Monday, September 20, 2021

FDA Posts Initial Batch of Four Deemed Final Administrative Orders for OTC Drugs - Drug Information Update

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FDA Center for Drug Evaluation and Research Division of Drug Information

FDA Posts an Initial Batch of Four Deemed Final Administrative Orders for Over-the-Counter Drugs 

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.

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