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<1085.1> Use of Recombinant Reagents in the Bacterial Endotoxins Test: Comments Received from Stakeholders

Type of Notice: General Announcement
Posting Date: 18–Nov–2020; updated 25–Nov–2020; updated 11–Dec–2020 

This is a follow up to the General Announcement Guidance on the Use of Recombinant Reagents for the Bacterial Endotoxins Test posted on the USP website August 28, 2020.

As stated in the announcement, USP planned to published comments received on the new proposed chapter <1085.1> Use of Recombinant Reagents in the Bacterial Endotoxins Test—Photometric and Fluorometric Methods Using Recombinantly Derived Reagents, published in PF 46(5) [Sep.–Oct. 2020]. In accordance to USP’s Rules and Procedures of the Council of Experts, USP is publishing the comments we have received from stakeholders. Their comments are available here. The link will be updated as new comments are received. The comment period closes on November 30, 2020.  

Additionally, USP has posted responses to the most Frequently Asked Questions (FAQs) in response to previous stakeholder comments here.

Should you have any questions or comments, please contact Leslie Furr, Associate Scientific Liaison, at

This Notice was updated on November 25, 2020 and again on December 11, 2020 to attach an updated compilation of comments