21 USC 379j-72 - Authority to assess and use OTC monograph fees

U.S Code last checked for updates: Jan 13, 2026

§ 379j–72.

Authority to assess and use OTC monograph fees

(a)

Types of fees

Beginning with fiscal year 2021, the Secretary shall assess and collect fees in accordance with this section as follows:

(1)

Facility fee

(A)

In general

(i)

Assessment of fees

(ii)

Applicable period

For purposes of clause (i), the applicable period is—

(I)

for fiscal year 2026, the 12-month period ending on December 31, 2025;

(II)

for fiscal year 2027, the 9-month period ending on September 30, 2026; and

(III)

for fiscal year 2028 and each subsequent fiscal year, the 12-month period ending on September 30 of the preceding fiscal year.

(B)

Exceptions

(i)

Facilities that cease activities

A fee shall not be assessed under subparagraph (A) if the identified OTC monograph drug facility—

(I)

has ceased all activities related to OTC monograph drugs prior to—

(aa)

for purposes of fiscal year 2026, January 1, 2025;

(bb)

for purposes of fiscal year 2027, January 1, 2026; and

(cc)

for purposes of fiscal year 2028 and each subsequent fiscal year, October 1 of the preceding fiscal year; and

(II)

has updated its registration to reflect such change under the requirements for drug establishment registration set forth in section 360 of this title.

(ii)

Contract manufacturing organizations

(C)

Amount

(D)

Due date

(i)

Fiscal year 2026

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

(I)

the first business day of June of such year; or

(II)

the first business day after the enactment of an appropriations Act providing for the collection and obligation of fees under this section for such year.

(ii)

Fiscal year 2027

For fiscal year 2027, the facility fees required under subparagraph (A) shall be due—

(I)

in a first installment representing 50 percent of such fee, on the later of—

(aa)

October 1, 2026; or

(bb)

the first business day after the enactment of an appropriations Act providing for the collection and obligation of fees under this section for such year; and

(II)

in a second installment representing the remaining 50 percent of such fee, on—

(aa)

February 1, 2027; or

(bb)

if an appropriations Act described in subclause (I)(bb) is not in effect on February 1, 2027, the first business day after enactment of such an appropriations Act.

(iii)

Subsequent fiscal years

For fiscal year 2028 and each subsequent fiscal year, the facility fees required under subparagraph (A) shall be due on the later of—

(I)

the first business day on or after October 1 of the fiscal year; or

(II)

the first business day after the date of enactment of an appropriations Act providing for the collection and obligation of fees under this section for the fiscal year.

(2)

OTC monograph order request fee

(A)

In general

Each person that submits an OTC monograph order request shall be subject to a fee for an OTC monograph order request. The amount of such fee shall be—

(i)

for a Tier 1 OTC monograph order request, $500,000, adjusted for inflation for the fiscal year (as determined under subsection (c)(1)(B)); and

(ii)

for a Tier 2 OTC monograph order request, $100,000, adjusted for inflation for the fiscal year (as determined under subsection (c)(1)(B)).

(B)

Due date

(C)

Exception for certain safety changes

A person who is named as the requestor in an OTC monograph order shall not be subject to a fee under subparagraph (A) if the Secretary finds that the OTC monograph order request seeks to change the drug facts labeling of an OTC monograph drug in a way that would add to or strengthen—

(i)

a contraindication, warning, or precaution;

(ii)

a statement about risk associated with misuse or abuse; or

(iii)

an instruction about dosage and administration that is intended to increase the safe use of the OTC monograph drug.

(D)

Refund of fee if order request is recategorized as a Tier 2 OTC monograph order request

(E)

Refund of fee if order request refused for filing or withdrawn before filing

(F)

Fees for order requests previously refused for filing or withdrawn before filing

(G)

Refund of fee if order request withdrawn

(3)

Refunds

(A)

In general

(B)

Disputes concerning fees

(4)

Notice

(b)

Fee revenue amounts

(1)

In general

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—

(A)

the annual base revenue for the fiscal year (as determined under paragraph (2));

(B)

the dollar amount equal to the inflation adjustment for the fiscal year (as determined under subsection (c)(1));

(C)

the dollar amount equal to the operating reserve adjustment for the fiscal year, if applicable (as determined under subsection (c)(2));

(D)

additional direct cost adjustments (as determined under subsection (c)(3));

(E)

an additional dollar amount equal to—

(i)

$2,373,000 for fiscal year 2026;

(ii)

$1,233,000 for fiscal year 2027; and

(iii)

$854,000 for fiscal year 2028; and

(F)

in the case of a fiscal year for which the Secretary applies the one-time facility fee workload adjustment under subsection (c)(4), the dollar amount equal to such adjustment.

(2)

Annual base revenue

For purposes of paragraph (1), the dollar amount of the annual base revenue for a fiscal year shall be—

(A)

for fiscal year 2026, the dollar amount of the total revenue amount established for fiscal year 2025 under this subsection as in effect on the day before November 12, 2025, not including any adjustments made for such fiscal year 2025 under subsection (c)(2), as so in effect; and

(B)

for fiscal years 2027 through 2030, the dollar amount of the total revenue amount established under this subsection for the previous fiscal year, not including any adjustments made for such previous fiscal year under subsection (c)(2) or (c)(3).

(c)

Adjustments; annual fee setting

(1)

Inflation adjustment

(A)

In general

For purposes of subsection (b)(1)(B), the dollar amount of the inflation adjustment to the annual base revenue for each fiscal year shall be equal to the product of—

(i)

such annual base revenue for the fiscal year under subsection (b)(2); and

(ii)

the inflation adjustment percentage under subparagraph (C).

(B)

OTC monograph order request fees

For purposes of subsection (a)(2), the dollar amount of the inflation adjustment to the fee for OTC monograph order requests for a fiscal year shall be equal to the product of—

(i)

for fiscal year 2026—

(I)

the fee for fiscal year 2025 under subsection (a)(2); and

(II)

the inflation adjustment percentage under subparagraph (C); and

(ii)

for each of fiscal years 2027 through 2030—

(I)

the applicable fee under subsection (a)(2) for the preceding fiscal year; and

(II)

the inflation adjustment percentage under subparagraph (C).

(C)

Inflation adjustment percentage

The inflation adjustment percentage under this subparagraph for a fiscal year is equal to the sum of—

(i)

the average annual percent change in the cost, per full-time equivalent position of the Food and Drug Administration, of all personnel compensation and benefits paid with respect to such positions for the first 3 years of the preceding 4 fiscal years, multiplied by the proportion of personnel compensation and b

enefits costs to total costs of OTC monograph drug activities for the first 3 years of the preceding 4 fiscal years; and

(ii)

the average annual percent change that occurred in the Consumer Price Index for urban consumers (Washington–Arlington–Alexandria–DC–VA–MD–WV; Not Seasonally Adjusted; All items; Annual Index) for the first 3 years of the preceding 4 years of available data multiplied by the proportion of all costs other than personnel compensation and benefits costs to total costs of OTC monograph drug activities for the first 3 years of the preceding 4 fiscal years.

(2)

Operating reserve adjustment

(A)

In general

(B)

Decrease

(C)

Rationale for adjustment

(3)

Additional direct cost adjustment

The Secretary shall, in addition to adjustments under paragraphs (1) and (2), further increase the fee revenue and fees for purposes of subsection (b)(1)(D) by an amount equal to—

(A)

$135,000 for fiscal year 2026;

(B)

$300,000 for fiscal year 2027;

(C)

$55,000 for fiscal year 2028;

(D)

$30,000 for fiscal year 2029; and

(E)

$0 for fiscal year 2030.

(4)

One-time facility fee workload adjustment

(A)

In general

(B)

Adjustment described

(i)

Conditions for adjustment

An adjustment under this paragraph may be made for a fiscal year only if—

(I)

an adjustment under this paragraph had not been made for any prior fiscal year;

(II)

the average number of OTC monograph drug facilities subject to a facility fee under subsection (a)(1) over the period of the preceding 3 fiscal years exceeds 1,625; and

(III)

with respect to facilities described in subclause (II), the average number of such facilities (expressed as a percentage) that appeared on the arrears lists pursuant to subsection (e)(1)(A)(i) over the period of the preceding 3 fiscal years is less than 30 percent.

(ii)

Amount of adjustment

An adjustment under this paragraph for a fiscal year shall equal the product of—

(I)

the total facility revenue amount determined under subsection (b) for the fiscal year, exclusive of the adjustment under this paragraph for such fiscal year; and

(II)

the excess facility percentage described in clause (iii).

(iii)

Excess facility percentage

The excess facility percentage described in this clause is—

(I)

the amount by which the average number of OTC monograph drug facilities subject to a facility fee under subsection (a)(1) over the preceding 3 fiscal years exceeds 1,625; divided by

(II)

1,625.

(5)

Annual fee setting

The Secretary shall, not later than 60 days before the first day of each fiscal year—

(A)

establish for such fiscal year, based on the revenue amounts under subsection (b) and the adjustments provided under this subsection—

(i)

OTC monograph drug facility fees under subsection (a)(1); and

(ii)

OTC monograph order request fees under subsection (a)(2); and

(B)

publish such fee revenue amounts, facility fees, and OTC monograph order request fees in the Federal Register.

(d)

Identification of facilities

Each person that owns an OTC monograph drug facility shall submit to the Secretary the information required under this subsection each year. Such information shall, for each fiscal year—

(1)

be submitted as part of the requirements for drug establishment registration set forth in section 360 of this title; and

(2)

include for each such facility, at a minimum, identification of the facility’s business operation as that of an OTC monograph drug facility.

(e)

Effect of failure to pay fees

(1)

OTC monograph drug facility fee

(A)

In general

Failure to pay the fee under subsection (a)(1) within 20 calendar days of the due date as specified in subparagraph (D) of such subsection shall result in the following:

(i)

The Secretary shall place the facility on a publicly available arrears list.

(ii)

All OTC monograph drugs manufactured in such a facility or containing an ingredient manufactured in such a facility shall be deemed misbranded under section 352(ff) of this title.

(B)

Application of penalties

(2)

Order requests

(3)

Meetings

(f)

Crediting and availability of fees

(1)

In general

(2)

Collections and appropriation Acts

(A)

In general

(B)

Use of fees and limitation

(C)

Compliance

(D)

Provision for early payments

(3)

Authorization of appropriations

(g)

Collection of unpaid fees

(h)

Construction

(June 25, 1938, ch. 675, § 744M, as added Pub. L. 116–136, div. A, title III, § 3862, Mar. 27, 2020, 134 Stat. 461; amended Pub. L. 119–37, div. F, title V, § 6504, Nov. 12, 2025, 139 Stat. 638.)

cite as: 21 USC 379j-72