USP Cancels Revisions to Packaging Chapters

March 21, 2018

Equipment and Processing Report

Equipment and Processing Report, Equipment and Processing Report-03-21-2018, Volume 11, Issue 3

Revisions to chapters on glass containers and elastomeric closures were canceled following review of comments.

In an online posting on Feb. 23. 2018, USP announced the cancellation of revisions to packaging-related general chapters pending “comprehensive and strategic redevelopment” following comments received on the proposed revisions.

The affected chapters, which were published for comment in Pharmacopeial Forum 43(3) [May–Jun. 2017], are as follows:

<660> Containers-Glass

<1660> Evaluation of the Inner Surface Durability of Glass Containers

<381> Elastomeric Closure for Injections

<382> Elastomeric Closure Functionality in Injectable Pharmaceutical Packaging/Delivery Systems

<1381> Elastomeric Evaluation of Elastomeric Components Used in Pharmaceutical Packaging/Delivery Systems

<1382> Assessment of Elastomeric Closure Functionality in Injectable Pharmaceutical Packaging/Delivery

USP noted that the revisions will appear on the Cancellations list for the Second Supplement to USP 41–NF 36, which will be posted on April 27, 2018. USP anticipates that it will publish revised proposals for the affected General Chapters in a future issue of the Pharmacopeial Forum.

Source: USP