News & Analysis as of

Distilleries Department of Health and Human Services (HHS)

Hogan Lovells

HHS forces FDA to withdraw notice for OTC user fees and creates new exemptions

Hogan Lovells on

On January 6, 2021, the U.S. Department of Health and Human Services (HHS) ordered the Food and Drug Administration (FDA) to “cease further collection efforts” related to the Over-the-Counter (OTC) Drug Monograph User Fee...more

Bergeson & Campbell, P.C.

Drug Facility Fees Will Not Apply to Distilleries Producing Hand Sanitizer

Last week, press reported that the U.S. Food and Drug Administration (FDA) would assess distilleries making hand sanitizer $14,060 in fees as Monograph Drug Facilities (MDF) under the Over-the-Counter (OTC) Monograph Drug...more

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