Volume 90 Issue 52 | p. 11 | News of The Week
Issue Date: December 24, 2012

Regulating Drug Compounders

Drug Safety: FDA pushes for new oversight of large compounding pharmacies
Department: Government & Policy
News Channels: Biological SCENE
Keywords: fungal meningitis, FDA, compounding pharmacy

On the heels of a multistate outbreak of fungal meningitis linked to a Massachusetts-based compounding pharmacy that produced injectable steroids, the Food & Drug Administration is pushing for new legislation that would strengthen its oversight of such facilities.

At a meeting with state pharmacy regulators last week, FDA Commissioner Margaret A. Hamburg proposed a system that would require large compounding pharmacies to register with FDA and undergo routine inspections by the agency. Compounding pharmacies are . . .

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