Considerations for implementing United States pharmacopeia chapter 797 pharmaceutical compounding-sterile preparation, part 3: risk levels.
The intent of United States Pharmacopeia Chapter 797 Pharmaceutical Compounding-Sterile Preparations is to prevent patient harm and fatalities that may result from nonsterility, excessive endotoxin load, large content errors in strength of correct ingredients, or the presence of incorrect ingredients. Understanding the different microbial contamination risk levels involved in compounding sterile preparations, how to appropriately assign those risk levels, and the steps needed to maintain sterility decreases the probability of a contaminated preparation.