2022 Updates on Compounding Chapters USP <795>, USP <797>, USP <800>, USP <825>


Certain areas of chapters written by US Pharmacopeia have evolved since being made official and have become standard best practices today.

Although the chapters written by US Pharmacopeia (USP) for USP <795>, USP <797>, USP <800>, and USP <825> are old, in some cases, there are still some areas that have evolved since the chapters were made official that have become standard best practices today, explained Patricia C. Kienle, MPA, RPh, BCSCP, FASHP, director of accreditation and medication safety at Cardinal Health, during a presentation at the American Society of Health-System Pharmacists 2022 Summer Meeting.

For USP <795>, which was first published in 2000, there was an updated version that was made official in 2014, which is the most current version of the chapter for compounding pharmacy practice today.

“[The 2014 version] only had a little bit of change from a prior one,” Kienle said. “The revised chapter was published, for the second time, in September of 2021, and that is still currently in that review process. I think we’re getting close, but it still hasn’t been voted on by the committee, so we still need to be dealing with that 2014 <795>.”

Kienle explained that USP <797> is in a similar situation as <795>. First published in 2004, USP <797> has been revised once in 2008, and that is the current official version. The proposed revision, for the second time, was published in September 2021 and is still under review by the committee.

“Progress has been made and all of the public contents have been addressed, but [USP <797>] is still in that editing phase,” Kienle said.

USP <800> was published in 2016 and remains an official chapter. Following the publication of USP <800>, although the official status of the chapter was delayed until December 2019, it did become official.

“But because it isn’t mentioned in an existing official chapter, like <795> or <797>, it’s still considered informational,” Kienle said. “However, many of your states have adopted it, and the whole point of <800> is protection for us as health care employees. So, you want to incorporate all those things that you can. Once <795> or <797> become official, that will trigger <800> to be enforceable as well.”

For USP <825>, the chapter is all about radiopharmaceuticals. Although the chapter is more than just about compounding, there is a compounding component within it as well.

“You may say, ‘Yeah, I don’t care. I don’t do any of that stuff,” [but I’ll say] ‘Yeah, you do,’” Kienle said. “Your nuclear medicine department is under that chapter.”

USP <825> is also in a similar situation as USP <800>, as it was published in 2019 and became official in December 2020. However, it still needs to be mentioned in one of the other compounding chapters to get federally enforceable.

“But your states can enforce it, and several states have already gone ahead and done that,” Kienle said. “You have to remember that these standards, as they’re written by USP, are minimum standards—they’re not stretch goals, they’re not things that you can take pieces of and decide whether you’re going to comply with one part of it and not the other. You have to comply with the law; it’s a minimum standard.”


Kienle PC. 2022 Compounding Update — Incorporating Best Practices into Compounding: USP <795>, USP <797>, USP <800>, and USP <825>. Presented at: ASHP Summer Meeting 2022; June 14, 2022; Phoenix, AZ.

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