According to the “OTC Monograph User Fee (OMUFA) Facility Delinquency List” released by the U.S. FDA on the 13th, the list includes some production facilities of South Korean companies, such as RPbio Inc.(314140)and KMPHARMACEUTICAL Co.,Ltd.(225430).
An OTC monograph is a set of common marketing standards established by the FDA that define the active ingredients, strengths, efficacy, dosage, and labeling requirements for over-the-counter (OTC) drugs. Products that meet these standards can be sold in the United States without individual product approval. OMUFA is the fee imposed on relevant manufacturing facilities and companies to operate this OTC monograph system.
The fees are broadly divided into annual facility fees and OTC Monograph Order Request (OMOR) fees. This list details the status of unpaid facility fees. Contract manufacturing organizations (CMOs) that manufacture OTC monograph drugs on a contract basis are also subject to these fees, but they are charged at two-thirds the rate of general manufacturing facilities (MDFs). As of this year, the fee per facility is set at $19,188 (approximately 28.31 million won) for MDFs and $12,792 (approximately 18.87 million won) for CMOs.
The FDA has set the deadline for this year’s OMUFA facility fee payments as June 1. Facilities that do not pay the full amount within 20 days after the deadline will be listed on the public delinquency list. A facility may be marked as delinquent or underpaid not only due to a simple failure to remit funds but also due to exchange rate fluctuations, wire transfer fees, or discrepancies in payment information.
If the delinquency is not resolved, it may result in certain restrictions on business operations in the United States. Under the U.S. Food, Drug, and Cosmetic Act, OTC monograph drugs manufactured at facilities with outstanding fees, or products using raw materials produced at such facilities, are considered “misbranded drugs.” Related sanctions remain in effect until the outstanding obligations are fully paid. The FDA will also not accept OTC Monograph Order Requests (OMORs) or meeting requests submitted by companies with outstanding fees or their affiliates.
However, major pharmaceutical and biotech companies included on this list are taking steps to provide explanations and proceed with follow-up procedures on a company-by-company basis to ensure there is no impact on their actual business operations. First, RPbio Inc. was listed as having failed to pay CMO fees this year. Since there was no record of non-payment in the previous fiscal year, it is understood that this is the first time the company has appeared on the list. However, it was confirmed that the company did not complete the fee payment process because it did not maintain a separate FDA facility registration related to a past export project that had already been completed.
RPbio Inc. official explained, “This FDA listing for non-payment of over-the-counter (OTC) drug fees stems from the conclusion of overseas export projects conducted with a specific partner from 2021 to 2023,” adding, “Since there was no longer a need to maintain the FDA registration for that project, we did not pay additional fees and allowed the relevant registration to expire naturally.”
The official continued, “As this pertains to a project that has already ended, there is absolutely no impact or disruption to the production, shipment, or sales activities of the OTC drugs and dietary supplements currently being supplied to domestic and international clients,” adding, “We will proceed as planned with expanding global exports based on partnerships with overseas business partners.”
KMPHARMACEUTICAL Co.,Ltd. was listed on the roster with an asterisk (*) next to the MDF entry. The asterisk indicates that the company did not fully meet its obligations due to an insufficient payment, rather than having failed to pay the fees at all.
The company explained that a time lag in the international wire transfer process was the reason for its inclusion on the list. A KMPHARMACEUTICAL Co.,Ltd. official said, “We have already paid the required fees, but we understand that the entry was marked as delinquent due to a discrepancy between the transfer date and the date the FDA confirmed receipt during the international wire transfer process,” adding, “We are currently submitting a response to the FDA and plan to make additional payments to finalize the process once any late fees are confirmed.”
The spokesperson continued, “We have confirmed that there are no issues regarding the shipment of products to the U.S. or previously approved quality control matters,” adding, “This matter pertains solely to the fee transfer and verification process and has no impact on production or business operations.”
Meanwhile, while the impact on current business operations is considered limited in this instance—as both companies are proceeding with registration rectification and clarification procedures—the increasingly stringent U.S. pharmaceutical regulations suggest that the ability to proactively manage such procedures will become a key factor in supporting future export growth and the acquisition of new orders.
A bioindustry official noted, “As regulations and uncertainties surrounding the U.S. intensify, the importance of personnel responsible for regulatory affairs is rapidly growing within the pharmaceutical and biotech industries,” adding, “Risks that may arise during overseas operations can only be mitigated by systematically managing not only product approvals and quality control but also administrative procedures.”
