Natural Medicine

HOUSE BILL 26-1325

BY REPRESENTATIVE(S) Caldwell and Feret, Bacon, Barron, Boesenecker, Brown, Clifford, Duran, Flanell, Froelich, Gonzalez R., Lieder, McCormick, Nguyen, Phillips, Rutinel, Rydin, Soper, Winter T., Lindsay, Ricks; also SENATOR(S) Ball and Pelton R., Catlin, Cutter, Danielson, Gonzales J., Hinrichsen, Kipp, Lindstedt, Marchman, Sullivan, Wallace, Coleman.

CONCERNING NATURAL MEDICINE.

Be it enacted by the General Assembly of the State of Colorado: SECTION 1. Legislative declaration. (1) The general assembly finds and declares that: (a) Colorado is facing a severe and worsening mental health crisis due to high rates of mental health conditions and substance use disorders, including opioid use disorder; (b) Existing treatment approaches for treating mental health conditions and substance use disorders are often inadequate for long-term remission and recovery, necessitating the exploration of innovative options;

Capital letters or bold & italic numbers indicate new material added to existing law; dashes through words or numbers indicate deletions from existing law and such material is not part of the act.

(c) lbogaine is a psychoactive indole alkaloid derived from the root bark of the tabemanthe iboga plant and other plants, such as the voacanga africana plant, that have shown significant potential as life-saving treatment options for substance use disorders and mental health conditions; (d) A carefully regulated, medically supervised, and therapeutic framework for administering ibogaine is necessary to make ibogaine accessible, facilitate rigorous research, and ensure patient safety; (e) The mental health and well-being of veterans is a priority of the general assembly, and ibogaine treatment has shown promise in treating severe service-related post-traumatic stress disorder and other mental health conditions related to combat deployments; and (f) Establishing a research pilot program to explore the therapeutic uses of ibogaine, better understand potential risks of ibogaine use, and lay the groundwork for a future comprehensive regulatory program is necessary to find additional treatment options for people suffering from a mental health condition or a substance use disorder.

SECTION 2. In Colorado Revised Statutes, add 27-60-207 as follows: 27-60-207. Ibogaine research pilot program - creation - federal approval - fund - rules - reporting - definitions - repeal. (1) AS USED IN THIS SECTION, UNLESS THE CONTEXT OTHERWISE REQUIRES:

(a)

"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.

(b) "FUND" MEANS THE IBOGAINE RESEARCH PILOT PROGRAM CASH FUND CREATED IN SUBSECTION (10) OF THIS SECTION. (c) "IBOGAINE PILOT SITE" MEANS A FACILITATION SITE SELECTED AND AUTHORIZED BY THE BHA TO ADMINISTER THE PILOT PROGRAM.

(d)

"PILOT PROGRAM" MEANS THE IBOGAINE RESEARCH PILOT

PROGRAM ESTABLISHED IN SUBSECTION (2) OF THIS SECTION. (2) THERE IS ESTABLISHED IN THE BHA THE IBOGAINE RESEARCH PILOT PROGRAM FOR THE PURPOSE OF SUPPORTING RESEARCH ON THE SAFETY AND EFFECTIVENESS OF USING IBOGAINE TO TREAT MENTAL HEALTH CONDITIONS AND SUBSTANCE USE DISORDERS. (3) THE BHA SHALL OPERATE THE PILOT PROGRAM. IN OPERATING THE PILOT PROGRAM, THE BHA: (a) MAY APPROVE UP TO FIVE IBOGAINE PILOT SITES;

(b) MAY REQUIRE A MEMORANDUM OF UNDERSTANDING WITH EACH PILOT SITE TO ENSURE PROPER ADMINISTRATION OF THE PILOT PROGRAM; (c)

IN PARTNERSHIP WITH THE IBOGAINE PILOT SITES, AND IN

COORDINATION WITH OTHER APPROPRIATE STATE AGENCIES, MAY SEEK FEDERAL AUTHORIZATION PURSUANT TO 21 U.S.C. SEC. 872(e) OR OTHER APPLICABLE FEDERAL LAW FOR PURPOSES OF EXPANDING OR ADVANCING IBOGAINE RESEARCH EFFORTS;

(d) SHALL ASSIST THE IBOGAINE PILOT SITES TO COMPLETE AND SUBMIT AN INVESTIGATIONAL NEW DRUG APPLICATION, OR REVISE AND EXPAND UPON AN EXISTING INVESTIGATIONAL NEW DRUG APPLICATION WITH

THE UNITED STATES FOOD AND DRUG ADMINISTRATION IN ACCORDANCE WITH 21 CFR PART 312;

(e)

SHALL CONSIDER WHETHER TO OBTAIN FEDERAL RESEARCH

PROGRAM STATUS UNDER 21 U.S.C. SEC.

872 OR OTHER APPLICABLE

FEDERAL LAW FOR THE PURPOSES OF EXPANDING OR ADVANCING RESEARCH EFFORTS OF THE PILOT SITES;

(f) MAY NEGOTIATE A MEMORANDUM OF UNDERSTANDING WITH THE UNITED STATES DRUG ENFORCEMENT ADMINISTRATION, UNITED STATES DEPARTMENT OF HEALTH AND HUMAN SERVICES, UNITED STATES FOOD AND DRUG ADMINISTRATION, UNITED STATES ATTORNEY GENERAL, OR ANY OTHER APPROPRIATE FEDERAL AGENCY, AS NECESSARY TO ENSURE FEDERAL COMPLIANCE AND PROPER ADMINISTRATION OF THE PILOT PROGRAM;

(g)

MAY CONTRACT WITH INDIVIDUALS WITH EXPERTISE IN

BEHAVIORAL HEALTH, NURSING, RESEARCHING A SCHEDULE I CONTROLLED SUBSTANCE, DRUG DEVELOPMENT, INSTITUTIONAL REVIEW BOARD AND UNITED

STATES

FOOD

AND

DRUG

ADMINISTRATION

REGULATORY

COMPLIANCE, AND PHYSICIAN CONSULTATION SERVICES TO ASSIST IN THE ADMINISTRATION OF THE PILOT PROGRAM;

(h)

MAY

ASSIST

IBOGAINE

PILOT

SITES

WITH

FUNDING

OPPORTUNITIES, INCLUDING IDENTIFYING AND APPLYING FOR STATE, FEDERAL, OR PRIVATE GRANTS;

(i)

MAY A WARD GRANTS TO SELECTED IBOGAINE PILOT SITES TO

ASSIST WITH OPERATIONAL COSTS; AND

U) MAY COLLABORATE AND ENTER INTO AGREEMENTS WITH OTHER STATES, STATE AGENCIES, FEDERALLY RECOGNIZED TRIBES, AND PUBLIC OR PRIVATE ENTITIES TO PARTICIPATE IN MULTI-STATE CONSORTIA OR SIMILAR EFFORTS, INCLUDING THE SHARING OF DATA, FUNDING, RESEARCH, CLINICAL PROTOCOLS, AND REGULA TORY BEST PRACTICES RELATED TO IBOGAINE AND IBOGAINE-RELATED THERAPIES.

(4) (a)

THE BHA SHALL ESTABLISH A PROCESS TO SOLICIT AND

SELECT IBOGAINE PILOT SITES.

(b)

THE

BHA SHALL ESTAB LISH A PILOT PROPOSAL REVIEW

COMMITTEE TO REVIEW APPLICATIONS RECEIVED FROM THE SOLICITATION PROCESS REQUIRED IN SUBSECTION (4)(a) OF THIS SECTION AND MAKE A RECOMMENDATION TO THE BHA ON THE SELECTION OR DENIAL OF EACH APPLICATION. THE BHA SHALL NOTIFY EACH APPLICANT OF THE SELECTION DECISION WITHIN NINETY DAYS AFTER THE APPLICATION DEADLINE SET BY THEBHA.

(5) TO BE ELIGIBLE AS AN IBOGAINE PILOT SITE, AN APPLICANT MUST: (a) DEMONSTRATE AN INTENT TO PURSUE THE FEDERAL APPROVAL TO OPERATE AN IBOGAINE PILOT SITE TO STUDY SAFETY AND TREATMENT EFFECTIVENESS OF THE USE OF IBOGAINE TO TREAT MENTAL HEALTH CONDITIONS AND SUBSTANCE USE DISORDERS; AND

(b) ESTABLISH A BENEFIT-SHARING PLAN, WHICH MAY BE DEVELOPED IN CONSULTATION WITH INDIGENOUS COMMUNITIES OR THEIR RECOGNIZED GOVERNING INSTITUTIONS TRADITIONALLY CONNECTED TO IBOGAINE OR IBOGA, THAT DIRECTLY BENEFITS THOSE COMMUNITIES AND SHARES IN THE BENEFITS

ARISING

FROM

RESEARCH,

THERAPEUTIC

USE,

OR

COMMERCIALIZATION OF IBOGAINE OR IBOGA. THE BENEFIT-SHARING PLAN MUST INCLUDE DOCUMENTATION OF THE SOURCING OF IBOGAINE OR IBOGA.

(c)

IN DEVELOPING A BENEFIT-SHARING PLAN PURSUANT TO THIS

SUBSECTION

APPLICANTS

MAY

CONSIDER

INTERNATIONALLY

RECOGNIZED PRINCIPLES RELATED 't'O EQUITABLE BENEFIT SHARING THAT MAY ARISE FROM THE USE OF RESOURCES AND TRADITIONAL KNOWLEDGE.

(6) (a)

THE COMMISSIONER SHALL ADOPT RULES THAT ARE

NECESSARY TO ESTABLISH AND ADMINISTER THE IBOGAINE PILOT PROGRAM. AT A MINIMUM, THE COMMISSIONER SHALL ADOPT RULES ON THE FOLLOWING: (I) THE APPLICATION PROCESS FOR PROSPECTIVE IBOGAINE PILOT SITE APPLICANTS; (II) CRITERIA FOR A WARDING GRANTS TO IBOGAINE PILOT SITES TO ASSIST THE IBOGAINE PILOT SITE WITH FUNDING; (III) DATA AND RESEARCH COLLECTION BY THE IBOGAINE PILOT SITES ON THE USE AND EFFECTIVENESS OF IBOGAINE IN TREATING MENTAL

HEALTH CONDITIONS AND SUBSTANCE USE DISORDERS; (IV) INFORMATION SHARING BETWEEN THE IBOGAINE PILOT SITES ANDTHEBHA; (V) ADVERSE EVENT REPORTING; AND (VI)

OTHER RULES THAT ARE NECESSARY FOR THE SAFE AND

EFFECTIVE OPERATION OF THE IBOGAINE PILOT SITES AND ADMINISTRATION OF THE IBOGAINE RESEARCH PILOT PROGRAM ESTABLISHED BY THIS SECTION.

(b) WITH THE EXCEPTION OF THE REQUIREMENTS OF SUBSECTION ( 6)( a) OF THIS SECTION, THE COMMISSIONER SHALL NOT ADOPT RULES THAT ARE DUPLICATIVE OF FEDERAL LAW.

(7) ON OR BEFORE A DATE SET BY THE BHA AND ANNUALLY THEREAFTER THAT THE PILOT PROGRAM IS OPERATIONAL, EACH IBOGAINE PILOT SITE MUST SUBMIT THE DATA AND RESEARCH AS REQUIRED PURSUANT TO SUBSECTION (6)(a)(III) OF THIS SECTION FOR THE PROCEEDING YEAR TO THEBHA.

AT LEAST ANNUALLY, BUT NOT MORE THAN QUARTERLY,

BEGINNING ONE MONTH AFTER THE DATE SET BY THE BHA DESCRIBED IN SUBSECTION (7) OF THIS SECTION WHILE THE PILOT PROGRAM IS OPERATIONAL, THE BHA MUST REVIEW THE DA TA AND RESEARCH SUBMITTED BY THE IBOGAINE PILOT SITES, AS REQUIRED BY SUBSECTION (7) OF THIS SECTION, AND POST A REPORT DETAILING THE IBOGAINE PILOT SITE FINDINGS ON THE BHA'S WEBSITE.

(9) THE BHA MAY SEEK, ACCEPT, AND EXPEND GIFTS, GRANTS, OR DONATIONS RECEIVED FROM PRIVATE OR PUBLIC SOURCES FOR THE PURPOSES OF THIS SECTION. THE BHA SHALL TRANSMIT ALL MONEY RECEIVED THROUGH GIFTS, GRANTS, OR DONATIONS TO THE STATE TREASURER, WHO SHALL CREDIT THE MONEY TO THE IBOGAINE RESEARCH PILOT PROGRAM CASH FUND CREATED IN SUBSECTION ( 10) OF THIS SECTION. THE BHA MAY ACCEPT DONATIONS OF IN-KIND SERVICES FOR PURPOSES OF THIS SECTION. (10)

THE IBOGAINE RESEARCH PILOT PROGRAM CASH FUND IS

CREATED IN THE STATE TREASURY. THE FUND CONSISTS OF GIFTS, GRANTS, AND DONATIONS CREDITED TO THE FUND PURSUANT TO SUBSECTION (9) OF

THIS SECTION AND ANY OTHER MONEY THAT THE GENERAL ASSEMBLY MAY APPROPRIATE OR TRANSFER TO THE FUND. THE STATE TREASURER SHALL CREDIT ALL INTEREST AND INCOME DERIVED FROM THE DEPOSIT AND INVESTMENT OF MONEY IN THE FUND TO THE FUND. MONEY IN THE FUND IS CONTINUOUSLY APPROPRIATED TO THE BHA FOR THE PURPOSE OF ADMINISTERING THE IBOGAINE RESEARCH PILOT PROGRAM AND A WARDING GRANTS TO SELECTED IBOGAINE PILOT SITES. ( 11) THE OPERATION OF AN IBOGAINE PILOT SITE IN ACCORDANCE WITH THIS SECTION IS CONTINGENT ON FEDERAL APPROVAL. (12)

THIS SECTION DOES NOT PRECLUDE A PERSON FROM

ADMINISTERING IBOGAINE OUTSIDE OF THE PILOT PROGRAM IN COMPLIANCE WITH FEDERAL LAW OR AS PERMITTED PURSUANT TO THE "NATURAL MEDICINE HEALTH ACT OF 2022", ARTICLE 170 OF TITLE 12, AND THE "COLORADO NATURAL MEDICINE CODE", ARTICLE 50 OF TITLE 44.

AN INDIVIDUAL OR ENTITY PARTICIPATING IN THE PILOT

PROGRAM MUST NOT BE PROSECUTED OR OTHER WISE DISCIPLINED FOR ACTIONS OR CONDUCT PERMITTED PURSUANT TO THIS SECTION. (14)

(a)

A

PHYSICIAN

OR

HEALTH-CARE

PROFESSIONAL

ADMINISTERING IBOGAINE TO PARTICIPANTS AS PART OF THE PILOT PROGRAM, OR AN IBOGAINE PILOT SITE, IS NOT LIABLE FOR MONEY DAMAGES IN A CIVIL MALPRACTICE ACTION, A PHYSICAL OR PSYCHOLOGICAL INJURY THAT

A

PARTICIPANT

MAY

EXPERIENCE

AS

A

RESULT OF

BEING

ADMINISTERED IBOGAINE AS A PARTICIPANT IN THE PILOT PROGRAM, UNLESS THE INJURY WAS THE DIRECT RESULT OF THE PHYSICIAN'S OR HEALTH-CARE PROFESSIONAL'S INTENTIONAL MISCONDUCT, GROSS NEGLIGENCE, OR A DEVIATION FROM THE GENERALLY ACCEPTED STANDARDS OF PRACTICE.

(b) THIS SUBSECTION ( 14) DOES NOT APPLY TO ADMINISTRATIVE PROCEEDINGS. ( 15) THE BHA SHALL WORK TO SECURE FEDERAL RESEARCH AND DEVELOPMENT FUNDING AVAILABLE THROUGH THE ADVANCED RESEARCH PROJECTS AGENCY FOR HEALTH WITHIN THE FEDERAL DEPARTMENT OF HEALTH AND HUMAN SERVICES, OR OTHER AVAILABLE FEDERAL FUNDING, IN ORDER TO ADVANCE RESEARCH EFFORTS ON THE USE OF IBOGAINE AS A TREATMENT FOR SERIOUS MENTAL ILLNESSES.

(16) SUBSECTIONS (1), (2), (3), (4), (5), (6), (7), (8), (11), (12), (13), (14), AND (15) OF THIS SECTION TAKE EFFECT IF THE BHA RECEIVES ONE HUNDRED FIFTY THOUSAND DOLLARS IN GIFTS, GRANTS, OR DONATIONS, OR IF THE BHA RECEIVES IN-KIND DONATIONS FOR WHICH THE VALUE IS EQUAL TOONEHUNDREDFIFTYTHOUSANDDOLLARS,BEFOREJANUARY 1,2028,FOR THE PURPOSE OF IMPLEMENTING THIS SECTION. THE COMMISSIONER OF THE BHA SHALL NOTIFY THE REVISOR OF STATUTES IN WRITING OF THE DA TE ON WHICH THE CONDITION SPECIFIED IN THIS SUBSECTION ( 16) HAS OCCURRED BY EMAILING THE NOTICE TO [email protected]. SUBSECTIONS (1), (2), (3), (4), (5), (6), (7), (8), (11), (12), (13), (14), AND (15) OF THIS SECTION TAKE EFFECT ON THE DATE IDENTIFIED IN THE NOTICE TO THE REVISOR OF STATUTES THAT THE BHA HAS RECEIVED ONE HUNDRED FIFTY THOUSAND DOLLARS IN GIFTS, GRANTS, OR DONATIONS, ORAN IN-KIND DONATION FOR WHICH THE VALUE IS EQUAL TO ONE HUNDRED FIFTY THOUSAND DOLLARS, FOR THE PURPOSE OF THIS SECTION, OR, IF THE NOTICE TO THE REVISOR OF STATUTES DOES NOT SPECIFY THAT DATE, ON THE DATE OF THE NOTICE TO THE REVISOR OF STATUTES. (17) (a) THE BHA MUST RECEIVE ADDITIONAL GIFTS, GRANTS, OR DONATIONS IN THE AMOUNT NECESSARY TO COVER THE TOTAL REMAINING COST OF OPERATING THE PILOT PROGRAM FOR THE DURATION OF THE PILOT PROGRAM, OR IN-KIND DONATIONS FOR WHICH THE VALUE IS EQUAL TO THE AMOUNT NECESSARY TO COVER THE TOTAL REMAINING COST OF OPERATING THE PILOT PROGRAM FOR THE DURATION OF THE PILOT PROGRAM, WITHIN THREE HUNDRED SIXTY-FIVE DAYS FOLLOWING THE DATE ON WHICH SUBSECTIONS (1 ), (2), (3), ( 4), (5), (6), (7), (8), ( 11 ), ( 12), (13), ( 14), AND ( 15) OF THIS SECTION TAKE EFFECT. (b)

THIS SECTION IS REPEALED IF THE BHA DOES NOT RECEIVE

ADDITIONAL GIFTS, GRANTS, OR DONATIONS IN THE AMOUNT NECESSARY TO COVER THE TOTAL REMAINING COST OF OPERA TING THE PILOT PROGRAM FOR THE DURATION OF THE PILOT PROGRAM, OR IN-KIND DONATIONS FOR WHICH THE VALUE IS EQUAL TO THE AMOUNT NECESSARY TO COVER THE TOTAL REMAINING COST OF OPERATING THE PILOT PROGRAM FOR THE DURATION OF THE PILOT PROGRAM, WITHIN THREE HUNDRED SIXTY-FIVE DAYS FOLLOWING THE DATE ON WHICH THE REVISOR OF STATUTES RECEIVES NOTICE PURSUANT TO SUBSECTION (16) OF THIS SECTION. THE COMMISSIONER OF THE BHA SHALL NOTIFY THE REVISOR OF STATUTES OF THE DATE ON WHICH THE CONDITION SPECIFIED IN THIS SUBSECTION (17)(b) HAS OCCURRED BY EMAILING THE NOTICE TO [email protected].

(18) (a) IF, ON OR BEFORE JANUARY 1, 2028, THE MONEY IN THE FUND HAS NEVER REACHED OR EXCEEDED ONE HUNDRED FIFTY THOUSAND DOLLARS, OR ADDITIONAL GIFTS, GRANTS, OR DONATIONS IN THE AMOUNT NECESSARY TO COVER THE TOTAL REMAINING COST OF THE PILOT PROGRAM ARE NOT RECEIVED WITHIN THREE HUNDRED SIXTY-FIVE DAYS FOLLOWING THE DATE ON WHICH THE REVISOR OF STA TUTES RECEIVES NOTICE PURSUANT TO SUBSECTION ( 16) OF THIS SECTION, THE STATE TREASURER SHALL RETURN FROM THE FUND TO THE GRANTOR OR DONOR THE AMOUNT OF THE GRANTOR'S

OR

DONOR'S

GIFTS,

GRANTS,

OR

DONATIONS

AND,

NOTWITHSTANDING SUBSECTION ( 17) OF THIS SECTION, THE BHA SHALL NOT ACCEPT ADDITIONAL GIFTS, GRANTS, OR DONATIONS FOR THE PURPOSES OF THIS SECTION. (b)

IF ANY MONEY REMAINS IN THE FUND AFTER THE STA TE

TREASURER RETURNS MONEY TO DONORS OR GRANTORS PURSUANT TO SUBSECTION (18)(a) OF THIS SECTION, AS APPLICABLE, THE STATE TREASURER SHALL, PRIOR TO THE REPEAL OF THE FUND, TRANSFER ALL UNEXPENDED AND UNENCUMBERED MONEY IN THE FUND TO THE REGULATED NATURAL MEDICINE CASH FUND CREATED IN SECTION 44-50-601.

SECTION 3. In Colorado Revised Statutes, 12-170-104, amend (1), (12)(b)(II), and (12)(c) as follows:

12-170-104. Definitions. As used in this article 170, unless the context otherwise requires: ( 1) "Administration session" means a session conducted at a healing center, or another location as allowed by this article 170 and article 50 of title 44, during which a participant eonsumes and cxpcricnecs MAY PURCHASE REGULATED NATURAL MEDICINE AND REGULATED NATURAL MEDICINE PRODUCT AND CONSUME AND EXPERIENCE the effects of regulated natural medicine or regulated natural medicine product under the supervision of a facilitator. (12) (b) In addition to the substances listed in subsection (12)(a) of this section, "natural medicine" includes: (II) Ibogaine, if recommended by the board and approved by the director and the executive director of the state licensing authority; AND

IBOGAINE

DERIVED

FROM

A

SEMI-SYNTHETIC

PROCESS

USING

THE

TABERNANTHE !BOGA PLANT OR VOACANGA AFRICANA PLANT, IF APPROVED BY THE BOARD AS A NATURAL MEDICINE AND TO THE EXTENT PERMITTED BY THE STATE LICENSING AUTHORITY, FOR USE IN THE ADMINISTRATION SESSIONS CONDUCTED IN ACCORDANCE WITH THIS ARTICLE 170 AND ARTICLE

50 OF TITLE 44; or (c) "Natural medicine" does not mean a synthetic or synthetic analog of the substances listed in subsections (12)(a) and (12)(b) of this section, including a derivative of a naturally occurring compound of natural medicine that is produced using chemical synthesis, chemical modification, or chemical conversion, EXCEPT FOR IBOGAINE DERIVED FROM A SEMI-SYNTHETIC PROCESS USING THE TABERNANTHE !BOGA PLANT, V OACANGA AFRICAN A PLANT, OR ANOTHER SOURCE THAT IS RECOMMENDED BY THE BOARD, PURSUANT TO SECTION 12-170-106, FOR USE AS A NATURAL MEDICINE AND TO THE EXTENT PERMITTED BY THE STATE LICENSING AUTHORITY, FOR USE IN ADMINISTRATION SESSIONS, PURSUANT TO THIS ARTICLE 170 AND ARTICLE 50 OF TITLE 44.

SECTION 4. In Colorado Revised Statutes, 12-170-105, amend (l)(a) introductory portion and (l)(a)(Il)(I); and add (l)(a)(I.5) as follows : 12-170-105. Director powers and duties - prohibition - rules. (I) In addition to any other powers and duties granted or imposed on the director pursuant to this article 170 or by any other law, the director has the following powers and duties: (a) To prnnmlgatc ADOPT rules pursuant to section 12-20-204 concerning the following subjects:

REQUIREMENTS FOR THE USE AND ADMINISTRATION OF

IBOGAINE, INCLUDING:

(A) REQUIRING MEDICAL PRESCREENING, WHICH MAY INCLUDE AN ELECTROCARDIOGRAM, BLOOD TESTS, GENETIC TESTS, AND ANY OTHER MEDICAL TEST, THE RESULTS OF WHICH MAY BE USED TO HELP REDUCE THE RISKS RELATED TO IBOGAINE ADMINISTRATION FOR A PARTICIPANT;

(8) REQUIRING CONTINUOUS MEDICAL MONITORING DURING AN

PAGE IO-HOUSE BILL 26-1325

IBOGAINE ADMINISTRATION SESSION; (C) REQUIRING APPROPRIATE OVERSIGHT BY TRAINED AND EXPERIENCED MEDICAL PROFESSIONALS DURING AN IBOGAINE ADMINISTRATION SESSION; AND

(D) REQUIRING EXTENDED INTEGRATION OR AFTERCARE, AS APPROPRIATE, WHICH MAY UTILIZE REFERRALS, MEDICAL AND MENTAL HEALTH PROFESSIONALS, AND CERTIFIED PEER SUPPORT SPECIALISTS; (II)

Requirements for the licensing of facilitators, practice of facilitation, and professional conduct of facilitators, including:

(I) Parameters for a facilitator's permissible and prohibited financial interests in a healing center, license pursuant to this article 170, or license pursuant to article 50 of title 44; except that a facilitator may not have a financial inte1cst in mote than five natmal medicine business licenses pu1suant to article 50 of title 44; SECTION 5. In Colorado Revised Statutes, 12-170-106, amend (1), (2), (4)(c), and (5)(f); repeal (3); and add (4)(d), (4)(e), and (4)(f) as follows: 12-170-106. Board - creation - appointment - duties - report. ( 1) There is created within the division a natural medicine advisory board, which consists of fifteen VOTING members AND ONE NONVOTING MEMBER DESCRIBED IN SUBSECTION (3) OF THIS SECTION, to advise the division and the state licensing authority concerning the implementation of this article 170 and article 50 of title 44. THE BOARD IS ADVISORY IN NATURE AND SHALL NOT EXERCISE LICENSING, ENFORCEMENT, RULE-MAKING, OR OPERATIONAL AUTHORITY. (2) (a) The govetno1 shall appoint initial boa1d membe1s on or bef-o1e January 31, 2023, with consent of the senate. The membets rnust include: THE GOVERNOR SHALL APPOINT THE FIFTEEN VOTING MEMBERS TO THE BOARD.

W (b) Seven membets with significant expertise and expetience in one 01 mote of the f-ollo wing at eas. Natutal medicine thetap:Y, medicine,

and 1esea1eh, mycology and natmal medicine cultivation, licensee qualifications, eme1geney medical set vices and set vices prnvided by fi:tst 1esponde1s, mental and behaviornl health ea1e, health-ea1e insmanee and health-earn policy, and public health, drug policy, and ha1m reduction, and IN MAKING APPOINTMENTS TO THE BOARD, THE GOVERNOR SHALL ENSURE THAT THE BOARD REFLECTS A DIVERSE RANGE OF PROFESSIONAL EXPERTISE, LIVED EXPERIENCE, AND PERSPECTIVES NECESSARY TO ADVISE ON THE SAFE, EFFECTIVE, AND EQUITABLE IMPLEMENTATION OF NATURAL MEDICINES AUTHORIZED PURSUANT TO THIS ARTICLE 170.

th} (c) Eight 1ne1nbe1 s with significant expertise and expet ienee in one 01 more of the following a1eas. Religious use of na-turnl medicines, issues eonfi: onting veternns, traditional tribal 01 Indigenous use of natm al medicines, levels and disparities in access to health-ea1e se1viees among different communities, and past eriminaljustiee 1efo1m efforts in Colorndo. At least one of the eight metnbe1s must have expertise or experience in traditional, ttibal, 01 Indigenous use of natural medicines. MEMBERS APPOINTED TO THE BOARD MUST HA VE RELEVANT EXPERIENCE TO THE NATURAL

MEDICINE

CURRENTLY

BEING

REGULATED

OR

UNDER

CONSIDERATION BY THE BOARD. RELEVANT EXPERIENCE MAY CONSIST OF WORK OR EXPERTISE IN THE FOLLOWING AREAS: (I)

MEDICAL,

CLINICAL,

SCIENTIFIC,

PHARMACOLOGICAL,

TOXICOLOGICAL, OR RESEARCH RELATED TO NATURAL MEDICINE;

(II) PHYSICAL HEALTH CARE, MENTAL HEALTH CARE, BEHAVIORAL HEALTH CARE, OR SUBSTANCE USE DISORDER TREATMENT;

(Ill) EMERGENCY MEDICAL SERVICES, FIRST RESPONDER SERVICES, OR ACUTE CARE MEDICINE;

(IV)

PUBLIC HEALTH, DRUG POLICY, HARM REDUCTION, OR

HEALTH-CARE POLICY;

(V) NATURAL MEDICINE CULTIVATION, SOURCING, PROCESSING, MANUFACTURING, SUPPORTIVE CARE PROVIDED PRIOR TO AND FOLLOWING THE ADMINISTRATION OF NATURAL MEDICINE, OR QUALITY CONTROL OF NATURAL MEDICINE;

(VI)

REGULATORY COMPLIANCE, PROFESSIONAL LICENSURE,

HEALTH-CARE REGULATION, OR LABORATORY STANDARDS;

(VII) RELIGIOUS, SPIRITUAL, TRADITIONAL, TRIBAL, OR INDIGENOUS USE OF NATURAL MEDICINE; (VIII)

ISSUES IMPACTING VETERANS OR OTHER POPULATIONS

DISPROPORTIONATELY IMPACTED BY SUBSTANCE USE DISORDER OR MENTAL HEALTH CONDITIONS;

(IX)

HEALTH-CARE ACCESS, HEALTH EQUITY, OR DISPARITIES IN

ACCESS TO CARE;

(X) CRIMINAL JUSTICE REFORM, DRUG POLICY REFORM, OR IMPACTS OF PRIOR DRUG ENFORCEMENT POLICIES; OR

(XI) ISSUES AFFECTING THE ECOLOGY OR CULTURE OF INDIGENOUS PEOPLE WHO HA VE HISTORICALLY USED NATURAL MEDICINE.

(d) NOTHING IN SUBSECTION (2)(c) OF THIS SECTION REQUIRES THE BOARD TO REPRESENT ALL AREAS OF EXPERTISE LISTED IN SUBSECTION (2)( c) OF THIS SECTION.

(e)

SUBSECTION (2)(c) OF THIS SECTION DOES NOT LIMIT THE

GOVERNOR'S DISCRETION TO APPOINT MEMBERS WHOSE QUALIFICATIONS ARE PARTICULARLY RELEVANT TO A SPECIFIC NATURAL MEDICINE THAT IS BEING REGULATED OR IS UNDER CONSIDERATION BY THE BOARD.

(3) The board includes the executive director of the department of revenue, or the exeeuti ve dir eetor 's designee, ser ving as a nonvoting meinber. (4) (c) Except for the executive director of the state licensing authority, or the executive director's designee, Members of the board may serve up to two consecutive terms. Metnbets ate subject to temoval for misconduct, incompetence, neglect of duty, 01 unprofessional conduct. (d)

MEMBERS ARE SUBJECT TO REMOVAL FOR MISCONDUCT,

INCOMPETENCE, NEGLECT OF DUTY, OR UNPROFESSIONAL CONDUCT, AND THE GOVERNOR MAY REMOVE A MEMBER FROM THE BOARD IF THE GOVERNOR DETERMINES THAT CHANGES TO THE BOARD'S COMPOSITION ARE NECESSARY

TO ENSURE THE BOARD POSSESSES THE EXPERTISE REQUIRED TO FULFILL ITS ADVISORY ROLE WITH RESPECT TO A NATURAL MEDICINE BEING REGULA TED OR UNDER CONSIDERATION BY THE BOARD.

(e) THE GOVERNOR SHALL FILL A VACANCY THAT OCCURS ON THE BOARD WITHIN ONE HUNDRED TWENTY DAYS AFTER THE VACANCY ARISES.

(f) A MEMBER APPOINTED PURSUANT TO SUBSECTION ( 4 )( e) OF THIS SECTION SERVES FOR THE DURATION OF THE TERM BEING FILLED, SUBJECT TO SUBSECTION (4)(d) OF THIS SECTION.

(5) The board shall make recommendations to the director and state licensing authority related to, but not limited to, the following areas: (f) The addition of other types of natural medicine to this article 170 and article 50 of title 44 pursuant to section 12-170-104 ( 12)(b )(I), (12)(b)(II), or (12)(b)(III) based on available medical, psychological, and scientific studies, research, and other information related to the safety and efficacy of each natural medicine, and shall prioritize considering the addition of ibogaine pursuant to section 12-170-104 (12)(b )(II), to this article 170, and to article 50 of title 44, INCLUDING ADDITIONAL GENERA OR SPECIES OF PLANTS THAT MAY BE CULTIVATED AND MANUFACTURED TO CREATE SEMI-SYNTHETIC IBOGAINE SUCH AS THE GENERA TABERNANTHE PLANT, VOACANGA AFRICANA PLANT, AND TABERNAEMONTANA PLANT;

SECTION 6. In Colorado Revised Statutes, 12-170-113, add (3) as follows: 12-170-113. Protections. (3) (a) A FACILITATOR IS NOT LIABLE FOR MONEY DAMAGES IN A CIVIL MALPRACTICE ACTION FOR A PHYSICAL OR PSYCHOLOGICAL INJURY THAT A PARTICIPANT MAY EXPERIENCE AS A RESULT OF THE FACILITATOR'S PERFORMANCE OR SUPERVISION OF NATURAL MEDICINE SERVICES FOR A PARTICIPANT, UNLESS THE INJURY WAS THE DIRECT RESULT OF THE FACILITATOR'S INTENTIONAL MISCONDUCT, GROSS NEGLIGENCE, OR A DEVIATION FROM THE GENERALLY ACCEPTED STANDARDS OF PRACTICE.

(b)

THIS SUBSECTION (3) DOES NOT APPLY TO ADMINISTRATIVE

PROCEEDINGS.

SECTION 7. In Colorado Revised Statutes, 44-50-103, amend (13)(b)(II) and (13)(c) as follows: 44-50-103. Definitions. As used in this article 50, unless the context otherwise requires: (13) (b) In addition to the substances listed in subsection (13)(a) of this section, "natural medicine" includes: (II) Ibogaine, if recommended by the board and approved by the director and the executive director of the state licensing authority for inclusion, AND IBOGAINE DERIVED FROM A SEMI-SYNTHETIC PROCESS USING THE TABERNANTHE IBOGA PLANT OR VOACANGA AFRICANA PLANT, IF APPROVED BY THE BOARD AS A NATURAL MEDICINE AND, TO THE EXTENT PERMITTED

BY

THE

STATE

LICENSING

AUTHORITY,

FOR

USE

IN

ADMINISTRATION SESSIONS CONDUCTED IN ACCORDANCE WITH THIS ARTICLE

50 AND ARTICLE 170 OF TITLE 12; or (c) "Natural medicine" does not mean a synthetic or synthetic analog of the substances listed in subsections ( 13 )(a) and ( 13 )(b) of this section, including a derivative of a naturally occurring compound of natural medicine that is produced using chemical synthesis, chemical modification, or chemical conversion, EXCEPT FOR IBOGAINE DERIVED FROM A SEMI-SYNTHETIC PROCESS USING THE TABERNANTHE IBOGA PLANT, VOACANA AFRICAN A PLANT, OR ANOTHER SOURCE THAT IS RECOMMENDED BY THE BOARD, PURSUANT TO SECTION 12-170-106, FOR USE AS A NATURAL MEDICINE AND, TO THE EXTENT PERMITTED BY THE STATE LICENSING AUTHORJTY, FOR USE IN ADMINISTRATION SESSIONS CONDUCTED IN ACCORDANCE WITH THIS ARTICLE 50 AND ARTICLE 170 OF THIS TITLE 12.

SECTION 8. In Colorado Revised Statutes, 18-18-434, amend (5)(c)(IV) and (12)(d); and add (5)(c)(VI), (5)(c)(VII), (5)(c)(VIII), and (5.5) as follows: 18-18-434. Offenses relating to natural medicine and natural medicine product - definitions. (5) (c) Nothing in this section permits a person to:

(IV) Dispense, distribute, or possess with intent to dispense or distribute natural medicine or natural medicine product as a part of a business promotion or commercial activity, except as provided by article 170 of title 12 and article 50 of title 44; or (VI) ADVERTISE BONA FIDE HARM REDUCTION SERVICES OR BONA FIDE SUPPORT SERVICES OFFERED FOR REMUNERATION EXCEPT AS PROVIDED FOR IN SECTION (12)(d) OF THIS SECTION;

(VII)

ADVERTISE NATURAL MEDICINE OR NATURAL MEDICINE

PRODUCT;OR

(VIII) USE HARM REDUCTION SERVICES OR SUPPORT SERVICES TO CONDUCT SALES OF NATURAL MEDICINE. PROHIBITED SALES ACTIVITIES RELATED TO HARM REDUCTION SERVICES OR SUPPORT SERVICES INCLUDE BUT ARE NOT LIMITED TO: (A) OPERATING A RETAIL STORE, VENDOR TABLE, VENDOR BOOTH, OR OTHER COMMERCIAL BUSINESS THAT DISPENSES FOR REMUNERATION ANY AMOUNT OF NATURAL MEDICINE OR NATURAL MEDICINE PRODUCT NOT INTENDED FOR CONSUMPTION UNDER SUPERVISION BY THE NATURAL PERSON OR ENTITY THAT DISPENSES THE NATURAL MEDICINE OR NATURAL MEDICINE PRODUCT; (B) SALES OF SERVICES OR ITEMS THAT INCLUDE THE TRANSFER OF NATURAL MEDICINE, WHICH DOES NOT PRECLUDE REMUNERATION FOR BONA FIDE HARM REDUCTION SERVICES OR BONA FIDE SUPPORT SERVICES;

(C) PAYING RECURRING FEES TO ACQUIRE NATURAL MEDICINE OR NATURAL MEDICINE PRODUCTS; AND

(D) ONLINE SALES THAT INCLUDE NATURAL MEDICINE OR NATURAL MEDICINE PRODUCTS.

(5.5) BONAFIDEHARMREDUCTIONSERVICESORBONAFIDESUPPORT SERVICES WITHOUT THE EXCHANGE OR SHARING OF NATURAL MEDICINE OR NATURAL MEDICINE PRODUCTS ARE NOT SUBJECT TO THIS SECTION.

(12) As used in this section, unless the context otherwise requires:

(d) "Personal use" means the consumption or use of natural medicine or natural medicine product; or the amount of natural medicine or natural medicine product a person may lawfully possess, cultivate, or manufacture that is necessary to share with another person who is twenty-one years of age or older within the context of counseling, spiritual guidance, beneficial community-based use and healing, supported use, or related services. "Personal use" does not mean the sale of natural medicine or natural medicine product for remuneration; the possession, cultivation, or manufacture of natural medicine or natural medicine product with intent to sell the natural medicine or natural medicine product for remuneration; or the possession, cultivation, manufacture, or distribution of natural medicine or natural medicine product for business or commercial purposes, except as provided by article 170 of title 12 and article 50 of title 44. Nothing in this section precludes remuneration for bona fide harm reduction services or bona fide support services used concurrently with the sharing of CONSUMPTION OF SHARED natural medicine or natural medicine product, prn~ided that IF there is no advertisement related to the sharing of natural medicine, natural medicine product, or the services provided, SERVICES OFFERED, and provided that IF the individual providing the services informs an individual engaging in the services that the individual is not a licensed facilitator pursuant to article 170 of title 12. SECTION 9. In Colorado Revised Statutes, 44-50-103, amend (l); and add (11.5) and (24.5) as follows: 44-50-103. Definitions.

As used in this article 50, unless the context otherwise requires: ( 1) "Administration session" means a session conducted at a healing center, or other location if permitted by this article 50 or rules promulgated ADOPTED pursuant to this article 50, during which a participant consumes and experiences MAY PURCHASE REGULATED NATURAL MEDICINE AND REGULATED NATURAL MEDICINE PRODUCT AND CONSUME AND EXPERIENCE the effects of natural medicine under the supervision of a facilitator. ( 11.5) "LIMITED REGULATED NATURAL MEDICINE SALES LICENSE" MEANS A LICENSE ISSUED TO AN OWNER AUTHORIZING THE LICENSE TO CO-LOCATE WITH A HEALING CENTER IN WHICH THERE IS AT LEAST ONE PERSON LICENSED AS AN OWNER ASSOCIATED WITH BOTH THE LIMITED

REGULATED NATURAL MEDICINE SALES LICENSE AND THE HEALING CENTER. (24.5) "TEMPORARY PREMISES" MEANS THE PHYSICAL LOCATION WHERE A NATURAL MEDICINE HEALING CENTER, LICENSED PURSUANT TO THIS ARTICLE 50, IS AUTHORIZED TO PROVIDE NATURAL MEDICINE SERVICES UNDER THE TERMS OF A TEMPORARY PREMISES PERMIT.

SECTION 10. In Colorado Revised Statutes, 44-50-104, amend (2) as follows:

44-50-104. Applicability. (2) A person applying for licensure pursuant to this article 50 must complete forms as provided by the state licensing authority and must pay the application fee and the licensing fee, which must be credited to the regulated natural medicine division cash fund established pursuant to section 44-50-601. The state licensing authority shall prioritize reviewing applications from applicants who have established resideney in Col01ado. IN THE FOLLOWING ORDER: (a) APPLICANTS WHO PARTICIPATED IN THE PILOT PROGRAM TO ADMINISTER IBOGAINE PURSUANT TO SECTION 27-60-207; (b) APPLICANTS WHO HA VE ESTABLISHED RESIDENCY IN COLORADO; AND

(c) APPLICANTS WHO DEMONSTRATE PRIORITY REVIEW STATUS AS ESTABLISHED BY THE STATE LICENSING AUTHORITY IN RULE.

SECTION 11. In Colorado Revised Statutes, 44-50-202, amend (l)(a); and add (10) as follows: 44-50-202. report - rules.

Powers and duties of state licensing authority -

(1) The state licensing authority shall: (a) Beginning on or before December 31, 2024, grant or refuse state licenses for the cultivation, manufacturing, testing, storage, distribution, transport, transfer, and dispensation of regulated natural medicine or

regulated natural medicine product; suspend, fine, restrict, or revoke sueh THE licenses, whether active, expired, or surrendered, upon a violation of this article 50 or a rule prnmulgated ADOPTED pursuant to this article 50; and impose any penalty authorized by this article 50 or a rule prnmulgated ADOPTED pursuant to this article 50. The state licensing authority may take any action with respect to a registration or permit pursuant to this article 50 as it may with respect to a license issued pursuant to this article 50, in accordance with the procedures established pursuant to this article 50. (I) THE INCORPORATION OF ADDITIONAL NATURAL MEDICINES, AS RECOMMENDED BY THE BOARD AND APPROVED BY THE DIRECTOR AND EXECUTIVE DIRECTOR OF THE STATE LICENSING AUTHORITY, IS SUBJECT TO AVAILABLE FUNDING TO COVER THE DIRECT AND INDIRECT COSTS OF ADMINISTERING THIS ARTICLE 50. THE STATE LICENSING AUTHORITY IS NOT REQUIRED TO INCORPORATE ADDITIONAL NATURAL MEDICINES IF THERE IS NOT SUFFICIENT FUNDING TO FINANCE PROGRAM ADMINISTRATION. (II) ONCE SUFFICIENT FUNDING IS SECURED FOR PROGRAM IMPLEMENTATION, THE STATE LICENSING AUTHORITY, IN CONSULTATION WITH THE BOARD, THE DEPARTMENT OF REGULATORY AGENCIES, THE BEHAVIORAL HEALTH ADMINISTRATION, AND THE DEPARTMENT OF PUBLIC HEALTH AND ENVIRONMENT, SHALL DETERMINE THE PROGRAM SCOPE FOR IMPLEMENTATION. ( 10) THE STATE LICENSING AUTHORITY IS NOT REQUIRED TO CONDUCT ROUTINE, PERIODIC, OR PRE-OPERATIONAL INSPECTIONS AS A CONDITION OF LI CENSURE UNLESS EXPRESSLY REQUIRED BY THIS ARTICLE 50.

SECTION 12. In Colorado Revised Statutes, 44-50-203, amend (l)(e), (2)(r), and (2)(s)(III); and add (l)(p), (l)(q), (2)(t), (2)(u), (2.5), (4)(c), (5), and (6) as follows:

44-50-203. State licensing authority - rules. (1) Mandatory rule-making. Rules adopted pursuant to section 44-50-202 (l)(b) must include the following subjects: ( 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 ha'\/ e a financial inte1 est in nro1 e than

f'ive natural medicine business licenses,

(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 REGULA TED 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 CO-LOCATED HEALING CENTER'S LICENSED PREMISES;

( 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 CO-LOCATED 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 CREA TED 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 (l)(b) may include, but need not be limited to, the following subjects: (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:

(Ill) 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;

(Ill)

ESTAB LI SH ING MINIMUM RECORD KEEPING REQUIREMENTS,

WHICH MAY INCLUDE AUTHORIZING LICENSEES OPERA TING 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

STAND ARDS

FOR

REQUIREMENTS

IBOGAINE

THAT

AND

IBOGAINE

PRODUCTS,

INCLUDING

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.

(4) (c) THE STATE LICENSING AUTHORITY MAY ESTAB LISH 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, ESTAB LISH A BENEFIT-SHARING PLAN THAT DIRECTLY BENEFITS THOSE

COMMUNITIES. A LICENSEE MAY USE OR RELY ON A THIRD PARTY FOR CONSULTATION.

THE

(b) A LICENSEE SHALL MAINTAIN DOCUMENTATION DEMONSTRATING CONSULTATION PROCESS AND THE DEVELOPMENT OF THE

BENEFIT-SHARING PLAN AND MAKE THE DOCUMENTATION PUBLICLY AVAILABLE UPON REQUEST. ( c) FOR PURPOSES OF 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; (Ill) 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.

SECTION 13. In Colorado Revised Statutes, 44-50-301, amend (2)(a)(IV) and (2)(a)(V); and add (2)(a)(VI) as follows: 44-50-301. Classes of licenses. (2) (a) The following are natural medicine business licenses: (IV) Natural medicine testing facility license; and

(V) Any natural medicine business license determined necessary by the state licensing author icy LIMITED REGULATED NATURAL MEDICINE SALES LICENSES; AND (VI)

ANY NATURAL MEDICINE BUSINESS LICENSE DETERMINED

NECESSARY BY THE STATE LICENSING AUTHORITY.

SECTION 14. In Colorado Revised Statutes, 44-50-401, amend (2); and add (7), (8), and (9) as follows: 44-50-401. collection - rules. (2)

A

Natural medicine healing center license - data

natural medicine healing center licensee may transfer

regulated natural medicine or regulated natural medicine product to another natural medicine healing center licensee, LIMITED REGULA TED NATURAL MEDICINE SALES LICENSEE, or a facilitator pursuant to rules promulgated ADOPTED by the state licensing authority.

(7) (a) A HEALING CENTER MAY APPLY FOR A TEMPORARY PREMISES PERMIT AT A SEPARATE LOCATION. THE DEPARTMENT MAY ISSUE A TEMPORARY PREMISES PERMIT TO A LICENSED NATURAL MEDICINE HEALING CENTER IF THE FOLLOWING CONDITIONS ARE MET:

(I) THE HEALING CENTER SUBMITS A COMPLETE APPLICATION AND PAYS ALL APPLICATION AND PERMIT FEES TO THE DEPARTMENT; (II) THE LOCATION IS APPROVED BY THE DEPARTMENT SUBJECT TO THE REQUIREMENTS IN SECTION 44-50-302; (III) THE LICENSEE'S USE OF THE TEMPORARY PREMISES DOES NOT EXCEED THE DURATION APPROVED UNDER THE PERMIT; (IV)

THE APPLICANT DEMONSTRATES THE LICENSED NATURAL

MEDICINE HEALING CENTER IS ENTITLED TO USE THE LOCATION AS A TEMPORARY PREMISES; AND (V) THE TEMPORARY PREMISES OTHERWISE COMPLIES WITH THIS ARTICLE 50 AND ALL OTHER RULES ADOPTED BY THE DEPARTMENT.

(b) A NATURAL MEDICINE HEALING CENTER'S TEMPORARY PREMISES IS NOT REQUIRED TO BE LOCATED IN THE SAME LOCAL JURISDICTION AS THE LICENSED PREMISES.

(c)

THE STATE LICENSING AUTHORITY SHALL NOT ISSUE A

TEMPORARY

PREMISES

PERMIT

FOR

A

LOCATION

AT

WHICH

THE

DISTRIBUTION, TRANSFER, AND DISPENSATION OF REGULATED NATURAL MEDICINE OR REGULATED NATURAL MEDICINE PRODUCT IS NOT PERMITTED UNDER THE ZONING CODE OF THE LOCAL JURISDICTION.

(8) A LIMITED REGULATED NATURAL MEDICINE SALES LICENSE MAY BE ISSUED ONLY TO A PERSON THAT APPLIES FOR AND IS APPROVED TO OPERA TE A HEALING CENTER LICENSE AND IS SUBJECT TO THE FOLLOWING REQUIREMENTS:

(a) THE LICENSE MUST BE CO-LOCATED WITH A HEALING CENTER AT WHICH AN ADMINISTRATION SESSION IS HELD, WHERE REGULATED NATURAL MEDICINE OR REGULATED NATURAL MEDICINE PRODUCT IS SOLD TO A PARTICIPANT.

(b)

THE LICENSE MUST HA VE COMMON OWNERSHIP WITH THE

CO-LOCATED HEALING CENTER. FOR PURPOSES OF THIS SECTION, COMMON OWNERSHIP MEANS THERE IS AT LEAST ONE PERSON LICENSED AS AN OWNER ASSOCIATED WITH BOTH THE LIMITED REGULATED NATURAL MEDICINE SALES LICENSE AND THE HEALING CENTER.

(c) THE LICENSE MAY BE EXERCISED TO STORE, PURCHASE, POSSESS, AND TRANSFER REGULATED NATURAL MEDICINE AND REGULATED NATURAL MEDICINE PRODUCT AND INVOICE A PARTICIPANT FOR REGULATED NATURAL MEDICINE AND REGULATED NATURAL MEDICINE PRODUCT TO BE USED SOLELY IN THE CONTEXT OF AN ADMINISTRATION SESSION AT A CO-LOCATED HEALING CENTER AND TO CONDUCT TRANSACTIONS ON BEHALF OF A FACILITATOR FOR THE NATURAL MEDICINE SERVICES

PROVIDED IN

ACCORDANCE WITH ARTICLE 170 OF TITLE 12.

(d) THE LICENSE IS NOT REQUIRED TO COMPLY WITH SUBSECTION ( 1) OF THIS SECTION SEPARATE FROM THE COMMONLY OWNED, CO-LOCATED HEALING CENTER LICENSE.

(e)

ANY OTHER REQUIREMENTS ESTABLISHED BY RULES OF THE

STATE LICENSING AUTHORITY PURSUANT TO THIS ARTICLE 50. (9) A HEALTH CENTER LICENSEE SHALL NOT SELL REGULATED NATURAL MEDICINE OR REGULATED NATURAL MEDICINE PRODUCT UNLESS A CO-LOCATED LIMITED REGULATED NATURAL MEDICINE SALES LICENSEE CONDUCTS THE TRANSACTION IN ACCORDANCE WITH THE PROVISIONS OF SUBSECTION (8) OF THIS SECTION. SECTION 15. In Colorado Revised Statutes, 44-50-402, amend ( 1) as follows: 44-50-402. Natural medicine cultivation facility license.

( 1) A natural medicine cultivation facility license may be issued pursuant to state licensing authority rules and only to a person who cultivates regulated natural medicine for transfer and distribution to natural medicine healing center licensees, natural medicine product manufacturer licensees, ALIMITED REGULATED NATURAL MEDICINE SALES LICENSEE, other natural medicine cultivation facility licensees, or other persons licensed under PURSUANT TO article 170 of title 12 or this article 50. SECTION 16. In Colorado Revised Statutes, 44-50-601, amend (l)(a) as follows: 44-50-601. Regulated natural medicine cash fund - created rules - fees.

( 1) (a) Aft Money collected by the state licensing authority pursuant to this article 50 or rules prnmulgated ADOPTED pursuant to this article 50 must be transmitted to the state treasurer, who shall credit the same to the regulated natural medicine division cash fund, which is hereb)I created IN THE STATE TREASURY. The regulated natural medicine division cash fund, referred to in this section as the "fund", consists of: (I) The money collected by the state licensing authority; and (II)

GIFTS, GRANTS, OR DONATIONS FROM PUBLIC OR PRIVATE

SOURCES;

(Ill) MONEY TRANSFERRED FROM THE IBOGAINE RESEARCH PILOT

PROGRAM CASH FUND, ESTABLISHED IN SECTION 27-60-207 (10); AND

tH} (IV) Any additional general fund money appropriated to the fund that is necessary for the operation of the state licensing authority.

SECTION 17. In Colorado Revised Statutes, add 44-50-702 as follows:

44-50-702. Unlawful exercise of the privileges of a license.

IF THE DIRECTOR OF THE NATURAL MEDICINE DIVISION

DETERMINES BASED UPON CREDIBLE EVIDENCE FROM A COMPLAINT OR INVESTIGATION THAT A PERSON IS ACTING OR HAS ACTED WITHOUT THE LICENSE REQUIRED TO OPERATE A NATURAL MEDICINE BUSINESS OR TO OWN, GROW, HARVEST, TRANSFER, MANUFACTURE, SUPERVISE, PROVIDE, OR ADMINISTER NATURAL MEDICINE, THE DIRECTOR MAY ISSUE AN ORDER TO CEASE AND DESIST THE ACTIVITY. THE ORDER MUST SET FORTH THE STATUTES AND RULES ALLEGED TO HAVE BEEN VIOLATED, THE FACTS ALLEGED TO CONSTITUTE THE VIOLATION, AND THE REQUIREMENT THAT ALL UNLAWFUL ACTS OR UNLICENSED ACTIVITY IM MEDIATELY CEASE. (2) WITHIN FOURTEEN DAYS AFTER SERVICE OF THE ORDER TO CEASE AND DESIST ISSUED PURSUANT TO SUBSECTION (1) OF THIS SECTION, THE RESPONDENT MAY REQUEST A HEARING BEFORE THE HEARINGS DIVISION ON THE QUESTION OF WHETHER THEIR ACTS OR PRACTICES WERE IN VIOLATION OF THIS TITLE 44 OR UNLICENSED ACTIVITY OCCURRED. (3)

THE HEARING MUST BE CONDUCTED PURSUANT TO SECTIONS

24-4-104 AND 24-4-105. (4) JUDICIAL REVIEW OF FINAL AGENCY ACTION REGARDING THE CEASE AND DESIST MUST BE CONDUCTED PURSUANT TO SECTION 24-4-106.

SECTION 18. Act subject to petition - effective date. This act takes effect at 12:01 a.m. on the day following the expiration of the ninety-day period after final adjournment of the general assembly (August 12, 2026, if adjournment sine die is on May 13, 2026); except that, if a referendum petition is filed pursuant to section 1 (3) of article V of the state constitution against this act or an item, section, or part of this act within such period, then the act, item, section, or part will not take effect unless

approved by the people at the general election to be held in November 2026 and, in such case, will take effect on the date of the official declaration of the vote thereon by the governor.

Julie McCluskie SPEAKER OF THE HOUSE OF REPRESENTATIVES

James Rashad Coleman, Sr. PRESIDENT OF THE SENATE

Vanessa Reilly CHIEF CLERK OF THE HOUSE OF REPRESENTATIVES

Esther van Mourik SECRETARY OF THE SENATE

APPROVED on Thursday June 4th 2026 at 12:00pm (Date and Time)

Jared S. Polis GOVERNOR OF THE STATE OF COLORADO