TITLE 22. EXAMINING BOARDS
PART 9. TEXAS MEDICAL BOARD
CHAPTER 173. OFFICE-BASED ANESTHESIA SERVICES
SUBCHAPTER
B.
The Texas Medical Board (Board) proposes new rule concerning Chapter 173, Office-Based Anesthesia Services, Subchapter B, concerning Parenteral Ketamine Therapy, §§173.6 - 173.18.
The proposed new sections are as follows:
New §173.6, Definitions, sets forth definitions for ketamine administration and psychotropic ketamine therapy (PKT).
New §173.7, Exception for Licensed Hospice Provider, provides an exception to the application of the rules under the subchapter for patients enrolled in a hospice program licensed by Texas Health and Human Services.
New §173.8, Mandatory Registration, requires registration for practice settings providing psychotropic ketamine therapy and provides exceptions to registration for certain practice settings.
New §173.9, Operation of PKT Clinics, sets forth requirements for operation of clinics providing PKT and limits the administration of psychotropic ketamine therapy to physicians and midlevel providers. The new section further specifies training, certification, patient monitoring, emergency management and consultation and delegation requirements for the provision of psychotropic ketamine therapy. The new section provides that delegating physicians are limited to delegating to no more than six delegates total or delegates at no more than three PKT clinics, whichever is less.
New §173.10, Physician Requirements, sets forth requirements for physicians ordering PKT for psychiatric indications. The requirements include education and training, delegation, Prescription Monitoring Program verifications, maintenance of ASA guidelines for moderate sedation, and pregnancy verification for women of child-bearing age.
New §173.11, Minimum Standards When Administering PKT, sets forth minimum standards related to medical record documentation, patient evaluation, diagnosis, informed consent, time out procedures, continuous monitoring; and equipment standards when providing psychotropic ketamine therapy.
New §173.12, Monitoring Requirements During PKT Administration, sets forth additional requirements for administering or delegating physicians to ensure adequate monitoring during PKT administration, until complete.
New §173.13, Monitoring Requirements After the Completion of PKT Administration, sets forth monitoring requirements for patients upon completion of PKT administration and prior to discharge.
New §173.14, Minimum Equipment Requirements, sets forth on-site equipment requirements for continuous monitoring and in cases of emergency.
New §173.15, Prohibited PKT Administration, provides that the following prohibitions on parenteral PKT apply: the administration of PKT outside of a registered clinic or an exempt setting set forth under Section 173.8 and the prescribing of PKT for home use.
New §173.16, Complaints and Investigations, clarifies that the medical director and physician owner(s) are responsible for the clinic's operations and regulatory compliance.
New §173.17, Renewal of PKT Clinic Registration, sets forth a registration term of two years and registration renewal requirements.
New §173.18, Audits, Inspections, and Investigations, mandates that psychotropic ketamine therapy clinics be subject to audits, inspections and investigations as outlined in Chapter 172 of the Board rules related to pain management clinics.
Mr. Scott Freshour, General Counsel for the Texas Medical Board, has determined that, for each year of the first five years the proposed new rules are in effect, the public benefit anticipated as a result of enforcing these proposed new rules will be to enhance the safety of the public health and welfare through the establishment of minimum standards for the provision of psychotropic ketamine therapy.
Mr. Freshour has also determined that for the first five-year period these proposed new rules are in effect, there will be no fiscal impact or effect on government growth as a result of enforcing the proposed sections.
Mr. Freshour has also determined that for the first five-year period these proposed new sections are in effect there may be a minimal economic cost to individuals required to comply with these proposed sections. Those economic costs will vary and may include the following: 1) new education and training requirements for ketamine clinic providers and staff; 2) possible increased staffing to meet requirements for the evaluation of patients and administering and monitoring of patients receiving PKT; and 3) costs related to purchasing equipment required for monitoring patients receiving PKT treatment. The expenditures described above will be one-time expenditures and may not apply if an individual subject to these rules already meets the requirements.
Pursuant to Texas Government Code §2006.002, the agency provides the following economic impact statement for these proposed new sections and determined that for each year of the first five years these proposed new sections will be in effect there will be no effect on small businesses, micro businesses, or rural communities. The agency has considered alternative methods of achieving the purpose of these proposed new sections and found none.
Pursuant to Texas Government Code §2001.024(a)(4), Mr. Freshour certifies that this proposal has been reviewed, and the agency has determined that for each year of the first five years these proposed new sections are in effect:
(1) TMB is unable to determine how many clinics exist at this time; however, the initial registration function can likely be absorbed with existing resources. The subsequent enforcement, if any, is variable based on the number of complaints received. TMB also has inspection authority which will be conducted with existing resources in a manner similar to the existing office-based anesthesia inspections. There is no additional estimated cost to the state or to local governments expected as a result of enforcing or administering these proposed new sections; the jurisdiction is exclusive to the Texas Medical Board.
(2) there are no estimated reductions in costs to the state or to local governments as a result of enforcing or administering these proposed new sections;
(3) there is no estimated loss and no increase in revenue to the state or to local governments as a result of enforcing or administering these proposed new sections; and
(4) there are no foreseeable implications relating to cost or revenues of the state or local governments with regard to enforcing or administering these proposed new sections.
Pursuant to Texas Government Code §2001.024(a)(6) and §2001.022, the agency has determined that for each year of the first five years these proposed amendments will be in effect, there will be no effect on local economy and local employment.
Pursuant to Government Code §2001.0221, the agency provides the following Government Growth Impact Statement for these proposed new sections. For each year of the first five years these proposed new sections will be in effect, Mr. Freshour has determined the following:
(1) the proposed rules do not create or eliminate a government program;
(2) implementation of the proposed rules does not require the creation of new employee positions or the elimination of existing employee positions;
(3) implementation of the proposed rules does not require an increase or decrease in future legislative appropriations to the agency;
(4) the proposed rules do not require an increase in fees paid to the agency;
(5) the proposed rules do create a new regulation;
(6) the proposed rules do not expand, limit, or repeal an existing regulation;
(7) the proposed rules do increase the number of individuals subject to the rule's applicability; and
(8) the proposed rules do not positively or adversely affect this state's economy.
Comments on the proposal may be submitted using this link https://forms.cloud.microsoft/g/WrgW5yPyKm or e-mail comments to: rules.development@tmb.state.tx.us. A public hearing will be held at a later date.
The proposed new rule(s) are proposed pursuant to Texas Occupations Code Section 153.001.
No other statutes, articles or codes are affected by this proposal.
§173.6.
The following words and terms when used in this chapter shall have the following meanings, unless the context clearly indicates otherwise.
(1) Ketamine Administration--The administration of parenteral ketamine (IV, subcutaneous and IM) is the practice of medicine under Section 157.002 of the Act and is subject to regulation by the Texas Medical Board, including required registration under this Chapter.
(2) Psychotropic Ketamine Therapy (PKT)--The administration of parenteral ketamine in a low-dose for psychiatric indications that have been evaluated and diagnosed by a physician such as PTSD, treatment-resistant depression and suicidal ideation.
§173.7.
The rules promulgated under this Subchapter do not apply to hospice programs licensed by the Texas Health and Human Services Commission with regard to the administration of ketamine to patients enrolled in such hospice programs.
§173.8.
(a) Any medical practice, clinic or facility providing PKT must be registered with the Board, except the following:
(1) a medical school or an outpatient clinic associated with a medical school;
(2) a hospital, including any outpatient facility or clinic of a hospital;
(3) a facility maintained or operated by this state;
(4) a medical clinic maintained or operated by the United States; or
(5) a health organization certified by the board under Section 162.001 of the Act.
(b) Registration requires completion of a board-approved application filed by a physician owner or medical director of the clinic including providing all required information and documentation.
(c) Applications are valid for 180 days from the date of submission. If the applicant fails to provide all required information and documentation the application will be deemed withdrawn.
(d) If the application is approved, the registration is good for two years from the date of approval.
§173.9.
(a) The provision of PKT must comply with all applicable federal and state laws.
(b) The physician prescribing PKT for psychiatric indications must have successfully completed within the past two years a formal airway management education or must have completed a course on airway management for moderate sedation and:
(1) training in mental health treatment; or
(2) a course on the use of ketamine for psychiatric conditions.
(c) The physician ordering the PKT must have a properly established physician-patient relationship and have properly documented and diagnosed psychiatric indications supporting PKT.
(d) PKT may be administered only by a physician, certified registered nurse anesthetist (CRNA), advanced practice registered nurse (APRN), or physician assistant (PA) acting under appropriate delegation by a licensed physician for psychiatric indication as identified in the definition of PKT.
(e) If the patient is simultaneously receiving ketamine treatment for any other medical condition, such as pain, then the physician must follow whichever standards or requirements are stricter, such as rules governing standards for office-based anesthesia, relating to Subchapter A of this Chapter.
(f) A CRNA, APRN, or PA working under physician delegation to administer PKT, or a CRNA, APRN, PA, or registered nurse (RN) working under physician delegation to monitor a patient during and after administration of PKT must have successfully completed within the past two years a formal airway management education or must have completed a course on airway management for moderate sedation.
(g) There must be a physician, CRNA, APRN, PA, or RN present as required in §173.11 of this Subchapter (relating to Minimum Standards When Administering PKT) and §173.12 of this Subchapter (relating to Monitoring Requirements During PKT Administration).
(h) In cases requiring consultation, the physician owner, medical director, or delegating physician must be immediately available throughout the PKT administration as follows:
(1) in-person on-site; or
(2) by two-way audiovisual technology.
(i) In cases requiring emergency management, if the physician owner, medical director, or delegating physician is not in-person on-site, then the physician owner, medical director, or delegating physician must have the ability to be on-site within 30 minutes by ground transportation.
(j) Any location administering PKT must keep and maintain an adverse event reporting log, organized by year. Each log must be maintained for a period of at least three years. The log must list any event involving airway intervention, EMS transport, hospitalization, or death. The log must include the following information:
(1) patient name;
(2) date of adverse event;
(3) type of adverse event; and
(4) outcome, if known.
(k) A physician owner, medical director, or delegating physician must physically inspect each clinic site once every 30 days.
(l) A medical director shall:
(1) be limited to registering and acting as medical director for a maximum of three PKT clinics; and
(2) meet the requirements of the prescribing physician under subsection (b) of this section.
(m) The physician owner or medical director may designate one or more delegating physicians who must be the physician ordering the PKT. Any delegating physician shall:
(1) be limited to delegating to no more than six delegates total or delegates at no more than three PKT clinics, whichever is less; and
(2) meet the requirements of the prescribing physician under subsection (b) of this section.
§173.10.
(a) The physician ordering PKT for psychiatric indications must have successfully completed:
(1) training in mental health treatment; or
(2) a course on the use of ketamine for psychiatric conditions.
(b) The physician ordering PKT must have a properly established physician-patient relationship and have properly documented and diagnosed psychiatric indications supporting PKT.
(c) The physician ordering PKT must ensure that the patient evaluation, the administration of PKT, and the monitoring of the patient meets the latest moderate sedation guidelines as published by the American Society of Anesthesiologists, depending on the intended level of anxiolysis or sedation to be achieved.
(d) The following physicians shall be considered equally responsible for meeting the American Society of Anesthesiologists moderate sedation guidelines, depending on the intended level of anxiolysis or sedation to be achieved, for all patients being treated with PKT regardless if the patient was treated by a physician, CRNA, APRN, or PA:
(1) the physician owner;
(2) the medical director; and
(3) the delegating physician.
(e) For women of childbearing age, a negative urine pregnancy test must be administered at the clinic on the day of treatment and documented in the records, unless it is documented in the medical record that such patient is medically unable to become pregnant.
(f) The physician ordering PKT must review the Prescription Monitoring Program when establishing a physician-patient relationship, and on at least a quarterly basis for existing patients.
(g) If the physician ordering PKT delegates the administration of PKT, the physician ordering PKT must have protocols or standing delegation orders issued and maintained at the location where the PKT is being administered.
(h) When providing or delegating PKT services, physicians must ensure compliance with delegation and supervision laws under Chapter 157 of the Act and Chapter 169 of this title (relating to Delegation).
§173.11.
(a) The following minimum standards must be met when PKT is administered:
(1) the PKT order from the delegating physician must be verified, if applicable;
(2) the physician is responsible for ensuring the standard of care is met;
(3) informed consent must be provided to the patient, including:
(A) a discussion of known risks of PKT; and
(B) the identity and licensure credentials of the person administering PKT;
(4) a time out period must be implemented immediately prior to beginning administration of PKT; and
(5) complete, contemporaneous, and legible medical records regarding patient monitoring and status must be maintained throughout the administration of PKT.
(b) Patient monitoring and status must include continuous appropriate physiologic monitoring of the patient, both during PKT administration and post administration until ready for discharge.
(c) Continuous monitoring for administration and discharge must include the following:
(1) blood pressure;
(2) pulse;
(3) respiration;
(4) oxygen saturation;
(5) cardiovascular status; and
(6) appropriate responsiveness to verbal stimuli.
(d) The administration of PKT is limited to a qualified physician, CRNA, APRN, or PA.
(e) If a physician is present on-site during the administration of PKT, then:
(1) the physician is limited to administering PKT to no more than four patients at a time; and
(2) if the physician is delegating the administration of PKT, then the physician has the discretion to allow each delegate to administer PKT to no more than four patients at a time.
(f) If a physician is not present on-site during the administration of PKT, then the delegating physician's delegate may not administer PKT to more than two patients at a time.
(g) If the administering physician or delegate is administering PKT to more than one patient simultaneously, then the administering physician or delegate cannot also be the sole person monitoring the patient during PKT administration.
(h) The administration of PKT is complete:
(1) Upon completion of the IV drip; or
(2) 40 minutes after the completion of the IM or subcutaneous injection.
§173.12.
(a) In addition to the general monitoring requirements set forth in §173.11 of this Subchapter (relating to Minimum Standards When Administering PKT), the administering or delegating physician must ensure there is monitoring of each patient until the PKT administration is complete as follows:
(1) If the delegating physician is on-site, then the delegating physician has the discretion to allow no more than four patients to be monitored by a single monitoring physician, CRNA, APRN, PA or RN; or
(2) If the delegating physician is not on-site, then no more than one patient may be monitored by a single monitoring CRNA, APRN, PA or RN.
(b) The monitoring of PKT administration is limited to a qualified physician, CRNA, APRN, PA, or RN.
§173.13.
(a) Upon completion of the PKT administration, each patient must meet the following recovery and monitoring requirements prior to discharge:
(1) A minimum 30-minute observation period;
(2) at least two blood pressure readings 10 minutes apart; and
(3) a full cognitive assessment (including an Aldrete score).
(b) The recovery, monitoring, and discharge assessment of patients shall have a maximum ratio of one monitoring delegate to every four patients.
§173.14.
(a) The following equipment must be utilized for continuous cardiorespiratory monitoring of the patient during and after administration of PKT:
(1) pulse oximetry; and
(2) incremental blood pressure checks.
(b) The following items must be on-site at all times and readily available, in case of an emergency:
(1) Supplemental oxygen,
(2) a bag-valve mask,
(3) an AED (or defibrillator) and
(4) an end-tidal carbon dioxide analyzer.
§173.15.
The following prohibitions on parenteral PKT apply:
(1) the administration of PKT outside of a registered clinic or an exempt setting set forth under §173.8 of this Subchapter (relating to Mandatory Registration); and
(2) the prescribing of PKT for home use.
§173.16.
The physician owner and medical director are responsible for the clinic's operations and patient care and ensuring compliance with all applicable regulations.
§173.17.
(a) Registration is effective for two years following the date of initial registration. At least 60 days prior to the expiration of the PKT registration, a physician, clinic or facility seeking renewal must submit:
(1) a board-approved application; and
(2) an attestation stating that the requirements, standards and equipment comply with all applicable laws and board rules.
(b) Upon expiration of the current registration, the clinic must cease PKT operations until the registration is renewed.
§173.18.
PKT clinics are subject to audits, inspections and investigations as outlined in Chapter 172 of the Board rules related to pain management clinics.
The agency certifies that legal counsel has reviewed the proposal and found it to be within the state agency's legal authority to adopt.
Filed with the Office of the Secretary of State on May 1, 2026.
TRD-202601866
Scott Freshour
General Counsel
Texas Medical Board
Earliest possible date of adoption: June 14, 2026
For further information, please call: (512) 305-7059
PART 10. TEXAS FUNERAL SERVICE COMMISSION
CHAPTER 203. LICENSING AND ENFORCEMENT--SPECIFIC SUBSTANTIVE RULES
SUBCHAPTER
C.
The Texas Funeral Service Commission (Commission) proposes new §203.36 of Title 22, Part 10, Chapter 203 of the Texas Administrative Code (TAC), to be titled Inspection of Solid Waste Disposal and Sanitation Facilities. The proposed new rule establishes procedures, as required by Texas Occupations Code §651.158(b), for the inspection of a funeral establishment's solid waste disposal and sanitation facilities when those facilities have not been inspected by the Texas Department of State Health Services (DSHS).
EXPLANATION OF AND JUSTIFICATION FOR THE RULE
The proposed rule under 22 TAC, Chapter 203, implements Texas Occupations Code §651.158, Inspection of Certain Facilities.
Section 651.158(a) authorizes the Commission to require a funeral establishment that has solid waste disposal and sanitation facilities that have not been inspected by the Texas Department of Health to be inspected by Commission inspectors. (The Texas Department of Health was abolished and its functions transferred to DSHS under House Bill 2292, 78th Legislature, Regular Session, 2003, effective September 1, 2004; references in §651.158 to the Texas Department of Health should be read as references to DSHS.) Section 651.158(b) requires the Commission, by rule, to establish procedures for any inspection required under that section. This rule satisfies that statutory directive.
Specifically, proposed new §203.36 authorizes a funeral establishment whose solid waste disposal and sanitation facilities have not been inspected by DSHS to be inspected for compliance with the standards specified by DSHS by Commission inspectors.
The proposed rule does not establish new substantive sanitation standards; rather, it creates a procedural pathway for demonstrating compliance with existing DSHS-equivalent standards in circumstances in which DSHS has not itself performed an inspection. The proposed rule preserves the Commission's authority to require additional or independent inspection under §651.158 or other applicable law.
FISCAL IMPACT ON STATE AND LOCAL GOVERNMENT
The Interim Executive Director of the Commission has determined that, for each year of the first five years the proposed rule is in effect, there are no foreseeable increases or reductions in costs to state government resulting from enforcement or administration of the proposed rule.
LOCAL EMPLOYMENT IMPACT STATEMENT
The proposed rule will not affect a local economy. Therefore, the Commission is not required to prepare a local employment impact statement under §2001.022, Texas Government Code.
PUBLIC BENEFIT & PROBABLE ECONOMIC COSTS TO PERSONS REQUIRED TO COMPLY WITH PROPOSAL
The Interim Executive Director has also determined that, for each year of the first five-year period the proposed rule is in effect, the public benefit will be: (1) clarification of the procedural pathway by which a funeral establishment whose solid waste disposal and sanitation facilities have not been inspected by DSHS may demonstrate compliance with applicable solid waste disposal and sanitation requirements; (2) protection of public health through verified sanitation compliance at funeral establishments; and (3) reduction of regulatory uncertainty for licensed funeral establishments.
The rule does not require any funeral establishment to expend funds for equipment, technology, staff, supplies, or infrastructure, unless it is not in compliance with DSHS Standards and does not impose any new fee payable to the Commission.
FISCAL IMPACT ON SMALL BUSINESSES, MICRO-BUSINESSES, AND RURAL COMMUNITIES
The proposed rule has no anticipated adverse economic effect on small businesses, micro- businesses, or rural communities that is distinct from the effect on any other funeral establishment. Therefore, an economic impact statement under Texas Government Code §2006.002 is not required.
REQUIREMENT FOR RULES WITH A FISCAL IMPACT
The proposed rule is necessary to protect the health, safety, and welfare of residents in Texas and is required to implement a legislative enactment. Therefore, the Commission is not required to provide a statement under Texas Government Code §2001.0045. Even if such a statement were required, the proposed rule does not impose a cost on regulated persons, another state agency, a special district, or a local government that exceeds the benefits of the rule. As a result, the Commission is not required to take any further action under §2001.0045.
TAKINGS IMPACT ASSESSMENT
The proposal does not impose a burden on private real property and, therefore, does not constitute a taking under Texas Government Code §2007.043.
GOVERNMENT GROWTH IMPACT STATEMENT
Pursuant to Texas Government Code §2001.0221, the Commission provides the following Government Growth Impact Statement for the proposed rule. For each year of the first five years the proposed rule will be in effect, the agency has determined the following:
1) The proposed rule does not create or eliminate a government program.
2) Implementation of the proposed rule would not require the creation of new employee positions or the elimination of existing employee positions.
3) Implementation of the proposed rule would not require an increase or decrease in future legislative appropriations to the Commission.
4) The proposed rule does not require an increase or decrease in fees paid to the Commission.
5) The proposed rule creates a new regulation. As described above, the proposed rule is required by Texas Occupations Code §651.158(b), which directs the Commission to establish, by rule, procedures for an inspection required under §651.158. The new regulation is created to comply with that statutory mandate.
6) The proposed rule does not expand, limit, or repeal an existing regulation.
7) The proposed rule does not increase or decrease the number of individuals subject to the rule's applicability; the rule applies to the same class of licensed funeral establishments already subject to §651.158.
8) The proposed rule neither positively nor adversely affects this state's economy.
PUBLIC COMMENTS
Comments on the proposed rule may be submitted to Maria Haynes, Interim Executive Director, by e-mail to legal@tfsc.texas.gov or by mail to Texas Funeral Service Commission, Attn: Maria Haynes, 1801 Congress Avenue, Suite 11-800, Austin, Texas 78701. The deadline for comments is 30 days after publication in the Texas Register.
STATUTORY AUTHORITY
The proposed rule is proposed under Texas Occupations Code §651.152, which authorizes the Commission to adopt rules necessary to administer and enforce Chapter 651 of the Occupations Code.
The proposed rule is also proposed pursuant to the authority set out in Texas Occupations Code §651.158(b), which requires the Commission, by rule, to establish procedures for an inspection of a funeral establishment's solid waste disposal and sanitation facilities required under §651.158(a) when those facilities have not been inspected by the Texas Department of Health (now the Texas Department of State Health Services).
Cross Reference. The new section implements Texas Occupations Code §651.158.
§203.36.
(a) Applicability. This section applies to a funeral establishment licensed or seeking licensure under Texas Occupations Code Chapter 651 whose solid waste disposal and sanitation facilities have not been inspected by the Texas Department of State Health Services (DSHS). As used in this section, references in Texas Occupations Code §651.158 to the Texas Department of Health are construed as references to DSHS, which has succeeded to the relevant functions of that agency.
(b) Authorization of Local Health Department Inspection. A funeral establishment described in subsection (a) of this section may satisfy any inspection requirement imposed by the Commission under Texas Occupations Code §651.158(a) by obtaining an inspection of its solid waste disposal and sanitation facilities from the municipal or county health department with jurisdiction over the physical location of the funeral establishment.
(c) Inspection Standards. A Commission inspector or local health department performing an inspection under this section shall apply the same sanitation and solid waste standards that DSHS applies, or would apply, to an inspection of a comparable funeral establishment facility, including any applicable standards adopted by DSHS under Health and Safety Code Chapters 341 and 343 and rules promulgated thereunder, currently specified at 25 Texas Administrative Code §1.136.
(d) Frequency. Unless the Commission requires inspection on a more frequent basis, a funeral establishment subject to this section shall obtain:
(1) an inspection under this section prior to the issuance of the establishment's initial license, if the facilities have not been inspected by DSHS; and
(2) a subsequent inspection under this section at least once every three years following the date of the most recent inspection, if DSHS has not performed an inspection during that period.
(e) Reservation of Commission Authority. Nothing in this section limits the authority of the Commission to:
(1) require additional inspection of a funeral establishment's solid waste disposal and sanitation facilities under Texas Occupations Code §651.158(a) or any other provision of law;
(2) accept a DSHS inspection in lieu of an inspection conducted under this section; or
(3) take disciplinary or enforcement action against a funeral establishment for any violation of Texas Occupations Code Chapter 651 or Commission rules.
The agency certifies that legal counsel has reviewed the proposal and found it to be within the state agency's legal authority to adopt.
Filed with the Office of the Secretary of State on May 4, 2026.
TRD-202601884
Maria Haynes
Interim Executive Director
Texas Funeral Service Commission
Earliest possible date of adoption: June 14, 2026
For further information, please call: (512) 936-3474
CHAPTER 206. ANATOMICAL FACILITIES, NON-TRANSPLANT ANATOMICAL DONATION ORGANIZATIONS, AND WILLED BODY PROGRAMS
22 TAC §206.9The Texas Funeral Service Commission (Commission) proposes a new rule to Texas Administrative Code (TAC), Title 22, Part 10, Chapter 206, Anatomical Facilities, Non-Transplant Anatomical Donation Organizations, and Willed Body Programs, §206.9, regarding the implementation of a donor acknowledgement form to be used by an adult of sound mind in Texas who is donating his or her body by will or other instrument to willed body programs and non-transplant anatomical donation organizations to be used for the advancement of medical or forensic science.
EXPLANATION OF AND JUSTIFICATION FOR THE RULE
The proposed rule under 22 TAC, Chapter 210, implements Texas Health and Safety Code Section 691.028, Donation of Body by Written Instrument.
The Texas Legislature amended Texas Health and Safety Code Section 691.028 to include a donor acknowledgment form as part of the informed consent requirements in order to make effective an adult's donation of his or her whole body to a university willed body program or a non-transplant anatomical donation organization to be used for the advancement of medical or forensic science. Section 691.028(b)(2) sets forth the elements that must be in the donor acknowledgment, and Section 691.028(b-1) requires the Commission, by rule, to design and adopt a form that complies with Section 691.028(b) that willed body programs and non-transplant anatomical donation organizations must use. This rule satisfies this statutory directive.
Specifically, proposed new §206.9 adopts the Commission prescribed Donor Acknowledgement Form that must be used by willed body programs and NADOs in order to use the decedent donor's body or body parts for the advancement of medical or forensic science if the decedent donated his or her body in a willed or written instrument. The proposed new rule further requires the elements that the donor acknowledgement form must include that are applicable to the particular willed body program and non-transplant anatomical donation organization.
Advisory Committee
State Anatomical Advisory Committee and stakeholder meetings were held on December 20, 2023 and January 17, 2024, to discuss the rules regarding the donor acknowledgment form and to implement Texas Health and Safety Code §§691.028(b)(2) and (b-1) requirements. An additional stakeholder meeting was held on April 28, 2026. Suggestions and comments made during those meetings are incorporated into the proposed rule.
FISCAL IMPACT ON STATE AND LOCAL GOVERNMENT
Maria Haynes, Interim Executive Director, has determined that for each year of the first five years the proposed rules are in effect, there are no estimated reductions in costs to state or local governments resulting from the enforcement or administration of the proposed rule. There are no foreseeable implications relating to the loss or increase of revenues to the state or local governments by enforcing or administering the proposed rule.
LOCAL EMPLOYMENT IMPACT STATEMENT
The proposed rule will not affect the local economy. Therefore, the Commission is not required to prepare a local employment impact statement under §2001.22, Texas Government Code.
PUBLIC BENEFIT & PROBABLE ECONOMIC COSTS TO PERSONS REQUIRED TO COMPLY WITH PROPOSAL
Maria Haynes also determined that for each year of the first five-year period the proposed rule is in effect, the public benefit includes greater transparency to individuals who are potentially interested in donating their whole body for the advancement of medical or forensic science to a willed body program or non-transplant anatomical donation organization regarding how their whole body donation could be used, possible consequences of the whole body donation, and the final disposition of the individual's whole body donation after the willed body program or non-transplant donation organization is finished using the body for the advancement of medical or forensic science. This allows the individual to make an informed decision about his or her donation.
Another public benefit is that the proposed rule provides clarity to willed body programs and non-transplant anatomical donation organizations of the specific form that is required under Texas Health and Safety Code §§691.028(b)(2) and (b-1) to be provided to adults of sound mind who are donating their whole bodies for the advancement of medical or forensic science in a will or other written instrument.
The proposed rule has no significant economic costs to persons that are authorized or registered by the Commission under Texas Health and Safety Code Chapter 691, businesses, or the general public in Texas. The rule does not impose additional fees upon registered or authorized persons by the Commission. The requirements created by the proposed rule would not cause licensees to expend funds for equipment, technology, staff, supplies, or infrastructure. There may be costs associated with printing the donor acknowledgement form to provide to the potential adult donor, but such costs would be de minimis.
FISCAL IMPACT ON SMALL BUSINESSES, MICRO-BUSINESSES, AND RURAL COMMUNITIES
The proposed rule has no anticipated adverse economic effect on small businesses, micro-businesses, or rural communities. Therefore, an economic impact statement is not required.
REQUIREMENT FOR RULES WITH A FISCAL IMPACT
The proposed rule is necessary to protect the health, safety, and welfare of residents in Texas, and, therefore, the Commission is not required to provide a statement under Texas Government Code §2001.45. Even if it was, the proposed rule does not have a fiscal note that imposes a cost on authorized or registered persons, including another state agency, a special district, or a local government. As a result, the Commission is not required to take any further action under §2001.45.
TAKINGS IMPACT ASSESSMENT
The proposal does not impose a burden on private real property and, therefore, does not constitute a taking under Texas Government Code §2007.43.
Government Growth impact Statement
Pursuant to Government Code §2001.221, the Commission provides the following Government Growth Impact Statement for the proposed rule. For each year of the first five years the proposed rule will be in effect, the agency has determined the following:
1) The proposed rule does not create or eliminate a government program.
2) Implementation of the proposed rule would not require the creation of new employee positions or the elimination of existing employee positions.
3) Implementation of the proposed rule would not require an increase or decrease in future legislative appropriations to the Commission.
4) The proposed rule does not require an increase or decrease in fees paid to the Commission.
5) The proposed rule creates a new regulation. As described previously, the proposed rule are required by Texas Health and Safety Code §691.028, which directs the Commission to "by rule . . . design and adopt a form" that complies with §§691.028(b) and (b-1) that "willed body programs and non-transplant anatomical donation organizations must use." The new regulation is created to comply with statutory mandate.
6) The proposed rule does not expand, limit, or repeal an existing regulation.
7) The proposed rule increases the number of individuals subject to the rule's applicability. During the 88th regular legislative session, the Texas Legislature passed Senate Bill 2040 (SB 2040), which abolished the Anatomical Board of the State of Texas, and transferred its duties, responsibilities, and jurisdiction to the Texas Funeral Service Code. Part of SB 2040 included amending Texas Health and Safety Code §691.028 to include new subsections (b)(2) and (b-1).
These subsections required a donor acknowledgement form must be provided to and signed by the adult donor acknowledging that he or she was informed about: 1) the consequences of the donation before providing consent that the donor's body would be used by the willed body program or non-transplant anatomical donation organization for the advancement of medical or forensic science; 2) the use the donee willed body program or non-transplant anatomical donation organization has for the donee's donated body parts; and 3) if applicable, any body part and the condition in which it will be returned to the person designated by the donor. The new statutory requirements went into effect on September 1, 2023.
When the new statute went into effect, it expanded the applicability of the number of individuals and entities subject to it and subsequently expanded the number of individuals and entities subject to the proposed rules which implement the new statute.
8) The proposed rule neither positively or adversely affects this state's economy.
PUBLIC COMMENTS
Comments on the proposed rules may be submitted to Maria Haynes, Interim Executive Director, by e-mail to legal@tfsc.texas.gov or by mail to Texas Funeral Service Commission, Attn: Maria Haynes, 1801 Congress Avenue, Suite 11-800, Austin, Texas 78701. The deadline for comments is 30 days after publication in the Texas Register.
STATUTORY AUTHORITY
The proposed rule is proposed under Texas Health and Safety Code §691.022(c), which authorizes the Texas Funeral Service Commission to adopt rules, establish procedures, and prescribe forms necessary to administer and enforce Texas Health and Safety Code Chapter 691.
The proposed rule is also proposed pursuant to the authority set out in Texas Health and Safety Code §691.028(b-1) which mandates the Commission "by rule" to "design and adopt a form" that complies with the statutory requirements in Texas Health and Safety Code §691.028(b)(2) and (b-1) regarding the donor acknowledgment form content and design that willed body programs and non-transplant anatomical donation organizations must use before an adult donor may give informed consent for his or her whole body donation to be used for the advancement of medical or forensic science under Texas Health and Safety Code §691.028.
Cross Reference. The new section implements Texas Health and Safety Code, §691.028(b)(2) and (b-1), as amended by Senate Bill 2040, 88th Texas Legislature, Regular Session, 2023.
§206.9.
(a) Pursuant to Texas Health and Safety Code §691.028(b), in order for an adult's donation of his or her whole body to be effective, the adult must be provided with, and execute, a Donor Acknowledgement Form by the willed body program or non-transplant anatomical donation organization seeking the donation.
(b) The Donor Acknowledgement Form published following this section is the form adopted by the Commission to comply with Texas Health and Safety Code §691.028(b).
(c) The Donor Acknowledgment Form must reflect the specific consequences of the whole body donation, uses of the donated whole body or body parts, and, if applicable, what body parts will be returned to the donor's family or designee and the conditions that apply to the particular willed body program or non-transplant anatomical donation organization seeking the whole body donation from the donor.
Figure: 22 TAC §206.9(c) (.pdf)
The agency certifies that legal counsel has reviewed the proposal and found it to be within the state agency's legal authority to adopt.
Filed with the Office of the Secretary of State on May 4, 2026.
TRD-202601883
Maria Haynes
Interim Executive Director
Texas Funeral Service Commission
Earliest possible date of adoption: June 14, 2026
For further information, please call: (512) 936-2474