Sterile and Non-Sterile Compounding
Three chapters, three standards
USP 795 covers non-sterile compounding, USP 797 covers sterile compounding, and USP 800 covers hazardous drugs. Know which standard applies before you touch a mortar or a needle.
Non-sterile basics: accurate weighing and measuring, geometric dilution for powders, wetting agents, levigation, and documentation of every component and lot. Beyond-use dates come from the default tables in the chapter; they may be shortened, and extended only with documented stability data-and never past the manufacturer's expiration of the starting materials.
Sterile basics: hand hygiene and garbing, an ISO Class 5 primary engineering control, the first-air principle, no disruption of airflow, critical sites kept in view, disinfection with the correct agent and contact time, and environmental monitoring. Non-hazardous compounds are prepared in a horizontal laminar airflow workbench; hazardous drugs require a containment ventilated enclosure or biological safety cabinet in a negative-pressure room, closed-system transfer devices, and chemotherapy-rated PPE.
Traps
- Believing the hood substitutes for hand hygiene and garbing.
- Extending a beyond-use date for scheduling convenience.
- Using a horizontal hood for hazardous drugs.
- Omitting preparation date and time, BUD, and storage conditions from the label.
- Assuming the technician performs the final check-the pharmacist does.
Worked example
An oral suspension is compounded from tablets and water at 3:00 p.m. You assign the shortest applicable default BUD from the USP 795 table, label the product with preparation date and time plus the beyond-use date and time, and never extend beyond the tablets' expiration date.
Rule of thumb: if a BUD, storage temperature, or garbing step is unclear, stop and ask the pharmacist before compounding.