USP <381> Elastomeric Closure for Injections

Recommendation

7/8 May 2024

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The United States Pharmacopeia, USP, posted a Notice of Intent to Revise Chapter <381> Elastomeric Closure for Injections on November 17, 2017.

USP says, "the current revision of <381> Elastomeric Closure for Injections references includes a reference to <231> Heavy Metals, which will be omitted on January 1, 2018.  Also as of January 1, 2018, the omission of General Chapter <231> Heavy Metals and all references to it will be official, and as such, General Chapter <231> will not be considered by USP to be available for demonstration of conformance with USP–NF requirements".

USP 40-NF 35 makes General Chapters <232> Elemental Impurities–Limits and <2232> Elemental Contaminants in Dietary Supplements applicable to drug product and dietary supplement monographs respectively on January 1, 2018.

USP states that in USP 41–NF 36, which is currently published and will become official on May 1, 2018, General Chapter <231> still appears in full, with the following note, “Chapter to remain official until January 1, 2018. After January 1, 2018, this chapter will no longer be required.” "References to General Chapter <231> also will remain in this version with revision markup that notes their omission date of January 1, 2018. General Chapter <231> and its references will be removed from the USP–NF as of USP 42–NF 37".

Therefore, the General Chapters—Packaging and Distribution Expert Committee intends to revise General Chapter <381> to include the necessary information to allow execution of the Heavy Metals test.

According to USP it is anticipated that a Revision Bulletin to the Chapter <381> Elastomeric Closure for Injections will be posted on December 29, 2017, and become official on January 1, 2018.

For more information please see the USP Compendial Notices webpage.