FDA 2018 Compounding Policy Priorities

January 2018, FDA Commissioner Scott Gottlieb issued the FDA 2018 Compounding Policy Priorities Plan on the FDA website.

This communication provides a summary background on how the FDA became involved in compounding pharmacies, and a summary of how FDA will prioritize actions to protect the public health as obligated under DQSA.

I found the following section particularly interesting:

Since enactment of the DQSA [which created the 503B and authorized FDA oversight] , the FDA has conducted nearly 500 inspections, issued more than 180 warning letters advising compounders of significant violations of federal law, issued more than 70 letters referring inspectional findings to state regulatory agencies, overseen more than 150 recalls involving compounded drugs and worked with the Department of Justice on multiple civil and criminal enforcement actions.

In addition – the FDA has created the Compounding Risk Alerts FDA page that provides information to health care professionals concerning adverse event reports related to compounded drugs.

FDA recognizes the benefit provided by compounding pharmacies, it will be interesting to observe how FDA implements the 2018 priority plan and risk based inspection.