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Advisory Board

DOR Overarching Questions for Board Consideration

July 21, 2023

Natural Medicine Advisory Board Meeting
DOR Presentation - Dominique Mendiola & Allison Robinette

 

The Natural Medicine Division works closely with DORA and the Natural Medicine Advisory Board, facilitated by DORA. For additional information about the Natural Medicine Advisory Board, please visit the DORA Website.

Introduction

The Department of Revenue’s Natural Medicine Division (DOR) created this resource to inform and support the DOR’s consultation with the Natural Medicine Advisory Board (Board) regarding the DOR’s implementation of SB23-290. As the DOR prepares for rulemaking (including stakeholder engagements/work groups to be announced in the coming weeks), the DOR’s goal is to complement the work of DORA and the Board.

Priority Areas of Focus

Priority Areas of Focus for the DOR include:

  • Subjects on which the Board is expressly directed to provide recommendations (12-170-106, C.R.S.); and

  • Mandatory rulemaking subjects SB23-290 expressly assigned DOR (44-50-203, C.R.S.)

Examples of subjects the DOR will seek Board and other stakeholder feedback are reflected in the table below.

Additional Context

While DORA is assigned to regulate Facilitator licensees, the DOR Natural Medicine Division is responsible for regulating Healing
Centers and other Natural Medicine entity license types (e.g. cultivations, manufacturing facilities, testing facilities). However, there
may be certain aspects of regulation that overlap between Facilitators and Healing Centers. Having clarity from the Board of where
those lines should be drawn will help guide the DOR in its rulemaking.

  • Example: Board recommendations related to Facilitator record keeping/retention may also inform the types of records Healing Centers are required to retain (such as a participant’s medical history or consent documentation when Administration Sessions are held at a Healing Center).

The DOR recognizes that Board members are already conducting work on subjects relevant to the DOR’s implementation
responsibilities. The DOR is not asking the Board to deviate from its ongoing work. Rather, the goal is to ensure awareness of and
support the Board’s work in areas that are directly relevant to the DOR’s implementation.

Information regarding upcoming stakeholder meetings associated with DOR’s implementation of SB23-290 will be published on the DOR’s Natural Medicine Division website.

Thank you for your service on the Natural Medicine Advisory Board.

 

DOR - Natural Medicine Division
Initial Focus Areas for Board Recommendations

The below Rulemaking Topics were presented to the Natural Medicine Advisory Board on the dates below:

Rulemaking Topics were presented to the Natural Medicine Advisory Board on July 21, 2023
Rulemaking TopicConsiderations & Questions
for Board Recommendations
Data Collection
(for annual reporting)

Consideration(s):
Statute requires the following of DOR: In coordination with other agencies, the SLA shall request data concerning LE incidences / adverse health events / impacts to health care systems / consumer protection claims / and behavioral health impacts.
See § 12-170-106(5)(h)

Question(s): What other data will be useful to measure implementation of the
program? For example:

  • Should DOR require applicants / licensees provide data such as demographic data?
  • Is there specific market data that should be collected and reported on? See MED Market Data Dashboard.
Develop and promote training materials for first responders and multi-responders

(Law enforcement, emergency medical
providers, social service providers, fire
fighters)

Consideration(s):
To support efficient and effective implementation:

  • Identify other agency / organization partnership and collaboration opportunities & existing training programs / relevant materials for first- and multi-responders

See § 12-170-106(5)(a)
 

Question(s):

  • Through the lens and perspectives of indigenous, religious, and spiritual use of natural medicines: Are there specific types of training / subject-matter that should be incorporated into training materials the DOR Natural Medicine Division makes available to first / multi - responders?
  • What information is most critical for:
    • Law enforcement and Fire Fighters
    • Emergency Medical Providers
    • Social Service Providers
    • Other public health / safety / emergency response teams
  • Response considerations for Administration Sessions at a Healing Center vs. a session occurring at a private residence (or other location)?
Permissible / Prohibited Financial Interests in a License

Consideration(s):
Statute mandates the following: A person cannot have a financial interest in more than five (5) Natural Medicine business licenses

Question(s):

  • Beyond the limitation regarding ownership of more than five (5) entity licenses, are there certain financial interests (e.g. in a Healing Center or other entity license type) that should be expressly permitted or prohibited?
Regulation of Licensed Premises

Consideration(s):
Statute allows co-location of a Healing Center with another Healing Center or
Health-Care Facility.

Question(s):

  • Are there specific permissive or prohibited activities that should be expressly addressed in rules for Healing Centers, Cultivations, Manufacturers, and/or Testing Facilities? For example, separation of cultivation and manufacturing activities
  • What are the various environments that potential facilitators and participants want to create within Healing Centers? Added Aug. 1, 2023
Product Requirements and
Restrictions

Consideration(s):

  • Ensuring youth access prevention measures
  • No misappropriation and exploitation of indigenous cultures
  • Traditional methods of consumption / other consumption trends and the
  • Types of products available / expected to be common for consumption in Administration Sessions
  • Limitations in categories / servings of products permitted to be manufactured or provided in Administration Sessions


Question(s):

  • What are appropriate manufacturing requirements for the manufacture of regulated natural medicine products? For example cGMP requirements.

 

Additional Rulemaking Topics were presented to the Natural Medicine Advisory Board on August 1, 2023
Rulemaking TopicConsiderations & Questions
for Board Recommendations
Develop and promote public
education campaigns

Considerations:
Statute expressly includes: public service announcements, educational materials, and crisis response materials. See § 12-170-106(5)(a)

Question(s):

  • What information is most critical for a participant, a non-facilitator employee, or interested community members to know to establish foundational education, where needed?
Natural Medicine Cultivation

Considerations:
For initial implementation, DOR is focused on cultivation standards and requirements for psilocybin and psilocin.

Question(s):

  • Should cultivation of psilocybin be limited by strain / species?
Manufacturing of Natural Medicine
Products

Considerations:
For initial implementation, DOR is focused on manufacturing standards and
requirements for psilocybin and psilocin.

  • What types of products have been traditionally used?

Question(s):

  • What types of products should be permitted within the regulated space?
  • What are the emerging product types and should those emerging products be subject to more stringent or additional
Storage and Transport

Question(s):

  • What is an appropriate method of measurement of Regulated Natural Medicine or Regulated Natural Medicine Product for transportation between licensed facilities, such as between a manufacturing facility and a Healing Center
  • Should there be a limit on on-hand Natural Medicine that a cultivation, manufacturer, or Healing Center can maintain at any given time?