The minimum requirements in this part apply to all wholesale drug distributors located in this state and to their officers, agents, representatives, and employees.
"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.
All facilities at which drugs are stored, warehoused, handled, held, offered, marketed, or displayed shall:
be of suitable size and construction to facilitate cleaning, maintenance, and proper operations;
have storage areas designed to provide adequate lighting, ventilation, temperature, sanitation, humidity, space, equipment, and security conditions;
have a physically separate area for storage of all drugs that are outdated, damaged, deteriorated, misbranded, or adulterated, or that are in immediate or sealed, secondary containers that have been opened;
be maintained in a clean and orderly condition; and
be free from infestation by insects, rodents, birds, or vermin of any kind.
The requirements in items A to C govern security.
All facilities used for wholesale drug distribution shall be secure from unauthorized entry as follows:
access from outside the premises shall be kept to a minimum and be well-controlled;
the outside perimeter of the premises shall be well-lighted; and
entry into areas where drugs are held shall be limited to authorized personnel.
All facilities shall be equipped with an alarm system to detect entry after hours.
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.
Items A to D govern storage of drugs.
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.
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.
Manual, electromechanical, or electronic temperature and humidity recording equipment, devices, or logs shall be used to document proper storage of prescription drugs.
The record keeping requirements in subpart 8 shall be followed for all stored drugs.
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.
Items A to D govern returned, damaged, outdated, deteriorated, misbranded, and adulterated drugs.
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.
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.
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.
The record keeping requirements in subpart 8 shall be followed for all damaged, outdated, deteriorated, misbranded, or adulterated drugs.
Items A to C govern record keeping.
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:
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;
the identity and quantity of the drugs received and distributed or disposed of; and
the dates of receipt and distribution or other disposition of the drugs.
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.
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.
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 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.
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:
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;
any voluntary action by the manufacturer to remove defective or potentially defective drugs from the market; or
any action undertaken to promote public health and safety by replacing of existing merchandise with an improved product or new package design.
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.
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.
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.
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.
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.
16 SR 1913; 36 SR 237
September 21, 2011
Official Publication of the State of Minnesota
Revisor of Statutes