USP releases new chapter <797> proposals

Abstract

The United States Pharmacopeia (USP) has finally released its updated Chapter <797> revisions. These revisions were written over the past 22 months while USP considered appeals filed by stakeholders. The 2019 version is mostly intact in the revision, but there are some changes to beyond-use dates (BUD) for certain institutions. In addition, USP clarifies when to identify microorganisms found during various sampling activities. “There’s very little difference in what was in the 2019 and the 2021 proposed revision,” said Patricia Kienle, RPh, MPA, BCSCP, director of accreditation and medication safety at Cardinal Health and a member of the USP compounding expert committee. (Her comments are her opinions and not the opinions of USP.) “If people were ready for the 2019 version, they’re fine with the 2021 proposed revision. There won’t be any cataclysmic change from what they were expecting from the 2019 version.” This should be reassuring news to hospitals that have been diligently working toward compliance with the 2019 version. Compounded sterile products (CSPs) were assigned one of two categories in the 2019 version. Category 1 CSPs were defined as being prepared in an unclassified segregated compounding area. These products were assigned the shortest BUDs: 12 hours or less at room temp, or 24 hours or less refrigerated. Category 2 CSPs were defined as being prepared in a compliant compounding cleanroom suite and were allowed longer dating. The new revision defines a third category, applicable to those who want to extend BUDs beyond that allowed for Category 2. Using stability-indicating analytical methods, which are based on USP Chapter <1225>, “Validation of Compendial Procedures,” institutions can assign a BUD of up to 180 days. Additional stricter garbing and cleaning procedures are also required for Category 3 CSPs. Hospital pharmacies that perform sterile compounding will see some changes in how specific they need to be when identifying microorganisms collected during surface or air sampling. Pharmacists can view the updated revisions for all of the nitty-gritty details on sampling changes (apha.us/USPrevs). “If sites have not geared up for monthly surface sampling, it is unlikely that the certifier will be able to do this,” said Kienle. “The pharmacy needs to be prepared for doing this more often if they have not already done so. Incubator space is needed, [as well as] the right media, a microbiologist will need to be referred to if an excursion is noted.” Institutions that have been preparing for the 2019 revisions will likely need to abide by additional requirements. State boards of pharmacy often have other requirements with CSPs. Any institution considering making changes to become compliant with the updated revisions should also check with their state board of pharmacy’s requirements. With these new revisions, it is possible that state boards of pharmacy may amend their existing CSP-related requirements. Pharmacists should pay close attention to what their state board of pharmacy is doing so they are not caught off-guard when the new chapter becomes enforceable. The USP compounding expert committee is allowing comments on the new revisions to be submitted until March 17, 2022. Afterward, they will review the comments and determine if additional changes need to be made to the revisions. There is no timeline defined for how long they may consider comments. Regardless, there will be a 6-month implementation window defined by USP whenever the new revisions are officially published. Upon completion of this 6-month window, the chapter will likely become enforceable in many states. If an institution has not made changes to the CSP compounding strategy after the 2019 revisions were proposed, work will be needed to get up to speed. If the institution has adequately prepared for the 2019 revisions, these new revisions will require some review and changes, but should not be overwhelming. Pharmacists should spend time reviewing these proposed revisions (and then the final versions once they are published), identify gaps at their institution, and plan accordingly.