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# Guide on OTC Monograph eSubmissions
- URL: https://www.fdaweb.com/guide-on-otc-monograph-esubmissions/
- Published: 2024-07-24T12:00:00.000Z
- Updated: 2026-09-14T14:36:17.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5157428

FDA has released a [final guidance](https://www.fda.gov/media/161822/download?ref=fdaweb.com) entitled “Providing Over-the-Counter Monograph Submissions in Electronic Format.” The document is intended to assist submitters by describing the electronic OTC monograph submissions requirements, and providing recommendations and other information on how to send such submissions to FDA.

FDA regulations require that all OTC monograph-related submissions must be in electronic format. Examples of such submissions include:

- OTC monograph order requests
- Public comments to a proposed administrative order or interim final administrative order
- Formal meeting requests and meeting packages
- Formal dispute resolution requests related to a final administrative order
- Administrative hearing requests related to a final administrative order
- Responses to record requests by FDA relating to minor changes
- Updates to drug listing information