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USP <797> states compounders must ensure products maintain labeled strength within monograph limits. The difficulty with determining limits (specifications) for compounded preparations is that there may not be a monograph to reference. In these cases, ARL assigns the specification by choosing them from a monograph that is closest to the product being tested.

For potency testing with respect to HPLC, IC and/or GC methodologies, ARL verifies by way of system suitability that we are capable of performing the analysis.

Now is the time to prepare for proposed changes to USP <797>.

Over the next few newsletters, we will highlight proposed changes to sterile compounding testing requirements and how ARL can help your pharmacy meet USP standards.

We begin with Personnel Qualification and Environmental Monitoring Requirements for Compounded Sterile Preparations (CSPs) Categories 1 and 2.