The USP 661 regulation is in place to support safety of pharmaceutical packaging, and specifically plastic packaging. It provides analytical standards that ensure polymer raw materials and packaging systems are suitable for their intended use and are well-characterized.
After several years of revisions to the plastics packaging chapters of the USP NF, USP 661 was replaced by USP 661.1 and USP 661.2 effective December 2025. This requires separate testing of the plastic materials of construction under USP 661.1 and plastic packaging systems under USP 661.2 to establish that the packaging is suitable for use. The changes clarify the definition of a well-characterized material and help eliminate ambiguity with equivalent testing across polymers. They also provide expanded standardized polymer coverage including PE, PP, PV, PC, PET, PETG, PA, COC, and EVA.
The new stringent testing changes affect packaging systems that have not yet gained regulatory approval for use in a marketed pharmaceutical product. However, if a new material is introduced into an approved package, or if an approved material has changed, the system will have to be re-tested.
Under the new USP 661 chapters, 'grandfathering' is removed for package systems that have previously been approved. Avient can assist with assessing legacy materials of construction and helping gain compliance to satisfy USP 661.1 updated requirements.
So, what does this mean to you, and what should you consider in your packaging to ensure you are in compliance with the new USP 661.1 guidelines?
- Ensure packaging materials are compliant and thoroughly tested to reduce risk
- Understand the potential impact of your material supply chain on quality and product consistency
- Maintain change control of packaging material formulations to avoid irregularities
- Confirm you have the proper global regulatory support for any existing or future products
For assistance in addressing your questions or challenges, contact one of our experts for support. Our customized formulations include a wide range of colorants and additives, and our global technical and regulatory healthcare teams can support customers in any location. Additionally, our Avient Design team includes industrial designers and project engineers who understand materials and can create a more streamlined experience.