1 Colo. Code Regs. § 212-3-5-5005

Current through Register Vol. 47, No. 20, October 25, 2024

Section 1 CCR 212-3-5-5005 - License Privileges

Basis and Purpose - 5005

The statutory authority for this rule includes but is not limited to sections 44-50-202(1)(b), 44-50-203(1)(d), 44-50-203(1)(i), 44-50-203(1)(l), 44-50-203(1)(n), 44-50-203(2)(a), and 44-50-402, C.R.S. The purpose of this rule is to establish licensing tiers and transfer authority for Natural Medicine Cultivation Facilities. The Division intends to revisit this rule and the cultivation tiers outlined in this Part 5 during a future rulemaking proceeding once baseline information and data is available from the Regulated Natural Medicine Program in order to determine if additional revisions to cultivation tiers are appropriate. Additional revisions may include a reduction or increase in the amount of Regulated Natural Medicine a Natural Medicine Cultivation Facility may cultivate and store on the Licensed Premises.

A. A Natural Medicine Cultivation Facility Licensee may only exercise the License privileges granted by the State Licensing Authority and these Rules.

1. No later than thirty days after beginning operations, the Natural Medicine Cultivation Facility Licensee must submit complete floor plans or diagrams of the Licensed Premises to the Division in a manner prescribed by the Division. Floor plans or diagrams must clearly show any areas designated as Administration Areas, if co-located with a Healing Center, any areas designated as Restricted Areas, and security camera placement required by these Rules.

2.Micro-Cultivation Tier. A Natural Medicine Cultivation Facility Licensee who has obtained a micro-cultivation tier License may store Regulated Natural Medicine up to 750 grams of dried Fruiting Bodies.

3.Standard Cultivation Tier. All new Natural Medicine Cultivation Facility Licensees are standard cultivation tier Licenses, unless the Licensee applied for and received a micro-cultivation tier License.

a. A standard cultivation tier License may store up to 5.000 kilograms of dried Fruiting Bodies of Regulated Natural Medicine at any one time.

b. In accordance with Rule 5015, a standard cultivation tier Licensee who can demonstrate demand in a manner and on a form prescribed by the Division may apply for approval to cultivate, process, and store more than 5.000 kilograms of dried Fruiting Bodies.

B.Authorized Regulated Natural Medicine Sources.

1. A Natural Medicine Cultivation Facility may only use Psilocybe cubensis spores and mycelium from the Licensee's previous inoculations to cultivate Regulated Natural Medicine. The Natural Medicine Cultivation Facility must maintain complete and accurate records of spore sources, including certificates of analysis or other documentation demonstrating the spore species, if available.

2. A Natural Medicine Cultivation Facility may accept transfers of Regulated Natural Medicine Waste from another Natural Medicine Cultivation Facility, a Natural Medicine Products Manufacturer, a Healing Center, or a Facilitator licensed by the Department of Regulatory Agencies to dispose of the Regulated Natural Medicine Waste. The Regulated Natural Medicine Waste must be tracked in the waste log and must be handled in accordance with the transfer requirements in Rule 3405.

C.Authorized Transfers.

1. A Natural Medicine Cultivation Facility may transfer Regulated Natural Medicine to a Natural Medicine Manufacturing Facility, a Natural Medicine Testing Facility, and a Healing Center in accordance with this subparagraph (C)(1).

a. Prior to transfer to a Natural Medicine Testing Facility, the Regulated Natural Medicine must comply with packaging requirements in Rule 3305(C).

b. Prior to transfer to a Healing Center, the Regulated Natural Medicine must pass all required testing in Rules 4005 - 4015.

c. Prior to transfer to a Healing Center or Facilitator, the Regulated Natural Medicine must be packaged and labeled pursuant to Rule 3305(D).

d. Prior to transfer to a Natural Medicine Products Manufacturer, the Regulated Natural Medicine must be packaged and labeled pursuant to Rule 3305(B).

2. A Natural Medicine Cultivation Facility may transfer up to 750 milligrams of Total Psilocin at one time of Regulated Natural Medicine that has passed all required testing and is packaged and labeled pursuant to Rule 3305(D) to a Facilitator for Administrations Sessions at authorized locations other than Healing Centers in accordance with this Rule.

a.Facilitator Request Requirements. A Natural Medicine Cultivation Facility may only transfer Regulated Natural Medicine to a Facilitator after receiving and verifying the Facilitator's request. All requests for Facilitator transfers must including the following information:

i. The Facilitator's Department of Regulatory Agencies issued license number;

ii. The requested amount of Regulated Natural Medicine;

iii. The number of Administration Sessions the Facilitator is requesting Regulated Natural Medicine for;

iv. The number of Participants that will be consuming the requested Regulated Natural Medicine; and

v. The requested date for pick-up.

b.Request Verification. A Natural Medicine Cultivation Facility must verify the Facilitator's Department of Regulatory Agencies issued license number in order to complete the transfer.

3. All transfers of Regulated Natural Medicine must comply with transport and inventory tracking requirements in Rules 3405 and 5025.

D.Cultivation & Processing Privileges. A Natural Medicine Cultivation Facility Licensee may cultivate, process, package, and label Regulated Natural Medicine, including inoculation, harvesting, and processing.

1. A Natural Medicine Cultivation Facility Licensee may process harvested Regulated Natural Medicine into whole dried Fruiting Bodies.

2. A Natural Medicine Cultivation Facility Licensee shall not produce Regulated Natural Medicine Product, which requires a Natural Medicine Products Manufacturer License.

E.Research and Development Testing. A Natural Medicine Cultivation Facility may conduct or submit Samples to a Natural Medicine Testing Facility for research and development testing on Regulated Natural Medicine.

1. A Natural Medicine Cultivation Facility may not conduct or submit Samples to a Natural Medicine Testing Facility for any research and development testing on any Regulated Natural Medicine obtained from a source other than the Natural Medicine Cultivation Facility.

2. Results of research and development testing conducted under this subparagraph E shall not count towards the fulfillment of any required testing mandated by these Rules.

3. The Natural Medicine Cultivation Facility Licensee must maintain full and accurate records regarding research and development test procedures, results, and other standard operating procedures consistent with these Rules.

1 CCR 212-3-5-5005

47 CR 17, September 10, 2024, effective 10/1/2024