In November 2022, United States Pharmacopeia (USP) announced revisions to its General Chapter <797>, a standard for sterile pharmaceutical compounding that plays a major role in guiding regulatory bodies and accrediting organizations (asamonitor.pub/3iUbtDn). These revisions included a clear distinction between administration and compounding, and effectively ended the “one-hour rule,” a restrictive standard stating that all immediate-use sterile products must be administered within one-hour after the start of preparation. Within this revised guidance, USP made clear that administration is officially outside the scope of Chapter <797>. Altogether, the revisions will resolve confusion and workflow disruptions our members have faced for years.
Shortly after the publication of USP's revised guidance and based on the USP <797> Frequently Asked Questions, The Joint Commission (TJC) also released a statement clarifying that the pre-spiking of I.V. bag also falls outside the scope of Chapter <797> (asamonitor.pub/3YjPVAp). This development will further prevent...
