybin provider to engage in patient management; allow access by the department and the department of inspections, appeals, and licensing; create a record each time a person accesses the system; and keeps a current record of the total number of individuals who have a psilocybin recommendation. The bill allows the department to release limited data from the electronic verification system for research, reporting, and official department purposes. A person who knowingly and intentionally releases information from the electronic verification system in violation of the bill is guilty of class “D” felony. A class “D” felony is punishable by confinement for no more than five years and a fine of at least $1,025 but not more than $10,245. A person who negligently or recklessly releases information from the electronic verification system in violation of the bill is guilty of a serious misdemeanor. A serious misdemeanor is punishable by confinement for no more than one year and a fine of at least $430 but not more than $2,560. A person who unlawfully obtains or attempts to obtain information from the electronic verification system is guilty of a class “D” felony.
   The bill prohibits a person from recommending the use of psilocybin unless the person is a qualified medical psilocybin provider, defined in the bill as a physician and surgeon or osteopathic physician and surgeon, a physician assistant, an advanced registered nurse practitioner, or an advanced practice registered nurse who is registered by the department to recommend treatment with psilocybin. The bill requires the department to issue a qualified medical psilocybin provider registration card to an individual if the individual submits an application, provides a report detailing the completion of continuing education requirements regarding the use of psilocybin listed in the bill, provides evidence that the person holds an appropriate license, and pays an application fee.
   The bill prohibits a qualified medical psilocybin provider from recommending the use of psilocybin unless the qualified medical psilocybin provider completes a thorough assessment of the patient’s condition and history, verifies that the patient is at least 21 years old, and meets with the patient in person if the qualified medical psilocybin provider has not previously recommended a psilocybin treatment to the patient. The bill places restrictions on advertisements by qualified medical psilocybin providers. A qualified medical psilocybin provider registration card expires after two years and may be renewed. The bill allows the department to revoke a qualified medical psilocybin provider registration card for failure to comply with the bill. The bill prohibits a qualified medical psilocybin provider from receiving compensation from certain persons involved in the production of psilocybin. A qualified medical psilocybin provider shall not be subject to a professional, civil, or criminal penalty solely for violating a federal law or regulation that would prohibit recommending, prescribing, possessing, or dispensing psilocybin.
   The bill prohibits discrimination against a person in the provision of medical care, including organ or tissue transplantation, on the basis of the usage of psilocybin as provided in the bill. The bill also prohibits the state or a political subdivision of the state from discriminating against an employee on the basis of the employee’s use of psilocybin as provided in the bill except under certain circumstances, as provided in the bill, and from removing a child from the home of a parent on the basis that the parent uses or possesses psilocybin as authorized by the bill.
   The bill does not require an insurer, a third-party administrator, or an employer to pay or reimburse for psilocybin. The bill does not restrict the prescription, distribution, or dispensing of a product that the United States food and drug administration has approved.
   The bill prohibits a person from administering a psilocybin treatment unless the department registers the person as a qualified medical psilocybin therapist, defined in the bill as a physician and surgeon or osteopathic physician and surgeon, a physician assistant, an advanced registered nurse practitioner, an advanced practice registered nurse, a psychologist, or a social worker. The department shall register a person as a qualified medical psilocybin therapist if the person submits an application, provides the address of the clinic where psilocybin will be administered, provides a report detailing the completion of continuing education requirements regarding the use of psilocybin listed in the bill, certifies that the individual has an inventory control system, provides evidence that person has an appropriate license, pays an application fee, and provides an emergency transport plan. A qualified medical psilocybin therapist shall not administer psilocybin to a patient unless the patient has a recommendation issued by a qualified medical psilocybin provider, the qualified medical psilocybin therapist has reviewed the patient’s mental health history, the qualified medical psilocybin therapist has provided the patient with a safety sheet created by the department, there are unexpired rescue medications on site, the administration session is video-recorded, and the qualified medical psilocybin therapist has a contractual relationship with a licensed physician and surgeon or osteopathic physician and surgeon who remains on call during the course of the administration session in case a patient requires nonemergency medical intervention.
   A qualified therapy provider shall only administer psilocybin in a qualified therapy provider location. The bill places limits on advertising by qualified therapy providers. A qualified therapy provider registration expires after two years and may be renewed. The bill requires a qualified therapy provider to submit a report to the department within seven days after the occurrence of an adverse event, defined in the bill. The bill allows the department to revoke a qualified therapy provider registration if a qualified therapy provider fails to maintain compliance with the requirements of the bill.
   The bill requires the department to submit a report to the general assembly on or before November 1, 2026, and annually by November 1 thereafter, regarding participation in the medical psilocybin program. The bill also requires the department to submit a report regarding the medical efficacy of psilocybin to the general assembly, including recommendations, by June 1, 2029.
   The bill grants the department enforcement authority for the enforcement of the bill, including by disciplining licenses and registrations, imposing fees, and seizing and destroying psilocybin. The department shall not revoke a license or registration issued pursuant to the bill without first conducting a contested case proceeding.
   The bill requires the department to adopt rules to allow for the production and sale of consumable goods containing psilocybin and psilocybin product. The bill makes a statement of state policy that contracts related to the production, sale, and administration of psilocybin pursuant to the bill are enforceable.
   The bill requires the department to conduct a study regarding the use of psychedelic compounds other than psilocybin in the treatment of medical conditions. The department shall submit a report to the general assembly, including its findings and recommendations, by January 1, 2027.
   A person who violates a provision of the bill for which another penalty is not provided is guilty of a simple misdemeanor punishable by a fine of $100, except that a person who intentionally or knowingly violates a provision of the bill for which no other penalty is provided three or more times is guilty of a serious misdemeanor punishable by a fine of $1,000.