28 Dec 2025

Texas Register December 26, 2025 Volume: 50 Number: 52

by | posted in: Texas Department of State Health Services, Texas Health and Human Services Commission, Texas State Board of Pharmacy, Uncategorized |

Texas Register Table of Contents

Texas State Board of Pharmacy

Proposed Rules Re:

Amending 22 TAC §291.33, to allow written information related to patient counseling to be provided electronically unless requested in a hard-copy format and remove the requirement to document the request.

CHAPTER 291. PHARMACIES
SUBCHAPTER B. COMMUNITY PHARMACY (CLASS A)
22 TAC §291.33

OVERVIEW

The Texas State Board of Pharmacy proposes amendments to §291.33, concerning Operational Standards. The amendments, if adopted, allow for written information reinforcing patient counseling to be provided electronically unless requested in a hard-copy format and remove the requirement to document the request.

Amending 22 TAC §291.104, to allow written information related to patient counseling to be provided electronically unless requested in a hard-copy format and remove the requirement to document the request.

CHAPTER 291. PHARMACIES
SUBCHAPTER F. NON-RESIDENT PHARMACY (CLASS E)
22 TAC §291.104

OVERVIEW

The Texas State Board of Pharmacy proposes amendments to §291.104, concerning Operational Standards. The amendments, if adopted, allow for written information reinforcing patient counseling to be provided electronically unless requested in a hard-copy format and remove the requirement to document the request.

Amending 22 TAC §295.8, to establish an electronic continuing education tracking system, update continuing education programs in preparation for the statutory continuing education tracking system, specify that record retention requirements apply to all required courses, and make grammatical corrections.

CHAPTER 295. PHARMACISTS
22 TAC §295.8

OVERVIEW

The Texas State Board of Pharmacy proposes amendments to §295.8, concerning Continuing Education Requirements. The amendments, if adopted, establish an electronic continuing education tracking system in accordance with Senate Bill 912, update continuing education programs in preparation for the statutory continuing education tracking system, specify that record retention requirements apply to all required courses, and make grammatical corrections.

Amending 22 TAC §297.8, to establish an electronic continuing education tracking system, update continuing education programs in preparation for the statutory continuing education tracking system, specify that record retention requirements apply to all required courses, and make grammatical corrections.

CHAPTER 297. PHARMACY TECHNICIANS AND PHARMACY TECHNICIAN TRAINEES
22 TAC §297.8

OVERVIEW

The Texas State Board of Pharmacy proposes amendments to §297.8, concerning Continuing Education Requirements. The amendments, if adopted, establish an electronic continuing education tracking system in accordance with Senate Bill 912, update continuing education programs in preparation for the statutory continuing education tracking system, specify that record retention requirements apply to all required courses, and make grammatical corrections.

Proposed Rule Reviews Re:

Reviewing Title 43, Part 10, to consider for readoption, revision, or repeal of the chapter concerning employment practices.

The Texas Department of Motor Vehicles (department) will review and consider whether to readopt, readopt with amendments, or repeal 43 Texas Administrative Code, Chapter 208, Employment Practices. This review is being conducted pursuant to Government Code, §2001.039.

The board will assess whether the reasons for initially adopting these rules continue to exist and whether the rules should be repealed, readopted, or readopted with amendments. No changes are currently proposed for Chapter 208.

Texas Department of State Health Services

Proposed Rules Re:

Amending 25 TAC §§300.100 – 300.103, to make minor editorial changes to improve clarity and consistency in formatting.

CHAPTER 300. MANUFACTURE, DISTRIBUTION, AND RETAIL SALE OF CONSUMABLE HEMP PRODUCTS
SUBCHAPTER A. GENERAL PROVISIONS
25 TAC §§300.100 – 300.103

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 §§300.100 – 300.103, 300.201 – 300.203, 300.301 – 300.303, 300.402 – 300.404, 300.501, 300.502, 300.601 – 300.606; and new §§300.204 – 300.208, 300.405 – 300.407, 300.701, and 300.702 concerning Manufacture, Distribution, and Retail Sale of Consumable Hemp Products.

BACKGROUND AND JUSTIFICATION

House Bill 1325 (86th Legislature, Regular Session) established Texas Health and Safety Code (HSC) Chapter 443 for the Manufacture, Distribution, and Sale of Consumable Hemp Products (CHPs). The rules in Title 25 Texas Administrative Code Chapter 300 implement HSC 443 and became effective on August 2, 2020.

On September 10, 2025, Governor Greg Abbott issued Executive Order GA-56 which directed the department to amend the rules to prohibit the sale of CHPs to minors by retail hemp registrants and manufacturers; to add age verification requirements; to update testing requirements; and to update record keeping requirements.

The proposal increases the initial and renewal licensing fees for consumable hemp manufacturers to $25,000 annually and increases the registration fees to $20,000 annually per location. The proposal adds a written consent requirement for Texas Alcoholic Beverage Commission (TABC) to enter the premises to conduct a physical inspection for both manufacturers and retail hemp registrants.

SECTION-BY-SECTION SUMMARY

DSHS made minor editorial changes to the rules to ensure consistency and improve overall clarity, including necessary renumbering, punctuation and grammatical edits, and changing the word “shall” to “must.”

The proposed amendment to §300.100 is a minor copy edit only.

The proposed amendment to §300.101 changes existing definitions of “approved hemp source,” “cannabidiol (CBD),” “Certificate of Analysis (COA),” “consumable hemp product,” “consumable hemp products license,” “delta-9 tetrahydrocannabinol,” “distributor,” “manufacturer,” “measurement of uncertainty,” “non-consumable hemp processor,” “registrant,” “tetrahydrocannabinol (THC),” and “smoking.” The proposed amendment adds new definitions for “batch date,” “batch ID number,” “cannabis,” “decarboxylation,” “hemp-derived cannabinoid product,” “marihuana,” “minor,” “private labeling,” “supplier,” “tetrahydrocannabinol acid (THCA),” “total THC,” and “total Delta-9 THC,” and removes the definition for “lot number.”

The proposed amendment to §300.102 adds Chapter 229, Subchapter O to the list of applicable regulations.

The proposed amendment to §300.103 consists primarily of editorial changes and clarifies citations to 21 United States Code.

Amending 25 TAC §§300.201 – 300.208, to add new requirements related to consumable hemp product license applicants’ licensing, record keeping, recall procedures, and general documentation, evaluation, and investigation procedures.

CHAPTER 300. MANUFACTURE, DISTRIBUTION, AND RETAIL SALE OF CONSUMABLE HEMP PRODUCTS
SUBCHAPTER B. MANUFACTURE, PROCESSING, AND DISTRIBUTION OF CONSUMABLE HEMP PRODUCTS
25 TAC §§300.201 – 300.208

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 §§300.100 – 300.103, 300.201 – 300.203, 300.301 – 300.303, 300.402 – 300.404, 300.501, 300.502, 300.601 – 300.606; and new §§300.204 – 300.208, 300.405 – 300.407, 300.701, and 300.702 concerning Manufacture, Distribution, and Retail Sale of Consumable Hemp Products.

BACKGROUND AND JUSTIFICATION

House Bill 1325 (86th Legislature, Regular Session) established Texas Health and Safety Code (HSC) Chapter 443 for the Manufacture, Distribution, and Sale of Consumable Hemp Products (CHPs). The rules in Title 25 Texas Administrative Code Chapter 300 implement HSC 443 and became effective on August 2, 2020.

On September 10, 2025, Governor Greg Abbott issued Executive Order GA-56 which directed the department to amend the rules to prohibit the sale of CHPs to minors by retail hemp registrants and manufacturers; to add age verification requirements; to update testing requirements; and to update record keeping requirements.

The proposal increases the initial and renewal licensing fees for consumable hemp manufacturers to $25,000 annually and increases the registration fees to $20,000 annually per location. The proposal adds a written consent requirement for Texas Alcoholic Beverage Commission (TABC) to enter the premises to conduct a physical inspection for both manufacturers and retail hemp registrants.

SECTION-BY-SECTION SUMMARY

The proposed amendment to §300.201 adds Texas Alcoholic Beverage Commission to the list of agencies a consumable hemp product (CHP) license applicant must consent to allow entry and clarifies the requirements for “business name.”

The proposed amendment to §300.202 clarifies what constitutes a valid license and updates license fees and terms.

The proposed amendment to §300.203 adds new subsections (d) and (e) to specify what and how records must be maintained and replaces “§519 or §520(g)” with “§360(i) or §360(j)” to reference the correct federal code.

Proposed new §300.204 contains specific requirements for master production records to promote uniformity across production batches.

Proposed new §300.205 contains specific requirements for individual batch production records.

Proposed new §300.206 contains specific source and traceability requirements for raw materials and ingredients.

Proposed new §300.207 contains requirements for conducting product recalls, including maintaining a written recall plan.

Proposed new §300.208 contains requirements for the documentation, evaluation, and investigation of consumer complaints by CHP licensees.

Amending 25 TAC §§300.301 – 300.303, to clarify testing requirements for certain hemp products and clarify language regarding acceptable delta-9 THC limits.

CHAPTER 300. MANUFACTURE, DISTRIBUTION, AND RETAIL SALE OF CONSUMABLE HEMP PRODUCTS
SUBCHAPTER C. TESTING OF CONSUMABLE HEMP PRODUCTS
25 TAC §§300.301 – 300.303

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 §§300.100 – 300.103, 300.201 – 300.203, 300.301 – 300.303, 300.402 – 300.404, 300.501, 300.502, 300.601 – 300.606; and new §§300.204 – 300.208, 300.405 – 300.407, 300.701, and 300.702 concerning Manufacture, Distribution, and Retail Sale of Consumable Hemp Products.

BACKGROUND AND JUSTIFICATION

House Bill 1325 (86th Legislature, Regular Session) established Texas Health and Safety Code (HSC) Chapter 443 for the Manufacture, Distribution, and Sale of Consumable Hemp Products (CHPs). The rules in Title 25 Texas Administrative Code Chapter 300 implement HSC 443 and became effective on August 2, 2020.

On September 10, 2025, Governor Greg Abbott issued Executive Order GA-56 which directed the department to amend the rules to prohibit the sale of CHPs to minors by retail hemp registrants and manufacturers; to add age verification requirements; to update testing requirements; and to update record keeping requirements.

The proposal increases the initial and renewal licensing fees for consumable hemp manufacturers to $25,000 annually and increases the registration fees to $20,000 annually per location. The proposal adds a written consent requirement for Texas Alcoholic Beverage Commission (TABC) to enter the premises to conduct a physical inspection for both manufacturers and retail hemp registrants.

SECTION-BY-SECTION SUMMARY

The proposed amendment to §300.301 clarifies testing requirements for raw hemp, hemp-derived ingredients, and CHP and adds new subsections (b) and (d) – (f) which outlines requirements for certificates of analysis (COAs).

The proposed amendment to §300.302 clarifies the language regarding acceptable delta-9 THC limits and business’ responsibility for providing samples to DSHS at the businesses’ own expense, and changes the title of the rule from Sample Analysis of Consumable Hemp and Certain Cannabinoid Oils to Sample Analysis of Consumable Hemp Products.

The proposed amendment to §300.303 clarifies that manufacturers must also meet the testing requirements of §300.301. The proposal repeals subsection (f) regarding DSHS acceptance of sample results from other accredited laboratories, subsection (h) regarding DSHS notification of license holders with sample results within 14 days, and subsection (k) regarding exemptions to testing requirements. The proposed amendment also clarifies the department’s responsibility to provide an updated list of analytes and upper limits.

Amending 25 TAC §§300.402 – 300.407, to clarify label and packaging requirements as well as make other minor edits to language.

CHAPTER 300. MANUFACTURE, DISTRIBUTION, AND RETAIL SALE OF CONSUMABLE HEMP PRODUCTS
SUBCHAPTER D. RETAIL SALE OF CONSUMABLE HEMP PRODUCTS
25 TAC §§300.402 – 300.407

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 §§300.100 – 300.103, 300.201 – 300.203, 300.301 – 300.303, 300.402 – 300.404, 300.501, 300.502, 300.601 – 300.606; and new §§300.204 – 300.208, 300.405 – 300.407, 300.701, and 300.702 concerning Manufacture, Distribution, and Retail Sale of Consumable Hemp Products.

BACKGROUND AND JUSTIFICATION

House Bill 1325 (86th Legislature, Regular Session) established Texas Health and Safety Code (HSC) Chapter 443 for the Manufacture, Distribution, and Sale of Consumable Hemp Products (CHPs). The rules in Title 25 Texas Administrative Code Chapter 300 implement HSC 443 and became effective on August 2, 2020.

On September 10, 2025, Governor Greg Abbott issued Executive Order GA-56 which directed the department to amend the rules to prohibit the sale of CHPs to minors by retail hemp registrants and manufacturers; to add age verification requirements; to update testing requirements; and to update record keeping requirements.

The proposal increases the initial and renewal licensing fees for consumable hemp manufacturers to $25,000 annually and increases the registration fees to $20,000 annually per location. The proposal adds a written consent requirement for Texas Alcoholic Beverage Commission (TABC) to enter the premises to conduct a physical inspection for both manufacturers and retail hemp registrants.

SECTION-BY-SECTION SUMMARY

The proposed amendment to §300.402 clarifies label requirements; adds new subsection (b) regarding warning statements on labels; and repeals subsection (c) regarding placement and QR code requirements.

The proposed amendment to §300.403 is a minor edit only replacing “this state” with “Texas,” and “registrant” with “person.”

The proposed amendment to §300.404 adds language to prohibit the transport of ingredients containing THC above 0.3% into Texas for further processing.

Proposed new §300.405 adds requirements for packaging that is tamper-evident, child-resistant, and non-attractive to children.

Proposed new §300.406 adds language regarding handling of packaging and labeling materials, including keeping written procedures and documentation.

Proposed new §300.407 adds language to prohibit labels that mislead consumers to believe products do not contain hemp-derived cannabinoids or are intended for medical use.

Amending 25 TAC §300.501, §300.502, to remove language that restricts the prohibition to products “containing CBD” and add language outlining license application requirements.

CHAPTER 300. MANUFACTURE, DISTRIBUTION, AND RETAIL SALE OF CONSUMABLE HEMP PRODUCTS
SUBCHAPTER E. REGISTRATION FOR RETAILERS OF CONSUMABLE HEMP PRODUCTS
25 TAC §300.501, §300.502

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 §§300.100 – 300.103, 300.201 – 300.203, 300.301 – 300.303, 300.402 – 300.404, 300.501, 300.502, 300.601 – 300.606; and new §§300.204 – 300.208, 300.405 – 300.407, 300.701, and 300.702 concerning Manufacture, Distribution, and Retail Sale of Consumable Hemp Products.

BACKGROUND AND JUSTIFICATION

House Bill 1325 (86th Legislature, Regular Session) established Texas Health and Safety Code (HSC) Chapter 443 for the Manufacture, Distribution, and Sale of Consumable Hemp Products (CHPs). The rules in Title 25 Texas Administrative Code Chapter 300 implement HSC 443 and became effective on August 2, 2020.

On September 10, 2025, Governor Greg Abbott issued Executive Order GA-56 which directed the department to amend the rules to prohibit the sale of CHPs to minors by retail hemp registrants and manufacturers; to add age verification requirements; to update testing requirements; and to update record keeping requirements.

The proposal increases the initial and renewal licensing fees for consumable hemp manufacturers to $25,000 annually and increases the registration fees to $20,000 annually per location. The proposal adds a written consent requirement for Texas Alcoholic Beverage Commission (TABC) to enter the premises to conduct a physical inspection for both manufacturers and retail hemp registrants.

SECTION-BY-SECTION SUMMARY

The proposed amendment to §300.501 removes language that restricts the prohibition to products “containing CBD.”

The proposed amendment to §300.502 adds language requiring the business or property owner to provide written consent for entry by DSHS, Texas Alcoholic Beverage Commission (TABC), or law enforcement when applying for a license. The amendment also increases fees. Additionally, the amendment specifies that an expired registration is no longer valid and repeals subsection (f) regarding the collection of Texas.gov fees.

Amending 25 TAC §§300.601 – 300.606, to clarify violation counts when calculating administrative penalties, remove certain requirements related to the destruction of THC products above the acceptable hemp TCH level, remove a good and sufficient bond for correction of adulterated or mislabeled products, and make several minor edits.

CHAPTER 300. MANUFACTURE, DISTRIBUTION, AND RETAIL SALE OF CONSUMABLE HEMP PRODUCTS
SUBCHAPTER F. ENFORCEMENT
25 TAC §§300.601 – 300.606

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 §§300.100 – 300.103, 300.201 – 300.203, 300.301 – 300.303, 300.402 – 300.404, 300.501, 300.502, 300.601 – 300.606; and new §§300.204 – 300.208, 300.405 – 300.407, 300.701, and 300.702 concerning Manufacture, Distribution, and Retail Sale of Consumable Hemp Products.

BACKGROUND AND JUSTIFICATION

House Bill 1325 (86th Legislature, Regular Session) established Texas Health and Safety Code (HSC) Chapter 443 for the Manufacture, Distribution, and Sale of Consumable Hemp Products (CHPs). The rules in Title 25 Texas Administrative Code Chapter 300 implement HSC 443 and became effective on August 2, 2020.

On September 10, 2025, Governor Greg Abbott issued Executive Order GA-56 which directed the department to amend the rules to prohibit the sale of CHPs to minors by retail hemp registrants and manufacturers; to add age verification requirements; to update testing requirements; and to update record keeping requirements.

The proposal increases the initial and renewal licensing fees for consumable hemp manufacturers to $25,000 annually and increases the registration fees to $20,000 annually per location. The proposal adds a written consent requirement for Texas Alcoholic Beverage Commission (TABC) to enter the premises to conduct a physical inspection for both manufacturers and retail hemp registrants.

SECTION-BY-SECTION SUMMARY

The proposed amendment to §300.601 clarifies each violation counts individually when calculating an administrative penalty.

The proposed amendment to §300.602 adds new language to classify the following prohibited acts: refusal of inspection, sample collection, photography, copy of records, and aggressive or threatening behavior.

The proposed amendment to §300.603 is a minor clarifying edit only.

The proposed amendment to §300.604 removes the requirement for a reverse distributor to destroy THC products above the acceptable hemp THC level and instead specifies referral to law enforcement.

The proposed amendment to §300.605 removes a good and sufficient bond for correction of adulterated or mislabeled products and a minor edit.

The proposed amendment to §300.606 is editorial in nature only.

Amending 25 TAC §300.701, §300.702, to prohibit the sale of CHPs to minors and define grounds for revocation in the event of the sale of CHPs to a minor.

CHAPTER 300. MANUFACTURE, DISTRIBUTION, AND RETAIL SALE OF CONSUMABLE HEMP PRODUCTS
SUBCHAPTER G. RESTRICTIONS ON SALE TO MINORS
25 TAC §300.701, §300.702

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 §§300.100 – 300.103, 300.201 – 300.203, 300.301 – 300.303, 300.402 – 300.404, 300.501, 300.502, 300.601 – 300.606; and new §§300.204 – 300.208, 300.405 – 300.407, 300.701, and 300.702 concerning Manufacture, Distribution, and Retail Sale of Consumable Hemp Products.

BACKGROUND AND JUSTIFICATION

House Bill 1325 (86th Legislature, Regular Session) established Texas Health and Safety Code (HSC) Chapter 443 for the Manufacture, Distribution, and Sale of Consumable Hemp Products (CHPs). The rules in Title 25 Texas Administrative Code Chapter 300 implement HSC 443 and became effective on August 2, 2020.

On September 10, 2025, Governor Greg Abbott issued Executive Order GA-56 which directed the department to amend the rules to prohibit the sale of CHPs to minors by retail hemp registrants and manufacturers; to add age verification requirements; to update testing requirements; and to update record keeping requirements.

The proposal increases the initial and renewal licensing fees for consumable hemp manufacturers to $25,000 annually and increases the registration fees to $20,000 annually per location. The proposal adds a written consent requirement for Texas Alcoholic Beverage Commission (TABC) to enter the premises to conduct a physical inspection for both manufacturers and retail hemp registrants.

SECTION-BY-SECTION SUMMARY

Proposed new §300.701 prohibits the sale of CHPs to minors and requires valid identification as proof of age for purchase.

Proposed new §300.702 establishes sale of CHPs to minors as grounds for the revocation of a CHP license or retail hemp registration.

Texas Health and Human Services Commission

Adopted Rules Re:

Adopting 1 TAC §354.1291, to expand Medicaid reimbursement for physical therapy (PT) services provided to a Medicaid recipient.

CHAPTER 354. MEDICAID HEALTH SERVICES
SUBCHAPTER A. PURCHASED HEALTH SERVICES
DIVISION 20. PHYSICAL THERAPY SERVICES
1 TAC §354.1291

OVERVIEW

The executive commissioner of the Texas Health and Human Services Commission (HHSC) adopts an amendment to §354.1291, concerning Benefits and Limitations.

Section 354.1291 is adopted with changes to the proposed text as published in the July 4, 2025, issue of the Texas Register (50 TexReg 3845). The rule will be republished.

BACKGROUND AND JUSTIFICATION

The purpose of the amendment is to expand Medicaid reimbursement for physical therapy (PT) services provided to a Medicaid recipient. The rule currently provides that PT services must be prescribed by a physician to be reimbursed by Medicaid. This amendment permits Medicaid reimbursement for PT services that are prescribed by a licensed physician assistant (PA) or an advanced practice registered nurse (APRN) licensed as a certified nurse practitioner (CNP) or a clinical nurse specialist (CNS), as authorized by their professional licensure and state law. This amendment aligns with the rules governing physical therapy as a home health benefit in Texas Administrative Code Title 1, §354.1031(b)(1)(B) and §354.1039(a)(5)(C).