One of the goals of OPENurses is to advocate for the full inclusion of nurses in psychedelic therapy. Doing this means making sure that nurses are included in the rulemaking that many government agencies, such as the Food and Drug Administration (FDA) and and Health Resources and Services Administration (HRSA) make that will impact the ability of nurses to participate in future medical psychedelic models.
Now is the time to influence this process. Once this ship leaves the dock, if nurses are not on it, it is not coming back for us.
As we are getting closer to possible FDA approval of psilocybin for depression/treatment resistant depression (Usona/Compass) and LSD for depression or generalized anxiety disorder (Definium), there is increasing attention to implementation of these treatments. The FDA and HRSA are already thinking about future guidance that will steer the implementation of these treatments.
Now is the time to be sure that these guidelines include the role of nursing and the perspective that nursing brings.
On September 14th, from 12:30-4:30pm Eastern, the FDA will be holding a public hearing in person and on Zoom (registration here) “to obtain feedback and perspectives on issues associated with the potential future therapeutic use of drug products containing a psychedelic drug substance in supervised and supportive settings.”
The FDA has requested public comments to help inform them on future decisions about how psychedelic treatments will be administered in the future. This is the time to tell regulators how nurses contribute to this critical work and should be fully included in implementation of psychedelic treatments.
There are three ways to participate in this process (and yes, you can do all three!:
1) The easiest is to sign on to a letter that OPENurses has written and will file as public comment.
2) You can submit your own comments here until October 5th. (Do remember that these comments will be published in the federal register and become public record). If you are willing, please also copy and paste your comments in an email to openurses@gmail.com
3) You can register to attend the meeting (in person or Zoom) and request to make a public comment.
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You may recall that in 2023, OPENurses ran a significant campaign to convince the FDA to broaden the categories of professionals who could be monitors in psychedelic studies through a public comment campaign and a statement from our organization. As originally drafted, the guidance would preclude ADN nurses from any participation, and would preclude any APRN’s other than PMHNP’s from being lead monitors.
Our advocacy was partially successful, as the FDA’s final guidance, published in July 2026 now states:
“Observation by two monitors for the duration of the treatment session.
– A health care provider with graduate-level professional training and clinical experience in psychotherapy, licensed to practice independently, serving as the lead monitor.
– An assistant monitor with a nursing or bachelor’s degree and at least 1 year of clinical experience in a licensed mental health care setting.”
This is great news for our ADN-trained nurse colleagues who could now be assistant monitors on studies, but continues to exclude any nurses who do not have mental health clinical experience. It also continues to exclude any non-PMHNP APRN’s from the lead monitor role.
It is also important to note that this guidance currently only applies to research studies. It is unclear what any future rules on clinical implementation, known as a REMS, will say on who can or should be in the room during a treatment session.
The guidance that nurses are providing to HRSA and the FDA now will guide these decisions in the future.
Be a part of the process. This is how we are included in these critical decisions.
Review and sign on to our letter here. The full text of the letter is below:
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August 17, 2026
Dockets Management Staff (HFA-305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852
Re: Docket No. FDA-2026-N-7542 – Considerations for Potential Future Therapeutic Use of Psychedelic Drugs; Public Hearing; Request for Comments
Submitted electronically via regulations.gov
Dear Dockets Management Staff:
The Organization of Psychedelic and Entheogenic Nurses (OPENurses) respectfully submits the following comments in response to the Food and Drug Administration's (FDA) notice seeking public input on the potential future therapeutic use of psychedelic drugs in supervised and supportive settings, issued jointly with federal partners in connection with Executive Order 14401, “Accelerating Medical Treatments for Serious Mental Illness.” We appreciate that FDA and its federal partners recognize that the safe, effective, and equitable delivery of psychedelic-assisted therapy will depend as much on the workforce and care-delivery model surrounding the drug product as on the pharmacology of the drug itself. We also submit these comments as informative to the parallel Health Resources and Services Administration (HRSA) Request for Information on training and care delivery models in ambulatory clinical settings, given the overlapping workforce and access issues raised by both notices.
OPENurses represents nurses at every level of training and practice – licensed practical/vocational nurses, registered nurses (RNs), and advanced practice registered nurses (APRNs) – who work with, study, or aspire to work with patients receiving psychedelic-assisted therapy. We advocate for evidence-based best practices in psychedelic care, maintain a code of ethics for nurses in this field, collaborate and advise psychedelic researchers and drug developers, and work to ensure that nurses are included as full partners – not auxiliary staff – on multidisciplinary psychedelic care teams. Our members bring direct clinical experience from psychiatric-mental health nursing, oncology, palliative and hospice care, emergency and critical care, addiction medicine, anesthesia, and primary care – the very specialties where set, setting, and safety monitoring are already core nursing competencies.
Executive Summary: Nursing as the Structural Backbone of Safe Psychedelic Care
Nurses are the largest segment of the U.S. health care workforce (there are over 5 million nurses in the United States, AACN) and the professionals most consistently present at the bedside, in infusion suites, in behavioral health units, and in rural and community health settings where psychedelic-assisted therapy will need to expand access to provide care to patients who often struggle to obtain cutting-edge treatments.
Of those 5 million nurses, 520,000 are Advanced Practice Registered Nurses, a group that includes Nurse Practitioners (NP’s) (including those who are specialized as Psychiatric/Mental Health Nurse Practitioners, or PMHNP’s), Certified Registered Nurse Anesthetists (CRNA), Certified Nurse Midwives (CNM), and Clinical Nurse Specialists. These APRN’s have completed advanced training at a Masters or Doctoral level and are skilled at providing high quality, generalist and specialty health care in all 50 states.
(By comparison, there are approximately 1 million physicians, 100,000 clinical psychologists, 75,000 Marriage and Family Therapists, and about 250,000 Clinical Social Workers in the United States.)
Nursing practice is already built around the exact functions FDA identifies as central to safe psychedelic administration: longitudinal assessment, vital sign and mental status monitoring, de-escalation and trauma-informed care, therapeutic presence, informed consent support, and care coordination across disciplines and phases of care.
We urge FDA and its federal partners to design training, credentialing, staffing, and access frameworks that formally recognize RNs and APRNs as core members of the psychedelic care team – including in monitoring and, where state scope of practice and training permit, administration and adjunctive support roles. Workforce and credentialing models that rely unnecessarily on a narrow pool of specialists could inadvertently limit geographic access, constrain capacity, decrease health equity, and increase the cost of care.
Excluding or narrowly circumscribing nursing's role will not make psychedelic therapy safer; it will reduce the supply of qualified personnel, concentrate delivery in a small number of high-cost urban centers, and undermine exactly the access goals that E.O. 14401 and the HRSA RFI identify as priorities.
1. Provider Training and Credentialing Evidence base, curricula, and the bodies that should develop them
A durable evidence base for training already exists in nursing education and practice: psychiatric-mental health nursing competencies (assessment of suicidality and psychosis risk, de-escalation, trauma-informed care), medical-surgical and critical care competencies (hemodynamic monitoring, recognition of serotonin syndrome and hypertensive crisis, airway management), and holistic/integrative nursing frameworks that already address mind-body and “set and setting” considerations in practice. We recommend that curricula for psychedelic-assisted therapy be developed and reviewed by a multidisciplinary body that formally includes nursing representation – for example, through collaboration among the American Nurses Association (ANA), the American Psychiatric Nurses Association (APNA), and the state boards of nursing, specialty organizations such as OPENurses, and existing psychedelic-specific training programs – rather than curricula developed solely by physician, psychology, or industry-training bodies with nursing added afterward as an afterthought.
Personnel and training needs by phase of care
Nursing roles differ meaningfully across the three phases of care that FDA identifies, and staffing models should reflect this:
• Screening and preparation – RNs/APRNs are well positioned to conduct medical and psychiatric intake screening, medication reconciliation (including checking for drug–drug interactions and contraindications such as certain cardiac, psychotic, or bipolar conditions), and to begin the therapeutic alliance and psychoeducation that supports informed consent. Nurse practitioners are permitted to prescribe medication, including controlled substances, in all 50 states and could be the prescribing clinician of any psychedelic treatment team.
• Administration and monitoring – At minimum, we recommend that FDA and federal partners specify that a licensed nurse (RN or APRN) be present or immediately available throughout drug administration and the acute monitoring window, with responsibility for continuous physiological and psychological safety monitoring, recognition and management of medical emergencies, and administration of rescue medications under protocol.
• Additionally, should future administrative requirements for drug administration require a health care professional who is qualified in psychotherapy, please be aware that Psychiatric/Mental Health Nurse Practitioners (PMHNP’s) and Psychiatric/Mental Health Clinical Nurse Specialists (PMH-CNS) are trained and certified in psychotherapy techniques.
• Non-prescriber personnel such as trained facilitators, licensed counselors, and peer support specialists play a complementary role in psychological support, but should not substitute for licensed clinical physiological safety monitoring, which requires the scope of practice, pharmacologic training, and legal accountability that nursing licensure provides.
• Follow-up and integration – Nurses are frequently the clinicians who maintain continuity with patients between sessions and across care settings; we recommend explicit roles for nursing in post-administration check-ins, symptom and adverse-event surveillance, and coordination of referrals for patients who experience a challenging or destabilizing psychedelic experience.
Training for care coordination across settings
Access also depends on preparing the broader nursing workforce - not only nurses who will directly deliver psychedelic-assisted therapies. Nurses across primary care, behavioral health, emergency care, community health, and other settings will encounter patients considering or receiving these treatments and should have access to foundational education appropriate to their roles.
Because patients receiving psychedelic-assisted therapy will often have primary care, behavioral health, and specialty relationships outside the treatment setting, psychedelic nursing training curricula should explicitly include care-coordination competencies: structured hand-off communication, shared documentation practices, medication reconciliation across prescribers, and protocols for communicating with a patient's existing care team before and after administration. Nurses already perform this coordinating function in nearly every other care setting and should be recognized as the natural coordinating hub for psychedelic care pathways as well.
Credentialing and licensure considerations
We imagine a future in which all health care professional students are taught about psychedelics as therapeutic modalities in their initial courses of training. We support programs such as the University Psychedelic Education Program (U-PEP) that endeavor to provide this fundamental curriculum to faculty in schools of Social Work, Medicine, Counseling, Psychology, and Nursing.
As existing nurses will likely require additional training and credentialing to work with psychedelic treatments, we recommend that credentialing build upon – rather than duplicate or bypass – existing RN and APRN licensure, using a tiered model:
(a) a baseline didactic curriculum covering psychedelic pharmacology, safety monitoring, trauma-informed and culturally responsive care, and ethics;
(b) supervised experiential hours in an active psychedelic-therapy setting; and
(c) ongoing competency verification analogous to existing specialty certifications (e.g., certified addictions registered nurse, psychiatric-mental health nursing certification).
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The current FDA guidance for clinical researchers, finalized in July 2026 wisely broadened the definition of the assistant monitor role as “An assistant monitor with a nursing or bachelor’s degree and at least 1 year of clinical experience in a licensed mental health care setting.” This guidance is wise as it permits RN’s who are trained at the level of an associate’s degree (approximately 27% of nurses in the United States) to serve as assistant monitors. However, the guidance that a nurse should have at least 1 year of mental health experience will disqualify large swaths of potential personnel who could serve in an assistant monitor role and we strongly encourage that this requirement for 1 year of mental health experience not be brought forward as written into any future clinical guidance, such as a REMS program.
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Because roughly 96 percent of the RN workforce practices outside dedicated psychiatric-mental health settings, we caution against credentialing frameworks that assume only psychiatric nurses are eligible; nurses from oncology, palliative care, emergency, critical care, anesthesia, labor and delivery, and addiction medicine bring directly relevant monitoring and crisis-management experience and should have a defined pathway into this specialty.
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Credentialing bodies should also ensure reciprocity across state lines is addressed early, given that scope-of-practice authority for RNs and APRNs varies by state. Nursing compact agreements have already created precedent for regulating nursing licenses across multiple collaborating states and similar agreements could be made for any future nursing credentialling related to psychedelic care.
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2. Promotion of Patient Safety Best practices for patient education, counseling, and set and setting
Nurses are trained to assess and shape the therapeutic environment holistically – physical comfort, sensory environment, staffing continuity, and the patient's psychological readiness – and should be included in the development of best-practice standards for set and setting, not only in their implementation. We recommend that best practices require a documented pre-session preparation visit conducted or co-conducted by a licensed nurse, standardized side-effect and risk education materials, and clearly defined criteria for what constitutes an appropriately supportive setting (private, monitored space; continuous clinical presence; access to emergency equipment and rescue medications).
Informed consent
We agree that informed consent procedures must explicitly address the amplified power imbalance between patient and provider during an altered state of consciousness, the use and limits of therapeutic touch, and the foreseeable risk of psychological distress or a challenging experience. We recommend that consent procedures also explicitly document: who will be physically present during administration and their credentials; the boundaries of physical contact and the process for a patient to set or revoke consent to touch in advance; the plan for managing a challenging or destabilizing experience; and the nurse's specific role in monitoring and intervening if the patient's physiological or psychological state warrants it. Nurses, as licensed professionals bound by codes of ethics and mandatory reporting obligations, are well suited to serve as an independent safeguard within the consent process, distinct from the individual guiding the psychotherapeutic content of the session.
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Pre-treatment screening
Comprehensive medical and psychiatric screening should be conducted or supervised by an APRN or physician and should include cardiovascular history and risk factors, personal and family history of psychosis or mania, current suicidality, medication review for interacting agents (e.g., MAOIs, lithium, certain serotonergic medications), and pregnancy status where relevant.
Mitigating diversion and non-medical use
Nurses already operate under some of the strictest controlled-substance handling, documentation, and diversion-monitoring requirements in the health care system, including two-nurse verification, automated dispensing cabinet tracking, and mandatory waste documentation for controlled substances. We recommend that psychedelic drug administration in supervised settings leverage these existing nursing-led controlled-substance protocols – witnessed administration and waste, chain-of-custody documentation, and integration with state prescription drug monitoring programs – rather than creating a parallel diversion-control system that does not draw on this established infrastructure.
Preventing, detecting, and reporting ethical violations
Given the vulnerability inherent in altered states of consciousness, we support mandatory reporting requirements modeled on existing nursing and health care mandatory-reporting statutes, paired with routine clinical supervision, mandatory co-facilitation or the presence of a second licensed clinician during administration, and a clear, protected channel for patients and staff to report boundary violations to a state licensing authority. As licensed professionals independently accountable to state boards of nursing, nurses can serve as a structural check on ethical violations by non-licensed facilitators, and we recommend that at least one team member present during administration hold independent professional licensure and reporting obligations for this reason.
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Monitoring and post-administration coordination
We recommend that FDA specify minimum criteria for continuous monitoring during drug administration (vital signs, mental status, and observation for medical emergencies) and a defined observation period following administration before a patient is discharged from the treatment setting, with documented criteria for discharge readiness as part of any drug label and/or REMS program. Nurses are often responsible for coordinating post-administration follow-up, including warm hand-offs to emergency or crisis response services when needed, and for ensuring that a patient's outpatient care team is notified of any adverse events or significant clinical findings, a role which they can easily fulfill within psychiatric treatment settings.
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3. Considerations for Access
Access to psychedelic-assisted therapy, if approved, will be shaped directly by workforce supply, and nurses are the workforce most capable of expanding safe access into medically underserved and rural communities. RNs and APRNs already deliver the majority of direct patient care in federally qualified health centers, rural health clinics, the Indian Health Service, and community mental health centers – precisely the ambulatory settings HRSA has identified as a priority. Credentialing and staffing models built primarily around psychiatrists, psychologists, or other scarce specialists will concentrate psychedelic therapy in a small number of well-resourced urban centers and place it financially out of reach for many patients.
FDA and its federal partners should consider models that enable appropriately educated and trained nurses and other qualified healthcare professionals to participate in psychedelic-assisted care consistent with applicable licensure, scope of practice, demonstrated competencies, and the evidence and safety requirements associated with each therapy.
Without these steps, we are concerned that safety frameworks – however well-intentioned – could inadvertently function as access barriers, particularly for rural, low-income, and medically underserved patients who most need alternative treatment options for serious mental illness.
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Conclusion
OPENurses supports FDA's and its federal partners' careful, coordinated approach to considering the future therapeutic use of psychedelic drugs, and we share the goal of ensuring these therapies are delivered safely, ethically, and equitably if approved. Nurses are not a peripheral workforce consideration in this effort – they are the clinicians most likely to be present during screening, administration, monitoring, and follow-up, and the profession whose existing scope of practice, licensure infrastructure, and distribution across underserved communities make broad, safe access achievable. We urge FDA and federal partners to design training, credentialing, safety, access, and data-standardization frameworks that formally recognize registered nurses and advanced practice registered nurses as central members of the psychedelic care team at every phase of care.
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We welcome the opportunity to provide oral testimony at the September 14, 2026 public hearing and to serve as a resource to FDA, HRSA, and other federal partners as this framework is developed. Thank you for the opportunity to comment.
Respectfully submitted,
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The Organization of Psychedelic and Entheogenic Nurses (OPENurses)