Home » Implementing Shutdown Orders for Compounders is Contingent on Communication, FDA Says
Implementing Shutdown Orders for Compounders is Contingent on Communication, FDA Says
September 22, 2016
Better communication with states is needed when the FDA stops a drug compounder from operating, the agency said in a new set of recommendations.
The agency has been working to address issues and concerns raised at past intergovernmental meetings on pharmacy compounding and has compiled a list of options it plans to explore in the event a compounder’s facility is deemed unsanitary.
The FDA says that if it recommends a compounder cease sterile and/or non-sterile operations until it has implemented appropriate corrective actions, the agency will send an email advising all 50 states of the recommendation and include a summary of any information about the reasons for the FDA’s recommendation that can be shared publicly.
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