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RE: usp monograph

Contribution from Bernd Renger written on 9/19/2008 at 09:21

Original contribution: usp monograph written by Tareq Taha on 9/18/2008 at 00:18)

You will find the required information in the following article:

Karen A. Russo, Roger L. Williams
US Pharmacopeia Guideline for Pending Monographs
PharmTech.com
Publish date: Aug 2, 2008


Here is one quote from this article:

"After posting on USP's website, the pending monograph is authorized rather than official (i.e., it is text authorized by USP, but it is not legally enforceable by FDA), and the manufacturer may not use USP on certificates of analysis or on container labeling."

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