22 Tex. Admin. Code § 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.
(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 name, address, 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) annually
reviewing 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.
Notes
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