The FDA has published the OTC monograph Drug User fee for the fiscal year 2021. FDA refers to the OTC monograph Drug User Fee Program as “OMUFA”.
FDA fee for OTC drugs explained
Facilities that are engaged in the manufacturing or processing of the finished dosage form of an OTC monograph drug are required to pay the fee. The FDA will assess and collect fees for two types of facilities.
The administrative order request to make changes in the OTC monograph is referred to as OMOR. Significant changes such as a request for the addition of a new active ingredient or indication are classified as Tier1 OMOR. Requests for minor changes such as the addition of an “other information” section in the drug facts, changes to “directions” sections are classified as Tier 2 OMOR.
An OTC monograph drug facility is a foreign or domestic business or other entity that is engaged in manufacturing or processing of the finished dosage form of an OTC monograph drug. This facility is also called a Monograph Drug Facility. (MDF)
A contract manufacturing organization (CMO) facility is an OTC monograph drug facility where neither the owner nor any affiliate of the owner of a facility sells the OTC monograph drug produced at such facility directly to wholesalers, retailers, or consumers in the United States.
A full facility fee will be assessed to each qualifying person that owns a facility identified as an MDF and a reduced facility fee of two-thirds will be assessed to each qualifying person that owns a facility identified as a CMO facility.
OTC monograph drug facilities are exempt from FY 2021 facility fees if they had ceased OTC monograph drug activities and updated their registration with FDA to that effect, prior to December 31, 2019 (should this be 2020?)
The facilities that only manufacture the active pharmaceutical ingredient (API) of an OTC monograph drug do not meet the definition of the OTC monograph drug facility.
A facility is not considered an OTC monograph drug facility if it performs the following functions:
The Drug establishment registration database will be utilized for identifying the qualifying facilities.
The FDA utilizes the Agency’s Electronic Drug Registration and Listing System (eDRLS) to estimate the number of qualifying facilities.
A facility fee will not be assessed if the identified OTC monograph drug facility:
The Agency will assess and collect fees from submitters of OMORs, except for OMORs that request certain safety-related changes. There are two levels of OMOR fees, based on whether the OMOR at issue is a Tier 1 or Tier 2.
Tier 1 OMOR fees
Tier 2 OMOR fees
MDF facility fees
CMO facility fees
When is the Over the Counter (OTC) monograph Drug User fee due?
OTC monograph drug facility fees for FY 2021 will be due on February 12, 2021, 45 days after publication of this Federal Register Notice.
The OTC drug fee should be paid by creating a user fee cover sheet. FDAbasics can assist you to create the cover sheet and pay the FDA fee, please contact us for more information.