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.

Here’s what you need to know:

1. Marketing Category: The categories “OTC monograph final” and “OTC monograph not final” will be replaced by the single term “OTC monograph drug.” This change reflects the new definition established for user fee purposes.
2. Application Number: The use of OTC monograph CFR parts has been discontinued. Instead, you will need to provide the appropriate Monograph ID for products marketed under a final order. For example, “M014” for an otic drug product marketed under OTC Monograph M014: Topical Otic Drug Products for OTC Human Use. If a drug is currently marketed pursuant to 505G(a)(3), please include the term “505G(a)(3)” in the application number field.

To ensure a smooth transition, we recommend updating your drug listings during the annual establishment registration renewal and drug listing certification period starting October 1, 2024. This will extend the certification period for calendar year 2025, unless the listed drug is being discontinued.

Reed Tech understands that these changes may require adjustments to your processes, and we are here to support you every step of the way! Our team is available to answer any questions or provide further guidance on navigating these updates. Reach out to [email protected] or +1(215) 557-3010 to learn more. As always, to learn more about industry updates, you can visit our Knowledge Center and follow us on LinkedIn and X.