Revision of USP <661.1> Plastic Materials

Design Controls for Drug-Device Combination Products - Live Online Training

Recommendation

17/18 June 2025

Design Controls for Drug-Device Combination Products - Live Online Training
How to ensure GMP compliant Development and LIfe-Cycle-Management for Drug-Device Combination Products

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>:

Polyamide 6: Physicochemical Tests (Water extraction)
Polyvinyl Chloride (PVC): Physicochemical Tests (Water extraction), Chlorine Content (Calculation and Equation)
Polyvinyl Chloride (PVC), Plasticized: Physicochemical Tests (Water extraction)

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.