What Is OMUFA and What It Means for Foreign OTC Drug Manufacturers

OMUFA — the Over-the-Counter Monograph User Fee Act — was enacted in 2020 as part of the CARES Act and represents the most significant change to how the FDA regulates OTC drug products in decades. Before OMUFA, the OTC monograph system operated under a rulemaking framework that was notoriously slow — the FDA had been working on some monographs for more than 40 years without finalizing them. OMUFA replaced that framework with an administrative order process and funded it through mandatory fees paid by OTC drug manufacturers. For foreign manufacturers selling OTC drugs in the United States, OMUFA created new financial and compliance obligations that did not exist before 2020.

What OTC monograph drugs are and who they cover

OTC monograph drugs are non-prescription drug products — pain relievers, antacids, cold medications, topical antiseptics, sunscreens, and similar products — that are marketed without individual FDA approval because they conform to a published monograph specifying permitted active ingredients, dosages, labeling requirements, and testing standards. If an OTC product conforms to a final monograph for its category, the manufacturer does not need a separate FDA drug application. OMUFA applies to manufacturers of these products — both domestic and foreign — who have facilities that manufacture, prepare, propagate, compound, or process OTC monograph drugs for distribution in the United States.

The facility fee under OMUFA and who pays it

OMUFA established two categories of fees: facility fees assessed annually on registered OTC monograph drug manufacturing facilities, and one-time OTC monograph order request fees for companies that submit requests to change existing monographs or establish new ones. The facility fee is the one that affects most foreign manufacturers. It is assessed on every facility identified in the FDA drug establishment registration as manufacturing an OTC monograph drug product for US distribution. The fee amount is set annually by the FDA and applies to both domestic and foreign facilities equally. Failure to pay the facility fee results in a facility being placed on a non-payment list, which can affect the import status of products from that facility.

What OMUFA means for foreign OTC manufacturers

A foreign manufacturer that makes OTC monograph products — sunscreens, hand sanitizers, pain relievers, or any product regulated as an OTC drug under US law — and sells them in the United States is subject to OMUFA facility fees starting from the fiscal year in which the facility is first registered for OTC drug manufacturing. The fee obligation applies even if the facility is registered for other product categories in addition to OTC drugs. The FDA invoices the registered facility's US Agent for the facility fee, which is another reason why maintaining a reliable, current US Agent designation is operationally important for foreign drug manufacturers, not just a regulatory formality.

How OMUFA connects to drug establishment registration

OMUFA facility fees are triggered by the drug establishment registration on file with the FDA. A facility that is registered as manufacturing OTC monograph drugs will receive a fee invoice. A facility that is not registered, or that is registered for a different activity that does not include OTC drug manufacturing, will not receive that invoice — but also cannot legally export OTC drugs to the United States. The FDA drug establishment registration, filed annually under 21 CFR Part 207, is the primary compliance document that connects a foreign OTC manufacturer to US regulatory requirements including OMUFA fees, drug listing obligations, and inspection authority.

How FDABridge supports foreign OTC drug manufacturers

FDABridge handles FDA drug establishment registration, drug listing, and ongoing registration maintenance for foreign drug manufacturers. We keep registration records current, coordinate with the US Agent for all FDA communications, and track annual re-registration deadlines. Visit fdabridge.com/drug to see our drug registration services or fdabridge.com/apply/drug to get started.