Current through Rules and Regulations filed through March 20, 2024
(1)
For the purpose of this rule, the following definitions shall apply:
(a) "Direct supervision" shall mean that a
pharmacist is physically present, providing care at the address listed on the
pharmacy license, and is in the prescription department, consultation room,
vaccination room, or areas where over-the-counter drugs, devices, or durable
medical equipment are displayed. The supervising pharmacist is professionally
responsible and accountable for all activities performed by authorized pharmacy
personnel and is available to provide assistance and direction to authorized
pharmacy personnel. This shall not require a pharmacist to maintain a direct
line of sight to authorized pharmacy personnel. The supervising pharmacist
shall provide a final check of prepared products and document final checks
before any prescription drug is dispensed.
(b) "Pharmacy care" shall mean those services
related to the interpretation, evaluation, or dispensing of prescription drug
orders, the participation in drug and device selection, drug administration,
and drug regimen reviews, and the provision of patient counseling related
thereto.
(c) "Preparation" shall
mean the functions of preparing a prescription to be dispensed, including
product selection, data entry into a pharmacy dispensing system, and any other
functions required to have the prescription ready to be verified, checked, and
dispensed by a pharmacist or pharmacy intern working under the direct
supervision of a pharmacist.
(d)
"Pharmacy" shall mean all areas of a facility when the prescription department
is not closed or locked separately from the facility or only the area of the
prescription department in those facilities where the prescription department
is locked and separated.
(e)
"Prescription Department" shall mean an area set aside for the preparation and
dispensing of prescription drugs. In a facility offering other departments and
types of merchandise not requiring a pharmacist to be open for business, this
term shall apply only to the area in which prescriptions are prepared and
dispensed.
(f) "Vaccination room"
is an area adjacent to the pharmacy where vaccinations are
administered.
(g) "Consultation
room" is an area adjacent to the pharmacy where patient or customer
consultations are done, and more in-depth pharmacy care may be
provided.
(2) Except for
retail pharmacies located in the same space as hospital pharmacies, the owner,
manager, or proprietor of each pharmacy shall designate an area, room or rooms,
which shall be known as the "Prescription Department," and which is primarily
devoted to activities related to prescriptions, including preparation and
dispensing.
(3) A licensed
pharmacist shall be in charge of each pharmacy. His or her name shall be upon
the application for the license of the pharmacy; he or she shall be the
pharmacist in charge of and have supervision of not more than one pharmacy at
one time; and he or she shall be responsible and accountable for the conduction
of business related to prescriptions within and access to said retail pharmacy.
(a) This regulation is not intended to
prohibit any pharmacist from engaging in the practice of pharmacy at more than
one pharmacy, if conducted in compliance with the other provisions of this rule
and regulation.
(b) This regulation
does not prohibit a pharmacist from being in charge of one separately licensed
Home Health Care Pharmacy, as defined by Board Rule 480-21, and/or one Nursing
Home Pharmacy, and/or one Long Term Health Care Facility Pharmacy, as both are
defined in Board Rule 480-24, in addition to being in charge of a retail
pharmacy, licensed under Rule 480-10, as long as each pharmacy is operated
under the same ownership and is located under the same roof, provided that
there is a physical separation of the two pharmacies and separate inventories
are maintained for the two pharmacies.
(4) Except for retail pharmacies located in
the same space as hospital pharmacies, a Licensed Pharmacist shall be present
and on duty in a licensed retail pharmacy as follows:
(a) Entire business establishments which are
licensed under O.C.G.A. §
26-4-110as a pharmacy shall have
a pharmacist on duty at all times the pharmacy is open for business as follows:
1. Such times when the pharmacist is absent
from the pharmacy cannot exceed three (3) hours daily, or more than one and one
half (1 1/2) hours at any one time. If a pharmacist is absent less than five
minutes from the prescription department, this absence is not considered an
"absence" within the meaning of this rule and will not require a posted notice,
provided that the prescription department's security is not
compromised.
2. In the absence of a
pharmacist from the pharmacy, the area designated as the prescription
department shall be closed and locked in such a manner as to prevent
unauthorized entry.
3. Whenever the
pharmacist is absent from the pharmacy, a sign shall be prominently displayed
on the entrance to the prescription department announcing, "Prescription
Department Closed" and such sign shall be clear and legible with letters not
less than three (3) inches in size.
4. The pharmacist on duty shall be
responsible and accountable for the direct supervision of all personnel working
in the pharmacy or prescription department. Pharmacy technicians and pharmacy
interns/externs can continue preparation of a prescription when the pharmacist
is in the immunization or consultation room or is providing pharmacy care
services.
(b) If a
pharmacy is located in a general merchandising establishment, or if the owner
of a business licensed as a pharmacy so chooses, a portion of the space in the
business establishment may be set aside and permanently enclosed or otherwise
secured; only the permanently enclosed area shall be subject to provisions of
this rule and shall be licensed as a pharmacy;
1. In such cases, the area to be licensed or
registered as a pharmacy shall be permanently enclosed with a partition built
from the floor to the ceiling or in a manner which meets security guidelines
submitted to and approved by the Board and upon inspection by the
GDNA.
2. In the absence of a
pharmacist from the Prescription Department, consultation room, vaccination
room, and area where over-the-counter drugs, devices, and durable medical
equipment are displayed, the area designated as the Prescription Department
shall be closed and locked in such a manner as to prevent unauthorized
entry.
3. Whenever the pharmacist
is absent from the Prescription Department, consultation room, vaccination
room, and area where over-the-counter drugs, devices, and durable medical
equipment are displayed, a sign shall be prominently displayed on the entrance
to the Prescription Department announcing, "Prescription Department Closed" and
such sign shall be clear and legible with letters not less than three (3)
inches in size.
4. If a pharmacist
is absent less than five minutes from the prescription department, this absence
is not considered an "absence" within the meaning of this rule and will not
require a posted notice, provided that the prescription department's security
is not compromised. No prescription shall be dispensed in the absence of a
licensed pharmacist. The pharmacist on duty shall be responsible and
accountable for the direct supervision of all personnel working in the pharmacy
or prescription department. Pharmacy technicians and pharmacy interns/externs
can continue preparation of a prescription when the pharmacist is in the
immunization or consultation room or is providing pharmacy care
services.
(5)
If a retail pharmacy license and hospital pharmacy license occupy the same
physical space, nothing shall prohibit one nursing supervisor from having
access to the pharmacy in accordance with Board Rule
480-13-.04(8).
O.C.G.A.
§§
26-4-27, 26-4-28, 26-4-82, 26-4-110.