USP 661.1 and USP 661.2 Implementation Date Just 60 Days Away

We are taking the time to inform clients that all package systems using plastic materials are subject to these new test requirements, including unique package systems like sealed blister cards. Blister can prove difficult to test but at CS Analytical we have developed sample preparation techniques that enable complete 661.2 to be completed as outlined by the USP

CLIFTON, N.J., Sept. 29, 2025 /PRNewswire/ -- CS Analytical Laboratory, the world's only FDA regulated contract laboratory exclusively dedicated to providing regulatory solutions and qualification testing services specifically for drug product and medical device container systems is formally reminding all current and potential clients that the pending changes to USP 661.2 and 661.2 testing for plastic container and package components will become officially effective December 1, 2025. As the implementation date is fast approaching, now is the time to consider the new test requirements noting that current materials in use will not be "grandfathered" in and retesting to the new standard will be required.

"We are happy to remind clients that while the implementation date is fast upon us, there is still time to meet these new requirements," noted Ronak Patel, Chemistry Laboratory Manager of CS Analytical. "We are also taking the time to inform clients that all package systems using plastic materials are subject to these new test requirements including unique package systems like sealed blister cards. Blister cards can prove difficult to test but at CS Analytical we have developed sample preparation techniques that enable complete 661.2 to be completed as outlined by the USP."

The numerous changes to USP 661.1 contain more rigorous standards regarding how raw materials are tested and verified as safe to use for health-related product packaging for both topical/oral dose package systems and higher risk injectables, inhalable and suppository type package systems. The requirements focus on direct contact, non-direct contact, and non-interactive materials, and align with a large variety of polymer types. USP 661.1 testing confirms the characteristics of these polymers in four key areas to include Identity of material, biological reactivity with other substances, general physicochemical properties and composition. It should be noted that performing tests under USP 661.1 is not a prerequisite for conducting USP 661.2 tests, however it can provide insights into how materials may fare in the required compliance testing.

USP 661.2 relates to a plastic packaging system as a whole and includes all components that make up that system. For example, the container, the closure, the dropper, the snap cap, etc. Collectively, USP 661.1 and 661.2 provide a comprehensive data package that will facilitate an appropriate evaluation for the correct selection of materials and protect patients more than would be possible with the current 661 test methods.

About CS Analytical Laboratory

The only FDA regulated, cGMP laboratory dedicated exclusively to the complex world of drug and medical device container and package qualification testing, the CS Analytical Team includes the world's leading experts on all relevant USP and EP requirements and the thought leaders and pioneers on CCI (container closure integrity – CCI) testing. Offering a full suite of laboratory services to include all USP, EP and JP procedures specific to glass, plastic and elastomers as well as complete USP <1207> services that span basic feasibility studies, component qualification programs and advanced method development and validation for helium leak testing, vacuum decay, high voltage and headspace analysis leak testing. CS Analytical is the one source that can ensure your medical product container and package system meets the strict and complex regulatory requirements.

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SOURCE CS Analytical