- Fats and Oils
Expert Committee Charge
- The Complex Excipients Expert Committee is charged with developing new and revising existing monographs and their associated reference standards for pharmaceutical excipients. The Expert Committee also advocates for the use of excipient standards and continuously engages its stakeholders through regular interactions, such as excipients stakeholder forums, workshops, and roundtables. The Expert Committee communicates its excipient science strategy through Stimuli articles and peer-reviewed journals, encouraging stakeholder participation in the standard setting process.
- Revise and maintain existing USP-NF monographs and associated RS that supports the update of existing monographs by introducing more specific analytical tests for Identification, assay, impurities and other tests that help to ensure the quality of the pharmaceutical excipient.
- Develop missing high priority excipients already in US regulated drug products on the market including novel excipients such as co-processed excipients
- Develop guidelines to define co-processed excipients/novel excipients, excipient nomenclature and impurities Advocate for the use and implementation of USP-NF excipient monographs and associated standards
Subgroups and Expert Panels
- The latest documentary standard 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
- Our Work on Excipients
- Excipients Newsletter
- Novel Excipients: New Hope for Therapeutic Innovations
- 2017 USP-FDA Workshop
- Excipients Priority List - new and modernized
- Excipient Characterization: USP’s AAPS Chalk Talk Videos
- Excipients Stakeholder Forum
- Challenges and Opportunities in Developing Up-to-Date USP–NF Excipients PART 1
- Challenges and Opportunities in Developing Up-to-Date USP–NF Excipient Monographs PART 2
- Challenges and Opportunities in Developing Up-to-Date USP–NF Excipient Monographs PART 3
- Characterization of Polymeric Excipients
- USP Novel Excipients Survey: Stakeholders’ Views on the Current State of Excipient Innovation