Revision of USP General Chapter <661.1> Plastic Materials of Construction

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Recommendation

12/13 November 2025

Complaint Handling and Recall Management - Live Online Training
How to implement EU-GMP Chapter 8

The USP General Chapters–Packaging and Distribution Expert Committee revised the general chapter <661.1> Plastic Materials of Construction. The chapter will become official on 1 December 2025 together with the corresponding chapter <661.2> Plastic Packaging Systems for Pharmaceutical Use (see also USP clarifies Requirements for Plastic Packaging Systems).

According to the announcement comments were received indicating that a revision to the following sections was needed:

Polycarbonate: For the Acidity or Alkalinity test in the Polycarbonate section, the procedure and acceptance criteria were inadvertently omitted during publication. To address this issue the procedure and acceptance criteria is being added to the section.
Polyvinyl Chloride (PVC): The requirement for tin stabilizers is being revised in the Polyvinyl Chloride section to allow the use of different ratios of these stabilizers to be consistent with materials that are currently available in the market.

More information is available in the Revision Bulletin on general chapter <661.1> Plastic Materials of Construction (Revision Bulletins are immediately incorporated into the USP-NF with the official date indicated).