National Formulary: Excipients Expert Committee
The Excipients Expert Committee concentrates on the development of new monographs and the revision of existing monographs
in Pharmacopeial Forum. The Expert Committee also works with both the General Chapters—Physical Analysis and Chemical Analysis Expert Committees in
the development of general chapters related to excipients. In addition to monograph content, the Expert Committee is also
responsible for approving USP reference standards used in their assigned monographs. Following is a list of key initiatives
for the Excipients Expert Committee:
New monograph development.
This work is an ongoing effort to establish new standards for excipients in NF.
Monograph modernization.
A key initiative in this cycle is modernization of monographs to replace outdated tests or procedures with updated methodology
and to add critical quality tests such as identification and impurities. Focus areas include nonspecific identification and
assay tests and impurities. USP has identified at least 150 excipient monographs that require modernization. The Expert Committees
will collaborate with Expert Committees in other areas (e.g., general chapters), Expert Panels, USP staff, regulators, and
stakeholders to outline strategies and implement tactics for monograph modernization.
Monograph redesign.
As is the case with monographs published in USP, after the recall of USP 33 -NF 28 most NF monographs remain in the old format. For both USP and NF, the conversion of monographs to the new format will be accomplished during several years, and USP-NF will be the primary publication for the migration of unrevised monographs in the new format. In addition, 149 excipient monographs
will be published in the USP Dietary Supplements Compendium Second Supplement.
Harmonization via the Pharmaceopeial Discussion Group (PDG).
Harmonize current and future excipient monographs and excipient-related general chapters via the defined work processes of the PDG.
Specific goals for the Excipients Expert Committee during this cycle include:
- Update the USP-NF Monograph Submission Guideline to include coprocessed excipients and to clarify the minimum criteria for monograph sponsors
who wish to submit requests for revision to NF.
- Collaborate with the Expert Panels associated with the General Chapters—Physical Analysis and Chemical Analysis Expert Committees
on the revision of Ex-cipient Performance <1059>, development of general information chapter Good Distribution Practices for Bulk Pharmaceutical Excipients <1197>, and updating general chapters dealing with rheology and material characterization.
- Work with the Chemical Analysis and Physical Analysis Expert Committees to develop a guidance chapter on economically motivated
adulteration.
- Continue collaborative efforts to harmonize excipient monographs and excipient-related general chapters by work with PDG.
- Work with USP's standards acquisition group to identify and work with sponsors in the procurement of monographs that are not
currently in NF but are listed in FDA's Inactive Ingredients Database.
Food Chemicals Codex: Food Ingredients Expert Committee
The charge of the Food Ingredients Expert Committee is to increase the number of monographs for food ingredients together
with their associated USP reference standards, to develop relevant chapters about general tests and assays, and to modernize
and revise all existing monographs and general tests and assays in Food Chemicals codex (FCC). All text in FCC is authorized (in distinction to official text, which is enforceable by regulators). FCC is recognized to various degrees as legally binding by the governments of the United States, Canada, Australia, New Zealand,
Israel, and others.
The workplan of the Food Ingredient Expert Committee for the 2010-2015 cycle includes the following:
- Identify, prioritize, and develop monographs for nationally and internationally approved food ingredients, food additives,
colorants, and others via interactions with FDA and other governmental organizations (national and international), innovators, associations, and interested
stakeholders.
- Continue to monitor published research for new toxicology and other data and evaluate the need to revise or modernize existing
monographs.
- Monitor technological developments and prioritize the modernization of test methods in monographs and general tests and assays,
taking into account the international reach of FCC and the variable rate at which different regions can adapt to new technologies.
- Work with the Toxicology Expert Committee to prioritize development of monographs for food ingredients that enjoy only self-affirmed
generally recognized as safe status.
- Develop monographs and general tests and assays for probiotics and prebiotics in collaboration with the Microbiology Expert
Committee.
- Develop further additions to the informational chapters on microbiological methods, methods to test authenticity, and tests
for specific contaminants—these may be helpful to analysts and decision makers but are not a mandatory part of the monograph.
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