Obtaining Information for Evaluating Nominated Bulk Drug Substances for Use in Compounding Drug Products Under Section 503B of the Federal Food, Drug, and Cosmetic Act

FDA has solicited nominations for the 503B bulks list and has received over 200, but these nominations often do not contain substantive information on the current and historical use of these substances in clinical practice to inform FDA’s evaluation. To inform our evaluation of bulk drug substances for inclusion on the 503B bulks list, we have entered into research studies with the University of Maryland (UMD) Center of Excellence in Regulatory Science and Innovation (CERSI) and the Johns Hopkins University (JHU) CERSI. We intend to seek input from the UMD-CERSI and JHU-CERSI on the use of these bulk drug substances in clinical practice by examining their current and historical use in compounding.

The latest form for Obtaining Information for Evaluating Nominated Bulk Drug Substances for Use in Compounding Drug Products Under Section 503B of the Federal Food, Drug, and Cosmetic Act expires 2022-06-30 and can be found here.

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