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# Suggestions for Elemental Impurities Draft Guidance
- URL: https://www.fdaweb.com/suggestions-for-elemental-impurities-draft-guidance/
- Published: 2016-08-30T12:00:00.000Z
- Updated: 2026-09-14T21:28:05.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5136653

The U.S. Pharmacopeial Convention says that an FDA draft guidance on elemental impurities in drug products “provides clarity and assistance to human drug product manufacturers regarding the control of elemental impurities consistent with implementation of International Council for Harmonization guidance for industry … and pursuant to the USP requirements for the control of elemental impurities….” The organization’s comment letter [says](https://www.regulations.gov/document?D=FDA-2016-D-1692-0011&ref=fdaweb.com) the group agrees with key recommendations in the draft and makes a number of specific recommendations for change.

Specific line-by-line suggestions and recommendations also were made by [Eli Lilly](https://www.regulations.gov/document?D=FDA-2016-D-1692-0012&ref=fdaweb.com) and [Impax Laboratories](https://www.regulations.gov/document?D=FDA-2016-D-1692-0010&ref=fdaweb.com).