Many of you are aware that several drugs required to care for ventilator patients have been in critically short supply. Pharmacies in areas with widespread COVID-19 infections are sometimes faced with difficult decisions to discard these medications or use them past the current maximum <797> beyond-use dates. In response, USP has posted a document with considerations from the Compounding Expert Committee with considerations for sterile compounding during the COVID-19 pandemic.
The document includes a statement from USP supporting risk-based enforcement discretion related to compounding standards. It addresses the assignment of beyond-use dates, considerations for certification and re certification of engineering controls, and recommendations for cleaning and disinfecting a facility when someone is sick.
Note that the document includes support for some beyond used dates (BUDs) in the 2019 revision of Chapter <797>, including a four-day BUD for low- and medium-risk CSPs stored at room temperature. While the 2019 revision was remanded due to appeals, USP explains that these BUDs were based on stakeholder input during two previous rounds of chapter revisions and were thoroughly evaluated by the Expert Committee during that process.
Also note that USP establishes standards but does not enforce them. We will continue engaging regulatory agencies to request discretionary enforcement during this unprecedented shortage of critical pharmacy resources.