From the Publisher: Updates to <797>

June 2007 - Vol. 4 No. 6

The time is finally upon us. The word on the street is USP will publish the much-awaited revisions to Chapter <797> sometime this month. So now the question is: How will your pharmacy be affected by the changes to <797>’s requirements?

For starters, the revisions will refine the airflow requirements for primary and secondary engineering controls, such as biological safety cabinets and compounding aseptic isolators. The amended chapter will also discuss the requirements for immediate-use compounded sterile preparations, a topic not addressed in detail in the initial version of <797>. At press time, USP had not yet announced the exact date of publication for the revised chapter, but it is certain that these changes will impact your pharmacy’s compounding operations.

How will you prepare to meet the demands of an updated <797>? The first step is familiarizing yourself with the updates themselves, which you can accomplish by reading the new chapter, as well as PP&P’s articles, which help you apply <797> requirements to your dayto-day practice. Another valuable resource is CriticalPoint’s sterile compounding curriculum (

The CriticalPoint courses – which offer a total of 32 hours of ACPE-accredited CE – are up to date with the proposed revisions to USP <797>, and once the revisions are finalized, will be consistent with those, as well. The easy-to-use training program walks you through all you need to know about <797> compliance, from physical plant requirements to personnel garbing to engineering controls to cleaning activities, and more. Training packages start at just $110. To learn more about this valuable resource for <797> compliance, visit and see the Product Spotlight on page 44 to hear Simone Bellamy’s take on the program.


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