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# Elemental Impurities Guidance Out
- URL: https://www.fdaweb.com/elemental-impurities-guidance-out/
- Published: 2016-06-30T12:00:00.000Z
- Updated: 2026-09-14T21:12:43.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5136092

FDA has issued a draft guidance, *Elemental Impurities in Drug Products*, with recommendations about controlling elemental impurities of human drug products marketed in the U.S. consistent with implementation of the International Council for Harmonization guidance for industry, *Q3D Elemental Impurities*. The [document](http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM509432.pdf?ref=fdaweb.com) says it also will assist manufacturers of compendial drugs to respond to a U.S. Pharmacopeia (USP) requirement for controlling elemental impurities. The draft makes recommendations on: 

- how applicants submitting NDAs or ANDAs for noncompendial drug products should control elemental impurities as described in ICH Q3D;
- how manufacturers of compendial drug products that are not marketed under an approved NDA or ANDA can comply with USP general chapters 232 and 233;
- how holders of NDAs or ANDAs for compendial drug products should report changes in chemistry, manufacturing, and controls specifications to FDA to comply with USP general chapters 232 and 233; and
- how manufacturers of noncompendial drug products that are marketed without an approved NDA or ANDA should control 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 permitted daily exposures. It also does not address biological products. It refers readers to the ICH Q3D for information on all of these topics.