Type of Posting: Notice of Intent to Revise
Posting Date: 15-Oct-2021
Targeted Official Date: 01-Jun-2022; Revision Bulletin
Expert Committee: Small Molecules 5
In accordance with the Rules and Procedures of the Council of Experts, this is to provide notice that the Small Molecules 5 Expert Committee intends to revise the Dextrose Injection monograph to change the official date of the new Sample solution for products that are terminally sterilized in the Assay from December 1, 2021 to June 1, 2022.
Comments with supporting data were received that indicate that the new Sample solution for products that are terminally sterilized in the Assay may not be suitable for all terminally sterilized products. Therefore, changing the official date to June 1, 2022 will allow the Expert Committee to evaluate the comments and develop a solution to revise the Sample solution preparation to address the comments.
It is anticipated that the proposed revision to change the official date of the Sample solution for products that are terminally sterilized will be published as Revision Bulletin on November 19, 2021 pursuant to the Rules and Procedures.
Should you have any questions, please contact Edith Chang, Principal Scientist – Team Leader (firstname.lastname@example.org).