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Texas State Board of PharmacyBoard RulesMarch 15, 2022TEXAS ADMINISTRATIVE CODETITLE 22 – EXAMINING BOARDSPART 15 – TEXAS STATE BOARD OF PHARMACY

Table of ContentsTexas State Board of Pharmacy . 1Table of Contents . 2CHAPTER 281 – ADMINISTRATIVE PRACTICE AND PROCEDURES . 8SUBCHAPTER A - GENERAL PROVISIONS . 8§281.1Objective and Scope . 8§281.2Definitions . 8§281.3Construction of This Chapter . 9§281.4Official Acts in Writing and Open to the Public . 9§281.5Initiating Proceedings Before the Board . 9§281.6Mental or Physical Examination . 10§281.7Grounds for Discipline for a Pharmacist License . 11§281.8Grounds for Discipline for a Pharmacy License . 14§281.9Grounds for Discipline for a Pharmacy Technician or a Pharmacy Technician Trainee . 15§281.10Denial of a License . 16§281.11Criminal History Evaluation Letter . 16§281.12Rules Governing Cooperating Practitioners . 17§281.13Official Action by Majority . 17§281.14Vendor Protest Procedures. 17§281.15Negotiated Rulemaking . 19§281.16Alternative Dispute Resolution . 19§281.17Historically Underutilized Businesses . 19§281.18Reporting Professional Liability Claims . 19§281.19Vehicles . 21SUBCHAPTER B - GENERAL PROCEDURES IN A CONTESTED CASE . 22§281.20Application of Other Laws. 22§281.21Complaints . 22§281.22Informal Disposition of a Contested Case . 22§281.23Subpoenas . 24§281.30Pleadings and Notice in a Contested Case . 24§281.31Burden of Proof. 25§281.32Failure to Attend Hearing and Default. 25§281.33Proposal for Decision . 26Texas Pharmacy Rules22 TAC, PART 15Click HERE to return to Table of Contents2

§281.34Record of Hearing . 26§281.35Temporary Suspension or Restriction. . 26SUBCHAPTER C - DISCIPLINARY GUIDELINES . 26§281.60General Guidance . 26§281.61Definitions of Discipline Authorized . 27§281.62Aggravating and Mitigating Factors . 27§281.63Considerations for Criminal Offenses . 28§281.64Sanctions for Criminal Offenses . 31§281.65Schedule of Administrative Penalties . 33§281.66Application for Reissuance or Removal of Restrictions of a License or Registration . 35§281.67Sanctions for Out-of-State Disciplinary Actions . 36§281.68Remedial Plan . 36§281.69Automatic Denial or Revocation . 37§281.70Surety Bond. 38CHAPTER 283 – LICENSING REQUIREMENTS FOR PHARMACISTS . 39§283.1Purpose . 39§283.2Definitions . 39§283.3Educational and Age Requirements . 40§283.4Internship Requirements . 40§283.5Pharmacist-Intern Duties . 44§283.6Preceptor Requirements and Ratio of Preceptors to Pharmacist-Interns . 44§283.7Examination Requirements. 46§283.8Reciprocity Requirements . 47§283.9Fee Requirements for Licensure by Examination, Score Transfer and Reciprocity . 47§283.10Requirements for Application for a Pharmacist License Which Has Expired . 49§283.11Examination Retake Requirements. 50§283.12Licenses for Military Service Members, Military Veterans, and Military Spouses . 51CHAPTER 291 – PHARMACIES . 55SUBCHAPTER A – ALL CLASSES OF PHARMACIES . 55§291.1Pharmacy License Application . 55§291.2Definitions . 55§291.3Required Notifications . 55§291.4Sworn Disclosure Statement . 60Texas Pharmacy Rules22 TAC, PART 15Click HERE to return to Table of Contents3

§291.5Closing a Pharmacy . 60§291.6Pharmacy License Fees . 61§291.7Prescription Drug Recalls by the Manufacturer . 62§291.8Return of Prescription Drugs . 62§291.9Prescription Pick Up Locations . 64§291.10Pharmacy Balance Registration/Inspection . 64§291.11Operation of a Pharmacy . 65§291.14Pharmacy License Renewal . 65§291.15Storage of Drugs . 65§291.16Samples . 66§291.17Inventory Requirements . 66§291.18Time Limit for Filing a Complaint . 68§291.19Administrative Actions as a Result of a Compliance Inspection . 68§291.22Petition to Establish an Additional Class of Pharmacy . 68§291.23Pilot or Demonstration Research Projects for Innovative Applications in the Practice of Pharmacy . 69§291.24Pharmacy Residency Programs . 70§291.27Confidentiality . 71§291.28Access to Confidential Records . 71§291.29Professional Responsibility of Pharmacists. 72SUBCHAPTER B – COMMUNITY PHARMACY (CLASS A) . 74§291.31Definitions . 74§291.32Personnel . 79§291.33Operational Standards . 83§291.34Records . 101§291.35Official Prescription Requirements . 117§291.36Pharmacies Compounding Sterile Preparations (Class A-S) . 117SUBCHAPTER C – NUCLEAR PHARMACY (CLASS B) . 118§291.51Purpose . 118§291.52Definitions . 118§291.53Personnel . 120§291.54Operational Standards . 123§291.55Records . 127Texas Pharmacy Rules22 TAC, PART 15Click HERE to return to Table of Contents4

SUBCHAPTER D – INSTITUTIONAL PHARMACY (CLASS C) . 132§291.71Purpose . 132§291.72Definitions . 132§291.73Personnel . 136§291.74Operational Standards . 142§291.75Records . 156§291.76Class C Pharmacies Located in a Freestanding Ambulatory Surgical Center . 161§291.77Pharmacies Compounding Sterile Preparations (Class C-S) . 175SUBCHAPTER E – CLINIC PHARMACY (CLASS D) . 177§291.91Definitions . 177§291.92Personnel . 178§291.93Operational Standards . 180§291.94Records . 186SUBCHAPTER F – NON-RESIDENT PHARMACY (CLASS E) . 188§291.101 Purpose . 188§291.102 Definitions . 188§291.103 Personnel . 189§291.104 Operational Standards . 189§291.105 Records . 194§291.106 Pharmacies Compounding Sterile Preparations (Class E-S) . 195SUBCHAPTER G – SERVICES PROVIDED BY PHARMACIES . 196§291.120 General. 196§291.121 Remote Pharmacy Services . 196§291.123 Central Prescription Drug or Medication Order Processing . 214§291.125 Centralized Prescription Dispensing . 216§291.127 Emergency Remote Pharmacy License . 218§291.129 Satellite Pharmacy . 219§291.131 Pharmacies Compounding Non-Sterile Preparations . 224§291.133 Pharmacies Compounding Sterile Preparations . 233SUBCHAPTER H – OTHER CLASSES OF PHARMACY . 267§291.151 Pharmacies Located in a Freestanding Emergency Medical Care Facility (Class F) . 267§291.153 Central Prescription Drug or Medication Order Processing Pharmacy (Class G). 280§291.155 Limited Prescription Delivery Pharmacy (Class H) . 285Texas Pharmacy Rules22 TAC, PART 15Click HERE to return to Table of Contents5

CHAPTER 295 – PHARMACISTS . 286§295.1Change of Address and/or Name . 286§295.2Change of Employment. 286§295.3Responsibility of Pharmacist . 286§295.4Sharing Money Received for Prescription . 286§295.5Pharmacist License or Renewal Fees . 286§295.6Emergency Temporary Pharmacist License . 287§295.7Pharmacist License Renewal . 287§295.8Continuing Education Requirements . 287§295.9Inactive License . 292§295.11Notification to Consumers . 293§295.12Pharmacist Certification Programs . 294§295.13Drug Therapy Management by a Pharmacist under Written Protocol of a Physician . 295§295.14Dispensing of Opioid Antagonist by Pharmacist . 298§295.15Administration of Immunizations or Vaccinations by a Pharmacist under Written Protocol of Physician . 299§295.16Administration of Epinephrine by a Pharmacist . 303CHAPTER 297 – PHARMACY TECHNICIANS AND PHARMACY TECHNICIAN TRAINEES . 305§297.1Purpose . 305§297.2Definitions . 305§297.3Registration Requirements . 305§297.4Fees . 307§297.5Pharmacy Technician Trainees . 307§297.6Pharmacy Technician and Pharmacy Technician Trainee Training . 307§297.7Exemption from Pharmacy Technician Certification Requirements . 309§297.8Continuing Education Requirements . 310§297.9Notifications . 314§297.10Registration for Military Service Members, Military Veterans, and Military Spouses . 314§297.11Temporary Emergency Registration . 316CHAPTER 303 – DESTRUCTION OF DRUGS . 318§303.1Destruction of Dispensed Drugs . 318§303.2Disposal of Stock Prescription Drugs . 320§303.3Records . 320Texas Pharmacy Rules22 TAC, PART 15Click HERE to return to Table of Contents6

CHAPTER 305 – EDUCATIONAL REQUIREMENTS . 321§305.1Pharmacy Education Requirements. 321§305.2Pharmacy Technician Training Programs . 321CHAPTER 309 – SUBSTITUTION OF DRUG PRODUCTS . 323§309.1Objective . 323§309.2Definitions . 323§309.3Substitution Requirements . 324§309.4Patient Notification . 327§309.5Communication with Prescriber . 327§309.6Records . 328§309.7Dispensing Responsibilities . 328§309.8Advertising of Generic Drugs by Pharmacies . 328CHAPTER 311 – CODE OF CONDUCT . 329§311.1Procedures . 329§311.2Procedures Regarding Complaints Filed against Board Members. 329CHAPTER 315 – CONTROLLED SUBSTANCES . 332§315.1Definitions - Effective September 1, 2016 . 332§315.2Official Prescription Form - Effective September 1, 2016 . 332§315.3Prescriptions . 333§315.4Exceptions to Use of Form - Effective September 1, 2016 . 335§315.5Pharmacy Responsibility - Generally . 335§315.6Pharmacy Responsibility - Electronic Reporting . 336§315.7Pharmacy Responsibility - Oral, Telephonic, or Emergency Prescription - Effective September 1, 2016 336§315.8Pharmacy Responsibility - Modification of Prescription - Effective September 1, 2016 . 337§315.9Pharmacy Responsibility - Out-of-State Practitioner - Effective September 1, 2016 . 337§315.10Return of Unused Official Prescription Form - Effective September 1, 2016 . 337§315.11Release of Prescription Data . 337§315.12Schedule III through V Prescription Forms - Effective September 1, 2016. 338§315.13Official Prescription Form - Effective September 1, 2016 . 338§315.14Official Prescription - Effective September 1, 2016 .

Texas State Board of Pharmacy Board Rules December 7, 2021 TEXAS ADMINISTRATIVE CODE TITLE 22 – EXAMINING BOARDS