Chapter 480-10 RETAIL PHARMACY REGULATIONS
Rule 480-10-.01 Controlled Substances and Dangerous Drugs: Inspection, Retention of Records and Security
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.
|(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.
|(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:
|(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.
|(4)|| Except for pharmacy benefit manager
retail pharmacies, a Licensed Pharmacist shall be present and on duty in a
licensed retail pharmacy as follows:
|(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
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;
|(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:
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:
|(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.
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:
|(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;|
|(3)||Date of issuance;|
|(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;
|(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.
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
|(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.|
pharmacist or pharmacy may receive eligible drugs for credit or reuse from
long-term care facilities provided that:
|(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
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:
|(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:
|(2)|| The following occurrences
require immediate notification to the Board at its address of record, unless
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.