The Enlightened Esquire

HRSA and SAMHSA Are Asking How Psychedelic Clinics Should Be Staffed. The Answers Become the Rules.

Two documents landed this summer that have almost nothing to say about whether psychedelics work. Both are about who runs the room.

On July 14, 2026, the Health Resources and Services Administration published a request for information titled Training and Care Delivery Models for Safe Administration of Potential FDA-Approved Psychedelic Therapies in Ambulatory Clinical Settings (91 FR 43103, docket HRSA-2026-0034). Six weeks later, the Substance Abuse and Mental Health Services Administration released Current Research, Regulatory, and Policy Considerations Regarding Psychedelics as Medicine (PEP26-01-004).

Neither is a rule. Neither binds anyone. Both are worth reading closely, because the questions an agency asks in a request for information tend to become the questions it answers later — in a condition of participation, a grant requirement, or a program manual.

What HRSA actually asked

HRSA organized its workforce questions around three phases of care.

  • Before administration. What training and competencies should providers have for patient eligibility, screening and counseling? Should screening be handled separately from administration, or by the same people? And — the question with the most money attached to it — should providers be required to hold a professional degree, or a medical degree?
  • The day of administration. What training should be required of providers administering psychedelic therapies in an ambulatory clinic? Should state licensure be required? Is telehealth acceptable?
  • Afterward. What training should providers have for follow-up in the days and weeks that follow?

It also asked which training models work best: didactic instruction, simulation, supervised practicum, apprenticeship, or certification.

A second cluster of questions is about the setting itself, with federally qualified health centers named specifically. What is essential for safe administration. What the room should look like. How much medical provider involvement is needed, and at what staffing levels. Whether certification should be required. What the effect on workforce productivity would be. And what facility, storage, security, and inventory-control requirements should apply.

A third cluster asks whether artificial intelligence and digital tools could carry part of the load — screening, eligibility determination, risk stratification, monitoring during administration, follow-up support, and training the workforce itself.

The comment period closed on August 13, 2026.

What SAMHSA put out

SAMHSA’s publication is described by the agency as an overview of recent advances in the use of psychedelics as medicine, along with research needs, safety considerations, and the system capacity and infrastructure needed to support their use. Its audience is the people who run state behavioral health systems, and the preparation it points them toward is operational: Medicaid implications, professional licensure, team training, site supervision, patient safety, how adverse events get reported, and how all of it coordinates with FDA and DEA requirements.

One practical note. SAMHSA’s own library page for PEP26-01-004 is returning an error as of this writing. The announcements from the National Association of State Controlled Substances Authorities and the American Academy of Addiction Psychiatry are the dependable pointers to it right now, and both are linked below.

Why these two documents matter more than they look like they do

A few words are carrying a great deal of weight. Ambulatory presumes an outpatient model rather than a residential or specialty-center one. Federally qualified health center is a safety-net term, and HRSA raising it is both an access signal and a Medicaid signal. Professional degree or medical degree is the business-model question for every facilitator-led, coach-led, or peer-supported structure in the field. And facility, storage, security, and inventory control is DEA vocabulary — it is where the scheduling question stops being abstract and starts being a locked cabinet with a reconciliation log.

Nobody is asking whether. Both documents take approval as the premise and ask what happens the morning after. That is a meaningful shift in posture, even though neither document has any legal force.

Whoever answers builds the record. A request for information is assembled from the responses it receives. Health systems, trade associations and academic centers answer these reliably. Small operators and independent practitioners usually do not, and then find the resulting standard was written from a record they are not in.

What to do about it

The HRSA window has closed. The FDA window has not. FDA’s public hearing on the potential future therapeutic use of psychedelic drugs is set for September 14, 2026, and its comment docket, FDA-2026-N-7542, stays open until October 5, 2026 (91 FR 43095). Anyone with real field experience — a clinician, a facilitator, a clinic operator, a patient — has a better claim on that record than most of the people filing into it.

In the meantime, write down what you already do. Not what you intend to do — what actually happens:

  • Screening and eligibility criteria, and who applies them
  • Who is in the room during administration, and at what ratio
  • The monitoring protocol during the session and immediately after
  • How an adverse event is defined, and the escalation path when one occurs
  • Records: what gets created, who can see it, how long it is kept
  • Storage, access control, and inventory reconciliation

Two reasons to do this now. When standards are eventually written, operators who can show a documented practice have something to point at, and something to argue from. And most of these obligations already attach to you through state licensure, professional ethics rules, and the ordinary standard of care — whatever the federal government eventually decides.

One caution

None of this changes anything today. With the exception of ketamine, the psychedelics under discussion remain predominantly Schedule I under federal law. A request for information is not a rule. A SAMHSA technical publication is not authority. Administrative preparation is not approval, and approval would not be the end of the legal questions.

But preparation is a tell. Agencies do not build workforce frameworks for therapies they expect to turn away.

Sources

Educational only; not legal advice, and no attorney–client relationship is created. Psychedelics remain predominantly Schedule I under federal law and the legal landscape changes quickly.

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