WASHINGTON (AP) — Large specialty pharmacies like the one that triggered a deadly meningitis outbreak last year would be subject to federal safety inspections and manufacturing standards, under a new Senate proposal introduced Friday.
The draft bill is the first effort by Senate lawmakers to address the outbreak tied to contaminated compounded drugs that sickened more than 700 Americans and killed more than 50 others.
The wave of deadly fungal infections was identified in September and linked to a large Massachusetts compounding pharmacy, which regulators said was operating more like a manufacturer.
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The new proposal would subject these large compounding operations to direct federal oversight by the Food and Drug Administration, rather than state pharmacy boards that have traditionally overseen such operations.
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