INSOURCING Sterile Compounding Services
Readiness Assessment Tool
Note: It is anticipated that the Assessment Tool will be updated to reflect final changes in USP Chapter <797>. In the meantime, its concepts reflect the current official version of USP Chapter <797> (revised 2008) and are valuable for sites assessing insourcing readiness.
The ASHP Foundation Insourcing Sterile Compounding Services Readiness Assessment Tool provides a systematic process to determine a hospital’s/health-system’s operational readiness for insourcing or internalizing production of compounded sterile preparations (CSPs) that are being provided by an outside vendor (outsourced). The contents of this tool can also be considered as part of a comprehensive organizational analysis to identify the best source for compounded sterile preparations. It is anticipated that the assessment tool will be updated to reflect final changes in USP Chapter <797>; in the meantime, its concepts are valuable for sites undergoing the decision-making process.
The tool consists of questions and lists of considerations. The tool tracks your answers and items for follow-up and creates a final report that can be downloaded as a PDF upon completing the assessment. The final report provides a checklist of items that need to be addressed, information that may need to be gathered, and data to be collected. This tool will not provide a justification that advocates for or against insourcing at a particular facility but rather helps focus follow-up efforts needed to make a decision.
This tool can be used to evaluate low-, medium-, and high-risk compounds. This tool is NOT intended for use in the evaluation of nuclear pharmacy and hazardous drug preparation or insourcing.