1. (a) Purpose. The purpose of this section is to provide standards for centralized prescription dispensing by a Class A (Community), Class C (Institutional) pharmacy, or Class E (Non-Resident) Pharmacy.
2. (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. Centralized prescription dispensing--the dispensing or refilling of a prescription drug order by a Class A (Community), Class C (Institutional), or Class E (Non-Resident) pharmacy at the request of another Class A (Community), or Class C (Institutional) and the return of the dispensed prescriptions to the requesting pharmacy for delivery to the patient or patient's agent, or at the request of the requesting pharmacy, direct delivery to the patient.

3. (c) Operational standards.

   1. (1) General requirements.

      1. (A) A Class A (Community) or Class C (Institutional) pharmacy may outsource prescription drug order dispensing to another Class A (Community), Class C (Institutional), or Class E (Non-Resident) pharmacy provided the pharmacies:

         1. (i) have:

            1. (I) the same owner; or
            2. (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
         2. (ii) share a common electronic file or have appropriate technology to allow access to sufficient information necessary or required to dispense or process a prescription drug order.

      2. (B) The pharmacist-in-charge of the dispensing pharmacy shall ensure that:

         1. (i) the pharmacy maintains and uses adequate storage or shipment containers and shipping processes to ensure drug stability and potency. Such shipping processes shall include the use of appropriate packaging material and/or devices to ensure that the drug is maintained at an appropriate temperature range to maintain the integrity of the medication throughout the delivery process; and
         2. (ii) the dispensed prescriptions are shipped in containers which are sealed in a manner as to show evidence of opening or tampering.
      3. (C) A Class A (Community) or Class C (Institutional) dispensing pharmacy shall comply with the provisions of §§291.31 - 291.35 of this title (relating to Definitions, Personnel, Operational Standards, Records, and Official Prescription Requirements in Class A (Community) Pharmacies) and this section.
      4. (D) A Class E (Non-Resident) dispensing pharmacy shall comply with §§291.101 - 291.105 of this title (relating to Purpose, Definitions, Personnel, Operational Standards, and Records in Class E (Non-Resident) Pharmacies) and this section.
      5. (E) Pharmacies dispensing compounded non-sterile or sterile preparations shall comply with the provisions of §291.131 of this title (relating to Pharmacies Compounding Non-Sterile Preparations) and §291.133 of this title (relating to Pharmacies Compounding Sterile Preparations).

   2. (2) Notifications to patients.

      1. (A) A pharmacy that outsources prescription dispensing to another pharmacy shall:

         1. (i) prior to outsourcing the prescription:

            1. (I) notify patients that their prescription may be outsourced to another pharmacy; and
            2. (II) give the name of that pharmacy or if the pharmacy is part of a network of pharmacies under common ownership and any of the network pharmacies may dispense the prescription, the patient shall be notified of this fact. Such notification may be provided through a one-time written notice to the patient or through use of a sign in the pharmacy; and
         2. (ii) if the prescription is delivered directly to the patient by the dispensing pharmacy and not returned to the requesting pharmacy, place on the prescription container or on a separate sheet delivered with the prescription container, in both English and Spanish, the local, and if applicable, the toll-free telephone number of the pharmacy and the statement: "Written information about this prescription has been provided for you. Please read this information before you take the medication. If you have questions concerning this prescription, a pharmacist is available during normal business hours to answer these questions at (insert the pharmacy's local and toll-free telephone numbers)."
      2. (B) The provisions of this paragraph do not apply to patients in facilities where drugs are administered to patients by a person required to do so by the laws of the state (i.e., hospitals or nursing homes).

   3. (3) Prescription Labeling. The dispensing pharmacy shall:

      1. (A) place on the prescription label, the name and address or name and pharmacy license number of the pharmacy dispensing the prescription and the name and address of the pharmacy which receives the dispensed prescription;
      2. (B) indicate in some manner which pharmacy dispensed the prescription (e.g., "Filled by ABC Pharmacy for XYZ Pharmacy"); and
      3. (C) comply with all other labeling requirements in §291.33 of this title.

   4. (4) Policies and Procedures. A policy and procedure manual as it relates to centralized dispensing shall be maintained at both pharmacies and be available for inspection. Each pharmacy is required to maintain only those portions of the policy and procedure manual that relate to that pharmacy's operations. The manual shall:

      1. (A) outline the responsibilities of each of the pharmacies;
      2. (B) include a list of the name, address, telephone numbers, and all license/registration numbers of the pharmacies involved in centralized prescription dispensing; and

      3. (C) include policies and procedures for:

         1. (i) notifying patients that their prescription may be outsourced to another pharmacy for centralized prescription dispensing and providing the name of that pharmacy;
         2. (ii) protecting the confidentiality and integrity of patient information;
         3. (iii) dispensing prescription drug orders when the filled order is not received or the patient comes in before the order is received;
         4. (iv) complying with federal and state laws and regulations;
         5. (v) 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
         6. (vi) annually reviewing the written policies and procedures and documenting such review.

4. (d) Records.

   1. (1) Records may be maintained in an alternative data retention system, such as a data processing system or direct imaging system provided:

      1. (A) the records maintained in the alternative system contain all of the information required on the manual record; and
      2. (B) the data processing system is capable of producing a hard copy of the record upon the request of the board, its representative, or other authorized local, state, or federal law enforcement or regulatory agencies.
   2. (2) Each pharmacy shall comply with all the laws and rules relating to the maintenance of records and be able to produce an audit trail showing all prescriptions dispensed by the pharmacy.

   3. (3) The requesting pharmacy shall maintain records which indicate the date:

      1. (A) the request for dispensing was transmitted to the dispensing pharmacy; and
      2. (B) the dispensed prescription was received by the requesting pharmacy, including the method of delivery (e.g., private, common, or contract carrier) and the name of the person accepting delivery.

   4. (4) The dispensing pharmacy shall maintain records which indicate:

      1. (A) the date the prescription was shipped to the requesting pharmacy;
      2. (B) the name and address where the prescription was shipped; and
      3. (C) the method of delivery (e.g., private, common, or contract carrier).

Source Note:The provisions of this §291.125 adopted to be effective September 18, 2007, 32 TexReg 6352.