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  1. Information for Industry | Drugs

USP Monograph Modernization Program

The FDA recognizes that there is an ongoing need to update and modernize the methods contained in the United States Pharmacopeia – National Formulary (USP-NF). In this respect, the FDA, with representation across the Agency, has established a Monograph Modernization Working Group that interfaces with the USP Monograph Modernization Program.

The direct participation of the pharmaceutical industry, and other interested stakeholders, in USP’s Monograph Modernization Program is encouraged to assist in providing updated public standards vital to strengthen efforts for both FDA and USP to protect the public health. Paramount to this effort is the submission of updated analytical methodology pertinent to a compendial article, as well as materials which could be used for independent validation. FDA encourages all stakeholders to fully support this effort.
Further information to become an active participant in this process is available on USP’s website at http://www.usp.org/usp-nf/development-process/monograph-modernization. Additionally, information, to include periodic status reports on this effort, is available at http://www.usp.org/usp-nf/key-issues/monograph-modernization.