The Food and Drug Administration announced late last week that it reversed its position and will not seek to charge distillers, who shifted to making hand sanitizer amid coronavirus-driven shortages, a $14,000 fine for operating as “drug facilities.”
Distillers, many of whom are suffering because of coronavirus-related lockdowns, received letters from the FDA in late December demanding $14,060 in fees for operating as “monograph drug facilities” — a new class of over-the-counter drug producers outlined in the CARES coronavirus relief act passed in May. Distilleries that produced any amount of sanitizer, for any price (or even those who gave the sanitizer away for free to needy medical facilities) were on the hook for the fine.
The San Joaquin Valley Sun was the first to report on the fines, kicking off a national outcry. On New Year’s Eve, the Department of Health and Human Services announced a swift reversal, likely in response.
BREAKING: @HHSGov Acts Swiftly to Protect Small