C.R.S. § 44-50-203: State licensing authority - rules.

(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;

(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;

(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;

(p) License privileges and restrictions of a limited regulated natural medicine sales license, which includes allowing the licensee to store, distribute, transport, purchase, possess, and transfer regulated natural medicine and regulated natural medicine product and to transfer for remuneration regulated natural medicine or regulated natural medicine products to a participant only for purposes of consumption during a facilitated administration session at a colocated healing center's licensed premises; and

(q) Eligibility requirements for an applicant to obtain a limited regulated natural medicine sales license, including, but not limited to:

(I) Requiring a limited regulated natural medicine sales license to have and maintain common ownership with the colocated healing center license issued pursuant to section 44-50-401 and any rules adopted by the state licensing authority; and

(II) Establishing application and license fees to cover the direct and indirect costs of implementing the limited regulated natural medicine sales license created pursuant to section 44-50-401 (6), which fees shall be deposited in the natural medicine case fund created in section 44-50-601.

(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 colocation permits to a licensee authorizing colocation 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;

(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;

(t) Application procedures and license requirements for a healing center to operate a temporary premises, in accordance with section 44-50-401 (6), and may include:

(I) Establishing the location eligibility requirements for a temporary premises;

(II) Establishing minimum security and surveillance requirements for a temporary premises, which must reflect the temporary nature of the use and any public health and safety considerations for administration of natural medicine services;

(III) Establishing minimum record-keeping requirements, which may include authorizing licensees operating a temporary premises to maintain required records at the healing center licensee's licensed premises;

(IV) Establishing notification requirements for when a healing center must report to the state licensing authority information that relates to the licensee's use of an approved temporary premises;

(V) Establishing criteria under which a healing center may apply and be approved for more than one temporary premises in a single application; and

(VI) Adjusting the amounts of the application and permit fees for a temporary premises to reflect the direct and indirect costs of administering the temporary premises permit; and

(u) Requirements for the cultivation, manufacture, testing, or dispensing of ibogaine, including:

(I) Limiting products containing ibogaine, as necessary, due to its health and safety risks; and

(II) Establishing minimum manufacturing and testing standards for ibogaine and ibogaine products, including requirements that licensees maintain records regarding cultivated and manufactured products source material, additives and ingredients, and any conducted test results, and requirements that products provided to healing centers be labeled with the same information.

(2.5) The state licensing authority may temporarily waive or adjust statutory or regulatory testing requirements for regulated natural medicine and regulated natural medicine products. Any waiver or adjustment of statutory or regulatory testing requirements are only permitted if there is no natural medicine testing facility certified or licensed to conduct required testing and must include:

(a) Procedures for licensees to submit representative test samples to an unlicensed, third-party testing laboratory;

(b) Minimum qualifications that the unlicensed third-party testing laboratory must meet to receive test samples;

(c) Minimum standards for certificates of analysis that a licensee must demonstrate the unlicensed, third-party testing laboratory can meet;

(d) Frequency of testing; and

(e) Licensee notification and record-keeping requirements for regulated natural medicine and regulated natural medicine products tested by unlicensed, third-party testing laboratories.

(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.

(c) The state licensing authority may establish different application fees for licenses based on the type of natural medicine that the licensee seeks to cultivate, manufacture, test, or dispense.

(5) (a) A licensee seeking to cultivate, manufacture, test, dispense, or administer ibogaine shall, in consultation with Indigenous communities or their authorized representative, establish a benefit-sharing plan that directly benefits those communities. A licensee may use or rely on a third party for consultation.

(b) A licensee shall maintain documentation demonstrating the consultation process and the development of the benefit-sharing plan and make the documentation publicly available upon request.

(c) As used in this subsection (5), "benefit-sharing plan" means an arrangement with Indigenous communities traditionally connected to the use of ibogaine or iboga that is intended to share in the benefits that arise from the research, therapeutic use, or commercialization of ibogaine or iboga. Benefits may include:

(I) Financial benefit sharing;

(II) Collaborative research or data sharing;

(III) Conservation support for plant species and habitats;

(IV) Community-identified development priorities;

(V) Cultural or educational exchanges; and

(VI) Utilizing a source for ibogaine that engages in benefit-sharing and ethical and sustainable cultivation practices.

(6) Nothing in this section shall be interpreted to require Indigenous communities to disclose or share traditional knowledge, ceremonial practices, or cultural expressions.