The Changing Dynamics of USP <661>

Understanding what is changing, and when, in this USP 661 healthcare regulation

The changing dynamics of USP

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.  

The revision process for the plastics packaging chapters of the USP-NF, including USP 661, has been underway for several years. USP 661 was initially set to be replaced in 2016, but the effective date of the revisions was delayed following an implementation period extension.  

The effective date of the replacement sections was deferred to December 1, 2025 when USP 661 will be replaced by USP 661.1 and USP 661.2. Once effective, this will require separate testing of the materials of construction under USP 661.1 and packaging systems under USP 661.2 to establish that the packaging is suitable for use. In the interim, testing under USP 661.1 and USP 661.2 is permitted by USP, and packaging systems conforming to these requirements prior to December 1, 2025 are considered to be in conformance with the USP–NF.  

The new stringent testing changes will only 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.  

One key change is that eight extractable elements have been taken out of USP 661.1 as these heavy metal testing requirements are addressed in another regulation, USP 232. However, Avient will continue to test these eight metals to gain insight into each element’s leaching characteristics and potential of elemental impurities which could leach, or extract, from the packaging component.  

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  

Listen to our recorded webinar to learn even more.  

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.