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The information collection burden associated with this measure is currently approved under OMB control number 0938-1270

Food and Drug Administration has provided regulatory guidance in the publication Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing available at: which is incorporated herein by reference in its entirety

This is a particular risk during benzodiazepine withdrawal when anxiety levels are usually high

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Reconstituted working solutions are typically held at 28 C and used within weeks, with aliquoting to minimize freeze-thaw degradation