Read theMandate

Continuing Appropriations, Agriculture, Legislative Branch, Military Construction and Veterans Affairs, and Extensions Act, 2026 › Section 6504

Authority to Assess and Use Otc Monograph Fees

Section 6504 · Sec. 6504 ·

What this chapter is about

Firms that make drugs sold without a prescription pay a fee for each plant. This part says who owes the fee, when it is due, and how the total is worked out. It runs the fees from 2026 through 2030.

5 proposals indexed from this chapter.

The document says “meansWho acts: Secretary of Health and Human ServicesHow: statuteSec. 6504 in the PDF
What the document says

“(ii) Applicable period.--For purposes of clause (i), the applicable period is--”

Making continuing appropriations and extensions for fiscal year 2026, and for other purposes, Sec. 6504

The section amends section 744M(a)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j-72(a)(1)). For fiscal year 2026 the period is the twelve months ending December 31, 2025. For fiscal year 2027 the period is the nine months ending September 30, 2026, and from fiscal year 2028 it is the twelve months ending on September 30 of the preceding year. A person who ceased all activities related to these drugs before a matching cutoff date does not owe the fee.

What the document actually says

“(ii) Applicable period.--For purposes of clause (i), the applicable period is--”

Making continuing appropriations and extensions for fiscal year 2026, and for other purposes, Sec. 6504
That sentence, in plain words

The law now says which stretch of time to look at for each year.

What this is about

The fee is owed by anyone who ran a plant during a set stretch of time. This says which stretch to use for each year.

No action is recorded against this proposal. That is not evidence that none has been taken, and nobody has yet read it against the record. See what the tracker does not yet cover.

The document says “shallWho acts: Secretary of Health and Human ServicesHow: statuteSec. 6504 in the PDF
What the document says

“For each of the fiscal years 2026 through 2030, fees under subsection (a)(1) shall be established to generate a total facility fee revenue amount equal to the sum of--”

Making continuing appropriations and extensions for fiscal year 2026, and for other purposes, Sec. 6504

The parts are the annual base revenue, an inflation adjustment, an operating reserve adjustment where one applies, direct cost adjustments, a set additional amount for three years, and a one-time workload adjustment if the Secretary applies one. The base for fiscal year 2026 is the total revenue set for fiscal year 2025 before adjustments, and after that it is the previous year's total.

What the document actually says

“For each of the fiscal years 2026 through 2030, fees under subsection (a)(1) shall be established to generate a total facility fee revenue amount equal to the sum of--”

Making continuing appropriations and extensions for fiscal year 2026, and for other purposes, Sec. 6504
That sentence, in plain words

For each year from 2026 to 2030 the fees must add up to a set total. That total is built from the parts listed below.

What this is about

The law does not name a fee for each plant. It names a total to collect. The agency then works out what each plant owes.

No action is recorded against this proposal. That is not evidence that none has been taken, and nobody has yet read it against the record. See what the tracker does not yet cover.

The document says “shallWho acts: Secretary of Health and Human ServicesHow: statuteSec. 6504 in the PDF
What the document says

“(i) $2,373,000 for fiscal year 2026;”

Making continuing appropriations and extensions for fiscal year 2026, and for other purposes, Sec. 6504

The added amounts are $2,373,000 for fiscal year 2026, $1,233,000 for fiscal year 2027 and $854,000 for fiscal year 2028. They are the only fixed dollar figures in the new fee formula, and they stop after 2028.

What the document actually says

“(i) $2,373,000 for fiscal year 2026;”

Making continuing appropriations and extensions for fiscal year 2026, and for other purposes, Sec. 6504
That sentence, in plain words

This is the sum added to the fee total for the first of the three years.

What this is about

The rest of the total moves with prices and costs. These three sums do not. They are written into the law.

No action is recorded against this proposal. That is not evidence that none has been taken, and nobody has yet read it against the record. See what the tracker does not yet cover.

The document says “shallWho acts: owners of facilities making over-the-counter monograph drugsHow: statuteSec. 6504 in the PDF
What the document says

“For fiscal year 2026, the facility fees required under subparagraph (A) shall be due on the later of--”

Making continuing appropriations and extensions for fiscal year 2026, and for other purposes, Sec. 6504

The two dates offered for fiscal year 2026 are the first business day of June and the first business day after an appropriations Act allows the fees to be collected and obligated. For fiscal year 2027 the fee is due in two halves, the first on October 1, 2026 or the first business day after an appropriations Act allows collection, and the second on February 1, 2027 or the first business day after such an Act is enacted.

What the document actually says

“For fiscal year 2026, the facility fees required under subparagraph (A) shall be due on the later of--”

Making continuing appropriations and extensions for fiscal year 2026, and for other purposes, Sec. 6504
That sentence, in plain words

The fee for 2026 is due on the later of two dates.

What this is about

The agency can only take these fees when a spending law lets it. So the due date waits on that law.

No action is recorded against this proposal. That is not evidence that none has been taken, and nobody has yet read it against the record. See what the tracker does not yet cover.

The document says “is amendedWho acts: CongressHow: statuteSec. 6504 in the PDF
What the document says

“in paragraph (3), by striking "2021 through 2025" and inserting "2026 through 2030"”

Making continuing appropriations and extensions for fiscal year 2026, and for other purposes, Sec. 6504

The section amends section 744M(f) of the Federal Food, Drug, and Cosmetic Act, moving the run of years over which the fees are credited and stay available.

What the document actually says

“in paragraph (3), by striking "2021 through 2025" and inserting "2026 through 2030"”

Making continuing appropriations and extensions for fiscal year 2026, and for other purposes, Sec. 6504
That sentence, in plain words

One run of five years is taken out. The next run of five years is put in.

What this is about

The fees are paid into an account the agency may spend from. That rule now covers the next five years.

No action is recorded against this proposal. That is not evidence that none has been taken, and nobody has yet read it against the record. See what the tracker does not yet cover.

Share this page
How to cite this
  1. The document itself

    Continuing Appropriations, Agriculture, Legislative Branch, Military Construction and Veterans Affairs, and Extensions Act, 2026, Public Law 119-37, sec. 6504, 139 Stat. 638 (2025).
    https://www.govinfo.gov/content/pkg/PLAW-119publ37/html/PLAW-119publ37.htm

  2. This page

    “Authority to Assess and Use Otc Monograph Fees,” Continuing Appropriations, Agriculture, Legislative Branch, Military Construction and Veterans Affairs, and Extensions Act, 2026, section 6504. Read the Mandate, https://readthemandate.org/continuing-appropriations-agriculture-legislative/section-6504/ (retrieved August 26, 2026).

Cite the document when the claim is about what the document says. Cite this page when the indexing, the wording or the record of what has happened is what is being relied on.

What This Page Covers, and What It Leaves Out

The four things the section settles: the period used to decide who owes a facility fee, how the total fee revenue is built up, the added dollar amounts for three years, and the due dates for fiscal years 2026 and 2027.

The long set of edits to the adjustment rules in section 744M(c), which change how inflation, the operating reserve, direct costs and a one-time workload adjustment are figured.

The section works by amending the Federal Food, Drug, and Cosmetic Act. That law is not indexed here, so this file does not say what any firm actually pays.