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This chapter provides procedures and requirements for compounding sterile preparations.
Sterile compounding differs from nonsterile compounding (see Pharmaceutical Compounding—Nonsterile Preparations 795 and Good Compounding Practices 1075) primarily by requiring a test for sterility. 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. Greater care is required for aqueous injections that are compounded sterile preparations (CSPs)—the most common CSPs used in therapy. 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. 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:
  1. Preparations prepared according to the maufacturer's labeled instructions and other manipulations when manufacturing sterile products that expose the original contents to potential contamination.
  2. Preparations containing nonsterile ingredients or employing nonsterile components and devices that must be sterilized before administration.
  3. 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 CSP’s 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:
  • Responsibilities of all compounding personnel
  • The basis for the classification of a CSP into a low-, medium-, and high-risk level, with examples of CSPs and their quality assurance practices in each of these risk levels
  • Verification of compounding accuracy and sterilization
  • Personnel training and evaluation in aseptic manipulation skills, including representative sterile microbial culture medium transfer and fill challenges
  • Environmental quality and control during the processing of CSPs
  • Equipment used in the preparation of CSPs
  • Verification of automated compounding devices for parenteral nutrition compounding
  • Finished preparation release checks and tests
  • Storage and beyond-use dating
  • Maintaining product quality and control after CSPs leave the compounding facility, including education and training of personnel
  • Packing, handling, storage, and transport of CSPs
  • Patient or caregiver training
  • Patient monitoring and adverse events reporting
  • A quality assurance program for CSPs It is the ultimate responsibility of all personnel who prepare CSPs to understand these fundamental practices and precautions, to develop and implement appropriate procedures, and to continually evaluate these procedures and the quality of final CSPs to prevent harm and fatality to patients who are treated with CSPs.