Reminder: Listing of OTC Monograph Drug Products No Longer Certifiable through Old Categories in the FDA’s Listing System | Customs & International Trade Law Blog

As of October 1, 2024, itemizing of over-the-counter (OTC) monograph drug merchandise will be unable to be licensed beneath the previous advertising and marketing classes and previous software quantity fields in FDA’s Digital Drug Registration and Itemizing System (eDRLS). As an alternative, the itemizing of such merchandise might want to embrace the present Advertising and marketing Class and Utility Quantity values.

New Certification Necessities Background

The FDA makes use of the eDRLS for a number of key applications together with drug high quality stories, hostile occasion stories, and drug import and export compliance.

On March 27, 2020, the Coronavirus Assist, Reduction, and Financial Safety Act (CARES Act) was signed into regulation. The regulation amended the Federal Meals, Drug and Beauty Act (FD&C Act) and modernized the OTC drug assessment course of.

The amendments required the FDA to replace the advertising and marketing class and software quantity fields for OTC monograph medicine within the eDRLS.

eDRLS Discipline Updates

The change in present values for use efficient October 1st, 2024, are:

For the advertising and marketing class area, the classes “OTC monograph closing” and “OTC monograph not closing” are completely changed with the one time period “OTC monograph drug,” for use for nonprescription drug merchandise marketed with out an authorized new drug software.
For the appliance quantity area, using OTC monograph CFR elements was discontinued beginning October 2023 and the previous submissions referencing the CFR elements should now be up to date to incorporate the suitable Monograph ID.

As of October 1, 2024, drug itemizing information that seek advice from the previous advertising and marketing classes and CFR elements citations will not be out there for certification.

OTC drug producers ought to guarantee their processes and procedures mirror these new necessities to keep away from delays with the FDA.

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