SB 23-290 Overview & Introduction
Slide 1
Natural Medicine Division
Listening Sessions
SB 23-290 Overview & Introduction
Dominique Mendiola, Senior Director, Department of Revenue Natural Medicine Division
Allison Robinette, Director of Policy & Regulatory Affairs, Department of Revenue Natural Medicine Division
Slide 2
Agenda
September 5, 2023
- Introduction to Natural Medicine Division (Division)
- Presentation of SB 23-290
- Statutory Responsibilities Assigned to DOR
- Overview of Priority Focus Areas presented to the Natural Medicine Advisory Board
- Anticipated Implementation Timeline
- Q & A Opportunity - Priorities & Implementation
- Listening Session Overview & Schedule
- Topics
- September Schedule
- Q & A Opportunity - Listening Sessions
Slide 3
Natural Medicine Division
Introduction
Heidi Humphreys, State Licensing Authority (Interim DOR Executive Director)
Dominique Mendiola, Senior Director
Kyle Lambert, Deputy Senior Director
Allison Robinette, Director of Policy & Regulatory Affairs
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Cash Funded Program
Staffing - Leveraging Existing State Resources & Subject Matter Expertise
Coordination with Other State Agencies
Programming - Integrating New Licensing Functions into Existing Platforms
Slide 4
DOR-MED Areas of Expertise
- Cultivation & Manufacturing Oversight: Security requirements; permitted and prohibited chemicals; waste management; packaging & labeling; keeping pace w/innovation
- Inventory Tracking: Manifest requirements
- Health & Safety Protocols: Adverse Health Event Reporting
- Data Driven Strategies: Market data monitoring, risk-based intervention strategies
- Licensing Application Development & Procedures: Licensing processes for cultivation, manufacture, transport, and testing operations
- Laboratory Testing Program Oversight: Testing standards & Certification processes
- Regulatory Oversight Involving Schedule I Controlled Substances: Experience navigating challenges with federal law and opportunity to inform a federal framework
- Social Equity Considerations: Lessons learned / Impacts from the War on Drugs
Slide 5
Prop 122 to SB 23-290
Signed May 23, 2023
Natural Medicine Defined
- Psilocybin & Psilocyn (Initially)
- Ibogaine (Prior to 2026)
- DMT, Mescaline (2026)
Primary Code Changes
- Title 12
- Title 25
- Title 44
- Titles 16 & 18
Outline of Provisions
- DORA Regulatory Program
- DOR Regulatory Program
- CDPHE Regulatory Role
- Personal Use Provisions
Implementation Timeline Extended
- Extended Timeline for Rulemaking & Applications
Slide 6
SB 23-290
Regulatory Program - DOR
The Department of Revenue (DOR) is responsible for licensing and regulating healing centers, cultivations, manufacturers, and testing facilities under a new Natural Medicine Division.
Other responsibilities include:
- Testing Program (coordination with CDPHE)
- Data collection (LE incidents, adverse health events, healthcare system impacts, consumer protection claims, behavioral health impacts)
- Public education campaigns
- Training materials for first and multi-responders
- Annual Reporting (in coordination with DORA)
Slide 7
State Licensing Authority
Powers & Duties
- Application Intake: On or before December 31, 2024
- Licensing and Enforcement powers
- Reporting, Public Education, & Training duties
- Other Duties & Limitations:
- Establish an equitable and inclusive program
- Measures to prevent youth access
- Production management
- Measures to prevent exploitation & commercialization
Slide 8
State Licensing Authority
Rulemaking Authority
Mandatory Rulemaking: The State Licensing Authority shall promulgate rules…
- General licensing requirements; qualifications and eligibility requirements for licensure; permitted and prohibited financial interests; testing program; regulation of licensed premises; transportation requirements; production management; record keeping; etc.
Other Requirements & Limitations:
- SLA shall consult with the Natural Medicine Advisory Board when considering and promulgating rules
Slide 9
Priority Focus Areas
Presented to the Natural Medicine Advisory Board
Slide 10
Priority Focus Areas
- Data Collection
- Develop and promote training materials for first responders and multi-responders
- Permissible / Prohibited Financial Interests in a License
- Regulation of Licensed Premises
- Product Requirements and Restrictions
- Develop and promote public education campaigns
- Natural Medicine Cultivation
- Manufacturing of Natural Medicine Products
- Storage and Transport
- Licensing Standards & Qualifications
Slide 11
Anticipated Implementation Timeline
| Task / Milestone | Goal Timing |
|---|---|
Data Collection & Reporting Requirements
| July-December 2023 |
Initial Fact Finding Work Groups Focused On:
| July-December 2023 |
Rulemaking
| January 2024 - June 2024 |
Natural Medicine Advisory Board Consultation
| January / February / March 2024 NMAB meeting |
Slide 12
| Task / Milestone | Goal Timing |
|---|---|
Rulemaking
| March 1, 2024 |
Rulemaking
| March 25, 2024 |
Rulemaking
| April 14, 2024 |
Rulemaking
| May 1, 2024 |
Rulemaking
| June 14, 2024* *Even with earlier effective date, may not being accepting applications before December 31, 2024 |
Slide 13
Q & A Opportunity
Focus Areas & Implementation
Slide 14
Listening Sessions Schedule
September
- September 12th: First & Multi-Responder Training Meeting #1
- 2:00 pm - 3:00 pm (MDT)
- September 22nd: Public Education Campaign Meeting #1
- 2:00 pm - 3:00 pm (MDT)
- September 27th: Testing Program Meeting #1
- 10:00 am - 11:00 am (MDT)
- October 3rd: Cultivation & Manufacturing Practices Meeting #1
- 10:00 am - 11:00 am (MDT)