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
Who has to pay the OTC monograph Drug User Fee?
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.
- Facility Fees from qualifying owners of OTC monograph drug facilities. (manufacturers and contract manufacturers).
- Fees from Submitters of qualifying OTC monograph order request (OMOR).
What is OMOR
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.
Definition of Monograph Drug Facility
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)
Definition of Contract Manufacturing Facility
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.
Who is exempted from the facility fee?
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:
- Production of clinical research supplies
- Placement of outer packaging on packages or packages containing multiple products
How are the facilities identified?
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:
- Has ceased all activities related to OTC monograph drugs prior to December 31 of the year immediately preceding the applicable fiscal year.
- Has updated its eDRLS registration to reflect that change (see section 744M(a)(1)(B)(i) of the FD&C Act).
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.
OTC monograph Drug User fee structure for FY 2021
|Tier 1 OMOR fees||$500,000|
|Tier 2 OMOR fees||$100,000|
|MDF facility fees||$14,060|
|CMO facility fees||$9,373|
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.
How Is The Fee Paid?
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.