The Food and Drug Administration puts in writing its instructions for infant formula providers to inform the agency about US supply disruptions nearly three years after the unexpected shutdown of a major plant caused widespread shortages.
US Infant Formula Supply Regulation Overhaul Extends To Guidance On Reporting Disruptions
Formula manufacturers must notify FDA of permanent discontinuance or interruption in production “likely to lead to a meaningful disruption in the supply … and the reasons for such discontinuance or interruption” no later than five business days after a problem is identified.
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