FDLI Presentation by Janet Woodcock, M.D. Director of FDA CDER on April 23, 2014--Includes What the FDA has done and is doing regarding compounding and outsourcing facilities

September 2012, outbreak of fungal meningitis tied to contaminated compounded steroid injections - 64 deaths, 750 infections, 20 states

•Between October 1, 2012 and March 31, 2014, FDA conducted almost 100 inspections of compounding pharmacies across the country – for cause and proactive - to identify pharmacies with deficient sterile compounding practices

•Serious quality problems were observed, including contaminated products and poor sterile practices that create a risk of contamination

•Over 40 recalls of sterile products have been conducted; over 25 firms chose to stop sterile compounding

•New problems continue to be identified at compounding pharmacies across the country
Removed unconstitutional provisions from existing law (section 503A of FDCA)

•Added new section regarding outsourcing facilities that may register with FDA and must comply with certain requirements to qualify for exemptions from new drug and adequate directions for use requirements of FDCA

•As of April 4, 2014, 38 facilities were registered as outsourcing facilities

•FDA is moving aggressively to implement the new law

Compounding Legislation Next Steps
•Continuing inspection and enforcement efforts begun in 2013

•Establishing CGMP requirements for outsourcing facilities and inspecting those that register

•Establishing framework for determining who qualifies for exemptions under 503A

•Working with States to enhance joint cooperation in oversight of compounding

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