Current through Register Vol. 47, No. 17, September 10, 2024
Basis and Purpose - 6005
The statutory authority for this rule includes but is not
limited to sections
44-50-202(1)(b),
44-50-203(1)(i),
44-50-203(1)(k),
44-50-203(1)(l),
44-50-203(2)(a),
44-50-203(2)(d),
44-50-203(2)(g),
44-50-203(2)(k),
and 44-50-403(1),
C.R.S. The purpose of this rule is to establish the privileges and permitted
acts for Natural Medicine Product Manufacturers.
A. A Natural Medicine Products Manufacturer
Licensee may only exercise the License privileges established under the Natural
Medicine Code and granted by the State Licensing Authority pursuant to these
Rules.
1. No later than thirty days after
beginning operations, the Natural Medicine Products Manufacturer 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.
B. A Natural Medicine Product Manufacturer
may only manufacture, distribute, and transfer Regulated Natural Medicine
Product intended for oral ingestion, and limited to the following product types
intended for oral ingestion, unless the Licensee has an extraction endorsement
pursuant to subparagraph (C) of this Rule:
1.
Intended for Oral Ingestion
a. Capsules; and
b. Tea bags.
2. No other Regulated Natural Medicine
Product type is allowed to be produced or transferred unless in accordance with
subparagraph (C) of this Rule.
C.
Extraction
Endorsement. A Natural Medicine Products Manufacturer with an
extraction endorsement may manufacture, distribute, and transfer the following
product types in addition to the product types in subparagraph (B) of this
Rule:
1.
Intended for Oral
Ingestion.
a.
Chocolate;
b. Gelatin- or
agar-based gummies in basic geometric shapes; and
c. Pressed tablets.
2.
Intended for Sublingual
Administration.
a.
Tinctures
3. No other
Regulated Natural Medicine Product type is allowed to be produced or
transferred.
4. A Natural Medicine
Products Manufacturer shall not manufacture or package a Regulated Natural
Medicine Product in a manner that reasonably appears to represent a
commercially manufactured food product or reasonably appears to target
individuals under the age of 21.
a.
Commercially manufactured food products may be used as ingredients in a
Regulated Natural Medicine Product when:
(1)
they are used in a way that renders them unrecognizable as the commercial food
product in the final Regulated Natural Medicine Product, and
(2) the Natural Medicine Products
Manufacturer does not represent that the final Regulated Natural Medicine
Product contains the commercially manufactured food
product.
5.
Only Natural Medicine Products Manufacturers with an extraction endorsement may
produce Regulated Natural Medicine Product using an extraction process. A
Natural Medicine Products Manufacturer without the extraction endorsement may
not use any extractive process. The following solvents are allowed to be used
for extraction processes:
a. Water;
b. Food grade, non-denatured ethanol;
and
c. Natural food-grade oils,
such as coconut oil.
6. A
Natural Medicine Products Manufacturer with an extraction endorsement shall not
transfer a Natural Medicine Product to a Healing Center or Facilitator until
the following actions are completed:
a. At
least one week prior to transfer, the Natural Medicine Products Manufacturer
completes a product registration form in a manner prescribed by the Division.
The registration requirement in this Rule applies to each type of product the
Licensee manufactures and must include the following:
i. A copy of the product manufacturing
standard operating procedure; and
ii. To the extent any of the following is not
included in the standard operating procedure:
A. A list of ingredients and processing
aids;
B. Any pertinent information
about the safety of the product and constituent ingredients; and
C. A picture of the label.
b. The Licensee receives
confirmation of submission from the Division for the Natural Medicine Product
intended for transfer.
D.
Authorized Sources of
Regulated Natural Medicine.
1.
Regulated Natural Medicine Product may only be manufactured using Regulated
Natural Medicine from a Licensed Natural Medicine Cultivation
Facility.
2. A Natural Medicine
Product Manufacturer may accept transfers of Regulated Natural Medicine Waste
from a Natural Medicine Cultivation Facility, another 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.
E.
Authorized Transfers.
1. A Natural Medicine Products Manufacturer
may transfer Regulated Natural Medicine Product to another Natural Medicine
Products Manufacturer, a Natural Medicine Testing Facility, and a Healing
Center in accordance with this subparagraph (E)(1).
a. Prior to transfer to a Natural Medicine
Testing Facility, the Regulated Natural Medicine Product must be in its final
form and must comply with packaging requirements in Rule 3305(C).
b. Prior to transfer to a Healing Center, the
Regulated Natural Medicine Product must pass all required testing in Rules 4005
- 4015.
c. Prior to transfer to a
Healing Center or Facilitator, all Regulated Natural Medicine Product must be
packaged and labeled pursuant to Rule 3305.
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 Products Manufacturer
may transfer up to 750 milligrams of Total Psilocin of Regulated Natural
Medicine Product that has passed all required testing and is packaged and
labeled pursuant to Rule 3305 to a Facilitator for Administration Sessions at
authorized locations other than Healing Centers in accordance with this Rule.
a.
Facilitator Request
Requirements. A Natural Medicine Products Manufacturer may only
transfer Regulated Natural Medicine Products 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 Product;
iii. The number of Administration Sessions
the Facilitator is requesting Regulated Natural Medicine Product(s)
for;
iv. The number of Participants
that will be consuming the requested Regulated Natural Medicine Product(s);
and
v. The requested date for
pick-up.
b.
Request Verification. A Natural Medicine Products
Manufacturer 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 Product must comply with transport and inventory tracking requirements
in Rules 3405 and 6020.
F.
Research and Development
Testing. A Natural Medicine Products Manufacturer may conduct or
submit Samples to a Natural Medicine Testing Facility for research and
development testing on Regulated Natural Medicine Product the Licensee
manufactured in the same Licensed Premises.
1.
A Natural Medicine Products Manufacturer may not conduct or submit Samples to a
Natural Medicine Testing Facility for any research and development testing on
any Regulated Natural Medicine Products obtained from a source other than the
Natural Medicine Products Manufacturer Facility.
2. Results of research and development
testing conducted under this subparagraph (F) shall not be relied upon for any
required testing as mandated by these Rules.
3. The Natural Medicine Products Manufacturer
Licensee must maintain full and accurate records regarding research and
development test procedures, results, and other standard operating procedures
consistent with these Rules.
