(7) |
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.
(a) |
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prescription drugs that are outdated, damaged, deteriorated, misbranded, or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. |
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(b) |
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. |
3. |
Entry
into areas where prescription drugs are held shall be limited to authorized
personnel. |
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. |
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(c) |
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
drugs. |
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(d) |
Examination
of materials.
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
the contents. |
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. |
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(e) |
Returned, damaged, and outdated
prescription drugs.
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. |
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(f) |
Record keeping:
1. |
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. |
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(g) |
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
otherwise 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
possess drugs.
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. |
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(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. |
(j) |
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. |
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