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Effective 10/1/24, New FDA Requirements for Listing OTC Monograph Drugs in eDRLS
Effective 10/1/24, New FDA Requirements for Listing OTC Monograph Drugs in eDRLS

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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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FDA Issued Final Guidance on Over-the-Counter Monograph Submissions in Electronic Format
FDA Issued Final Guidance on Over-the-Counter Monograph Submissions in Electronic Format

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The FDA has issued the final guidance “Providing Over-the-Counter Monograph Submissions in Electronic Format.” This new guidance mandates electronic submission of all Over-the-Counter (OTC) monograph materials, marking a significant shift in the regulatory landscape. By transitioning to electronic submissions, the FDA has expressed aim to streamline the review process, enhance transparency and facilitate faster decision-making for OTC drug approvals.

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