Gottlieb Lays Out 2019 Compounding Agenda As He Departs FDA

Days before the end of his tenure at FDA, agency commissioner Scott Gottlieb laid out a roadmap for FDA to shape its regulatory system for drug compounding in 2019. The outgoing agency chief announced the agency will issue guidance, propose rules, and host a public meeting and listening sessions in four key areas: maintaining quality manufacturing and compliance; creating lists of bulk drug substances; finalizing FDA’s partnership with states; and clarifying compounding requirements for hospitals and health systems. Though Gottlieb...