Issue Date: April 13, 2023
Issued by: Center for Drug Evaluation and Research
Topic(s): Over-the-Counter Drugs
Status: Draft
Over-the-Counter Monograph Order Requests: Format and Content
This guidance is intended to assist requestors in preparing over-the-counter (OTC) monograph order requests (OMORs) for submission to FDA under section 505G of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355h). This guidance provides FDA’s recommendations on the format and content of the information that requestors should provide in an OMOR and identifies relevant guidance documents to assist requestors in preparing their OMORs.
Download the Guidance Document
