2020–2025 Biologics Monographs 3 - Complex Biologics & Vaccines Expert Committee Work Plan

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Focus Areas

  • Anticoagulants and protamine, GAGs, carbohydrates, and vaccine monographs and reference standards
  • Selected general chapters that pertain to the above therapeutic classes

Expert Committee Charge

The Biologics Monographs 3 – Complex Biologics & Vaccines Expert Committee is responsible for the development and revision of USP–NF monographs and their associated USP Reference Standards in the following therapeutic categories: Anticoagulants and protamine, GAGs, carbohydrates, and vaccines.

Key Issues

  • Work with other Biologics Expert Committees, FDA and stakeholders
  • Improve existing complex biologics and vaccines monographs

Associated Expert Bodies

  • Vaccines Expert Panel
  • 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

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