(1) Every drug wholesale distributor,
wherever located, who engages in drug wholesale distribution into, out of, or
within the State of Georgia must be licensed by the Georgia State Board of
Pharmacy in accordance with the laws and regulations of this State before
engaging in wholesale distribution of prescription drugs.
Minimum Required Information for
Licensure: The Board requires the following from each wholesale drug
distributor as part of the initial licensing procedure and as part of any
renewal of such license.
(a) The name, full
business address, and telephone number of the licensee;
(b) All trade or business names used by the
(c) Address, telephone
numbers, and the names of contact persons for the facility used by the licensee
for the storage, handling, and distribution of prescription drugs;
(d) The type of ownership or operations
(i.e., partnership, corporation, or sole proprietorship); and
The name(s) of the owner and/or operator
of the licensee, including:
1. If a person,
the name of the person;
2. If a
partnership, the name of each partner, and the name of the
3. If a corporation,
the name and title of each corporate officer and director, the corporate names,
and the name of the incorporation; and the name of the parent company, if
4. If a sole proprietorship,
the full name of the sole proprietorship and the name of the business
operations are conducted at more than one location by a single drug wholesale
distributor, each such location shall be licensed by the Board.
(g) Every drug wholesale distributor in this
state, which is licensed by the Board, is required to be located in a
commercially zoned business district and possess the appropriate local business
license in order to conduct business. No drug wholesale distributor may be
located in or operate out of a residential dwelling, building, or location, or
a building, dwelling or location attached to a residential location. A drug
wholesale distributor located in a hospital pharmacy or a retail pharmacy is
deemed to meet this requirement.
Applications for Licensure.
(a) Registration of a drug wholesaler
distributor will be considered on the basis of the application filed with the
Board, fee paid, and a report from the Director of the GDNA certifying the
applicant possesses the necessary qualifications of a license.
(b) Application fees shall not be
(c) Licenses become
null and void upon the sale, transfer or change of mode of operation or
location of the business.
Licenses are renewed for two years 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. An application for
reinstatement shall be required. Reinstatement shall be at the sole discretion
of the Board.
(e) Changes in any
information in this section shall be submitted to the Board prior to such
The Board will consider
the following factors in determining eligibility for licensure for persons who
engage in the wholesale distribution of prescription drugs:
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 applicant's past experience in the
manufacture or distribution of prescription drugs, including controlled
4. The furnishing by
the applicant of false or fraudulent material in any application made in
connection with drug manufacturing or distribution;
5. Suspension or revocation by Federal,
State, or local government of any license currently or previously held by the
applicant for the manufacture or distribution of any drugs, including
Compliance with licensing requirements under previously granted licenses, if
7. 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 drug wholesale distributors; and
8. Any other factors or qualifications the
Board considers relevant to and consistent with the public health and
(b) The Board
reserves the right to deny a license to any applicant if it determines that the
granting of such a license would not be in the public's interest.
(5) Personnel. The licensed
wholesale distributor shall employ adequate personnel with the education and
experience necessary to safely and lawfully engage in the wholesale
distribution of drugs.
(a) A license issued to a
wholesale distributor pursuant to this part shall be subject to revocation or
suspension upon conviction of the license holder for violations of Federal,
State, or local drug laws and/or regulations.
(b) Violation of any of the provisions of any
applicable Board laws or rules shall be grounds for the suspension or
revocation of the license issued hereunder.
(c) Any revocation or suspension of a license
pursuant to this part shall be carried out pursuant to the Georgia
Administrative Procedure Act, O.C.G.A. Title 50 Chapter 13.
(d) Drug samples shall not be sold in any
Minimum Requirements for the Storage and Handling of Prescription Drugs and for
the Establishment and Maintenance of Prescription Drugs Distribution Records.
The following are required for the storage and handling of prescription drugs,
and for the establishment and maintenance of prescription drug distribution
records by wholesale drug distributors and their officers, agents,
representatives, and employees.
Facilities. All facilities at which prescription drugs are stored, warehoused,
handled, held, offered, marketed, or displayed shall:
1. Be of suitable size and construction to
facilitate cleaning, maintenance, and proper operations;
2. Have storage areas designed to provide
adequate lighting, ventilation, temperature, sanitation, humidity, space,
equipment, and security conditions;
3. Have a quarantine area for storage or
prescription drugs that are outdated, damaged, deteriorated, misbranded, or
adulterated, or that are in immediate or sealed, secondary containers that have
been opened; 4. Be maintained in a clean and orderly condition; and 5. Be free
from infestation by insects, rodents, birds, or vermin of any kind.
Security. All facilities used
for wholesale drug distribution shall be secure from unauthorized entry.
1. Access from outside the premises shall be
kept to a minimum and be well controlled.
2. The outside perimeter of the premises
shall be well lighted.
into areas where prescription drugs are held shall be limited to authorized
4. All facilities shall
be equipped with an alarm system to detect entry after hours.
5. All facilities shall be equipped with a
security system that will provide suitable protection against theft and
diversion. When appropriate, the security system shall provide protection
against theft or diversion that is facilitated or hidden by tampering with
computers or electronic records.
Storage. All prescription drugs or
chemicals shall be stored at appropriate temperatures and under appropriate
conditions in accordance with requirements, if any, in the labeling of such
drugs, or with requirements in the current edition of an official compendium,
such as the United States Pharmacopeia (USP) Compendium.
1. If no storage requirements are established
for a prescription drug, the drug may be held at "controlled" room temperature,
as defined in the official compendium, to help ensure that its identity,
strength, quality, and purity are not adversely affected.
2. Appropriate manual, electromechanical, or
electronic temperature and humidity recording equipment, devices, and/or logs
shall be utilized to document proper storage of prescription drugs.
3. The record keeping requirements in
subparagraph (f) of this section shall be followed for all stored
1. Upon receipt, each outside
shipping container shall be visually examined for identity and to prevent the
acceptance of contaminated prescription drugs or prescription drugs that are
otherwise unfit for distribution. This examination shall be adequate to reveal
container damage that would suggest possible contamination or other damage to
2. Each outgoing
shipment shall be carefully inspected for identity of the prescription drug
products and to ensure that there is no delivery of prescription drugs that
have been damaged in storage or held under improper conditions.
3. The record keeping requirements in
subparagraph (f) of this section shall be followed for all incoming and
outgoing prescription drugs.
Returned, damaged, and outdated
1. Prescription drugs that
are outdated, damaged, deteriorated, misbranded, or adulterated shall be
quarantined and physically separated from other prescription drugs until they
are destroyed or returned to their supplier.
2. Any prescription drugs whose immediate or
sealed outer or sealed secondary containers have been opened or used shall be
identified as such, and shall be quarantined as such, and shall be quarantined
and physically separated from other prescription drugs until they are either
destroyed or returned to the supplier.
3. If the conditions under which a
prescription drugs has been returned cast doubt on the drug's safety, identify,
strength, quality, or purity, then the drug shall be destroyed, or returned to
the supplier, unless examination, testing, or other investigation proves that
the drug meets appropriate standards of safety, identity, strength, quality,
and purity. In determining whether the conditions under which the drug has been
returned cast doubt on the drug's safety, identity, strength, quality, or
purity, the wholesale drug distributor shall consider, among other things, the
conditions under which the drugs has been held, stored, or shipped before or
during its return and the condition of the drug and its container, carton, or
labeling as a result of storage or shipping.
4. The record keeping requirements in
subparagraph (f) of this section shall be followed for all outdated, damaged,
deteriorated, misbranded, or adulterated prescription drugs.
Wholesale drug distributors shall
establish and maintain inventories and records of all transactions regarding
the receipt and distribution or other disposition of prescription drugs. These
records shall include the following information:
(i) The source of the drugs, including the
name and principal address of the seller or transferor, and the address of the
location from which the drugs are shipped;
(ii) The identity and quantity of the drugs
received and distributed or disposed of; and
(iii) The date of receipt and distribution or
other disposition of the drugs.
For each person or firm, whether located
inside or outside the State of Georgia, to which a drug wholesale distributor,
located inside the State of Georgia, sells to, ships to, delivers to, or
wise distributes drugs to, such drug wholesale
distributor shall request and maintain a copy of that person or firm's current
license or permit which authorizes them to purchase, buy, receive, or otherwise
1. NO drug wholesale
distributor, located inside the State of Georgia, may ship to, sell to, or
otherwise deliver a dangerous drug or controlled substance to a person or firm
unless that person or firm holds a license or permit which authorizes them to
purchase, buy, receive or otherwise possess drugs.
(h) Nothing in this chapter or Georgia law
authorizes any drug wholesale distributor, located inside the State of Georgia,
to sell, ship, or otherwise distribute any drugs to any person or firm located
outside the United States of America or its territories without first receiving
written permission to do so from the Board. Such permission can only be granted
by the Board after it has received a written request from the drug wholesale
distributor giving the details of the proposed transaction. The Board reserves
the right to have the GDNA investigate any and all such requests, and the Board
reserves the right to deny any such request.
(i) Inventories and all records required
under this rule shall be made available for inspection and photocopying by any
authorized official of a government agency charged
with enforcement of these regulations for a period of two (2) years following
deposition of the drugs.
Records described in this rule that are kept at the inspection site or that can
be immediately retrieved by computer or other electronic means shall be made
readily available for authorized inspection during the retention period.
Records kept at a central record keeping location apart from the inspection
site and not electronically retrievable, shall be made available for inspection
within two (2) working days of a request by an authorized official of any
governmental agency charged with enforcement of these regulations.
Written Policies and
Procedures. Wholesale drug distributors shall establish, maintain, and adhere
to written policies and procedures, which shall be followed for the receipt,
security, storage, inventory, and distribution of prescription drugs, including
policies and procedures for identifying recording, and reporting losses or
thefts, and for correcting all errors and inaccuracies in inventories.
Wholesale drug distributors shall include in their written policies the
(a) A procedure whereby the oldest
approved stock of a prescription drug product is distributed first. The
procedure may permit deviation from this requirement, if such deviation is
temporary and appropriate.
procedure to be followed for handling recalls and withdrawals of prescription
drugs. Such procedure shall be adequate to deal with recalls and withdrawals
1. Any action initiated at the request
of the FDA or other Federal, State, or local law enforcement or other
government agency, including the Georgia State Board of Pharmacy;
2. Any voluntary action by the manufacturer
to remove defective or potentially defective drugs from the market;
3. Any action undertaken to
promote public health and safety by replacing of existing merchandise with an
improved product or new package design.
(c) A procedure to ensure that wholesale drug
distributors prepare for, protect against, and handle any crisis that affects
security or operation of any facility in the event of strike, fire, flood, or
other natural disaster, or other situations of local, state, or natural
(d) A procedure to
ensure that any outdated prescription drugs shall be segregated from other
drugs and either returned to the manufacturer or destroyed. This procedure
shall provide for written documentation of the disposition of outdated
prescription drugs. This documentation shall be maintained for two (2) years
after disposition of the outdated drugs.
(9) Responsible persons. Wholesale drug
distributors shall establish and maintain lists of officer, directors,
managers, and other persons in charge of wholesale drug distribution, storage,
and handling, including a description of their duties and a summary of their
with Federal, State, and local laws. Wholesale drug distributors shall operate
in compliance with applicable Federal, State, and local laws and regulations.
(a) Wholesale drug distributors shall permit
the Georgia State Board of Pharmacy and authorized Federal, State, and local
law enforcement officials to enter and inspect their premises and delivery
vehicles, and to audit their records and written operation procedures, at
reasonable times and in a reasonable manner, to the extent authorized by
(b) Wholesale drug
distributors that deal in controlled substances shall register with the
appropriate State controlled substance authority and with the Drug Enforcement
Administration (DEA), and shall comply with all applicable State, Local, and
Salvaging and reprocessing. Wholesale drug distributors shall be subject to the
provisions of any applicable Federal, State or local laws or regulations that
relate to prescription drug product salvaging or reprocessing.
Ga. Comp. R. & Regs.
Original Rule entitled
"Wholesale Distributor Licensing Requirements" adopted. F.
Feb. 21, 1992; eff.
Mar. 12, 1992.
Repealed: New Rule entitled "Drug Wholesale
Distribution Licensing Requirements" adopted. F. Aug.
6, 2001; eff. Aug. 26, 2001.
Amended: F. June 29,
2015; eff. July 19, 2015.