Revision Bulletin
General Chapter <381> Elastomeric Closures for Injections

Orignal Posting Date: August 7, 2008
Revision Date: November 10, 2008
Official Date: May 1, 2009
Expert Committee: Parenteral Products–Industrial
Transfers to Accelerated Revision History section: May 1, 2009

In accordance with the Rules and Procedures of the 2005-2010 Council of Experts, the Parenteral Products–Industrial Expert Committee has approved the General Chapter <381> Elastomeric Closures for Injections Revision Bulletin. The Revision Bulletin clarifies the applicable tests for barrier and non–barrier coated closures and their base formulation(s), describes the testing requirements for such closures, and includes a new table that summarizes the test requirements for each closure type. The official date for this Revision Bulletin has been postponed to May 1, 2009.

The currently official General Chapter <381> Elastomeric Closures for Injections (USP 31–NF 26) will continue to be official until April 30, 2009. It does not, however, appear in the USP–NF Online product. Below is a link to the currently official chapter.

Should you have any questions, please contact Desmond Hunt, Ph.D., Scientist and Liaison to the Parenteral Products–Industrial Expert Committee (301–816–8341 or ).

Currently Official (until April 30, 2009):

General Chapter <381> Elastomeric Closures for Injections (USP 31-NF 26) (43KB)