- Monographs and Reference Standards (RS) for antibiotics that currently still use microbial assay test
- General chapters that pertain to antibiotics
- Modernization of outdated monographs
- Identification and development of new RS
Expert Committee Charge
The Biologics Monographs 4 – Antibiotics Expert Committee will guide USP’s ongoing scientific efforts to update monograph requirements and associated reference standards for antibiotics that are currently still assessed and potency-assigned by antimicrobial activity.
- Work with other Expert Committees, FDA and stakeholders for human and veterinary antibiotics.
- Transition of microbial assay to non-cell based assay
Associated Expert Bodies
- Joint Subcommittee (Reference Materials)
- The latest ballot results can be found here (results can be filtered by particular ECs).
- The status of Revisions, Deferrals, Cancellations, Commentary, and Index for each USP–NF and Supplement can be found here.
Learn more about the impact of this EC and its Associated Expert Bodies