Texas Medical Board's Proposed Ketamine Therapy Rules: What Physicians and Clinic Operators Need to Know

Last updated: August 11, 2026

The Texas Medical Board (TMB) has republished proposed rules that would create an entirely new regulatory framework for psychotropic ketamine therapy (PKT) in Texas. The latest set of proposed rules – published in the July 10, 2026, issue of the Texas Register – would establish mandatory clinic registration, physician oversight requirements, patient monitoring standards, and equipment mandates that many current ketamine operators do not meet today.

This article summarizes the proposed rules for physicians and practice operators, explains where they depart from existing Texas Medical Board anesthesia rules, outlines the likely timeline to adoption, and identifies the steps you should take now.

Where Things Stand: These rules have been published in the Texas Register three times: originally January 2, 2026, then republished May 15, 2026, and again on July 10, 2026 – each republication restarting the public comment period after the TMB incorporated revisions from stakeholder feedback. Comments on the current version may be submitted online or via email to rules.development@tmb.state.tx.us. A public hearing will be held at a later date.

Is Ketamine Therapy Still Legal in Texas?

Yes. The proposed rules do not ban ketamine therapy in Texas. Psychotropic ketamine therapy for diagnosed psychiatric conditions remains a legal medical treatment. What the Texas Medical Board is doing is regulating how and where it must be delivered – requiring clinic registration, qualified physician oversight, specific patient monitoring standards, and minimum equipment. Clinics that meet those requirements can continue to operate. Clinics that do not will need to restructure or close.

What the Proposed Rules Require

The proposed addition to the TMB standards for Office-Based Anesthesia Services creates 12 new rule sections covering every aspect of PKT practice operations. Here is what each section requires.

1. Definitions (Section 173.6)

The July proposed rules significantly expand the definitions section. Key terms:

• Psychotropic ketamine therapy (PKT): Parenteral ketamine administered by a physician, APRN, PA, or RN under delegatory authority for psychiatric indications including – but not limited to – PTSD, treatment-resistant depression, severe anxiety, OCD, bipolar depression, and suicidal ideation. Dosages are limited to below moderate sedation levels. Psychiatric indications may have been originally diagnosed by a physician or by an APRN, PA, or licensed mental health provider (PsyD, LPC, LCSW, LMFT, and others) under proper delegation and supervision. Importantly, the ordering practitioner is required to evaluate the diagnosis for psychiatric indications if not making the original diagnosis.
• Adverse event: Any event requiring or resulting in emergency transportation, a compromised airway, resuscitative efforts, psychotropic events, hospitalization, or death. The term “psychotropic events” is not defined by the Board.
• Initial dose: The starting dose for any PKT administration, not to exceed 0.5mg per kilogram of body weight over a 40-minute period. The dose may be incrementally adjusted based on protocol and clinical judgment in conjunction with appropriate physician consultation.
• PKT practice: Any medical practice, clinic, or facility that administers PKT and is not regulated or licensed by another Texas agency or commission.
• Medical director: The physician who provides medical oversight at a PKT practice.
• Practitioner: An APRN or PA, for the purpose of these rules. Note that RNs are authorized to administer PKT under specific conditions but are treated separately from practitioners throughout the rules.

2. Mandatory Registration (Sections 173.7 and 137.8)

Every PKT practice must register with the Texas Medical Board before operating. Registration must be filed by the medical director (not the physician owner). Exempt from registration:

• Medical schools and their affiliated outpatient clinics
• Hospitals and their outpatient facilities
• State-maintained or state-operated facilities
• U.S. government medical clinics
• Health organizations certified by the TMB under Section 162.001 of the Texas Occupations Code
• Hospice programs licensed by the Texas Health and Human Services Commission

Applications are filed by the medical director and are valid for 180 days from submission. If the applicant fails to provide all required information and documentation within those 180 days, the application will be deemed withdrawn. Approved registrations are effective for two years.

PKT practices have 180 days to come into full compliance with the new rules once adopted. There is one exception: adverse event reporting requirements take effect immediately on the adoption date – not after the grace period.

3. Medical Director Requirements (Section 173.10)

The July proposed rules create a substantial standalone section on medical director eligibility, duties, and restrictions. To be eligible, a physician must:

• Hold a current, full, and unrestricted Texas medical license
• Have no prior disciplinary action or history regarding any medical license in any state, including Texas
• Have no pending investigation or proceeding regarding any medical license in any state, including Texas

Once designated, the medical director is subject to the following requirements and restrictions:

• Physical inspections: The medical director must physically inspect each location where PKT is administered within seven days of becoming medical director, and at least once every 90 days thereafter.
• Disclosure and visibility: The medical director's name, title, and license number must be disclosed in writing to all patients, displayed in each public area and treatment room, and clearly identified on the PKT practice's website and advertising.
• Physical presence in Texas: Under Section 173.10, the medical director need not be on-site at the PKT practice during administration but must be physically within Texas while providers are administering PKT and immediately available for emergency consultation. This rule does not require in-person emergency consultation. In comparison, the proposed emergency response requirements under Section 173.14 require the physician to be located within close proximity of the PKT practice and nearby hospitals.
• Approval authority: The medical director must approve in writing all physicians, practitioners, and RNs administering PKT or monitoring PKT patients. The medical director may approve additional physicians to serve as delegating and supervising physicians for practitioners and RNs at the practice.
• Prohibition on separate supervision requirements: The medical director may not require any practitioner or RN to obtain a separate delegating and supervising physician. It is not clear how this provision will be interpreted or enforced, considering the medical director’s authority to approve additional physicians for the express purpose of serving as delegating and supervising physicians at the practice.
• Concurrent oversight responsibility: The medical director retains concurrent responsibility for delegation and supervision of all practitioners and RNs at the practice – even when those providers are administering or monitoring PKT under an approved physician's direction. By maintaining clinical responsibility for PKT delivered to patients, it could be argued that the medical director will be practicing medicine in their capacity as the medical director of the PKT practice. The recently revised Section 15.50 of the Texas Business and Commerce Code specifies that the practice of medicine does not include managing or directing medical services in an administrative capacity for purposes of determining whether certain elements of the non-compete law apply to a non-compete covenant involving a licensed physician. If the proposed rule is adopted as-is, Texas courts will have to reconcile this provision with the non-compete law.
• Clinic cap: The medical director may provide oversight at no more than three medical practices, clinics, or facilities of any type – not just PKT practices.

4. Operation of PKT Practices (Section 173.11)

Each PKT practice must have one – and no more than one – medical director at all times. Other key operational requirements include:

• Authorized administrators: PKT may only be administered by a physician, APRN, PA, or RN acting under appropriate physician delegation. CRNAs are no longer specifically listed as authorized PKT administrators under the proposed July rules. This does not mean that CRNAs are not eligible to operate as a PKT administrator or practitioner. A certified nurse-midwife (CNM), certified nurse practitioner (CNP), certified registered nurse anesthetist (CRNA), and clinical nurse specialist (CNS) are each considered an advanced practice registered nurse (APRN) under the Texas Occupations Code and the Board of Nursing Rules. In order to serve as a practitioner for purposes of ordering PKT, the APRN must possess prescriptive authority, enter into a prescriptive authority agreement with a supervising and delegating physician, and register such agreement with the Texas Medical Board. A CRNA does not require a prescriptive authority agreement when ordering drugs and devices necessary for the CRNA to administer an anesthetic or an anesthesia-related service ordered by a physician in the context of anesthetizing a patient for surgery. However, a CRNA would require a prescriptive authority agreement to serve as a practitioner for ordering PKT. Additionally, if an RN is administering PKT, a physician or practitioner (APRN or PA) must be physically on-site at all times
• Patient ratios during administration: When a physician is on-site, each practitioner may administer to up to four patients; each RN may administer to up to two patients. When a physician is not on-site, each practitioner may administer to up to three patients; each RN may administer to only one patient.
• Informed consent: Must include a discussion of known PKT risks and the identity and licensure credentials of both the person administering PKT and the person delegating and supervising the administering clinician, if applicable.
• Pregnancy verification: For women of childbearing age, the practice must obtain either a pregnancy test or written affirmation from the patient that she is not pregnant, documented on the day of treatment.
• Time out: A formal time-out period must be conducted immediately before beginning administration.
• Continuous monitoring during administration: Must include blood pressure, pulse, respiration, oxygen saturation, cardiovascular status by three-lead EKG, and appropriate responsiveness to verbal stimuli documented by RASS or Aldrete Score. All monitoring must be documented in the chart at minimum every 10 minutes.
• Simultaneous conditions: If a patient is simultaneously receiving ketamine for a non-psychiatric condition, the ordering practitioner must review the primary diagnosis and applicable standard of care, review the PMP before every treatment, and not exceed the initial dose without consulting the medical director or an approved physician.

5. Monitoring After Completion of PKT Administration (Section 173.12)

Before a patient may be discharged, the following recovery and monitoring requirements must be completed:

• A minimum 30-minute observation period
• At least two blood pressure readings, 10 minutes apart
• A full cognitive assessment including an Aldrete score

Post-completion monitoring allows a maximum ratio of one monitoring delegate to every four patients.

6. Minimum Equipment Requirements (Rule 173.13)

The following equipment must be on-site and readily available to manage adverse events at all times:

• Supplemental oxygen
• Bag-valve mask
• AED or defibrillator
• A monitor with a quantitative end-tidal carbon dioxide (ETCO₂) analyzer

Medications must also be maintained on-site for managing adverse events, including for airway management, hemodynamic instability, seizures, and other possible psychotropic events. Neither the scope of possible psychotropic events nor specific medications are listed within proposed rule 173.13. The medical director will be responsible for ensuring appropriate medications are available for all possible psychotropic events.

7. Emergency Response Requirements and Adverse Event Reporting (Section 173.14)

This section, substantially revised in the July rules, governs both physician availability during administration and adverse event reporting obligations.

• Non-emergency consultation: A physician must be immediately available throughout PKT administration – either in-person at the location or by two-way audiovisual technology.
• Emergency response: At all times when PKT is being administered, the medical director or an approved physician must either (a) be able to physically respond to the clinic's location in less time than the average EMS response time for that location per Texas Department of State Health Services (DSHS) data, or (b) hold clinical privileges at the hospital where the patient would be transferred and be physically available to go to that hospital to manage the admitted patient.
• Adverse event log: Each PKT practice must document adverse events within 24 hours of occurrence – including outcomes if known – and maintain those records for three years. The log must include the patient's name, date of the event, a list of all personnel administering PKT, a list of all physicians, practitioners, and RNs present at the time, the type of adverse event, and the outcome if known.
• 24-hour Board reporting: For two specific adverse events – emergency transportation and death – the medical director must ensure the practice submits a written report to the TMB on a Board-approved form within 24 hours of the event.

8. Prohibitions (Section 173.15)

PKT may not be administered outside of a registered clinic or an exempt setting, and may not be prescribed for home use.

9. Complaints (Section 173.16)

The medical director is responsible for the clinic's operations and patient care. The medical director must also ensure the practice complies with TMB rules on mandatory complaint notification – including posting instructions on how patients may file complaints with the TMB.

10. Registration Renewal and Audits (Sections 173.9 and 173.17)

Registrations must be renewed every two years. At least 60 days before expiration, the medical director must submit:

• A board-approved renewal application
• An attestation of compliance with all applicable laws and Board rules
• The PKT practice's adverse event log (new requirement in July rules)
• Any other documentation required by the Board

A clinic that allows its registration to lapse must immediately cease PKT operations until renewal is approved.

PKT practices are subject to audits, inspections, and investigations on the same basis as pain management clinics under Chapter 172 of the Board rules.

How These Rules Differ from Current Texas Medical Board Requirements

The current Texas Medical Board rules governing office-based anesthesia services apply broadly to any outpatient setting providing Level II through Level IV anesthesia. Ketamine – classified as a hypnotic – is already regulated as anesthesia under those rules. The proposed new rules create a separate, more targeted framework for PKT specifically.

Here is where the proposed rules depart meaningfully from what is currently in place:

• New registration requirement. Physicians who are currently registered to perform office-based anesthesia would still need a PKT registration. The proposed rules require every PKT practice – unless exempt – to register with the TMB before operating, modeled on the pain management clinic framework.
• Medical director eligibility restrictions. Current rules impose no clean-license requirement on physicians overseeing anesthesia services. The proposed rules bar any physician with prior disciplinary action or a pending investigation – in any state, not just Texas – from serving as medical director.
• Physician availability. Since intravenous ketamine infusions are currently regulated as a Level III service under the office-based anesthesia rules, on-site presence of a physician is currently required. The proposed rules do no require the physician to be on-site during PKT administration, but require the physician to be located within close physical proximity of the PKT practice and nearby hospitals to comply with the proposed emergency response rules.
• Psychiatric scope and dosage limitation. Current office-based anesthesia rules do not recognize use of ketamine outside of the context of anesthetizing a patient. The proposed rules define PKT as parenteral ketamine for psychiatric treatment, administered at dosages below moderate sedation. Ketamine for pain or other non-psychiatric conditions remains subject to the existing – potentially stricter – office-based anesthesia rules.
• Oversight structure. Current rules impose no cap on the number of clinics a physician may oversee and require no periodic site visits. The proposed rules limit medical directors to three facilities of any type, require physical inspection of each location at least every 90 days, and hold the medical director solely responsible for practice operations.

Likely Timeline to Adoption

These proposed rules have now been through three publication cycles: originally published January 2, 2026, republished May 15, 2026, and republished again July 10, 2026. Each republication reflects TMB revisions in response to stakeholder feedback and restarts the public comment period. The scope and direction of the changes across all three versions make clear that the Board is committed to establishing a PKT regulatory framework. The question is what the final version will look like, not whether one will be adopted.

The TMB will schedule a public hearing, review submitted comments, and vote to adopt or further modify the rules. If adopted, PKT practices will then have a 180-day compliance window – with the exception of adverse event reporting, which takes effect immediately.

What Ketamine Clinic Owners and Physicians Should Do Now

Whether you currently operate a PKT practice or are planning to open one, the time to assess compliance is now – before the rules take effect. Here is where to start.

1. Identify and Qualify Your Medical Director

The medical director eligibility requirements are strict and non-negotiable under the proposed rules. Confirm that your intended medical director holds a full, unrestricted Texas license and has no disciplinary history or pending investigation in any state. If your current medical oversight arrangement does not meet this standard, you will need to identify a qualified physician before the rules take effect. Also confirm the physician is not already serving as medical director at three or more other facilities.

2. Determine Whether You Need to Register

If your PKT practice is not a hospital, medical school, government facility, certified health organization, or licensed hospice program, registration is mandatory. The medical director must file the board-approved application. Begin gathering required documentation now and plan for the 180-day registration review window.

3. Begin Adverse Event Reporting Compliance Immediately

Adverse event reporting is the one requirement that takes effect on the adoption date – not after the 180-day grace period. Establish or update your adverse event log now to capture all required information: patient name, event date, personnel administering PKT, all physicians and clinical staff present, event type, and outcome. Build the 24-hour Board reporting workflow for emergency transport and death events before the rules take effect.

4. Evaluate Your Physician Oversight Model

The medical director must be physically present in Texas and be located in close proximity to the PKT practice to comply with the proposed emergency response rules. Review your current oversight arrangement against the new emergency response standard: can the medical director or approved physician reach your clinic faster than local EMS response time, or do they hold clinical privileges at the hospital where patients would be transferred? Remote-only oversight models that cannot meet either prong of this test are non-compliant.

5. Assess Provider Mix – Particularly CRNA Roles

CRNAs are no longer listed as authorized PKT administrators under the July rules. If your clinic currently relies on CRNAs to administer PKT, you will need to restructure those roles or ensure those individuals are credentialed as APRNs under the proposed framework. Also confirm that any RNs administering PKT will have a physician or practitioner physically on-site at all times as required.

6. Review Your Patient Population and Documentation

The proposed rules apply to PKT as defined: parenteral ketamine at below-moderate-sedation dosages for diagnosed psychiatric indications. Review your patient base for documented diagnoses – PTSD, treatment-resistant depression, severe anxiety, OCD, bipolar depression, suicidal ideation, and similar conditions. Update your informed consent forms to capture the required disclosures for both the administering clinician and the delegating/supervising physician.

7. Assess Your Equipment and Medications

Walk through your clinic against both the equipment and medication requirements. If you do not currently have a monitor with a quantitative ETCO₂ analyzer on-site, plan for that capital expenditure now. Confirm your supplemental oxygen, bag-valve mask, and AED or defibrillator are present and maintained. Work with your medical director to establish an on-site medication inventory covering airway management, hemodynamic instability, seizures, and psychotropic events.

8. Consider Submitting Public Comments

The TMB is actively seeking input. If specific provisions create an undue operational burden, submitting a well-reasoned comment is an opportunity to influence the final rules. Comments may be submitted online or by email to rules.development@tmb.state.tx.us.

Frequently Asked Questions

Are the proposed PKT rules final?

No. As of July 2026, the rules are in the public comment stage following their third republication. The TMB must hold a public hearing and vote on adoption before they take effect. Given that the TMB has now republished the rules three times rather than withdrawing them, adoption in some form is widely expected.

Do these rules apply to ketamine administered for pain management?

No. The proposed rules govern PKT as defined: parenteral ketamine for psychiatric indications at dosages below moderate sedation. Ketamine administered for pain management or other non-psychiatric conditions remains subject to the existing office-based anesthesia rules. If a patient is receiving ketamine for both psychiatric and non-psychiatric indications simultaneously, specific additional safeguards apply – including PMP review before every treatment and a prohibition on exceeding the initial dose without medical director or approved physician consultation.

Does the physician have to be on-site during every PKT infusion?

Not under the proposed rules – but the physician must be in Texas and immediately available for emergency consultation. For emergency response, the medical director or an approved physician must be able to physically reach the clinic faster than the average local EMS response time (per Texas DSHS data) or hold clinical privileges at the hospital where the patient would be transferred and be available to respond there.

What happens if a clinic continues operating without registration after the rules take effect?

Operating without registration would constitute a violation of TMB rules. The medical director is solely responsible for clinic compliance under the July rules. Violations can result in Texas Medical Board investigation, disciplinary action against physician licenses, and forced closure of non-compliant operations.

What qualifies as demonstrated proficiency to order PKT?

The July rules shift responsibility for provider qualifications to the medical director, who must ensure that physicians and practitioners ordering PKT demonstrate "current and ongoing proficiency" in the use of PKT for psychiatric conditions. The prior version of the rules specified a two-year training course requirement; the July version does not. Specific course requirements, minimum hours, and accreditation standards are not defined. The TMB is expected to provide guidance on this point, and medical directors should document the basis for any proficiency determination they make.

Get Experienced Guidance Before the Rules Take Effect

The proposed PKT rules represent a significant and evolving shift in how Texas regulates ketamine clinics. With three rounds of rulemaking already completed and adoption on the horizon, the window for compliance planning is narrowing.

Hendershot Cowart P.C. helps Texas ketamine clinic owners and physicians navigate Texas Medical Board compliance, structure new PKT practice operations, and respond to TMB investigations.

Whether you need a regulatory compliance attorney to audit your existing practice, a ketamine clinic setup attorney to structure a new operation from the ground up, or guidance on the proposed rules' impact on your current business model, our Houston-based healthcare attorneys are ready to help.

Call (713) 783-3110 or contact us online to schedule a consultation.