BRIEFING

 〈381〉 Elastomeric Components in Injectable Pharmaceutical Product Packaging/Delivery Systems. This proposal is based on the version of the chapter official as of December 1, 2020. The General Chapters—Packaging and Distribution Expert Committee is proposing to remove 4.3 Functionality Tests, as this section will be redundant due to the introduction of Elastomeric Component Functional Suitability in Parenteral Product Packaging/Delivery Systems 〈382〉, which will become official on December 1, 2025. Chapter 〈382〉 focuses on assessing the functional suitability of packaging and delivery systems intended for parenteral dosage forms, particularly those involving primary packaging components made partially or entirely from elastomeric materials. Elastomeric components, when properly integrated into dimensionally compatible packaging and delivery systems, serve the purpose of safeguarding and containing the package contents while ensuring safe and effective product access during use. Chapter 〈382〉 was officially incorporated into USP–NF on December 1, 2020, with a 5-year implementation delay to allow industry ample time for adoption. Therefore, the proposed revision to remove section 4.3 Functionality Tests is aimed at ensuring the harmonization of 〈381〉 and 〈382〉 by December 1, 2025.

 Additionally, minor editorial changes have been made to update the chapter to current USP style.

 (GCPD: D. Hunt)

 Case ID—SUB-774