| (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.
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