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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Agency’s recent responses denying three petitions filed in 2001 by US industry trade groups and in 2002 by pharmaceutical ingredient and chemicals firm explain the changes requested can be proposed in “OTC monograph order requests” pathway established in program overhaul.
The public health emergency has shown that the US needs more hand sanitizers on store shelves, not less, right?
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.