Where can low and medium-risk hazardous drug compounded sterile preparations (CSPs) be prepared according to USP 800?

Low and medium-risk hazardous drug compounded sterile preparations (CSPs) can be prepared in an unclassified containment segregated compounding area (C-SCA) according to USP 800 guidelines. The C-SCA serves as a designated area that helps to contain the handling and potential contamination of hazardous drugs while allowing for the preparation of these CSPs in a controlled environment.

USP 800 emphasizes the importance of creating a safer environment for personnel and preventing cross-contamination, and the C-SCA is designed for this purpose. It is essential that the C-SCA is equipped with proper ventilation and other safety features to mitigate risks.

Locations such as general pharmacy settings or open workspaces may not provide the necessary safeguards required for handling hazardous drugs, and sterile environments typically refer to areas that may be classified for aseptic processing, which does not apply to low and medium-risk preparation outside of specific containment strategies. Therefore, the C-SCA is the most appropriate and compliant choice for the preparation of low and medium-risk hazardous drug CSPs.