The U.S. Food and Drug Administration, FDA, recently published its final guidance on Elemental Impurities in Drug Products which finalizes the draft guidance issued July 1, 2016. The guidance provides recommendations regarding the required documentation related to the control of elemental impurities (EIs) consistent with ICH Q3D and USP General Chapters <232> and <233>. The new document applies to manufacturers of noncompendial and compendial drug products. The control of EIs for all finished drug products is also addressed in 21 CFR part 211.

In detail the guidance deals with the following:

  • How applicants submitting new drug applications (NDAs) or abbreviated new drug applications (ANDAs, Generics) for noncompendial drug products should control EIs as described in ICH Q3D.
  • How manufacturers of compendial drug products that are not marketed under an approved NDA or ANDA can comply with United States Pharmacopeia, USP, General Chapters <232> Elemental Impurities—Limits and <233> Elemental Impurities—Procedures.
  • How holders of NDAs or ANDAs for compendial drug products should report CMC changes to FDA to comply with General Chapters <232> and <233>.
  • How manufacturers of noncompendial drug products that are marketed without an approved NDA or ANDA should control EIs (e.g. nonprescription OTC products marketed under an FDA monograph).