1 Colo. Code Regs. § 213-1-1-1025
Basis and Purpose - 1025
The statutory authority for this rule includes but is not limited to sections 44-50-103, 44-50-202(1)(b), 44-50-203(1)(d), 44-50-203(1)(n), 44-50-203(2)(a), 44-50-203(2)(g), and 44-50-203(2)(r), C.R.S. The purpose of this rule is to provide necessary definitions of terms used throughout the Rules. Defined terms are capitalized where they appear in the Rules to let the reader know to refer back to these definitions. When a term is used in a conventional sense, and is not intended to be a defined term, it is not capitalized.
"Administration Area" means a designated and secured area within the Licensed Premises of a Healing Center where Regulated Natural Medicine and Regulated Natural Medicine Product may be stored and transferred to a Participant, where a Participant may consume Regulated Natural Medicine and Regulated Natural Medicine Product, and where Administration Sessions may take place. The Administration Area may not be part of the Restricted Area.
"Administration Session" means a session conducted at a Healing Center or another location as allowed by article 170 or article 50 of title 44 during which a participant consumes and experiences the effects of Regulated Natural Medicine or Regulated Natural Medicine Product under the supervision of a Facilitator.
"Adverse Health Event" means any untoward and unexpected health condition or medical occurrence associated with the use of natural medicine or natural medicine product. An adverse event or suspected adverse reaction is considered "life-threatening" if its occurrence places the participant at immediate risk of death. It does not include an adverse event or suspected adverse reaction that, had it occurred in a more severe form, might have caused death. An adverse event or suspected adverse reaction is considered "serious" if it results in any of the following outcomes: Death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, or a congenital anomaly/birth defect. Important medical events that may not result in death, be life-threatening, or require hospitalization may be considered serious when, based upon appropriate medical judgment, they may jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the outcomes listed in this definition.
"Applicant" means an individual or entity that submitted an application under these rules and the Natural Medicine Code that was accepted by the Division for review but has not been approved or denied by the State Licensing Authority.
"Child Resistant" means special packaging that is:
This Rule definition does not include any later amendments or editions to the Code of Federal Regulations. The Division maintains copies of 16 C.F.R. 1700.15 (1995) and 16 C.F.R. 1700.20 (1995), at 1697 Cole Boulevard, Suite 200, Lakewood, Colorado, 80401, which are available to the public for inspection during the Division's regular business hours.
"Code" means the Natural Medicine Code at sections 44-50-101, et seq., C.R.S.
"Division" means the Department of Revenue Natural Medicine Division.
"Facilitator" means a natural person who is 21 years of age or older, has the necessary qualifications, training, experience, and knowledge to perform and supervise natural medicine services for a participant, and is licensed by the director of the division of professions and occupations to engage in the practice of facilitation.
"Final Agency Order" means an order of the State Licensing Authority issued in accordance with the Natural Medicine Code and the state Administrative Procedure Act. The State Licensing Authority will issue a Final Agency Order following review of the Initial Decision and any exceptions filed or at the conclusion of the declaratory order process. A Final Agency Order is subject to judicial review under section 24-4-106, C.R.S.
"Financial Interest" means entitlement or agreement to receive a portion of revenue, proceeds or profits from a Natural Medicine Business or a Natural Medicine Business Applicant; or a membership interest, partnership interest or other ownership interest, including but not limited to a share of stock, in a Natural Medicine Business or Natural Medicine Business Applicant.
"Fruiting Body(ies)" means the spore producing organs of the fungi Psilocybe cubensis.
"Harvest Lot" means a specifically identified quantity of Fruiting Bodies that is cultivated from the same Inoculation and dried under the same conditions and harvested in the same area within the Licensed Premises, that may be partially harvested, and may use the substrate material for multiple harvests. A Harvest Lot must not contain more than 1.000 kilogram by dry weight.
"Healing Center" means a facility where an entity is licensed by the State Licensing Authority pursuant to article 50 of title 44 that permits a Facilitator to provide and supervise Natural Medicine Services for a Participant.
"Inoculation" means the process by which spores or mycelium is introduced to a substrate for cultivation of fungus. Any Fruiting Bodies that are produced from the resulting colonized substrate will be considered the same Harvest Lot.
"License" means a license, permit, or registration pursuant to the Natural Medicine Code.
"Licensed Premises" means the premises specified in an application for a license pursuant to this article 50 that the Licensee owns or is in possession of and within which the Licensee is authorized to cultivate, manufacture, test, store, distribute, transport, transfer, or dispense Regulated Natural Medicine or Regulated Natural Medicine product in accordance with the Natural Medicine Code.
"Licensee" means a person licensed, registered, or permitted pursuant to the Natural Medicine Code or rules promulgated pursuant to article 50.
"Local Jurisdiction" means a county, municipality, or city and county.
"Mycelium" means the fungal threads or hyphae of Psilocybe cubensis.
"Natural Medicine" has the same meaning as in section 44-50-103(13), C.R.S.
"Natural Medicine Business" means any of the following entities licensed pursuant to the Natural Medicine Code:
"Natural Medicine Cultivation Facility" means a location where Regulated Natural Medicine is grown, harvested, and prepared in order to be transferred and distributed to either a Healing Center, Facilitator, a Natural Medicine Products Manufacturer, or to another Natural Medicine Cultivation Facility.
"Natural Medicine Handler License" means a license issued by the State Licensing Authority pursuant to the Natural Medicine Code, to a natural person who is not an Owner. Any natural person who is not an Owner, who has unrestricted access to Regulated Natural Medicine or Regulated Natural Medicine Product or handles Regulated Natural Medicine or Regulated Natural Medicine Product must hold a Natural Medicine Handler License. For purposes of these Rules, handling Regulated Natural Medicine or Regulated Natural Medicine Product means the cultivation, manufacturing, testing, storage, distribution, transport, transfer, or dispensation of Regulated Natural Medicine and Regulated Natural Medicine Product.
"Natural Medicine Product" has the same meaning as in section 44-50-103(15), C.R.S.
"Natural Medicine Products Manufacturer" means a person who manufactures Regulated Natural Medicine Products for transfer to a Healing Center, Facilitator, or to another Natural Medicine Products Manufacturer.
"Natural Medicine Services" means a preparation session, administration session, and integration session as provided pursuant to article 170 of title 12.
"Natural Medicine Testing Facility" means a public or private laboratory licensed, or approved by the Division, to perform testing and research on Regulated Natural Medicine and Regulated Natural Medicine Product.
"Nonconformance" means a non-fulfillment of a requirement or departure from written procedures, work instructions, or quality system, as defined by the Licensee's written corrective action and preventive action (CAPA) procedures.
"Owner" means an individual or an entity that owns, possesses, or is entitled to any Financial Interest in a Natural Medicine Business or a Natural Medicine Business Applicant; an individual or an entity that owns a share of stock in a corporation, a membership in a nonprofit corporation, a membership interest in a limited liability company, the interest of a member in a cooperative or in a limited cooperative association, a partnership interest in a limited partnership, a partnership interest in a partnership, or the interest of a member in a limited partnership association that holds any interest in a Natural Medicine Business.
"Participant" means a person who is 21 years of age or older and who receives Natural Medicine Services performed by or under the supervision of a Facilitator.
"Production Lot" means psilocybin pressed tablets, tea bags, chocolate, gelatin- or agar- based gummies, or powdered capsules of the same type that were manufactured under the same conditions at the same time using the same manufacturing method, ingredients, and standard operating procedures.
"Regulated Natural Medicine" means Natural Medicine that is cultivated, manufactured, tested, stored, distributed, transported, transferred, or dispensed pursuant to the Natural Medicine Code. Regulated Natural Medicine includes:
"Regulated Natural Medicine Product" means Natural Medicine product that is cultivated, manufactured, tested, stored, distributed, transported, transferred, or dispensed pursuant to the Natural Medicine Code.
"Regulated Natural Medicine Waste" means waste material that is:
"Restricted Area" means areas of Natural Medicine Cultivation Facilities, Natural Medicine Products Manufacturers, and Natural Medicine Testing Facilities where Regulated Natural Medicine or Regulated Natural Medicine Product is cultivated, manufactured, tested, or stored. Only Natural Medicine Handler Licensees and Owner Licensees may access Restricted Areas without supervision or documenting access on a visitor log. A Healing Center must have a Restricted Area, but a micro-Healing Center is not required to have a Restricted Area.
"Rules" mean these Colorado Regulated Natural Medicine Rules at 1 CCR 213-1.
"Sample" means a composite of Sample Increments collected from the same Harvest Lot or Production Lot and submitted for testing pursuant to Part 4 of these Rules.
"Sample Increment" means a portion of Regulated Natural Medicine that is removed from a Harvest Lot or Regulated Natural Medicine Product that is removed from a Production Lot and combined into a Sample for required testing under Part 4 of these Rules.
"State Licensing Authority" means the authority created for the purpose of regulating and controlling the licensing of the cultivation, manufacturing, testing, storage, distribution, transportation, transfer, and dispensation of Regulated Natural Medicine and Regulated Natural Medicine Product in Colorado pursuant to section 44-50-201, C.R.S.
"Total Psilocin" means psilocybin multiplied by 0.719 plus psilocin. Total Psilocin shall be expressed as a weight (i.e. mg Total Psilocin = (mg psilocybin x 0.719) + mg psilocin) or weight percent (i.e. % Total Psilocin = (% psilocybin x 0.719) + % psilocin).
"Unit" means a serving of no more than 10 milligrams of Total Psilocin.
1 CCR 213-1-1-1025