Inside USP: Revising USP General Notices - Pharmaceutical Technology

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Inside USP: Revising USP General Notices
USP is revising key documents to make them easier to use.


Pharmaceutical Technology


Crosswalks. The General Notices page also provides a crosswalk document that shows current USP, NF, and FCC text side-by-side with the proposed revised text for easy comparison. The proposed revisions as they compare to the General Notices in USP 30, NF 25, and FCC 5th Edition are presented at USP's website.

Revision process. After the close of the initial comment period on Aug. 31, 2007, USP staff will review carefully all comments received and incorporate revisions as appropriate. Throughout the summer of 2007, USP Expert Committees also will review the draft, comment on proposals, and consider related changes that may be necessary, including changes to General Chapters.

USP anticipates that a second draft of the proposed General Notices will be available at the USP Annual Science Meeting, Sept. 25–28, 2007. USP anticipates publishing this second draft on the USP website for comment and in Pharmacopeial Forum 33(6) in November 2007. The comment period will close on Feb. 15, 2008.

USP anticipates presenting comments received on the second draft as well as staff members' proposed resolution of the issues raised in the comments to the Council of Experts Executive Committee in spring 2008 for their consideration and approval. The proposed revised General Notices will not be published in USP and NF as official before USP 32–NF 27 (November 2008) and will not be published as official in FCC before the Supplement to the 6th edition (February 2009).

Revising the General Notices is a timely and thoughtful activity that USP is undertaking at the urging of its volunteer community and constituents, whom we thank in advance for their participation.

Roger L. Williams, MD,* is executive vice-president and chief executive officer; Todd L. Cecil, PhD, is vice-president of Documentary Standards Division (DSD), Ruth K. Miller, JD, is counsel of Legal Department, Stefan Schuber, PhD, is director, scientific reports in DSD, all at the US Pharmacopeia, 12601 Twinbrook Parkway, Rockville, MD 20852-1790, tel. 301.816.8300,
. Dr. Williams is also a member of Pharmaceutical Technology's editorial advisory board.

*To whom all correspondence should be addressed.

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