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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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