Frequently Asked Questions: <797> Pharmaceutical Compounding—Sterile Preparations
Adapted from USP's FAQ on Compounding.
- When was General Chapter <797> was last revised?
- Is USP considering revisions to General Chapter <797>?
- How can I obtain a copy of General Chapter <797>?
- When will the final revision to General Chapter <797> be published?
- How can I get status updates on the proposed revisions to General Chapter <797>?
- Is <797> still enforceable?
- How can I obtain a copy of the currently official General Chapter <797>?
General Chapter <797> was first published in 2004. The chapter was last revised in USP31–NF26 2nd Supplement, which became official on June 1, 2008.
Yes, the Compounding Expert Committee began the revision process for General Chapter <797> in July 2010 and completed their work in 2015. The proposed revision was published for public comment in Pharmacopeial Forum 41(6) Nov—Dec 2015 and at www.usp.org/usp-nf/notices/general-chapter-797-proposed-revision. Public comments on the proposed chapter were due on January 31, 2016. The Compounding Expert Committee is currently reviewing all of the public comments received.
You can download a copy of the proposed revisions to <797> at www.usp.org/usp-nf/notices/general-chapter-797-proposed-revision.
The earliest that General Chapter <797> may be published is on November 1, 2016 in USP 40-NF35 with the earliest official date of May 1, 2017. However, please note that this is highly dependent on the public comments that are submitted on the chapter. Based on the nature and significance of the public comments received, the Committee will determine whether the chapter will be revised, republished in the Pharmacopeial Forum, or forwarded to ballot. More information about USP’s development process can be found here and the publication and comment schedule can be found here.
To follow the status of the chapter, stakeholders can sign up the USP Healthcare Quality Standards Update at http://www.usp.org/HQS-Signup-Form. More information about USP’s development process can be found here and the publication and comment schedule can be found here.
Although General Chapter <797> is undergoing revision, the published version of the chapter which became official on June 1, 2008 is currently the official and enforceable standard.