Dear Subscriber,
Founder’s Corner: Approval Is a Beginning
Last Week’s Webinar Recap: Getting Ready for Psychedelic Therapy: A Therapist's Guide to What's Next
Pre-register for the Post-Approval COMP360 Psilocybin Certificate Program Now: Initial Dates Posted Now
Final Call to Register for the October 20th Session of Essentials of Psychedelic Therapy
Recent Updates in the Psychedelic Therapy Space
Happy reading!
Over the past several months, a version of the same question has come to me in conference hallways, during webinars, and in notes from clinicians: If psilocybin is FDA-approved, how soon can my clients get it? It is a fair question. This year has brought positive late-stage trial results, an executive order on psychedelic treatments for serious mental illness, priority vouchers for three psychedelic drug developers, final FDA guidance on psychedelic clinical investigations, and an FDA public hearing on the future therapeutic use of these drugs. Momentum is clearly building toward a big change.
If and when it comes, that change will happen in a single moment, and I want to offer a more nuanced picture of the changes that will unfold over time before patients may be able to access, so that you can read the news clearly and set realistic expectations with clients and colleagues. This topic is close to our own work. Fluence is preparing to launch a healthcare provider training for the future delivery of COMP360*, an investigational psilocybin treatment, to meet the field’s need for training designed to support safe and consistent treatment administration at scale in the event of FDA approval.
What FDA approval does, and what it leaves open
FDA approval is permission for a specific sponsor to market a specific product with specific safety and efficacy data for a specific indication, under the conditions described in that product’s label. It governs what the company can claim about its drug and how it can be marketed. An approval of one sponsor’s psilocybin formulation for treatment-resistant depression covers that product for that condition, and leaves psilocybin mushrooms, other psilocybin products, and other medical conditions outside its scope.
The label also spells out the conditions of use, and for psychedelics these are likely to include a Risk Evaluation and Mitigation Strategy, or REMS: a set of safety requirements that can restrict where a drug is given, who may administer it, and how patients are monitored. Sponsors are already working with the FDA on what these labels and safety programs will look like, and the details of each REMS will shape how treatment is provided.
Why prescription status is the threshold for health care
Some clinicians already live in places where psilocybin is available in some form outside of established healthcare institutions. Oregon and Colorado operate state-regulated psilocybin programs, and a number of cities and states have decriminalized or deprioritized enforcement related to personal use. Fluence has trained practitioners for the licensed programs in both Oregon and Colorado, and these developments matter. Still, none of these developments bring psilocybin into the health care system as most of our clients experience it, nor do they result in health insurance coverage for psilocybin treatment. Psilocybin remains in Schedule I, the federal category for drugs with a high potential for abuse and no currently accepted medical use. Drugs in Schedule I cannot be prescribed, dispensed by a pharmacy, or covered by an insurer.
It is worth being precise about prescribing authority. A prescriber’s license to practice comes from their state licensing board, and prescribing controlled substances also requires a Drug Enforcement Administration (DEA) registration, plus a state registration in many states. DEA registration covers Schedules II through V; Schedule I registrations are limited to research and
manufacturing. So a psychedelic must be approved by the FDA and moved out of Schedule I before a psychiatrist can order it and a health plan can pay for it. Prescription status is what connects a drug to prescribers, pharmacies, hospitals, clinics, and payers.
The stages of rollout
As I see it, the path from approval to the treatment room has four overlapping stages. Their timing is uncertain and will vary by drug, but the sequence is a useful guide to what comes next.
Stage one: FDA approval of a specific drug product, for a specific indication
The first FDA approval decision could come as early as the end of this year or early 2027, though the timing remains uncertain. In April, the FDA awarded Commissioner’s National Priority Vouchers to three psychedelic development programs, which could shorten review from the standard ten to twelve months to as little as one to two. That timeline has been described as a target rather than a commitment, and I think the caution is warranted. Other programs, including some without vouchers, are further back.
Stage two: Federal scheduling
When the FDA approves a drug that the Department of Health and Human Services (HHS) recommends placing in Schedules II through V, federal law requires the DEA to issue an interim final scheduling rule within 90 days of the later of two events: receipt of the HHS scheduling recommendation, or notification of FDA approval. Congress added this requirement in 2015 to end long delays between approval and availability. Because sponsors can submit the eight-factor abuse potential analysis that informs the HHS recommendation in advance, federal rescheduling could follow approval within days or take the full 90.
Precedent also suggests the DEA may schedule the approved product rather than the substance as a whole. When the FDA approved Marinol, a synthetic THC product, Marinol was placed in Schedule II while cannabis remained in Schedule I. If that pattern holds, an approved psilocybin product could become a prescription medicine while psilocybin itself, including mushrooms and other formulations, stays in Schedule I.
Stage three: State scheduling
States keep their own controlled substance schedules, and a drug must be rescheduled at the state level before it can be prescribed there. Some states automatically follow federal changes, while others require action by a board of pharmacy, a health agency, or the legislature. A few have acted in advance: South Dakota enacted a law in March 2026 that moves an FDA-approved crystalline psilocybin product to Schedule IV upon approval. It’s been estimated that roughly 93 percent of the U.S. population lives in states expected to reschedule within 30 days of federal action. That is encouraging, and it also means local availability may trail the national headlines for some clinicians.
Stage four: Building the delivery system
Scheduling makes a drug prescribable. Creating places where patients can receive it is slower work involving certified sites, staffing that meets REMS requirements, billing codes, and insurance coverage. The first sites are likely to be clinics and health care organizations that already have the infrastructure for supervised treatment: interventional psychiatry clinics, including many already set up to administer Spravato (esketamine) for treatment-resistant depression, and organizations such as multisite group practices or agencies that employ dozens of therapists and can treat many patients.
Reimbursement follows its own process. Category III CPT codes for psychedelic treatment exist, but they are temporary tracking codes without established payment rates, and one sponsor has estimated that the move to permanent Category I codes could take about 18 months. Medicare, Medicaid, and commercial payers will each decide coverage on their own timelines. In August, SAMHSA released a policy paper encouraging state mental health systems to prepare now for credentialing standards, safety protocols, informed consent, and Medicaid coverage.
Training at the scale of a health system
This shift in setting brings one of the central challenges of rollout into focus. A clinic or agency preparing to offer psychedelic treatment will need to train whole teams consistently, often across several sites, and show that each clinician has the skills the REMS and the organization require. At the FDA’s September hearing, several speakers called for training that includes an assessment clinicians must pass, in addition to hours completed.
Fluence has helped drug sponsors solve a version of this problem in large-scale Phase 2 and 3 trials of psychedelics. A multisite trial needs every therapist and session monitor to deliver the same intervention with fidelity, and it needs documentation showing that they did. Part of our work now is bridging that infrastructure into post-approval care. We will use the same methodology, proprietary software, and competency assessment systems we developed for clinical trials to train clinicians at scale in this new environment, and to create audit-ready training documentation at the organizational level, so that a clinic or health system can show who has been trained, to what standard, and when. The goal is the same in both settings: confidence, for organizations and for the patients they serve, that the people in the room are prepared to do this work well.
What this means for psychotherapists
For most of our readers, the practical questions are about role. Psychotherapists do not prescribe, and where they fit will depend on what each product’s label and REMS require. At the FDA’s hearing, one of the clearest disagreements was over exactly this: who needs to be in the room, whether psychotherapy must accompany dosing, and whether credentialing should follow the evidence each sponsor submits for its own product. I expect these questions to be answered product by product.
What seems clear is that delivery will require coordinated teams, and psychotherapists have a great deal to contribute across the arc of care: preparation, session monitoring where the REMS allows it, integration, and the longer therapeutic relationship around any single treatment. Clinicians in private practice may also become important referral partners for the organizations offering treatment, and helping clients understand what these treatments can offer, and when, is meaningful clinical work in its own right.
Where this leaves us
Approval will be a real milestone, one many people in this field have worked toward for decades. I also expect the months that follow to move more slowly than the headlines suggest, as federal scheduling, state action, site certification, training, and reimbursement catch up. Understanding these stages helps us set honest expectations with clients who are hoping for relief, and we will keep sharing what we learn as each step unfolds.
Thanks for reading,
Co-Founder & CEO
*Disclosure: Fluence is one of five organizations awarded a grant through Compass Pathways’ U.S. healthcare provider training grant program, which partially funds the development of a training program for sites of care delivering psychedelic treatments, including a module specific to COMP360. Fluence develops this program independently and retains final approval over its content, faculty selection, and educational design.
Thank you to everyone who joined us on September 30 for our webinar with the Trauma Therapist Network. Fluence co-founder and CEO Elizabeth Nielson, PhD, and Laura Reagan, LCSW-C, host of the Therapy Chat Podcast and founder of the Trauma Therapist Network, talked through what clinicians can expect as psychedelic therapies move toward FDA approval. Attendees brought thoughtful questions, and the discussion reflected how many therapists are already thinking seriously about their next steps.
The conversation gave viewers an inside look at where clinical training is heading after approval and how credentialing may work for clinicians entering the field. Elizabeth and Laura also explored why a background in trauma therapy carries over so well into psychedelic therapy work, and what that means for clinicians weighing this path for their own practice.
If you weren't able to attend live, or would like to revisit the discussion, the full recording is now available to watch on demand.
Watch now
Pre-registration for Fluence's Post-Approval COMP360 Psilocybin Certificate Program is open now, so you can secure your spot before the program launches. Reserving your seat means you'll be first in line for enrollment, certification, and every update as the curriculum comes together.
Start dates for the first two courses in the program are now set:
January 4, 2027
February 1, 2027
March 1, 2027
Reserve your seat with a $500 deposit. Your deposit locks in the introductory program price before general enrollment opens. The deposit will apply to whichever start date works best for you, once general enrollment opens soon. Stay tuned!
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Enrolling a Group?
Fluence helps clinics and group practices build and maintain a consistently trained clinical team as your services evolve, without coordinating it alone. Bulk enrollment support pairs with Fluence Sync, our proprietary platform for tracking trainee progress, readiness, and audit-ready reporting. It's how we help you inform your protocols and build consistent clinical competency across your team with high-quality, practitioner-led training. For detailed information on how Fluence can support your clinic or group practice as you integrate COMP360 into your business, schedule a consultation here: http://meetings.hubspot.com/kcooppan-boyd
Curious about additional training opportunities beyond COMP360? Start your journey now and move toward certification in Ketamine-Assisted Psychotherapy or Psychedelic Harm Reduction and Integration at the current, lower rate.
All certificate programs start with our six-week Essentials of Psychedelic Therapy course, with the October cohort taught by Dominique Morisano, PhD, CPsych.
Psychedelic Harm Reduction and Integration Therapy
Oct 20 - March 31, 2027
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Oct 20 - April 13, 2026
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All Fluence alumni who have taken a live-online course are eligible to join our 1200+ person Google Group. Members can work through protocol questions, share what they are seeing in the field, and get perspectives from colleagues doing the same work. If you have taken a live-online course but have not received your invite to the group, reach out here: info@fluencetraining.com.
FDA public hearing brings practitioner questions to the surface
On September 15, the FDA held a public hearing on the potential future therapeutic use of psychedelic drugs, with testimony from researchers, psychiatrists, nurses, therapists, veterans' advocates, and safety experts. Psychiatric Times reported that speakers disagreed on who should be qualified to administer treatment, how much of the benefit comes from the drug versus the accompanying therapy, and how adverse events should be monitored once these treatments reach clinical practice.
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Researchers propose a new approach to blinding in psychedelic trials
Writing in JAMA Psychiatry, a team from UCSF, UC San Diego, and Stanford looked at a longstanding problem in psychedelic research: participants can usually tell whether they received the active drug or a placebo. They propose a framework called UMBRAA, which combines FDA-approved medications to produce an unfamiliar altered state that is harder to tell apart from psilocybin, and they note that the approach still needs validation research.
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Ketamine-assisted psychotherapy with adolescents and young adults: a longitudinal clinical review
Researchers from the Ketamine Research Foundation reviewed four years of charts from a community outpatient clinic, covering 19 patients aged 14 to 24 across 167 KAP sessions. Depression and anxiety scores went down over the course of treatment, suicidality fell in all 13 at-risk patients, and no serious adverse events were recorded. Because the study was retrospective and had no control group, the authors describe the findings as hypothesis-generating and call for controlled trials.
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Psilocybin shows protective effects against chemotherapy-induced nerve damage in preclinical models
A study from MD Anderson Cancer Center, published in Science, found that giving psilocybin before chemotherapy prevented peripheral neuropathy in preclinical models across several common chemotherapy agents. The effect appears to work through 5-HT2A receptors. A Phase 2 trial called NeuroGuard is now planned to test whether the finding holds up in patients receiving cancer treatment.
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