What should be done with CSPs that have visible defects?

When it comes to Compounded Sterile Preparations (CSPs) that exhibit visible defects, the proper course of action is to immediately discard them. This practice is crucial in maintaining patient safety and ensuring the integrity of sterile products. Visible defects could indicate contamination, improper formulation, or other issues that compromise the sterility and efficacy of the preparation.

For instance, defects such as discoloration, particulate matter, or cloudiness could suggest that the CSP might not be safe for administration. Discarding these preparations prevents any potential harm to patients that might arise from using compromised products. Furthermore, regulatory standards, such as those outlined in USP 797, emphasize the importance of maintaining strict quality control during the compounding process to ensure that all CSPs are safe and effective.

Other actions, such as storing for later inspection or repackaging for reuse, could risk exposing the preparation to further contamination and do not align with the guidelines intended to protect patient health. Sending defective CSPs back to the manufacturer might be appropriate in some scenarios, but it does not address the immediate need to prevent the defective product from being used. Therefore, immediate disposal is the best practice for handling CSPs with visible defects.