Effective 10/1/24, New FDA Requirements for Listing OTC Monograph Drugs in eDRLS
The Coronavirus Aid, Relief, and Economic Security Act (CARES Act) has introduced reforms to the OTC drug review process. Starting October 1, 2024, the listing of OTC monograph drug products will require the use of the current Marketing Category and Application Number values in the FDA’s Electronic Drug Registration and Listing System (eDRLS), and will not be able to be certified under the old marketing categories and old application number fields.
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