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Update for October 17, 2012
Congress, FDA Weigh Regulatory Changes to Compounding in Wake of Meningitis Outbreak
In response to the fungal meningitis outbreak linked to a New England pharmacy, Congress and the FDA are considering changes to the existing regulatory structure to reflect modern pharmacy practices. Twenty-three deaths have been linked to a compounded batch of preservative-free methylprednisolone acetate, a steroid injection. The FDA previously warned the pharmacy that provided the drug that its practices could be viewed as drug manufacturing and not compounding. The pharmacy, the New England Compounding Center, has since closed and recalled its products.
Click here to preview a summary of notices which appeared in the October 12 - October 18, 2012 Federal Register.
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