Official versus authorized text. The proposed revision to the General Notices attempts to clarify the distinction between official and authorized text. In this proposal, official text appears in USP, NF, FCC, or SALMOUS. All other text would be authorized.
Currently, all General Chapters are official by virtue of their inclusion in USP–NF and are recognized in law as official compendia of the United States. USP–NF distinguishes between enforceable and informational General Chapters by means of chapter numbers: Chapters numbered below
1000 are intended to be enforceable by FDA, but chapters numbered above 1000 are intended by USP to be informational only.
USP is aware that this numerical distinction is not entirely adequate and causes confusion within industry and regulatory
authorities. Inclusion of General Information Chapters in the official compendium may at times cause them to be given greater
regulatory status than USP intended. In addition, the distinction is imperfect: some chapters with numbers above 1000 may
be referenced in a monograph, which makes the General Chapters mandatory for those monographs.
The current draft revision of the General Notices clarifies the text that is official, and therefore enforceable, in a new way:
USP, NF, FCC, and SALMOUS monographs all would be official
- The General Notices would remain official
- General Chapters and FCC General Tests and Assays that are included in USP, NF, or FCC would be official and therefore enforceable, whether the chapter number is above or below 1000. These would include every
General Chapter that is referenced in an official USP, NF, FCC, or SALMOUS monograph. Other General Chapters also would be included, as determined by the relevant USP Expert Committees.
General Chapters that remain official might include those that provide information that is necessary to perform compendial
procedures and those that are anticipated to be referenced in a monograph in the near future.
- Some information that currently is published in USP–NF would be considered authorized text only and would no longer be official. This text is expected to move to a new volume (the
Companion Volume) that would not be called USP–NF in order to clarify to regulatory authorities that these materials are not intended to be enforceable. Some USP General Chapters would move to the Companion Volume. These chapters would retain their chapter numbers. The Reference Tables section of USP, including the Description and Solubility Table, also would move to the Companion Volume as authorized text.
- Pending Standards would remain authorized text. Manufacturers are not permitted to claim conformance to a Pending Standards
- Other text, such as Information monographs, would remain authorized and would remain outside of USP–NF and FCC.
The General Notices revision process
An overview of the General Notices revision process is posted on USP's website at
http://www.usp.org/USPNF/generalNoticeshtml. The page contains a link to the 21-page proposed revisions. The revisions page will remain live for a first round of comments
until August 31, 2007, and constituents are invited to submit comments via email to GeneralNotices@usp.org
Attn: General Notices
12601 Twinbrook Pkwy
Rockville MD 20852-1790