As of October 1, 2024, listing of over-the-counter (OTC) monograph drug products will not be able to be certified under the old marketing categories and old application number fields in FDA's Electronic Drug Registration and Listing System (eDRLS). Instead, the listing of such products will need to include the current Marketing Category and Application Number values.
New Certification Requirements Background
The FDA utilizes the eDRLS for several key programs including drug quality reports, adverse event reports, and drug import and export compliance.
On March 27, 2020, the Coronavirus Aid, Relief, and Economic Security Act (CARES Act) was signed into law. The law amended the Federal Food, Drug and Cosmetic Act (FD&C Act) and modernized the OTC drug review process.
The amendments required the FDA to update the marketing category and application number fields for OTC monograph drugs in the eDRLS.
eDRLS Field Updates
The change in current values to be used effective October 1st, 2024, are:
- For the marketing category field, the categories "OTC monograph final" and "OTC monograph not final" are permanently replaced with the single term "OTC monograph drug," to be used for nonprescription drug products marketed without an approved new drug application.
- For the application number field, the use of OTC monograph CFR parts was discontinued starting October 2023 and the old submissions referencing the CFR parts must now be updated to include the appropriate Monograph ID.
As of October 1, 2024, drug listing records that refer to the old marketing categories and CFR parts citations will no longer be available for certification.
OTC drug manufacturers should ensure their processes and procedures reflect these new requirements to avoid delays with the FDA.
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