FDA Announces New Changes to Permitted Marketing Status of OTC Monograph Drugs

Posted by on June 2, 2020

Although the announcement for OTC Monograph user fees is pending, the FDA is actively working to clarify the new regulations for non-prescription products. As previously explained, the enactment of the CARES Act on March 27th included several additions to the Monograph Drug Review process, such as the OTC Monograph User Fee program (OMUFA), as well as changes to the permitted marketing of OTC drugs.

In a recent webinar hosted by the FDA, Dr. Theresa M. Michele, director of the Office of Nonprescription Drugs at CDER, revealed a significant update on the generally recognized as safe and effective (GRASE) status of hundreds of Monograph ingredients. The FDA has deemed 21 CFR 310.545 as a final administrative order – meaning that all active ingredients included under this part are not GRASE for the listed therapeutic indications.

The active ingredients under this part vary in classification and therefore, the impact on product marketing changes is dependent on the current Category according to existing monographs.

An OTC product can remain on the market if it:

  • Conforms to an existing final monograph or is Category I under a tentative final monograph (TFM).
  • Category I under advanced notice of proposed rulemaking (ANPR) and/or Category III under TFM.

An OTC product must be removed from market by September 23, 2020 if it contains any Category II drug.

To avoid being deemed misbranded, manufacturers of Category II drug products are required to undergo reformulation to fit the approved specifications discussed above, or succumb to the cumbersome NDA process.

In addition, manufacturers of any Monograph drug will be deemed misbranded if they fail to pay OMUFA fees within 45 days of fee publication.

With all the reform and modernization happening at FDA, it becomes increasingly important for OTC Monograph drug marketers to stay ahead of deadlines. ISS has decades of experience in handling regulatory interactions with the FDA on behalf of clients. Our scientific and regulatory experts are highly skilled at OTC product formulation, CMC and quality review, labeling, preparing for FDA meetings, and other regulatory interactions. Let ISS assist you in navigating the complex regulatory arena of OTC Monograph Review now!

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