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Colorado Passes Bill Legalizing Pharmaceutical Psilocybin Upon FDA Approval

State lawmakers have passed similar laws for federally prohibited substances that show medical promise.
Image: Pweson holds psilocybin mushroom in palm of hand
Colorado lawmakers have approved legislation allowing doctors to prescribe a form of synthetic psilocybin, but only if the FDA approves it first. Flickr/waqas anees
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Colorado lawmakers have approved legislation allowing doctors to prescribe a form of synthetic psilocybin, but only if the United States Food and Drug Administration approves it first.

The personal cultivation, possession and use of psilocybin mushrooms have been legal for adults 21 and up in Colorado since late 2022, and the state's first licensed psilocybin healing centers are expected to open this summer. However, doctors cannot prescribe any form of psilocybin medicine for pickup at pharmacies.

And they still can't if Governor Jared Polis signs House Bill 25-1063, as is expected. But if the federal government ever gives crystalline polymorph psilocybin the green light as a depression medication, Colorado will be ready to implement the change.

The measure's primary sponsor, Republican State Representative Anthony Hartsook, introduced the bill after seeing military veterans struggle with mental health. A combat Army veteran, Hartsoo says he wanted the synthetic form of psilocybin to be available for "veterans or anybody that has PTSD, a traumatic brain injury, depression that hasn't responded to other treatments."

Colorado lawmakers have passed similar laws for substances that were federally prohibited but showed medical promise. In 2018, the state legislature approved a law clearing the path for Epidiolex, a cannabis-derived seizure drug from GW Pharmaceuticals, to be prescribed after FDA approval — which it achieved in 2018. In 2022, lawmakers legalized MDMA as a prescribable mental health medication in Colorado should it be approved by the FDA.

However, the FDA rejected MDMA-assisted therapy for post-traumatic stress disorder last year, and no form of psilocybin has been approved by the FDA yet, either. But there's still hope for psilocybin, according to legislative staffers, who cite FDA policy from 2023 allowing drug manufacturers "to conduct clinical trials which can be evaluated by the FDA to consider approving psilocybin as a legal substance."

The bill passed through the House relatively quickly with bipartisan support after being introduced in January, but had to wait to get a hearing in the Senate. HB 1063 cleared the Senate within a week of its first hearing earlier this month, however, with final approval March 12. According to the legislature's website, it was sent to Polis's desk today, March 26.

New Mexico state lawmakers considered a similar bill for crystalline polymorph psilocybin this year, but the measure was rejected in February.


What Is Crystalline Polymorph Psilocybin?

Crystalline polymorph psilocybin, the form of psilocybin approved by Colorado lawmakers, isn't found in magic mushrooms. Instead, it's created in a lab and turned into crystal forms called polymorphs. Crystalline polymorph psilocybin is currently considered the most likely form of psilocybin to receive FDA approval, but it has been at the center of controversy in recent years.

After several filings and legal challenges, British pharmaceutical company Compass Pathways successfully achieved two patents for a specific kind of crystalline polymorph psilocybin, Polymorph A, in 2023. Colorado's bill allows for any FDA-approved drug containing crystalline polymorph psilocybin to be prescribed, not just Polymorph A — but as the only patent holder for any kind of crystalline polymorph psilocybin, the company could yield unprecedented power over the future of clinical psilocybin.

Objections to Compass Pathway's patents on Polymorph A claimed that it wasn't really a new or unseen form of psilocybin, but a combination of psilocybin crystalline forms that had already been made. The patents were also opposed by smaller psilocybin businesses, personal healers and others, who worry that patents on psilocybin could create more federal interference and profits for Big Pharma.

Compass Pathways lobbied in support of the bill, which did not have any registered opposition, according to the Colorado Secetary of State's Office.

Colorado's burgeoning space surrounding clinical and personal-use psychedelics could deal with "confusion" and be viewed as "unlicensed practice" in the eyes of federal regulators if psilocybin ever is regulated by the FDA, according to HB 1063's fiscal note. If any future changes to federal psilocybin policy do occur, "the Department of Law may need to provide legal services to these agencies," which would be "addressed through the annual budget process," the note adds.