Type of Posting: Notice of Intent to Revise
Posting Date: 27-Aug-2021
Targeted Official Date: 1-Aug-2023; USP–NF 2023, Issue 2
Expert Committee: Non-Botanical Dietary Supplements
In accordance with the Rules and Procedures of the Council of Experts, this is to provide notice that the Non-Botanical Dietary Supplements Expert Committee intends to revise the monograph Bifidobacterium bifidum.
Comments with supporting data were received that indicate additional information needs to be included in the Identification section (Nucleic-acid based Identification). The Expert Committee proposes to revise Bifidobacterium bifidum to refer to the use of a positive control, where appropriate, in the sample preparation and analysis by Polymerase chain reaction (PCR). In addition, some reagents included in this monograph will be directly linked to the USP Reagent Specifications database to describe the specifications required for the corresponding tests. Editorial changes will also be made to update the monograph to current USP style, as appropriate.
It is anticipated that the proposed revision will be published as In-Process Revision in Pharmacopeial Forum 48(1) [Jan–Feb. 2021] pursuant to the Rules and Procedures. The comment period for this publication will end on March 1, 2022.
Should you have any questions, please contact Maria Monagas, Principal Scientist (firstname.lastname@example.org).