What is OMUFA?

The Over-the-Counter Monograph User Fee Program (OMUFA) is a program established by the U.S. Food and Drug Administration (FDA) to collect fees from manufacturers of over the counter (OTC) drugs to help fund and streamline the regulatory process for these products. OMUFA was created as part of the Coronavirus Aid, Relief, and Economic Security (CARES) Act in 2020. It aims to modernize the oversight of OTC drug products by enabling the FDA to better manage resources, improve safety standards, and speed up the process of updating OTC drug monographs.

What is the importance of the Over-the-Counter Monograph User Fee Program?

• Modernizing OTC Drug Regulation: OMUFA significantly improves the efficiency and timeliness of the FDA’s regulation of OTC drugs, which are available without a prescription. Before OMUFA, the monograph process was slow and outdated, resulting in delays in updates to labeling, safety warnings, and the approval of new formulations.
• Increased Resources for FDA: By collecting user fees from industry participants, OMUFA provides the FDA with additional resources to review and update OTC drug monographs more quickly. This allows the FDA to respond more rapidly to safety concerns and scientific advancements.
• Improved Public Health Protection: With a modernized regulatory process, the FDA can ensure that OTC drug products meet up-to-date safety, efficacy, and quality standards. This helps protect consumers from potential health risks associated with outdated or unsafe formulations.
• Faster Access to New OTC Products: The user fee program incentivizes innovation by making it easier for manufacturers to introduce new OTC products or reformulate existing ones. This ensures that consumers have access to a broader range of safe and effective self-care options.

General points to know about the OMUFA

Useful guidance documents include “Assessing User Fees Under the Over-the-Counter Monograph Drug User Fee Program” and the most recent federal register documents can be found here: Federal Register Documents.

Under the OMUFA, the US FDA collects 2 types of user fees which are 1 Facility Fees, and 2 OTC Monograph Order Request (OMOR) fees.

All companies pay the same applicable fee for facility and/or OMOR no matter what their size.

DDReg’s Capabilities

DDReg offers comprehensive regulatory services that are tailored to support pharma companies looking to navigate OMUFA and comply with the US FDA’s OTC requirements. This includes support for OMUFA registration and fee compliance, monography compliance & review, safety and labeling requirements, change notifications & updates, regulatory strategy & risk mitigation and more.