Relating to the production of psilocybin and the administration of psilocybin to persons with post-traumatic stress disorder, and providing penalties

This bill relates to the production of psilocybin and administration of psilocybin to persons with post-traumatic stress disorder. 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.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 and annually to consider license renewal applications. 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 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 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, 2026. The board shall renew a license if the licensee continues to meet the requirements for initial licensure, the board 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 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 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 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 limits the number of psilocybin recommendations in the state to 5,000 patients. An individual’s psilocybin recommendation expires if the individual has not received treatment from a qualified therapy provider with psilocybin or a psilocybin product by the later of one year from the day a qualified medical psilocybin provider provided the recommendation or one year from the day of the individual’s most recent administration of psilocybin or a psilocybin product by a qualified therapy provider. 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 has post-traumatic stress disorder, verifies that the patient is at least 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. 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, 2025, and annually by November 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, 2028. 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. 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.