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GUIDANCE DOCUMENT

Over-the-Counter Monograph Order Requests: Format and Content April 2023

Download the Draft Guidance Document Read the Federal Register Notice
Draft Level 1 Guidance

Not for implementation. Contains non-binding recommendations.

This guidance is being distributed for comment purposes only.

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Submit Comments Online

Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the FDA considers your comment on a draft guidance before it begins work on the final version of the guidance, submit either online or written comments on the draft guidance before the close date.

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-2023-D-1188

Docket Number:
FDA-2023-D-1188
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research

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.

 
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