Live Webinar: Implementing USP <661.1> & <661.2>
Don’t wait until the last minute.
October 29, 2025
11:00 am to 12:00 pm (ET)
Join this webinar and get ahead of the regulatory curve - understand what the new testing requirements mean from a compliance and business perspective and learn how to take the right steps now to ensure a smooth and compliant transition.
Navigating the Shift - Implementing USP <661.1> & <661.2> by December 2025
Preparing for the Obsolescence of USP <661>: What It Means for Pharmaceutical Packaging
The clock is ticking. By December 2025, USP General Chapter <661> will be officially obsolete - replaced by two more specific and rigorous chapters: USP <661.1> (Plastic Materials of Construction) and USP <661.2> (Plastic Packaging Systems for Pharmaceutical Use).
These changes mark a critical regulatory shift that impacts virtually all pharmaceutical and biotech companies - whether you're developing new packaging systems or managing existing products already on the market.
Join us for this informative webinar as we break down:
- What’s changing: A breakdown of the differences between <661>, <661.1>, and <661.2>
- Impact assessment: How the new requirements affect both new and legacy packaging systems
- Testing strategies: What tests are required, when, and how to prepare
- Risk mitigation: How to avoid costly regulatory delays or non-compliance
- Best practices: Practical guidance for navigating the shift with confidence
Why This Matters
USP <661.1> and <661.2> are not just updates - they represent a fundamental change in how plastic materials and packaging systems are evaluated for pharmaceutical use. These chapters introduce:
- Enhanced chemical characterization requirements
- Stricter material testing protocols
- Greater focus on patient safety and product compatibility
Ensuring a robust strategy today can help avoid product launch delays or regulatory challenges down the road.
Who Should Attend:
Regulatory Affairs
Quality Assurance & Compliance
Packaging Development & Engineering
Pharmaceutical R&D
Supply Chain & Procurement
Contract Manufacturing
Presenter: Ronak Patel
Chemistry Services Laboratory Manager
Ronak is an experienced analytical testing professional with over a decade of expertise in the contract laboratory space. He holds a bachelor's degree in chemistry and an MBA, combining a strong scientific foundation with business acumen. At CS Analytical, Ronak leads the company’s routine container testing programs, with a focus on delivering high-quality, reliable results across a variety of compendial methods. He has deep experience in elemental impurities analysis and plays a key role in helping clients develop and implement effective container testing strategies tailored to their specific product–package systems.
Frequently asked questions
Are the <661.1> and <661.2> Chapters now effective and required?
The short answer is no. USP <661.1> and USP <661.2> becomes official on December 1, 2025 and until such time USP 661 still applies. However, as stated in the USP early adoption of 661.1 and 661.2 is encouraged early and if early adoption is chosen, then USP 661 does not need to be done. It is important to note that all packaging materials must meet USP 661.1 and 661.2 requirements after December 1, 2025 even if they had only met the requirements of USP 661 previously.
What is the key difference between USP 661.1 and 661.2?
USP 661.1 relates to a plastic material of construction used to manufacture a packaging system. It is best to think of this at the resin level. If your container is made of HDPE, the 661.1 testing is designed to test that specific resin. USP 661.2 relates to a 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.
What are the expectations for biocompatibility testing?
USP 661.1 and 661.2 describes the biocompatibility testing requirements that are dependent on the dosage form, therefore knowledge of the end use is required. Oral and topical dosage forms do not require USP 87 Biological Reactivity Test, In Vitro. Testing for compliance to USP 661.1 or USP 661.2 for all other dosage forms require the 87 testing. USP 88 Biological Reactivity Tests, In Vivo is not directly referenced in these chapters. USP 87 does however note that materials that fail USP 87 should be further tested to USP 88 standards.
Is an Extractable and Leachables (E&L) study required?
E&L Testing is not a stated and specific requirement. As directed by the USP, a “Chemical Safety Assessment” is required for packaging systems as described in USP 661.2 that is “risk-based”. This risk-based assessment is based on the packaging system, its materials of construction, its components of construction, and the actual drug product it will hold. Where testing is needed as part of a chemical safety assessment, it must be based on sound and justifiable scientific principles which are outlined in USP 1663 and USP 1664.
How will one apply new chapters in the real world?
USP 661.1 and 661.2 can be applied depending on whether the end-user seeks to evaluate an individual plastic material or an entire packaging system. For example, let’s consider a package system that uses a High-Density Polyethylene (HDPE) bottle in conjunction with a Polypropylene (PP) closure. HDPE and PP resin used to develop this packaging system are considered well-characterized if they meet the USP requirements as outlined and required in the 661.1 chapter. The individual bottle (HDPE) would be tested, and the separate and individual closure (PP) would be tested. As a whole package system (bottle and closure combined, the USP661.2 would be required. As a simple rule, 661.1 applies to INDIVIDUAL COMPONENTS or plastic types and 661.2 applies to entire PACKAGE SYSTEMS.
How will one apply new chapters in the real world?
USP 661.1 and 661.2 can be applied depending on whether the end-user seeks to evaluate an individual plastic material or an entire packaging system. For example, let’s consider a package system that uses a High-Density Polyethylene (HDPE) bottle in conjunction with a Polypropylene (PP) closure. HDPE and PP resin used to develop this packaging system are considered well-characterized if they meet the USP requirements as outlined and required in the 661.1 chapter. The individual bottle (HDPE) would be tested, and the separate and individual closure (PP) would be tested. As a whole package system (bottle and closure combined, the USP661.2 would be required. As a simple rule, 661.1 applies to INDIVIDUAL COMPONENTS or plastic types and 661.2 applies to entire PACKAGE SYSTEMS.