12 AAC 52.630. Drug storage

(a) A wholesale drug distributor shall ensure that all drugs are stored at appropriate temperatures in accordance with label requirements or official United States Pharmacopoeia (USP), 1995 revision, compendium requirements, to help ensure that the identity, strength, quality, and purity of the products are not affected. If a temperature requirement is not listed for a drug, the drug may be stored at controlled room temperature as defined in the USP.

(b) A wholesale drug distributor shall ensure that a separate quarantine storage area is provided for drugs that are deteriorated, outdated, damaged, misbranded, adulterated, or are in a secondary container that has been opened or the seal of which has been broken.

(c) A wholesale drug distributor shall ensure that appropriate manual, electromechanical, or electronic temperature and humidity recording equipment or handwritten logs are used to document how drugs have been stored.

History: Eff. 1/16/98, Register 145

Authority: AS 08.80.005

AS 08.80.030

AS 08.80.157

AS 08.80.480

Editor's note: A copy of the United States Pharmacopoeia may be obtained from the United States Pharmacopoeial Convention, Inc., P.O. Box 560, Williston, VT 05495.

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