The Coronavirus Aid, Relief, and Economic Security Act (CARES Act) enacted on March 27, 2020, authorizes the FDA to assess and collect user fees dedicated to OTC monograph drug regulatory activities in a timely manner and ultimately help provide the public with access to innovative OTC monograph drugs.
OTC Monograph Reform is expected to accomplish the following:
- Improve the process by replacing rulemaking with administrative orders
- Improve efficiency, timeliness, and predictability
- Facilitate innovation
- Establish a process to rapidly address safety issues
- Finalize pending monographs
- Provide FDA with user fees to support OTC monograph drug activities
If a facility does not pay the annual facility fee within 20 calendar days of the due date, the Agency will place the facility on a publicly available arrears list (Current: February 24, 2023), and all OTC monograph drug products produced at that facility (or containing an ingredient manufactured at that facility) shall be deemed misbranded. Additionally, OMORs and meeting requests related to OMORs will not be accepted from persons, or their affiliate(s) in arrears.
Entities that registered with FDA during the Coronavirus Disease 2019 (COVID-19) pandemic, and whose sole activity consists (or had consisted) of manufacturing OTC hand sanitizer products, are identified as OTC monograph drug facilities (MDF), and are now subject to OMUFA facility fees.
FDA collects two types of user fees under Over-The-Counter Monograph Drug User Fee Program (OMUFA):
▪ Facility fees
▪ OTC Monograph Order Request (OMOR) fees
Tier 1: $517,381
Tier 2: $103,476
Domestic and foreign companies seeking our assistance pay a much smaller annual service fee.
- Company Registration
- Product Listing
- U.S. Agent Service
FDA recognizes that the FY 2022 facility fee rates were an increase of 19 percent in comparison to the FY 2021 facility fee rates, and that increase was largely attributed to the decrease in the number of fee-liable facilities.
Any lessons learned for the FY 2023 facilities rates? Not really.
The CARES Act requires FDA to report annually on its progress in achieving the goals identified in the Over-the-Counter Monograph Drug User Fee Program (OMUFA) performance goals and procedures document.
Effective December 31, 2021, companies manufacturing alcohol-based hand sanitizers under the temporary policies must cease production of these products.
Hand sanitizers manufactured before or on December 31, 2021, and produced under the temporary guidance can no longer be sold or distributed by manufacturers after March 31, 2022.