(a) Purpose.
  (1) The purpose of this section is to provide standards for a centralized prescription drug or medication order processing pharmacy.
  (2) Any facility established for the primary purpose of processing prescription drug or medication drug orders shall be licensed as a Class G pharmacy under the Act. A Class G pharmacy shall not store bulk drugs or dispense a prescription drug order. Nothing in this subsection shall prohibit an individual pharmacist employee, individual pharmacy technician employee, or individual pharmacy technician trainee employee who is licensed in Texas from remotely accessing the pharmacy's electronic database from a location other than a licensed pharmacy in order to process prescription or medication drug orders, provided the pharmacy establishes controls to protect the privacy and security of confidential records, and the Texas-licensed pharmacist, pharmacy technician, or pharmacy technician trainee does not engage in the receiving of written prescription or medication orders or the maintenance of prescription or medication drug orders at the non-licensed remote location.
(b) Definitions. The following words and terms, when used in this section, shall have the following meanings, unless the context clearly indicates otherwise. Any term not defined in this section shall have the definition set out in the Act.
  (1) Centralized prescription drug or medication order processing--The processing of prescription drug or medication orders by a Class G pharmacy on behalf of another pharmacy, a health care provider, or a payor. Centralized prescription drug or medication order processing does not include the dispensing of a prescription drug but includes any of the following:
    (A) receiving, interpreting, or clarifying prescription drug or medication orders;
    (B) data entering and transferring of prescription drug or medication order information;
    (C) performing drug regimen review;
    (D) obtaining refill and substitution authorizations;
    (E) verifying accurate prescription data entry;
    (F) interpreting clinical data for prior authorization for dispensing;
    (G) performing therapeutic interventions; and
    (H) providing drug information concerning a patient's prescription.
  (2) Full-time pharmacist--A pharmacist who works in a pharmacy from 30 to 40 hours per week or, if the pharmacy is open less than 60 hours per week, one-half of the time the pharmacy is open.
(c) Personnel.
  (1) Pharmacist-in-charge.
    (A) General. Each Class G pharmacy shall have one pharmacist-in-charge who is employed on a full-time basis, who may be the pharmacist-in-charge for only one such pharmacy.
    (B) Responsibilities. The pharmacist-in-charge shall have responsibility for the practice of pharmacy at the pharmacy for which he or she is the pharmacist-in-charge. The pharmacist-in-charge may advise the owner on administrative or operational concerns. The pharmacist-in-charge shall have responsibility for, at a minimum, the following:
      (i) educating and training pharmacy technicians and pharmacy technician trainees;
      (ii) maintaining records of all transactions of the Class G pharmacy required by applicable state and federal laws and regulations;
      (iii) adhering to policies and procedures regarding the maintenance of records in a data processing system such that the data processing system is in compliance with Class G pharmacy requirements; and
      (iv) legally operating the pharmacy, including meeting all inspection and other requirements of all state and federal laws or regulations governing the practice of pharmacy.
  (2) Owner. The owner of a Class G pharmacy shall have responsibility for all administrative and operational functions of the pharmacy. The pharmacist-in-charge may advise the owner on administrative and operational concerns. The owner shall have responsibility for, at a minimum, the following, and if the owner is not a Texas licensed pharmacist, the owner shall consult with the pharmacist-in-charge or another Texas licensed pharmacist:
    (A) providing the pharmacy with the necessary equipment and resources commensurate with its level and type of practice; and
    (B) establishing policies and procedures regarding maintenance, storage, and retrieval of records in a data processing system such that the system is in compliance with state and federal requirements.
  (3) Pharmacists.
    (A) General.
      (i) The pharmacist-in-charge shall be assisted by a sufficient number of additional licensed pharmacists as may be required to operate the Class G pharmacy competently, safely, and adequately to meet the needs of the patients of the pharmacy.
      (ii) All pharmacists shall assist the pharmacist-in-charge in meeting his or her responsibilities.
      (iii) Pharmacists are solely responsible for the direct supervision of pharmacy technicians and pharmacy technician trainees and for designating and delegating duties, other than those listed in subparagraph (B) of this paragraph, to pharmacy technicians and pharmacy technician trainees. Each pharmacist shall be responsible for any delegated act performed by pharmacy technicians and pharmacy technician trainees under his or her supervision.
      (iv) Pharmacists shall directly supervise pharmacy technicians and pharmacy technician trainees who are entering prescription data into the pharmacy's data processing system by one of the following methods.
        (I) Physically present supervision. A pharmacist shall be physically present to directly supervise a pharmacy technician or pharmacy technician trainee who is entering prescription order or medication order data into the data processing system. Each prescription or medication order entered into the data processing system shall be verified at the time of data entry.
        (II) Electronic supervision. A pharmacist may electronically supervise a pharmacy technician or pharmacy technician trainee who is entering prescription order or medication order data into the data processing system provided the pharmacist:
          (-a-) has the ability to immediately communicate directly with the technician/trainee;
          (-b-) has immediate access to any original document containing prescription or medication order information or other information related to the dispensing of the prescription or medication order. Such access may be through imaging technology provided the pharmacist has the ability to review the original, hardcopy documents if needed for clarification; and
          (-c-) verifies the accuracy of the data entered information prior to the release of the information to the system for storage.
        (III) Electronic verification of data entry by pharmacy technicians or pharmacy technician trainees. A pharmacist may electronically verify the data entry of prescription information into a data processing system provided:
          (-a-) the pharmacist has the ability to immediately communicate directly with the technician/trainee;
          (-b-) the pharmacist electronically conducting the verification is either a:
            (-1-) Texas licensed pharmacist; or
            (-2-) pharmacist employed by a Class E pharmacy that has the same owner as the Class G pharmacy where the pharmacy technicians/trainees are located, or that has entered into a written contract or agreement with the Class G pharmacy which outlines the services to be provided and the responsibilities and accountabilities of each pharmacy in compliance with federal and state laws and regulations;
          (-c-) the pharmacy establishes controls to protect the privacy and security of confidential records; and
          (-d-) the pharmacy keeps permanent records of prescriptions electronically verified for a period of two years.
      (v) All pharmacists while on duty, shall be responsible for complying with all state and federal laws or rules governing the practice of pharmacy.
    (B) Duties. Duties which may only be performed by a pharmacist are as follows:
      (i) receiving oral prescription drug or medication orders for controlled substances and reducing these orders to writing, either manually or electronically;
      (ii) interpreting prescription drug or medication orders;
      (iii) selecting drug products;
      (iv) verifying the data entry of the prescription drug or medication order information at the time of data entry prior to the release of the information to a Class A, Class C, or Class E pharmacy for dispensing;
      (v) communicating to the patient or patient's agent information about the prescription drug or device which in the exercise of the pharmacist's professional judgment, the pharmacist deems significant, as specified in §291.33(c) of this title (relating to Operational Standards);
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(vi) communicating to the patient or the patient's agent on his or her request information concerning any prescription drugs dispensed to the patient by the pharmacy;
      (vii) assuring that a reasonable effort is made to obtain, record, and maintain patient medication records; and
      (viii) interpreting patient medication records and performing drug regimen reviews.
  (4) Pharmacy Technicians and Pharmacy Technician Trainees.
    (A) General. All pharmacy technicians and pharmacy technician trainees shall meet the training requirements specified in §297.6 of this title (relating to Pharmacy Technician and Pharmacy Technician Trainee Training).
    (B) Duties.
      (i) Pharmacy technicians and pharmacy technician trainees may not perform any of the duties listed in paragraph (3)(B) of this subsection.
      (ii) A pharmacist may delegate to pharmacy technicians and pharmacy technician trainees any nonjudgmental technical duty associated with the preparation and distribution of prescription drugs provided:
        (I) a pharmacist verifies the accuracy of all acts, tasks, and functions performed by pharmacy technicians and pharmacy technician trainees; and
        (II) pharmacy technicians and pharmacy technician trainees are under the direct supervision of and responsible to a pharmacist.
      (iii) Pharmacy technicians and pharmacy technician trainees may perform only nonjudgmental technical duties associated with the preparation of prescription drugs, as follows:
        (I) initiating and receiving refill authorization requests; and
        (II) entering prescription or medication order data into a data processing system.
      (iv) In addition to the duties listed above in clause (iii) of this subparagraph, pharmacy technicians may perform the following nonjudgmental technical duties associated with the preparation and distribution of prescription drugs:
        (I) receiving oral prescription drug or medication orders for dangerous drugs and reducing these orders to writing, either manually or electronically; and
        (II) transferring or receiving a transfer of original prescription drug or medication order information for a dangerous drug on behalf of a patient.
  (5) Identification of pharmacy personnel. All pharmacy personnel shall be identified as follows.
    (A) Pharmacy technicians. All pharmacy technicians shall wear an identification tag or badge that bears the person's name and identifies him or her as a pharmacy technician, or a certified pharmacy technician, if the technician maintains current certification with the Pharmacy Technician Certification Board or any other entity providing an examination approved by the board.
    (B) Pharmacy technician trainees. All pharmacy technician trainees shall wear an identification tag or badge that bears the person's name and identifies him or her as a pharmacy technician trainee.
    (C) Pharmacist interns. All pharmacist interns shall wear an identification tag or badge that bears the person's name and identifies him or her as a pharmacist intern.
    (D) Pharmacists. All pharmacists shall wear an identification tag or badge that bears the person's name and identifies him or her as a pharmacist.
(d) Operational Standards.
  (1) General requirements.
    (A) A Class A, Class C, or Class E Pharmacy may outsource prescription drug or medication order processing to a Class G pharmacy provided the pharmacies:
      (i) have:
        (I) the same owner; or
        (II) entered into a written contract or agreement which outlines the services to be provided and the responsibilities and accountabilities of each pharmacy in compliance with federal and state laws and regulations; and
      (ii) share a common electronic file or have appropriate technology to allow access to sufficient information necessary or required to perform a non-dispensing function.
    (B) A Class G pharmacy shall comply with the provisions applicable to the class of pharmacy contained in §§291.31 - 291.35 of this title (relating to Definitions, Personnel, Operational Standards, Records, and Official Prescription Requirements in a Class A (Community) Pharmacy), §§291.72 - 291.75 of this title (relating to Definitions, Personnel, Operational Standards, and Records in a Class C (Institutional) Pharmacy), or §§291.102 - 291.105 of this title (relating to Definitions, Personnel, Operational Standards, and Records in a Class E (Non-Resident) Pharmacy) to the extent applicable for the specific processing activity and this section including:
      (i) duties which must be performed by a pharmacist; and
      (ii) supervision requirements for pharmacy technicians and pharmacy technician trainees.
  (2) Licensing requirements.
    (A) A Class G pharmacy shall register with the board on a pharmacy license application provided by the board, following the procedures specified in §291.1 of this title (relating to Pharmacy License Application).
    (B) A Class G pharmacy which changes ownership shall notify the board within 10 days of the change of ownership and apply for a new and separate license as specified in §291.3 of this title (relating to Required Notifications).
    (C) A Class G pharmacy which changes location and/or name shall notify the board of the change within 10 days and file for an amended license as specified in §291.3 of this title.
    (D) A Class G pharmacy owned by a partnership or corporation which changes managing officers shall notify the board in writing of the names of the new managing officers within 10 days of the change, following the procedures in §291.3 of this title.
    (E) A Class G pharmacy shall notify the board in writing within 10 days of closing, following the procedures in §291.5 of this title (relating to Closing a Pharmacy).
    (F) A fee as specified in §291.6 of this title (relating to Pharmacy License Fees) will be charged for issuance and renewal of a license and the issuance of an amended license.
    (G) A separate license is required for each principal place of business and only one pharmacy license may be issued to a specific location.
  (3) Environment.
    (A) General requirements.
      (i) The pharmacy shall be arranged in an orderly fashion and kept clean. All required equipment shall be in good operating condition.
      (ii) The pharmacy shall be properly lighted and ventilated.
      (iii) The pharmacy is not required to have a sink exclusive of restroom facilities.
    (B) Security.
      (i) Each pharmacist while on duty shall be responsible for the security of the prescription department, including provisions for effective control against theft or diversion of prescription drug records.
      (ii) Pharmacies shall employ appropriate measures to ensure that security of prescription drug records is maintained at all times to prohibit unauthorized access.
  (4) Policy and Procedures. A policy and procedure manual shall be maintained by the Class G pharmacy and be available for inspection. The manual shall:
    (A) outline the responsibilities of each of the pharmacies;
    (B) include a list of the name, address, telephone numbers, and all license/registration numbers of the pharmacies involved in centralized prescription drug or medication order processing; and
    (C) include policies and procedures for:
      (i) protecting the confidentiality and integrity of patient information;
      (ii) maintaining appropriate records to identify the name(s), initials, or identification code(s) and specific activity(ies) of each pharmacist or pharmacy technician who performed any processing;
      (iii) complying with federal and state laws and regulations;
      (iv) operating a continuous quality improvement program for pharmacy services designed to objectively and systematically monitor and evaluate the quality and appropriateness of patient care, pursue opportunities to improve patient care, and resolve identified problems; and
      (v) annually reviewing the written policies and procedures and documenting such review.
(e) Records.
  (1) every record required to be kept under the provisions of this section shall be:
    (A) kept by the pharmacy and be available, for at least two years from the date of such inventory or record, for inspecting and copying by the board or its representative and to other authorized local, state, or federal law enforcement agencies; and
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(B) supplied by the pharmacy within 72 hours, if requested by an authorized agent of the board. If the pharmacy maintains the records in an electronic format, the requested records must be provided in a mutually agreeable electronic format if specifically requested by the board or its representative. Failure to provide the records set out in this section, either on site or within 72 hours, constitutes prima facie evidence of failure to keep and maintain records in violation of the Act.
  (2) The pharmacy shall maintain appropriate records which identify, by prescription drug or medication order, the name(s), initials, or identification code(s) of each pharmacist, pharmacy technician, or pharmacy technician trainee who performs a processing function for a prescription drug or medication order. Such records may be maintained:
    (A) separately by each pharmacy and pharmacist; or
    (B) in a common electronic file as long as the records are maintained in such a manner that the data processing system can produce a printout which lists the functions performed by each pharmacy and pharmacist.
  (3) In addition, the pharmacy shall comply with the record keeping requirements applicable to the class of pharmacy to the extent applicable for the specific processing activity and this section.

Source Note: The provisions of this §291.153 adopted to be effective January 1, 2011, 35 TexReg 8358; amended to be effective July 11, 2011, 36 TexReg 4413; amended to be effective June 7, 2012, 37 TexReg 4047; amended to be effective March 26, 2014, 39 TexReg 2081; amended to be effective March 7, 2018, 43 TexReg 1278; amended to be effective June 20, 2019, 44 TexReg 2952; amended to be effective September 9, 2020, 45 TexReg 6237; amended to be effective December 10, 2020, 45 TexReg 8865