Chapter 480-10A CENTRAL FILLING REGULATIONS
For purposes of these Rules and Regulations, the following
definitions apply:
| (1) |
"Board" shall
mean the Georgia Board of Pharmacy. |
| (2) |
"Originating Pharmacy" shall mean the
licensed retail pharmacy from which a prescription is physically received and
dispensed to the patient or patient's caregiver which is outsourcing
prescription filling services. This pharmacy shall be the dispensing
pharmacy. |
| (3) |
"Central Fill
Pharmacy" shall mean a pharmacy which is permitted by the state in which it is
located to prepare prescription orders for dispensing pursuant to a valid
prescription transmitted to it by an originating pharmacy and to return the
labeled and filled prescriptions to the originating pharmacy for delivery to
the ultimate user. |
| (1) |
All pharmacies providing central filling
services to retail pharmacies in Georgia must be appropriately licensed in
Georgia. |
| (2) |
A central fill
pharmacy shall be deemed "authorized" to fill prescriptions on behalf of an
originating pharmacy only if the parties have a contractual relationship
permitting such activity or share a common owner.
| (a) |
The contract or agreement shall outline
the services to be provided and the responsibilities and accountabilities of
each pharmacy, in relation to such services, in compliance with federal and
state laws, rules and regulations. |
| (b) |
Central prescription filling of
controlled substances requires compliance with all Drug Enforcement
Administration ("DEA") regulations permitting a central fill pharmacy to fill
prescriptions for controlled substances on behalf of an originating pharmacy as
well as state laws, rules and regulations. |
|
| (3) |
The originating and central fill pharmacy
shall be jointly responsible for all prescriptions filled utilizing central
fill services. |
| (1) |
A licensed retail pharmacy that desires
to provide and/or use central prescription filling services must maintain
policies and procedures, which are readily retrievable for submission to the
Board or Georgia Drugs and Narcotics Agency ("GDNA") upon request.
| (a) |
The policies and procedures must include:
| 1. |
A clear description of the activities in
the prescription filling process to be performed by each pharmacy; |
| 2. |
An outline of the responsibilities of each
pharmacy; |
| 3. |
An outline of the
accountabilities of each pharmacy; |
| 4. |
A list of the names, addresses, telephone
numbers, and all license/registration numbers for the pharmacies participating
in the central prescription filling; |
| 5. |
Guidelines for:
| (i) |
Protection of the confidentiality and
integrity of patient information; |
| (ii) |
Maintenance of appropriate records to
identify the names, initials, or identification codes and specific activities
of each pharmacist who performed any processing; and |
| (iii) |
Compliance with all federal and state
laws, rules, and regulations pertaining to the central filling of
prescriptions. |
|
|
|
| (1) |
The transmission and labeling of
controlled substance prescriptions processed utilizing central fill services
must comply with all federal and state laws, rules, and regulations. |
| (2) |
The originating pharmacy must comply with
the minimum required information for the patient record system and all
requirements of a prescription drug order as outlined in the Georgia law and
Board rules prior to sending a prescription to the central fill
pharmacy. |
| (3) |
All prescriptions may
be transmitted electronically from an originating pharmacy to a central fill
pharmacy including via facsimile. |
| (4) |
All transmission records must include the
following:
| (a) |
"CENTRAL FILL" written on the
face of a prescription if it is a hard copy prescription, |
| (b) |
The name, address, telephone number,
Georgia license number, and DEA registration number (if the prescription is a
controlled substance), of the central fill pharmacy to which the prescription
has been transmitted, |
| (c) |
Number of
refills already dispensed and number of refills remaining (if
applicable), |
| (d) |
The name of the
originating pharmacy pharmacist transmitting the prescription, and |
| (e) |
The date of transmittal. |
|
| (5) |
All receipt of transmission
records must include all information included in subsection 4 and the name,
address, telephone number, Georgia license number, and DEA registration number
(if the prescription is a controlled substance), of the originating pharmacy
transmitting the prescription. |
| (6) |
The label affixed to the container of a dangerous drug or other non-controlled
substance filled by a central fill pharmacy must contain the following:
| (a) |
Date of fill or refill, |
| (b) |
The originating pharmacy name, address,
and telephone number, |
| (c) |
The
central fill pharmacy's unique identifier, |
| (d) |
The serial number of the
prescription, |
| (e) |
The name of the
patient, |
| (f) |
The name of the
prescribing practitioner, |
| (g) |
Name
of supervising physician if applicable, |
| (h) |
Expiration date of the dispensed drug,
and |
| (i) |
The directions for use and
cautionary statements, if any, contained in such prescription or required by
law. |
|
| (1) |
The originating
and central fill pharmacies must share common electronic files or have
appropriate technology to allow secure access to sufficient information
necessary or required to process and dispense the prescription. |
| (2) |
The originating pharmacy shall be
responsible for maintaining compliance with the Prescription Drug Monitoring
Program for all qualifying prescriptions pursuant to O.C.G.A. § 16-13-59
including those filled utilizing central fill services. |
| (3) |
The record keeping of prescriptions
processed utilizing central fill services must comply with all federal and
state laws, rules, and regulations. |
| (4) |
The originating pharmacy must have a
pharmacist, pharmacy intern, pharmacy extern, or pharmacy technician sign for
the receipt of all prescriptions received from the central fill pharmacy.
| (a) |
Such receipts must be maintained as a
part of the prescription record. Receipts shall include the date of receipt,
the method of delivery (private, common, or contract carrier) and the name of
the originating pharmacy employee accepting delivery. |
| (b) |
The pharmacist on duty at the originating
pharmacy must verify the receipt of all controlled substances. |
|
| (5) |
The originating pharmacy is
responsible for maintaining records of the processing of all prescriptions
entered into their information system including prescriptions filled at a
central fill pharmacy.
| (a) |
The information
system must have the ability to audit the activities of the individuals at the
central fill pharmacy filling the originating pharmacy's
prescriptions. |
|
| (1) |
It shall be the responsibility of the
pharmacist on duty at the originating pharmacy to perform patient counseling of
all prescriptions. |
| (2) |
The central
fill pharmacy shall not perform patient counseling on behalf of the originating
pharmacy. |
| (1) |
An originating pharmacy that utilizes
central filling services must, prior to outsourcing the prescription, notify
patients that prescription filing may be outsourced to another pharmacy.
| (a) |
The patient shall have the choice to not
have the prescription outsourced. |
| (b) |
Notification may be provided through the
use of a sign located in the originating pharmacy which is clearly visible to
and readable by the public. |
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