Current through Register Vol. 49, No. 13, September 23, 2024
Subpart 1.
Application.
The minimum requirements in this part apply to all wholesale
drug distributors located in this state and to their officers, agents,
representatives, and employees.
Subp.
2.
Incorporation by reference.
"United States Pharmacopeia/National Formulary" means the
United States Pharmacopeia/National Formulary published by the United States
Pharmacopeia, which is incorporated by reference. The United States
Pharmacopeia/National Formulary is subject to frequent change. The book is
available for inspection and copying at the Biomedical Library, University of
Minnesota, Diehl Hall, 505 Essex Street S.E., Minneapolis, Minnesota 55455, or
through the Minitex interlibrary loan system.
Subp. 3.
Facilities.
All facilities at which 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 physically separate area for
storage of all drugs that are outdated, damaged, deteriorated, misbranded, or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.
Subp. 4.
Security.
The requirements in items A to C govern security.
A. All facilities used for wholesale drug
distribution shall be secure from unauthorized entry as follows:
(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; and
(3)
entry into areas where drugs are held shall be limited to authorized
personnel.
B. All
facilities shall be equipped with an alarm system to detect entry after
hours.
C. 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.
Subp. 5.
Storage.
Items A to D govern storage of drugs.
A. All drugs shall be stored at temperatures
and under conditions in accordance with the requirements, if any, in the
labeling of such drugs, or with requirements in the current edition of the
United States Pharmacopeia/National Formulary.
B. If no storage requirements are established
for a drug, the drug may be held at "controlled room temperature," as defined
in the United States Pharmacopeia/National Formulary, to help ensure that its
identity, strength, quality, and purity are not adversely affected.
C. Manual, electromechanical, or electronic
temperature and humidity recording equipment, devices, or logs shall be used to
document proper storage of prescription drugs.
D. The record keeping requirements in subpart
8 shall be followed for all
stored drugs.
Subp. 6.
Examination of materials.
Upon receipt, each outside shipping container shall be
visually examined for identity and to prevent the acceptance of contaminated
drugs or 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.
Each outgoing shipment shall be carefully inspected for
identity of the drug products and to ensure that there is no delivery of drugs
that have been damaged in storage or held under improper conditions.
The record keeping requirements in subpart
8 shall be followed for all
incoming and outgoing drugs.
Subp.
7.
Returned, damaged, and outdated drugs.
Items A to D govern returned, damaged, outdated,
deteriorated, misbranded, and adulterated drugs.
A. Drugs that are damaged, outdated,
deteriorated, misbranded, or adulterated shall be physically separated from
other drugs until they are destroyed or returned to their supplier.
B. Any drugs whose immediate or sealed outer
or sealed secondary containers have been opened or used shall be identified as
such, and shall be physically separated from other drugs until they are either
destroyed or returned to the supplier.
C. If the conditions under which a drug has
been returned cast doubt on the drug's safety, identity, 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 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 record keeping requirements in subpart
8 shall be followed for all
damaged, outdated, deteriorated, misbranded, or adulterated drugs.
Subp. 8.
Record
keeping.
Items A to C govern record keeping.
A. Wholesale drug distributors shall
establish and maintain inventories and records of all transactions regarding
the receipt and distribution or other disposition of drugs. These records shall
include the following information:
(1) 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;
(2) the identity and
quantity of the drugs received and distributed or disposed of; and
(3) the dates of receipt and distribution or
other disposition of the drugs.
B. Inventories and records shall be made
available for inspection and photocopying by authorized federal, state, or
local law enforcement agency officials for a period of two years following
disposition of the drugs.
C.
Records described in this part 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 a federal, state, or local law enforcement
agency.
Subp. 9.
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 drugs. They must
include 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 the written policies and procedures
described in items A to D.
A. A
procedure where the oldest approved stock of a drug product is distributed
first. The procedure may permit deviation from this requirement, if the
deviation is temporary and appropriate.
B. A procedure to be followed for handling
recalls and withdrawals of drugs. The procedure shall be adequate to deal with
recalls and withdrawals due to:
(1) any action
initiated at the request of the Food and Drug Administration or other federal,
state, or local law enforcement or other government agency, including the Board
of Pharmacy;
(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 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
national emergency.
D. A procedure
to ensure that any outdated 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 drugs. This
documentation shall be maintained for two years after disposition of the
outdated drugs.
Subp.
10.
Responsible persons.
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.
Subp. 11.
Compliance with federal,
state, and local law.
Wholesale drug distributors shall operate in compliance with
applicable federal, state, and local laws and regulations.
Wholesale drug distributors shall permit the Board of
Pharmacy and authorized federal, state, and local law enforcement officials to
enter and inspect both 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.
Wholesale drug distributors who deal in controlled substances
shall register with the Board of Pharmacy and with the Drug Enforcement
Administration, and shall comply with all applicable state, local, and Drug
Enforcement Administration regulations.
Subp. 12.
Salvaging and
reprocessing.
Wholesale drug distributors are subject to any applicable
federal, state, or local laws or regulations that relate to drug product
salvaging or reprocessing, including Code of Federal Regulations, title 21,
parts 207, 210, and 211, and Minnesota Statutes, section
151.39.
Statutory Authority: MS s
151.06;
151.42
