Yesterday, the FDA published a web page entitled, Mitigating Risks of Compounded Drugs Through Surveillance (here) which provides an overview of FDA’s Compounding Incidents Program. It discusses how the program works in evaluating reports of adverse events and a broad range of drug product quality complaints and what the outcomes can occur based on the program’s evaluation. We have seen warning letters, FDA’s publication of Compounding Risk Alerts and other enforcement actions.
The information gleaned from the reports may also form the basis of guidance the Agency may issue to help pharmacy compounders and Outsourcing facilities better meet FDA requirements. The posting also describes more fully what types of actions has the Compounding Incidents Program has taken, where the reports come from and how the reports are evaluated by the program.
The article provides two informative charts, reproduced below, that describe in Figure 1, the “total number of incidents (adverse events and other complaints) reported to FDA’s Compounding Incidents Program by fiscal year” and Figure 2, “the number of adverse events and other complaints received by firm type in fiscal year 2021.”
The importance of the program to improving the safety of compounded products, protecting the public health, and assuring proper compliance with FDA regulations is invaluable.