USP recalls USP 33–NF 28

Electronic version to be reissued in March 2010

The United States Pharmacopeial Convention (USP) is recalling its latest United States Pharmacopeia–National Formulary (USP 33–NF 28) after discovering monograph errors "errors arising from an activity termed Monograph Redesign," according to an e-mail communication to USP members. Information about the recall and USP’s plans to reissue the publication are provided in Public Notices that appear on the USP website. According to the notice, 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 USP Board of Trustees has formed a task force composed of volunteers, including volunteers drawn from the Council of the Convention, to evaluate the basis for the recall and reissue of USP 33-NF 28. USP 32–NF 27 remains official; USP 33–NF 28 is not official and should not be used. USP plans to reissue the online and a CD version of USP 33–NF 28 in March 2010 with an official date 6months after reissue. 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. 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.

The USP–NF is a three-volume combination of two official compendia—the United States Pharmacopeia and the National Formulary. Monographs for drug substances and preparations are featured in the USP. Monographs for dietary supplements and ingredients appear in a separate section of the USP. Excipient monographs are in the NF.

Posted by Carli Richard (crichard@aphanet.org)

January 11, 2010; updated January 14