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.
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The US Food and Drug Administration should require that outsourcing facilities collect bioavailability data for compounded bioidentical hormone replacement therapy products, while compounding pharmacies should be required to report adverse events to state pharmacy boards and the FDA. Such actions would help resolve some of the safety concerns for these products, says a 1 July report from the National Academy of Sciences, Engineering and Medicine.
There is scant evidence to support use of compounded topical pain creams, and tougher controls are needed to regulate 503A pharmacies, according to a recent study by the National Academies.
Under the US FDA’s final MOU on interstate compounding, states are given more time to decide whether to sign the agreement and investigate complaints of adverse events associated with drugs compounded by 503A pharmacies. Agreement draws mixed reactions from pharmacy groups.