The OTC Monograph Order Request: How the CARES Act Let Industry Change a Monograph Without Rulemaking

For nearly fifty years, the only way to change an OTC drug monograph was to ask the FDA to run notice and comment rulemaking. This process routinely consumed decades and in several categories never finished at all. The CARES Act replaced that machinery in March 2020 with the OTC monograph order request, a filing that lets any company ask FDA to add, remove or change a monograph condition by administrative order. The current price of admission is $587,529.

What an OTC Monograph Order Request Actually Is

An OTC monograph order request, or OMOR, is a request that FDA issue an administrative order under section 505G(b) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 355h(b). Congress created section 505G in section 3851 of the CARES Act, Pub. L. 116-136, signed March 27, 2020, and in doing so it swapped the monograph system’s rulemaking engine for an order-based one. FDA can now add, remove or change the conditions under which a nonprescription drug is generally recognized as safe and effective by issuing an order rather than by amending a regulation, and either FDA or industry can start that process. When industry starts it, the filing is the OMOR, authorized at section 505G(b)(5), 21 U.S.C. § 355h(b)(5).

The statute defines who may file broadly. A requestor is any person or group of persons marketing, manufacturing, processing or developing a drug, per section 505G(q)(3), which means the door is open to companies that have never sold a monograph product and to consortia filing jointly. Two kinds of requests are available under section 505G(b)(5)(B)(i). A requestor may ask FDA to determine that a drug is generally recognized as safe and effective, exempt from prescription dispensing and not required to be the subject of an approved application, which is how a new active ingredient enters a monograph. Or a requestor may ask FDA to determine that a change to a condition of use of an already recognized drug is itself generally recognized as safe and effective, which is how an existing monograph ingredient picks up a new concentration, a new dosage form, a new indication or new labeling.

Understand what the resulting order is and what it is not. A final administrative order is a category-level GRASE determination, the same instrument FDA uses when it acts on its own initiative, and once effective it sets conditions that any marketer may rely on. It is not a product approval, and outside the exclusivity window discussed below, your competitors inherit the full benefit of the order you paid for.