Statement on improving adverse event reporting of compounded drugs to protect patients | FDA

Statement on improving adverse event reporting of compounded drugs to protect patients | FDA

Statement from Janet Woodcock, M.D., director of the Center for Drug Evaluation and Research on improving adverse event reporting of compounded drugs to protect patients

Compounded drugs can serve an important medical need for certain patients, however, they also present risks to patients since they are not evaluated by the FDA for safety, effectiveness and quality. The FDA’s compounding program aims to help protect patients from poor-quality compounded drugs, while preserving access to lawfully-marketed compounded drugs for patients who have a medical need for them.  Along with the development of policy and enforcement of the law, and collaboration with states and industry, our inspections of compounding facilities are vital aspects of this effort. Understanding the nature of the activity these compounders—especially outsourcing facilities— are engaged in helps minimize the risks to patients. While the FDA inspects outsourcing facilities regularly according to

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