March 25, 2021 (Washington, D.C.) — The leadership at ACSA today spoke with officials from the US Food and Drug Administration (FDA), which alerted the association to an update that went into the Federal Register today for publication tomorrow, March 26, that will exempt distilleries from an Over-the-Counter Monograph Drug User Fee Assessment (OMUFA) if they registered to produce hand sanitizer after January 27, 2020.
Our understanding is that any spirits producers who registered to make hand sanitizer after the date mentioned above will not be assessed a fee, provided that those distillers produced sanitizer in accordance with the parameters of the agency’s emergency guidance.
“We greatly appreciate the FDA reaching out to ACSA directly to ensure that we are a key part of this critical conversation,” says ACSA CEO Margie A.S. Lehrman, who was on today’s call with FDA, along with ACSA President Becky Harris of Catoctin Creek Distilling Co. and ACSA Government Affairs Committee Chair Mark Shilling. “The official publication tomorrow will likely be good news for our membership.”
Read the pre-published federal document here.
We will update with further details and guidance as soon as they become available.
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