Saturday, January 19, 2013

A Brief History of FDA Compounding Oversight

  • Pediatric Annals
  • January 2013 - Volume 42 · Issue 1: 2-3
  • DOI: 10.3928/00904481-20121221-01
This issue highlights a series of challenging pediatric dermatology cases organized bySarah L. Chamlin, MD, an outstanding pediatric dermatologist and the dermatology section editor of Pediatric Annals. Be sure to look at each case and formulate your opinion before finding out the answer!

Fungal Meningitis Outbreak

You’ve likely heard the news about the disastrous outbreak of fungal meningitis associated with the intrathecal injection of methylprednisolone acetate for adults with chronic back pain.1,2 The contaminated lots of steroid were compounded at a Massachusetts facility called the New England Compounding Center (NECC) and shipped to a wide area of the US.3 The vast majority of the more than 500 patients (including 36 deaths) in 19 states were infected with the rare fungus Exserohilum rostratum. Fungal contamination of unopened compounded drug vials was documented.2
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