2020–2025 Biologics Monographs 4 - Antibiotics Expert Committee Work Plan

Interested in learning more about the work of this Expert Committee?

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Focus Areas

  • 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  • Modernization of outdated monographs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.

Key Issues

  • 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

  • Bridging Study Working Group
  • Joint Subcommittee (Reference Materials)

Standard Development

  • 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