Texas State Board of Pharmacy

1 Texas State Board of Pharmacy Board Rules June 18, 2020. 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 .. 9. SUBCHAPTER A - GENERAL PROVISIONS .. 9. Objective and 9. Definitions .. 9. Construction of This Chapter .. 10. Official Acts in Writing and Open to the Public .. 10. Initiating Proceedings Before the Board .. 10. Mental or Physical Examination .. 11. Grounds for Discipline for a Pharmacist 12. Grounds for Discipline for a Pharmacy 15. Grounds for Discipline for a Pharmacy Technician or a Pharmacy Technician Trainee .. 16. Denial of a License .. 17. Criminal History Evaluation Letter .. 17. Rules Governing Cooperating Practitioners .. 18. Official Action by Majority .. 18. Vendor Protest Procedures .. 18. Negotiated 20. Alternative Dispute Resolution.

2 20. Historically Underutilized Businesses .. 20. Reporting Professional Liability Claims .. 20. Vehicles .. 22. SUBCHAPTER B - GENERAL PROCEDURES IN A CONTESTED CASE .. 23. Application of Other Laws .. 23. Complaints .. 23. Informal Disposition of a Contested Case .. 23. Subpoenas .. 25. Pleadings and Notice in a Contested Case .. 25. Burden of Proof .. 26. Failure to Attend Hearing and Default .. 26. Proposal for Decision .. 27. Texas Pharmacy Rules 22 TAC, PART 15 2. Click HERE to return to Table of Contents Record of Hearing .. 27. Temporary Suspension or Restriction.. 27. SUBCHAPTER C - DISCIPLINARY GUIDELINES .. 27. General 27. Definitions of Discipline Authorized .. 28. Aggravating and Mitigating Factors .. 28. Considerations for Criminal Offenses .. 29. Sanctions for Criminal Offenses .. 31. Schedule of Administrative Penalties .. 33. Application for Reissuance or Removal of Restrictions of a License or Registration.

3 36. Sanctions for Out-of- State Disciplinary Actions .. 37. Remedial Plan .. 37. Automatic Denial or Revocation .. 38. Surety Bond .. 38. CHAPTER 283 LICENSING REQUIREMENTS FOR PHARMACISTS .. 40. Purpose .. 40. Definitions .. 40. Educational and Age Requirements .. 41. Internship Requirements .. 41. Pharmacist-Intern Duties .. 45. Preceptor Requirements and Ratio of Preceptors to Pharmacist-Interns .. 46. Examination Requirements .. 47. Reciprocity Requirements .. 48. Fee Requirements for Licensure by Examination, Score Transfer and Reciprocity .. 49. Requirements for Application for a Pharmacist License Which Has Expired .. 50. Examination Retake Requirements .. 52. Licenses for Military Service Members, Military Veterans, and Military Spouses .. 52. CHAPTER 291 PHARMACIES .. 56. SUBCHAPTER A ALL CLASSES OF PHARMACIES .. 56. Pharmacy License Application .. 56. Definitions .. 56. Required Notifications .. 56.

4 Sworn Disclosure Statement .. 61. Texas Pharmacy Rules 22 TAC, PART 15 3. Click HERE to return to Table of Contents Closing a Pharmacy .. 61. Pharmacy License Fees .. 62. Prescription Drug Recalls by the Manufacturer .. 63. Return of Prescription 63. Prescription Pick Up Locations .. 65. Pharmacy Balance Registration/Inspection .. 65. Operation of a Pharmacy .. 65. Pharmacy License Renewal .. 66. Storage of 66. Samples .. 67. Inventory Requirements .. 67. Time Limit for Filing a Complaint .. 69. Administrative Actions as a Result of a Compliance Inspection .. 69. Petition to Establish an Additional Class of Pharmacy .. 69. Pilot or Demonstration Research Projects for Innovative Applications in the Practice of Pharmacy .. 70. Pharmacy Residency Programs .. 71. Confidentiality .. 71. Access to Confidential Records .. 72. Professional Responsibility of Pharmacists .. 73. SUBCHAPTER B COMMUNITY Pharmacy (CLASS A).

5 75. Definitions .. 75. Personnel .. 78. Operational Standards .. 83. 100. Official Prescription Requirements .. 116. Pharmacies Compounding Sterile Preparations (Class A-S).. 116. SUBCHAPTER C NUCLEAR Pharmacy (CLASS B) .. 117. Purpose .. 117. Definitions .. 117. Personnel .. 119. Operational Standards .. 122. 127. SUBCHAPTER D INSTITUTIONAL Pharmacy (CLASS C) .. 131. Texas Pharmacy Rules 22 TAC, PART 15 4. Click HERE to return to Table of Contents Purpose .. 131. Definitions .. 131. Personnel .. 135. Operational Standards .. 141. 156. Class C Pharmacies Located in a Freestanding Ambulatory Surgical Center .. 161. Pharmacies Compounding Sterile Preparations (Class C-S) .. 174. SUBCHAPTER E CLINIC Pharmacy (CLASS D) .. 176. Definitions .. 176. Personnel .. 178. Operational Standards .. 179. 186. SUBCHAPTER F NON-RESIDENT Pharmacy (CLASS E) .. 187. Purpose .. 187. Definitions .. 187. Personnel .. 189. Operational Standards.

6 189. Records .. 194. Pharmacies Compounding Sterile Preparations (Class E-S) .. 194. SUBCHAPTER G SERVICES PROVIDED BY PHARMACIES .. 195. General .. 195. Remote Pharmacy Services .. 196. Central Prescription Drug or Medication Order Processing .. 213. Centralized Prescription Dispensing .. 215. Emergency Remote Pharmacy License .. 217. Satellite Pharmacy .. 218. Pharmacies Compounding Non-Sterile Preparations .. 222. Pharmacies Compounding Sterile Preparations .. 232. SUBCHAPTER H OTHER CLASSES OF Pharmacy .. 265. Pharmacies Located in a Freestanding Emergency Medical Care Facility (Class F) .. 265. Central Prescription Drug or Medication Order Processing Pharmacy (Class G) .. 279. Limited Prescription Delivery Pharmacy (Class H) .. 284. CHAPTER 295 PHARMACISTS .. 285. Texas Pharmacy Rules 22 TAC, PART 15 5. Click HERE to return to Table of Contents Change of Address and/or Name .. 285. Change of Employment.

7 285. Responsibility of Pharmacist .. 285. Sharing Money Received for Prescription .. 285. Pharmacist License or Renewal Fees .. 285. Emergency Temporary Pharmacist License .. 286. Pharmacist License Renewal .. 286. Continuing Education Requirements .. 286. Inactive License .. 291. Notification to Consumers .. 292. Pharmacist Certification Programs .. 293. Drug Therapy Management by a Pharmacist under Written Protocol of a Physician .. 294. Dispensing of Opioid Antagonist by Pharmacist .. 297. Administration of Immunizations or Vaccinations by a Pharmacist under Written Protocol of Physician .. 298. Administration of Epinephrine by a Pharmacist .. 302. CHAPTER 297 Pharmacy TECHNICIANS AND Pharmacy TECHNICIAN TRAINEES .. 304. Purpose .. 304. Definitions .. 304. Registration Requirements .. 304. Fees .. 306. Pharmacy Technician Trainees .. 306. Pharmacy Technician and Pharmacy Technician Trainee Training .. 306.

8 Exemption from Pharmacy Technician Certification Requirements .. 308. Continuing Education Requirements .. 309. Notifications .. 313. Registration for Military Service Members, Military Veterans, and Military Spouses .. 313. Temporary Emergency Registration .. 315. CHAPTER 303 DESTRUCTION OF DRUGS .. 317. Destruction of Dispensed Drugs .. 317. Disposal of Stock Prescription Drugs .. 319. 319. CHAPTER 305 EDUCATIONAL REQUIREMENTS .. 320. Pharmacy Education Requirements .. 320. Texas Pharmacy Rules 22 TAC, PART 15 6. Click HERE to return to Table of Contents Pharmacy Technician Training Programs .. 320. CHAPTER 309 SUBSTITUTION OF DRUG PRODUCTS .. 322. Objective .. 322. Definitions .. 322. Substitution Requirements .. 323. Patient Notification .. 326. Communication with Prescriber .. 326. 327. Dispensing Responsibilities .. 327. Advertising of Generic Drugs by Pharmacies .. 327. CHAPTER 311 CODE OF CONDUCT .. 328.

9 Procedures .. 328. Procedures Regarding Complaints Filed against Board Members .. 328. CHAPTER 315 CONTROLLED SUBSTANCES .. 331. Definitions - Effective September 1, 2016 .. 331. Official Prescription Form - Effective September 1, 331. Prescriptions .. 332. Exceptions to Use of Form - Effective September 1, 2016 .. 333. Pharmacy Responsibility - Generally - Effective September 1, 2016 .. 334. Pharmacy Responsibility - Electronic Reporting .. 334. Pharmacy Responsibility - Oral, Telephonic, or Emergency Prescription - Effective September 1, 2016 .. 335. Pharmacy Responsibility - Modification of Prescription - Effective September 1, 2016 .. 335. Pharmacy Responsibility - Out-of- State Practitioner - Effective September 1, 2016 .. 335. Return of Unused Official Prescription Form - Effective September 1, 2016 .. 336. Release of Prescription Data .. 336. Schedule III through V Prescription Forms - Effective September 1, 2016.

10 336. Official Prescription Form - Effective September 1, 2016 .. 336. Official Prescription - Effective September 1, 2016 .. 337. Access Requirements .. 337. Patient Access to Prescription Monitoring Program Prescription Record .. 337. Texas Pharmacy Rules 22 TAC, PART 15 7. Click HERE to return to Table of Contents Texas Pharmacy Rules 22 TAC, PART 15 8. Click HERE to return to Table of Contents CHAPTER 281 ADMINISTRATIVE PRACTICE AND PROCEDURES. SUBCHAPTER A - GENERAL PROVISIONS. 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 .