# 28 Tex. Admin. Code § 21.3010: 28 TAC § 21.3010. Definitions; Coverage of Off-Label Drugs, DIVISION 3. OFF-LABEL DRUGS > Texas · Regulations · In force URL: https://www.frixlaw.com/law-library/statutes/STATE_TX_TAC_T28_P1_C21_S21_3010 ## Section - **Citation:** 28 Tex. Admin. Code § 21.3010 - **Heading:** 28 TAC § 21.3010. Definitions; Coverage of Off-Label Drugs, DIVISION 3. OFF-LABEL DRUGS - **Jurisdiction:** Texas - **Kind:** Regulations - **Status:** In force - **Text as of:** August 14, 2026 - **Source:** Compiled text - **Location:** Texas Administrative Code / Title 28 INSURANCE / Part 1 TEXAS DEPARTMENT OF INSURANCE / Chapter 21 TRADE PRACTICES / 28 TAC § 21.3010 ## Text The following words and terms, when used in this division have the following meanings, unless the context clearly indicates otherwise: (1) Chronic illness--A disease, syndrome, or condition of expected long duration, showing little change or slow progression. (2) Contraindication--As defined in Insurance Code §1369.001(1). (3) Disabling illness--A disease, syndrome, or condition determined by an enrollee's health care practitioner to have caused or have the potential to cause: (A) a physical or mental impairment that substantially limits, or may limit, one or more of the activities of daily living of the enrollee including, but not limited to, eating, bathing, dressing, grooming, routine hair and skin care, meal preparation, exercising, toileting, and transfer and ambulation; (B) an impairment substantially limiting an enrollee's cognitive acuity; (C) an impairment substantially limiting an enrollee's ability to work, home make, or engage in leisure or educational activities; or (D) a condition regarded as an impairment by an enrollee's licensed health care practitioner. (4) Drug--As defined in the Texas Pharmacy Act, Occupations Code §551.003. (5) Enrollee--A person covered by a health benefit plan. (6) Health benefit plan--As described in Insurance Code §1369.002, but not those described in §1369.003. This term includes health benefit plans providing coverage for pharmacy benefits only. (7) Health care practitioner--An advanced practice nurse, doctor of medicine, doctor of dentistry, physician assistant, doctor of osteopathy, doctor of podiatry, or other licensed person with prescriptive authority. (8) Impairment--Any loss or abnormality of psychological, physiological, or anatomical structure or function. (9) Indication--As defined in Insurance Code §1369.001(3). (10) Issuer--Those entities described in Insurance Code §1369.002, but not those excluded by Insurance Code §1369.003. (11) Life-threatening illness--A disease or condition for which the likelihood of death is probable unless the course of the disease or condition is interrupted. (12) Off-label drug use--The use of a drug that is approved by the Food and Drug Administration for the treatment of one medical condition but is used to treat another medical condition, or at different dosage forms, dosage regimens, populations, or other parameters not mentioned in the approved labeling. (13) Peer-reviewed medical literature--A published scientific study in a journal or other publication in which original manuscripts are published only after they have been critically reviewed by unbiased independent experts in the same field for scientific accuracy, validity, and reliability, and have been determined by the International Committee of Medical Journal Editors to have met the Uniform Requirements for Manuscripts submitted to biomedical journals. Peer-reviewed medical literature does not include publications or supplements to publications sponsored to a significant extent by a pharmaceutical manufacturing company or an issuer of a health benefit plan. (14) Standard drug reference compendia-- (A) The American Hospital Formulary Service-Drug Information; or (B) The United States Pharmacopoeia-Drug Information. ## Nearby sections - [28 Tex. Admin. Code § 21.3001 28 TAC § 21.3001. Applicability and Severability, DIVISION 1. GENERAL PROVISIONS](https://www.frixlaw.com/law-library/statutes/STATE_TX_TAC_T28_P1_C21_S21_3001.md) - [28 Tex. Admin. Code § 21.3002 28 TAC § 21.3002. Definitions; Pharmacy Identification Cards, DIVISION 2. IDENTIFICATION CARDS](https://www.frixlaw.com/law-library/statutes/STATE_TX_TAC_T28_P1_C21_S21_3002.md) - [28 Tex. Admin. Code § 21.3003 28 TAC § 21.3003. Standard Identification Cards, DIVISION 2. IDENTIFICATION CARDS](https://www.frixlaw.com/law-library/statutes/STATE_TX_TAC_T28_P1_C21_S21_3003.md) - [28 Tex. Admin. Code § 21.3004 28 TAC § 21.3004. Issuance of Standard Identification Cards, DIVISION 2. IDENTIFICATION CARDS](https://www.frixlaw.com/law-library/statutes/STATE_TX_TAC_T28_P1_C21_S21_3004.md) - [28 Tex. Admin. Code § 21.3010 28 TAC § 21.3010. Definitions; Coverage of Off-Label Drugs, DIVISION 3. OFF-LABEL DRUGS](https://www.frixlaw.com/law-library/statutes/STATE_TX_TAC_T28_P1_C21_S21_3010.md) - [28 Tex. Admin. Code § 21.3011 28 TAC § 21.3011. Minimum Standards of Coverage for Off-Label Drug Use, DIVISION 3. OFF-LABEL DRUGS](https://www.frixlaw.com/law-library/statutes/STATE_TX_TAC_T28_P1_C21_S21_3011.md) - [28 Tex. Admin. Code § 21.3020 28 TAC § 21.3020. Definitions; Prescription Drug Formulary, DIVISION 4. PRESCRIPTION DRUG FORMULARY COVERAGE AND DISCLOSURE REQUIREMENTS](https://www.frixlaw.com/law-library/statutes/STATE_TX_TAC_T28_P1_C21_S21_3020.md) - [28 Tex. Admin. Code § 21.3022 28 TAC § 21.3022. Continuation of Benefits, DIVISION 4. PRESCRIPTION DRUG FORMULARY COVERAGE AND DISCLOSURE REQUIREMENTS](https://www.frixlaw.com/law-library/statutes/STATE_TX_TAC_T28_P1_C21_S21_3022.md) - [28 Tex. Admin. Code § 21.3023 28 TAC § 21.3023. Nonformulary Prescription Drugs; Adverse Determination, DIVISION 4. PRESCRIPTION DRUG FORMULARY COVERAGE AND DISCLOSURE REQUIREMENTS](https://www.frixlaw.com/law-library/statutes/STATE_TX_TAC_T28_P1_C21_S21_3023.md) - [28 Tex. Admin. Code § 21.3030 28 TAC § 21.3030. Availability of Formulary Information, DIVISION 4. PRESCRIPTION DRUG FORMULARY COVERAGE AND DISCLOSURE REQUIREMENTS](https://www.frixlaw.com/law-library/statutes/STATE_TX_TAC_T28_P1_C21_S21_3030.md) - [28 Tex. Admin. Code § 21.3031 28 TAC § 21.3031. Formulary Information for Individual Health Benefit Plans on Issuer's Website, DIVISION 4. PRESCRIPTION DRUG FORMULARY COVERAGE AND DISCLOSURE REQUIREMENTS](https://www.frixlaw.com/law-library/statutes/STATE_TX_TAC_T28_P1_C21_S21_3031.md) - [28 Tex. Admin. Code § 21.3032 28 TAC § 21.3032. Formulary Disclosure Requirements for Individual Health Benefit Plans, DIVISION 4. PRESCRIPTION DRUG FORMULARY COVERAGE AND DISCLOSURE REQUIREMENTS](https://www.frixlaw.com/law-library/statutes/STATE_TX_TAC_T28_P1_C21_S21_3032.md) - [28 Tex. Admin. Code § 21.3033 28 TAC § 21.3033. Facilitating Comparison Shopping for Individual Health Benefit Plans, DIVISION 4. PRESCRIPTION DRUG FORMULARY COVERAGE AND DISCLOSURE REQUIREMENTS](https://www.frixlaw.com/law-library/statutes/STATE_TX_TAC_T28_P1_C21_S21_3033.md) --- Source: Frix Law Library, https://www.frixlaw.com/law-library/statutes/STATE_TX_TAC_T28_P1_C21_S21_3010. Check the current official text before relying on it. Not legal advice.