Revision Bulletin: Postponement

General Chapter <1> Injections Labeling on Ferrules and Cap Overseals Section

USP has received comments from industry about implementation challenges relating to the Labeling on Ferrules and Cap Overseals section of General Chapter <1> Injections, which appears in USP 31–NF 26, with an official date of February 1, 2009.

As a result, and in accordance with the Section 9.08 of the 2005–2010 Rules and Procedures of the Council of Experts, the Parenteral Products–Industrial (PPI) Expert Committee members have voted to delay the official date of the Labeling on Ferrules and Cap Overseals section, as specified in the USP31–NF 26, to May 1, 2010. The PPI Expert Committee's decision to delay the official date is to allow industry time for implementation of the standard. No additional revisions to the section are planned at this time. USP has informed the Food and Drug Administration of this postponement.

Should you have any questions, please contact Desmond Hunt, Ph.D., (301–816–8341 or ).

• August 2008 Letter to Industry  (51KB)
• June 27, 2008 Notes-USP Meeting with Industry  (83KB)
• June 30, 2008 PhRMA Letter to USP  (333KB)
• July 21, 2008 USP Response Letter to PhRMA  (60KB)