1. HBW Insight
  2. >>Health
  3. >>Policy & Regulation
  4. >>Regulation

FDA’s Final Rule On OTC Antiseptic Rubs Affects Just 3% Of Market; Alcohol Rulemaking Deferred

 
• By Ryan Nelson

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.

Hand Sanitizer

The US market for OTC consumer antiseptics – including germ-killing soaps, hand sanitizers and wipes – hangs in the balance as industry works to deliver data to FDA demonstrating general recognition of safety and effectiveness for active ingredients of highest priority.

FDA released a final rule April 11 for consumer antiseptic rubs – i.e., hand sanitizers, wipes and other products...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on HBW Insight for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required
Start Free Trial

Already a subscriber?

More from Regulation

EU Green Claims Directive: Commission Says It ‘Has Not Withdrawn’ From Negotiations

 
• By David Ridley

What's going on with the EU Green Claims Directive? HBW Insight speaks to the European Commission, Parliament and Council to find out why trilogue negotiations seem to have stalled.

German Switch Committee Supports OTC Melatonin And Acyclovir, Rejects Rupatadine

 
• By David Ridley

Germany’s Expert Committee for Prescription supports the Rx-to-OTC switches of melatonin and buccal acyclovir but rejects rupatadine.

Green Regulation Is ‘A Baseline Not A Burden’ – Behind Opella’s B Corp Journey

 
• By David Ridley

“For us, regulation is the floor, not the ceiling,” Opella's chief sustainability officer Marissa Saretsky tells HBW Insight as the firm gains B Corp Certification. Other topics covered in this exclusive interview include Opella's position on the revised Urban Wastewater Treatment Directive.

US FDA: No Replacement Yet For Animal Methods In Testing Systemic Effects Of Sunscreens

 
• By Lauren Nardella

While FDA fully supports the recent roadmap to reduce and eliminate animal testing, animal tests are still necessary for assessing systemic effects, says Jacqueline Corrigan-Curay, acting director for CDER, during a House Energy and Commerce Health Subcommittee hearing.

More from Policy & Regulation

Green Regulation Is ‘A Baseline Not A Burden’ – Behind Opella’s B Corp Journey

 
• By David Ridley

“For us, regulation is the floor, not the ceiling,” Opella's chief sustainability officer Marissa Saretsky tells HBW Insight as the firm gains B Corp Certification. Other topics covered in this exclusive interview include Opella's position on the revised Urban Wastewater Treatment Directive.

FDA Warns Whoop BPI App Is Unauthorized Device; Firm Says Wearable Is A Wellness Tool

 
• By Brian Bossetta

Recent FDA warning letter claims Boston firm specializing in wearable technology marketed a blood pressure device without agency approval, but the company rejects the assertion and says the agency is out of step with federal regulations.

Questions For FDA On OTC Switches, Alternative Tests And Budget Cuts At OMUFA Hearing

 
• By Malcolm Spicer

Texas Democrat Lizzie Fletcher didn’t pose questions for witnesses at House Health Subcommittee hearing but used her floor time to question whether Congress will keep federal agencies afloat. “I have real concerns that even if we reauthorize these programs, we won't have the funding or the staff to