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KANSAS ADMINISTRATIVE REGULATIONS
AGENCY 68 KANSAS STATE BOARD OF PHARMACY
ARTICLE 14. WHOLESALE DISTRIBUTORS
Date:
08/31/2009
Document:
68-14-7. Minimum requirements for the storage and handling of prescription-only drugs and for the establishment and maintenance of prescription-only drug distribution records.
Each registrant shall meet the following minimum requirements for the storage and handling of prescription-only drugs, and for the establishment and maintenance of prescription-only drug distribution records by wholesale distributors and their officers, agents, representatives, and employees.
(a) Facilities. Each facility at which prescription-only drugs are stored, warehoused, handled, held, offered, marketed, or displayed shall meet the following requirements:
(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(3) have a quarantine area for storage of prescription-only drugs that are outdated, damaged, deteriorated, misbranded, or adulterated, or that are in immediate or sealed, secondary containers that have been opened;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.
(b) Security.
(1) Each facility 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-only drugs are held shall be limited to authorized personnel.
(2) Each facility shall be equipped with an alarm system to detect entry after hours.
(3) Each facility 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.
(c) Storage. All prescription-only drugs shall be stored at appropriate temperatures and under appropriate conditions in accordance with requirements, if any, in the labeling of these drugs, or with requirements in the 1995 edition of the United States pharmacopeia/national formulary (USP/NF), which is adopted by reference.
(1) If no storage requirements are established for a prescription-only 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.
(2) Appropriate manual, electromechanical, or electronic temperature and humidity-recording equipment, devices, logs, or a combination of these methods shall be utilized to document proper storage of prescription-only drugs.
(3) The record-keeping requirements in subsection (f) of this regulation shall be followed for all stored drugs.
(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-only drugs or prescription-only 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-only drug products and to ensure that there is no delivery of prescription-only drugs that have been damaged in storage or held under improper conditions.
(3) The record-keeping requirements in subsection (f) of this regulation shall be followed for all incoming and outgoing prescription-only drugs.
(e) Returned, damaged, and outdated prescription-only drugs.
(1) Prescription-only drugs that are outdated, damaged, deteriorated, misbranded, or adulterated shall be quarantined and physically separated from other prescription-only drugs until they are destroyed or returned to their supplier.
(2) Any prescription-only drugs 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-only drugs until they are either destroyed or returned to the supplier.
(3) If the conditions under which a prescription-only 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 investigations prove that the drug meets appropriate standards of safety, identity, strength, quality, and purity. In determining whether or not the conditions under which a drug has been returned cast doubt on the drug's safety, identity, strength, quality, or purity, the wholesale distributor shall consider, among other factors, 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.
(4) The record-keeping requirements in subsection (f) of this regulation shall be followed for all outdated, damaged, deteriorated, misbranded, or adulterated prescription-only drugs.
(f) Record keeping.
(1) Each wholesale distributor shall establish and maintain inventories and records of all transactions regarding the receipt and distribution or other disposition of prescription-only 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 either distributed or disposed of; and
(C) the dates of receipt and either distribution or other disposition of the drugs.
(2) Inventories and records shall be made available for inspection and photocopying by authorized federal, state, or local law enforcement agency officials for five years following disposition of the drugs.
(3) Records described in this regulation 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.
(g) Written policies and procedures. Each wholesale distributor shall establish, maintain, and adhere to written policies and procedures concerning the receipt, security, storage, inventory, and distribution of prescription-only drugs, including policies and procedures for identifying, recording, and reporting losses or thefts, and for correcting all errors and inaccuracies in inventories. In addition, each wholesale distributor shall establish, maintain, and adhere to the following written policies and procedures:
(1) a procedure by which the oldest approved stock of a prescription-only drug product is distributed first. The procedure may permit deviation from this requirement, if the deviation is temporary and appropriate;
(2) a procedure to be followed for handling recalls and withdrawals of prescription-only drugs. This procedure shall be adequate to deal with recalls and withdrawals due to any of the following:
(A) 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;
(B) any voluntary action by the manufacturer to remove defective or potentially defective drugs from the market; or
(C) any action undertaken to promote public health and safety by replacing existing merchandise with an improved product or new package design;
(3) a procedure to ensure that wholesale 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; and
(4) a procedure to ensure that any outdated prescription-only 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-only drugs. This documentation shall be maintained for five years after disposition of the outdated drugs.
(h) Responsible persons. Each wholesale distributor shall establish and maintain lists of officers, directors, managers, and other persons in charge of wholesale prescription-only drug distribution, storage, and handling, including a description of their duties and a summary of their qualifications.
(i) Compliance with federal, state, and local law. Each wholesale distributor that deals in controlled substances shall register with the drug enforcement administration.
Each wholesale distributor shall permit the board's authorized personnel and authorized federal, state, and local law enforcement officials to enter and inspect the distributor's premises and delivery vehicles, and to audit the records and written operating procedures, at reasonable times and in a reasonable manner, to the extent authorized by law. These officials shall be required to show appropriate identification before being permitted access to wholesale distributors' premises and delivery vehicles.
(j) Salvaging and reprocessing. Each wholesale distributor shall be subject to the provisions of any applicable federal, state, or local laws or regulations that relate to prescription-only drug product salvaging or reprocessing.
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