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Natural Medicine Division

Listening Sessions

Catch-All

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Dominique Mendiola, Allison Robinette, Kyle Lambert, Amelia Myers�Department of Revenue Natural Medicine Division

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Agenda

February 23, 2024

  1. Welcome Back
  2. Overview of Statutory Authority & Rulemaking
  3. Recap of Prior Work & Updates
  • Discussion
    • Licensing Considerations
    • Inventory Tracking
    • Packaging & Labeling
    • Open Discussion
  • Next Steps

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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

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  • Outline of Provisions
    • DORA Regulatory Program
    • DOR Regulatory Program
    • CDPHE Regulatory Role
    • Personal Use Provisions
  • Implementation Timeline Extended
    • Extended Timeline for Rulemaking & Applications

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State Licensing Authority

Powers & Duties

  • Application Intake: On or before December 31, 2024
  • Licensing and Enforcement powers
  • Reporting, Public Education, & First Responder Training duties
  • Other Duties & Limitations:
    • Establish an equitable and inclusive program
    • Establish a testing program
    • Measures to prevent youth access
    • Production management
    • Measures to prevent exploitation & commercialization

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State Licensing Authority

Rulemaking Authority

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Licensing & Equity:

  • Licensing procedures
  • Qualifications & eligibility requirements
  • Permissible & prohibited financial interests
  • Environmental, social, and governance criteria

Inventory Tracking:

  • Limits on transportation
  • Limits on the amount allowed to produce
  • Requirements of licensees to track and manage inventory

Packaging & Labeling:

  • Standards avoiding misappropriation, exploitation, and excessive commercialization
  • Including warning labels, serving sizes, per-package serving amounts, and concentration of product

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Recap of Prior Work & Updates

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Previous Listening Sessions (Materials & Recordings Available on Division Website)

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Licensing Considerations

  • What kind of information should applicants be required to submit regarding financial interests?
  • If the Department has the authority to limit the number of cultivation and manufacturing licenses issued, should it?
  • Is a tiered model for cultivation an appropriate strategy to proactively address concerns related to overproduction?
  • Are there any unique concerns or considerations to allowing a cultivation facility or manufacturing facility to co-locate with other license types (For example, occupational health and safety concerns).
  • Occupational Licensing: Should the Division consider incorporating any aspects of Oregon’s established framework for issuing worker permits? See Rule 475A.480
  • Equity Considerations: Should applicants for Natural Medicine Operation licenses be required to submit a Equity Impact Plan with initial and renewal applications? (For example: Outlining how the licensee will support equity and inclusion while avoiding commercialization and exploitation).

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We are taking a 10-minute break and will be back at

10:35

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Inventory Tracking

  • What inventory tracking mechanisms used by other industries could serve as a model for tracking regulated natural medicine?
  • At what point should regulated natural medicine be required to be tracked? (For example: from inoculation through administration vs. from harvest through administration).
  • How should the Division track any natural medicine that is ultimately not administered during an administration session? For example, how should licensees handle any natural medicine that is left after an administration session?

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Packaging & Labeling

  • What information will be most critical for facilitators and participants to have access to on the label of regulated natural medicine and regulated natural medicine products?
  • What information would be critical for first responders or other emergency response professionals to have access to? Should this information also be on the label?

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Final Thoughts & Discussion

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Wrap Up & Next Steps

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