10/11 March 2021
The United States Pharmacopeia (USP) recently informed about the delayed implementation of General Chapters <661.1> and <661.2> together with information on the revision of General Chapter <661>. In addition, the Packaging and Distribution Expert Committee (PDEC) of the USP intends to revise USP chapter <661.1> Plastic Materials of Construction. The targeted official date is 1 March 2021.
Based on comments received the PDEC proposes to revise the following sections of USP chapter <661.1>:
According to the USP, It is expected that the proposed revision will be published as a Revision Bulletin on 26 February 2021. The chapter <661.1> will otherwise become official on December 1, 2025. Early adoption of the requirements in chapter <661.1> together with chapter <661.2> Plastic Packaging Systems for Pharmaceutical Use are permitted by USP. When early adoption is not used, USP chapter <661> Plastic Packaging Systems and Their Materials of Construction will still apply.
For more information please read USP´s Notice of Intent to Revise: <661.1> Plastic Materials of Construction.