USP Moves Implementation Date for Elemental Impurities Provisions

From DCAT Value Chain Insights (VCI)

By Regulatory News posted 01-20-2015 09:22


The United States Pharmacopeial Convention (USP) is announcing plans to establish January 1, 2018 as the new date of applicability of General Chapters <232> Elemental Impurities—Limits and <2232> Elemental Contaminants in Dietary Supplements. This new date is intended to align the implementation of General Chapter <232> more closely with that of the ICH Q3D Guideline for Elemental Impurities.

USP has posted a Notice of Intent to Revise General Notices Section 5.60.30, which will establish this new date. USP has posted a separate Notice of Intent to Revise General Chapter <231> Heavy Metals and its references in monographs to delay their omission. Through these changes it is USP’s intention that users could either continue to utilize the current <231> approach or implement the new <232>/<2232> approaches until January 1, 2018, at which time General Chapters <232> and <2232> will be made applicable to drug product and dietary supplement monographs as described in General Notices 5.60.30.

Source: USP


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