US FDA Clarifies Testing In Sanitizer Production Temporary Guidances To Tighten Compliance
The agency clarifies in documents providing temporary guidance on preparing or compounding alcohol-based hand sanitizer products, and manufacturing alcohol for those products, that each lot of alcohol obtained from another source should be tested for methanol.
You may also be interested in...
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.
HHS says FDA made subject to monograph program facility fees businesses that began making hand sanitizers in response to temporary guidance easing manufacturing standards "about the same time” the department withdrew the user fee schedule.
More than 6.2m containers of sanitizers have been recalled since mid-October due to methanol contamination. Total includes 67,440 made by Genesis Partnership Co., the first manufacturer in Guatemala that the FDA identified as making contaminated hand sanitizers distributed in the US.