The United States Pharmacopeial Convention (USP) provides additional information about its recall of the United States Pharmacopeia 33–National Formulary 28 (USP 33–NF 28) and its plans to reissue the publication.
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 approximatgely 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.
Official text in USP–NF evolves through continuous revision and appears in several publications. While USP 33–NF 28 is being recalled as a publication, other official text related to the publication remain available and may be used with confidence, as follows:
Accelerated Revisions
Accelerated Revisions posted on the New Official Text section of the USP Web site are not affected by the recall and are official as of the dates indicated on the Web site. See: https://www.usp.org/USPNF/newOfficialText.
Other USP Publications
Other USP publications related to USP–NF are not affected by the recall because their content comes from USP 32–NF 27 and additional sources. Thus, official and authorized text in the following publications can be used with confidence:
Reissuance of USP 33–NF 28
Electronic: USP plans to reissue the online and a CD version of USP 33–NF 28 in March 2010 with an official date six months after reissue. Only new and revised monographs available since the Second Supplement to USP 32–NF 27 will be in the redesigned format.
Print: Coincident with release of the electronic forms of the publication, USP intends to reissue a print volume of new and revised monographs and other official text available since the Second Supplement to USP 32–NF 27. The monographs will appear in the redesigned format. This smaller volume, combined with official text in USP 32–NF 27 and its Supplements without redesign will be the print version of USP 33–NF 28. Its official date will be the same as the official date of the electronic versions.
USP plans to release the First Supplement to USP 33–NF 28 at the same time as the reissued USP 33–NF 28 and with the same official date.
Date: January 12, 2010
Source: United States Pharmacopeial Convention (USP)
Filed Under: Drug Discovery
