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GUIDANCE DOCUMENT

Providing Over-the-Counter Monograph Submissions in Electronic Format July 2024

Final Level 1 Guidance
Docket Number:
FDA-2022-D-2059
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled “Providing Over-the-Counter Monograph Submissions in Electronic Format.”  This guidance is intended to assist submitters by describing the electronic over-the-counter (OTC) monograph submissions requirement in the Federal Food, Drug, and Cosmetic Act (FD&C Act) and providing recommendations and other information on how to send such OTC monograph submissions to FDA in electronic format.  This guidance finalizes the draft guidance of the same title issued on September 28, 2022.


Submit Comments

You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2022-D-2059.

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