Adverse Event Reporting for Compounded Drugs

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FDA issued a statement about the importance of reporting adverse events resulting from the use of compounded drugs.

Janet Woodcock, MD, director of FDA’s Center for Drug Evaluation and Research, issued a statement on Sept. 9, 2019 stressing the importance of adverse events reporting regarding the use of compounded drugs. Woodcock also announced that FDA will be taking steps to improve adverse event reporting and analysis.

Outsourcing facilities are required to report adverse events to FDA and include information about these events on compounded drug labeling. Along with agency inspections, FDA relies on adverse event reporting to alert the agency of any potential health threats regarding the use of a compounded drug. In her statement, Woodcock described a situation in which more than 4000 adverse events found during an inspection of a compounder of hormone products were never reported to FDA. These adverse events indicated that the compounded products may possibly be associated with serious health risks, including cancer. However, the information regarding the events was never reported to the agency.

As a result of this case, and others, FDA is taking steps to work with outsourcing facilities to improve the reporting of adverse events. The agency is also working with state regulatory partners to investigate adverse event complaints. In addition, the National Academy of Sciences, Engineering, and Medicine (NASEM) will be conducting a study on the risks associated with compounded hormone products.


“Because compounding can serve an important role for patients whose medical needs cannot be met by an FDA-approved drug, we must work to protect patients from the risk of contaminated or otherwise harmful products. As we develop our policy and oversight program, the FDA continually strives to strike a balance between preserving access to compounded drugs for patients who have a medical need for them while protecting patients from the risks associated with compounded drugs that are not made in accordance with applicable quality standards or other requirements,” Woodcock said in the statement.

Source: FDA