tx-September42026-157: 25 TAC §229.420 (Amendment) — Food and Drug

Adopted Rules Title 25 TITLE 25. HEALTH SERVICES PART 1. DEPARTMENT OF STATE HEALTH SERVICES CHAPTER 229. FOOD AND DRUG SUBCHAPTER W. LICENSING OF WHOLESALE DISTRIBUTORS OF PRESCRIPTION DRUGS--INCLUDING GOOD MANUFACTURING PRACTICES 25 TAC §229.420 The executive commissioner of the Texas Health and Human Services Commission (HHSC), on behalf of the Texas Department of State Health Services (DSHS), adopts an amendment to §229.420, concerning Medical Gases. Section 229.420 is adopted without changes to the proposed text as published in the May 29, 2026, issue of the Texas Register (51 TexReg 3677). This rule will not be republished. BACKGROUND AND JUSTIFICATION The amendment to Title 25 of the Texas Administrative Code (TAC) Chapter 229, Subchapter W, relating to Licensing of Wholesale Distributors of Prescription Drugs--Including Good Manufacturing Practices (GMP) is necessary to comply with applicable federal laws pertaining to medical gases. Specifically, the amendment aligns the minimum standards in the current rule with new Medical Gases GMP requirements under 21 Code of Federal Regulations (CFR) Part 213 and 21 CFR Part 230, which are already in effect. The amendment will adopt the new 21 CFR Part 213 and 21 CFR Part 230 in 25 TAC §229.420(a). COMMENTS The 31-day comment period ended June 29, 2026. DSHS received one comment regarding the proposed rule from University of Texas Southwestern Medical Center. A summary of the comment relating to the rule and the DSHS response follows. Comment: The commenter agrees with the adoption of federal laws pertaining to medical gases and suggests amending §229.420 to direct wholesale distributors to Food and Drug Administration (FDA)-published guidance documents on compliance with 21 CFR Part 213 and Part 230. Response: DSHS disagrees with the comment and declines to amend the rule in response to this comment. Section 229.420 adopts applicable federal statutes and regulations by reference. FDA guidance documents are not legally binding and do not establish enforceable requirements. The rule therefore does not reference FDA guidance documents. To assist regulated entities, DSHS will instead provide information regarding applicable FDA guidance on the DSHS website. STATUTORY AUTHORITY The amendment is adopted under Texas Government Code §524.0151, which provides that the executive commissioner of HHSC shall adopt rules for the operation and provision of services by the health and human services system, and Texas Health and Safety Code (HSC) §1001.075, which authorizes the executive commissioner of HHSC to adopt rules and policies for the operation and provision of health and human services by DSHS and for the administration of HSC Chapter 1001, and by HSC §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 21 CFR as a rule under Chapter 431. 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 18, 2026. TRD-202603626 Cynthia Hernandez General Counsel Department of State Health Services Effective date: September 7, 2026 Proposal publication date: May 29, 2026 For further information, please call: (512) 834-6755