USP Recalls Latest Monographs

Jan 14, 2010

The US Pharmacopeial Convention (USP) is recalling USP 33–NF 28. According to an USP press release, multiple monograph errors were introduced into the publication when it was converted into a new format and published on Nov. 1, 2009.

The official date for USP 33–NF 28 to go into effect was May 1, 2010. According to a public notice of Jan. 12, 2010, the redesign of the publication, including all 4000 monographs, encompassing more than 4100 pages, 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…. While many of the monographs were successfully redesigned, a significant number contained errors."

The notice explains that USP’s errata process for issuing corrections to USP–NF on an ongoing basis is inefficient for the current problem, thus necessitating the recall of USP 33–NF 28 in its entirety.

Other official texts related to the recalled publication remain available and may be used with confidence, including the USP Dietary Supplement Compendium Food Chemicals Codex, Sixth Edition, and its supplements; USP Pharmacists' Pharmacopeia, Second Edition, and its supplements; and the 2009 USP Dictionary. In addition, Accelerated Revisions posted on the New Official Text section of the USP website are not affected by the recall and are official as of the dates indicated on the website.

USP will reissue the online and CD versions 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. The convention will also 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 serve as the print version of USP 33–NF 28. Its official date will be the same as the official date of the electronic versions. Finally, USP will 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.

Until the publication and its related supplements are reissued, says USP, industry should continue to use USP 32- NF 27, which remains official.

USP–NF "provides access to official standards enforceable by the US Food and Drug Administration for drugs and related products manufactured and marketed in the United States." Official revisions to the pharmaceutical monographs are published annually or as supplements (twice yearly), as well as in the Pharmacopeial Forum in between. USP 33–NF 28 was made available in English in three formats — print, CD and online.

Additional information can be found on the USP recall website.