USP-NF General Notices

December 21, 2007

USP is proposing to revise the General Notices of the United States Pharmacopeia and National Formulary.

View the proposed General Notices revisions  (309KB) (new text begins on page 50)

The proposed changes are being published in Pharmacopeial Forum 34(1) (Jan. - Feb. 2008) and are open for public comment until April 15, 2008. Comments on the proposal may be submitted via email to or to:

Executive Secretariat
Attn: General Notices
US Pharmacopeia
12601 Twinbrook Pkwy
Rockville MD 20852

The General Notices are key resources for users of the compendia, but have not been updated in a number of years and have seen an accretion of information over time. USP is taking this opportunity to re-organize and streamline the General Notices to make them more readable and easier to use. The proposed changes to General Notices would:

  • Update the language, some of which dates to at least 1920
  • Add headings to aid navigation and to allow users to refer to specific sections of the General Notices
  • Refocus the text on essential information by moving other material to the Mission and Preface or to a General Chapter
  • Clarify the circumstances under which alternative procedures should be submitted to USP for evaluation as potential supplemental or replacement procedures
  • Clarify the intended application of text to, e.g., compounded preparations vs. drug products and active pharmaceutical ingredients vs. excipients

Crosswalks

In addition to the revised General Notices, USP also will provide "crosswalk" documents showing current USP and NF text side-by-side with the proposed text for easy comparison. Check back soon for these documents.

Revision Process

The draft presented here and in PF 34(1) is the second draft of the revised General Notices. The first draft was made available on this Web site in May 2007 and was available for public comment until August 31, 2007. Numerous comments were received, carefully considered, and incorporated as appropriate into this second draft.

Brief summaries of many of the comments received, and USP's responses to the comments, including requests for additional input, are included in an Explanatory Note  (86KB).

USP plans to present comments received on the second draft, with proposed resolutions for the issues raised in the comments, to the Council of Experts Executive Committee in the late spring of 2008 for their consideration and approval. The proposed revised General Notices are targeted for publication in USP and NF as official in USP 32-NF 27 (November 2008).

Topics for Continuing Dialogue

As a result of comments received, USP has decided to continue conversations in 2008 on a number of topics that would have a significant impact on the compendia and their users. Following these discussions, additional changes to the General Notices may be proposed later in 2008, in a second phase of the revision process. Those changes would not become official before USP 33-NF 28 (November 2009).

Topics that were covered in the first draft of the revised General Notices but are not included in this second draft and are pending additional dialogue include:

  • Clarify that all compendia published by USP are covered by the General Notices, which is important because the General Notices contain the terms essential for understanding any monograph
  • Standardize language among the compendia to make it easier for users who refer both to FCC and USP-NF
  • Accommodate new USP initiatives: FCC, Pending Standards, and Standards for Articles Legally Marketed outside the United States (SALMOUS)
  • Clarify the distinction between General Chapters intended to be enforceable and those intended to be informational

More information about the changes that were proposed in the first draft that are still under consideration is available here.