CS Analytical Laboratory has announced that significant changes to testing standards for plastic packaging will come into effect on December 1, 2025. These updates pertain to the United States Pharmacopeia (USP) standards, specifically USP 661.1 and USP 661.2, which will require all packaging systems utilizing plastic materials to comply with new testing protocols. This includes unique packaging systems such as sealed blister cards, which have traditionally posed challenges in testing.
The announcement, made on September 29, 2025, serves as a reminder to both current and potential clients about the urgency of adapting to these new requirements. According to Ronak Patel, Chemistry Laboratory Manager at CS Analytical, “While the implementation date is fast upon us, there is still time to meet these new requirements.” This emphasizes the need for companies to reassess their current materials, as existing products will not be “grandfathered” and will require retesting under the revised standards.
Overview of New Testing Requirements
The modifications to USP 661.1 introduce more stringent standards for how raw materials are tested and verified for safety in health-related product packaging. This is particularly important for both topical and oral dose package systems, as well as higher-risk injectables, inhalables, and suppository-type packages. The updated requirements focus on several categories, including direct contact, non-direct contact, and non-interactive materials, covering a diverse range of polymer types.
Testing under USP 661.1 is designed to confirm the characteristics of polymers across four critical areas: the identity of the material, biological reactivity with other substances, general physicochemical properties, and composition. Though performing these tests is not a prerequisite for conducting USP 661.2 tests, they can provide valuable insights into how materials might perform during compliance testing.
Implications for Packaging Systems
USP 661.2 addresses the plastic packaging system as a whole, encompassing all components, including the container, closure, dropper, and snap cap. Together, USP 661.1 and USP 661.2 offer a comprehensive data package essential for evaluating material selection. This is crucial for ensuring patient safety and compliance with regulatory standards.
CS Analytical Laboratory, located in Clifton, New Jersey, is recognized as the only FDA-regulated contract laboratory solely focused on providing regulatory solutions and qualification testing services for drug products and medical device container systems. The laboratory is equipped with advanced testing capabilities and offers a full suite of services, including those specific to USP, European Pharmacopeia (EP), and Japanese Pharmacopeia (JP) procedures related to glass, plastic, and elastomers.
As the deadline approaches, companies are urged to act promptly in order to align with the new requirements, ensuring that their packaging systems meet the stringent standards set forth by the USP. With the expertise of CS Analytical, organizations can navigate these changes effectively and maintain compliance in a complex regulatory landscape.
