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How do I propose new monographs and revisions to official standards in the USP-NF or to revisions already proposed in Pharmacopeial Forum?

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How do I propose new monographs and revisions to official standards in the USP-NF or to revisions already proposed in Pharmacopeial Forum?

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A. Contact the USP in writing with any change you wish to make to the USP-NF. USP contact information can be found at http://www.usp.org/aboutUSP/contactUs, in the front pages of the USP-NF or the Staff Directory, printed in one of the front sections of every Pharmacopeial Forum. You can also contact USP Science Support at 1-301-816-8151 or stdsmonographs@usp.org. As described in the USP general chapter Validation of Compendial Methods , all proposals must be supported by relevant data including scientific rationale, complete analytical procedures, and appropriate validation data. Revision proposals will be considered only after receipt of supporting data and justification. Proprietary data should be labeled “Confidential”. All proposals approved by the USP Expert Committees are published in the Pharmacopeial Forum for public comment, with the eventual goal of official adoption in USP-NF. Detailed information on how to submit monographs and revisions is available online at http://www.u

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