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Proposed Revisions to the General Notices and Requirements to be Published for Comment in Pharmacopeial Forum 41(1) [Jan.–Feb. 2015]

Type of Posting: General Announcement

Posting Date: 05–Dec–2014

Targeted Official Date: 01–May–2016

Expert Committee: Council of Experts Executive Committee

To provide additional time for review and input, USP is posting in advance the proposed General Notices and Requirements (GN) section of the United States Pharmacopeia and the National Formulary (USP–NF) that will be published for public notice and comment in Pharmacopeial Forum 41(1) [Jan.–Feb. 2015]. GN is regularly revised to refine and clarify its content. GN was most recently revised in the Second Supplement to USP 37–NF 32 (published June 1, 2014; official December 1, 2014). This current proposal has been informed by input from stakeholders on the General Notices Project Team, representatives of the U.S. Food and Drug Administration, and members of the Council of Experts Executive Committee, who discussed these revisions in their September 16–17, 2014 meeting. The following links provide access to both a summary of changes that are proposed for this round of GN revisions and to the GN file itself.

Following subsequent consideration and balloting by the Council of Experts Executive Committee, it is anticipated that these revisions will be included in USP 39–NF 34, which will be published November 1, 2015 and become official May 1, 2016.

Please note that this proposal does not include any revisions to section 5.60.30 Elemental Impurities in USP Drug Products and Dietary Supplements that may result from activities related to the implementation of the ICH Q3D Step 4 guideline. Please subscribe to the Compendial Updates email service for any related announcements.

The deadline for submitting comments on the proposed changes is March 31, 2015. Questions or official comments should be submitted to Mario Sindaco, Director, Compendial Affairs and Executive Secretariat, Council of Experts (301-816-8246 or