Implementing Shutdown Orders for Compounders is Contingent on Communication, FDA Says

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.