Revised USP Chapter <661> Plastic Packaging Systems and Their Materials of Construction

The USP General Chapters Packaging and Distribution Expert Committee (PDEC) has revised the general chapter <661> Plastic Packaging Systems and Their Materials of Construction.

Background

The intention behind the development of the USP chapters <661.1> Plastic Materials of Construction and <661.2> Plastic Packaging Systems for Pharmaceutical Use, was that, once these chapters became official, the test methods and acceptance criteria currently found in chapter <661> would be omitted because they would be redundant to the requirements established in chapters <661.1> and <661.2>. The two chapters became official on 1 December 2025. Therefore, the purpose of this revision is to remove the test methods and acceptance criteria that are currently published in <661> to ensure stakeholders do not continue to use outdated methods and criteria that are no longer applicable.

The revised USP chapter <661> is official as of 1 February 2026. For more information please see USP's Revision Bulletins.