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

The Coronavirus Aid, Relief, and Economic Security Act (CARES Act) introduced reforms to the OTC drug review process. As of October 1, 2024, the listing of OTC monograph drug products requires the use of the current Marketing Category and Application Number values in the FDA’s Electronic Drug Registration and Listing System (eDRLS) and can no longer be certified under the old marketing categories and old application number fields.

What changed for OTC monograph drug listings in eDRLS

1. Marketing category: The categories “OTC monograph final” and “OTC monograph not final” have been replaced by the single term “OTC monograph drug.”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, manufacturers must 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), include the term “505G(a)(3)” in the application number field.

Manufacturers should ensure their drug listings have been updated to reflect the current eDRLS requirements during the annual establishment registration renewal and drug listing certification period. Any updates to a product listing, such as a change in product ingredients, must be provided annually.

LexisNexis Life Sciences understands that these changes may require adjustments to your processes. Our regulatory submission services and SPL labeling and FDA compliance services are available to help you navigate these updates and ensure your OTC monograph drug listings remain compliant. Learn more about our pharma solutions or contact us directly.

For the latest industry updates, visit the LexisNexis Life Sciences community.

Contact us