Written By Ronak Patel, Manager, Analytical Chemistry
The clock is Ticking—Take Action Now Instead of Waiting Until the Last Moment!
As of December 1, 2025, USP Chapters 661.1 and 661.2 will officially replace the current USP 661 standards. Until that time, USP 661 still applies, but the USP encourages early adoption of the updated chapters. By adopting USP 661.1 and 661.2 before the deadline, you can bypass the need for compliance with USP 661, streamlining the transition process.
It’s important to understand that, after December 1, 2025, all packaging materials must comply with the new USP 661.1 and 661.2 standards, regardless of whether they previously met the requirements of the old USP 661. This means that even if your packaging materials have been compliant with USP 661 in the past, they will need to meet the updated requirements from December 1, 2025 and onwards.
Here’s a brief recap of USP 661, 661.1, and 661.2:
Plastics are a wide range of synthetic or semi-synthetic materials that use polymers as the main ingredient, having a range of molecular weights. Plastic materials may contain other substances such as residues from the polymerization process and additives such as plasticizers, stabilizers, antioxidants, pigments, and lubricants. Drug products can chemically interact with their associated packaging systems and the system’s plastic materials of construction while the drug product is being manufactured, shipped, stored, and administered. The magnitude of these interactions should not adversely affect the suitability of the packaged drug product, which includes both quality aspects and performance aspects such as efficacy, stability, purity, and compendial compliance. Suitability for use, as determined by the impact of the interaction between a drug product and its packaging system, is assessed and established via the appropriate testing of the materials of construction, components, and packaging systems. USP<661> general chapter had been historically used to evaluate chemical interactions from packaging systems and the systems plastic materials of construction. Initially effective May 1st, 2016, general chapter <661.1> and <661.2> were introduced to provide more robust chemical characterization of plastic material and package systems compared to the USP<661>, while simultaneously providing testing options for newer polymeric materials, which will be discussed further in this document.
USP<661>: The purpose of the USP <661> Plastic Packaging Systems and Their Materials of construction chapter is to provide standards to evaluate physicochemical characterization for plastic articles (materials, components, and systems) used to package medical articles (pharmaceuticals, biologics, and dietary supplements).
USP<661.1>: Testing and characterizing materials of construction for attributes relevant to their suitability provide a rational basis for material selection in designing a packaging system and minimizing the risk that a system made from those materials will be. Therefore, the characterization of materials for construction is the first step in developing and qualifying suitable packaging materials. Chemical characterization data may also provide the basis for effective and appropriate change control. USP<661.1> aims to provide standards for plastic materials of construction used to manufacture a packaging system.
USP<661.2>: A packaging system contains or is intended to contain a drug product, including pharmaceuticals and biologics. The packaging system provides the means for storing and distributing drug products and, in some cases, the means for administering the drug product. A plastic packaging system is composed wholly or of a substantial portion of plastic materials and/or components and refers to the sum of packaging components that contain the drug product, including closures (e.g., rubber seals, foil closures, laminated closures). Considering the packaging system as the test article, USP<661.2> aims to provide standards for establishing the packaging system’s suitability.
Why You Should Act Now on USP 661.1 and 661.2 Testing
As the industry approaches the deadline for the new USP 661.1 and 661.2 chapters, companies should start preparing now rather than waiting until the regulations officially take effect. Here are several reasons why it’s crucial to act sooner rather than later:
- Variety of Components and Systems in Scope: Many companies utilize a diverse array of container systems and components that necessitate rigorous testing under USP 661.1 and 661.2 standards. This could involve the evaluation of hundreds of individual items, making the testing process potentially time-consuming and resource intensive. To mitigate the risk of delays and ensure seamless progression, it is critical to begin the planning and scoping of this work at the earliest opportunity. CSA can provide invaluable assistance by reviewing your existing matrices, offering expert guidance, and discussing a customized approach that is tailored to the specific requirements of your container systems. This proactive collaboration will streamline the navigation of complex regulatory requirements, ensuring compliance and efficiency throughout the process.
- Vendor Approval Process: Pharmaceutical, biotechnology, and medical device companies typically have stringent internal quality protocols in place, which necessitate the completion of several key agreements, including but not limited to Non-Disclosure Agreements (NDAs), Confidentiality Agreements (CDAs), and Master Service Agreements (MSAs). In addition to these legal and contractual obligations, it is essential for the Contract Service Provider to be formally listed as an approved supplier within the company’s vendor management system. Furthermore, to ensure compliance with industry standards and regulations, comprehensive vendor audits may be required prior to the initiation of any testing activities. Given the complexity and time requirements of these processes, it is crucial to initiate them well in advance. Proactively managing these steps will help ensure that all necessary approvals, agreements, and audit requirements are completed in a timely manner, allowing the testing phase to proceed without delay.
It is important to note that CSA does not require customers to fulfill such prerequisites before submitting samples from various clients. CSA only requires sample(s) and completed Sample Submission Form, along with a Purchase Order (P.O.) or Credit Card information for payment processing. Please refer to our Terms of Service for more details.
- Comprehensive Testing with Longer Turnaround Times: USP 661.1 testing encompasses a comprehensive set of evaluations, extending beyond the requirements outlined in the 661 chapter, with a typical turnaround time of 20 business days. However, certain tests, such as Bio In Vitro (Elution Method) assessments, may require up to 35 business days for completion. In Vivo testing generally requires up to 75 business days to provide a final report. To prevent unexpected delays, it is crucial to plan ahead and allow ample time for these processes. Additionally, if the material being tested falls into the unaddressed material category, additional time may be needed to perform method verification and validation, utilizing techniques that are comparable to those used for materials specified in the chapter.
CSA regularly conducts USP 661.2 testing on a wide range of container systems, including bottles, caps, syringes, pouches, stick packs, and blisters. CSA is uniquely positioned as the only laboratory offering 661.2 testing for blister packaging systems. This specialized testing requires custom tooling for sample preparation, a process that typically takes 4-5 weeks to complete. Therefore, starting early is essential to ensure timely completion and avoid potential delays.
- Strategic Budgeting for USP 661.1 and 661.2: As companies finalize their budgets for early 2025, it is a strategic decision to prioritize USP 661.1 and 661.2 testing within the current fiscal year’s budget. Waiting until later in the year, when funds may be limited or exhausted, could lead to unnecessary delays and potential financial constraints. By addressing testing needs early, companies can ensure a smoother allocation of resources and better overall financial management. Additionally, many organizations may need to allocate time for establishing CSA within their procurement systems, including processing invoicing and payment arrangements. Starting these steps early mitigates the risk of encountering bottlenecks and ensures that the necessary administrative processes are completed in a timely manner, allowing testing activities to proceed without interruption. Planning ahead not only supports efficient budgeting but also guarantees that testing requirements are met in alignment with both financial and operational objectives.
- Strategic Planning for Sourcing Samples for Testing: Given the current global supply and demand challenges within the pharmaceutical and related industries, acquiring the necessary materials for testing can often be a lengthy and complex process. The availability of specific container systems or components required for USP 661.1 and 661.2 testing may be subject to delays, making it crucial to plan ahead. To ensure that an adequate quantity of samples is secured in time for testing, it is highly recommended to initiate the sourcing process well in advance. This proactive approach not only mitigates the risk of delays but also allows for smoother coordination with suppliers, ensuring that testing can proceed without interruption. By factoring in potential supply chain complexities, companies can avoid last-minute hurdles and ensure the timely availability of all required materials for testing, thus maintaining project timelines and regulatory compliance.
Ronak Patel, who manages routine container testing at CSA, reports, “There has been a notable surge in inquiries for USP 661.1 and 661.2 testing since Q4 of 2024, continuing into Q1 of 2025, with expectations for even greater demand throughout the year.” CS Analytical stands out from other labs by not charging any additional rush fees for testing. However, it’s important to note that last-minute requests, such as 661.2 testing for blisters, can be time-consuming and may result in limited flexibility regarding turnaround times.
In summary, the process of preparing for USP 661.1 and 661.2 testing requires careful planning and coordination. Acting now helps avoid unnecessary delays and ensures that your products comply with the new regulations on time. If you need support, CSA is here to help you navigate this process smoothly.