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<ns0:ActionText>INTRODUCED</ns0:ActionText>
<ns0:ActionDate>2026-02-20</ns0:ActionDate>
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<ns0:SessionYear>2025</ns0:SessionYear>
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<ns0:AuthorText authorType="LEAD_AUTHOR">Introduced by Assembly Member Lowenthal</ns0:AuthorText>
<ns0:AuthorText authorType="PRINCIPAL_COAUTHOR_ORIGINATING">(Principal coauthor: Assembly Member Jeff Gonzalez)</ns0:AuthorText>
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<ns0:Legislator>
<ns0:Contribution>LEAD_AUTHOR</ns0:Contribution>
<ns0:House>ASSEMBLY</ns0:House>
<ns0:Name>Lowenthal</ns0:Name>
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<ns0:Contribution>PRINCIPAL_COAUTHOR</ns0:Contribution>
<ns0:House>ASSEMBLY</ns0:House>
<ns0:Name>Jeff Gonzalez</ns0:Name>
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<ns0:Title> An act to amend Sections 11213 and 11392 of, and to add and repeal Article 1.5 (commencing with Section 11214) of Chapter 5 of Division 10 of, the Health and Safety Code, relating to controlled substances. </ns0:Title>
<ns0:RelatingClause>controlled substances</ns0:RelatingClause>
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<ns0:Subject>Controlled substances: research.</ns0:Subject>
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<html:p>Existing law, the California Uniform Controlled Substances Act, classifies controlled substances into 5 designated schedules, with the most restrictive limitations generally placed on controlled substances classified in Schedule I, and the least restrictive limitations generally placed on controlled substances in Schedule V. Existing law creates the Research Advisory Panel, as specified, to conduct hearings on, and in other ways study, research projects concerning controlled substances. Existing law authorizes the panel to approve research projects that have been registered with the Attorney General concerning the nature and effects of cannabis or hallucinogenic drugs and the treatment of abuse of controlled substances. Existing law authorizes a person who, under federal law, is entitled to use controlled substances for the purpose of research, instruction, or analysis to lawfully obtain
and use those controlled substances upon approval by the panel, as specified.</html:p>
<html:p>This bill, the California Veterans’ Right to Try Act, would, until January 1, 2028, authorize the Research Advisory Panel to submit an investigational new drug application to the United States Food and Drug Administration requesting approval for a clinical trial of Schedule I or Schedule II controlled substances, as specified. The bill would authorize the Research Advisory Panel to, upon the failure of the United States Food and Drug Administration to timely approve an application, provide expedited approval of the research project if the application meets certain requirements, including proof of an independent peer review of the study for scientific merit and rigor by certain entities. The bill would require a veteran, in order to participate, to have been diagnosed with 2 or more severe or life-threatening mental health conditions and have been deemed ineligible to participate in United
States Food and Drug Administration approved trials.</html:p>
<html:p>This bill would make conforming changes and would make related findings and declarations.</html:p>
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<ns0:Preamble>The people of the State of California do enact as follows:</ns0:Preamble>
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<ns0:Num>SECTION 1.</ns0:Num>
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<html:p>The Legislature finds and declares all of the following:</html:p>
<html:p>
(a)
<html:span class="EnSpace"/>
California is home to over 1,500,000 United States military veterans, with the largest veteran population of any state in the nation.
</html:p>
<html:p>
(b)
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Since 2001, over 125,000 veterans have died by suicide, and 29 percent of veterans of the Global War on Terrorism are known to suffer from post-traumatic stress disorder (PTSD). The disproportionate incidence of serious health conditions, including PTSD, treatment-resistant depression, substance use disorders, and traumatic brain injuries, among veterans is also a driver of the disproportionate incidence of suicide among them. We lose between 17 and 44 veterans to suicide every
day in the United States. Suicide is also a leading cause of violent death in California and our state loses veterans to suicide at a rate significantly more than double the rate that other Californians are lost to suicide each year.
</html:p>
<html:p>
(c)
<html:span class="EnSpace"/>
According to the most recent data available from the United States Department of Veterans Affairs, California’s veterans accounted for 449 of the 4,193 Californians, and 6,407 of all veterans, lost to suicide in the same year.
</html:p>
<html:p>
(d)
<html:span class="EnSpace"/>
California’s veterans are overrepresented among our state’s unhoused population, and disproportionately impacted by substance use disorders.
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<html:p>
(e)
<html:span class="EnSpace"/>
The mental health crisis experienced by veterans in our state and across our nation has reached staggering proportions. Our great state needs to redouble efforts to address the mental health needs of these brave
and unselfish Californians.
</html:p>
<html:p>
(f)
<html:span class="EnSpace"/>
There is a mental health emergency severely impacting California’s military veterans and it is necessary for the state to initiate ongoing and urgent action to address the veteran mental health emergency in California, until the rate of veteran suicide in California is no greater than the rate of suicide impacting all Californians.
</html:p>
<html:p>
(g)
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The United States Food and Drug Administration (FDA) has granted breakthrough therapy designation (BTD) to CYB003, a novel, proprietary, and synthetic psilocybin analog designed to provide the therapeutic benefits of classical psychedelics. The FDA’s BTD is reserved for drugs that substantially improve over existing therapies in treating severe or life-threatening conditions. BTD status not only accelerates the development and review process, but it also facilitates closer collaboration between the drug developer and
the FDA. The ultimate goal is to bring promising treatments to patients more quickly and efficiently. In awarding BTD status to a psilocybin analog in the treatment of major depressive disorder, the FDA recognized not only the revolutionary potential of psychedelic-assisted therapies in treating medical and psychiatric conditions that disproportionately impact veterans, they also recognized the urgent need to make access to these therapies broadly available in the United States.
</html:p>
<html:p>
(h)
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Veterans exploring treatment solutions are currently forced to leave our country in order to access novel medicines and psychedelic assisted therapies. This crisis necessitates swift action and coordination by the federal and state governments to explore and develop these novel treatments for service-related health conditions fueling the disproportionate incidence of suicide among veterans. However, FDA regulations and guidelines for approving investigational new
drug research strongly discourage research protocols permitting trial participants with certain comorbidities, the overlapping occurrence of two or more medical or psychiatric conditions in a single subject, effectively deeming veterans with severe and life-threatening psychiatric conditions ineligible from participating in FDA-approved clinical trials, and leaving critical gaps in clinical research on the safety and efficacy of psychedelic-assisted therapies. At the same time, growing scientific evidence shows that psychedelics may be especially effective in treating patients with the types of comorbidities that are fueling the disproportionate incidence of veteran suicide, requiring a different approach to clinical trials of psychedelic compounds. Both the scale and immediacy of the crisis require concerted state and federal government action to address.
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<html:p>
(i)
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Psychedelic medicines can help lay the foundation for further healing, and the
approval of these new treatments would represent a revolutionary advance in care for those suffering from these health conditions. This advance has the potential to save the lives of countless veterans in California, and others throughout our great country, who might otherwise be lost to suicide.
</html:p>
<html:p>
(j)
<html:span class="EnSpace"/>
Our veterans need both state and federal laws to enable urgent clinical research of psychedelic treatments that actually includes veteran subjects. Veterans have largely been excluded from participating in FDA-regulated clinical trials due to the incidence of multiple overlapping mental health conditions commonly experienced by our veterans returning from war zones. Despite these barriers, the research is critical to advancing safe and effective treatments through the FDA’s drug approval process, so that veterans can access them through the Department of Veterans Affairs and their medical facilities.
</html:p>
<html:p>
(k)
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In order to facilitate urgently needed clinical research with veteran participants, and facilitate clinical research with readily available, nonproprietary botanical forms of breakthrough treatments, and thereby provide veterans with debilitating or life-threatening mental health indications with timely, lawful, and medically supervised access to FDA-designated breakthrough therapies, it is necessary to provide the state’s public hospitals and research institutions with the ability to conduct that research in compliance with state law. In order to provide this critical ability, the Legislature finds it is necessary to pass this act to amend Sections 11213 and 11392 of the Health and Safety Code, and add Article 1.5 (commencing with Section 11214) to Chapter 5 of Division 10 of the Health and Safety Code.
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<ns0:Num>SEC. 2.</ns0:Num>
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Section 11213 of the
<ns0:DocName>Health and Safety Code</ns0:DocName>
is amended to read:
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<ns0:Num>11213.</ns0:Num>
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<html:p>
(a)
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Persons who, pursuant to any law, are lawfully entitled to use Schedule I, Schedule II, or both, controlled substances for the purpose of research, instruction, or analysis, may lawfully obtain and use those substances, as defined in this division, for those purposes upon approval for use of those controlled substances in bona fide research, instruction, or analysis by the Research Advisory Panel established pursuant to Section 11480.
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<html:p>
(b)
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Such research, instruction, or analysis shall be carried on only under the auspices of the
head of a research project that has been approved by the Research Advisory Panel pursuant to Section 11480.1. Complete records of receipts, stocks at hand, and use of these controlled substances shall be kept.
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<ns0:Num>SEC. 3.</ns0:Num>
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Article 1.5 (commencing with Section 11214) is added to Chapter 5 of Division 10 of the
<ns0:DocName>Health and Safety Code</ns0:DocName>
, to read:
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<ns0:LawHeading type="ARTICLE" id="id_89700D80-31F8-4A20-9790-44A0A21427FD">
<ns0:Num>1.5.</ns0:Num>
<ns0:LawHeadingVersion id="id_7172809D-333A-4497-A735-3FBAF40BE7E6">
<ns0:LawHeadingText>California Veterans’ Right to Try Act</ns0:LawHeadingText>
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<ns0:Num>11214.</ns0:Num>
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<html:p>This article shall be known, and may be cited, as the California Veterans’ Right to Try Act.</html:p>
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<ns0:Num>11214.1.</ns0:Num>
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<html:p>
(a)
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In order to facilitate urgently needed human clinical research to address the statewide veteran mental health emergency declared by the Legislature, the state authorizes the Research Advisory Panel to submit one or more investigational new drug applications to the United States Food and Drug Administration, requesting federal approval for a multisite human clinical trial of psilocybin, ibogaine, or other Schedule I or Schedule II controlled substances, at between 20 and 30 sites throughout the state, studying the administration and efficacy of those compounds among a patient pool comprised exclusively of veteran subjects with comorbidities that commonly overlap with the incidence of suicidality among veterans.
</html:p>
<html:p>
(b)
<html:span class="EnSpace"/>
For the purposes of this
article, those applications shall be held by the panel on behalf of the state, and are referred to throughout this article as RAP-C IND.
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<ns0:LawSection id="id_8B6A212D-272E-4514-96BC-D9874E3674E1">
<ns0:Num>11214.2.</ns0:Num>
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<html:p>
(a)
<html:span class="EnSpace"/>
Notwithstanding any other law, and only upon the failure of the United States Food and Drug Administration to timely approve a RAP-C IND submitted pursuant to Section 11214.1, the panel may approve research projects investigating the safety and efficacy of the Schedule I or Schedule II controlled substance administered to human subjects.
</html:p>
<html:p>
(b)
<html:span class="EnSpace"/>
In order to qualify for the project, the bona fide clinical research on the safety and efficacy of those Schedule I or Schedule II controlled substances when provided to subjects shall meet both of the following requirements:
</html:p>
<html:p>
(1)
<html:span class="EnSpace"/>
Provided to veterans diagnosed with two or more severe or life-threatening mental health conditions.
</html:p>
<html:p>
(2)
<html:span class="EnSpace"/>
The veterans were deemed ineligible to participate in United States Food and Drug Administration-approved trials.
</html:p>
<html:p>
(c)
<html:span class="EnSpace"/>
The Research Advisory Panel shall review applications for research projects, using the process set forth in subdivision (d), provided that those applications include both of the following:
</html:p>
<html:p>
(1)
<html:span class="EnSpace"/>
Proof of independent peer review of the study for scientific merit and rigor by the National Institutes of Health, the United States Department of Defense, the Heffter Research Institute, the United States National Science Foundation, or a comparable group within an institutional setting that has previous experience with research or grant review.
</html:p>
<html:p>
(2)
<html:span class="EnSpace"/>
An approval letter from an institutional review board established in accordance with federal law,
including, but not limited to, Part 46 of Title 45 of the Code of Federal Regulations, demonstrating that the board’s evaluation of the underlying research protocol has considered relevant federal and state laws regarding the use of human subjects, including, but not limited to, the Protection of Human Subjects in Medical Experimentation Act (Chapter 1.3 (commencing with Section 24170) of Division 20) and laws governing research involving inmates, as described in Title 2.1 (commencing with Section 3500) of Part 3 of the Penal Code, the Information Practices Act of 1977 (Chapter 1 (commencing with Section 1798) of Title 1.8 of Part 4 of Division 3 of the Civil Code), and laws governing birth and death certificates, as described in Part 1 (commencing with Section 102100) of Division 102, Applicants who propose to conduct their research at a municipal or county public health facility may obtain and submit an approval letter from the State Committee for the Protection of Human Subjects, or an independent
third-party institutional review board applying state law. A letter submitted pursuant to this paragraph may indicate approval by the board conditioned upon the approval of the panel.
</html:p>
<html:p>
(d)
<html:span class="EnSpace"/>
Upon receiving a research project application that satisfies the criteria in subdivision (c), the panel chairperson, in consultation with the panel’s executive officer, may assign two or more individual panel members to conduct an expedited review of eligible research applications and deputize those panel members to approve those applications on behalf of the panel without the need for a full panel vote at a regularly scheduled meeting. Assigned panel members may approve eligible research project applications. Individual panel members also may communicate and consult asynchronously with other individual panel members with complementary core competencies outside of panel meetings in order to conduct their individual reviews. Panel members assigned to conduct a
review pursuant to this subdivision are not a state body under the Bagley-Keene Open Meeting Act. Panel members shall notify the panel’s chairperson and executive officer of their decision to approve or withhold approval of the eligible research applications assigned for their review.
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<ns0:Num>11214.3.</ns0:Num>
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<html:p>This article shall remain in effect only until January 1, 2028, and as of that date is repealed.</html:p>
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<ns0:Num>SEC. 4.</ns0:Num>
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Section 11392 of the
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is amended to read:
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<ns0:Num>11392.</ns0:Num>
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<html:p>Spores or mycelium capable of producing mushrooms or other material that contains psilocin or psilocybin may be
lawfully obtained and used for bona fide research, instruction, or analysis, if not in violation of state law, and if the research, instruction, or analysis is approved by the Research Advisory Panel established pursuant to Section 11480.</html:p>
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