SECTION 291.125. Centralized Prescription Dispensing

(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.

(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) Central fill pharmacy--a Class A, Class A-S, Class C, Class C-S, Class E, or Class E-S pharmacy that prepares prescription drug orders for dispensing pursuant to a valid prescription transmitted to the central fill pharmacy by an outsourcing pharmacy.

(2) Centralized prescription dispensing--the dispensing or refilling of a prescription drug order by a Class A, Class C, or Class E pharmacy at the request of another Class A, Class C, or Class E pharmacy and the return of the dispensed prescriptions to the outsourcing pharmacy for delivery to the patient or patient's agent, or at the request of the outsourcing pharmacy for direct delivery to the patient.

(3) Outsourcing pharmacy--a Class A, Class C, or Class E pharmacy that transmits a prescription drug order via facsimile or communicates prescription information electronically to a central fill pharmacy to be dispensed by the central fill pharmacy.

(c) Operational standards.

(1) General requirements.

(A) A Class A or Class C pharmacy may outsource prescription drug order dispensing to a central fill 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 dispense or process a prescription drug order.

(B) Unless compliance would violate the pharmacy or drug laws or rules in the state in which the pharmacy is located, a Class E pharmacy may outsource prescription drug order dispensing to a central fill pharmacy provided the pharmacies meet the requirements of subparagraph (A) of this paragraph.

(C) The pharmacist-in-charge of the central fill pharmacy shall ensure that:

(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

(ii) the dispensed prescriptions are shipped in containers which are sealed in a manner as to show evidence of opening or tampering.

(D) A Class A or Class C central fill 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) and this section.

(E) A Class E central fill pharmacy shall comply with §§291.101 - 291.105 of this title (relating to Purpose, Definitions, Personnel, Operational Standards, and Records) and this section.

(2) Notifications to patients.

(A) A pharmacy that outsources prescription dispensing to a central fill pharmacy shall:

(i) prior to outsourcing the prescription:

(I) notify patients that their prescription may be outsourced to a central fill pharmacy; and

(II) give the name of the central fill 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

(ii) if a prescription that is not for a controlled substance is delivered directly to the patient by the central fill pharmacy and not returned to the outsourcing 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)." A prescription for a controlled substance may not be delivered directly to the patient by the central fill pharmacy.

(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 (e.g., hospitals or nursing homes).

(3) Prescription Labeling. The central fill pharmacy shall place on the prescription label the name and address of the outsourcing pharmacy and a unique identifier (i.e., the central fill pharmacy's DEA registration number or, if the pharmacy does not have a DEA registration number, the central fill pharmacy's Texas license number) indicating that the prescription was dispensed by the central fill pharmacy; and comply with all other labeling requirements in §291.33 of this title.

(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:

(A) outline the responsibilities of each of the pharmacies;

(B) include a list of the names, addresses, telephone numbers, and all license/registration numbers of the pharmacies involved in centralized prescription dispensing; and

(C) include policies and procedures for:

(i) notifying patients that their prescription may be outsourced to a central fill pharmacy for dispensing and providing the name of that pharmacy;

(ii) protecting the confidentiality and integrity of patient information;

(iii) dispensing prescription drug orders when the dispensed order is not received or the patient comes in before the order is received;

(iv) complying with federal and state laws and regulations;

(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

(vi) reviewing annually the written policies and procedures and documenting such review.

(d) Records.

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

(A) the records maintained in the alternative system contain all of the information required on the manual record; and

(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) 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) The outsourcing pharmacy shall maintain records, in addition to the prescription drug order, which indicate the:

(A) date:

(i) the request for dispensing was transmitted to the central fill pharmacy; and

(ii) the dispensed prescription was received by the outsourcing pharmacy, including the method of delivery (e.g., private, common, or contract carrier) and the name of the person accepting delivery; and

(B) name, address, license number, and the unique identifier of the central fill pharmacy.

(4) The central fill pharmacy shall maintain records, in addition to the prescription drug order, which indicate the:

(A) date the prescription was shipped to the outsourcing pharmacy or the patient;

(B) name and address where the prescription was shipped;

(C) method of delivery (e.g., private, common, or contract carrier); and

(D) name, address, and license number of the outsourcing pharmacy.

(e) Nothing in this section shall be construed as requiring a nonresident pharmacy that outsources drug order dispensing to a central fill pharmacy to be licensed as a Class E pharmacy in accordance with §291.101 of this title, provided that the nonresident pharmacy does not physically ship, mail, or deliver prescription drugs or devices directly to a patient or patient's agent in this state.

Source Note: The provisions of this §291.125 adopted to be effective September 18, 2007, 32 TexReg 6352; amended to be effective March 26, 2014, 39 TexReg 2080; amended to be effective June 7, 2018, 43 TexReg 3592; amended to be effective August 24, 2022, 47 TexReg 4977