USP Revises Compounding Pharmacy Rule to Address Sterile Drugs
[Posted on: Thursday, October 1, 2015]

Since the fungal meningitis outbreak of 2012 linked to contaminated injectable drugs prepared a Massachusetts compounding pharmacy, multiple laws have been passed to regulated compounding pharmacies primarily requiring cGMP compliance and registration with FDA. However, the processes used for compounding are still described in USP monographs. This week, USP announced a much anticipated update to Monograph 797, Pharmaceutical Compounding—Sterile Preparations which closes the loop on all sterile compounding practices. Under the extensively revised new monograph, no sterile compounded drugs are considered low risk. All sterile compounded drugs are classified into two categories; Category 1: drugs for short-term storage, and Category 2: drugs for long-term storage. The conditions for Category 2 must be pharmaceutical grade clean room, while Category 1 drugs may be compounded in segregated compounding area such as a biosafety cabinet. The extensively rewritten monograph greatly revised the process of compounding sterile drugs to add high quality sterile processing, packaging, labeling and handling conditions similar to pharmaceutical GMP conditions. Although in its announcement, USP mentioned that these revisions have been in the works since 2010, the provisions are clearly intended to address the concerns raised in the 2012 accident. Unlike the FDA rules that apply to only a select fraction of compounding pharmacies, the USP monograph applies to all compounding pharmacies for sterile drugs effectively closing the loop-holes left in the system by FDA rules.