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picture1_Pharmacy Pdf 152473 | Tsbp Rules Master File


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Pharmacy Pdf 152473 | Tsbp Rules Master File

icon picture PDF Filetype PDF | Posted on 16 Jan 2023 | 2 years ago
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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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