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Texas State Board of Pharmacy Board Rules August 24, 2022 TEXAS ADMINISTRATIVE CODE TITLE 22 – EXAMINING BOARDS PART 15 – TEXAS STATE BOARD OF PHARMACY Table of Contents Texas State Board of Pharmacy .............................................................................................................................................. 1 Table of Contents .................................................................................................................................................................... 2 CHAPTER 281 – ADMINISTRATIVE PRACTICE AND PROCEDURES ........................................................................................... 8 SUBCHAPTER A - GENERAL PROVISIONS ............................................................................................................................. 8 §281.1 Objective and Scope ..................................................................................................................................... 8 §281.2 Definitions ..................................................................................................................................................... 8 §281.3 Construction of This Chapter ........................................................................................................................ 9 §281.4 Official Acts in Writing and Open to the Public ............................................................................................ 9 §281.5 Initiating Proceedings Before the Board ....................................................................................................... 9 §281.6 Mental or Physical Examination ................................................................................................................. 10 §281.7 Grounds for Discipline for a Pharmacist License ........................................................................................ 11 §281.8 Grounds for Discipline for a Pharmacy License .......................................................................................... 14 §281.9 Grounds for Discipline for a Pharmacy Technician or a Pharmacy Technician Trainee ............................. 15 §281.10 Denial of a License ...................................................................................................................................... 16 §281.11 Criminal History Evaluation Letter .............................................................................................................. 16 §281.12 Rules Governing Cooperating Practitioners ................................................................................................ 17 §281.13 Official Action by Majority .......................................................................................................................... 17 §281.14 Vendor Protest Procedures ......................................................................................................................... 17 §281.15 Negotiated Rulemaking .............................................................................................................................. 19 §281.16 Alternative Dispute Resolution ................................................................................................................... 19 §281.17 Historically Underutilized Businesses ......................................................................................................... 19 §281.18 Reporting Professional Liability Claims ....................................................................................................... 19 §281.19 Vehicles ....................................................................................................................................................... 21 SUBCHAPTER B - GENERAL PROCEDURES IN A CONTESTED CASE .................................................................................... 22 §281.20 Application of Other Laws ........................................................................................................................... 22 §281.21 Complaints .................................................................................................................................................. 22 §281.22 Informal Disposition of a Contested Case ................................................................................................... 22 §281.23 Subpoenas ................................................................................................................................................... 24 §281.30 Pleadings and Notice in a Contested Case .................................................................................................. 24 §281.31 Burden of Proof ........................................................................................................................................... 25 §281.32 Failure to Attend Hearing and Default ........................................................................................................ 25 §281.33 Proposal for Decision .................................................................................................................................. 26 Texas Pharmacy Rules 22 TAC, PART 15 2 Click HERE to return to Table of Contents §281.34 Record of Hearing ....................................................................................................................................... 26 §281.35 Temporary Suspension or Restriction. ........................................................................................................ 26 SUBCHAPTER C - DISCIPLINARY GUIDELINES .................................................................................................................... 26 §281.60 General Guidance ....................................................................................................................................... 26 §281.61 Definitions of Discipline Authorized ........................................................................................................... 27 §281.62 Aggravating and Mitigating Factors ............................................................................................................ 27 §281.63 Considerations for Criminal Offenses ......................................................................................................... 28 §281.64 Sanctions for Criminal Offenses .................................................................................................................. 31 §281.65 Schedule of Administrative Penalties ......................................................................................................... 33 §281.66 Application for Reissuance or Removal of Restrictions of a License or Registration ................................. 35 §281.67 Sanctions for Out-of-State Disciplinary Actions .......................................................................................... 37 §281.68 Remedial Plan ............................................................................................................................................. 37 §281.69 Automatic Denial or Revocation ................................................................................................................. 38 §281.70 Surety Bond ................................................................................................................................................. 38 CHAPTER 283 – LICENSING REQUIREMENTS FOR PHARMACISTS ........................................................................................ 39 §283.1 Purpose ....................................................................................................................................................... 39 §283.2 Definitions ................................................................................................................................................... 39 §283.3 Educational and Age Requirements ............................................................................................................ 40 §283.4 Internship Requirements ............................................................................................................................ 40 §283.5 Pharmacist-Intern Duties ............................................................................................................................ 44 §283.6 Preceptor Requirements and Ratio of Preceptors to Pharmacist-Interns .................................................. 44 §283.7 Examination Requirements ......................................................................................................................... 46 §283.8 Reciprocity Requirements ........................................................................................................................... 47 §283.9 Fee Requirements for Licensure by Examination, Score Transfer and Reciprocity .................................... 47 §283.10 Requirements for Application for a Pharmacist License Which Has Expired ............................................. 49 §283.11 Examination Retake Requirements............................................................................................................. 50 §283.12 Licenses for Military Service Members, Military Veterans, and Military Spouses ..................................... 51 CHAPTER 291 – PHARMACIES ............................................................................................................................................... 55 SUBCHAPTER A – ALL CLASSES OF PHARMACIES .............................................................................................................. 55 §291.1 Pharmacy License Application .................................................................................................................... 55 §291.2 Definitions ................................................................................................................................................... 55 §291.3 Required Notifications ................................................................................................................................ 55 §291.4 Sworn Disclosure Statement ....................................................................................................................... 60 Texas Pharmacy Rules 22 TAC, PART 15 3 Click HERE to return to Table of Contents §291.5 Closing a Pharmacy ..................................................................................................................................... 60 §291.6 Pharmacy License Fees ............................................................................................................................... 61 §291.7 Prescription Drug Recalls by the Manufacturer .......................................................................................... 62 §291.8 Return of Prescription Drugs ...................................................................................................................... 62 §291.9 Prescription Pick Up Locations .................................................................................................................... 64 §291.10 Pharmacy Balance Registration/Inspection ................................................................................................ 64 §291.11 Operation of a Pharmacy ............................................................................................................................ 65 §291.14 Pharmacy License Renewal ......................................................................................................................... 65 §291.15 Storage of Drugs ......................................................................................................................................... 65 §291.16 Samples ....................................................................................................................................................... 66 §291.17 Inventory Requirements ............................................................................................................................. 66 §291.18 Time Limit for Filing a Complaint ................................................................................................................ 68 §291.19 Administrative Actions as a Result of a Compliance Inspection ................................................................. 68 §291.22 Petition to Establish an Additional Class of Pharmacy ............................................................................... 68 §291.23 Pilot or Demonstration Research Projects for Innovative Applications in the Practice of Pharmacy ........ 69 §291.24 Pharmacy Residency Programs ................................................................................................................... 70 §291.27 Confidentiality ............................................................................................................................................. 71 §291.28 Access to Confidential Records ................................................................................................................... 71 §291.29 Professional Responsibility of Pharmacists ................................................................................................. 72 SUBCHAPTER B – COMMUNITY PHARMACY (CLASS A) .................................................................................................... 74 §291.31 Definitions ................................................................................................................................................... 74 §291.32 Personnel .................................................................................................................................................... 78 §291.33 Operational Standards ................................................................................................................................ 83 §291.34 Records ..................................................................................................................................................... 100 §291.35 Official Prescription Requirements ........................................................................................................... 116 §291.36 Pharmacies Compounding Sterile Preparations (Class A-S) ..................................................................... 116 SUBCHAPTER C – NUCLEAR PHARMACY (CLASS B) ......................................................................................................... 117 §291.51 Purpose ..................................................................................................................................................... 117 §291.52 Definitions ................................................................................................................................................. 117 §291.53 Personnel .................................................................................................................................................. 119 §291.54 Operational Standards .............................................................................................................................. 123 §291.55 Records ..................................................................................................................................................... 127 Texas Pharmacy Rules 22 TAC, PART 15 4 Click HERE to return to Table of Contents
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