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. The quality control and testing for CSPs in this chapter are appropriate and necessary. The content of this chapter applies to health care institutions, pharmacies, physician practice facilities, and other facilities in which CSPs are prepared, stored, and dispensed. For the purposes of this chapter, CSPs include any of the following:
Preparations prepared according to the maufacturer's labeled instructions and other manipulations when manufacturing sterile products that expose the original contents to potential contamination.
Preparations containing nonsterile ingredients or employing nonsterile components and devices that must be sterilized before administration.
Biologics, diagnostics, drugs, nutrients, and radiopharmaceuticals that possess either of the above two characteristics, and which include, but are not limited to, baths and soaks for live organs and tissues, implants, inhalations, injections, powders for injection, irrigations, metered sprays, and ophthalmic and otic preparations.
The sections in this chapter are organized to facilitate practitioners understanding of the fundamental accuracy and quality practices of CSPs. They provide a foundation for the development and implementation of essential procedures for the safe preparation of CSPs in the three risk levels, which are classified according to the potential for microbial, chemical, and physical contamination. The chapter is divided into the following main sections: