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(a) A wholesale drug facility in which drugs are stored, repacked, or sold to persons, businesses, or government agencies that may legally purchase drugs must
(1) have storage areas that ensure proper lighting, ventilation, temperature, sanitation, humidity, space, equipment, and security conditions;
(2) be of suitable size, construction, and location to facilitate cleaning, maintenance, and proper operations;
(3) be equipped with an alarm system to detect entry into the wholesale drug facility after business hours;
(4) meet all applicable federal, state, and local building standards;
(5) be secure from unauthorized entry from outside the facility, including having exterior lighting along the outside perimeter of the facility;
(6) restrict entry into areas inside the facility where drugs are stored; entry must be open to authorized personnel only;
(7) have a quarantine area for storage of drugs that are outdated, damaged, deteriorated, misbranded, or adulterated, or that are in a secondary container that has been opened or the seal of which has been broken;
(8) be maintained in a clean and orderly condition; and
(9) be free from infestation by insects, rodents, birds, or vermin of any kind.
(b) A wholesale drug facility must develop internal security policies, including protection of computer records, to provide reasonable protection against theft or diversion of drugs by personnel.
(c) A wholesale drug facility may not be located in a residence.
History: Eff. 1/16/98, Register 145
Authority: AS 08.80.005
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Last modified 7/05/2006