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ISMP would like to thank the 715 practitioners, mostly pharmacy directors and managers, staff pharmacists, clinical pharmacists, and medication safety pharmacists, who responded to our recent survey on drug storage, stability, and beyond use dating of injectable drugs.We conducted the survey to learn more about what resources pharmacists rely on to guide drug storage, stability, and beyond use dating.

Also, If the compounded formulation is an official monograph in the USP/NF, the beyond use date given in the monograph can be used provided the procedure in the monograph was followed.We were specifically interested in learning about conditions that may result in unnecessary waste of drugs during the ongoing drug shortage crisis or waste of very expensive medications given the ever rising cost associated with healthcare.The Centers for Medicare & Medicaid Services (CMS) standard 42 CFR §482.25(b)(3) states that “Outdated, mislabeled, or otherwise unusable drugs and biologicals must not be available for patient use.” To avoid the use of outdated drugs, CMS requires pharmacists to follow the manufacturer’s directions regarding storage, stability, and beyond use dating in the official US Food and Drug Administration (FDA)-approved prescribing information (package insert) [§482.25(a)].USP 797 - USP Chapter 797, Pharmaceutical Compounding-Sterile Preparations, provides the first set of enforceable sterile compounding standards issued by the United States Pharmacopeia (USP).USP Chapter 797 describes the procedures and requirements for compounding sterile preparations and sets the standards that apply to all settings in which sterile preparations are compounded.




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First, sedation is recommended to allow patients the ability to tolerate unpleasant diagnostic or surgical procedures and to relieve anxiety and discomfort.


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