Type of Posting: General Announcement
Posting Date: 28–Dec–2012; updated 04–Feb–2013*
Targeted Official Date: 01–May–2014
Expert Committee: Council of Experts Executive Committee
The General Notices and Requirements (GN) section of the United States Pharmacopeia and the National Formulary (USP–NF) were most recently revised in USP 34–NF 29 (published November 1, 2010, official May 1, 2011). Since those revisions were undertaken, new issues have continued to be identified, and there also has been recognition of the need to coordinate certain references in GN with other USP–NF changes that have occurred or are pending.
Draft revisions were discussed with the Council of Experts Executive Committee on April 16, July 26, and September 18, 2012. Outlined below is a brief description and summary of changes that are proposed for the next round of GN revisions; the text of the proposed changes is being published for public notice and comment in Pharmacopeial Forum 39(1) [Jan.–Feb. 2013]. Following opportunity for public comment on the PF proposal, and consideration and adoption by the Council of Experts Executive Committee, these General Notices revisions are anticipated to be included in USP 37–NF 32, which will be published November 1, 2013 and become official May 1, 2014.
The deadline for submitting comments on the proposed changes is March 31, 2013. Comments and suggestions should be submitted to Mario Sindaco, Director, Compendial Affairs and Executive Secretariat (301-816-8246 or email@example.com).
*The Briefing for the General Notices and Requirements section was inadvertently omitted from Pharmacopeial Forum 39(1) [Jan.–Feb. 2013] that was posted on December 21, 2012. USP has reposted PF 39(1) and replaced the General Notices and Requirements section with the correct revision, which includes a Briefing explaining the revisions.