Type of Posting: Revision Bulletin
Posting Date: 01–Dec–2007
The 2nd Supplement to USP 30, recently published and official on December 1, 2007, included a revision to General Chapter <671> Containers—Performance Testing. USP received two formal appeals and two informal requests from pharmaceutical companies, all asking that USP cancel and retract the revised chapter due to the additional Phase 2 test and other changes made to <671> after it had appeared in Pharmacopeial Forum (PF). After consideration of these requests and appeals, USP and the Executive Committee of the Council of Experts have determined that the sections of <671> containing these additional changes will be retracted and returned to PF for additional review and comment (see Intent to Revise Statement).
As a result of this determination, General Chapter <671> Containers—Performance Testing will become official as of December 1, 2007, as it was originally published in PF 32(4). A link to this version of the General Chapter is provided below. This text will appear in print in the First Supplement to USP 31–NF 26.
Should you have any questions about General Chapter <671>, please contact Susan S. de Mars, Chief Legal Officer (301-816-8296 or sdm@usp.org).