- Short answer
- Usually no — FDA bills the OMUFA facility fee to whoever owns the facility that makes the drug, not to a brand that only puts its label on it.
- The fee moves next fiscal year
- FDA's published FY2027 facility fees run 149% above FY2026 — your supplier's cost, not usually yours.
- No small-business break
- FDA's draft guidance: waivers and reductions are not authorized under the statute; the fee does not vary by size.
- Where this page stops
- Scope: the US OMUFA facility fee only. FDA registration and listing duties sit on our cosmetic-to-OTC page.
- No FDA page states this outright
- No FDA page we read on September 5, 2026 pairs a private-label brand owner with the facility fee.
Who does FDA bill for the OMUFA facility fee?
FDA bills the owner of the facility, not the brand on the carton. The agency's OMUFA program page states the rule in one sentence.
The facility fee will be assessed on qualifying persons who own an OTC monograph drug facility, including contract manufacturing organization facilities.
The second rule sits in the registration regulations. 21 CFR 207.1 defines a private label distributor as a person who did not manufacture, repack, relabel, or salvage the drug but under whose label or trade name it is commercially distributed. In the ordinary private-label arrangement the contract manufacturer that makes your OTC product owns the facility; you do not.
So the answer is assembled from two FDA rules, not lifted from one page. No FDA page we read on September 5, 2026 pairs a private-label brand owner with the OMUFA facility fee: we read the program page twice that day and searched the 20-page draft fee guidance for “private label”, which returned nothing.
Registration is the neighbouring question — whether facility registration reaches you or your manufacturer is worked through on our cosmetic-to-OTC page.
MDF or CMO: which fee does your manufacturer pay?
The owner of a contract manufacturer's facility is billed the lower CMO rate — two-thirds of the full facility fee — when neither that owner nor any affiliate of the owner or facility sells the drug the facility makes directly to US wholesalers, retailers or consumers.
The two billed categories, and where a brand owner sits
| Party | What FDA bills that owner | FY2026 fee | FY2027 fee |
|---|---|---|---|
| Owner of a Monograph Drug Facility (MDF) | The full fee — its site manufactures or processes the finished dosage form and does not meet the CMO definition | $19,188 | $47,891 |
| Owner of a Contract Manufacturing Organization (CMO) facility | Two-thirds of the full fee — neither it nor an affiliate sells the drug directly to US wholesalers, retailers or consumers | $12,792 | $31,927 |
| Private-label brand owner | Not billed unless it owns an OTC monograph drug facility (usually not) | — | — |
FY2026 rates: Federal Register, March 18, 2026. FY2027 rates and the 149% figure: FDA's OMUFA program page, read September 5, 2026. The third row is our reading of the two definitions, not an FDA category.
A typical private-label arrangement puts the owner of your manufacturer's facility in the CMO row: the direct sale to US wholesalers, retailers or consumers is yours, not theirs.
Timing matters more than the size of the jump. The FY2026 rates run through September 30, 2026; the FY2027 rates FDA has published — 149% above FY2026 — start on October 1, 2026. Either way FDA assesses the fee on the qualifying person who owns the facility that makes your product, so an OMUFA line on your manufacturer's invoice is that supplier's own cost priced into what you pay — a contract question with them, not a bill you owe FDA.
When does a brand owner become the payer?
You become the payer once you own the facility that makes the drug. Own lines are common in beauty and skincare. Buying a line, or building one, moves you to the manufacturing side, and the fee follows the site.
The two definitions in the table also change the rate: a facility you own that makes the OTC monograph drug you sell directly to US wholesalers, retailers or consumers is not a CMO facility, so the full fee applies rather than two-thirds.
The registration exemption breaks at the same moment. 21 CFR 207.17 exempts private label distributors who do not also manufacture, repack, relabel, or salvage drugs — all four verbs, so taking any one in-house ends it.
Which exceptions change the answer, and which do not?
FDA's draft fee guidance names five activities that draw no facility fee when a site does only those — and the small-business break merchants expect is not one of them, nor is any waiver or reduction authorised at all. The one that matters here: no OMUFA facility fee is assessed with respect to facilities that solely manufacture or process human OTC drug products marketed under an application approved under section 505 of the FD&C Act or section 351 of the Public Health Service Act.
“Solely” is the load-bearing word. A site that also makes monograph products falls outside the exclusion — the ordinary case for a private-label manufacturer. One boundary while we're on exclusions: OMUFA collects two types of user fees, facility fees and OTC Monograph Order Request (OMOR) fees, and this page answers only for the facility fee.
Waivers and reductions to OMUFA facility fees are not authorized under the statute and thus not available. All companies pay the same applicable facility fee (i.e., MDF or CMO) regardless of size.
So the practical test is ownership of the plant behind your label: your contract manufacturer's today, yours the day you buy or build a line — and then at the full MDF rate.
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