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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.

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More from Policy & Regulation

Congress, Researchers Highlight Security Risks At DNA Testing Services

 
• By Elizabeth Orr

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The new telework policy returns to the pre-COVID-19 pandemic standard, but still requires reviewers to be at White Oak for sponsor meetings and divisions to have an in-office presence every day.