FDA’s Final Rule On OTC Antiseptic Rubs Affects Just 3% Of Market; Alcohol Rulemaking Deferred
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.
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Purell Battling Class Actions Over Disease Claims While World Scrambles To Increase Hand Sanitizer Supplies
Leading chemical firms, beauty and consumer health companies, even distilleries and medical marijuana cultivators are adapting operations to meet global demand for hand sanitizers amid the COVID-19 pandemic. Meanwhile, plaintiff’s attorneys are busy with multiple class actions against Purell manufacturer GOJO Industries for alleged false advertising following a January warning letter to the firm from the US FDA.
Agency says compounding pharmacies are more familiar with standards and methods for producing drug products than “untrained consumers.” It will allow operations that might otherwise get sanctioned for marketing adulterated drugs because their products likely are better than some remedies consumers are making. It is aware consumers are experiencing difficulties accessing alcohol-based hand sanitizers and are concocting their own hand sanitizers.
Agency refrains from enforcing certain FD&C Act requirements against compounders who prepare alcohol-based hand sanitizers during COVID-19 public health emergency.