- (a) A wholesale drug distributor shall ensure that all drugs are stored at appropriate temperatures in accordance with label requirements to help ensure that the identity, strength, quality, and purity of the products are not affected.
- (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drug distributor shall ensure that a separate quarantine storage area is provided for drugs that are deteriorated, outdated, damaged, misbranded, adulterated, or are in a secondary container that has been opened or the seal of which has been broken.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.
(Eff. 1/16/98, Register 145; am 10/31/2019, Register 232)
Authority: AS 08.80.005, AS 08.80.157, AS 08.80.480, AS 08.80.030, AS 08.80.159