The basic understanding for CSTDs is that they should not be used to extend BUD.However, does this prevent multiple entries into the bag by creating a sealed barrier between the product and the direct compounding area (DCA)? It is interesting to note that the media-fill test procedure for low-risk compounding includes transferring four 5-m L aliquots of TSA into a single 30-m L vial. A CSP prepared under low-risk conditions receives a 48 hour BUD when stored at controlled room temperature.
The chapter is divided into the following main sections: Compounding personnel are responsible for ensuring that CSPs are accurately identified, measured, diluted, and mixed; and are correctly purified, sterilized, packaged, sealed, labeled, stored, dispensed, and distributed.
These performance responsibilities include maintaining appropriate cleanliness conditions and providing labeling and supplementary instructions for the proper clinical administration of CSPs.
Aqueous injections for administration into the vascular and central nervous systems pose the greatest risk of harm to patients if there are issues of nonsterility and large errors in ingredients.
The intent of this chapter is to prevent harm and fatality to patients that could result from microbial contamination (nonsterility), excessive bacterial endotoxins, large content errors in the strength of correct ingredients, and incorrect ingredients in CSPs.
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.
Introduction The United States Pharmacopeial Convention (USP) is developing a chapter for the National Formulary (USP-NF) that will establish safety standards for handling hazardous drugs (HDs).1 Although guidelines on hazardous drug handling are available from other organizations, USP has yet to include a specific chapter on this in the USP-NF.2-7 The current USP chapter emphasizes HD containment in order to protect personnel and the environment when handling both sterile and nonsterile HDs.
This chapter will be a resource for healthcare practitioners and staff, occupational health and safety specialists, and human resources.
Sterile compounding also requires cleaner facilities; specific training and testing of personnel in principles and practices of aseptic manipulations; air quality evaluation and maintenance; and sound knowledge of sterilization and solution stability principles and practices.