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# ICH Elemental Impurities Guidance
- URL: https://www.fdaweb.com/ich-elemental-impurities-guidance/
- Published: 2018-08-07T12:00:00.000Z
- Updated: 2026-09-15T00:24:04.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5142049

FDA has issued a guidance, *Elemental Impurities in Drug Products*, with recommendations regarding the control of elemental impurities of human drug products marketed in the U.S. consistent with implementation of the International Council for Harmonization *Q3D Elemental Impurities* guidance. The [document](http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCK509432.pdf?ref=fdaweb.com) also is to assist manufacturers of compounded drug products respond to issuance of the United States Pharmacopeia requirement for the control of elemental impurities.

The guidance does not include specific recommendations on the evaluation of toxicity data for potential elemental impurities, application of a risk-based approach to control elemental impurities in drug products, or PDE (prescription drug event).