Texas State Board of Pharmacy Board Rules June 2019

Texas State Board of Pharmacy

Board Rules September 9, 2021

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

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?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.......................................................................................... 36 ?281.68 Remedial Plan ............................................................................................................................................. 36 ?281.69 Automatic Denial or Revocation ................................................................................................................. 37 ?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.................................................. 45 ?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

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?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 ................................................................................................................................ 82 ?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) ......................................................................................................... 116 ?291.51 Purpose ..................................................................................................................................................... 116 ?291.52 Definitions ................................................................................................................................................. 117 ?291.53 Personnel .................................................................................................................................................. 119 ?291.54 Operational Standards .............................................................................................................................. 122 ?291.55 Records ..................................................................................................................................................... 126

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SUBCHAPTER D ? INSTITUTIONAL PHARMACY (CLASS C) ............................................................................................... 130 ?291.71 Purpose ..................................................................................................................................................... 130 ?291.72 Definitions ................................................................................................................................................. 131 ?291.73 Personnel .................................................................................................................................................. 135 ?291.74 Operational Standards .............................................................................................................................. 141 ?291.75 Records ..................................................................................................................................................... 155 ?291.76 Class C Pharmacies Located in a Freestanding Ambulatory Surgical Center ............................................ 160 ?291.77 Pharmacies Compounding Sterile Preparations (Class C-S)...................................................................... 173

SUBCHAPTER E ? CLINIC PHARMACY (CLASS D).............................................................................................................. 175 ?291.91 Definitions ................................................................................................................................................. 175 ?291.92 Personnel .................................................................................................................................................. 177 ?291.93 Operational Standards .............................................................................................................................. 178 ?291.94 Records ..................................................................................................................................................... 185

SUBCHAPTER F ? NON-RESIDENT PHARMACY (CLASS E) ................................................................................................ 186 ?291.101 Purpose ..................................................................................................................................................... 186 ?291.102 Definitions ................................................................................................................................................. 186 ?291.103 Personnel .................................................................................................................................................. 188 ?291.104 Operational Standards .............................................................................................................................. 188 ?291.105 Records ..................................................................................................................................................... 193 ?291.106 Pharmacies Compounding Sterile Preparations (Class E-S) ...................................................................... 193

SUBCHAPTER G ? SERVICES PROVIDED BY PHARMACIES ............................................................................................... 195 ?291.120 General...................................................................................................................................................... 195 ?291.121 Remote Pharmacy Services....................................................................................................................... 195 ?291.123 Central Prescription Drug or Medication Order Processing ..................................................................... 213 ?291.125 Centralized Prescription Dispensing ......................................................................................................... 214 ?291.127 Emergency Remote Pharmacy License ..................................................................................................... 217 ?291.129 Satellite Pharmacy .................................................................................................................................... 218 ?291.131 Pharmacies Compounding Non-Sterile Preparations ............................................................................... 222 ?291.133 Pharmacies Compounding Sterile Preparations ....................................................................................... 232

SUBCHAPTER H ? OTHER CLASSES OF PHARMACY ......................................................................................................... 265 ?291.151 Pharmacies Located in a Freestanding Emergency Medical Care Facility (Class F) .................................. 265 ?291.153 Central Prescription Drug or Medication Order Processing Pharmacy (Class G)...................................... 279 ?291.155 Limited Prescription Delivery Pharmacy (Class H) .................................................................................... 284

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CHAPTER 295 ? PHARMACISTS ........................................................................................................................................... 285 ?295.1 Change of Address and/or Name.............................................................................................................. 285 ?295.2 Change of Employment............................................................................................................................. 285 ?295.3 Responsibility of Pharmacist..................................................................................................................... 285 ?295.4 Sharing Money Received for Prescription ................................................................................................ 285 ?295.5 Pharmacist License or Renewal Fees ........................................................................................................ 285 ?295.6 Emergency Temporary Pharmacist License .............................................................................................. 286 ?295.7 Pharmacist License Renewal..................................................................................................................... 286 ?295.8 Continuing Education Requirements ........................................................................................................ 286 ?295.9 Inactive License ......................................................................................................................................... 291 ?295.11 Notification to Consumers ........................................................................................................................ 292 ?295.12 Pharmacist Certification Programs ........................................................................................................... 293 ?295.13 Drug Therapy Management by a Pharmacist under Written Protocol of a Physician.............................. 294 ?295.14 Dispensing of Opioid Antagonist by Pharmacist....................................................................................... 297 ?295.15 Administration of Immunizations or Vaccinations by a Pharmacist under Written Protocol of Physician .... .................................................................................................................................................................. 298 ?295.16 Administration of Epinephrine by a Pharmacist ....................................................................................... 302

CHAPTER 297 ? PHARMACY TECHNICIANS AND PHARMACY TECHNICIAN TRAINEES........................................................ 304 ?297.1 Purpose ..................................................................................................................................................... 304 ?297.2 Definitions ................................................................................................................................................. 304 ?297.3 Registration Requirements ....................................................................................................................... 304 ?297.4 Fees ........................................................................................................................................................... 306 ?297.5 Pharmacy Technician Trainees ................................................................................................................. 306 ?297.6 Pharmacy Technician and Pharmacy Technician Trainee Training ........................................................... 306 ?297.7 Exemption from Pharmacy Technician Certification Requirements......................................................... 308 ?297.8 Continuing Education Requirements ........................................................................................................ 309 ?297.9 Notifications.............................................................................................................................................. 313 ?297.10 Registration for Military Service Members, Military Veterans, and Military Spouses ............................. 313 ?297.11 Temporary Emergency Registration ......................................................................................................... 315

CHAPTER 303 ? DESTRUCTION OF DRUGS.......................................................................................................................... 316 ?303.1 Destruction of Dispensed Drugs ............................................................................................................... 316 ?303.2 Disposal of Stock Prescription Drugs ........................................................................................................ 318 ?303.3 Records ..................................................................................................................................................... 318

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CHAPTER 305 ? EDUCATIONAL REQUIREMENTS ................................................................................................................ 319 ?305.1 Pharmacy Education Requirements.......................................................................................................... 319 ?305.2 Pharmacy Technician Training Programs.................................................................................................. 319

CHAPTER 309 ? SUBSTITUTION OF DRUG PRODUCTS ........................................................................................................ 321 ?309.1 Objective ................................................................................................................................................... 321 ?309.2 Definitions ................................................................................................................................................. 321 ?309.3 Substitution Requirements ....................................................................................................................... 322 ?309.4 Patient Notification................................................................................................................................... 325 ?309.5 Communication with Prescriber ............................................................................................................... 325 ?309.6 Records ..................................................................................................................................................... 326 ?309.7 Dispensing Responsibilities ....................................................................................................................... 326 ?309.8 Advertising of Generic Drugs by Pharmacies............................................................................................ 326

CHAPTER 311 ? CODE OF CONDUCT ................................................................................................................................... 327 ?311.1 Procedures ................................................................................................................................................ 327 ?311.2 Procedures Regarding Complaints Filed against Board Members............................................................ 327

CHAPTER 315 ? CONTROLLED SUBSTANCES ....................................................................................................................... 330 ?315.1 Definitions - Effective September 1, 2016 ................................................................................................ 330 ?315.2 Official Prescription Form - Effective September 1, 2016 ........................................................................ 330 ?315.3 Prescriptions ............................................................................................................................................. 331 ?315.4 Exceptions to Use of Form - Effective September 1, 2016 ....................................................................... 333 ?315.5 Pharmacy Responsibility - Generally ........................................................................................................ 333 ?315.6 Pharmacy Responsibility - Electronic Reporting ....................................................................................... 334 ?315.7 Pharmacy Responsibility - Oral, Telephonic, or Emergency Prescription - Effective September 1, 2016 334 ?315.8 Pharmacy Responsibility - Modification of Prescription - Effective September 1, 2016 .......................... 335 ?315.9 Pharmacy Responsibility - Out-of-State Practitioner - Effective September 1, 2016 ............................... 335 ?315.10 Return of Unused Official Prescription Form - Effective September 1, 2016 ........................................... 335 ?315.11 Release of Prescription Data..................................................................................................................... 335 ?315.12 Schedule III through V Prescription Forms - Effective September 1, 2016............................................... 336 ?315.13 Official Prescription Form - Effective September 1, 2016 ........................................................................ 336 ?315.14 Official Prescription - Effective September 1, 2016.................................................................................. 336 ?315.15 Access Requirements ................................................................................................................................ 336 ?315.16 Patient Access to Prescription Monitoring Program Prescription Record................................................ 337

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CHAPTER 281 ? ADMINISTRATIVE PRACTICE AND PROCEDURES

SUBCHAPTER A - GENERAL PROVISIONS

?281.1 Objective and Scope The objective of this chapter is to obtain a just, fair, and equitable determination of any matter within the jurisdiction of the board. To the end that this objective may be attained with as great expedition and at the least expense as possible to the parties and the state, the provisions of this chapter shall be given a liberal construction. The provisions of this chapter govern the procedure for the institution, conduct, and determination of all proceedings before the board. All actions taken by the board shall be in accordance with the Act, the Government Code, the Occupations Code, the board's rules and any other applicable laws or rules.

?281.2 Definitions The following words and terms, when used in this chapter, have the following meanings, unless the context clearly indicates otherwise:

(1) Act--The Texas Pharmacy Act, Chapters 551 - 566, Texas Occupations Code, as amended. (2) Administrative law judge--A judge employed by the State Office of Administrative Hearings. (3) Agency--The Texas State Board of Pharmacy, and its divisions, departments, and employees. (4) Administrative Procedure Act (APA)--Government Code, Chapter 2001, as amended. (5) Board--The Texas State Board of Pharmacy. (6) Confidential address of record--The home address required to be provided by each individual, who is a licensee, registrant, or pharmacy owner and where service of legal notice will be sent. The address is confidential, as set forth in ?555.001(d) of the Act, and not subject to disclosure under the Public Information Act. (7) Contested case--A proceeding, including but not restricted to licensing, in which the legal rights, duties, or privileges of a party are to be determined by the board after an opportunity for adjudicative hearing. (8) Diversion of controlled substances--An act or acts which result in the distribution of controlled substances from legitimate pharmaceutical or medical channels in violation of the Controlled Substances Act or rules promulgated pursuant to the Controlled Substances Act or rules relating to controlled substances promulgated pursuant to this Act. (9) Diversion of dangerous drugs--An act or acts which result in the distribution of dangerous drugs from legitimate pharmaceutical or medical channels in violation of the Dangerous Drug Act or rules promulgated pursuant to the Dangerous Drug Act or rules relating to dangerous drugs promulgated pursuant to this Act. (10) Executive director/secretary--The secretary of the board and executive director of the agency. (11) License--The whole or part of any agency permit, certificate, approval, registration, or similar form of permission required by law. (12) Licensee--Any individual or person to whom the agency has issued any permit, certificate, approved registration, or similar form of permission authorized by law. (13) Licensing--The agency process relating to the granting, denial, renewal, revocation, suspension, annulment, withdrawal, or amendment of a license. (14) Official act--Any act performed by the board pursuant to a duty, right, or responsibility imposed or granted by law, rule, or regulation. (15) Person--An individual, corporation, government or governmental subdivision or agency, business trust, estate, trust, partnership, association, or any other legal entity. (16) President--The president of the Texas State Board of Pharmacy. (17) Presiding Officer--The president of the Texas State Board of Pharmacy or, in the president's absence, the highest ranking officer present at a board meeting.

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