Current through 2024-38, September 18, 2024
1.
Personnel
A wholesale drug distributor shall employ adequate levels
of personnel with the education and experience necessary to safely and lawfully
engage in the wholesale distribution of drugs.
2.
Facilities
All facilities at which prescription drugs are stored,
warehoused, handled, held, offered, marketed or displayed shall:
A. Be of suitable size and construction to
facilitate cleaning, maintenance and proper operations;
B. Have storage areas designed to provide
adequate lighting, ventilation, temperature, sanitation, humidity, space,
equipment and security conditions;
C. Have a quarantine area for storage of
drugs that are outdated, damaged, defective, deteriorated, misbranded or
adulterated, or that are in immediate or sealed secondary containers that have
been opened;
D. Be maintained in a
clean and orderly condition; and
E.
Be free from infestation by insects, rodents, birds or vermin of any
kind.
3.
Security
All facilities used for wholesale drug distribution shall
be secure from unauthorized entry:
A.
Access from outside the premises shall be kept to a minimum and be
well-controlled;
B. The outside
perimeter of the premises shall be well-lighted;
C. Entry into areas where prescription drugs
are held shall be limited to authorized personnel;
D. All facilities shall be equipped with an
alarm system to detect entry after hours; and
E. All facilities shall be equipped with a
security system that provides 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.
4.
Storage
A. All prescription
drugs 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.
B. If no storage
requirements are established for a prescription drug, the drug may be held at
"controlled" room temperature, as defined in an official compendium, to help
ensure that its identity, strength, quality and purity are not adversely
affected.
C. Appropriate manual,
electromechanical or electronic temperature and humidity recording equipment,
devices and/or logs shall be utilized to document proper storage of
prescription drugs.
D. The
recordkeeping requirements in Section
2(7) of this chapter
shall be followed for all stored drugs.
5.
Examination of Materials
A. 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.
B. 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.
C. The recordkeeping requirements in Section
2(7) of this chapter
shall be followed for all incoming and outgoing prescription drugs.
6.
Returned, Damaged and
Outdated Prescription Drugs
A.
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.
B. Any prescription drug
whose immediate or sealed outer or sealed secondary containers have been opened
or used shall be identified as such, and shall be quarantined and physically
separated from other prescription drugs until they are either destroyed or
returned to the supplier.
C. If the
conditions under which a prescription drug has been returned to the wholesaler
cast doubt on the drug's safety, identity, strength, quality or purity, then
the drug shall be quarantined and physically separated from other prescription
drugs and 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 a 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 drug 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.
D. The recordkeeping
requirements in Section
2(7) of this chapter
shall be followed for all outdated, damaged, deteriorated, misbranded or
adulterated prescription drugs.
7.
Recordkeeping
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:
A.
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 were
shipped;
B. The identity and
quantity of the drugs received and distributed or disposed of; and
C. The dates of receipt and distribution or
other disposition of the drugs;
D.
Inventories and records shall be made available for inspection and photocopying
by any authorized official of any governmental agency charged with enforcement
of these rules for a period of 2 years following disposition of the
drugs;
E. Records described in this
section that are kept at the inspection site or that can be immediately
retrieved by computer or other electronic means shall be readily available for
authorized inspection during the retention period. Records kept at a central
location apart from the inspection site and not electronically retrievable
shall be made available for inspection within two working days of a request by
an authorized official of any governmental agency charged with enforcement of
these rules.
8.
Written policies and procedures
Wholesale drug distributors shall establish, maintain and
adhere to written policies and procedures 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 and procedures the
following:
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;
B. A
procedure to be followed for handling recalls and withdrawals of prescription
drugs. The procedure shall be adequate to deal with recalls and withdrawals due
to:
(1) Any action initiated at the request of
the FDA or other federal, state or local law enforcement or other government
agency, including the board;
(2)
Any voluntary action by the manufacturer to remove defective or potentially
defective drugs from the market; or
(3) Any action undertaken to promote public
health and safety by replacing existing merchandise with an approved product or
new package design.
C. A
procedure to ensure that wholesale drug outlets 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 national emergency; and
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 2 years after disposition of the outdated
drugs.
9.
Responsible individuals
Wholesale drug distributors shall establish and maintain
lists of officers, 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 qualifications.
10.
Compliance with Law
A. Wholesale drug distributors shall operate
in compliance with
21
USC §353(e), the other
federal laws and rules specified in Chapter 29, Section
1 of the board's rules, and other
applicable state and local laws and rules.
B. Wholesale drug distributors shall permit
the board 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 operating procedures, at reasonable times and in a
reasonable manner to the extent authorized by law. Such officials shall be
required to show appropriate identification prior to being permitted access to
wholesale drug distributors' premises and delivery vehicles.
C. Wholesale drug distributors that deal in
controlled substances shall register with the DEA and shall comply with all
applicable DEA rules.
11.
Salvaging and Reprocessing
Wholesale drug distributors shall be subject to the
provisions of any applicable federal, state or local laws or rules that relate
to any drug product salvaging or reprocessing, including 21 CFR Parts 207, 210
and 211, Subpart K.
