The DEA Wants Five Psychedelic Tryptamines in Schedule I Again. Here Is Why Canadian Practitioners Should Follow the Fight

One week after the US Food and Drug Administration held its first public hearing on how psychedelic-assisted therapy should be delivered, a different American agency moved in what many researchers see as the opposite direction. On September 23, 2026, the Drug Enforcement Administration (DEA) published a proposed rule in the Federal Register that would place five psychedelic tryptamines into Schedule I of the US Controlled Substances Act, the most restrictive category available.

For Canadian nurses, physicians, psychologists and therapists building careers in this field, the story shows how drug-control law and clinical drug development can pull against each other even as the evidence base grows.

Medically reviewed by Jacque Lovely, RN, MN, MBA, PMP, Reg #74334.

What the DEA is proposing

The five compounds named in the proposed rule are 4-hydroxy-N,N-diisopropyltryptamine (4-OH-DiPT), 5-methoxy-alpha-methyltryptamine (5-MeO-AMT), 5-methoxy-N-methyl-N-isopropyltryptamine (5-MeO-MiPT), 5-methoxy-N,N-diethyltryptamine (5-MeO-DET) and N,N-diisopropyltryptamine (DiPT). Schedule I placement would apply full regulatory controls and criminal sanctions to their manufacture, distribution, import, export, research and possession.

The DEA's stated basis is that the substances are structurally similar to existing Schedule I hallucinogens, act through serotonin receptors, have no approved medical use in the United States, and have appeared in law-enforcement seizures with documented adverse-event reports. The agency wrote that the five tryptamines are "expected to have significant overlap in effects with schedule I hallucinogenic substances such as DMT, psilocybin, and others."

Public comments and requests for a hearing are due by October 23, 2026, a 30-day window.

This is the second attempt

The proposal is not new. The DEA first published a notice to schedule the same five compounds on January 14, 2022. Several parties requested a formal hearing, including two drug developers investigating tryptamines for therapeutic use and independent researchers. An administrative law judge ordered a public hearing, but on July 27, 2022 the DEA withdrew both the proposal and the hearing notice, saying it would seek an updated scientific evaluation from the Department of Health and Human Services (HHS).

The 2026 rule references that updated HHS evaluation, provided to the DEA on April 2, 2026.

Why one molecule makes this more than an obscure scheduling notice

Most practitioners will never encounter 5-MeO-DET or DiPT in a clinical context. But 4-OH-DiPT is different: it is the parent molecule of luvesilocin (RE104), an investigational drug developed by Reunion Neuroscience and described by the company as a patented prodrug of 4-OH-DiPT given by subcutaneous injection. In February 2026, the FDA granted it Breakthrough Therapy Designation for postpartum depression after a Phase 2 trial, RECONNECT, met its primary endpoint with a statistically significant reduction in depression scores at Day 7. The company reported that 70 percent of participants on the 30 mg dose met remission criteria at both Day 7 and Day 28, and said it expects to start a pivotal Phase 3 trial in 2026. These are the sponsor's reported figures from a single Phase 2 study, and they will need to be confirmed in larger trials.

Breakthrough Therapy Designation exists to speed development of treatments for serious conditions. Schedule I placement of the underlying chemistry, by contrast, typically adds registration requirements, manufacturing quotas and security obligations for every laboratory and trial site that handles it. The DEA's own notice acknowledges that the FDA "is not aware of any diversion from research or legitimate manufacturing activities" involving these compounds.

Attorney Robert Rush, who works on psychedelic regulatory matters, put the tension bluntly to Marijuana Moment: the FDA is trying to move a promising new treatment forward while the DEA works to obstruct its development. Patent attorney Graham Pechenik, who represented challengers in 2022, told The Microdose that the real impact of the DEA's action would be to impede research.

What this means for practitioners in Canada

Canada has its own version of this dynamic. Psilocybin, MDMA and related compounds are controlled under the Controlled Drugs and Substances Act, and clinical access runs through Health Canada's case-by-case authorization pathway, clinical trials and section 56 exemptions rather than through any approved product. Canadian practitioners already work in a system where the same molecule can be the subject of an authorized clinical trial and a criminal offence depending on the pathway.

Two practical takeaways stand out.

First, regulatory literacy is a core clinical competency. A practitioner who understands how scheduling, clinical-trial authorization and compassionate-access programs interact is better positioned to counsel patients accurately, participate in research and avoid overstating what is legally available.

Second, the pipeline is broader than psilocybin and MDMA. Postpartum depression is a condition that nurses, midwives, family physicians and perinatal mental-health clinicians see regularly. If a tryptamine-derived treatment eventually reaches approval in the United States, Canadian regulators and clinicians will face questions about access, training and scope of practice, and cross-border trial supply and multi-site research can be affected by US scheduling decisions.

Where this goes next

The comment period closes on October 23, 2026. If interested parties again request a hearing, the process could stretch into 2027, as it did in 2022. Alternatively, the DEA could finalize the rule, placing the compounds in Schedule I while licensed research continues under a more burdensome framework. Either way, the proposal is an early test of how the DEA and FDA reconcile their roles as psychedelic medicines move closer to approval, and a reminder that clinicians who understand the regulatory system, alongside the therapeutic skills themselves, will be best prepared to serve patients as access expands.

Building the foundation

ATMA CENA's training programs are designed for regulated healthcare professionals who want to understand both the clinical and the regulatory realities of this field. Advanced Pathways are complete programs that include the Psychedelic Therapy Foundations course as part one, and most courses are delivered online so practitioners across Canada can participate. If you are weighing where psychedelic-assisted therapy fits in your practice, you can explore the training programs or book a conversation with a program advisor to talk through your options.

Sources

1. Schedules of Controlled Substances: Placement of 4-OH-DiPT, 5-MeO-AMT, 5-MeO-MiPT, 5-MeO-DET, and DiPT Into Schedule I (Proposed Rule). Federal Register, Drug Enforcement Administration, 91 FR 60338, 2026.
2. DEA Moves To Ban Several Psychedelics As FDA Takes Steps To Accelerate Legal Access To Therapies. Marijuana Moment, 2026.
3. Federal drug enforcement revives proposal to place five hallucinogens in Schedule I category. The Microdose (UC Berkeley Center for the Science of Psychedelics), 2026.
4. U.S. FDA Grants Reunion Neuroscience's Luvesilocin (RE104) Breakthrough Therapy Designation Status. Reunion Neuroscience, 2026.
5. Inside the Challenge to DEA's Proposed Scheduling of 5 Psychedelic Tryptamines. Psychedelic Alpha, 2022.
6. Health Canada notice to stakeholders: requests involving psychedelic-assisted psychotherapy. Health Canada, 2024.