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

The executive commissioner of the Texas Health and Human Services Commission (HHSC), on behalf of the Texas Department of State Health Services (DSHS), proposes an amendment to §229.420, concerning Medical Gases.

BACKGROUND AND PURPOSE

The proposed 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 required to continue adherence with applicable federal laws pertaining to medical gases. Specifically, the proposed 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 proposed amendment will adopt the new 21 CFR Part 213 and 21 CFR Part 230 in 25 TAC §229.420(a).

SECTION-BY-SECTION SUMMARY

The proposed amendment to §229.420 updates federal reference citations and updates numbering for consistency throughout this section.

FISCAL NOTE

Christy Havel Burton, Chief Financial Officer, has determined that for each year of the first five years that the rule will be in effect, enforcing or administering the rule does not have foreseeable implications relating to costs or revenues of state or local governments.

GOVERNMENT GROWTH IMPACT STATEMENT

DSHS has determined that during the first five years that the rule will be in effect:

(1) the proposed rule will not create or eliminate a government program;

(2) implementation of the proposed rule will not affect the number of DSHS employee positions;

(3) implementation of the proposed rule will result in no assumed change in future legislative appropriations;

(4) the proposed rule will not affect fees paid to DSHS;

(5) the proposed rule will not create a new regulation;

(6) the proposed rule will not expand, limit, or repeal existing regulations;

(7) the proposed rule will not change the number of individuals subject to the rule; and

(8) the proposed rule will not affect the state's economy.

SMALL BUSINESS, MICRO-BUSINESS, AND RURAL COMMUNITY IMPACT ANALYSIS

Christy Havel Burton has also determined that there will be no adverse economic effect on small businesses, micro-businesses, or rural communities because the rule does not impose any additional costs on small businesses, micro-businesses, or rural communities that are required to comply with the rule.

LOCAL EMPLOYMENT IMPACT

The proposed rule will not affect a local economy.

COSTS TO REGULATED PERSONS

Texas Government Code §2001.0045 does not apply to this rule because the rule is necessary to protect the health, safety, and welfare of the residents of Texas, does not impose a cost on regulated persons, and is necessary to receive a source of federal funds or comply with federal law.

PUBLIC BENEFIT AND COSTS

Timothy Stevenson, Deputy Commissioner, Consumer Protection Division, has determined that for each year of the first five years the rule is in effect, the public benefit will include improved rule clarity and greater compliance with updated Good Manufacturing Practices, which help ensure that medical gases produced in the state are safe and effective for their intended use.

Christy Havel Burton has also determined that for the first five years the rule is in effect, there are no anticipated economic costs to persons who are required to comply with the proposed rule because the amendment is adopting federal regulations that will not have additional costs.

TAKINGS IMPACT ASSESSMENT

DSHS has determined that the proposal does not restrict or limit an owner's right to the owner's property that would otherwise exist in the absence of government action and, therefore, does not constitute a taking under Texas Government Code §2007.043.

PUBLIC COMMENT

Written comments on the proposal, including information related to the cost, benefit, or effect of the proposed rule, as well as any applicable data, research, or analysis, may be submitted to Rules Coordination Office, P.O. Box 13247, Mail Code 4102, Austin, Texas 78711-3247, or street address 4601 West Guadalupe Street, Austin, Texas 78751; or emailed to HHSRulesCoordinationOffice@hhs.texas.gov.

To be considered, comments must be submitted no later than 31 days after the date of this issue of the Texas Register. Comments must be (1) postmarked or shipped before the last day of the comment period; (2) hand-delivered before 5:00 p.m. on the last working day of the comment period; or (3) emailed before midnight on the last day of the comment period. If the last day to submit comments falls on a holiday, comments must be postmarked, shipped, or emailed before midnight on the following business day to be accepted. When emailing comments, please indicate "Comments on Proposed Rule 26R054" in the subject line.

STATUTORY AUTHORITY

The amendment is authorized by Texas Government Code §524.0151 and Texas Health and Safety Code (HSC) §1001.075, which authorize the executive commissioner of HHSC to adopt rules for the operation and provision of health and human services by DSHS and for the administration of Texas Health and Safety Code Chapter 1001, and by 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 chapter 431.

The amendment affects Texas Government Code §524.0151 and HSC Chapters 1001 and 431.

§229.420. Applicable Laws and Regulations.

(a) The department adopts by reference the following laws and regulations:

(1) Federal Food, Drug, and Cosmetic Act, 21 United States Code (USC) §301 et seq., as amended;

(2) 9 Code of Federal Regulations (CFR) Part 113, Standard Requirements, as amended;

(3) 21 CFR Part 70, Color Additives, as amended;

(4) 21 CFR Part 71, Color Additive Petitions, as amended;

(5) 21 CFR Part 73, Listing of Color Additives Exempt From Certification, as amended;

(6) 21 CFR Part 74, Listing of Color Additives Subject to Certification, as amended;

(7) 21 CFR Part 80, Color Additive Certification, as amended;

(8) 21 CFR Part 81, General Specifications and General Restrictions for Provisional Color Additives for Use in Foods, Drugs, and Cosmetics, as amended;

(9) 21 CFR Part 82, Listing of Certified Provisionally Listed Colors and Specifications, as amended;

(10) 21 CFR Part 200, General, as amended;

(11) 21 CFR Part 201, Labeling, as amended;

(12) 21 CFR Part 202, Prescription Drug Advertising, as amended;

(13) 21 CFR Part 203, Prescription Drug Marketing, as amended;

(14) 21 CFR Part 205, Guidelines for State Licensing of Wholesale Prescription Drug Distributors, as amended;

(15) 21 CFR Part 206, Imprinting of Solid Oral Dosage Form Drug Products for Human Use, as amended;

(16) 21 CFR Part 207, Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs That Are Regulated Under a Biologics License Application, and Animal Drugs, and the National Drug Code, as amended;

(17) 21 CFR Part 210, Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding of Drugs; General, as amended;

(18) 21 CFR Part 211, Current Good Manufacturing Practice for Finished Pharmaceuticals, as amended;

(19) 21 CFR Part 212, Current Good Manufacturing Practice for Positron Emission Tomography Drugs, as amended;

(21) [(20)] 21 CFR Part 216, Human Drug Compounding, as amended;

(22) [(21)] 21 CFR Part 225, Current Good Manufacturing Practice for Medicated Feeds, as amended;

(23) [(22)] 21 CFR Part 226, Current Good Manufacturing Practice for Type A Medicated Articles, as amended;

(25) [(23)] 21 CFR Part 250, Special Requirements For Specific Human Drugs, as amended;

(26) [(24)] 21 CFR Part 251, §804, Importation Program, as amended;

(27) [(25)] 21 CFR Part 290, Controlled Drugs, as amended;

(28) [(26)] 21 CFR Part 299, Drugs; Official Names and Established Names, as amended;

(29) [(27)] 21 CFR Part 300, General, as amended;

(30) [(28)] 21 CFR Part 310, New Drugs, as amended;

(31) [(29)] 21 CFR Part 312, Investigational New Drug Application, as amended;

(32) [(30)] 21 CFR Part 314, Applications for FDA Approval to Market a New Drug, as amended;

(33) [(31)] 21 CFR Part 315, Diagnostic Radiopharmaceuticals, as amended;

(34) [(32)] 21 CFR Part 316, Orphan Drugs, as amended;

(35) [(33)] 21 CFR Part 320, Bioavailability and Bioequivalence Requirements, as amended;

(36) [(34)] 21 CFR Part 361, Prescription Drugs for Human Use Generally Recognized as Safe and Effective and Not Misbranded: Drugs Used in Research, as amended;

(37) [(35)] 21 CFR Part 500, General, as amended;

(38) [(36)] 21 CFR Part 510, New Animal Drugs, as amended;

(39) [(37)] 21 CFR Part 511, New Animal Drugs for Investigational Use, as amended;

(40) [(38)] 21 CFR Part 514, New Animal Drug Applications, as amended;

(41) [(39] 21 CFR Part 515, Medicated Feed Mill License, as amended;

(42) [(40)] 21 CFR Part 516, New Animal Drugs for Minor Use and Minor Species, as amended;

(43) [(41)] 21 CFR Part 520, Oral Dosage Form New Animal Drugs, as amended;

(44) [(42)] 21 CFR Part 522, Implantation or Injectable Dosage Form New Animal Drugs, as amended;

(45) [(43)] 21 CFR Part 524, Ophthalmic and Topical Dosage Form New Animal Drugs, as amended;

(46) [(44)] 21 CFR Part 526, Intramammary Dosage Form New Animal Drugs, as amended;

(47) [(45)] 21 CFR Part 528, Intentional Genomic Alterations in Animals [New Animal Drugs in Genetically Engineered Animals], as amended;

(48) [(46)] 21 CFR Part 529, Certain Other Dosage Form New Animal Drugs, as amended;

(49) [(47)] 21 CFR Part 530, Extralabel Drug Use in Animals, as amended;

(50) [(48)] 21 CFR Part 556, Tolerances for Residues of New Animal Drugs in Food, as amended;

(51) [(49)] 21 CFR Part 558, New Animal Drugs for Use in Animal Feeds, as amended;

(52) [(50)] 21 CFR Part 589, Substances Prohibited From Use in Animal Food or Feed, as amended;

(53) [(51)] 21 CFR Part 600, Biological Products: General, as amended;

(54) [(52)] 21 CFR Part 601, Licensing, as amended;

(55) [(53)] 21 CFR Part 610, General Biological Products Standards, as amended;

(56) [(54)] 21 CFR Part 660, Additional Standards for Diagnostic Substances for Laboratory Tests, as amended;

(57) [(55)] 21 CFR Part 680, Additional Standards for Miscellaneous Products, as amended;

(58) [(56)] 21 CFR Part 700, General, as amended;

(59) [(57)] 21 CFR Part 701, Cosmetic Labeling, as amended;

(60) [(58)] 21 CFR Part 740, Cosmetic Product Warning Statements, as amended;

(61) [(59)] 21 CFR Part 1271, Human Cells, Tissues, and Cellular and Tissue-Based Products, as amended;

(62) [(60)] 21 CFR Part 1300, Definitions, as amended;

(63) [(61)] 21 CFR Part 1301, Registration of Manufacturers, Distributors, and Dispensers of Controlled Substances, as amended;

(64) [(62)] 21 CFR Part 1302, Labeling and Packaging Requirements For Controlled Substances, as amended;

(65) [(63)] 21 CFR Part 1304, Records and Reports of Registrants, as amended;

(66) [(64)] 21 CFR Part 1305, Orders for Schedule I and [Schedule] II Controlled Substances, as amended;

(67) [(65)] 21 CFR Part 1306, Prescriptions, as amended;

(68) [(66)] 21 CFR Part 1307, Miscellaneous; and

(69) [(67)] 21 CFR Part 1317, Disposal, as amended.

(b) Copies of these laws and regulations are indexed and filed at the Texas Department of State Health Services, 1100 West 49th Street, Austin, Texas 78756, and are available for inspection during normal working hours. Electronic copies of these laws and regulations are available online at www.dshs.texas.gov.

(c) Nothing in this subchapter relieves any person of the responsibility for complying with other applicable Texas and federal laws and regulations.

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 15, 2026.

TRD-202602056

Cynthia Hernandez

General Counsel

Department of State Health Services

Earliest possible date of adoption: June 28, 2026

For further information, please call: (512) 834-6755