CDER’s Office of Compliance to Lead Compounder Regulation

June 17, 2019

As part of its ongoing enforcement efforts against drug compounders, the FDA plans to move the program’s base of operations from CDER’s Office of the Center Director to the Office of Compliance.

“Within the Office of Compliance, a new compounding team has been established within the Immediate Office with responsibility for overall management of the program,” CDER Director Janet Woodcock said.

The agency originally created a lead position for compounding in the Office of the Center Director in response to the 2012 fungal meningitis outbreak, which resulted in more than 64 deaths and hundreds of non-fatal injuries.

Other CDER offices will still be in the mix, Woodcock said. The Office of New Drugs will continue to review bulk substances, while the Office of Pharmaceutical Quality will carry on its work on developing CGMP policies for outsourcing facilities. In addition, the Office of Regulatory Policy will remain in its collaborative role on regulations and guidance.

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