Ohio Administrative Code
Title 4729:5 - Dangerous Drugs
Chapter 4729:5-5 - Outpatient Pharmacies
Section 4729:5-5-19 - Central fill pharmacies
Universal Citation: OH Admin Code 4729:5-5-19
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 prescription. A central fill pharmacy may also be
the originating pharmacy pursuant to paragraph (D) of this
rule.
(2)
"Originating pharmacy" means an outpatient pharmacy
licensed as a terminal distributor of dangerous drugs that uses a central fill
pharmacy to fill or refill a prescription.
(B) A central fill pharmacy and originating pharmacy may process a request for the filling or refilling of a prescription received by an originating pharmacy only 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. The contract shall expressly state who is responsible for performing
the patient counseling requirements in accordance with rule
4729:5-5-09 of the
Administrative Code.
(2)
The central fill pharmacy shall maintain a record of
all originating pharmacies, including name, address, terminal distributor of
dangerous drugs license number, and, if applicable, drug enforcement
administration registration number, for which it processes a request for the
filling or refilling of a prescription 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
prescription.
(4)
The originating pharmacy shall comply with the minimum
required information for a patient profile pursuant to rule
4729:5-5-07 of the
Administration Code prior to sending a prescription 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. The date on which the prescription was dispensed shall be
the date on which the central fill pharmacy filled the prescription.
(a)
If the
originating pharmacy and the central fill pharmacy are not under common
ownership, either of the following shall apply:
(i)
The name of the
central fill pharmacy shall be included on the prescription label or an
auxiliary label; or
(ii)
A statement is included on the prescription information
accompanying the dangerous drug that indicates a central fill pharmacy was used
to fill the prescription and includes the name of the central fill
pharmacy.
(7)
The originating
pharmacy shall provide, upon the request of a patient or caregiver, the name
and address of the central fill pharmacy and a contact phone number where the
patient or caregiver can receive further assistance regarding prescriptions
filled by a central fill pharmacy.
(8)
The originating
pharmacy shall maintain the original of all prescription orders received for
purposes of filing and recordkeeping as required by state and federal law,
rules, and regulations.
(9)
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 prescription orders for purposes of filing and
recordkeeping as required by state and federal law, rules, and
regulations.
(10)
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 paragraph (A) of rule
4729:5-5-04 of the
Administrative Code.
(11)
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 that originally filled the prescription for the express 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) A central fill pharmacy may dispense a prescription directly to a patient pursuant to the following requirements:
(1)
A prospective
drug utilization review is conducted pursuant to a written contract or
agreement in accordance with rule
4729:5-5-08 of the
Administrative Code;
(2)
Patient counseling is provided pursuant to a written
contract or agreement in accordance with rule
4729:5-5-09 of the
Administrative Code;
(3)
The dispensing is conducted in accordance with all
other applicable state and federal laws, regulations and rules, including those
specified in 68 CFR 37405 (7/24/2003).
(F) 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.
(G) Drugs that are repackaged or relabeled by a central fill pharmacy shall comply with the requirements of rule 4729:5-5-17 of the Administrative Code.
Replaces: 4729-5-28
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