JUN 23 PCAC

The Committee intends to discuss six bulk drug substances nominated for inclusion on the section 503A bulk drug substances list. FDA intends to discuss the following nominated bulk drug substances: Chrysin, cesium chloride, sodium dichloroacetate, pyruvic acid, tea tree oil, and 2,3-Dimercapto-1-propanesulfonic acid (DMPS). The nominators of these substances will be invited to make a short presentation supporting the nomination. During the afternoon session, the Committee will receive updates on certain issues to follow up on discussions from previous meetings, including the option for obtaining access to investigational new drugs under expanded access. FDA announcement