(1) Mandatory rule-making. Rules adopted pursuant to section 44-50-202 (1)(b) must include the following
subjects:
(a) Procedures and requirements consistent with this article 50 for the
issuance, denial, renewal, reinstatement, modification, suspension, and revocation
of licenses;
(b) Oversight requirements for licensees;
(c) A schedule of application, licensing, and renewal fees for licenses;
(d) Qualifications and eligibility requirements for licensure pursuant to this
article 50, including continuing eligibility expectations, including timely paying
taxes owed to the department of revenue, timely filing tax returns, and timely
curing any tax deficiencies, and authorization for the department of revenue to have
access to licensing information to ensure tax payment for the effective
administration of this article 50;
(e) Permissible and prohibited financial interests in a license issued pursuant
to this article 50 or a license issued pursuant to article 170 of title 12; except that
an individual shall not have a financial interest in more than five natural medicine
business licenses;
(f) (I) Establishment of a natural medicine independent testing and
certification program for licensees within an implementation time frame
established by the division, requiring licensees to test regulated natural medicine
and regulated natural medicine product to ensure, at a minimum, that regulated
natural medicine and regulated natural medicine product transferred for human
consumption by persons licensed pursuant to this article 50 do not contain
contaminants that are injurious to health and to ensure correct labeling, as well as:
(A) Certification requirements for laboratories that test regulated natural
medicine and regulated natural medicine product and requirements that the test
results produced by a laboratory must not be used unless the laboratory is
certified;
(B) Testing requirements for regulated natural medicine and regulated
natural medicine product by licensees;
(C) Whether to allow for any natural person to request and utilize testing
services of natural medicine and natural medicine product if the natural person is
twenty-one years of age or older;
(D) Definitions, permissions, and prohibitions concerning conflicts of interest
related to, and economic interests for, persons who own or are associated with a
natural medicine testing license and other licenses; and
(E) Procedures and requirements necessary to facilitate the coordination of
duties with respect to the natural medicine testing and certification program with
the department of public health and environment.
(II) The state licensing authority shall promulgate rules pursuant to this
subsection (1)(f) in coordination with the department of public health and
environment to ensure consistency between rules.
(g) Regulation of a licensed premises, including rules that allow a natural
medicine healing center licensee's licensed premises to be co-located with another
natural medicine healing center licensee's licensed premises or a health-care
facility;
(h) Requirements for the transportation of regulated natural medicine and
regulated natural medicine product, including:
(I) Security requirements;
(II) Transportation vehicle requirements, including requirements for
surveillance;
(III) Limits on the amount of regulated natural medicine and regulated
natural medicine product that may be carried in a transportation vehicle;
(IV) Record-keeping requirements; and
(V) Transportation manifest requirements;
(i) Limits on the amount of regulated natural medicine and regulated natural
medicine product that is allowed for production by a natural medicine cultivation
facility license or natural medicine product manufacturer license based on a metric
or set of metrics. When considering any limitations, the state licensing authority
shall consider the total current and anticipated demand for regulated natural
medicine and regulated natural medicine product in Colorado and attempt to
minimize the market for unlawful natural medicine and natural medicine product.
(j) Records to be kept by licensees and the required availability of the
records for inspection by the state licensing authority;
(k) Requirements to prevent the transfer or diversion of natural medicine or
natural medicine product to persons under twenty-one years of age;
(l) Permitted and prohibited transfers of regulated natural medicine and
regulated natural medicine product between licensees;
(m) Standards for advertising and marketing a licensee's services, including:
Avoiding the misappropriation and exploitation of the federally recognized
American tribes, as defined in section 12-170-104 (7), and Indigenous people,
communities, cultures, and religions; avoiding the excessive commercialization of
natural medicine, natural medicine product, and natural medicine services;
prohibiting advertising and marketing of natural medicine, natural medicine
product, and natural medicine services directed to individuals who are under
twenty-one years of age; and other parameters determined necessary by the state
licensing authority;
(n) Standards for qualification as a licensee, including environmental, social,
and governance criteria directed to the findings and declarations set forth in
section 12-170-102; and
(o) Requirements for clear and easily understandable regulated natural
medicine labels and regulated natural medicine product labels, which labeling
requirements must include:
(I) A prohibition on labels that are attractive to individuals under twenty-one
years of age;
(II) A prohibition on the use of colors, pictures, and cartoon images on the
label;
(III) A prohibition on the use of the word candy or candies on the label;
and
(IV) A prohibition on a label that is likely to cause confusion as to whether
the regulated natural medicine or regulated natural medicine product is a
trademarked food product.
(2) Permissive rule-making. Rules adopted pursuant to section 44-50-202
(1)(b) may include, but need not be limited to, the following subjects:
(a) Establishment of licenses, and the privileges and restrictions pursuant to
such licenses, determined necessary by the state licensing authority to implement
or administer this article 50;
(b) Establishment of a principle file process and requirements for an
applicant seeking to exercise the privileges of a license type in multiple locations or
seeking to exercise the privileges of multiple license types;
(c) Requirements for issuance of co-location permits to a licensee
authorizing co-location with another licensed premises;
(d) Requirements and restrictions on different types of regulated natural
medicine or regulated natural medicine product, including:
(I) Requiring licensed natural medicine product manufacturers to submit a
product registration form, which includes a full list of ingredients used in the
manufacturer's natural medicine product;
(II) Prohibiting a regulated natural medicine product that is likely to create
confusion for consumers as to whether the product is a trademarked food product;
and
(III) Prohibiting regulated natural medicine products that are attractive to
individuals under twenty-one years of age;
(e) Packaging and labeling requirements for regulated natural medicine or
regulated natural medicine product, including:
(I) Warning labels;
(II) Individual serving and per-package serving amounts; and
(III) Concentration of the regulated natural medicine or regulated natural
medicine product;
(f) Security requirements for licensed premises, including lighting, physical
security, video, and alarm requirements, and other minimum procedures for internal
control as deemed necessary by the state licensing authority to properly administer
and enforce the provisions of this article 50, including reporting requirements for
changes, alterations, modifications to the premises, or activities or incidents on the
premises;
(g) Health and safety regulations and standards;
(h) Sanitary requirements;
(i) Waste, disposal, and destruction requirements of regulated natural
medicine or regulated natural medicine product, including record-keeping
requirements;
(j) Storage and transportation of regulated natural medicine or regulated
natural medicine product;
(k) Requirements of licensees to track and manage inventory;
(l) Compliance with, enforcement of, or violation of any provision of this
article 50, article 18 of title 18, or any rule promulgated pursuant to this article 50,
including procedures and grounds for denying, suspending, fining, modifying,
restricting, or revoking a state license issued pursuant to this article 50 or any rule
promulgated pursuant to this article 50;
(m) Establishing a schedule of penalties for alleged violations of statutes
and rules;
(n) Specifications of duties of officers and employees of the state licensing
authority;
(o) Guidance for law enforcement officers;
(p) Requirements for inspections, investigations, searches, seizures,
forfeitures, embargoes, quarantines, recalls, destruction, and such additional
activities as may become necessary;
(q) Prohibition of misrepresentation and unfair practices;
(r) Such other matters as are necessary for the fair, impartial, stringent, and
comprehensive administration of this article 50; and
(s) Requirements that healing centers collect data and information related to
regulated natural medicine services and provide the data and information to the
department of public health and environment in accordance with section 44-50-401
(6), which data and information must include:
(I) Demographic information of individuals who use regulated natural
medicine services;
(II) Outcome data related to an individual's participation in regulated natural
medicine services; and
(III) Other information as determined by the state licensing authority in
consultation with the department of public health and environment.
(3) The state licensing authority shall consult the board when considering
and promulgating rules pursuant to this section.
(4) (a) The state licensing authority may, by rule, establish procedures for the
initial application and conditional issuance of an employee license and an owner
license at the time of application.
(b) (I) The state licensing authority shall base its issuance of an employee
license or an owner license pursuant to this subsection (4) on the results of an initial
investigation that demonstrates the applicant is qualified to hold a license. The
employee license application or the owner license application for which an
employee license or an owner license was issued pursuant to this subsection (4)
remains subject to denial pending the complete results of the applicant's initial
name-based judicial record check.
(II) Results of a name-based judicial record check that demonstrate that an
applicant possessing an employee license or an owner license pursuant to this
subsection (4) is not qualified to hold a license issued pursuant to this article 50 are
grounds for denial of the employee license application or the owner license
application. If the employee license application or the owner license application is
denied, the applicant shall return the employee license or the owner license to the
state licensing authority within a time period that the state licensing authority
establishes by rule.