US Pharmacopeial Convention Announces Revised Official Dates for Elemental Impurities Chapters

January 31, 2013
Jennifer Markarian

Jennifer Markarian is manufacturing editor of BioPharm International.

Two general chapters on elemental impurities? limits and procedures are to become official Feb. 1, 2013, with implementation proposed for May 1, 2014.

The United States Pharmacopeial Convention (USP) published General Chapters <232> Elemental Impurities—Limits and <233> Elemental Impurities—Methods in USP 35-NF 30, Second Supplement, with a Dec. 1, 2012 official date, but this official date was postponed to consider an appeal of the two general chapters. In January 2013, the USP Executive Committee of the Council of Experts (CoE EC) ruled to uphold the two general chapters and re-established their official date as Feb. 1, 2013, according to a Jan. 28, 2013 Revision Bulletin. There are no requirements for articles covered by an applicable USP–NF monograph to comply with the general chapters’ provisions on this official date, but companies can now use the general chapters to prepare for the proposed implementation date in 2014.

In considering the appeal, the Executive Committee found that USP followed its processes and adequately considered appellants’ comments, and that there were no new data or evidence presented to justify further consideration or continued postponement. The provision to make General Chapters <232> and <233> applicable to all articles in the compendia (except where noted otherwise) on May 1, 2014 has been proposed in the Jan–Feb 2013 Pharmacopoeial Forum (PF) 39(1) and is open for public comment until Mar. 31, 2013. USP may also consider further revisions based on new information, such as information from ongoing International Conference on Harmonization (ICH) deliberations.

Typically, a standard becomes official six months after publication in a book or supplement, and implementation is required as of that official date. In this case, however, the official date is separate from the implementation date, noted USP in the Revision Bulletin. Implementation will not occur until the general chapters are referenced in a monograph or in General Notices, which is proposed to occur on May 1, 2014. The Executive Committee encourages those with specific issues regarding applying the new general chapters to a particular monograph or monographs to work with USP and the relevant Expert Committees to gain resolution prior to the planned implementation of the general chapters next year.