FDA webinar details OMUFA 2 reauthorization, new fee dates, rates and payment rules

Commissioner and program staff from the U.S. Food and Drug Administration briefed industry stakeholders on OMUFA 2 implementation, explaining new fee due dates and liability periods, FY2026 fee levels and the payment and enforcement process.

Commander Tamara Dam, senior program management officer in the Policy and Operations Branch, Division of User Fee Management at CDER, told attendees that OMUFA 2 (reauthorized for FY2026–2030) aligns facility-fee due dates with the federal fiscal year. "If your company registered and manufactured OTC monograph drug products during calendar year 2025, then your company was liable for the FY2026 OMUFA facility fee with a due date of 06/01/2026," Dam said, summarizing the FY2026 liability window as Jan. 1–Dec. 31, 2025.

Madeline Fonts, branch chief, Division of User Fee Management, said the FY2027 transition moves the due date to Oct. 1 and splits the facility fee into two equal installments to help firms manage cash flow: 50% due Oct. 1, 2026, and 50% due Feb. 1, 2027, for the 01/01/2026–09/30/2026 liability period. "Starting in FY2027, we will be invoicing companies in installments," Fonts said.

Why it matters: the timing change affects when manufacturers become fee-liable and when they must pay. Dam and Fonts repeatedly urged companies not to register or list products until they are actually ready to manufacture, because a single day of activity during a fee-liable period can trigger a facility fee.

Key figures and fee structure FDA staff gave the FY2026 target and fee amounts. Fonts said FDA applied a downward operating-reserve adjustment of $23,898,506 (about 30 weeks) and set the FY2026 OMUFA target facility fee revenue at $16,885,000 (rounded). Per-facility fees for FY2026 were announced as $19,188 for a monograph drug facility (MDF) and $12,792 for a contract manufacturing organization (CMO); the CMO rate equals 0.667 of the MDF fee. OMOR (OTC monograph order request) fees were quoted as well: a tier-1 OMOR fee of $587,529 and a tier-2 OMOR fee of $117,505.

Registration, SPL codes and exemptions Dam reviewed registration mechanics and Structured Product Labeling (SPL) business-operation qualifier codes that determine fee liability. FDA identified two SPL codes tied to annual facility fees: C131708 for MDF and C170729 for CMO. Dam stressed that if a facility registers as both MDF and CMO, it will be charged the higher MDF fee and not the CMO fee.

Dam also described exemptions and limited exceptions for FY2026: facilities that ceased OTC monograph activities and updated registrations before 01/01/2025 are exempt from the FY2026 facility fee; certain API-only operations and some clinical-supplies or overpackaging activities also were identified as not OMUFA-fee-liable for FY2026. She cautioned that the statute provides no authority for waivers or reductions based on company size or revenue.

Payments, penalties and refunds Fonts explained the payment process: companies create an OMUFA user-fee cover sheet in FDA’s user-fee system (providing identifiers such as the facility FEI), obtain a cover-sheet number, and submit payment via pay.gov (ACH/e-check/credit card up to limits) or wire transfer (include the unique user-fee ID). FDA issued FY2026 facility-fee invoices on 04/20/2026 and will send reminders via GovDelivery.

On consequences for nonpayment, Fonts said FDA will place delinquent facilities on a publicly available arrears list, OMOR filings will not be accepted from parties with outstanding fees, and OTC monograph drug products produced at a facility on the arrears list "shall be deemed misbranded." Interest begins to accrue one day after the invoice due date (06/02/2026) and will not be charged if payment is made within 30 days (by 07/01/2026 for FY2026); a 6% annual penalty begins to accrue concurrently but will not be charged if payment is made within 90 days (by 08/30/2026 for FY2026). Interest and penalties continue to accrue daily thereafter.

Refunds: Fonts said that if an OMOR is refused for filing or withdrawn before acceptance, 75% of the OMOR fee will be refunded; if FDA recharacterizes an OMOR from tier 1 to tier 2, the fee difference will be refunded. Overpayment refunds require a written request and submission of FDA Form 3913 within 180 calendar days of payment.

Common questions and agency guidance In the webinar Q&A, Dam reiterated that liability is based on activity during the liability period (for example, manufacturing in calendar year 2025 creates FY2026 liability even though the fee is due in 2026). She advised attendees who receive an invoice they believe is incorrect (for example, receiving an MDF invoice while qualifying as a CMO) to update their electronic registration to the correct SPL code and contact the OMUFA user-fee staff (cedarcollections@fda.hhs.gov) for assistance.

Fonts and Dam also advised that OMOR fees are assessed to the person who submits the request and are due on the date of submission; entities that only distribute, sell, or market OTC monograph products (and do not manufacture, pack, or label them) are not fee-liable and do not need to register.

Next steps and resources FDA directed attendees to the FY2026 Federal Register Notices (including the 03/18/2026 FRN) for detailed fee calculations, to the OMUFA website for monthly arrears and paid-facilities lists, and to the agency’s user-fee staff (cedarcollections@fda.hhs.gov) for registration or invoice disputes. The webinar concluded with a Q&A session.