Statement on improving adverse event reporting of compounded drugs to protect patients
In brief
The FDA announced it is strengthening oversight of adverse event reporting for compounded drugs, requiring outsourcing facilities to meet their reporting obligations and taking appropriate enforcement action against non-compliant facilities. During a 2018 inspection of BioTE Medical, the FDA found 4,202 adverse events that had never been reported, involving compounded hormone pellets occurring between 2013 and 2018; because key information was missing, the FDA could attribute only 61 of them to pellets containing testosterone.
Why it matters
The 4,202 unreported adverse events found on inspection, with only 61 attributable, show an information gap in safety monitoring of compounded hormone pellets.
