US FDA Allows Compounding Of Hand Sanitizers During Pandemic
Agency refrains from enforcing certain FD&C Act requirements against compounders who prepare alcohol-based hand sanitizers during COVID-19 public health emergency.
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The majority of over-the-counter hand sanitizers and wipes on the US market rely on ethyl alcohol, one of three active ingredients for which final rulemaking has been deferred to allow industry to generate additional safety and effectiveness data. FDA's final rule, released April 11, completes a series of related actions pertaining to OTC antiseptic drug products.