Texas State Board of Pharmacy Board Rules June 6, 2022, Lecture notes of Pharmacy

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Texas State Board of Pharmacy

Board Rules

June 6, 2022

TEXAS ADMINISTRATIVE CODE

TITLE 22 – EXAMINING BOARDS

PART 15 – TEXAS STATE BOARD OF PHARMACY

Table of Contents

• Texas Pharmacy Rules 22 TAC, PART
• Texas State Board of Pharmacy
• Table of Contents
• CHAPTER 281 – ADMINISTRATIVE PRACTICE AND PROCEDURES
  • SUBCHAPTER A - GENERAL PROVISIONS
    • §281.1 Objective and Scope
    • §281.2 Definitions
    • §281.3 Construction of This Chapter
    • §281.4 Official Acts in Writing and Open to the Public
    • §281.5 Initiating Proceedings Before the Board
    • §281.6 Mental or Physical Examination
    • §281.7 Grounds for Discipline for a Pharmacist License
    • §281.8 Grounds for Discipline for a Pharmacy License
    • §281.9 Grounds for Discipline for a Pharmacy Technician or a Pharmacy Technician Trainee
    • §281.10 Denial of a License
    • §281.11 Criminal History Evaluation Letter
    • §281.12 Rules Governing Cooperating Practitioners................................................................................................
    • §281.13 Official Action by Majority
    • §281.14 Vendor Protest Procedures.........................................................................................................................
    • §281.15 Negotiated Rulemaking
    • §281.16 Alternative Dispute Resolution
    • §281.17 Historically Underutilized Businesses
    • §281.18 Reporting Professional Liability Claims
    • §281.19 Vehicles
  • SUBCHAPTER B - GENERAL PROCEDURES IN A CONTESTED CASE
    • §281.20 Application of Other Laws...........................................................................................................................
    • §281.21 Complaints
    • §281.22 Informal Disposition of a Contested Case...................................................................................................
    • §281.23 Subpoenas
    • §281.30 Pleadings and Notice in a Contested Case
    • §281.31 Burden of Proof...........................................................................................................................................
    • §281.32 Failure to Attend Hearing and Default........................................................................................................
    • §281.33 Proposal for Decision
• Texas Pharmacy Rules 22 TAC, PART - §281.34 Record of Hearing - §281.35 Temporary Suspension or Restriction.........................................................................................................
  • SUBCHAPTER C - DISCIPLINARY GUIDELINES
    • §281.60 General Guidance
    • §281.61 Definitions of Discipline Authorized
    • §281.62 Aggravating and Mitigating Factors
    • §281.63 Considerations for Criminal Offenses
    • §281.64 Sanctions for Criminal Offenses
    • §281.65 Schedule of Administrative Penalties
    • §281.66 Application for Reissuance or Removal of Restrictions of a License or Registration
    • §281.67 Sanctions for Out-of-State Disciplinary Actions
    • §281.68 Remedial Plan
    • §281.69 Automatic Denial or Revocation
    • §281.70 Surety Bond.................................................................................................................................................
• CHAPTER 283 – LICENSING REQUIREMENTS FOR PHARMACISTS - §283.1 Purpose - §283.2 Definitions - §283.3 Educational and Age Requirements - §283.4 Internship Requirements - §283.5 Pharmacist-Intern Duties - §283.6 Preceptor Requirements and Ratio of Preceptors to Pharmacist-Interns - §283.7 Examination Requirements......................................................................................................................... - §283.8 Reciprocity Requirements - §283.9 Fee Requirements for Licensure by Examination, Score Transfer and Reciprocity - §283.10 Requirements for Application for a Pharmacist License Which Has Expired - §283.11 Examination Retake Requirements............................................................................................................. - §283.12 Licenses for Military Service Members, Military Veterans, and Military Spouses
• CHAPTER 291 – PHARMACIES
  • SUBCHAPTER A – ALL CLASSES OF PHARMACIES
    • §291.1 Pharmacy License Application
    • §291.2 Definitions
    • §291.3 Required Notifications
    • §291.4 Sworn Disclosure Statement
• Texas Pharmacy Rules 22 TAC, PART - §291.5 Closing a Pharmacy - §291.6 Pharmacy License Fees - §291.7 Prescription Drug Recalls by the Manufacturer - §291.8 Return of Prescription Drugs - §291.9 Prescription Pick Up Locations - §291.10 Pharmacy Balance Registration/Inspection - §291.11 Operation of a Pharmacy - §291.14 Pharmacy License Renewal - §291.15 Storage of Drugs - §291.16 Samples - §291.17 Inventory Requirements - §291.18 Time Limit for Filing a Complaint - §291.19 Administrative Actions as a Result of a Compliance Inspection - §291.22 Petition to Establish an Additional Class of Pharmacy - §291.23 Pilot or Demonstration Research Projects for Innovative Applications in the Practice of Pharmacy - §291.24 Pharmacy Residency Programs - §291.27 Confidentiality - §291.28 Access to Confidential Records - §291.29 Professional Responsibility of Pharmacists.................................................................................................
  • SUBCHAPTER B – COMMUNITY PHARMACY (CLASS A)
    • §291.31 Definitions
    • §291.32 Personnel
    • §291.33 Operational Standards
    • §291.34 Records
    • §291.35 Official Prescription Requirements
    • §291.36 Pharmacies Compounding Sterile Preparations (Class A-S)
  • SUBCHAPTER C – NUCLEAR PHARMACY (CLASS B)
    • §291.51 Purpose
    • §291.52 Definitions
    • §291.53 Personnel
    • §291.54 Operational Standards
    • §291.55 Records
• Texas Pharmacy Rules 22 TAC, PART
  • SUBCHAPTER D – INSTITUTIONAL PHARMACY (CLASS C)
    • §291.71 Purpose
    • §291.72 Definitions
    • §291.73 Personnel
    • §291.74 Operational Standards
    • §291.75 Records
    • §291.76 Class C Pharmacies Located in a Freestanding Ambulatory Surgical Center
    • §291.77 Pharmacies Compounding Sterile Preparations (Class C-S)
  • SUBCHAPTER E – CLINIC PHARMACY (CLASS D)
    • §291.91 Definitions
    • §291.92 Personnel
    • §291.93 Operational Standards
    • §291.94 Records
  • SUBCHAPTER F – NON-RESIDENT PHARMACY (CLASS E)
    • §291.101 Purpose
    • §291.102 Definitions
    • §291.103 Personnel
    • §291.104 Operational Standards
    • §291.105 Records
    • §291.106 Pharmacies Compounding Sterile Preparations (Class E-S)
  • SUBCHAPTER G – SERVICES PROVIDED BY PHARMACIES
    • §291.120 General......................................................................................................................................................
    • §291.121 Remote Pharmacy Services
    • §291.123 Central Prescription Drug or Medication Order Processing
    • §291.125 Centralized Prescription Dispensing
    • §291.127 Emergency Remote Pharmacy License
    • §291.129 Satellite Pharmacy
    • §291.131 Pharmacies Compounding Non-Sterile Preparations
    • §291.133 Pharmacies Compounding Sterile Preparations
  • SUBCHAPTER H – OTHER CLASSES OF PHARMACY
    • §291.151 Pharmacies Located in a Freestanding Emergency Medical Care Facility (Class F)
    • §291.153 Central Prescription Drug or Medication Order Processing Pharmacy (Class G)......................................
    • §291.155 Limited Prescription Delivery Pharmacy (Class H)
• Texas Pharmacy Rules 22 TAC, PART
• CHAPTER 295 – PHARMACISTS
  • §295.1 Change of Address and/or Name..............................................................................................................
  • §295.2 Change of Employment.............................................................................................................................
  • §295.3 Responsibility of Pharmacist
  • §295.4 Sharing Money Received for Prescription
  • §295.5 Pharmacist License or Renewal Fees
  • §295.6 Emergency Temporary Pharmacist License
  • §295.7 Pharmacist License Renewal
  • §295.8 Continuing Education Requirements
  • §295.9 Inactive License
  • §295.11 Notification to Consumers
  • §295.12 Pharmacist Certification Programs
  • §295.13 Drug Therapy Management by a Pharmacist under Written Protocol of a Physician
  • §295.14 Dispensing of Opioid Antagonist by Pharmacist
  • §295.16 Administration of Epinephrine by a Pharmacist
• CHAPTER 297 – PHARMACY TECHNICIANS AND PHARMACY TECHNICIAN TRAINEES........................................................
  • §297.1 Purpose
  • §297.2 Definitions
  • §297.3 Registration Requirements
  • §297.4 Fees
  • §297.5 Pharmacy Technician Trainees
  • §297.6 Pharmacy Technician and Pharmacy Technician Trainee Training
  • §297.7 Exemption from Pharmacy Technician Certification Requirements.........................................................
  • §297.8 Continuing Education Requirements
  • §297.9 Notifications
  • §297.10 Registration for Military Service Members, Military Veterans, and Military Spouses
  • §297.11 Temporary Emergency Registration
• CHAPTER 303 – DESTRUCTION OF DRUGS
  • §303.1 Destruction of Dispensed Drugs
  • §303.2 Disposal of Stock Prescription Drugs
  • §303.3 Records
• Texas Pharmacy Rules 22 TAC, PART
• CHAPTER 305 – EDUCATIONAL REQUIREMENTS
  • §305.1 Pharmacy Education Requirements..........................................................................................................
  • §305.2 Pharmacy Technician Training Programs
• CHAPTER 309 – SUBSTITUTION OF DRUG PRODUCTS
  • §309.1 Objective
  • §309.2 Definitions
  • §309.3 Substitution Requirements
  • §309.4 Patient Notification
  • §309.5 Communication with Prescriber
  • §309.6 Records
  • §309.7 Dispensing Responsibilities
  • §309.8 Advertising of Generic Drugs by Pharmacies
• CHAPTER 311 – CODE OF CONDUCT
  • §311.1 Procedures
  • §311.2 Procedures Regarding Complaints Filed against Board Members............................................................
• CHAPTER 315 – CONTROLLED SUBSTANCES
  • §315.1 Definitions - Effective September 1,
  • §315.2 Official Prescription Form - Effective September 1,
  • §315.3 Prescriptions
  • §315.4 Exceptions to Use of Form - Effective September 1,
  • §315.5 Pharmacy Responsibility - Generally
  • §315.6 Pharmacy Responsibility - Electronic Reporting
  • §315.7 Pharmacy Responsibility - Oral, Telephonic, or Emergency Prescription - Effective September 1,
  • §315.8 Pharmacy Responsibility - Modification of Prescription - Effective September 1,
  • §315.9 Pharmacy Responsibility - Out-of-State Practitioner - Effective September 1,
  • §315.10 Return of Unused Official Prescription Form - Effective September 1,
  • §315.11 Release of Prescription Data
  • §315.12 Schedule III through V Prescription Forms - Effective September 1, 2016...............................................
  • §315.13 Official Prescription Form - Effective September 1,
  • §315.14 Official Prescription - Effective September 1,
  • §315.15 Access Requirements
  • §315.16 Patient Access to Prescription Monitoring Program Prescription Record

Texas Pharmacy Rules 22 TAC, PART 15 8

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.

Texas Pharmacy Rules 22 TAC, PART 15 10

(b) Other. In any other matter, any person desiring that the board perform some official act permitted or required by law shall request such performance in writing. Such requests shall be directed to the executive director/secretary of the board. Any written request shall be deemed sufficient to initiate the proceedings and present the subject matter to the board for its official determination if the request reasonably gives notice to the board of the act desired. The board may also initiate proceedings on its own motion.

§281.6 Mental or Physical Examination For the purposes of the Act, §§565.001(a)(4), 565.052, 568.003(a)(5), and 568.0036, shall be applied as follows. (1) The board may discipline an applicant, licensee, or registrant if the board finds that the applicant, licensee, or registrant has developed an incapacity that in the estimation of the board would prevent a pharmacist from engaging in the practice of pharmacy or a pharmacy technician or pharmacy technician trainee from practicing with a level of skill and competence that ensures the public health, safety, and welfare. (2) Upon a finding of probable cause, as determined by the board or an authorized agent of the board, that the applicant, licensee, or registrant has developed an incapacity that in the estimation of the board would prevent a pharmacist from engaging in the practice of pharmacy or a pharmacy technician or pharmacy technician trainee from practicing with a level of skill and competence that ensures the public health, safety, and welfare, the following is applicable. (A) The executive director/secretary, legal counsel of the agency, or other representative of the agency as designated by the executive director/secretary, shall request the applicant, licensee, or registrant to submit to a mental or physical examination by a physician or other healthcare professional designated by the board. The individual providing the examination shall be approved by the board. Such examination shall be coordinated through the entity that contracts with the board to aid impaired pharmacists and pharmacy students. The applicant, licensee, or registrant shall: (i) provide the entity with written notice of the appointment at least three days prior to the appointment; (ii) execute and return to the entity an authorization for release of relevant information on the form required by the entity, within ten days of receipt of request for the release from the entity; and (iii) follow all other procedures of the entity for each examination. (B) The applicant, licensee, or registrant shall be notified in writing, by either personal service or certified mail with return receipt requested, of the request to submit to the examination. (C) The applicant, licensee, or registrant shall submit to the examination within 30 days of the date of the receipt of the request. (D) The applicant, licensee, or registrant shall authorize the release of the results of the examination and the results shall be submitted to the board within 15 days of the date of the examination. (3) If the applicant, licensee, or registrant does not comply with the provisions of paragraph (2) of this section, the following is applicable. (A) The executive director/secretary shall cause to be issued an order requiring the applicant, licensee, or registrant to show cause why he/she will not submit to the examination. (B) The executive director/secretary shall schedule a hearing on the order before a panel of three members of the board appointed by the president of the board, within 30 days after notice is served on the applicant, licensee, or registrant. (C) The applicant, licensee, or registrant shall be notified of the hearing by either personal service or certified mail with return receipt requested. (D) At the hearing, the applicant, licensee, or registrant has the burden of proof once probable cause has been established by the board, as required by §565.062 of the Act to rebut the probable cause. The applicant, licensee, or registrant, and if applicable, the applicant's, licensee's, or registrants' attorney, are entitled to present testimony and other evidence to show why probable cause has not been

Texas Pharmacy Rules 22 TAC, PART 15 11

established requiring the applicant, licensee, or registrant to submit to the examination. An evaluation that has not been approved by the board and coordinated by the entity that contracts with the board to aid impaired pharmacist and pharmacy students according to its procedure cannot be admitted at the hearing in lieu of one that has been properly approved and coordinated. (E) After the hearing, the panel shall issue an order either requiring the applicant, licensee, or registrant to submit to the examination not later than the 60th day after the date of the order or withdraw the request for examination, as applicable.

§281.7 Grounds for Discipline for a Pharmacist License (a) For the purposes of the Act, §565.001(a)(2), "unprofessional conduct" is defined as engaging in behavior or committing an act that fails to conform with the standards of the pharmacy profession, including, but not limited to, criminal activity or activity involving moral turpitude, dishonesty, or corruption. This conduct shall include, but not be limited to: (1) dispensing a prescription drug pursuant to a forged, altered, or fraudulent prescription; (2) dispensing a prescription drug order pursuant to a prescription from a practitioner as follows: (A) the dispensing of a prescription drug order not issued for a legitimate medical purpose or in the usual course of professional practice shall include the following: (i) dispensing controlled substances or dangerous drugs to an individual or individuals in quantities, dosages, or for periods of time which grossly exceed standards of practice, approved labeling of the federal Food and Drug Administration, or the guidelines published in professional literature; or (ii) dispensing controlled substances or dangerous drugs when the pharmacist knows or reasonably should have known that the controlled substances or dangerous drugs are not necessary or required for the patient's valid medical needs or for a valid therapeutic purpose; (B) the provisions of subparagraph (A)(i) and (ii) of this paragraph are not applicable for prescriptions dispensed to persons with intractable pain in accordance with the requirements of the Intractable Pain Treatment Act, or to a narcotic drug dependent person in accordance with the requirements of Title 21, Code of Federal Regulations, §1306.07, and the Regulation of Narcotic Drug Treatment Programs Act; (3) delivering or offering to deliver a prescription drug or device in violation of this Act, the Controlled Substances Act, the Dangerous Drug Act, or rules promulgated pursuant to these Acts; (4) acquiring or possessing or attempting to acquire or possess prescription drugs in violation of this Act, the Controlled Substances Act, the Dangerous Drug Act, or rules adopted pursuant to these Acts; (5) distributing prescription drugs or devices to a practitioner or a pharmacy not in the course of professional practice or in violation of this Act, the Controlled Substances Act, Dangerous Drug Act, or rules adopted pursuant to these Acts; (6) refusing or failing to keep, maintain or furnish any record, notification or information required by this Act, the Controlled Substances Act, the Dangerous Drug Act, or rules adopted pursuant to these Acts; (7) refusing an entry into any pharmacy for any inspection authorized by the Act; (8) making false or fraudulent claims to third parties for reimbursement for pharmacy services; (9) operating a pharmacy in an unsanitary manner; (10) making false or fraudulent claims concerning any drug; (11) persistently and flagrantly overcharging for the dispensing of controlled substances; (12) dispensing controlled substances or dangerous drugs in a manner not consistent with the public health or welfare; (13) failing to practice pharmacy in an acceptable manner consistent with the public health and welfare; (14) refilling a prescription upon which there is authorized "prn" refills or words of similar meaning, for a period of time in excess of one year from the date of issuance of such prescription;

Texas Pharmacy Rules 22 TAC, PART 15 13

(B) prescription drugs provided by a manufacturer in replacement for such manufacturer's drugs that were dispensed pursuant to written starter prescriptions; or (C) prescription drug samples possessed by a pharmacy of a health care entity which provides health care primarily to indigent or low income patients at no or reduced cost and if: (i) the samples are possessed in compliance with the Prescription Drug Marketing Act of 1987; (ii) the pharmacy is owned by a charitable organization described in the Internal Revenue Code of 1986, §501(c)(3), or by a city, state or county government; and (iii) the samples are for dispensing or provision at no charge to patients of such health care entity; (27) selling, purchasing, or trading or offering to sell, purchase, or trade prescription drugs: (A) sold for export use only; (B) purchased by a public or private hospital or other health care entity; or (C) donated or supplied at a reduced price to a charitable organization described in the Internal Revenue Code of 1986, §501(c)(3); (D) provided that subparagraphs (A) - (C) of this paragraph do not apply to: (i) the purchase or other acquisition by a hospital or other health care entity which is a member of a group purchasing organization or from other hospitals or health care entities which are members of such organization; (ii) the sale, purchase, or trade of a drug or an offer to sell, purchase, or trade a drug by an organization described in subparagraph (C) of this paragraph to a nonprofit affiliate of the organization to the extent otherwise permitted by law; (iii) the sale, purchase or trade of a drug or an offer to sell, purchase, or trade a drug among hospitals or other health care entities which are under common control; (iv) the sale, purchase, or trade of a drug or an offer to sell, purchase, or trade a drug for emergency medical reasons including the transfer of a drug between pharmacies to alleviate temporary shortages of the drug arising from delays in or interruptions of regular distribution schedules; or (v) the dispensing of a prescription drug pursuant to a valid prescription drug order to the extent otherwise permitted by law; (28) selling, purchasing, or trading, or offering to sell, purchase, or trade: (A) misbranded prescription drugs; or (B) prescription drugs beyond the manufacturer's expiration date; (29) failing to respond and to provide all requested records within the time specified in an audit of continuing education records under §295.8 of this title (relating to Continuing Education Requirements); or (30) allowing an individual whose license to practice pharmacy, either as a pharmacist or a pharmacist-intern, or a pharmacy technician/trainee whose registration has been disciplined by the board, resulting in the license or registration being revoked, canceled, retired, surrendered, denied or suspended, to have access to prescription drugs in a pharmacy. (b) For the purposes of the Act, §565.001(a)(3), the term "gross immorality" shall include, but not be limited to: (1) conduct which is willful, flagrant, and shameless, and which shows a moral indifference to standards of the community; (2) engaging in an act which is a felony; (3) engaging in an act that constitutes sexually deviant behavior; or (4) being required to register with the Department of Public Safety as a sex offender under Chapter 62, Code of Criminal Procedure. (c) For the purposes of the Act, §565.001(a)(5), the terms "fraud," "deceit," or "misrepresentation" in the practice of pharmacy or in seeking a license to act as a pharmacist shall be defined as follows:

Texas Pharmacy Rules 22 TAC, PART 15 14

(1) "Fraud" means an intentional perversion of truth for the purpose of inducing another in reliance upon it to part with some valuable thing belonging to him, or to surrender a legal right, or to issue a license; a false representation of a matter of fact, whether by words or by conduct, by false or misleading allegations, or by concealment of that which should have been disclosed, which deceives or is intended to deceive another. (2) "Deceit" means the assertion, as a fact, of that which is not true by any means whatsoever to deceive or defraud another. (3) "Misrepresentation" means a manifestation by words or other conduct which is a false representation of a matter of fact.

§281.8 Grounds for Discipline for a Pharmacy License (a) For the purposes of §565.002(a)(9) of the Act, a pharmacy fails to establish and maintain effective controls against diversion of prescription drugs when: (1) there is inadequate security or procedures to prevent unauthorized access to prescription drugs; or (2) there is inadequate security or procedures to prevent the diversion of prescription drugs. (b) For the purposes of §565.002(a)(3) of the Act, it is grounds for discipline for a pharmacy license when: (1) during the time an individual's license to practice pharmacy, either as a pharmacist or a pharmacist-intern, or a pharmacy technician's registration has been disciplined by the Board, resulting in the license or registration being revoked, canceled, retired, surrendered, denied or suspended, the pharmacy employs or allows such individual access to prescription drugs; (2) the pharmacy possesses or engages in the sale, purchase, or trade or the offer to sell, purchase, or trade prescription drug samples; provided however, this paragraph does not apply to: (A) prescription drugs provided by a manufacturer as starter prescriptions or as replacement for such manufacturer's outdated drugs; (B) prescription drugs provided by a manufacturer in replacement for such manufacturer's drugs that were dispensed pursuant to written starter prescriptions; or (C) prescription drug samples possessed by a pharmacy of a health care entity which provides health care primarily to indigent or low income patients at no or reduced cost and if: (i) the samples are possessed in compliance with the Prescription Drug Marketing Act of 1987; (ii) the pharmacy is owned by a charitable organization described in the Internal Revenue Code of 1986, §501(c)(3), or by a city, state or county government; and (iii) the samples are for dispensing or provision at no charge to patients of such health care entity; (3) the pharmacy possesses or engages in the sale, purchase, or trade or the offer to sell, purchase, or trade of prescription drugs: (A) sold for export use only; (B) purchased by a public or private hospital or other health care entity; or (C) donated or supplied at a reduced price to a charitable organization described in the Internal Revenue Code of 1986, §501(c)(3), and possessed by a pharmacy other than one owned by the charitable organization; (D) provided that subparagraphs (A) - (C) of this paragraph do not apply to: (i) the purchase or other acquisition by a hospital or other health care entity which is a member of a group purchasing organization or from other hospitals or health care entities which are members of such organization; (ii) the sale, purchase, or trade of a drug or an offer to sell, purchase, or trade a drug by an organization described in paragraph (2)(C)(ii) of this subsection to a nonprofit affiliate of the organization to the extent otherwise permitted by law; (iii) the sale, purchase or trade of a drug or an offer to sell, purchase, or trade a drug among hospitals or other health care entities which are under common control;

Texas Pharmacy Rules 22 TAC, PART 15 16

(7) failing to respond and to provide all requested records within the time specified in an audit of continuing education records under §297.8 of this title (relating to Continuing Education Requirements). (c) For the purposes of the Act, §568.003(a)(2), the term "gross immorality" shall include, but not be limited to: (1) conduct which is willful, flagrant, and shameless, and which shows a moral indifference to standards of the community; (2) engaging in an act which is a felony; (3) engaging in an act that constitutes sexually deviant behavior; or (4) being required to register with the Department of Public Safety as a sex offender under Chapter 62, Code of Criminal Procedure. (d) For the purposes of the Act, §568.003(a)(3), the terms "fraud," "deceit," or "misrepresentation" shall apply to an individual seeking a registration as a pharmacy technician, as well as making an application to any entity that certifies or registers pharmacy technicians, and shall be defined as follows: (1) "Fraud" means an intentional perversion of truth for the purpose of inducing the board in reliance upon it to issue a registration; a false representation of a matter of fact, whether by words or by conduct, by false or misleading allegations, or by concealment of that which should have been disclosed, which deceives or is intended to deceive the board. (2) "Deceit" means the assertion, as a fact, of that which is not true by any means whatsoever to deceive or defraud the board. (3) "Misrepresentation" means a manifestation by words or other conduct which is a false representation of a matter of fact.

§281.10 Denial of a License If an applicant's original application or request for renewal of a license is denied, he shall have 30 days from the date of denial to make a written request for a hearing. If so requested, the hearing will be granted and the provisions of APA and this chapter with regard to a contested case shall apply.

§281.11 Criminal History Evaluation Letter (a) A person, who is enrolled or planning to enroll in an educational program that prepares the person for a license as a pharmacist or a registration as a pharmacy technician or trainee, or planning to take an examination required for such a license or registration, and who has reason to believe that he or she may be ineligible due to a conviction or deferred adjudication for a felony or misdemeanor offense, may request a criminal history evaluation letter regarding his or her eligibility for a license or registration. (b) The person must submit an application for the criminal history evaluation letter on a form provided by the board which includes: (1) a statement indicating the reasons and basis for potential ineligibility, including each criminal offense for which the person was arrested, charged, convicted, or received deferred adjudication; (2) all legal documents related to the reasons and basis for potential ineligibility including, but not limited to, police reports, indictments, orders of deferred adjudication, judgments, probation records and evidence of completion of probation, if applicable; (3) all requirements necessary in order for the Board to access the criminal history record information, including submitting fingerprint information and paying the required fees; and (4) a non-refundable fee of $150 for processing the application. (c) The application is considered complete when all documents and other information supporting the potential reasons and basis for potential ineligibility has been received by the board. If such documentation is not received within 120 days of the initial receipt of the application, the application is considered to be expired and must be refilled along with the appropriate fees. (d) The board shall conduct an investigation of the application and the person's eligibility for a license or registration.

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(e) The person or the Board may amend the application to include additional grounds for potential ineligibility at any time before a final determination is made. (f) A determination of eligibility will be made by the Board or its designees. Notification of the determination will be provided to the person in writing. (1) If no grounds for ineligibility are identified, the notification shall address the determination regarding each ground of potential ineligibility. (2) If grounds for ineligibility exist, the notification shall set out each basis for potential ineligibility and the corresponding determination. (g) The board shall mail the determination of eligibility no later than the 90th day after the complete application, as required by subsections (b) and (c) of this section, has been received by the board. (h) The determination of eligibility shall be made based on the law in effect on the date of receipt of a complete application. (i) Any information the person fails to disclose on the application or any information determined to be inaccurate or incomplete shall invalidate the determination of eligibility on the basis of the information, in the discretion of the board. (j) The administrative rules regarding disciplinary guidelines and regarding considerations and sanctions for criminal conduct apply in making the determination regarding eligibility. (k) If a person submits an application for license or registration at the same time or within 90 days after the receipt of a complete application for criminal history evaluation letter, board will process only the application for license or registration and will not issue a separate determination of eligibility.

§281.12 Rules Governing Cooperating Practitioners For the purposes of the Act, §565.063, a person acting under the supervision of a Board employee engaged in the lawful enforcement of the Act shall include, but not be limited to, a practitioner who provides prescriptions for use in investigations of licensees when such prescriptions are issued by a practitioner at the request of and under the supervision of a Board investigator.

§281.13 Official Action by Majority Any official act or decision of the board shall be concurred in by a majority of its members present at a meeting. Such act or decision shall be based upon information presented to members present at official meetings of the board. There shall be at least a quorum of the board members present at any official meeting of the board. Private solicitation of individual members in an effort to in any way influence their official actions through information or arguments not simultaneously presented to other members of the board is improper.

§281.14 Vendor Protest Procedures (a) The purpose of this section is to establish procedures for resolving vendor protests relating to purchasing issues. (b) A vendor who submitted a written response to a solicitation may file a protest with the executive director for actions taken by the board on the following: (1) the solicitation documents or actions associated with the publication of solicitation documents; (2) the evaluation or method of evaluation for a solicitation; or (3) the award of a contract. (c) Filing requirements. (1) To be considered, a protest must be: (A) in writing and contain: (i) the specific rule, statute or regulation the protesting vendor alleges the solicitation, contract award, or tentative award violated;

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§281.15 Negotiated Rulemaking (a) The board's policy is to encourage the use of negotiated rulemaking for the adoption of board rules in appropriate situations. (b) The board's general counsel or the designee of the general counsel shall be the board's negotiated rulemaking coordinator (NRC). The NRC shall perform the following functions, as required: (1) coordinate the implementation of the policy set out in subsection (a) of this section and in accordance with the Negotiated Rulemaking Act, Chapter 2008, Government Code; (2) serve as a resource for any staff training or education needed to implement negotiated rulemaking procedures; and (3) collect data to evaluate the effectiveness of negotiated rulemaking procedures implemented by the board. (c) The board or the executive director may direct the NRC to begin negotiated rulemaking procedures on a specified subject.

§281.16 Alternative Dispute Resolution (a) The board's policy is to encourage the resolution and early settlement of internal and external disputes, including contested cases, through voluntary settlement processes, which may include any procedure or combination of procedures described by Chapter 154, Civil Practice and Remedies Code. Any ADR procedure used to resolve disputes before the board shall comply with the requirements of Chapter 2009, Government Code, and any model guidelines for the use of ADR issued by the State Office of Administrative Hearings. (b) The board's general counsel or the designee of the general counsel shall be the board's dispute resolution coordinator (DRC). The DRC shall perform the following functions, as required: (1) coordinate the implementation of the policy set out in subsection (a) of this section; (2) serve as a resource for any staff training or education needed to implement the ADR procedures; and (3) collect data to evaluate the effectiveness of ADR procedures implemented by the board. (c) The board, a committee of the board, a respondent in a disciplinary matter pending before the board, the executive director, or a board employee engaged in a dispute with the executive director or another employee, may request that the contested matter be submitted to ADR. The request must be in writing, be addressed to the DRC, and state the issues to be determined. The person requesting ADR and the DRC will determine which method of ADR is most appropriate. If the person requesting ADR is the respondent in a disciplinary proceeding, the executive director shall determine if the board will participate in ADR or proceed with the board's normal disciplinary processes. (d) Any costs associated with retaining an impartial third party mediator, moderator, facilitator, or arbitrator, shall be borne by the party requesting ADR. (e) Agreements of the parties to ADR must be in writing and are enforceable in the same manner as any other written contract. Confidentiality of records and communications related to the subject matter of an ADR proceeding shall be governed by §154.073 of the Civil Practice and Remedies Code. (f) If the ADR process does not result in an agreement, the matter shall be referred to the board for other appropriate disposition.

§281.17 Historically Underutilized Businesses The Texas State Board of Pharmacy adopts by reference the rules promulgated by the Texas Building and Procurement Commission, which are set forth in Subchapter B of 1 TAC §111.11, et al. regarding Historically Underutilized Business Certification Program.

§281.18 Reporting Professional Liability Claims (a) Reporting responsibilities. (1) Every insurer or other entity providing pharmacist's professional liability insurance, pharmacy technician professional and supplemental liability insurance, or druggist's professional liability insurance covering a

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pharmacist, pharmacy technician, or pharmacy license holder in this state shall submit to the board the information described in subsection (b) of this section at the time prescribed. (2) The information shall be provided with respect to a notice of claim letter or complaint filed against an insured in a court, if the notice or complaint seeks damages relating to the insured's conduct in providing or failing to provide appropriate service within the scope of pharmaceutical care or services, and with respect to settlement of a claim or lawsuit made on behalf of the insured. (3) If a pharmacist, pharmacy technician, or a pharmacy licensed in this state does not carry or is not covered by pharmacist's professional liability insurance, pharmacy technician professional and supplemental liability insurance, or druggist's professional liability insurance, or if a pharmacist, pharmacy technician, or a pharmacy licensed in this state is insured by a non-admitted carrier or other entity providing pharmacy professional liability insurance that does not report under this Act, the duty to report information under subsection (b) of this section is the responsibility of the particular pharmacist, pharmacy technician, or pharmacy license holder. (4) For the purposes of this section a professional liability claim or complaint shall be defined as a cause of action against a pharmacist, pharmacy, or pharmacy technician for conduct in providing or failing to provide appropriate service within the scope of pharmaceutical care or services, which proximately results in injury to or death of the patient, whether the patient's claim or cause of action sounds in tort or contract, to include pharmacist's interns, pharmacy residents, supervising pharmacists, on-call pharmacists, consulting pharmacists. (b) Information to be reported and due dates. The following reports are required for claims initiated or resolved on or after September 1, 1999. (1) Initial report. Not later than the 30th day after receipt of the notice of claim letter or complaint by the insurer if the insurer has the duty to report, or by the pharmacist, pharmacy technician, or a pharmacy if the license holder has the duty to report, the following information must be furnished to the board on a form provided by the board: (A) the name and address of the insurer; (B) the name and address of the insured and type of license or registration held (pharmacist, pharmacy or pharmacy technician): (C) the insured's Texas pharmacist or pharmacy license number or pharmacy technician registration number; (D) certification, if applicable; (E) the policy number; (F) name(s) of plaintiff(s); (G) date of injury; (H) county of injury; (I) cause of injury, e.g., dispensing error; (J) nature of injury; (K) type of action, e.g., claim only or lawsuit; (L) name and phone number of the person filing the report; and (M) a copy of the notice of claim letter or the lawsuit filed in court. (2) Follow-up report. Within 105 days after disposition of the claim, the following information must be provided to the board on a form provided by the board: (A) the name and address of the insured and type of license or registration held (pharmacist, pharmacy or pharmacy technician): (B) the insured's Texas pharmacist or pharmacy license number or pharmacy technician registration number; (C) name(s) of plaintiff(s); (D) date of disposition; (E) type of disposition, e.g., settlement, judgment; (F) amount of disposition;