FDA’s Compounding Oversight: What Price Safety?

As meningitis outbreak widens, FDA and members of Congress are calling for clarification of what jurisdiction the agency has over pharmacies, but agency officials are stopping short of asking for clear new authorities.

The legacy of the meningitis infections linked to fungal contamination of preservative-free methylprednisolone acetate produced and distributed by the New England Compounding Center may be determined to a large degree by the amount of additional authority that FDA is willing to request.

At the moment, FDA notes that unclear lines of authority make it difficult for the agency to regulate compounding pharmacies so as to prevent illicit mass-manufacture of approved drugs under...

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