TITLE 25. HEALTH SERVICES

PART 1. DEPARTMENT OF STATE HEALTH SERVICES

CHAPTER 229. FOOD AND DRUG

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 §§229.40, 229.41, 229.241 - 229.252, and 229.419 - 229.430. The amendments to §§229.40, 229.41, 229.241 - 229.252, and 229.419 - 229.430 are adopted without changes to the proposed text as published in the June 14, 2024, issue of the Texas Register (49 TexReg 4177), and therefore will not be republished.

BACKGROUND AND JUSTIFICATION

The amendments to Texas Administrative Code, Title 25, Chapter 229, Subchapters D, O, and W reflect current federal law, statute, and rule references since the rules were last adopted. The amendments revise and add definitions to clarify intent and improve compliance, update agency addresses and websites, and include clarifying language to ensure consistency in interpretation of the rules.

COMMENTS

The 31-day comment period ended July 15, 2024. During this period, DSHS did not receive any comments regarding the proposed rules.

SUBCHAPTER D. REGULATION OF COSMETICS

25 TAC §229.40, §229.41

STATUTORY AUTHORITY

The amendments are adopted under Texas Health and Safety Code §431.241 and §431.244, which provide the Executive Commissioner of HHSC with authority to adopt rules enforcing the Texas Food, Drug, and Cosmetic Act, and adopt specific rules under the Code of Federal Regulations, Title 21, as a rule under this chapter; and Texas Government Code §531.0055, and Texas Health and Safety Code §1001.075, which authorize the Executive Commissioner of HHSC to adopt rules and policies necessary for the operation and provision of health and human services by DSHS and for the administration of Texas Health and Safety Code Chapter 1001, including Chapter 431, the Texas Food, Drug, and Cosmetic Act.

The agency certifies that legal counsel has reviewed the adoption and found it to be a valid exercise of the agency's legal authority.

Filed with the Office of the Secretary of State on August 29, 2024.

TRD-202404055

Cynthia Hernandez

General Counsel

Department of State Health Services

Effective date: September 18, 2024

Proposal publication date: June 14, 2024

For further information, please call: (512) 864-6755


SUBCHAPTER O. LICENSING OF WHOLESALE DISTRIBUTORS OF NONPRESCRIPTION DRUGS--INCLUDING GOOD MANUFACTURING PRACTICES

25 TAC §§229.241 - 229.252

STATUTORY AUTHORITY

The amendments are adopted under Texas Health and Safety Code §431.241 and §431.244, which provide the Executive Commissioner of HHSC with authority to adopt rules enforcing the Texas Food, Drug, and Cosmetic Act, and adopt specific rules under the Code of Federal Regulations, Title 21, as a rule under this chapter; and Texas Government Code §531.0055, and Texas Health and Safety Code §1001.075, which authorize the Executive Commissioner of HHSC to adopt rules and policies necessary for the operation and provision of health and human services by DSHS and for the administration of Texas Health and Safety Code Chapter 1001, including Chapter 431, the Texas Food, Drug, and Cosmetic Act.

The agency certifies that legal counsel has reviewed the adoption and found it to be a valid exercise of the agency's legal authority.

Filed with the Office of the Secretary of State on August 29, 2024.

TRD-202404056

Cynthia Hernandez

General Counsel

Department of State Health Services

Effective date: September 18, 2024

Proposal publication date: June 14, 2024

For further information, please call: (512) 864-6755


SUBCHAPTER W. LICENSING OF WHOLESALE DISTRIBUTORS OF PRESCRIPTION DRUGS--INCLUDING GOOD MANUFACTURING PRACTICES

25 TAC §§229.419 - 229.430

STATUTORY AUTHORITY

The amendments are adopted under Texas Health and Safety Code §431.241 and §431.244, which provide the Executive Commissioner of HHSC with authority to adopt rules enforcing the Texas Food, Drug, and Cosmetic Act, and adopt specific rules under the Code of Federal Regulations, Title 21, as a rule under this chapter; and Texas Government Code §531.0055, and Texas Health and Safety Code §1001.075, which authorize the Executive Commissioner of HHSC to adopt rules and policies necessary for the operation and provision of health and human services by DSHS and for the administration of Texas Health and Safety Code Chapter 1001, including Chapter 431, the Texas Food, Drug, and Cosmetic Act.

The agency certifies that legal counsel has reviewed the adoption and found it to be a valid exercise of the agency's legal authority.

Filed with the Office of the Secretary of State on August 29, 2024.

TRD-202404057

Cynthia Hernandez

General Counsel

Department of State Health Services

Effective date: September 18, 2024

Proposal publication date: June 14, 2024

For further information, please call: (512) 864-6755