<<Prev Rule

Texas Administrative Code

Next Rule>>
TITLE 22EXAMINING BOARDS
PART 15TEXAS STATE BOARD OF PHARMACY
CHAPTER 291PHARMACIES
SUBCHAPTER GSERVICES PROVIDED BY PHARMACIES
RULE §291.129Satellite Pharmacy

(a) Purpose. The purpose of this section is to create a new class of pharmacy for the provision of pharmacy services by a Class A or Class C pharmacy in a location that is not at the same location as the Class A or Class C pharmacy through a satellite pharmacy and to provide standards for the operation of this class of pharmacy established under §560.053 of the Texas Pharmacy Act.

(b) Definitions. The following words and terms, when used in this section, shall have the following meanings, unless the context clearly indicates otherwise. All other words and terms shall have the meanings as defined in the Act or in §291.31 of this title (relating to Definitions).

  (1) Provider pharmacy--The Class A or Class C pharmacy providing satellite pharmacy services.

  (2) Satellite pharmacy--A facility not located at the same location as a Class A or Class C pharmacy at which satellite pharmacy services are provided.

  (3) Satellite pharmacy services--The provision of pharmacy services, including the storage and delivery of prescription drugs, in an alternate location.

(c) General requirements.

  (1) A Class A or Class C provider pharmacy may establish a satellite pharmacy in a location that is not at the same location as the Class A or Class C pharmacy.

  (2) The pharmacist-in-charge of the provider pharmacy is responsible for all pharmacy operations involving the satellite pharmacy including supervision of satellite pharmacy personnel and compliance with this section.

  (3) A satellite pharmacy may not store bulk drugs and may only store prescription medications that have been previously verified and dispensed by the provider pharmacy.

  (4) A Class C pharmacy that is a provider pharmacy dispensing outpatient prescriptions for a satellite pharmacy shall comply with the provisions of §§291.31 - 291.34 of this title (relating to Definitions, Personnel, Operational Standards, and Records for Class A (Community) pharmacies) and this section.

  (5) The provider pharmacy and the satellite pharmacy must have:

    (A) the same owner; and

    (B) share a common electronic file or have appropriate technology to allow access to sufficient information necessary or required to process a non-dispensing function.

(d) Personnel.

  (1) All individuals working at the satellite pharmacy shall be employees of the provider pharmacy and must report their employment to the board as such.

  (2) A satellite pharmacy shall have sufficient pharmacists on duty to operate the satellite pharmacy competently, safely, and adequately to meet the needs of the patients of the pharmacy.

  (3) 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 paragraph (7) of this subsection, to pharmacy technicians and pharmacy technician trainees. Each pharmacist:

    (A) shall verify the accuracy of all acts, tasks, and functions performed by pharmacy technicians and pharmacy technician trainees; and

    (B) shall be responsible for any delegated act performed by pharmacy technicians and pharmacy technician trainees under his or her supervision.

  (4) A pharmacist shall be physically present to directly supervise a pharmacy technician or pharmacy technician trainee who is entering prescription data into the data processing system. Each prescription entered into the data processing system shall be verified at the time of data entry.

  (5) All pharmacists, while on duty, shall be responsible for complying with all state and federal laws or rules governing the practice of pharmacy.

  (6) A pharmacist shall ensure that the drug is dispensed and delivered safely and accurately as prescribed. A pharmacist shall ensure the safety and accuracy of the portion of the process the pharmacist is performing.

  (7) Duties in a satellite pharmacy that may only be performed by a pharmacist are as follows:

    (A) receiving oral prescription drug orders for controlled substances and reducing these orders to writing, either manually or electronically;

    (B) interpreting or clarifying prescription drug orders;

    (C) 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;

    (D) communicating to the patient or the patient's agent on his or her request for information concerning any prescription drugs dispensed to the patient by the pharmacy;

    (E) assuring that a reasonable effort is made to obtain, record, and maintain patient medication records;

    (F) interpreting patient medication records and performing drug regimen reviews; and

    (G) performing a specific act of drug therapy management for a patient when delegated to a pharmacist by a written protocol from a physician licensed in this state in compliance with the Medical Practice Act.

  (8) Pharmacy technicians and pharmacy technician trainees may not perform any of the duties listed in paragraph (7) of this subsection. However, 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:

    (A) a pharmacist verifies the accuracy of all acts, tasks, and functions performed by pharmacy technicians and pharmacy technician trainees; and

    (B) pharmacy technicians and pharmacy technician trainees are under the direct supervision of, and responsible to, a pharmacist.

  (9) Pharmacy technicians and pharmacy technician trainees in a satellite pharmacy may perform only nonjudgmental technical duties associated with the preparation and distribution of prescription drugs as follows:

    (A) initiating and receiving refill authorization requests;

    (B) entering prescription data into a data processing system; and

    (C) reconstituting medications.

  (10) In addition to the duties listed above in paragraph (9) of this subsection, pharmacy technicians may perform the following nonjudgmental technical duties associated with the preparation and distribution of prescription drugs:

    (A) receiving oral prescription drug orders for dangerous drugs and reducing these orders to writing, either manually or electronically; and

    (B) transferring or receiving a transfer of original prescription information for a dangerous drug on behalf of a patient.

  (11) All satellite pharmacy personnel shall wear identification tags or badges that bear the person's name and identifies him or her as a pharmacist, pharmacist intern, pharmacy technician, or pharmacy technician trainee.

(e) Operational requirements.

  (1) Application for permission to provide satellite pharmacy services.

    (A) A Class A or Class C pharmacy shall make an application to the board to provide satellite pharmacy services. The application shall include the following:

      (i) the name, address, and license number of the provider pharmacy;

      (ii) the name and address of the facility where the satellite pharmacy will be located;

      (iii) the anticipated date of opening and hours of operation; and

      (iv) a copy of the lease agreement or, if the location of the satellite pharmacy is owned by the applicant, a notarized statement certifying such location ownership.

    (B) A renewal application shall be resubmitted every two years in conjunction with the application for renewal of the provider pharmacy's license. The renewal application shall contain the documentation required in subparagraph (A) of this paragraph.

    (C) Upon approval of the application, the provider pharmacy will be issued a certificate which must be displayed at the satellite pharmacy.

  (2) Notification requirements.

    (A) A provider pharmacy shall notify the board in writing within ten days of a change of location, discontinuance of service, or closure of a satellite pharmacy that is operated by the pharmacy.

    (B) A provider pharmacy shall comply with appropriate federal and state controlled substance registrations for each satellite pharmacy if controlled substances are maintained at the satellite pharmacy.

  (3) Environment.

    (A) The satellite pharmacy shall be arranged in an orderly fashion and kept clean. All required equipment shall be clean and in good operating condition.

    (B) A satellite pharmacy shall contain an area which is suitable for confidential patient counseling.

Cont'd...

Next Page

Link to Texas Secretary of State Home Page | link to Texas Register home page | link to Texas Administrative Code home page | link to Open Meetings home page