What type of compounding requires a semi-annual media fill test?

High-risk compounding involves the preparation of sterile products using non-sterile ingredients or through a process that carries a high risk of contamination. Because of the elevated risk factors associated with this type of compounding, stringent testing and quality assurance measures are mandated to ensure the safety and effectiveness of the compounded preparations.

To mitigate the potential for contamination, the Pharmacy Compounding Compendium and guidelines from bodies such as the United States Pharmacopeia (USP) stipulate that facilities engaged in high-risk compounding must perform semi-annual media fill tests. These tests assess the aseptic technique of compounding personnel and the integrity of the compounding environment. The aim is to ensure that the compounded products are sterile and suitable for patient use.

In contrast, simple compounding involves basic formulations that do not require a sterile environment and typically do not pose the same level of risk, thus not requiring such rigorous testing. Low-risk compounding, while still requiring careful procedures, also does not necessitate a semi-annual media fill test unless certain conditions are met. Immediate use compounding is reserved for urgent situations and has its unique considerations, but it does not fall under the high-risk category that triggers the need for semi-annual testing.