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;
PAGE 2-HOUSE BILL 26-1325
(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 HEAL TH
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 INVESTIGA TIONAL NEW DRUG APPLICATION WITH
PAGE 3-HOUSE BILL 26-1325
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 HEAL TH 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 EST AB LISH A PILOT PROPOSAL REVIEW
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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 OPERA TE AN IBOGAINE PILOT SITE TO STUDY SAFETY AND TREATMENT
EFFECTIVENESS OF THE USE OF IBOGAINE TO TREAT MENTAL HEAL TH
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 (5), 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
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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.
(8) 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
PAGE 6-HOUSE BILL 26-1325
THIS SECTION AND ANY OTHER MONEY THAT THE GENERAL ASSEMBLY MAY
APPROPRIATE OR TRANSFER TO THE FUND. THE ST ATE 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.
(13) 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
HEAL TH 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.
PAGE 7-HOUSE BILL 26-1325
(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 ST A TUTES IN WRITING OF THE DA TE ON
WHICH THE CONDITION SPECIFIED IN THIS SUBSECTION ( 16) HAS OCCURRED
BY EMAILING THE NOTICE TO REVISOROFSTATUTES.GA@COLEG.GOV.
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 ST A TUTES DOES NOT SPECIFY THAT DA TE, ON THE DA TE
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 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 OPERA TING
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 TOT AL 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 OPERA TING 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 REVISOROFSTATUTES.GA@COLEG.GOV.
PAGE 8-HOUSE BILL 26-1325
(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 DA TE ON WHICH THE REVISOR OF ST A TUTES RECEIVES NOTICE PURSUANT
TO SUBSECTION ( 16) OF THIS SECTION, THE STATE TREASURER SHALL RE TURN
FROM THE FUND TO THE GRANTOR OR DONOR THE AMOUNT OF THE
GRANTOR'S OR DONOR'S GIFTS, GRANTS, OR DONATIONS AND,
NOTWITHSTANDING SUBSECTION ( 1 7) 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 ST A 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
PAGE 9-HOUSE BILL 26-1325
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 T ABERNANTHE !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:
(1.5) 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,
PAGE 11-HOUSE BILL 26-1325
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 v eternns, 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 HEAL TH 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,
PAGE 12-HOUSE BILL 26-1325
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 v e dir eetor 's designee, ser v ing 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
PAGE 13-HOUSE BILL 26-1325
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.
PAGE 14-HOUSE BILL 26-1325
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:
PAGE 15-HOUSE BILL 26-1325
(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 R EDUCTION 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:
PAGE 16-HOUSE BILL 26-1325
( 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
PAGE 17-HOUSE BILL 26-1325
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. Powers and duties of state licensing authority -
report -rules.
(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
PAGE 18-HOUSE BILL 26-1325
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 ST ATE 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
PAGE 19-HOUSE BILL 26-1325
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 REGULA TED
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:
PAGE 20-HOUSE BILL 26-1325
(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) EST AB 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 HEAL TH AND SAFETY RISKS; AND
(II) ESTABLISHING MINIMUM MANUFACTURING AND TESTING
PAGE 21-HOUSE BILL 26-1325
ST AND ARDS 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.
( 4) ( c) THE STATE LICENSING AUTHORITY MAY EST AB 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,
EST AB LISH A BENEFIT-SHARING PLAN THAT DIRECTLY BENEFITS THOSE
PAGE 22-HOUSE BILL 26-1325
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) 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
PAGE 23-HOUSE BILL 26-1325
(V) Any natural medicine business license determined necessary by
the state licensing author icy LIMITED REGULA TED 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. Natural medicine healing center license - data
collection -rules.
(2) A 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.
PAGE 24-HOUSE BILL 26-1325
(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
PAGE 25-HOUSE BILL 26-1325
STATE LICENSING AUTHORITY PURSUANT TO THIS ARTICLE 50.
(9) A HEAL TH 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, A LIMITED REGULA TED 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 ST ATE 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
PAGE 26-HOUSE BILL 26-1325
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.
(1) 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 OPERA TE 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
PAGE 27-HOUSE BILL 26-1325
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.
J~
SPEAKER OF THE HOUSE
OF REPRESENTATIVES
v~~
Vanessa Reilly
CHIEF CLERK OF THE HOUSE
OF REPRESENTATIVES
James Rashad Coleman, Sr.
PRESIDENT OF
THE SENATE
Esther van Mourik
SECRETARY OF
THE SENATE
APPROVED oV\ ,n~'\ ~VN..-4-""' 2..oU/,1 t?\,f I 1 :oo~
(Date and Time)
Jared S. Pol
GOVERNO
PAGE 28-HOUSE BILL 26-1325