344x Filetype PDF File size 2.79 MB Source: www.pharmacy.texas.gov
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
no reviews yet
Please Login to review.