USP Updates Chapter <661> on Plastic Packaging Systems

The United States Pharmacopeia (USP) has revised its general chapter <661> Plastic Packaging Systems and Their Materials of Construction, according to the Packaging and Distribution Expert Committee (PDEC).

The revision follows the introduction of two updated standards—<661.1> Plastic Materials of Construction and <661.2> Plastic Packaging Systems for Pharmaceutical Use—which became official on 1 December 2025. These chapters were designed to replace the earlier testing methods and acceptance criteria previously included in chapter <661>.

As a result, the updated version of chapter <661> removes outdated testing procedures to prevent stakeholders from continuing to rely on obsolete requirements. The change ensures that manufacturers and industry professionals follow the latest guidelines for evaluating plastic materials used in pharmaceutical packaging.

The revised chapter officially came into effect on 1 February 2026, aligning USP standards with the newer chapters that now govern testing and compliance for plastic packaging systems used in pharmaceutical products.

08-03-2026