The Latest Effort to Legalize Psychedelic Services in California
In October 2023, California Governor Newsom vetoed Senate Bill (“SB”) 58, proposed by Senator Scott Wiener, which aimed to decriminalize the personal use of certain psychedelics and lay the groundwork to build a regulated adult-use program where individuals could consume psychedelics under the supervision of a licensed facilitator.
In his veto letter, Governor Newsom asserted that psychedelic therapy is “an exciting frontier and California will be on the front-end of leading it.” However, the governor decided to veto Senator Wiener’s bill because it would have decriminalized personal possession of psychedelics before setting up guidelines for psychedelic use in a regulated treatment setting.
Governor Newsom urged the legislature to present updated legislation in 2024 that “includes therapeutic guidelines” and stated he is willing to consider “potential broader decriminalization in the future” once best practices and safety guardrails are implemented. In response to the Governor’s request, Senator Wiener introduced SB 1012 for consideration in the current legislative cycle.
SB 1012 aims to legalize the use of certain psychedelic substances for therapeutic purposes under the supervision of a licensed facilitator, and would create a state licensing board to oversee the licensing and regulation of professional facilitators. Contrary to SB 58, SB 1012 would not permit the personal possession, use, or sale of psychedelics outside of a regulated therapeutic framework.
Rulemaking is Underway to Establish the Details for Colorado’s Natural Medicine Program
In November 2022, the State of Colorado passed the Natural Medicine Health Act, which decriminalized certain psychedelic substances and created a legal supervised-use natural medicine program. In May 2023, Colorado Governor Jared Polis signed SB 23-290 into law, which provided additional clarification and regulations to govern the natural medicine program.
Two Colorado state agencies, the Colorado Department of Regulatory Agencies (DORA) and Colorado Department of Revenue (DOR), are in the midst of the rulemaking process to design and implement the rules which will govern the structure and requirements of the program.
DORA is responsible for creating and implementing rules surrounding facilitator qualifications and practice guidelines, and DOR is responsible for creating and implementing the rules that regulate natural medicine businesses, including healing centers, cultivators, manufacturers, and testing facilities.
In February 2024, DORA published draft rules covering several key topics relating to facilitator requirements. These rules are statutorily required to be finalized and made effective by December 31, 2024.
DOR also recently launched its public rulemaking process and published its first draft rules for licensing application requirements and procedures. DOR will host several additional rulemaking meetings on various topics between now and July 2024, which will provide greater detail on the scope of the licensing rules that will apply to operators across the natural medicine supply chain. DOR’s listening sessions allow the public to review and provide feedback on all of these proposed rules before they are finalized, which DOR is striving to complete by October 1, 2024.
Importantly, the rules published by both DORA and DOR thus far are simply drafts, and are subject to change in response to feedback received throughout the rulemaking process. Nonetheless, these draft rules provide useful guidance for understanding how the natural medicine program will operate.
The following provides a high-level overview of key topics covered in the current version of the draft rules that aspiring facilitators, training programs, and business operators should be aware of.
Proposed Facilitator Types, Licensure Pathways & Scope of Practice
- DORA is proposing two main facilitator license types: “Facilitator” and “Clinical Facilitator”.
- Generally, both “Facilitators” and “Clinical Facilitators” must be 21 years of age or older, provide proof of Basic Life Support (BLS) certification, and complete at least 150 hours of didactic instruction, 40 hours of supervised practicum experience, and 50 hours of consultation.
- A Clinical Facilitator license will be available to individuals who hold an active secondary license in Colorado that involves diagnosing and treating medical or mental health conditions (e.g., psychologists, social workers, nurse practitioners, and the like).
- Facilitators are authorized to provide natural medicine services to participants who do not have certain risky medical and physical conditions (such as seizure disorders, cardiovascular disease, and schizophrenia), unless the participant received a direct referral for natural medicine services or received clearance from their medical provider. Facilitator licensees may not independently engage in the “practice of medicine” or “psychotherapy”.
- Clinical Facilitators may provide natural medicine services to participants for the purpose of treating mental or physical conditions within the scope of their secondary license.
- A temporary “Training License” will be available to students who have completed the 150-hour education and Basic Life Support (BLS) certification requirements, and engage in consultation with “an individual experienced in the provision of natural medicine services” for a minimum of 50 hours over 6 months.
- A “Distinguished Educator” license will provide a licensure pathway for individuals from other jurisdictions with extensive professional experience.
- Licenses can be obtained through either an “Original Licensure” pathway, for all general applicants, or an “Accelerated Licensure” pathway, for applicants with transferable qualifications and experience, including legacy healers.
- The “Occupational Credential Portability Program” proposes to enable individuals who have held a facilitation license in another state for one year to achieve licensure by endorsement.
Proposed Requirements for Facilitator Training Programs
- Facilitator training programs curriculums must offer at least 150 hours of didactic education on a range of topics, including, but not limited to: ethics, relational boundaries, suicide risk, trauma informed care, and preparation, administration, and integration.
- There must be a minimum of two full-time faculty members, including at least one licensed Facilitator and Director, plus a sufficient number of faculty with ranging expertise.
- Training program Directors must hold an active Facilitator license, or hold a secondary professional license that would qualify for licensure as a Clinical Facilitator.
- Before the full approval process is implemented, training programs may request pre-approval by submitting the same fees and information required for approval.
- Training programs must receive approval before offering classes. Training programs with pre-approval may operate and offer courses.
A Sample of General Licensing Requirements
- An “Employee License” issued by the Natural Medicine Division is required for all individuals with unrestricted access to the licensed premises of a Natural Medicine Business or handle “Regulated Natural Medicine Product”.
- Applications for “Natural Business Licenses” must include, among other things, a premises diagram demonstrating that the proposed location conforms with local zoning regulations and security and surveillance plan for premises.
- An Owner of a Natural Medicine Testing Facility may not hold any financial interest in a Healing Center, Natural Medicine Cultivation Facility, or Natural Medicine Product Manufacturer.
- The Division of Natural Medicine may prioritize business license applications from applications that include: one or more owners of traditional, tribal, or indigenous history with Natural Medicine; one or more owners who are veterans; or a Community Impact Plan demonstrating that the Natural Medicine Business will serve a rural community, offer discounted or free natural medicine services, or include sustainability measures to minimize adverse environmental impacts associated with natural medicine operations.
- An Owner may have a financial interest in no more than five Natural Medicine Business Licenses.
- Facilitators and Clinical Facilitators may hold financial interests in healing centers.
- Distinguished Educators and Student Facilitators are not eligible to own a healing center, unless they have contracted with or employ a Facilitator or Clinical Facilitator.
Anticipated Rulemaking Timeline
From March until July 2024, DOR will host several formal rulemaking sessions to discuss draft rules covering various aspects of the natural medicine program, and provide opportunities for the public to provide stakeholder comments. DOR is striving to finalize all rules by October 1, 2024, and DORA must open facilitator license applications by December 31, 2024. Below is a timeline of key dates that will provide greater insight and detail into how the natural medicine program will operate, and what will be required of the various types of licensees.
- March 20, 2024 – DOR rulemaking hearing to discuss Licensing & Application Requirements & Procedures
- May 1, 2024 – DOR rulemaking hearing to discuss Healing Center Requirements
- May 22, 2024 – DOR rulemaking hearing to discuss Advertising, Packaging & Labeling, Recordkeeping Requirements
- June 12, 2024 – DOR rulemaking hearing to discuss Cultivation & Manufacturing Requirements
- June 25, 2024 – DOR rulemaking hearing to discuss Testing Requirements & Testing Facilities
- July 1, 2024 – DOR rulemaking hearing to discuss Fees, Enforcement, Discipline
- October 1, 2024 – DOR’s target effective date for all rules governing the requirements and procedures governing natural medicine businesses, including healing centers, cultivators, manufacturers, and testing facilities.
- December 31, 2024 – The date by which the rules must be effective and applications must open for natural medicine facilitators.
- December 31, 2024 – Colorado Department of Public Health and Environment is anticipated to issue testing and laboratory rules informed by the DOR’s workgroup session on the topic.
- March 31, 2025 – The date by which the Office of Natural Medicine expects to establish the full approval process for facilitator training programs. Training programs may submit a request for pre-approval to the Office of Natural Medicine by submitting the same fees and information required for approval before this time.
Manzuri Law Psychedelic Law Firm
Manzuri Law’s team of California psychedelic attorneys is keeping a close eye on the trajectory of proposed rules and legislation that will affect facilitators and operators in the budding psychedelic markets in Colorado and California.
Contact Manzuri Law with any questions regarding the scope of commercial opportunity in these markets, the expected timeline for rulemaking and implementation, or how these rules may affect you.