The pre-administration storage duration and temperature limits specified apply in the absence of direct sterility testing results that justify different limits for specific CSPs.
The risk levels defined in the apply to the quality of CSPs immediately after the final aseptic mixing or filling or immediately after the final sterilization, unless precluded by the specific characteristics of the preparation.
The risk levels and requirements for each are summarized in Online Table 1.
Table 1: USP BUD = beyond use date; ISO = International Organization for Standardization; TPN = total parenteral nutrition.
The quality control and testing for CSPs in this chapter are appropriate and necessary.
These performance responsibilities include maintaining appropriate cleanliness conditions and providing labeling and supplementary instructions for the proper clinical administration of CSPs.It is important to note that some CSPs are prepared and administered in clinics, at the bedside, in procedural areas, and in operating rooms with little direct pharmacy oversight.While quality and safety programs exist within other health care professions, pharmacy knowledge and involvement in these activities ensures compliance with best practices and also provides an opportunity for pharmacy to take ownership of the complete medication use process.While the safety of compounded sterile preparations (CSPs) has been an important topic in the practice of pharmacy for decades, the recent tragic deaths related to fungal contamination of preservative-free methylprednisolone injection have once again put the topic on the national stage.In light of this call to ensure patient safety, hospital pharmacies have been evaluating their use of outsourcing and their own compliance with United States Pharmacopeial Convention (USP) chapter Microbial contamination of CSPs can occur in any practice setting and puts patients at risk of significant morbidity and mortality.