FCC Monograph Modernization

USP Seeks Submission of Proposals for Monograph Modernization

October 29, 2010
USP is actively engaged in efforts to modernize those Food Chemicals Codex (FCC) monographs that utilize outdated technology (e.g, use of packed gas chromatography columns), have assays with insufficient specificity, have safety/environmental concerns (e.g, chlorinated solvents, etc) or are missing procedures for key aspects such as impurities among other criteria. To facilitate the modernization efforts, USP has identified and prioritized a selection of monographs in need of modernization and is seeking proposals to replace the current procedures or add procedures, as needed.

This selection of monographs in need of modernization is presented in a downloadable spreadsheet that includes information on what procedure needs modernization and the current status of the modernization. Some monographs have more than one procedure in need of modernization and each procedure is presented as a separate line item. There are more monographs in need of modernization and they will be added to the spreadsheet periodically as work progresses. Submissions for monograph modernizations that are not listed are also encouraged and can be submitted at anytime. The spreadsheet will be periodically updated.

All submissions should include data and other information recommended in the USP Guideline for Submitting Revisions to FCC Monographs. A summary of these requirements can also be found in the Checklist for Submitting Requests for Revision to the FCC. Some modernization proposals may generate new USP Reference Standards and USP invites the sponsor of the proposal to donate the necessary bulk reference materials. For more information, please review the USP Guideline for Suppliers of Reference Standard Materials.

Electronic submissions (e.g., pdf, access to ftp site) are preferred and can be submitted to Mr. Markus Lipp at mxl@usp.org. USP also accepts hard copies and they can be sent accordingly to the following address:

Mr. Markus Lipp, Ph.D.
Senior Director, Food Standards
United States Pharmacopeia
12601 Twinbrook Parkway
Rockville, MD 20852
mxl@usp.org 301-230-6366

Food Chemicals Codex Monographs Needing Modernization

Posting Date: October 29, 2010