FDA Releases Draft Elemental Impurities Guidance

FDA has released its draft guidance on the control of elemental impurities. The guidance is consistent with the implementation of the International Council for Harmonization’s (ICH’s) Q3D Elemental Impurities guideline. The guidance also addresses the United States Pharmacopeial Convention’s (USP’s) requirements for controlling elemental impurities in compendial drug products.

The guidance details how applicants submitting new drug applications (NDAs) or abbreviated new drug applications (ANDAs) for noncompendial drugs should control elemental impurities by applying a risk-based approach, as described in ICH Q3D. It also addresses how noncompendial drug products marketed without an approved NDA or ANDA should control elemental impurities.

According to the guidance, manufacturers of compendial drug products not marketed under an NDA or ANDA can comply with USP General Chapters <232> and <233> and the Federal Food, Drug, and Cosmetic Act. The guidance also addresses how NDA and ANDA holders for compendial drugs should report changes in chemistry, manufacturing, and controls (CMC) specifications to FDA.

Not addressed in the guidance are specific recommendations on the evaluation of toxicity data or biological products. FDA refers manufacturers to ICH Q3D.

Source: FDA