Compounding, the whole story · Part 2: The 2012 meningitis outbreak
How the tragedy changed U.S. law
Lesson 5.2.3 · 6 min read · Advanced plan
What you'll learn
- Before 2013, court rulings left FDA's compounding authority unclear and different by region.
- The DQSA, enacted November 27, 2013, was Congress's response to the outbreak.
- It cleaned up 503A, created 503B outsourcing facilities and improved FDA-state communication.
- FDA's later inspections found problems in most compounders it visited.
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