Is Your Ketamine Clinic Ready? Texas Proposes Mandatory Registration and What It Means for the Industry
Synopsis: The Texas Medical Board has proposed sweeping new regulations that would require mandatory registration for ketamine clinics, onsite physician presence during all treatments, enhanced monitoring standards, and a complete ban on home-use parenteral ketamine. Published January 2, 2026, these rules would fundamentally change how ketamine therapy is delivered in Texas—and could set a precedent for the rest of the nation. This guide breaks down what's being proposed, how it affects Texas providers, and why every ketamine clinic owner should be paying attention, regardless of location.
Key Takeaways:
Texas is creating the first comprehensive regulatory framework specifically for ketamine therapy clinics, requiring mandatory PKT clinic registration, onsite physicians during all treatments, enhanced monitoring equipment, and prohibiting all home-use parenteral ketamine—raising the bar significantly for safety standards while potentially creating access barriers.
Texas providers face immediate operational changes: If adopted, these rules would require staffing model overhauls (onsite physicians, not remote supervision), equipment upgrades (end-tidal CO2 monitoring, emergency equipment), enhanced documentation systems, and complete elimination of take-home parenteral ketamine models.
What happens in Texas won't stay in Texas: As the second-most populous state with one of the largest medical communities, Texas regulatory frameworks often become templates for other states—making these proposed rules a preview of where ketamine therapy regulation is likely heading nationwide, regardless of whether you currently practice in Texas.
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Table of Contents:
The Current Issue: What the Proposed Rule Changes Are
How Proposed Rules Would Change Current Ketamine Clinic Operations (Quick Reference Table)
Why This Matters for Texas Ketamine Clinics
Why This Matters for All of Us in the Industry
Relevant Links - including original proposed regulations & Texas Medical board.
The Texas Medical Board has proposed the first comprehensive regulatory framework specifically for ketamine therapy clinics, introducing mandatory registration, enhanced monitoring standards, and strict operational requirements that would fundamentally change how parenteral ketamine is delivered in the state.
Introduction
The Texas Medical Board just dropped proposed regulations that could fundamentally change how ketamine therapy is delivered in the Lone Star State. Published in the Texas Register on January 2, 2026, these rules would create the first comprehensive regulatory framework specifically for ketamine therapy clinics in Texas.
If you're operating a ketamine clinic in Texas, these aren’t just guidelines.
They would be mandatory requirements that would affect everything from your staffing model to your business operations.
And if you're outside Texas? Pay attention. This could be setting a new precedent that affects other states - so what happens in Texas may NOT stay in Texas
Let's break down what's being proposed, why it matters for Texas clinics, and what this could mean for the ketamine therapy industry nationwide.
Important Note: This blog post provides an overview of the the publicly available proposed regulations. We strongly encourage all Texas providers to read the complete proposed rules (Subchapter B, §173.6-173.15) directly from the Texas Medical Board. The actual rule text contains additional procedural details, legal language, and nuances that may be relevant to your specific practice situation. This summary is not a substitute for reviewing the official proposal.
The Current Issue: What the Proposed Rule Changes Are
The Texas Medical Board is proposing a new subchapter (173.6-173.15) that would establish comprehensive regulations for ketamine therapy. Here's what's on the table:
Mandatory PKT Clinic Registration
Any medical practice providing parenteral ketamine (IV, IM, or subcutaneous) for psychiatric indications would need to register with the Texas Medical Board as a ”Psychotropic Ketamine Therapy" (PKT) clinic. This registration would be:
Filed by a physician owner or medical director
Valid for two years
Subject to renewal with attestation of compliance
Required to operate. And if your registration lapses, you must cease PKT operations immediately
Exemptions include medical schools, hospitals, state-operated facilities, federal clinics, and board-certified health organizations under Section 162.001 of the Act.
Additionally, the rules do not apply to ketamine administration for patients enrolled in a hospice program licensed by Texas Health and Human Services. This carve-out recognizes the distinct nature of palliative care and end-of-life treatment.
Onsite Physician Requirement
This is a big one. The proposed rules require that a delegating physician must be "immediately available onsite for in-person consultation and emergency management throughout the PKT administration."
This means having a physician on call but not onsite wouldn't cut it anymore. The physician must be physically present at the facility during treatments.
Provider Training and Qualifications
Physicians providing PKT must have either:
Training in mental health treatments OR
Completed a course on the use of ketamine for psychiatric conditions
Plus, anyone administering PKT (physicians, APRNs, PAs, or RNs) must have formal airway management education or completion of a moderate sedation airway management course.
Enhanced Monitoring Standards
The proposed rules now establish specific monitoring requirements that mirror procedural sedation protocols:
During Treatment:
Continuous monitoring of blood pressure, pulse, respiration, O2 saturation, cardiovascular status, and responsiveness
Required equipment: pulse oximetry, incremental blood pressure checks, end-tidal CO2 analyzer
Emergency equipment on-site: supplemental oxygen, bag-valve mask, AED/defibrillator
Post-Treatment:
Minimum 30-minute observation period
At least two blood pressure readings 10 minutes apart
Full cognitive assessment including Aldrete score before discharge
Documentation and Safety Requirements
Clinics would need to:
Obtain informed consent that includes both a discussion of known risks of PKT AND disclosure of the identity and licensure credentials of the person administering the treatment (this means patients must know not just what could go wrong, but also who exactly is providing their care)
Implement a "time out" protocol immediately before PKT administration (similar to surgical procedures)
Maintain an adverse event log for at least three years, documenting any airway intervention, EMS transport, hospitalization, or death
Review the Texas Prescription Monitoring Program (PMP)when establishing care and quarterly for existing patients
Maintain complete, contemporaneous, and legible medical records
Complete Ban on Home-Use Parenteral Ketamine
Section 173.12 is crystal clear: "Any home use, prescribing, or administration of parenteral ketamine is prohibited."
If you're currently providing any form of take-home parenteral ketamine in Texas, this would shut down that model entirely.
Enforcement on Par with Pain Management Clinics
Perhaps most significantly, PKT clinics would be subject to the same audits, inspections, and investigations framework as pain management clinics under Chapter 172 of Board rules. This signals that the Board views ketamine therapy clinics with similar regulatory scrutiny as pain management clinics.
To help you quickly assess the scope of these changes, here's a comprehensive overview of each requirement and its operational impact:
How Proposed Rules Would Change Current Ketamine Clinic Operations
| Proposed Requirement | Impact on Current Practice |
|---|---|
| Mandatory PKT Clinic Registration (§173.8) | Clinics must register with Texas Medical Board, renew every 2 years, and cease operations if registration lapses. Creates new administrative burden and compliance costs. |
| Onsite Physician Presence (§173.9(f)) | Physician must be physically present and "immediately available onsite" during all treatments. Eliminates remote supervision, on-call models, and APRN/PA-only staffing structures. Significantly increases overhead. |
| Provider Mental Health Training (§173.9(b), §173.10(a)) | Physicians must complete either mental health treatment training OR ketamine-specific coursework. May require additional education for providers without psychiatric background. |
| Airway Management Certification (§173.9(e)) | All providers (physicians, APRNs, PAs, RNs) must complete formal airway management education or moderate sedation airway course. Requires staff training and certification. |
| End-Tidal CO2 Monitoring (§173.11(e)) | Continuous capnography required during and after treatment. Clinics without this equipment must purchase monitors (~$2,000-5,000+ per unit). |
| Enhanced Vital Sign Monitoring (§173.11(c)) | Continuous monitoring of BP, pulse, respiration, O2 sat, cardiovascular status, and responsiveness. May require workflow changes and additional monitoring equipment. |
| 30-Minute Post-Treatment Observation (§173.11(d)) | Minimum 30-min observation period with two BP readings 10 minutes apart and full cognitive assessment (Aldrete score). Extends treatment time and affects scheduling capacity. |
| Emergency Equipment On-Site (§173.11(f)) | Must have supplemental oxygen, bag-valve mask, and AED/defibrillator readily available at all times. Requires equipment purchase if not already present. |
| Time-Out Protocol (§173.11(a)(4)) | Formal time-out procedure before each treatment (similar to surgical protocols). Adds procedural step and documentation requirement. |
| Adverse Event Log (§173.9(g)) | Must maintain 3-year log of airway interventions, EMS transport, hospitalizations, or deaths. Creates ongoing documentation obligation. |
| Quarterly PMP Review (§173.10(c)) | Physician must check Prescription Monitoring Program when establishing care and quarterly for existing patients. Adds recurring administrative task. |
| Complete Home-Use Ban (§173.12) | All home use, prescribing, or administration of parenteral ketamine prohibited. Eliminates take-home IV/IM/SC models entirely; requires complete business model pivot. |
| Delegation Protocol Documentation (§173.10(d)) | Written protocols or standing delegation orders required and maintained on-site. Creates formal documentation requirement for delegation practices. |
| Informed Consent Specifics (§173.11(a)(3)) | Must include risks discussion AND identity/licensure credentials of person administering treatment. May require consent form updates. |
| Medical Director Responsibility (§173.13) | Medical Director and physician owners explicitly responsible for all operations and compliance. Creates clear legal accountability at leadership level. |
| Pain Clinic-Level Oversight (§173.15) | Subject to same audits, inspections, and investigations as pain management clinics. Signals high regulatory scrutiny and enforcement priority. |
Prefer to Listen?
If you'd rather listen to this analysis on your commute, during a workout, or while reviewing your clinic operations, we've recorded an audio version of this blog post.
Texas ketamine clinic providers face significant operational changes under proposed PKT regulations, from mandatory registration to onsite physician requirements that could fundamentally alter current practice models.
Why This Matters for Texas Ketamine Clinics
If you're operating a ketamine clinic in Texas, these proposed rules would likely require significant changes to your current operations. Let’s be direct about what this could mean:
Operational Changes
Staffing Model Overhaul
If you're currently operating with APRNs seeing patients while a physician supervises remotely or is available by phone, that model won't work under these rules. You'll need a physician physically present during all treatments.
This could lead to an increase in overhead and as a result affect your cost structure.
Equipment and Infrastructure Upgrades
If you're not currently using continuous end-tidal CO2 monitoring or don't have all the required emergency equipment on hand, you'll need to invest in this medical equipment. The monitoring requirements essentially bring ketamine infusions in line with procedural sedation standards.
If your practice was not already using this equipment, then staff training would be required and this potentially could affect your current patient flow.
Documentation Burden The adverse event log, PMP quarterly reviews, time-out protocols, and enhanced record-keeping requirements all add administrative tasks. You'll need systems in place to ensure compliance.
Registration and Renewal Requirements
The mandatory registration creates a new administrative hurdle. Applications are valid for only 180 days. If you can't provide all required documentation in that window, your application is withdrawn and you'd need to start over.
Under §173.13, the Medical Director and physician owner(s) are explicitly responsible for the clinic's operations, patient care, and ensuring compliance with all applicable regulations. This means accountability sits squarely with clinic leadership. You can't delegate away regulatory responsibility.
The renewal process itself has strict timelines. Clinics must submit renewal applications at least 60 days prior to registration expiration, along with attestation that all requirements, standards, and equipment comply with applicable laws and board rules. This means you can't wait until the last minute. Planning for renewal needs to start well in advance. If you miss that renewal deadline, you must stop operations until you're re-registered.
Public Comment Opportunity
The proposed rules are open for public comment until February 20, 2026 at 5:00 p.m. This is your chance to weigh in.
If you have concerns about implementation feasibility, specific provisions that could negatively impact patient care, or suggestions for modifications that would balance safety with access, submit written comments to the Texas Medical Board during this window.
As of the publication of this post, a public hearing will be held at a later date.
What happens in Texas rarely stays in Texas - as the second-most populous state establishes comprehensive ketamine therapy regulations, other state medical boards are watching closely and may follow suit.
Why This Matters for All of Us in the Industry
Even if you're not in Texas, you should be paying close attention. Here's why:
Texas as a Bellwether State
Texas is the second-most populous state and has one of the largest medical communities in the country. Therefore when Texas establishes regulatory frameworks, other states’ healthcare regulators are looking and could follow.
If these PKT rules take effect in Texas and appear to work, expect other state medical boards to consider similar frameworks.
The Trend Toward Formalization
Texas isn't creating these rules in a vacuum. We're seeing a broader trend toward formalizing ketamine therapy regulations, especially as we as an industry seek to legitimize this treatment for insurance coverage. Additionally,we face increased scrutiny following high-profile cases with poor outcomes.
The Texas proposal represents one vision of what comprehensive ketamine regulation looks like. Whether you agree with every provision or not, this is a direction in we're likely heading nationally.
The Professionalization of Ketamine Therapy
These proposed regulations represent a shift from ketamine therapy as an emerging, somewhat unregulated field to a more formalized medical specialty with specific standards.
This professionalization has both benefits and costs:
Benefits:
Clear standards of care
Enhanced patient safety
Greater credibility and acceptance
Protection from bad actors who undermine the field
Costs:
Higher barriers to entry
Increased operational complexity
Potential reduction in innovative care models
Risk of over-regulation stifling the field
What other unforeseen costs or benefits will occur? Time will only tell if these changes are passed. Wherever you stand on the perspective of formal regulation, ready or not the professionalization is coming. It’s not a matter of if, but rather when.
The Access to Care Tension
The Texas rules force us to confront a fundamental question that every state will eventually face: Where do we draw the line between safety requirements and access to care?
In our course, we've always recommended having a physician onsite during ketamine treatments. But we also recognize the tension this creates.
Onsite physicians make ketamine therapy more expensive to deliver. For clinics using APRNs and PAs to keep costs manageable and increase access, this could force difficult decisions:
Raise prices, leading to potentially pricing out patients who need care
Reduce treatment hours, thus limiting availability
Closure of clinic and patients seeking care elsewhere
This is the inherent tension in healthcare regulation: How do we balance patient safety with access to care?
The onsite physician requirement is a perfect example. From a pure safety standpoint, it makes sense. From an access standpoint, it creates barriers.
This isn't a debate with easy, straightforward answers. But it's a conversation we all need to be having, not just in Texas, but in every state.
Implications for Different Practice Models
These rules would favor those who have the resources to meet these requirements, such as larger clinics with physician partners who can be onsite, or well-capitalized practices that can absorb increased overhead. Hospital-based or hospital-affiliated programs would also be able to meet these requirements (note: under this proposal they are exempt from the registration as a PKT).
Small practices such as solo practitioners or small practices using APRNs/PAs, clinics in rural or under served areas with limited physician availability, or clinics that rely on telemedicine or hybrid care models would be greatly challenged.
If this becomes the national template, we could see consolidation in the ketamine therapy space, with smaller independent practices drastically changing their operations to accommodate these changes, closing or being acquired by larger organizations.
Ketamine clinic owners must assess current operational protocols against proposed Texas regulations, identifying gaps in staffing models, monitoring equipment, documentation systems, and compliance readiness.
What Should You Do Now?
Whether you're in Texas or watching from another state, here are some things to consider:
If You're in Texas:
Review your current operations against these proposed requirements. Do you have gaps, and if so, where are the gaps?
Calculate the financial impact of compliance. Can your current business model sustain an onsite physician requirement? Enhanced monitoring? Registration and renewal costs?
Start planning for compliance even though these are still proposed rules. If adopted, you'll need to be ready to implement quickly.
Connect with other Texas ketamine therapy providers to discuss concerns and potentially submit coordinated feedback to the Board.
Consider submitting public comments by February 20, 2026. Be specific about:
Provisions that could inadvertently harm patient care or access
Implementation challenges you foresee
Alternative approaches that could achieve safety goals while preserving access
If You're Outside Texas:
Use this as a planning exercise. What would compliance look like in your state if similar rules were adopted?
Strengthen your clinical protocols. Regardless of regulatory requirements, are you meeting the highest standards of care? The onsite physician requirement may not be law in your state, but is it the right thing for your patients?
Build relationships with state medical associations and regulatory bodies. When regulations do come, you want to have a seat at the table.
Final Thoughts
The Texas proposed rules represent a significant moment for ketamine therapy. Whether you view them as necessary safety measures or access-limiting overregulation, probably depends on how you currently run your practice.
Our take? The truth is somewhere in the middle.
We absolutely need standards to ensure patient safety and clinical quality. At Ketamine StartUp, we've always advocated for onsite physicians during treatments and proper monitoring. We've been concerned about unsupervised at-home use. From a pure safety standpoint, much of what Texas is proposing makes sense.
But we also are worried about unintended consequences. Will these requirements price out patients who desperately need care? Will they force quality providers out of the market? Will they create a two-tiered system where only wealthy patients in urban areas can access treatment?
These are real concerns that deserve serious consideration.
What we know for certain is this: The era of unregulated ketamine therapy is ending whether that is in a few months or a few years. The question isn't whether we'll have rules. It's what those rules will look like and whether they'll have the right balance between safety and access.
Texas is attempting the first draft of that answer. The rest of us should be paying attention.
Relevant Links:
Texas Register January 2, 2026 Volume: 51 Number: 1
Texas Medical Board Rule Changes
Comments on the proposed rules may be submitted online or via email
Frequently Asked Questions
Q: Do I need to register my ketamine clinic with the Texas Medical Board under these proposed rules?
A: If you're providing parenteral ketamine (IV, IM, or subcutaneous) for psychiatric indications like PTSD, treatment-resistant depression, or suicidal ideation, yes—you would need to register as a PKT clinic. However, exemptions apply for medical schools, hospitals (including their outpatient facilities), state-operated facilities, federal clinics, licensed hospice programs, and health organizations certified under Section 162.001 of the Act. Registration would be valid for two years and must be filed by a physician owner or medical director.
Q: Does a physician need to be physically present in my clinic during ketamine treatments?
A: Yes. Under §173.9(f) of the proposed rules, the delegating physician must be "immediately available onsite for in-person consultation and emergency management throughout the PKT administration." This means remote supervision, video monitoring, or having a physician on-call but not physically present would not meet the requirement. The physician must be in the building and immediately available during all treatments.
Q: Can I prescribe take-home parenteral ketamine to patients in Texas?
A: No. Section 173.12 explicitly states: "Any home use, prescribing, or administration of parenteral ketamine is prohibited." This would completely prohibit take-home IV, IM, or subcutaneous ketamine models. Note that these rules specifically address parenteral ketamine—oral, sublingual, and intranasal routes are not covered in this subchapter.
Q: When is the deadline to submit public comments on these proposed rules?
A: Written comments must be submitted to the Texas Medical Board by February 20, 2026 at 5:00 p.m. This is your opportunity to provide feedback on implementation feasibility, suggest modifications, or raise concerns about how these rules might impact patient care and access. A public hearing will be scheduled at a later date.
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Texas proposes mandatory ketamine clinic registration, onsite physician requirements, and home-use ban. What it means for your practice and the industry.
Texas proposes mandatory ketamine clinic registration, onsite physician requirements, and home-use ban. What it means for your practice and the industry.