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.
Based on the nature and significance of the public comments received, the chapter will be republished in the Pharmacopeial Forum for another round of public comments. The Compounding Expert Committee is currently reviewing all of the public comments submitted on the proposed revisions to General Chapter <797>. The chapter is currently being revised based on the public input received. Due to the high volume of comments received, USP does not have a date for the republication.
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.