FDA Elemental Impurities in Drug Products Guidance for Industry

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Elemental Impurities in Drug Products 1

Guidance for Industry This guidance represents the current thinking of the Food and Drug Administration (FDA or Agency) on this topic. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. To discuss an alternative approach, contact the FDA office responsible for this guidance as listed on the title page. I. INTRODUCTION This guidance provides recommendations regarding the control of elemental impurities of human 2

drug products marketed in the United States consistent with implementation of International 3

Council for Harmonisation (ICH) guidance for industry Q3D Elemental Impurities (ICH Q3D). This guidance will also assist manufacturers of compendial drug products in responding to the 4

issuance of the United States Pharmacopeia (USP) requirement for the control of elemental 5

impurities. Specifically, with respect to implementation of ICH Q3D and of USP General Chapters <232> and <233>, this guidance makes recommendations on the following: • How applicants submitting new drug applications (NDAs) or abbreviated new drug applications (ANDAs) for noncompendial drug products should control elemental impurities as described in ICH Q3D. ICH Q3D contains recommendations on applying a risk-based approach to control elemental impurities and permitted daily exposure (PDE). • How manufacturers of compendial drug products that are not marketed under an approved NDA or ANDA can comply with USP General Chapters <232> Elemental Impurities—Limits and <233> Elemental Impurities—Procedures and the Federal Food, 6

Drug, and Cosmetic (FD&C) Act. 1

This guidance has been prepared by the Office of Pharmaceutical Quality in the Center for Drug Evaluation and Research in cooperation with the Center for Biologics Evaluation and Research at the Food and Drug Administration. 2

Prescription and nonprescription. 3

The ICH guidance was adopted as an FDA guidance document. We update guidances periodically. To make sure you have the most recent version of a guidance, check the FDA Drugs or Biologics guidance Web pages at https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm and https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm. 4

USP General Chapters <232> Elemental Impurities—Limits and <233> Elemental Impurities—Procedures. 5

Note that control of elemental impurities for all finished drug products is also addressed in 21 CFR part 211. 6

See section 501(b) of the FD&C Act (21 U.S.C. 351(b)).

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