My understanding of the recent history of Chapter <797>

[Mariah Nelson]

I want to share my understanding of the recent history of Chapter <797>.  

• The current version of <797> was first published in 2008 and has not changed in any edition of USP/NF since then;
• On September 25, 2015, the USP published a Notice of its Intention to Revise <797>.  In this announcement, it noted that the proposed revision would be published in the Nov-Dec 2015 Pharmacopeial Forum, which would open the period of review and comments from the public.  Comments were accepted until January 31, 2016.
• The proposed revisions were also posted on the USP website and are still available and downloadable there today in pdf format.  The first page of the pdf is a briefing.  On pages 2-84 of the pdf all of the lines are crossed out.  This is because the lines on pages 2-84 are the language of the 2008 version, that the revision is proposed to replace.
• The Lines on Pages 85-143 of the pdf represent the language that was proposed as the revision in 2015.
• The USP received nearly 9,000 comments during the comment period for the first proposed revision.
• Based on the nature and significance of the public comments, the Compounding Expert Committee announced on January 27, 2017 that <797> “is currently undergoing revision” and that it will be posted for a SECOND ROUND of public comments before any revision is published as official.  The announcement reminded us that the chapter which became official on June 1, 2008 is currently the official standard.  It stated that USP does not have an anticipated date for the chapter’s republication.
• The announcement made no reference to Chapter <800> or the fact that Chapter <800> is due to become official on July 1, 2018.  It made no reference to the fact that <797> and <800> need to be harmonized before that date.

You can download and read both the current (2008 version) language of the Chapter as crossed out lines and the originally-proposed, but now-obsolete revision language as the later lines that are not crossed out, but it’s important to realize that <797> is integrally related in vital ways to several other Chapters.  The USP makes available a “Compounding Compendium” at a more affordable price ($150 USD), which compiles only the Chapters that we all need for our practice (including the published-but-not-yet-official <800>).  I can send you the hyperlink to the webpage where you can purchase the Compendium, but if you Google USP Compounding Compendium, it will be at or near the top.

I am not associated or affiliated with, nor do I speak for the U.S. Pharmacopeial Convenention (USP).  The information above is merely my current interpretation and opinion and I welcome any clarifications or corrections of any errors.  I hope this is useful to you.

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