Synopsis
Compounding in general, and sterile compounding in particular, cannot be safely and successfully conducted in pharmacies without the creation of a proper “state of control,” This “state of control” – speaks to the compounder’s ability to control and demonstrate that the conditions that exist around the processes and medications that are being manipulated. If you carefully read the USP General Chapters that speak to extemporaneous compounding in all its forms– USP 795 Non-Sterile, USP 797 Sterile, USP 800 Handling of Hazardous Drugs, and even USP 825 Radiopharmaceuticals, it is clear that all the guidance described within these documents are all focused on the creation of a controlled process as the only way we can hope to begin to create this quality mosaic as a basis of this control.
