Pharmacy News

Dr Marie Sartain
/ Categories: APhA News

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. 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.

“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.”

For the full article, please visit for the February 2022 issue of Pharmacy Today.

Joey Sweeney, PharmD

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