FAQs: <797> Pharmaceutical Compounding—Sterile Preparations

Last updated: August 18, 2017

Adapted from USP's FAQ on Compounding.

1. When was General Chapter <797> last revised?

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.

2. Is USP considering revisions to General Chapter <797>?

Yes, the Compounding Expert Committee began the revision process for General Chapter <797> in July 2010 and proposed a revision to the chapter for public comment in September 2015. Based on the nature and significance of the public comments submitted to USP, the chapter is currently being revised and will be published for another round of public comments.

3. How can I obtain a copy of the proposed revisions to General Chapter <797>?

The proposed revision to <797> is available at www.uspnf.com/notices/general-chapter-797-proposed-revision. Please note that this chapter is not official. The Compounding Expert Committee is currently in the process of revising the chapter and will be re-publishing it for another round of public comments.

4. When will the final revision to General Chapter <797> be published?

The Compounding Expert Committee is currently reviewing all of the public comments submitted on the proposed revisions to General Chapter <797> and making revisions to the chapter. Due to the high volume of comments received and the need for further revisions, USP does not have an anticipated date for the republication.

5. How can I get status updates on the proposed revisions to General Chapter <797>?

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. The publication and comment schedule can be found here.

6. Is <797> still enforceable?

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.

7. How can I obtain a copy of the currently official General Chapter <797>?

You may purchase a copy of the currently official chapter through several publications. You may purchase the chapter through a subscription to the USP Compounding Compendium or USP-NF.

8. General Chapter <797> references both ISO 14644-1 and CAG-002-2006–section 2.09. Is there a conflict between these two guidance documents?

No, there is no conflict between these two guidance documents. General Chapter <797> references ISO 14644-1 to define the ISO classification of particulate matter in the primary and secondary engineering control. Additionally, the chapter specifies certification of engineering controls following procedures “such as those outlined in Certification Guide for Sterile Compounding Facilities (CAG-003-2006).” USP <797> further references CAG-002-2006 section 2.09 as sample procedures for placing Compounding Aseptic Isolators (CAI) and Compounding Aseptic Containment Isolators (CACI) outside of an ISO Class 7 buffer area. CAG-002-2006 section 2.09 is specifically referenced because it defines tests that prove whether a CAI or CACI can be placed outside of an ISO classified room. The test procedures in CAG-002-2006 are more robust than ISO 14644-1 because the tests increase the background particulate count. Section 2.09 increases background levels to prove that particulate contamination from the room is not dragged into the CAI or CACI when materials are transferred into or removed from the isolator. The procedures in ISO 14644-1 are not relevant to CAG-002-2006 section 2.09, and thus specific test procedures outlined in ISO 14644-1 are not referenced in these sections. Consequently, there is no conflict between CAG-002-2006 section 2.09 and ISO 14644-1.