Starting December 1, 2025, USP Chapters <661.1> and <661.2> will officially replace the current USP <661> standard. Until then, USP <661> remains in effect, but the USP strongly encourages early adoption of the updated chapters. The implementation of USP<661.1> and <661.2> allows for an initial risk assessment at a fraction of the cost and time than the previous USP <661> requirements. This should streamline the assessment of extractable and leachables risk for most products.

By transitioning to USP <661.1> and <661.2> now, you can avoid dual compliance with USP <661> later and ensure a smoother, more efficient transition before the deadline.

After December 1, 2025, all plastic packaging materials must comply with the new USP <661.1> and <661.2> standards, regardless of prior compliance with USP <661>. In other words, even packaging that previously met USP <661> will require reevaluation and qualification under the new standards.

Understanding the USP <661> Series

Plastics—synthetic or semi-synthetic materials made primarily of polymers—often include additives such as plasticizers, stabilizers, antioxidants, pigments, and lubricants. These substances can interact with drug products throughout manufacturing, storage, shipping, and administration. Such interactions must not compromise the quality, safety, efficacy, or stability of the packaged product.

The USP <661> series provides a framework to evaluate the suitability of plastic packaging systems through appropriate testing of materials, components, and systems.

‍

USP <661> — Plastic Packaging Systems and Their Materials of Construction

Originally developed to evaluate the physicochemical properties of plastic materials used to package pharmaceuticals, biologics, and dietary supplements.

‍

USP <661.1> — Plastic Materials of Construction

Focuses on the testing and characterization of plastic materials to ensure their suitability for use in packaging systems. This chapter supports informed material selection and change control, providing a foundation for designing compliant and safe packaging systems.

‍

USP <661.2> — Plastic Packaging Systems for Pharmaceutical Use

Addresses the entire packaging system—including bottles, closures, seals, and laminated components—used to store, distribute, and in some cases, administer drug products. It establishes standards for assessing system suitability and performance as a whole.

Partner with Scientech for Compliance Testing

Scientech routinely performs USP <661.1> and <661.2> testing on a wide range of plastic containers and closure systems. Although these chapters will become effective in December 2025, we are already advising and supporting our clients to proactively incorporate these requirements into their current testing and compliance strategies.

‍

Contact us today to ensure your packaging materials are fully compliant ahead of the 2025 deadline.

‍