V5 Ultimate
Compliance

OMUFA

OTC Monograph User Fee Program · otc monograph user fee · otc monograph user fee act

TL;DR

User-fee program funding FDA's OTC monograph review activity — annual facility fees and OMR (order-request) fees.

Established by the CARES Act's OTC Monograph Reform, OMUFA funds FDA's OTC monograph review activity. OTC monograph drug manufacturers and contract manufacturers pay annual facility fees, while OMR (OTC Monograph Order Request) sponsors pay request fees to FDA for an Administrative Order on a monograph.

Facility fees are due on the federal-fiscal-year cycle; non-payment causes products produced at the facility to be deemed misbranded — a hard distribution stop. The most common gap is administrative: the OMUFA invoice doesn't reach the responsible compliance owner and a fee is missed. Tracking OMUFA facility status as a site-level obligation with renewals avoids the failure.

Regulatory anchors
  • FD&C Act § 744L
Industries that live with this
PharmaceuticalConsumer ProductsCosmetics
How V5 handles it
Score your compliance gap — then download the validation pack.
A guided self-assessment walks you against the regulator clauses that apply to your industry. The validation pack — IQ/OQ/PQ scripts, traceability matrix, risk assessment, intended-use statement — generates from the same evidence so you can hand it to an auditor on day one.
Document control with hard kiosk-level training enforcement.
Versioned SOPs are only useful if operators are actually trained on the current version. V5 enforces it at the kiosk.
Related terms
OTC monograph
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