Tex. Gov't Code Section 549.0101
Definitions

In this subchapter:

(1)

“Labeler” means a person that:

(A)

has a labeler code from the United States Food and Drug Administration under 21 C.F.R. Section 207.33; and

(B)

receives prescription drugs from a manufacturer or wholesaler and repackages those drugs for later retail sale.

(2)

“Manufacturer” means a manufacturer of prescription drugs as defined by 42 U.S.C. Section 1396r-8(k)(5), including a subsidiary or affiliate of a manufacturer.

(3)

“Supplemental rebate” means a cash rebate a manufacturer pays to this state:

(A)

on the basis of appropriate quarterly health and human services program utilization data relating to the manufacturer’s products; and

(B)

in accordance with a state supplemental rebate agreement negotiated with the manufacturer and, if necessary, approved by the federal government under 42 U.S.C. Section 1396r-8.

(4)

“Wholesaler” means a person licensed under Subchapter I (Definitions), Chapter 431 (Texas Food, Drug, and Cosmetic Act), Health and Safety Code.
Added by Acts 2023, 88th Leg., R.S., Ch. 769 (H.B. 4611), Sec. 1.01, eff. April 1, 2025.

Source: Section 549.0101 — Definitions, https://statutes.­capitol.­texas.­gov/Docs/GV/htm/GV.­549.­htm#549.­0101 (accessed May 26, 2025).

549.0001
Bulk Purchasing with Another State of Prescription Drugs and Other Medications 549.0002
Value-based Arrangement in Medicaid Vendor Drug Program 549.0003
Period of Validity of Prescriptions Under Medicaid 549.0004
Certain Medications for Sex Offenders Prohibited 549.0005
Prior Approval of and Pharmacy Provider Access to Certain Communications with Certain Recipients and Enrollees 549.0051
Periodic Review of Vendor Drug Program Purchases 549.0052
Medicaid Prescription Drug Use and Expenditure Patterns 549.0101
Definitions 549.0102
Requirement to Negotiate for Supplemental Rebates for Certain Programs 549.0103
Voluntary Negotiation for Manufacturer and Labeler Supplemental Rebates 549.0104
Considerations in Supplemental Rebate Negotiations 549.0105
Required Disclosures in Negotiations for Supplemental Rebates 549.0106
Program Benefits Instead of Supplemental Rebates 549.0107
Limitations on Agreement to Accept Program Benefits Instead of Supplemental Rebates 549.0108
Treatment of Program Benefits for Certain Purposes 549.0151
Certain Prescription Drug Information Confidential 549.0152
General Prescription Drug Information Not Confidential 549.0153
Existence or Nonexistence of Supplemental Rebate Agreement Not Confidential 549.0201
Definition 549.0202
Preferred Drug Lists Required for Medicaid Vendor Drug and Child Health Plan Programs 549.0203
Preferred Drug Lists Authorized for Certain Programs 549.0204
Limitation on Drugs Included on Preferred Drug Lists 549.0205
Considerations for Including Drug on Preferred Drug Lists 549.0206
Submission of Evidence to Support Including Drug on Preferred Drug Lists 549.0207
Publication of Information Relating to and Distribution of Preferred Drug Lists 549.0251
Drugs Subject to Prior Authorization Requirements 549.0252
Prior Authorization and Certain Protocol Requirements Prohibited for Certain Antiretroviral Drugs 549.0253
Prior Authorization Prohibited for Certain Nonpreferred Antipsychotic Drugs 549.0254
Administration of Prior Authorization Requirements 549.0255
Prerequisite to Implementing Prior Authorization Requirement for Certain Drugs 549.0256
Notice of Prior Authorization Requirement Implementation and Procedures 549.0257
Prior Authorization Procedures 549.0258
Prior Authorization Automation and Point-of-sale Requirements 549.0259
Applicability of Prior Authorization Requirements to Prior Prescriptions 549.0260
Appeal of Prior Authorization Denial Under Medicaid Vendor Drug Program 549.0301
Definition 549.0302
Board Composition 549.0303
Conflicts of Interest 549.0304
Board Member Terms 549.0305
Presiding Officer 549.0306
Inapplicability of Other Law to Board 549.0307
Administrative Support for Board 549.0308
Rules for Board Operation 549.0309
General Powers and Duties of Board 549.0310
Board Meetings 549.0311
Board Summary of Certain Information Required 549.0312
Public Disclosure of Certain Board Recommendations Required 549.0351
Definitions 549.0352
Drug Use Reviews 549.0353
Annual Report 549.0401
Definition 549.0402
Provision of Program Information by Pharmaceutical Company 549.0403
Public Access to Program Information 549.0451
Development and Implementation of State Prescription Drug Program 549.0452
Program Eligibility 549.0453
Rules 549.0454
Generic Equivalent Authorized 549.0455
Program Funding and Funding Priorities
Green check means up to date. Up to date

Verified:
May 26, 2025

§ 549.0101. Definitions's source at texas​.gov