House Bill 25-1063

BY REPRESENTATIVE(S) Hartsook and Brown, Bacon, Boesenecker, Camacho, Carter, Duran, Lindsay, McCormick, Phillips, Rutinel, Smith, Stewart R., Valdez, Woodrow, Zokaie;

also SENATOR(S) Michaelson Jenet, Hinrichsen.

Concerning the lawful use of crystalline polymorph psilocybin that is approved by the United States food and drug administration.

Be it enacted by the General Assembly of the State of Colorado:

SECTION 1.  Legislative declaration. (1)  The general assembly finds that:

(a)  Treatment-resistant depression is defined by the federal food and drug administration as depression that has failed to respond to 2 or more medications of adequate dose and duration during a single depressive episode;

(b)  Serious public health implications are associated with treatment-resistant depression, including a high cost of illness caused by the need for higher intensity treatments, impaired psychosocial function, a greater need for disability benefits, workplace absenteeism, negative impact on caregivers, and increased suicidality;

(c)  According to the largest study ever conducted on the limitations of treating depression, treatment-resistant depression occurs in approximately one-third of people treated for major depressive disorder;

(d)  Veterans are disproportionately likely to suffer from treatment-resistant depression and other mental health conditions;

(e)  According to a recent psychiatric journal publication, approximately 68% of psychiatric clinic outpatient veterans satisfied criteria for treatment-resistant depression;

(f)  According to a recent medical journal publication, approximately half of active-duty service members with post-traumatic stress disorder also suffer from major depressive disorder, which is the parent indication of treatment-resistant depression; and

(g)  In clinical trials, crystalline polymorph psilocybin was shown to reduce depression scores significantly for patients with treatment-resistant depression when compared to active placebos.

(2)  Therefore, the general assembly declares that it is in the best interests of the people of Colorado that behavioral health professionals in Colorado have the ability to provide crystalline polymorph psilocybin to treat patients with treatment-resistant depression if the federal food and drug administration ultimately approves it for prescription use.

SECTION 2.  In Colorado Revised Statutes, 18-18-203, amend (2)(c)(XXI) as follows:

18-18-203.  Schedule I. (2)  Unless specifically excepted by Colorado or federal law or Colorado or federal regulation or more specifically included in another schedule, the following controlled substances are listed in schedule I:

(c)  Any material, compound, mixture, or preparation containing any quantity of the following hallucinogenic substances, including any salts, isomers, and salts of isomers of them that are theoretically possible within the specific chemical designation:

(XXI)  Psilocybin; except that psilocybin does not include a prescription drug product containing crystalline polymorph psilocybin approved by the federal food and drug administration and placed on a schedule of the federal "Controlled Substances Act", 21 U.S.C. sec. 801 et seq., other than schedule I, or exempt from one or more provisions of that act, and that is intended for prescribed use and dispensed by a pharmacy or prescription drug outlet registered by the state of Colorado and only possessed by a person authorized to possess a controlled substance pursuant to section 18-18-302. Any prescription drug product containing crystalline polymorph psilocybin that is approved by the federal food and drug administration must be controlled in Colorado in the same manner as required by any federal control designation pursuant to the federal "Controlled Substances Act", or any exemption from one or more provisions of that act; and is subject to the provisions set forth in part 1 of article 280 of title 12 and part 3 of this article 18. Nothing in this subsection (2)(c)(XXI) exempts a person from any violation of part 4 of this article 18.

SECTION 3.  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; 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.