By David Morgan | Reuters – 23 mins ago
WASHINGTON (Reuters) - U.S. states should remain the primary regulators for compounding pharmacies, rather than the U.S. Food and Drug Administration, despite a deadly fungal meningitis outbreak that has killed 32 people since September, an industry group said on Thursday.
The International Academy of Compounding Pharmacists, headquartered in Missouri City, Texas, told a U.S. Senate oversight panel that the meningitis outbreak raging across 19states occurred because regulatory officials at both the state and federal levels failed to take action under current laws.
The company, Framingham, Massachusetts-based New England Compounding Center (NECC), faces several investigations including a federal criminal probe over unsanitary conditions at its production site and operations that critics say amounted to drug manufacturing that eluded scrutiny by FDA and the Massachusetts Board of Registration in Pharmacy.
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