1. HBW Insight

FDA, USP ‘Walk Companies Through The Basics’ Of GMPs After Widespread OTC Sanitizer Adulteration

Threat To Safety Across A Drug Category In US Has Precedent, But Not During A Pandemic

 
• By Malcolm Spicer

Widespread findings in the US of methanol in OTC hand sanitizers labeled as containing ethyl or isopropyl alcohol are not without precedent as adulteration affecting a specific type of product. But surging sales hand sanitizers, sub-potent formulations as well as methanol-contaminated, prompted more immediate and comprehensive responses from FDA.

Rampant adulterations in specific categories previously have hit US drug ingredient supplies, but none threatened the safety of a type of product soaring in demand due to a public health emergency or prompted an import alert imposed on an entire country.

Widespread findings in the US during 2020 of methanol in OTC hand sanitizers labeled as containing ethanol or isopropyl alcohol...

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

More from Policy & Regulation