General Chapter <381> Elastomeric Closures for Injections

Type of Posting: 
Revision Bulletin
Posting Date: 
07–Aug–2008
Revised Date: 
10–Nov–2008
Official Date: 
01–May– 2009
Expert Committee: 
Parenteral Products—Industrial
Transferred to Accelerated Revision History section: 
01–May–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 dgh@usp.org).