Current through Register Vol. 47, No. 17, September 10, 2024
The statutory authority for this rule includes but is not
limited to sections
44-50-202(1)(b),
44-50-203(1)(b),
44-50-203(1)(h),
44-50-203(1)(j),
44-50-203(1)(k),
44-50-203(2)(i),
44-50-203(2)(k),
44-50-203(2)(r),
C.R.S. The purpose of this rule is to establish requirements for Natural
Medicine Cultivation Facilities to record and track Regulated Natural Medicine
transferred to and from Natural Medicine Cultivation Facilities.
A. All Natural Medicine Cultivation
Facilities must have at least one designated Natural Medicine Handler Licensee
or Owner Licensee to maintain inventory records.
1. For each tracking event required to be
tracked, information must be documented in accordance with subparagraph (A)(3)
of this Rule and Rule 3405.
2.
Licensees must report on a monthly basis all inventory tracking events from the
previous calendar month in a manner prescribed by the Division, using any forms
provided by the Division.
3.
Tracking Events. For purposes of required inventory
tracking, tracking events include events when Regulated Natural Medicine
progresses through the cultivation process and moves from the Natural Medicine
Cultivation Facility to another Natural Medicine Business or Facilitator.
Tracking events include at least the following:
a. Harvest Lot activities required by these
Rules;
b. Transfers of Regulated
Natural Medicine permitted by these Rules.
B.
Natural Medicine Cultivation
Tracking Requirements.
1. The
following tracking information must be kept on the inventory tracking document
and kept as a Business Record according to Rule 3010.
a.
The Harvest Lot
number. The following naming conventions must be used to assign a
Harvest Lot number by a Natural Medicine Cultivation: Two-digit year, two-digit
month, two-digit day. For example, January 1, 2024 would be 240101.
b. The wet weight of the harvest.
c. The dried weight of the harvest.
d.
Psilocybe cubensis strain
type.
e. The date of the initial
packaging.
f. Bill of Materials
(BOM) detailing the weight, measure or count of each component or ingredient
needed to process the Harvest Lot;
2. The following tracking information must be
kept on the inventory tracking document for transfer to a Natural Medicine
Testing Facility:
a. Harvest Lot
number;
b. Sample weight;
c. Date of transfer;
d. The Natural Medicine Testing Facility's
License number, name, and phone number.
3. The following tracking information must be
kept on the inventory tracking document for transfer to a Natural Medicine
Product Manufacturer:
a. Harvest Lot
number;
b. Weight (in grams) of the
Regulated Natural Medicine;
c. Date
of the transfer; and
d. The Natural
Medicine Product Manufacturer's License number, name, and phone
number.
4. The following
tracking information must be kept on the inventory tracking document for
transfer to a Facilitator.
a. Harvest Lot
number;
b. Weight of the Regulated
Natural Medicine;
c. Date of the
transfer;
d. If applicable, the
Facilitator's Natural Medicine Handler License number, name, and phone number;
and
e. The information required by
Rule 5005(C)(2)(a).
5.
The following tracking information must be kept on the inventory tracking
document for transfer to a Healing Center.
a.
Harvest Lot number;
b. Weight of
the Regulated Natural Medicine;
c.
Date of the transfer; and
d. The
Healing Center's License number, name, and phone number.
6. If a Natural Medicine Cultivation Facility
generates waste while harvesting, processing, or producing Regulated Natural
Medicine, or if the Regulated Natural Medicine Waste was previously designated
as a finished product, the Licensee must document:
a. A reason for the Regulated Natural
Medicine Waste in the inventory tracking document.
b. The exact time and method of destruction
in the inventory tracking document.