BRIEFING

 Bacillus coagulans Capsules. This proposal is based on the version of the monograph official as of June 1, 2019. On the basis of comments received, it is being proposed to make the following revisions:

1. Add a new Identification test A. Microscopic Identification.

2. Replace the primer sequences and their acceptance criteria in Identification B.

3. Revise the PCR Sample preparation and PCR amplification condition in Identification B.

4. Add a PCR positive control to Identification B.

5. Revise the sample weight, heat shock directions, and dilutions in the Sample solution in the Assay.

6. Replace some reagents with USP reagents to properly describe the specifications required for the corresponding tests.

 Additionally, minor editorial changes have been made to update the monograph to current USP style.

 (NBDS: B. Koshy)

 Case ID—SUB-2132