FAQs: <797> Pharmaceutical Compounding—Sterile Preparations

Last updated: July 27, 2018

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. *New - When will the revised USP General Chapter <797> be available for the next round of public comment?

The public comment period for <797> will occur between July 27 and November 30, 2018. During this period, you will be able to provide written comments through an electronic form. More information can be found at http://www.usp.org/compounding/general-chapter-797.

Revisions to General Chapter <797> are now published for a second round of public comment. Since the first public comment period, which began in September 2015, there has been significant input from stakeholders including roundtable meetings, discussion forums, and review of more than 8,000 written public comments. Expert consultants have been engaged to assist the Expert Committee during this revision process. The Expert Committee has reviewed all of the public comments from the September 2015 proposal along with additional guidance from many stakeholders to propose a new revision for a second round of public comment.

The revision to <797> will be harmonized with USP General Chapter <800>, with an anticipated official date of December 2019.

3. When will the final revision to General Chapter <797> be published and official?

The revised USP General Chapter <797> is expected to be published in USP 42-NF 37 Second Supplement on June 1, 2019 and become official on December 1, 2019. Sections of the revised <797> may have longer implementation dates that will allow time for adoption of the standard. More information can be found at http://www.usp.org/compounding/updates-on-standards.

4. How can I get status updates on the proposed revisions to General Chapter ?

Sign up for USP Updates to receive notifications for USP General Chapter <797> revisions and other Healthcare Quality & Safety standard.

5. Is USP General Chapter <797> still enforceable?

While USP General Chapter <797> is undergoing revision, the published version of the chapter which became official on June 1, 2008 is currently official and enforceable.

6. How can I obtain a copy of the currently official General Chapter ?

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.

7. 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.