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# Format/Content of OTC Monograph Order Request
- URL: https://www.fdaweb.com/format-content-of-otc-monograph-order-request/
- Published: 2023-04-12T12:00:00.000Z
- Updated: 2026-09-14T18:25:21.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5154194

FDA has published a draft guidance, *Over-the-Counter Monograph Order Requests (OMORs): Format and Content*, to assist requestors in preparing OMORs for submission to the agency. The [document](https://www.fda.gov/regulatory-information/search-fda-guidance-documents/over-counter-monograph-order-requests-format-and-content?ref=fdaweb.com) provides FDA’s recommendations on the format and content of the information that requestors should provide in an OMOR and identifies relevant guidances to assist requestors in preparing their OMORs.

FDA says the guidance gives an overview of the information that the agency may recommend for a sufficiently complete OMOR. It is not intended to indicate the studies and related information that a requestor must submit in a specific OMOR. Requestors can ask for a formal meeting with FDA to discuss specific data, studies, and related information to be submitted in the OMORs, the document says.

Under a process included in the Coronavirus Aid, Relief, and Economic Security Act, FDA has the authority to issue a final order that adds, removes, or changes generally recognized as safe and effective (GRASE) conditions for an over-the-counter monograph drug. Either FDA or a requestor can initiate the order process. Requestors can initiate the process by submitting an OMOR for certain drugs, classes of drugs, or combinations of drugs. The OMOR may request the issuance of an order determining whether a drug is GRASE or whether a change to a drug’s condition of use is GRASE.

OMORs must be submitted to FDA in the form and manner it specifies. FDA will file an OMOR if it determines that the OMOR is sufficiently complete and formatted to permit the agency to conduct a substantive review