The US Food and Drug Administration is taking steps to improve the reporting of adverse events with compounded drugs, and aims to finalize a memorandum of understanding with states agreeable to reporting such events to the FDA when they occur at state-regulated compounding pharmacies.
The US FDA Acts To Bolster Adverse Event Reporting For Compounded Drugs
After discovering one firm suppressed over 4,000 compounded-hormone adverse event reports, agency leans on compounders and outsourcers to improve reporting.