FDA Requests Comments on Planned 503B List Study

The FDA issued a request for stakeholder comment as it develops a list of bulk drug substances for use in drug compounding.

To compile the list, the agency has proposed a research study with the University of Maryland’s Center of Excellence in Regulatory Science and Innovation (CERSI) and the Johns Hopkins University CERSI.

“We intend to seek input from the CERSI-UMD on the use of these bulk drug substances in clinical practice by examining their current and historical use in compounding,” the FDA says. “Information regarding the historical and current use of the substances in compounding obtained by this research will help inform our assessments as to the clinical need for outsourcing facilities to use the substance in compounding.”