Now Official: Revised USP Plastic Packaging Chapters <661.1> and <661.2>

Recommendation

7/8 May 2024

Extractables & Leachables - Live Online Training
Challenges and Solutions for Packaging and Single Use Systems

The USP Expert Committee General Chapters—Packaging and Distribution posted on April 28, 2017, the previously announced Revision Bulletins, Postponement, regarding general chapters <659>, <661>, <661.1> and <661.2>. The revisions of the four general chapters have become official on May 1, 2017.

As reported under "Three-year period for implementation of USP Plastic Packaging Chapters <661.1> and <661.2>" the reason for the revisions is

• to provide a three-year period for implementation of the requirements specified in General Chapters <661.1> and <661.2>, which otherwise will become applicable on May 1, 2017 through General Chapter <659>;
• to reinstate requirements previously expressed in General Chapter <661> during this three-year period;
• to enable early adoption of the requirements in General Chapters <661.1> and <661.2> at any time during the three-year period instead of meeting the reinstated <661> requirements; and
• to remove the current exemption to General Chapters <661.1> for previously approved packaging systems.

To find more details please see the USP Official Text.