FDA posts four deemed final administrative orders for OTC drugs

Sept. 22, 2021

The U.S. Food and Drug Administration posted an initial batch of four deemed final administrative orders (deemed final orders) issued as part of Over-the-Counter (OTC) Monograph Reform under the Coronavirus Aid, Relief, and Economic Security Act (CARES Act).

The first four deemed final orders include:

  • Nighttime Sleep-Aid Drug Products for OTC Human Use;
  • Antiflatulent Drug Products for OTC Human Use;
  • Topical Otic Drug Products for OTC Human Use;
  • Corn and Callus Remover Drug Products for OTC Human Use.     

The FDA will post deemed final orders using a phased approach on the FDA’s new IT system, OTC Monographs@FDA. This system also will provide the public with the ability to search for proposed administrative orders and final administrative orders that add, remove or change conditions for an OTC monograph.

FDA announcement

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