Draft Guidance - Q3D(R2)— "Guideline for Elemental Impurities.”

News category: 
Monday, May 17, 2021

The Food and Drug Administration (FDA or Agency) just announced today the availability of a draft guidance for industry entitled “Q3D(R2)—Guideline for Elemental Impurities.” The draft guidance was prepared under the auspices of the International Council for Harmonisation (ICH), formerly the International Conference on Harmonisation.

The draft guidance provides Permissible Daily Exposures (PDEs) for the cutaneous and transcutaneous routes of administration and relevant risk assessment considerations to supplement previous guidance for the oral, parenteral, and inhalation routes of administration. In addition, error corrections to previously identified PDEs for gold (oral, parenteral, and inhalation routes), silver (parenteral route), and nickel (inhalation route) are provided. The draft guidance is intended to recommend acceptable amounts for the listed elemental impurities in pharmaceuticals for the safety of the patient and provide recommendations for conducting a risk assessment for pharmaceutical products.

You can access the Federal Register announcement at the following link:

Federal Register :: Q3D(R2)-Guideline for Elemental Impurities; International Council for Harmonisation; Draft Guidance for Industry; Availability

The draft Guidance itself can be accessed at the following link:


The FDA is looking for any comments by July 12, 2021.