In a prepublication Federal Register notice here, the FDA announced its FY 2026 OTC monograph order requests (OMOR). The Agency has indicated that it will publish the FY 2026 OMUFA facility fee rates (i.e., monograph drug facility (MDF) and contract manufacturing organization (CMO) facility fee rates) in a subsequent Federal Register notice.

There are two tiers of OMOR fees, Tier 1 and Tier 2. Tier 1 is described as follows:

  • A new ingredient to a monograph that already has one or more ingredients that have been found to be GRASE;
  • A new indication to a monograph that already has one or more ingredients that have been found to be GRASE, and the new indication applies to one or more of the GRASE ingredients;
  • A new monograph therapeutic category (each ingredient proposed for the new therapeutic category will be a separate OMOR);
  • A Tier 1 OMOR, as described in section 744L(8) of the FD&C Act, is any request not determined to be a Tier 2 OMOR.

 

Tier 2 OMOR is described as follows (per section 744L(9) of the FD&C Act):

  • Reordering of existing information in the drug facts label of an OTC monograph drug;
  • Addition of information to the “Other Information” section of the drug facts label of an OTC monograph drug (subject to certain limitations);
  • Modification to the “Directions for Use” section of the drug facts label of an OTC monograph drug, consistent with a minor dosage form change;
  • Standardization of the concentration or dose of a specific finalized ingredient within a particular finalized monograph;
  • Change to ingredient nomenclature to align with nomenclature of a standards-setting organization; or
  • Addition of an interchangeable term in accordance with section 330.1 of title 21, Code of Federal Regulations (or any successor regulations).

 

The FDA basically says that anything that does not comply with a tier 1 classification is a tier 2. The Agency also notes that “[a]n OMOR fee will not be assessed if the OMOR seeks to make certain safety changes with respect to an OTC monograph drug. Specifically, no fee will be assessed if FDA finds that the OMOR seeks to change the drug facts labeling of an OTC monograph drug in a way that would add to or strengthen: (1) a contraindication, warning, or precaution; (2) a statement about risk associated with misuse or abuse; or (3) an instruction about dosage and administration that is intended to increase the safe use of the OTC monograph drug (see section 744M(a)(2)(C) of the FD&C Act).”

The fees for FY 2026, which began on October 1, 2025 and are in effect until September 30, 2026, along with the FY 2025 fees, for comparison, are as follows:

Since fees are due at the time of submission of an OMOR request, it’s interesting that we’re well past the beginning of FY 2026 for these fees to be published. Perhaps the shutdown had an impact on timing. As it appears, what goes up never seems to come down as the OMOR fees have risen in each of the years since their existence!