Update on the Implementation of USP´s revised Plastic Packaging Chapters

Recommendation

7/8 May 2024

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The United States Pharmacopeia (USP) recently posted an update on the previously announced delayed implementation of General Chapters <661.1> and <661.2> together with information on the revision of General Chapter <661>.

Background

In Pharmacopeial Forum 45(2) [March–April 2019] General Chapters <661.1> Plastic Materials of Construction and <661.2> Plastic Packaging Systems for Pharmaceutical Use were revised as an In-Process Revision. The purpose of the proposed revisions was to

• provide clarity of chapter text;
• extend the implementation period of the chapters which otherwise were to become applicable on May 1, 2020;
• allow early adoption of the requirements in General Chapters <661.1> and <661.2> at any time during the implementation delay period.

The USP Packaging and Distribution Expert Committee has approved the extension of the implementation date from May 1, 2020 to December 1, 2025, together with other changes to be published in the First Supplement to USP 43–NF 38, which will be available on February 1, 2020.

In addition, the USP intends to revise General Chapter <661> Plastic Packaging Systems and Their Materials of Construction in response to the revision of General Chapter <1661> Evaluation of Plastic Packaging Systems for Pharmaceutical Use and Their Materials of Construction. General Chapter <1661> was proposed for comment in Pharmacopeial Forum 45(2) and will also appear in the First Supplement to USP 43–NF 38. Since <661> references General Chapter <1661> (and thus requires revision) it will be updated in USP 43–NF 38, First Supplement, along with <1661>.

USP General Chapters with numbers >1000 are not mandatory. They are considered to be explanatory texts. However, General Chapters with numbers below 1000 are mandatory in the US. All modifications will become official on August 1, 2020, to coincide with the official date of the revised General Chapter <1661>. Interested stakeholders are encouraged to alert USP to any impact they may recognize related to the update of those monographs. More information can be found on USP´s Compendial Notices-Website.