USP Provides Information on Recall and Reissuance of USP 33–NF 28
Posted on | January 23, 2010 | Comments Off
http://www.usp.org/USPNF/recall.html
USP 32–NF 27 is official at this time and remains official until further notice. USP 33–NF 28, which was released on November 1, 2009 and recalled on January 8, 2010, was not scheduled to become official until May 1, 2010 and should not be used. The current official standards in USP 32–NF 27 can be used with confidence.
Reason for Recall
USP recalled USP 33–NF 28 because of errors that occurred when monographs were redesigned into a new format. The redesign was intended to improve ease of use, streamline presentation, and update and harmonize terminology, but was not intended to change any of the monograph requirements. The effort was comprehensive: all of the ~4000 monographs in the USP 33–NF 28 were redesigned, encompassing more than 4100 pages, over 4 million words, and many figures and tables. While many of the monographs were successfully redesigned, a significant number contained errors.
While USP has an Errata process for issuing corrections to USP–NF on an on–going basis, this process was inadequate to address the number of errors resulting from the redesign. Because maintaining the integrity and accuracy of its standards is of paramount importance, USP recalled USP 33–NF 28 in its entirety.
