To the Members of the Texas Medical Board: We, the undersigned, respectfully urge the Texas Medical Board to delay adoption of the proposed rules under Chapter 173, Subchapter B, Sections 173.6 through 173.15 concerning parenteral ketamine therapy, and to allow additional time for public comment and stakeholder review. If adopted as written, these proposed rules may significantly reduce access to care for Texans suffering from severe depression, PTSD, suicidality, and other serious mental health conditions. The concern is not theoretical. In Central Texas, respected ketamine clinics have already begun shutting down or preparing to shut down because of the anticipated burden these regulations may create. If that trend continues, patients in crisis may lose access to a treatment option that has provided relief when other therapies have failed. For many patients, ketamine treatment is not a convenience. It is a lifeline. This is especially true for first responders, veterans, trauma survivors, and individuals living with chronic suicidal ideation. Safe outpatient ketamine care is already being delivered in Texas. At Austin Ketamine Clinic, more than 7,000 individual ketamine treatments have been administered in less than six years without a single serious adverse event. That record demonstrates that established clinics can provide structured, physician-supervised care responsibly and safely. We support appropriate oversight, accountability, and patient safety. However, any rule intended to improve safety must also account for the real-world consequences of reduced access to care. Regulations should not unintentionally force compliant clinics to close or leave vulnerable Texans without treatment. We therefore respectfully ask the Texas Medical Board to extend the timeline for action, allow additional public comment, and more fully evaluate the impact these rules may have on patients, providers, and mental health access across Texas. Formal Comment on Proposed Texas PKT Rules 22 TAC Chapter 173, Subchapter B, §§173.6–173.15 To Whom It May Concern, I write in strong opposition to several aspects of the Texas Medical Board’s proposed rules for Parenteral Ketamine Therapy under 22 TAC Chapter 173, Subchapter B, §§173.6–173.15.[1][2] My concern is not with reasonable safety standards. My concern is that the current proposal combines inconsistent operational logic, rigid staffing assumptions, and burdensome registration and oversight requirements in a way that threatens patient access without clearly demonstrating a commensurate increase in safety.[1] The published proposal creates a new regulatory framework for PKT clinics that includes mandatory registration, clinic operations standards, physician requirements, minimum administration standards, prohibited uses, medical director and owner responsibility, renewal requirements, and audit or inspection authority.[1] This is not a minor clarification to existing practice. It is a broad clinic-level regulatory structure aimed specifically at outpatient PKT settings.[1] The rule defines PKT as the administration of low-dose parenteral ketamine for psychiatric indications and identifies those indications to include conditions such as PTSD, treatment-resistant depression, and suicidal ideation.[1] It then requires registration for medical practices, clinics, or facilities that provide PKT, while exempting certain settings such as hospitals, some medical-school clinics, state-run facilities, federal clinics, and certain certified health organizations.[1] That means the proposal is designed not only to regulate what happens at the bedside, but also who may operate, under what conditions, and under what level of state scrutiny.[1] My first concern is that the proposal appears to regulate PKT primarily through an anesthesia-risk lens without fully accounting for the clinical realities of psychiatric ketamine treatment.[1] The Board’s own public description says the proposal offers additional guidance and regulations regarding various therapeutic uses for low-dose ketamine.[3] But for patients with severe depression, suicidality, PTSD, and related disorders, ketamine is not an academic issue. It is often sought precisely because conventional psychiatric treatment has failed, sometimes repeatedly and over many years. A rule that materially reduces access to treatment should be held to a very high standard of justification. My second concern is the onsite physician requirement. Under proposed §173.9(f), there must be an APRN, PA, or RN present at all times when administering PKT, and the delegating physician must be “immediately available onsite for in-person consultation and emergency management throughout the PKT administration.”[4] That language is not a small wording adjustment. It is a major operational mandate. For many smaller clinics, it effectively eliminates existing delegation models in which trained non-physician clinicians provide monitored care under physician oversight that is documented, protocol-driven, and immediately reachable, but not physically in the building.[4] My third concern is that the staffing logic in the proposal is internally inconsistent. The rule allows PKT to be administered only by a physician, APRN, PA, or RN acting under physician delegation for the psychiatric indications identified in the definition of PKT.[5] It further requires a physician, APRN, PA, or RN working under physician delegation to have formal airway management education or to have completed a course on airway management for moderate sedation.[4] But the rule then treats physical physician presence as though it is the decisive safety safeguard, even though actual emergency performance depends less on title and more on bedside competency, recognition skills, rescue readiness, and hands-on experience with deterioration.[4][5] This is where the proposal raises a particularly serious practical concern. The inclusion of registered nurses as administering personnel is explicit in the rule text.[5] But the fact that RNs are included does not answer the deeper question of why they are included as part of the personnel solely permitted to administer PKT while the rule simultaneously implies that physician physical presence is indispensable for safety.[4][5] If airway compromise and emergency response are truly the Board’s concern, then the rule should regulate demonstrated competency directly. It should not rely on title-based assumptions that do not reliably reflect real-world airway experience across physicians, APRNs, PAs, and RNs. Stated plainly, neither nursing licensure nor midlevel licensure automatically confers advanced airway proficiency. Most registered nurses do not receive training in endotracheal intubation or advanced airway rescue as part of ordinary RN education. Many PAs and APRNs likewise do not routinely manage crashing airways in their day-to-day practice. The same is true for many physicians outside of anesthesiology, emergency medicine, and critical care. In actual deterioration events, the clinicians most likely to have deep airway-management experience are typically anesthesiologists, CRNAs, emergency medicine physicians, and paramedics. A sound rule should reflect that reality rather than assume that physical physician presence solves the competency problem. My fourth concern is the physician-patient relationship requirement. Proposed §173.9(c) and §173.10(b) state that the physician ordering PKT must have a properly established physician-patient relationship and must have properly documented and diagnosed the psychiatric indication supporting PKT.[5] But the PKT subchapter, as published, does not itself clearly spell out within this section what is required to establish that relationship in this specific context.[5] By contrast, the rule is highly specific when it wants to be: it expressly requires the delegating physician to be onsite for in-person consultation during administration.[4] That leaves clinics and ordering physicians with asymmetry in the proposal—less precision at the front end of the treatment relationship and maximal rigidity at the point of administration.[4][5] My fifth concern is the sheer breadth of the compliance burden. The proposed rules require a clinic to maintain an adverse-event reporting log organized by year and preserved for at least three years, and that log must list any event involving airway intervention, EMS transport, hospitalization, or death.[6] The rules also require protocols or standing delegation orders when administration is delegated.[7] The Board’s public summary further states that the proposed subchapter includes physician requirements, documentation and monitoring standards, equipment standards, prohibited home use, clinic-level responsibility, and audit or inspection authority.[1][3] Taken together, this is a sweeping structure, not a narrow patient-safety refinement.[1][3][6][7] That matters all the more because the proposal already contains safety mechanisms that are far more directly tied to patient care than a blanket onsite-physician mandate. The Board’s public summary explains that the new minimum-standards section addresses medical record documentation, patient evaluation, diagnosis, informed consent, monitoring, and equipment standards when providing PKT.[3] Those are meaningful safety safeguards. If the Board’s true objective is proportional regulation, then it should focus on competency, monitoring, preparedness, protocols, documentation, and emergency-response systems—not reflexively on a universal onsite physician requirement. The economic assumptions behind the proposal are also difficult to reconcile with operational reality. In the Texas Register, the Board states there will be only a probable minimal economic cost to individuals required to comply and no effect on small businesses, micro businesses, or rural communities.[8] Yet for smaller clinics, the combination of registration, onsite physician availability, staffing restrictions, delegation protocols, log maintenance, inspection exposure, and renewal compliance is plainly not trivial.[4][6][8] To characterize that burden as minimal, especially for independent outpatient clinics, does not reflect the actual cost of maintaining a physician physically onsite throughout administration while also meeting the proposal’s other compliance demands.[4][6][8] The Texas Medical Board’s own rulemaking page confirms that the Chapter 173 PKT proposal was published in the January 2, 2026 issue of the Texas Register, that written comments are being accepted, and that a public hearing will be held at a later date.[2] That means this is the proper moment to reconsider whether the current proposal is overbroad, internally inconsistent, and likely to reduce access to care in ways the Board has underestimated.[2] Texas should regulate parenteral ketamine therapy responsibly, but not irrationally. A more balanced approach would preserve the core safety measures already described in the proposal—proper physician-patient relationship requirements, psychiatric diagnosis, informed consent, monitoring, equipment, emergency logs, protocols, and prohibition of home administration—while allowing flexibility for clinics that can demonstrate actual competency and safe outcomes without requiring a physician to be physically onsite at all times.[3][4][5][6] The real question should not be whether a physician is in the building as a symbolic safeguard. The real question should be whether the clinic can demonstrate safe patient selection, appropriate psychiatric evaluation, clear delegation, effective monitoring, documented staff training, immediate rescue capability, and accountable oversight. For those reasons, I respectfully urge the Texas Medical Board to revise the proposed PKT rules before adoption. Specifically, the Board should clarify the physician-patient relationship standard, reconsider the categorical onsite-physician requirement, and align the staffing provisions with actual clinical competency rather than title-based assumptions.[4][5] Texas patients with treatment-resistant psychiatric illness deserve access to safe, evidence-informed ketamine care. Clinics that already provide that care responsibly should not be regulated out of reach. Respectfully submitted,    Jon V. Wolfe, LP/MPA-EM  CEO/Cofounder Austin Ketamine Clinic   Sources
[1] Texas Register, January 2, 2026: proposed Chapter 173, Subchapter B, Parenteral Ketamine Therapy §§173.6–173.15 (https://www.sos.state.tx.us/texreg/pdf/backview/0102/0102prop.pdf
[2] Texas Medical Board: Rule Changes page for Chapter 173 PKT proposal and public comment process (https://www.tmb.state.tx.us/laws-rules/rule-changes
[3] Texas Medical Board newsroom summary of the December 2025 meeting and proposed Chapter 173 PKT rule (https://www.tmb.state.tx.us/about-us/newsroom/tmb-disciplines-13-physicians-at-december-meeting-adopts-rule-changes
[4] Texas Register text showing airway education requirement and onsite physician requirement in proposed §173.9(e)–(f) (https://www.sos.state.tx.us/texreg/pdf/backview/0102/0102prop.pdf
[5] Texas Register text showing physician-patient relationship language and allowed administering personnel in proposed §173.9(c)–(d) and §173.10(b) (https://www.sos.state.tx.us/texreg/pdf/backview/0102/0102prop.pdf
[6] Texas Register text showing adverse-event reporting log requirement in proposed §173.9(g) (https://www.sos.state.tx.us/texreg/pdf/backview/0102/0102prop.pdf
[7] Texas Register text showing delegation protocols or standing orders requirement in proposed §173.10(d) (https://www.sos.state.tx.us/texreg/pdf/backview/0102/0102prop.pdf
[8] Texas Register economic impact statement for the PKT proposal (https://www.sos.state.tx.us/texreg/pdf/backview/0102/0102prop.pdf