Texas Register Table of Contents
- 1 Texas State Board of Pharmacy
- 2 Texas Department of State Health Services
- 3 Texas Council for Developmental Disabilities
- 4 Texas Health and Human Services Commission
- 4.0.1 Adopted Rules Re:
- 4.0.1.1 Adopting 26 TAC §511.2, to define the term “facility.”
- 4.0.1.2 Adopting 26 TAC §511.12, to correct a reference related to the qualified rural hospital definition.
- 4.0.1.3 Adopting 26 TAC §511.79, to define the requirements for the workplace violence prevention plan and membership requirements for an advisory committee.
- 4.0.2 Adopted Rule Reviews Re:
- 4.0.1 Adopted Rules Re:
Texas State Board of Pharmacy
Proposed Rules Re:
Amending 22 TAC §291.133, to update pharmacy compounding sterile preparation procedures.
CHAPTER 291. PHARMACIES
SUBCHAPTER G. SERVICES PROVIDED BY PHARMACIES
22 TAC §291.133
OVERVIEW
The Texas State Board of Pharmacy proposes amendments to §291.133, concerning Pharmacies Compounding Sterile Preparations. The amendments, if adopted, update the personnel, environment, compounding process, cleaning and disinfecting, beyond-use dating, cleansing and garbing, environmental testing, sterility testing, recall procedure, and recordkeeping requirements for pharmacies compounding sterile preparations.
Texas Department of State Health Services
Proposed Rules Re:
Amending 25 TAC §§229.432 – 22.437, 22.439 – 22.443, to replace language and update wording for improved consistency.
CHAPTER 229. FOOD AND DRUG
SUBCHAPTER X. LICENSING OF DEVICE DISTRIBUTORS AND MANUFACTURERS
25 TAC §§229.432 – 22.437, 22.439 – 22.443
OVERVIEW
The executive commissioner of the Texas Health and Human Services Commission (HHSC), on behalf of the Department of State Health Services (DSHS), proposes amendments to §§229.432 – 229.437, 229.439 – 229.443, concerning Licensing of Device Distributors and Manufacturers, and the repeal of §229.444, concerning Device Distributors and Manufacturers Advisory Committee.
BACKGROUND AND JUSTIFICATION
The purpose of the proposal is to continue adherence with applicable federal laws pertaining to medical devices. The proposed amendments align the minimum standards in the Texas Administrative Code with new device Good Manufacturing Practice requirements under 21 Code of Federal Regulations (CFR) Part 820, which take effect on February 2, 2026. The proposal repeals §229.444 because the advisory committee no longer exists. The proposed amendment to §229.443 adds language relating to enforcement and penalties. The proposed amendments update the licensure fees based on a licensee’s gross sales. The proposed amendments update definitions to clarify intent and improve compliance by harmonizing state and federal regulations. Lastly, the proposed amendments update the rules with plain language requirements to improve readability.
SECTION-BY-SECTION SUMMARY
The proposed amendment to §229.432 replaces wording for consistency throughout this section. The proposed amendment updates the link to the DSHS website. The proposed amendment updates a federal reference.
The proposed amendment to §229.433 adds definitions to comply with CFR updates and replaces wording for consistency throughout this section. The proposed amendment provides deleted, revised, and new definitions. The proposed amendment adds clarity to the rule language and ensures consistency in interpretation of the rule. The proposed amendment updates federal reference citations.
The proposed amendment to §229.434 provides revised language to add clarity to the rule language.
The proposed amendment to §229.435 updates wording for clarity and updates DSHS contact information.
The proposed amendment to §229.436 updates the link to the DSHS website and replaces wording for consistency throughout this section.
The proposed amendment to §229.437 replaces wording for consistency throughout this section and adds clarity to rule language.
The proposed amendment to §229.439 replaces wording for consistency throughout this section and adds clarity to rule language. The proposed amendments update the licensure fees based on a licensee’s gross sales. The proposed amendment updates the link to the DSHS website.
The proposed amendment to §229.440 replaces wording for consistency throughout this section.
The proposed amendment to §229.441 replaces wording for consistency throughout this section and adds clarity to rule language. The proposed amendment updates federal and state citations throughout this section. The proposed amendment expands on definitions to add clarity to rule interpretation. The proposed amendment corrects grammatical errors.
The proposed amendment to §229.442 replaces wording for consistency throughout this section.
The proposed amendment to §229.443 adds new language on general enforcement actions and penalties, and replaces wording for consistency throughout this section.
Amending 25 TAC §229.444, to repeal the section because the advisory committee no longer exists.
CHAPTER 229. FOOD AND DRUG
SUBCHAPTER X. LICENSING OF DEVICE DISTRIBUTORS AND MANUFACTURERS
25 TAC §229.444
OVERVIEW
The executive commissioner of the Texas Health and Human Services Commission (HHSC), on behalf of the Department of State Health Services (DSHS), proposes amendments to §§229.432 – 229.437, 229.439 – 229.443, concerning Licensing of Device Distributors and Manufacturers, and the repeal of §229.444, concerning Device Distributors and Manufacturers Advisory Committee.
BACKGROUND AND JUSTIFICATION
The purpose of the proposal is to continue adherence with applicable federal laws pertaining to medical devices. The proposed amendments align the minimum standards in the Texas Administrative Code with new device Good Manufacturing Practice requirements under 21 Code of Federal Regulations (CFR) Part 820, which take effect on February 2, 2026. The proposal repeals §229.444 because the advisory committee no longer exists. The proposed amendment to §229.443 adds language relating to enforcement and penalties. The proposed amendments update the licensure fees based on a licensee’s gross sales. The proposed amendments update definitions to clarify intent and improve compliance by harmonizing state and federal regulations. Lastly, the proposed amendments update the rules with plain language requirements to improve readability.
SECTION-BY-SECTION SUMMARY
The proposed repeal of §229.444 is required because the advisory committee no longer exists.
Adopted Rules Re:
Adopting 25 TAC §97.62, §97.64, to provide greater access to affidavits for individuals claiming an exclusion from required immunizations and expand exclusions from compliance for students in institutions of higher education based on religious beliefs, reasons of conscience, and an active duty status with the United States armed forces.
CHAPTER 97. COMMUNICABLE DISEASES
SUBCHAPTER B. IMMUNIZATION REQUIREMENTS IN TEXAS ELEMENTARY AND SECONDARY SCHOOLS AND INSTITUTIONS OF HIGHER EDUCATION
25 TAC §97.62, §97.64
OVERVIEW
The executive commissioner of the Texas Health and Human Services Commission (HHSC), on behalf of the Department of State Health Services (DSHS), adopts amendments to §97.62, concerning Exclusions from Compliance and §97.64, concerning Required Vaccinations and Exclusions for Students Enrolled in Health-related and Veterinary Courses in Institutions of Higher Education.
Section 97.62 is adopted with changes to the proposed text as published in the August 15, 2025, issue of the Texas Register (50 TexReg 5300). This rule will be republished.
Section 97.64 is adopted without changes to the proposed text as published in the August 15, 2025, issue of the Texas Register (50 TexReg 5300). This rule will not be republished.
BACKGROUND AND JUSTIFICATION
The amendments are necessary to comply with Texas Health and Safety Code §161.0041, as amended by House Bill (HB) 1586, 89th Legislature, Regular Session, which requires the department to develop a blank affidavit form to be used by a person claiming an exemption from a required immunization and make the affidavit form available on the DSHS website. DSHS has posted a blank affidavit form on the website for a person to download and submit to their child-care facility, school, or institution of higher education, including students enrolled in health-related and veterinary courses.
The amendments allow individuals to print these documents themselves (or request that DSHS send them a blank affidavit, which does not need to be printed on the security sealed paper).
To comply with HB 1586 implementation guidelines beginning with the 2025-2026 school year, a proposal was published in the July 4, 2025, issue of the Texas Register (50 TexReg 3854). DSHS withdrew that rule proposal to ensure the language from HB 1586 and related statutes were properly reflected in the Texas Administrative Code. The notice stating the withdrawal was published in the July 25, 2025, issue of the Texas Register (50 TexReg 4411). A revised proposal was published in the August 15, 2025, issue of the Texas Register (50 TexReg 5300). DSHS now adopts these amendments.
Adopted Rule Reviews Re:
Adopting Title 25, Part 1, concerning occupational diseases.
The Texas Health and Human Services Commission (HHSC), in its own capacity and on behalf of the Texas Department of State Health Services (DSHS), adopts the review of the chapter below in Title 25, Part 1, of the Texas Administrative Code (TAC):
Chapter 99, Occupational Diseases
Texas Council for Developmental Disabilities
Proposed Rules Re:
Amending 40 TAC §877.1, §877.2, to clarify and revise language for greater consistency.
CHAPTER 877. GRANT AWARDS
40 TAC §877.1, §877.2
OVERVIEW
The Texas Council for Developmental Disabilities (TCDD) proposes amendments to §877.1 concerning General and §877.2 concerning Application and Review Process.
The purpose of the amendments to §877.1 is to clarify language regarding that number of allowable grants from an organization and to §877.2 is to apply consistent language to all sections regarding the Council Request for Applications process.
Proposed Rule Reviews Re:
Reviewing Title 40, Part 21, to consider for readoption, revision, or repeal of the chapter concerning general provisions and grant awards.
In accordance with Texas Government Code §2001.039, the Texas Council for Developmental Disabilities (TCDD) submits notice of its intention to review its rules. These rules appear under Texas Administrative Code Title 40, Part 21. TCDD will consider, among other things, whether the reasons for readoption of these rules continue to exist and following the assessment will readopt, readopt with amendments, or repeal the rules. Comments will be accepted from any interested persons or groups.
Chapter 876. General Provisions
Chapter 877. Grant Awards
Texas Health and Human Services Commission
Adopted Rules Re:
Adopting 26 TAC §511.2, to define the term “facility.”
CHAPTER 511. LIMITED SERVICES RURAL HOSPITALS
SUBCHAPTER A. GENERAL PROVISIONS
26 TAC §511.2
OVERVIEW
The executive commissioner of the Texas Health and Human Services Commission (HHSC) adopts amendments to §511.2, concerning Definitions, and §511.12, concerning Application and Issuance of Initial License; and new §511.79, concerning Workplace Violence Prevention.
Amended §511.2 and §511.12, and new §511.79, are adopted without changes to the proposed text as published in the June 6, 2025, issue of the Texas Register (50 TexReg 3416). These rules will not be republished.
BACKGROUND AND JUSTIFICATION
The new section is necessary to implement Senate Bill (SB) 240, 88th Legislature, Regular Session, 2023. SB 240 added new Texas Health and Safety Code (THSC) Chapter 331 which requires certain facilities, including limited services rural hospitals, to establish a workplace violence prevention committee or authorize an existing facility committee to develop the workplace violence prevention plan. THSC Chapter 331 also requires facilities to adopt, implement, and enforce a written workplace violence prevention policy and plan and to respond to workplace violence incidents.
The new section requires limited services rural hospitals to establish a workplace violence prevention committee or authorize an existing facility committee to develop the workplace violence prevention plan. The new section specifies the required membership for a committee. The new section requires a hospital to adopt, implement, and enforce a written workplace violence prevention policy and plan to protect health care providers and employees from violent behavior and threats of violent behavior occurring at the hospital. The new section requires the committee to annually evaluate the written workplace violence prevention plan and report the results of the evaluation to the hospital’s governing body. The new section requires each hospital to make a copy of the hospital’s workplace violence prevention plan available to each hospital health care provider or employee while providing protection from the release of information in the plan that would pose a security threat if made public.
The new section establishes minimum requirements for a hospital to respond to workplace violence incidents and creates protections for individuals with respect to reporting incidents of workplace violence.
The amended sections are necessary to add a definition of the term “facility” to the chapter and to correct a cross reference for the qualified rural hospital definition.
CHAPTER 511. LIMITED SERVICES RURAL HOSPITALS
SUBCHAPTER B. LICENSING REQUIREMENTS
26 TAC §511.12
OVERVIEW
The executive commissioner of the Texas Health and Human Services Commission (HHSC) adopts amendments to §511.2, concerning Definitions, and §511.12, concerning Application and Issuance of Initial License; and new §511.79, concerning Workplace Violence Prevention.
Amended §511.2 and §511.12, and new §511.79, are adopted without changes to the proposed text as published in the June 6, 2025, issue of the Texas Register (50 TexReg 3416). These rules will not be republished.
BACKGROUND AND JUSTIFICATION
The new section is necessary to implement Senate Bill (SB) 240, 88th Legislature, Regular Session, 2023. SB 240 added new Texas Health and Safety Code (THSC) Chapter 331 which requires certain facilities, including limited services rural hospitals, to establish a workplace violence prevention committee or authorize an existing facility committee to develop the workplace violence prevention plan. THSC Chapter 331 also requires facilities to adopt, implement, and enforce a written workplace violence prevention policy and plan and to respond to workplace violence incidents.
The new section requires limited services rural hospitals to establish a workplace violence prevention committee or authorize an existing facility committee to develop the workplace violence prevention plan. The new section specifies the required membership for a committee. The new section requires a hospital to adopt, implement, and enforce a written workplace violence prevention policy and plan to protect health care providers and employees from violent behavior and threats of violent behavior occurring at the hospital. The new section requires the committee to annually evaluate the written workplace violence prevention plan and report the results of the evaluation to the hospital’s governing body. The new section requires each hospital to make a copy of the hospital’s workplace violence prevention plan available to each hospital health care provider or employee while providing protection from the release of information in the plan that would pose a security threat if made public.
The new section establishes minimum requirements for a hospital to respond to workplace violence incidents and creates protections for individuals with respect to reporting incidents of workplace violence.
The amended sections are necessary to add a definition of the term “facility” to the chapter and to correct a cross reference for the qualified rural hospital definition.
Adopting 26 TAC §511.79, to define the requirements for the workplace violence prevention plan and membership requirements for an advisory committee.
CHAPTER 511. LIMITED SERVICES RURAL HOSPITALS
SUBCHAPTER C. OPERATIONAL REQUIREMENTS
26 TAC §511.79
OVERVIEW
The executive commissioner of the Texas Health and Human Services Commission (HHSC) adopts amendments to §511.2, concerning Definitions, and §511.12, concerning Application and Issuance of Initial License; and new §511.79, concerning Workplace Violence Prevention.
Amended §511.2 and §511.12, and new §511.79, are adopted without changes to the proposed text as published in the June 6, 2025, issue of the Texas Register (50 TexReg 3416). These rules will not be republished.
BACKGROUND AND JUSTIFICATION
The new section is necessary to implement Senate Bill (SB) 240, 88th Legislature, Regular Session, 2023. SB 240 added new Texas Health and Safety Code (THSC) Chapter 331 which requires certain facilities, including limited services rural hospitals, to establish a workplace violence prevention committee or authorize an existing facility committee to develop the workplace violence prevention plan. THSC Chapter 331 also requires facilities to adopt, implement, and enforce a written workplace violence prevention policy and plan and to respond to workplace violence incidents.
The new section requires limited services rural hospitals to establish a workplace violence prevention committee or authorize an existing facility committee to develop the workplace violence prevention plan. The new section specifies the required membership for a committee. The new section requires a hospital to adopt, implement, and enforce a written workplace violence prevention policy and plan to protect health care providers and employees from violent behavior and threats of violent behavior occurring at the hospital. The new section requires the committee to annually evaluate the written workplace violence prevention plan and report the results of the evaluation to the hospital’s governing body. The new section requires each hospital to make a copy of the hospital’s workplace violence prevention plan available to each hospital health care provider or employee while providing protection from the release of information in the plan that would pose a security threat if made public.
The new section establishes minimum requirements for a hospital to respond to workplace violence incidents and creates protections for individuals with respect to reporting incidents of workplace violence.
The amended sections are necessary to add a definition of the term “facility” to the chapter and to correct a cross reference for the qualified rural hospital definition.
Adopted Rule Reviews Re:
Reviewing Title 26, Part 1, to consider for readoption, revision, or repeal of the chapter concerning client care of individuals receiving services at state supported living centers.
The Texas Health and Human Services Commission (HHSC) adopts the review of the chapter below in Title 26, Part 1, of the Texas Administrative Code (TAC):
Chapter 967, Client Care of Individuals Receiving Services at State Supported Living Centers