Chapter 480-10 RETAIL PHARMACY REGULATIONS
| (1) |
Every retail pharmacy, possessing or
having possessed any controlled substances and/or dangerous drugs, within a
period of two years, and/or possessing any record related to the same, which is
required to be kept by O.C.G.A. T. Ch. 16-13, shall exercise diligent care in
protecting such controlled substances and/or dangerous drugs and/or records
related to the same from loss or theft.
| (a) |
Every licensed retail pharmacy shall ensure that all controlled substances
and/or dangerous drugs are purchased from and/or returned to firms holding a
current permit issued by the Georgia State Board of Pharmacy (Board). This
requirement can be met by a pharmacy maintaining a copy of such firms' current
Georgia Board permit. |
|
| (2) |
All controlled substances and/or
dangerous drugs shall be kept in the prescription department, accessible only
to an authorized person, except where contained in a collection receptacle
compliant with state and federal law and regulation. |
| (3) |
The Georgia Drugs and Narcotics Agency
(GDNA) shall have the authority to conduct inspections of any place or premises
used by any such licensed retail pharmacy in relation to such controlled
substances and/or dangerous drugs and/or any records pertaining to their
acquisition, dispensing, disposal, or loss. |
| (4) |
The GDNA shall have the authority to
examine, copy, or remove all such records, and to examine, copy, remove, or
inventory all such controlled substances and/or dangerous drugs.
| (a) |
It shall be the responsibility to such
person possessing such controlled substances and/or dangerous drugs and/or
records to make the same available for such inspection, copying, examination,
or inventorying by said GDNA. |
| (b) |
At the conclusion of an inspection, the GDNA personnel examining said drugs
and/or records shall have the responsibility of providing to such retail
pharmacy a copy of an inspection report on which any deficiencies or violations
are made along with any recommendations, if any, concerning the satisfactory
storage, keeping, handling and security of controlled substances and/or
dangerous drugs. |
|
| (5) |
Any
person possessing controlled substances and/or dangerous drugs and/or records
may request that such an inspection be made, and upon receipt of such written
request, the GDNA Director shall make, or cause to be made, without reasonable
delay, an inspection in compliance with said request. |
| (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
pharmacy benefit manager retail 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 pharmacy benefit manager
retail 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. § 26-4-110
as 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 (11/2) 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; and |
| 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;
and |
| 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. |
|
|
| (1) |
All drugs or devices which bear, or are
required to bear, upon the package, the words "Caution, Federal Law Prohibits
Dispensing Without Prescription","Rx Only", or words of like import, shall be
stored within the prescription department of the pharmacy possessing such drugs
or devices; and |
| (2) |
All dangerous
drugs (legend drugs), controlled substances, or poisons shall be kept in the
prescription department, and shall be kept from the public in a secure
manner. |
There shall be provided within the prescription department of
each pharmacy sufficient shelf, drawer, counter or cabinet space for the neat
and orderly storage of all drugs, equipment, publications and other items kept
therein. In addition, there shall be such clear floor space within each
prescription department as to permit pharmacists, interns/externs, and/or
technicians employed therein, to adequately, safely, and accurately fulfill
their duties, related to prescriptions and drugs. The minimum floor space of a
retail pharmacy shall be 150 square feet.
There shall be provided within each prescription department
adequate facilities for the proper storage of drugs or devices which require
refrigeration, and such drugs or devices shall be stored therein in such manner
as to preserve their therapeutic activity.
| (1) |
Licensure and
Applications
| (a) |
Every retail pharmacy must
be licensed by the Board in accordance with the laws and regulations of this
State. As used in these rules, a "retail pharmacy" shall mean all pharmacies,
except hospital, clinic, prison, and specialty pharmacies, located in this
state where pharmacy is practiced as defined in O.C.G.A. §§ 26-4-4
and
26-4-5,
and shall mean every pharmacy benefit manager, as defined in O.C.G.A. § 26-4-110.1,
providing services or benefits in this State that constitute the practice of
pharmacy as defined in O.C.G.A. § 26-4-4. |
| (b) |
All retail pharmacies shall renew
biennially by June 30th of the odd-numbered years with the Georgia State Board
of Pharmacy; certificates of registration shall be issued only to those retail
pharmacies who comply with this rule. |
| (c) |
Certificates of registration shall be
issued only to those retail pharmacies who meet the following requirements:
| 1. |
Submission of an application with the
following information:
| i. |
The name, full
business address, and telephone number of the licensee; |
| ii. |
All trade or business names used by the
licensee; |
| iii. |
Address, telephone
number, and the name of the Pharmacist in Charge; |
| iv. |
The type of ownership or operations
(i.e., partnership, corporation, or sole proprietorship); and |
| v. |
The name(s) of the owner and/or operator
of the licensee, including:
| (I) |
If a person,
the name of the person; |
| (II) |
If a
partnership, the name of the partnership and the name of each
partner; |
| (III) |
If a sole
proprietorship, the full name of the sole proprietorship and the name of the
business entity; or |
| (IV) |
If a
corporation, the corporate name, the name and title of each corporate officer
and director, the state of incorporation; and the name of the parent company,
if any. |
|
| vi. |
Where
operations are conducted at more than one location by a single retail pharmacy,
each such location shall be licensed by the Board. |
|
| 2. |
Payment of an application fee. Application
fees shall not be refundable. |
| 3. |
Filing a report from the Director of the Georgia Drugs and Narcotics Agency
(GDNA) certifying the applicant possesses the necessary qualifications for a
license. |
|
| (c) |
Licenses
become null and void upon the sale, transfer or change of mode of operation or
location of the business. |
| (d) |
Licenses are renewed for two year periods and expire on June 30th of each odd
numbered year and may be renewed upon the payment of the required fee for each
place of business and the filing of an application for renewal. If the
application for renewal is not made and the fee paid before September 1st, of
the odd numbered year, the license shall lapse and shall not be renewed except
by application for a new license. |
| (e) |
Changes in any information in this rule
shall be submitted to the Board prior to such change. |
| (f) |
The Board will consider the following
factors in determining eligibility for licensure of applicants in charge of the
facility who are applying for a retail pharmacy license:
| 1. |
Any convictions of the applicant under any
Federal, State, or local laws relating to drug samples, wholesale or retail
drug distribution, or distribution of controlled substances; |
| 2. |
Any felony convictions of the applicant
under Federal, State, or local laws; |
| 3. |
The furnishing by the applicant of false
or fraudulent material in any application made in connection with drug
manufacturing or distribution; |
| 4. |
Suspension or revocation by Federal, State, or local government of any
pharmacist, pharmacy or other health care license currently or previously held
by the applicant; |
| 5. |
Compliance
with licensing requirements under previously granted licenses, if
any; |
| 6. |
Compliance with
requirements to maintain and/or make available to the State Licensing Authority
or to Federal, State, or local law enforcement officials, those records
required to be maintained by retail pharmacies; and |
| 7. |
Other factors or qualifications the Board
considers relevant to and consistent with the public health and
safety. |
|
| (g) |
The Board
reserves the right to deny a license to an applicant if it determines that the
granting of such a license would not be in the best interest of the
public. |
|
| (2) |
The
pharmacist's wall certificate issued by the Georgia State Board of Pharmacy
(Board), along with the current renewal license of each full-time Pharmacist,
employed at the pharmacy, shall be displayed in a conspicuous place, near the
prescription department where such pharmacist is actively engaged in the
practice of Pharmacy;
| (a) |
While employed in a
pharmacy on a full-time basis, if a pharmacist has not yet received their Board
issued Pharmacist Wall Certificate, in its place such pharmacist shall post a
copy of their current Board issued pocket license card; |
| (b) |
Any pharmacist employed on a part-time
basis at a pharmacy shall post a copy of their current Board issued pocket
license instead of posting their Pharmacist Wall Certificate; and |
| (c) |
Any pharmacist employed as a relief or
"prn" pharmacist need not post any type of Board issued license, but such
pharmacist must maintain and present upon request their current Board issued
pocket license. |
|
| (3) |
Any
letter(s) from the Board which have granted a licensee any exception(s) and/or
exemption(s) from this, or any other rule, must be posted and/or displayed next
to the current Board of Pharmacy renewal permit; and |
| (4) |
No pharmacist or intern/extern shall
display his or her license in any pharmacy where he or she is not employed or
engaged in the practice of pharmacy, and shall not knowingly permit any other
person to use his or her license for the purpose of misleading anyone to
believe that such person is the holder or recipient of said license or intern
certificate. |
| (5) |
Every pharmacy
benefit manager providing services or benefits in this state which constitutes
the practice of pharmacy as defined in Code Section
26-4-4
shall be licensed as a retail pharmacy in this state and shall comply with the
provisions of 26-4-110 as required under
26-4-110.1(b). |
No Pharmacy shall operate a prescription department which is
under unclean, unsanitary, overcrowded, or unhealthy conditions, or under any
condition which endangers the health, safety or welfare of the
public.
The required equipment of a pharmacy shall be in a clean
condition and shall be stored in a clean and sanitary manner. When not in use,
vessels shall be inverted upon a clean towel or suspended upon a
rack.
Only a licensed pharmacist or a licensed pharmacy
intern/extern, acting under the direct personal supervision of a licensed
pharmacist, may accept an oral prescription drug order of any nature, and upon
so accepting such prescription drug orders, the pharmacist or intern/extern
shall immediately reduce the same to writing.
| (1) |
Only a licensed pharmacist or a licensed
pharmacy intern/extern, acting under the direct supervision of a licensed
pharmacist, may prepare, receive, read, or transfer a copy of a prescription
drug order to any person, and then only to a licensed pharmacist or licensed
pharmacy intern/extern, acting under the direct supervision of a licensed
pharmacist, who is authorized to receive and give such information as follows:
| (a) |
When a copy of prescription drug order is
received manually, meaning without the use of a computer or other electronic
means, the person receiving such copy shall immediately reduce the information
to writing by creating a hard-copy prescription drug order which, besides the
required prescription data, should include at a minimum the following
information;
| 1. |
The name of the pharmacist or
pharmacy intern/extern who received the prescription drug order; |
| 2. |
The name of the transferring pharmacy and
its telephone number along with the name of the pharmacist or pharmacy
intern/extern who provided the information for the prescription drug order
copy; |
| 3. |
The date the prescription
drug order copy was received. |
|
| (b) |
When a prescription drug order copy is
sent and handled manually, meaning without the use of a computer or other
electronic means, the person giving such copy shall record immediately upon his
or her hard copy prescription drug order the following information:
| 1. |
That a copy of the prescription has been
given and the prescription drug order is null and void, with the word "VOID"
being marked on its face; |
| 2. |
The
name of the pharmacy, and telephone number, where the prescription drug order
was transferred; |
| 3. |
The name of the
pharmacist, or pharmacy intern/extern who received the transferred prescription
drug order information; and |
| 4. |
The
date on which the prescription drug order was transferred. |
|
| (c) |
When a prescription drug order copy is
either sent or received by aid of a computer, or other electronic means, the
pharmacist or pharmacy intern/extern should use the procedures for prescription
drug order transfers detailed in Rule
480-27-.07. |
|
The Pharmacist in Charge of each Pharmacy shall cause
examination of the stock of the prescription department, of that Pharmacy, by
persons qualified to do so, and shall cause to be removed from stock all
out-dated and deteriorated drugs, and such shall be done at regular intervals
of not more than six months duration, and under no circumstances will any
Pharmacy or Pharmacist permit any drug or device to be dispensed which bears a
date of expiration which has been reached, or any drug or device which is in a
deteriorated condition.
| (1) |
No pharmacy licensed in accordance with
O.C.G.A. T. 26, Ch. 4, shall engage in the practice of filling, compounding or
dispensing prescriptions unless it shall possess the following items:
| (a) |
Copies of and/or computer or electronic
access to current reference materials appropriate to the individual pharmacy
practice. These reference materials shall be authoritative on at least the
topics of drug interactions; patient counseling; compounding and pharmaceutical
calculations; and generic substitution. |
| (b) |
The telephone number of a poison control
center. This number shall be conspicuously posted within the prescription
department. |
| (c) |
Current copies of
and/or computer or electronic access to the following:
| 1. |
Georgia Pharmacy Practice Act, O.C.G.A. T.
26, Ch. 4; |
| 2. |
Georgia Controlled
Substances Act & Dangerous Drug Act, O.C.G.A. T. 16, Ch. 13; and |
| 3. |
Official Rules of the Georgia State Board
of Pharmacy. |
|
| (d) |
Equipment (appliances):
| 1. |
Refrigerator in
operating condition with a thermometer; and |
| 2. |
Sink in working condition with both hot
and cold running water. |
|
| (e) |
Weighing and labeling:
| 1. |
Class A Balance, Class I or II Electronic
Balance, or as approved in writing by the Board; |
| 2. |
Assortment of weights: metric and
apothecary, only if utilizing a Class A Balance; |
| 3. |
Appropriate prescription labels consistent
with the requirements of the Georgia Drug and Cosmetic Act, O.C.G.A. Title 26,
Chapter 3; and |
| 4. |
Appropriate
auxiliary labels that should be used in the pharmacist's professional
judgment. |
|
| (f) |
Other
equipment:
| 1. |
Graduates of assorted
sizes; |
| 2. |
Two mortars and pestles
of assorted sizes; |
| 4. |
One pill counting
tray; |
| 5. |
Ointment slab, tile or
ointment paper pad; |
| 7. |
Typewriter, word processor
or computer with label-printer; and |
| 8. |
Any other equipment necessary for a
specialized practice setting where such a specialized practice takes
place. |
|
| (g) |
Adequate
supply of drugs most commonly prescribed (ONLY to be on hand after a permit has
been issued by the Board). |
| (h) |
Assorted sizes and types of child-resistant dispensing containers. |
|
| (2) |
The pharmacist-in-charge of a
facility may submit to the Georgia State Board of Pharmacy a typed request for
a variance to these provisions relating to minimum equipment requirements.
Stated reasons for application for variances must be included in submitted
request. A variance may be granted by the Board only when, in the judgment of
the Board, there are sound reasons for doing so which relate to the necessary
or efficient delivery of health care.
| (a) |
Any
variance granted by the Board must be in writing, and this variance must be
posted in the pharmacy next to the current Board issued permit/renewal
certificate. |
|
Pharmacies shall keep syringes for injections behind the
dispensing counter in their prescription departments and in no other place. No
person other than a licensed pharmacist or a pharmacy intern/extern, acting
under the direct supervision of a licensed pharmacist, shall sell, distribute,
exchange, or give, to any person a hypodermic syringe or needle designed or
marketed primarily for human use. No hypodermic needle or syringe shall be sold
by a pharmacist or pharmacy intern/extern, acting under the direct supervision
of a licensed pharmacist, if such person has reasonable cause to believe that
it will be used for an unlawful purpose.
| (1) |
All controlled
substances which are outdated or expired must be disposed of in a manner which
generates a DEA Form 41 (Drug Destruction Form), a copy of which must be
retained by the pharmacy. Such controlled substances can be disposed of by one
of the following:
| (a) |
Representatives of the
Georgia Drugs and Narcotics Agency (GDNA); |
| (b) |
Agents of the U.S. Drug Enforcement
Administration (DEA); or |
| (c) |
A
reverse distributor holding a current permit issued by the Georgia State Board
of Pharmacy (Board). |
|
| (2) |
Dangerous drugs which are outdated or expired must be disposed of by a reverse
distributor holding a current permit issued by the Georgia State Board of
Pharmacy. |
A Prescription Drug Order (defined as a "lawful order of a
Practitioner for a Drug or Device for a specific patient") shall include, but
not be limited to the following information as well as any information required
by Rule 480-22:
| (1) |
Full name and
address of the patient; |
| (2) |
Name,
address of the prescribing practitioner and DEA registration number in the case
of controlled substances; |
| (4) |
Name, strength, if
needed, dosage form and quantity of drug prescribed; |
| (5) |
Directions for use by the
patient; |
| (6) |
Refills authorized, if
any; |
| (7) |
If a written Prescription
Drug Order, prescribing practitioner's signature; and |
| (8) |
A serial number assigned by the
Pharmacist so that Prescription Drug Orders may be filed in a numerical and
retrievable sequence. |
As set forth by O.C.G.A.
26-4-110,
the Board may provide in its rules and regulations the manner in which the
prescription department of a retail pharmacy may be secured. This requirement
will be met in the following manner:
| (1) |
Any retail pharmacy located in a general
merchandising establishment which does not have a prescription department set
aside and permanently enclosed with a partition from floor to ceiling as set
forth in O.C.G.A.
26-4-110,
must submit to the Board in writing a request to approve its particular
security system accompanied by a detailed description of that security system.
This request must be made prior to a pharmacy receiving its retail pharmacy
permit;
| (a) |
Any retail pharmacy located in a
general merchandising establishment which chooses to close its prescription
department for more than three (3) hours per day, and more than one and one
half (1 1/2) hours at any one time, MUST have its prescription department
permanently enclosed with a partition from floor to ceiling; |
| (b) |
Any retail pharmacy located in a general
merchandising establishment in which the prescription department is not
permanently enclosed and utilizes ONLY an electronic security system to
separate the prescription department from the rest of the business
establishment, MAY NOT close for more than three (3) hours per day, nor more
than one and one half (1 1/2) hours at any one time. Board approval of a
pharmacy's electronic security system, without the presence of a permanent
partition, does not exempt a pharmacy from this requirement. |
|
| (2) |
Each security system
description shall be reviewed and either approved or disapproved by the
Board. |
| (3) |
The Board shall notify
the pharmacy submitting the security description in writing as to whether or
not the Board approves or disapproves the system. In cases in which a system is
not approved, the Board may submit suggestions or reasons as to why the system
was not acceptable. |
| (4) |
Upon
receiving a written approval of a security system, a pharmacy MUST maintain a
copy of the Board's approval letter, along with a copy of the security system
description, making both available in the pharmacy for inspection by the GDNA.
This requirement can be met by posting the approval letter with the last GDNA
inspection report. |
| (5) |
Any change
in a security system must first be approved in writing by the Board and a copy
of the approval maintained by the pharmacy. |
| (6) |
In the case of multiple retail pharmacies
being operated by a parent corporation, the parent corporation may submit a
request for a blanket approval of the same security system to be used by all
pharmacies operated by that corporation. A copy of the written Board approval
and the system description must be maintained at each pharmacy operated by the
corporation. Thereafter, any new pharmacy operated by that corporation may
utilize the same security system which was previously approved by the
Board. |
| (7) |
Whenever a corporation
or business entity operates multiple pharmacies, each of which has a secured
prescription department, whether or not it is an electronically secured or
permanently enclosed area, the pharmacist in charge (PIC) shall develop a
method, approved by the Board, of allowing authorized access to that area. This
method may consist of a Board approved lockbox containing a key, security
access code, or other means by which security is maintained. Nothing in this
rule is meant to prevent the PIC from having the authority to limit access to
such area in regards to non-pharmacy related persons.
| (a) |
Before any such pharmacy can utilize a
method of such access, a description of this method, including details of any
lockbox to be utilized, must be submitted to the Board for approval.
| 1. |
A corporation or business entity may
choose to utilize the same method of access to secure a key or access code for
each pharmacy it operates in the State of Georgia by notifying the Board in
writing. A copy of the Board approved method must be attached to the last GDNA
inspection report. Any change in such method must be approved by the
Board. |
|
| (b) |
Upon
approving or disapproving a method, the Board will notify the pharmacy of such
in writing. A copy of such approvals must be posted by the pharmacy with the
last GDNA inspection report. When a method is not approved, the Board may offer
suggestions as to what must be done before the method can be
approved. |
|
| (8) |
All
pharmacies licensed on or after January 1, 2006 that utilize a drive-through
system for the delivery of drugs, or any currently licensed pharmacy that
relocates or has construction or modification of the pharmacy or pharmacy
department on or after January 1, 2006 that creates a drive-through or alters
an existing drive-through system for delivery of drugs, must submit the
construction and security plans for utilization of a pharmacy drive-through to
the Board before such construction or modification, and any such drive-through
must be approved by the Board and must meet the requirements set forth herein.
For purposes of this rule, a pharmacy drive-through is a delivery method by
which a patient, or their designated agent, hereafter referred to as "patient",
leaves a prescription to be filled or receives a filled prescription drug at
the licensed pharmacy location other than by physically being inside the
pharmacy.
| (a) |
Any Pharmacy Drive-Through must
include a window of transparent material, measuring no less than 2 X 3 feet.
The window must be placed in a wall of the prescription department or pharmacy.
A pharmacist must be able to observe the patient through the window, whether or
not the patient is in a drive-through lane directly next to the window or in a
drive-through lane which is one lane over from the window. There shall be no
more than two drive-through lanes with the lane farthest from the
pharmacy/prescription department drive-through window being no more than
twenty-four feet from the window. |
| (b) |
Any Pharmacy Drive-Through that utilizes
a pneumatic tube system, through which prescription drug orders are received
from the patient or prescription drugs are dispensed to the patient, must meet
the following standards:
| 1. |
Secured carriers
must be utilized in the pneumatic tube system; |
| 2. |
Tubes must be constructed in a manner as
to prevent access by unauthorized persons; |
| 3. |
The tube must originate in the
prescription drug area of the pharmacy, be accessible only by a pharmacist or
personnel in the pharmacy and must terminate in a secure terminal in the
drive-through. |
|
| (c) |
Access to the pneumatic tube system must be constructed in such a way as to
provide protection from the natural elements for the patient accessing the
prescription. |
| (d) |
Any Pharmacy
Drive-Through must be inspected by a GDNA Special Agent prior to utilization.
Such Special Agent must file an inspection report with the Board with a
recommendation for approval or non-approval. |
|
| (9) |
All pharmacies licensed prior to January
1, 2006 that utilize drive-throughs that do not comply with subsection 8(a)
through (d) shall be grandfathered in. |
| (1) |
"Long-term care
facility" means an intermediate care home, skilled nursing home, or
intermingled home subject to regulation as such by the Department of Human
Resources. |
| (2) |
"Eligible drugs"
means unit dosage drugs which have been paid for or reimbursed through the
Department of Medical Assistance under O.C.G.A. Title 49, Chapter 4, Article
7. |
| (3) |
"Unit dosage drug" means a
dangerous drug under O.C.G.A. Title 16, Chapter 13, which is individually
packaged by the manufacturer to contain only one dosage unit of the drug and
which includes on such individual packaging the brand or generic name,
strength, lot number, and expiration date of such drug. |
| (4) |
A pharmacist or pharmacy may receive
eligible drugs for credit or reuse from long-term care facilities provided
that:
| (a) |
The drugs were originally dispensed
by that pharmacist or pharmacy to the facility; |
| (b) |
The pharmacist has assurance from a
person in responsible charge of the drugs at the facility that the drugs have
been stored in accordance with the manufacturer's recommendations and USP
standards; |
| (c) |
The drugs are still
in the manufacturer's packaging with the expiration date and lot number and the
integrity of the product and package have been maintained; |
| (d) |
The drugs are not expired and have a
minimum of six (6) months remaining on the expiration date; and |
| (e) |
Under the pharmacist's professional
judgment the drugs are appropriate for return and reuse. |
|
| (5) |
Any pharmacist or pharmacy accepting
eligible drugs for return or reuse must adopt written policies and procedures
governing such drugs to assure compliance with Section (4) of this Rule. Such
procedures and policies shall be established and implemented by the
pharmacist-in-charge. |
| (6) |
A
pharmacist or pharmacy which has accepted drugs for return in accordance with
Section (4) of this Rule, may only re-dispense said drugs for reuse to a
resident of a long-term care facility whose drugs are eligible for payment or
reimbursement by the Department of Medical Assistance according to O.C.G.A.
Title 49, Chapter 4, Article 7. |
| (a) |
As used in this
rule, the following terms shall mean:
| (1) |
"Automated pharmacy systems" (APS) means a mechanical system that perform
operations or activities, other than compounding or administration, relative to
storage, packaging, and labeling of medication for the purpose of dispensing of
medication to a patient or patient's agent. |
| (2) |
"Robotic pharmacy systems" (RPS) means a
mechanical system controlled by a computer that performs operations or
activities relative to the storage, packaging, and labeling of medication for
the purpose of distribution (dispensing) of medication to a patient or a
patient's agent. |
| (3) |
"Board" shall
mean the Georgia State Board of Pharmacy. |
|
| (b) |
A Georgia licensed retail pharmacy may
use automated pharmacy systems or robotic pharmacy systems in the preparation
of medication for dispensing provided such systems meet the following
requirements:
| (1) |
The system collects,
controls, and maintains all transaction information; |
| (2) |
The system is located within the licensed
pharmacy, or if in a general merchandising store, within the pharmacy
department; |
| (3) |
Medication loaded
into the system can be visually identified as well as identified by bar code or
other such secondary identification system to ensure the proper medication is
being placed into and recognized as the correct medication by the
system; |
| (4) |
The system has adequate
security systems and procedures to prevent unauthorized access to the
system; |
| (5) |
The system complies
with federal laws and state regulations; |
| (6) |
The system maintains patient
confidentiality; |
| (7) |
The system
provides a visual image or a description of the medication at final
verification. |
| (8) |
The system can
only be accessed by personal code. |
|
| (c) |
Each retail pharmacy utilizing an APS or
RPS must maintain documentation, as to type of equipment, serial numbers,
content, policies and procedures, on-site in the pharmacy for review by an
agent of the Board. |
| (d) |
The
filling/stocking of all medications in the APS or RPS shall be performed by
licensed pharmacist, licensed pharmacy intern or a registered pharmacy
technician under the direct, on-site supervision of a licensed pharmacist. An
electronic or hard copy record of medications produced by the system shall be
maintained for 2 years, and shall include identification of the person
stocking/filling the system, and if a pharmacy intern or registered pharmacy
technician, the name of the pharmacist providing the supervision. |
| (e) |
Access to and limits on access to the APS
or RPS must comply with state and federal laws and regulations. Proper
identification and access control, including electronic passwords, biometric
identification, unique credentials or other coded identification, must be
authorized by the pharmacist on duty. A record of who was assigned the
identifications, credentials or passwords must be maintained for 2 years in
order to ascertain who accessed the APS or RPS. |
| (f) |
The pharmacist in charge ("PIC") of the
retail pharmacy is responsible for maintaining all records pertaining to the
access, usage, audits and maintenance of the systems. These records must be
readily accessible and available for inspection upon request by an agent of the
Board. In addition, the PIC is responsible for developing and maintaining
policies and procedures to assign, discontinue, or change access to the system,
insure that access to the medications comply with state and federal
regulations, and insure that the system is filled/stocked. |
| (g) |
The pharmacist in charge is responsible
to assure that the APS or RPS is in good working order. |
| (h) |
Any pharmacist utilizing the APS or RPS
must assure that the system is accurately producing the correct strength,
dosage form, and quantity of the drug prescribed while maintaining appropriate
record keeping and security safeguards. |
| (i) |
Any retail pharmacy utilizing an APS or
RPS in violation of this rule is subject to disciplinary action which may
include, but is not limited to, a restriction on the authority to utilize an
APS or RPS. |
| (j) |
Nothing herein
shall relieve a pharmacist of the professional responsibility to verify the
accuracy of the medication being dispensed prior to its being delivered to the
patient or the patient's agent |
| (1) |
For purposes of this rule, the following
terms shall means as follow:
| (a) |
"Board"
shall mean the Georgia Board of Pharmacy; |
| (b) |
"Immediate notification" shall mean
written notification sent within twenty-four hours of the event; |
| (c) |
"Significant adverse drug reaction" shall
mean any reaction which requires any medical treatment beyond a consultation
between Pharmacist/patient, Pharmacist/Prescriber, patient/prescriber or
Pharmacist/patient/Prescriber; and |
| (d) |
"Written notification" shall mean in
writing and sent by statutory overnight delivery or by email. |
|
| (2) |
The following occurrences
require immediate notification to the Board at its address of record, unless
otherwise provided:
| (a) |
Permanent closing of a
licensed pharmacy. Notification shall include the name and contact information
for the person responsible for maintaining the pharmacy records after the
pharmacy has closed and location of the records. |
| (b) |
Change of ownership or location of a
licensed pharmacy. Since a pharmacy license cannot be transferable, unless such
change has been previously approved by the Board following the submission of
the appropriate applications, the existing pharmacy license is void and there
is no continuing authority to operate as a pharmacy. |
| (c) |
Change in management of a licensed
pharmacy. |
| (d) |
Change of the
pharmacist in charge of a licensed pharmacy. When the Board receives notice
that a pharmacy no longer has a pharmacist in charge and no replacement
pharmacist in charge is named, the pharmacy's license is suspended pending
further action by the Board. |
| (e) |
Any theft or loss of drugs or devices of a licensed pharmacy. This notification
must also be made to the Georgia Drugs and Narcotics Agency, and if involving
controlled substances, the pharmacy must comply with Rule
480-16-.06. |
| (f) |
Any known conviction of any employee of a
licensed pharmacy of any state or federal drug laws, not previously
reported. |
| (g) |
Disasters or
accidents involving the licensed pharmacy. |
| (h) |
Thefts or break-ins at the licensed
pharmacy. |
| (i) |
Theft, destruction,
or loss of records of a licensed pharmacy required to be maintained by state or
federal law. |
| (j) |
Occurrence at a
licensed pharmacy of a significant adverse drug reaction by a customer or
person receiving medication dispensed or compounded by the licensed
pharmacy. |
|
All pharmacies are required to purchase or receive dangerous
drugs and/or controlled substances from a firm licensed by this state as a drug
wholesaler, distributor or manufacturer.
