In an email to staff distributed Monday, Janet Woodcock, director of the Center for Drug Evaluation and Research (CDER) at the US Food and Drug Administration (FDA), said the agency plans to “institutionalize” its compounding regulatory program within the center’s Office of Compliance.
In the aftermath of the 2012 fungal meningitis outbreak linked to the New England Compounding Center that led to at least 60 deaths, FDA created an agency lead for compounding within CDER’s Office of the Center Director.
The outbreak also prompted Congress to pass the Drug Quality and Security Act
(DQSA), which amended the Federal Food, Drug and Cosmetic Act
(FDCA) to clarify requirements for compounders and created a pathway for certain compounders to register with FDA as outsourcing facilities.
Since then, FDA has issued dozens of guidance documents related to compounding, stepped up its inspection and enforcement efforts and taken legal action against compounders found in violation of the FDCA.
“Within the Office of Compliance, a new compounding team has been established within the Immediate Office with responsibility for overall management of the program,” Woodcock said.
The program will be led by Acting Associate Director for Compounding Gail Bormel, who will report to Compliance Director Donald Ashley and coordinate compounding efforts with other offices within CDER, including the Office of Pharmaceutical Quality, Office of New Drugs and Office of Regulatory Policy.
The announcement comes two months after FDA announced
its compounding priorities for 2019, which include setting up a Center of Excellence on Compounding for Outsourcing Facilities and continuing to update the agency’s lists of bulk drug substances that can be compounded under sections 503A and 503B of the FDCA.