Enforcing Shutdown Orders for Compounders Relies 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 that have arisen at past intergovernmental meetings on pharmacy compounding and has created a list of options it plans to explore in the event a compounder’s facility is deemed unsanitary.
The FDA said 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.
Additionally, the agency plans to distribute a summary of its teleconference with the affected compounder, describing the recommendation as well as the compounder’s response to the recommendation, to all 50 states.
The FDA will also consider publishing guidance on unsanitary conditions at facilities that take part in compounding, and as part of that will continue the discussion with states regarding coordination on oversight of outsourcing facilities.
With Managing Product Pipeline Communications you’ll be able to confidently account for the various perspectives — regulators on both sides, investors and the general public — and ensure that the right people get the information they should from you every time.