USP <661.1>, <661.2>, and <1661>: How to Be Ready for the December 1, 2025 Compliance Deadline

USP <661.1>, <661.2>, and <1661>: How to Be Ready for the December 1, 2025 Compliance Deadline
Adapting to new regulatory standards is essential for pharmaceutical manufacturers as USP <661.1>, <661.2>, and <1661> reshape the evaluation of plastic packaging systems. This Smithers whitepaper delivers actionable guidance on the latest requirements, risk-based assessment strategies, and compliance deadlines.

With the December 1, 2025 transition approaching, the industry faces a significant shift from the legacy USP <661> standard to a more comprehensive framework. These chapters emphasize material interactions, robust testing, and scientifically justified strategies to ensure product integrity and regulatory success.

What You’ll Discover in the Whitepaper

  • The regulatory shift from USP <661> to USP <661.1>, <661.2>, and <1661>, and what it means for pharmaceutical packaging systems.
  • Scope and purpose of each chapter, including material-level and system-level evaluation requirements.
  • Guidance on risk-based assessment strategies, chemical suitability, and extractables and leachables testing.
  • Comparison of USP <661.1> and <661.2> requirements, including physicochemical, biological, and chemical suitability assessments.
  • Key compliance timelines and actionable steps to avoid regulatory delays.
  • Overview of referenced USP chapters, such as USP <661.1>, USP <661.2>, USP <1661>, USP <1663>, and USP <1664>.

Ready to meet the new USP <661.1>, <661.2>, and <1661> standards?

Download the whitepaper for expert guidance, practical strategies, and a clear roadmap to compliance.
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