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  1. Human Drug Compounding

Many serious patient illnesses and deaths linked to poor quality compounded drugs have occurred since the 2012 fungal meningitis outbreak. In response, FDA has established an Incidents Program to identify and prevent outbreaks through surveillance of adverse events and product quality incidents. This effort has led to many actions by FDA including the issuance of compounding risk alerts to inform health care professionals, compounders and consumers about risks associated with compounded drugs, including information on adverse events, outbreaks or product quality. These are intended to alert stakeholders of the risks so that practitioners can more effectively protect patients from unsafe, ineffective and poor-quality compounded medicines.

Please contact compounding@fda.hhs.gov if you have any questions regarding the information provided in a compounding risk alert below:

FDA encourages health care professionals to report adverse events and product quality defects associated with compounded drugs to FDA’s MedWatch Adverse Event Reporting program: 

 

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