The NPWR Initiative gives notice of its intent to develop the National Psychedelic Workforce Registry (NPWR or the Registry), a single, public, permanent system of record for the clinicians and sites of care who deliver psychedelic therapy in the United States. This notice describes the need for such a record, the trajectory of the field in its absence, the proposed instrument and its principles, its anticipated uses, and relevant precedent, and solicits written comment from all parties with a stake in the outcome before design or development begins. A public summary of the comment record will be published. The Initiative intends to submit that summary to FDA Docket No. FDA-2026-N-7542 in connection with the agency's September 14, 2026 public hearing on the potential future therapeutic use of psychedelic drugs.
Supplementary information: This notice is organized as follows. Section I provides background on Federal and State activity. Section II states the problem. Section III addresses timing and need. Section IV describes the proposed Registry and its principles. Section V describes anticipated uses. Section VI reviews precedent. Section VII addresses stewardship, governance, and sustainability. Section VIII sets out the questions on which comment is solicited. Section IX describes how to comment and the disposition of comments received.
Federal activity concerning psychedelic therapies has accelerated in 2026. Executive Order 14401 of April 18, 2026 directed Federal agencies to accelerate the review of treatments for serious mental illness, including psychedelic therapies. On April 24, 2026, the Food and Drug Administration (FDA) issued national priority review vouchers to three psychedelic drug sponsors. A psilocybin application is under rolling review, with full submission targeted for the fourth quarter of 2026. On July 14, 2026, FDA published final guidance for clinical investigations of psychedelic drugs and announced a public hearing on their potential future therapeutic use, to be held September 14, 2026 (91 FR 43095; Docket No. FDA-2026-N-7542). At least ten psychedelic medicines stand in Phase 3 trials or beyond (Psychedelic Alpha drug development tracker, July 2026), with additional candidates in earlier stages.
State activity has preceded the Federal timeline. Oregon has licensed psilocybin facilitators since 2023; Colorado began licensure in 2025; additional States are developing programs. Where portability between State programs exists, it operates as an individualized administrative process: a facilitator relocating between States must generally wait one year and re-document training and experience individually, because no shared record exists to convey them.
In addition, one psychedelic-adjacent medicine is already delivered at scale. Esketamine has been administered since 2019 under a certified-site Risk Evaluation and Mitigation Strategy (REMS), a system that reaches the treatment setting and no further, while ketamine therapy more broadly is practiced at thousands of sites without a common workforce standard.
When Federal approvals arrive, psychedelic care will be delivered by a workforce drawn from multiple professions, including prescribers, therapists, nurses, monitors, and facilitators, working in teams. No system of record currently exists in which the basic questions about that workforce can be answered: who has been trained, and to what standard; where an individual may practice; and whether the individual remains in good standing.
A. Relationship to Risk Evaluation and Mitigation Strategies. Each approved medicine can be expected to carry its own REMS, and a REMS is itself a form of registry; the mechanism is familiar to FDA where these medicines are concerned. A REMS, however, is developed by a single sponsor, for a single drug, to satisfy a single regulatory requirement. It typically certifies the treatment setting and enrolls patients. Where it reaches individual clinicians, it records only the safety attestation required for that drug; it does not record licensure, depth of training, supervision, or standing across programs. Its data are proprietary to the sponsor, are not public, and are designed to sunset with the program. Five approved medicines would therefore produce five separate systems, none interoperable with the others. A REMS is accordingly not a substitute for a workforce record, although its use demonstrates that registry mechanisms are already regarded as necessary for these medicines.
B. The role of the workforce in the safety of these therapies. A psychedelic medicine is typically administered a limited number of times. The surrounding clinical work of screening, preparation, monitoring, and integration is performed by people, and the safety of the therapy depends substantially on that work. FDA's review of the first psychedelic application addressed this question directly. In this field, the qualifications of the workforce function as a primary safety control rather than an administrative detail.
C. Limits of existing systems of record. An individual physician in an established specialty already appears in multiple systems of record: a State medical board roster, national specialty board certification, the National Provider Identifier, Drug Enforcement Administration registration, the National Practitioner Data Bank, and payer credentialing files. Few of these are titled registries; each performs a registry's function. They exist because established specialties fit existing structures of one profession, one board, and one specialty. The psychedelic workforce spans licensed and non-licensed roles, medical and non-medical training, and State and Federal frameworks, and no single existing structure reads across it.
The relevant complexity is present now. Five or more medicines stand in Phase 3 trials or beyond, each expected to carry a sponsor-run REMS. Six or more professions participate in the treatment room, each answerable to its own boards in each State. Two State programs license today, additional States are drafting programs, and each maintains separate credential lists. Dozens of training programs issue certificates that other institutions cannot independently interpret. The recent expansion of ketamine therapy illustrates the trajectory when practice scales faster than shared standards: rapid growth, uneven quality, and publicized incidents that affect confidence in the legitimate field.
Absent a shared record, these systems multiply the burden of verification rather than add to it. Each new medicine, jurisdiction, and profession requires additional verification pathways to be constructed individually, from sponsor to board, board to program, and program to payer. A practitioner prepared to deliver two medicines in two States would hold one license, two REMS enrollments, and a set of certificates that no employer, payer, or regulator could verify from a single source.
Workforce infrastructure for psychedelic medicine will, in some form, be built. The question this notice addresses is whether that infrastructure is designed in advance and in public, or assembled after an adverse event under the pressures of that event. The Initiative has issued this notice to make the first course available.
The Registry is proposed as one permanent record for every qualified practitioner, comprising identity, training, credential, jurisdiction, and standing, that follows the practitioner across State lines and across programs and is verifiable by anyone. Sites of care would be recorded alongside the individuals who staff them, because readiness in this field is a property of teams: REMS certifies settings, licensure certifies single professions, and no existing record describes the multidisciplinary team that delivers care.
Four principles are proposed in advance of design:
Standing would be public in all cases. The extent to which additional information is visible, to whom, and at what depth would be governed by role and by practitioner consent, and is among the questions on which comment is solicited (Q9 and Q10).
Scope. The Registry would not license practitioners or displace State boards or State programs. It would not train practitioners or itself certify competence; it would record and verify what qualified bodies attest. It would hold no patient or outcomes data. It would not operate as a marketplace or referral directory, and it is not a government program.
The following uses are anticipated. Each is impracticable today and would become routine upon the establishment of a single shared record.
Shared systems of record are the established instrument by which American health care has organized its clinical workforces and other high-stakes clinical functions for more than a century. The names vary (boards, registries, data banks, identifiers); the function does not. Federal law already requires every State to maintain a workforce registry for nurse aides, and every prescriber of a scheduled medicine holds a Federal registration.
Each of these systems was established after a documented failure demonstrated its necessity: the Data Bank after the malpractice crisis of the 1980s, the nurse aide registries after documented failures in nursing home care, and iPLEDGE after earlier isotretinoin safeguards proved insufficient. Psychedelic medicine has the opportunity to establish its record in advance of harm rather than in response to it.
It is likewise established practice for a field to act before statute. The United States Pharmacopeia set national drug standards privately beginning in 1820, and Federal law adopted those standards in 1906. The Joint Commission accredited hospitals for fourteen years before Medicare elected to rely on its accreditation rather than duplicate it, and NCQA performed the equivalent function for health plans. The course proposed here follows that precedent: built by the field, chartered in public, and offered for adoption.
NPWR is initiated by Sabba, a Public Benefit Corporation that builds training and readiness infrastructure for psychedelic care. That fact raises an evident question, and this notice raises it directly: an organization that operates training products should not be positioned to privilege its own offerings within a registry on which the field relies. The charter must be structured so that no steward, including Sabba, can do so. The governance questions are accordingly listed first, and the Initiative's position is that the Registry must ultimately be held by independent, multi-stakeholder governance, with operations accountable to that governance and replaceable by it.
Financial sustainability is treated as a design requirement. The systems described in Section VI are funded by fees paid by the institutions that rely on them (the Data Bank through query fees, and credentialing utilities through plan subscriptions), while public verification remains free of charge. The Initiative expects the Registry to follow that pattern and solicits comment on its design (Q4).
The Initiative solicits comment on the following questions. Commenters need not address every question and are asked to reference question numbers where possible.
Comments are due on or before September 5, 2026, at 11:59 p.m. ET, through the form at npwr.org/comment. Every comment will be read. After the close of the comment period, the Initiative will publish a public summary of the comment record at NPWR.org, honoring each commenter's attribution preference, and intends to submit that summary as a written comment to FDA Docket No. FDA-2026-N-7542 (comments due October 5, 2026) and, if selected, to present it at FDA's September 14, 2026 public hearing.
Institutions interested in a founding-partner role may write, in confidence and without commitment, to partners@npwr.org.
Submit a commentThe National Psychedelic Workforce Registry is an independently proposed initiative of Sabba Collective. It is not affiliated with, and has not been endorsed by, any government agency.