Current through all regulations passed and filed through September 16, 2024
(A)
As used in this
chapter:
(1)
"Central fill pharmacy" means a pharmacy licensed as a
terminal distributor of dangerous drugs acting as an agent of an originating
pharmacy to fill or refill a medication order. A central fill pharmacy may be
used to replenish automated drug storage systems and automated pharmacy
systems.
(2)
"Originating pharmacy" means an institutional pharmacy
licensed as a terminal distributor of dangerous drugs that uses a central fill
pharmacy to fill or refill medication order. A central fill pharmacy may be
used to replenish automated drug storage systems and automated pharmacy
systems.
(B)
A central fill pharmacy and originating pharmacy may
process a request for the filling or refilling of a medication order received
by an originating pharmacy pursuant to the following requirements:
(1)
The central fill
pharmacy either has the same owner as the originating pharmacy or has a written
contract with the originating pharmacy outlining the services to be provided
and the responsibilities of each pharmacy in fulfilling the terms of the
contract in compliance with federal and state law, rules and
regulations.
(2)
The central fill pharmacy shall maintain a record of
all originating pharmacies, including name, address, terminal distributor
number, and, if applicable, drug enforcement administration registration
number, for which it processes a request for the filling or refilling of a
medication order received by the originating pharmacy. The record shall be made
readily retrievable and maintained for a period of three years.
(3)
The central fill
pharmacy and originating pharmacy shall have access to common electronic files
as part of a real time, online database or have appropriate technology to allow
secure access to sufficient information necessary or required to dispense or
process the medication order.
(4)
The originating
pharmacy shall comply with the minimum required information for a patient
profile pursuant to rule
4729:5-9-02.5 of the
Administrative Code prior to sending a medication order to the central fill
pharmacy.
(5)
The originating pharmacy shall remain responsible for
compliance with the dangerous drug dispensing requirements of this chapter and
the compounding requirements of Chapter 4729:7-2 of the Administrative Code
that are not assumed in writing by the central fill pharmacy.
(6)
The prescription
label attached to the container shall contain the name and address of the
originating pharmacy and the name of the central fill pharmacy. If applicable,
the date on which the medication order was dispensed shall be the date on which
the central fill pharmacy filled the order.
(7)
The originating
pharmacy shall maintain the original of all medication orders received for
purposes of filing and record keeping as required by state and federal law,
rules, and regulations.
(8)
The central fill pharmacy shall maintain all original
fill and refill requests received from the originating pharmacy and shall treat
them as original and refill medication orders for purposes of filing and record
keeping as required by state and federal law, rules, and
regulations.
(9)
The central fill pharmacy and originating pharmacy
shall each maintain records to capture the positive identification of the
licensed or registered individuals responsible for performing respective
activities in accordance with rule
4729:5-9-02.3 of the
Administrative Code.
(10)
The central fill pharmacy and originating pharmacy
shall adopt a written quality assurance 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,
resolve identified problems, and ensure compliance with this rule. The quality
assurance plan shall be reviewed and updated annually.
(C)
Dangerous drugs may be returned by the originating pharmacy
to the central fill pharmacy for the purpose of being returned to the central
fill pharmacy's stock shelves in accordance with the following:
(1)
The central fill
pharmacy complies with the requirements of rule
4729:5-3-16 of the
Administrative Code; and
(2)
The originating and central fill pharmacy are under
common ownership and control.
(D)
An originating
pharmacy may return dangerous drugs received by a central fill pharmacy to
stock shelves in accordance with rule
4729:5-3-16 of the
Administrative Code.
(E)
All written documentation required by this rule shall
be maintained for three years from the date of execution or review and shall be
made readily retrievable.
(F)
An institutional pharmacy may utilize a central fill
pharmacy to dispense outpatient prescriptions in accordance with rule
4729:5-5-19 of the
Administrative Code.
(G)
Drugs that are repackaged or relabeled by a central
fill pharmacy shall comply with the requirements of rule
4729:5-9-02.12 of the
Administrative Code.
Replaces: 4729-5-28
