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 recertification of engineering controls, and recommendations for cleaning and disinfecting a facility when someone is sick.