USP Makes January 2018 Implementation Date for Elemental Impurity Provisions

From DCAT Value Chain Insights (VCI)

By Regulatory News posted 04-07-2015 12:13


The United States Pharmacopeial Convention (USP) has announced the establishment of an implementation date of January 1, 2018 for General Chapters <232> Elemental Impurities—Limits and <2232> Elemental Contaminants in Dietary Supplements in USP’s compendia of public standards, United States Pharmacopeia—National Formulary (USP–NF). USP has also announced that the removal from USP–NF of General Chapter <231> Heavy Metals and monograph references to this chapter will be delayed until January 1, 2018.

Through these revisions, USP specifies that users may either continue to use the current <231> approach or implement the new 232/2232 approaches until January 1, 2018. On that date, General Chapters <232> and <2232> will be made applicable to drug product and dietary supplement monographs and will be required unless specified otherwise in a monograph.

Following the December 2014 release of the International Conference on Harmonization (ICH) Q3D Guideline for Elemental Impurities and based on dialogue with representatives of industry and the U.S. Food and Drug Administration, USP revised General Notices Section 5.60.30 Elemental Impurities in USP Drug Products and Dietary Supplements in USP–NF to: specify the timing of the applicability of General Chapters <232> and <2232> for January 1, 2018 to align more closely with the implementation date of the ICH Q3D Guideline for existing products; note the delay in omission of General Chapter <231> Heavy Metals until January 1, 2018 to align with the applicability of <232>; allow early adoption of the General Chapters <232> and <2232> in the interim to enable users to determine whether to use the existing <231> or the new <232>/<2232> approaches.

The revision to Section 5.60.30 appeared in a March 27, 2015 Revision Bulletin. The revised text will become official April 1, 2015. USP has posted a separate Revision Bulletin to delay the removal of General Chapter <231> Heavy Metals and its references in monographs. Additional information, including updates to Frequently Asked Questions and the Revision Plan, can be found on the Elemental Impurities Key Issue page on USP’s Website.

Source: USP


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