Type of Notice: General Announcement
Posting Date: 28–Aug–2020
This is an update to the Guidance on the Use of Recombinant Reagents for Bacterial Endotoxin Test Compendial Notice, posted on the USP website on May 29, 2020.
In order to facilitate further discussion, USP intends to publish the comments received on the proposed new general chapter <1085.1> Use of Recombinant Reagents in the Bacterial Endotoxins Test- Photometric and Fluorometric Methods Using Recombinantly Derived Agents. The chapter proposal will be published in PF 46(5) [Sep-Oct 2020], with the comment period open until November 30, 2020. Under the Rules and Procedures of the Council of Experts, all comments submitted to USP in response to proposals published in Pharmacopeial Forum, as well as the identities of the commenters, are considered public information unless clearly and specifically designated as confidential.
USP looks forward to continued engagement from industry, the U.S. Food and Drug Administration (FDA), and other stakeholders. In response to previous stakeholder comments, USP has posted responses to the most Frequently Asked Questions (FAQs) or comments here.
Should you have any questions or comments, please contact Leslie Furr, Associate Scientific Liaison, at firstname.lastname@example.org.