New Timeline for USP Plastics Packaging Chapters

Recommendation

7/8 May 2024

Extractables & Leachables - Live Online Training
Challenges and Solutions for Packaging and Single Use Systems

The USP (United States Pharmacopeia) Packaging and Storage Expert Committee posted a Notice of Intent to Revise on October 26, 2018, to provide notice that the Committee intends to revise the following USP chapters:

• <659> Packaging and Storage Requirements
• <661> Plastic Packaging Systems and Their Materials of Construction
• <661.1> Plastic Materials of Construction
• <661.2> Plastic Packaging Systems for Pharmaceutical Use
• <1661> Evaluation of Plastic Packaging Systems And Their Materials of Construction With Respect to Their User Safety Impact

According to USP the purpose of the proposed revisions will be to provide an implementation period extension of the requirements specified in General Chapters <661.1> and <661.2>, which otherwise were to become applicable on May 1, 2020. Now, the implementation of the new requirements will be delayed until December 1, 2025. The proposed revisions will also be used to reformat and revise the extractable element approach, and to clarify content in <661.1>, <661.2> and <1661>.

In the text of the new chapters <661.1> and <661.2> especially the sections regarding extractable elements, the new requirement for <87> Biological Reactivity Tests, In Vitro testing for packaging materials and systems for oral and topical dosage forms, and the remove of the exemption to General Chapter <661.1> for plastic materials and packaging systems previously approved by a regulatory authority, have been highly discussed. 

The USP states that it is anticipated that the proposed revisions will be published in Pharmacopeial Forum 45(2) [March–April 2019], with a pre-posting on the USP Website on January 1, 2019. The comment period for this revision will end on May 31, 2019. In the absence of any adverse comments the proposed revision is anticipated to become official on August 1, 2020.

More Information is available on the USP Website in the Notice of Intent to Revise: Revisions to Plastics Packaging Chapters <659>, <661>, <661.1>, <661.2>, and <1661.