Current through Register Vol. 47, No. 17, September 10, 2024
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.
