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# Guidance on Elemental Drug Impurities
- URL: https://www.fdaweb.com/guidance-on-elemental-drug-impurities/
- Published: 2016-07-01T12:00:00.000Z
- Updated: 2026-09-14T21:13:01.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5136107

*Federal Register* Notice: FDA is making available a draft guidance for industry entitled *Elemental Impurities in Drug Products*. It provides recommendations on the control of elemental impurities of human drug products marketed in the U.S. consistent with implementation of International Council for Harmonization (ICH) guidance for industry Q3D Elemental Impurities. This draft guidance will also assist manufacturers of compendial drug products in responding to the issuance of the United States Pharmacopeia requirement for the control of elemental impurities. To download this guidance, click [here.](http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM509432?ref=fdaweb.com) To view this notice, click [here.](https://www.gpo.gov/fdsys/pkg/FR-2016-07-01/pdf/2016-15704.pdf?ref=fdaweb.com)