USP releases new chapter <797> proposals

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