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 §229.249, concerning Licensure Fees, and §229.427, concerning Licensure Fees. The amendments are adopted without changes to the proposed text as published in the August 2, 2019, issue of the Texas Register (44 TexReg 4026), and therefore will not be republished.

BACKGROUND AND JUSTIFICATION

DSHS adopted rules under the authority of Texas Health and Safety Code, Chapter 431, Subchapters I and N, relating to the licensing and regulation of wholesale distribution of nonprescription drugs and prescription drugs. Title 25, Texas Administrative Code, Chapter 229, Subchapters O and W relate to the licensing and regulation of manufacturers and distributors of nonprescription and prescription drugs. DSHS has legal authority to set fees in amounts that are reasonable and necessary and allow DSHS to recover biennial expenditures under Texas Health and Safety Code, §431.409(b). Currently, the fees for prescription drug manufacturers and nonprescription drug distributors who are manufacturers are divided into three levels. DSHS is proposing a new fee structure which expands the fee structure into five levels. This change aligns the nonprescription drug manufacturer fees with prescription drug manufacturer fees assessed by DSHS. Adding additional levels will result in a reduction of fees for some businesses with gross annual sales ranging from $200,000 to $19,999,999.99.

Under the authority of Texas Health and Safety Code, Chapter 431, the Food and Drug Safety program protects Texans from unnecessary morbidity and mortality through its regulation of people and entities that provide products and services that may pose a health threat if manufactured or used in an unapproved manner. The Drug Manufacturing program ensures that drugs are safe to consume and use, are properly labeled, and are not fraudulently presented. The Drug Manufacturing program issues two specific license types: nonprescription and prescription drug manufacturing. The objective of the rules is to create parity between small and large businesses and ensure smaller businesses are not paying a fee that is disproportionate to the amount of their sales.

COMMENTS

The 31-day comment period following publication of the proposed changes ended September 3, 2019. During this period, DSHS did not receive comments regarding the proposed rules.

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

25 TAC §229.249

STATUTORY AUTHORITY

The amendments are adopted under Texas Health and Safety Code, §431.241, which authorizes the Executive Commissioner of HHSC to adopt rules necessary for the implementation and enforcement of Chapter 431 by DSHS; Texas Health and Safety Code, §431.409(b) and §431.204(b) authorizes DSHS to collect fees for licenses; and Texas Government Code, §531.0055, and Texas Health and Safety Code, §1001.075, which provides that the Executive Commissioner of HHSC shall 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.

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 October 25, 2019.

TRD-201903905

Barbara L. Klein

General Counsel

Department of State Health Services

Effective date: November 14, 2019

Proposal publication date: August 2, 2019

For further information, please call: (512) 834-6670


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

25 TAC §229.427

STATUTORY AUTHORITY

The amendments are adopted under Texas Health and Safety Code, §431.241, which authorizes the Executive Commissioner of HHSC to adopt rules necessary for the implementation and enforcement of Chapter 431 by DSHS; Texas Health and Safety Code, §431.409(b) and §431.204(b) authorizes DSHS to collect fees for licenses; and Texas Government Code, §531.0055, and Texas Health and Safety Code, §1001.075, which provides that the Executive Commissioner of HHSC shall 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.

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 October 25, 2019.

TRD-201903906

Barbara L. Klein

General Counsel

Department of State Health Services

Effective date: November 14, 2019

Proposal publication date: August 2, 2019

For further information, please call: (512) 834-6670