Upcoming Changes to USP 661 Regulations: What You Need to Know Before December 2025
As the implementation date of December 1, 2025, approaches, the urgency for organizations utilizing plastic packaging to adhere to the new USP 661.1 and USP 661.2 testing requirements cannot be overstated. CS Analytical Laboratory, recognized for its exclusive focus on regulatory solutions in drug product and medical device container systems, has been proactive in preparing its clients for these critical changes.
The new regulations outline stricter testing protocols that every plastic container and its components must satisfy. This includes containers, closures, droppers, and caps—all integral parts of the packaging system that come into contact with health-related products. Notably, the current materials used in packaging will not be exempt from these new regulations; therefore, companies must conduct retesting to meet the updated standards.
The revisions to USP 661.1 delve deeper into the evaluation of raw materials. They establish more rigorous guidelines for how materials are tested to ensure their safety for product packaging, particularly for sensitive categories such as injectable, inhalable, and suppository packages. The updates emphasize the need for extensive testing in four critical areas: the identity of materials, biological reactivity with substances, general physicochemical properties, and the overall composition. Although undergoing tests under USP 661.1 is not a prerequisite for USP 661.2, it can provide valuable insights into material performance during compliance testing.
Notably, the new round of changes will pose challenges for unique packaging systems, especially sealed blister cards. Traditionally difficult to analyze due to their intricate designs, these systems require specialized sample preparation techniques that CS Analytical has developed to ensure compliance with USP 661.2. Ronak Patel, the Chemistry Laboratory Manager at CS Analytical, highlights the importance of these methodologies in understanding how materials behave under the new standards.
USP 661.2, on the other hand, addresses the entire packaging system as a cohesive unit. It demands that all components associated with the packaging meet the newly outlined standards for testing, ensuring a comprehensive evaluation of how each part interacts. This holistic approach aims to enhance patient safety and product reliability, going beyond capabilities of previous testing methodologies.
CS Analytical's unique position as the sole FDA regulated contract laboratory dedicated to these specific testing services means they possess unparalleled expertise in navigating complications associated with packaging compliance. With a team of leading experts in USP and EP requirements, they provide comprehensive solutions, including a full suite of laboratory services concerning various materials such as glass, plastic, and elastomers.
Companies are encouraged to begin reassessing their current materials and prepare for retests to align with the upcoming requirements. With the deadline rapidly approaching, taking action now ensures that manufacturers avoid disruptions to their supply chain and maintain compliance with the new regulations. This preparation is not just about compliance; it is about protecting customer safety and demonstrating a commitment to quality assurance in the healthcare industry.
In summary, the changes to USP 661.1 and 661.2 marks a significant evolution in the oversight of medical and drug packaging. Organizations must act promptly to ensure all their packaging meets the rigorous standards set forth in these updated regulations. By partnering with specialists like CS Analytical, companies can navigate this transition smoothly, ensuring that their packaging systems are safe, reliable, and compliant with the evolving regulatory landscape.
This is an opportunity for organizations to affirm their dedication to quality and safety in product packaging, safeguarding both their brand reputation and consumer health.
The new regulations outline stricter testing protocols that every plastic container and its components must satisfy. This includes containers, closures, droppers, and caps—all integral parts of the packaging system that come into contact with health-related products. Notably, the current materials used in packaging will not be exempt from these new regulations; therefore, companies must conduct retesting to meet the updated standards.
The revisions to USP 661.1 delve deeper into the evaluation of raw materials. They establish more rigorous guidelines for how materials are tested to ensure their safety for product packaging, particularly for sensitive categories such as injectable, inhalable, and suppository packages. The updates emphasize the need for extensive testing in four critical areas: the identity of materials, biological reactivity with substances, general physicochemical properties, and the overall composition. Although undergoing tests under USP 661.1 is not a prerequisite for USP 661.2, it can provide valuable insights into material performance during compliance testing.
Notably, the new round of changes will pose challenges for unique packaging systems, especially sealed blister cards. Traditionally difficult to analyze due to their intricate designs, these systems require specialized sample preparation techniques that CS Analytical has developed to ensure compliance with USP 661.2. Ronak Patel, the Chemistry Laboratory Manager at CS Analytical, highlights the importance of these methodologies in understanding how materials behave under the new standards.
USP 661.2, on the other hand, addresses the entire packaging system as a cohesive unit. It demands that all components associated with the packaging meet the newly outlined standards for testing, ensuring a comprehensive evaluation of how each part interacts. This holistic approach aims to enhance patient safety and product reliability, going beyond capabilities of previous testing methodologies.
CS Analytical's unique position as the sole FDA regulated contract laboratory dedicated to these specific testing services means they possess unparalleled expertise in navigating complications associated with packaging compliance. With a team of leading experts in USP and EP requirements, they provide comprehensive solutions, including a full suite of laboratory services concerning various materials such as glass, plastic, and elastomers.
Companies are encouraged to begin reassessing their current materials and prepare for retests to align with the upcoming requirements. With the deadline rapidly approaching, taking action now ensures that manufacturers avoid disruptions to their supply chain and maintain compliance with the new regulations. This preparation is not just about compliance; it is about protecting customer safety and demonstrating a commitment to quality assurance in the healthcare industry.
In summary, the changes to USP 661.1 and 661.2 marks a significant evolution in the oversight of medical and drug packaging. Organizations must act promptly to ensure all their packaging meets the rigorous standards set forth in these updated regulations. By partnering with specialists like CS Analytical, companies can navigate this transition smoothly, ensuring that their packaging systems are safe, reliable, and compliant with the evolving regulatory landscape.
This is an opportunity for organizations to affirm their dedication to quality and safety in product packaging, safeguarding both their brand reputation and consumer health.
Topics Health）
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