All prescription drugs shall be stored and shipped at appropriate temperatures and under appropriate conditions in accordance with requirements, if any, in the labeling of such drugs or with requirements in the current edition of the United States Pharmacopeia. Manual, electromechanical, or electronic temperature and humidity monitoring and recording equipment, devices, or logs shall be utilized to document proper storage of prescription drugs to prevent and detect excursions. Shipment of prescription drugs requiring refrigeration shall maintain temperature requirements in accordance with the manufacturer requirements or as described in the current edition of the United States Pharmacopeia. All excursions shall be evaluated to determine any adverse impact on the integrity of the drug. The requirements of this rule do not apply to nonsaleable returns handled by returns processors.
Iowa Admin. Code r. 657-17.11