PRIA, Government Policy, Made Personal

Summary

The Secretary must charge and collect fees from owners of OTC monograph drug facilities and from people who submit requests to change OTC monograph rules. Owners of any facility identified as an OTC monograph drug facility during the applicable period for a fiscal year must pay an annual facility fee. For fiscal year 2026 the applicable period ends December 31, 2025; for fiscal year 2027 it is the 9-month period ending September 30, 2026; and for fiscal year 2028 and later it is the 12-month period ending on September 30 of the previous fiscal year. No fee is charged if a facility stopped all OTC monograph drug activities before the cutoff date for the year (January 1, 2025 for FY2026; January 1, 2026 for FY2027; October 1 of the previous fiscal year for FY2028+) and updated its registration. A contract manufacturing organization facility pays two-thirds of the regular facility fee. For FY2026 facility fees are due on the later of the first business day of June 2026 or the first business day after an appropriations Act allows the fees. For FY2027 fees are due in two payments: 50% due on the later of October 1, 2026 or the first business day after an appropriations Act, and 50% due on February 1, 2027 (or the first business day after appropriation if not yet in effect). For FY2028 and later, fees are due on the later of the first business day on or after October 1 of the fiscal year or the first business day after the appropriation that allows the fees. People who file an OTC monograph order request must pay a fee when they submit it. A Tier 1 request costs $500,000 adjusted for inflation; a Tier 2 request costs $100,000 adjusted for inflation. The Secretary will not charge the requestor if the request only adds or strengthens certain safety labels or dosage instructions that improve safe use. If a request is reclassified from Tier 1 to Tier 2, the Secretary must refund the difference. The Secretary must refund 75 percent of the order-request fee if the request is refused for filing or withdrawn before acceptance or refusal. If a withdrawn or refused request is resubmitted or filed over protest, the full fee applies. The Secretary may refund fees when no substantial work was done, and some refund decisions are final and not reviewable. Facility fees are not refundable except for fees paid in error if a written request is filed within 180 days. Each year the Secretary will publish the fee amounts in the Federal Register at least 60 days before the fiscal year. Facility owners must report their facility status each year as part of drug establishment registration. If a facility owner does not pay a facility fee within 20 days after the due date, the Secretary will list the facility on a public arrears list and drugs made there are treated as misbranded until the fee is paid. Unpaid fees not made within 30 days become a government claim under federal debt law. The law also sets how total fee revenue is calculated for FY2026–2030 (including exact add-on amounts of $2,373,000 for FY2026, $1,233,000 for FY2027, and $854,000 for FY2028, plus smaller direct-cost adjustments of $135,000 in FY2026, $300,000 in FY2027, $55,000 in FY2028, $30,000 in FY2029, and $0 in FY2030), how fees are adjusted for inflation, and rules about operating reserves, one-time workload adjustments, and appropriations that limit how fees may be used.

Title 21, §379j–72

Food and Drugs, Source: USLM XML via OLRC

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

(1)(A)(i)Each person that owns a facility identified as an OTC monograph drug facility at any time during the applicable period specified in clause (ii) for a fiscal year shall be assessed an annual fee for each such facility as determined under subsection (c).

(ii)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)(i)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)The amount of the fee for a contract manufacturing organization facility shall be equal to two-thirds of the amount of the fee for an OTC monograph drug facility that is not a contract manufacturing organization facility.

(C)The amount of fees established under subparagraph (A) shall be established under subsection (c).

(D)(i)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)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)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)(A)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)The OTC monograph order request fees required under subparagraph (A) shall be due on the date of submission of the OTC monograph order request.

(C)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)If the Secretary determines that an OTC monograph request initially characterized as Tier 1 shall be re-characterized as a Tier 2 OTC monograph order request, and the requestor has paid a Tier 1 fee in accordance with subparagraph (A)(i), the Secretary shall refund the requestor the difference between the Tier 1 and Tier 2 fees determined under subparagraphs (A)(i) and (A)(ii), respectively.

(E)The Secretary shall refund 75 percent of the fee paid under subparagraph (B) for any order request which is refused for filing or was withdrawn before being accepted or refused for filing.

(F)An OTC monograph order request that was submitted but was refused for filing, or was withdrawn before being accepted or refused for filing, shall be subject to the full fee under subparagraph (A) upon being resubmitted or filed over protest.

(G)If an order request is withdrawn after the order request was filed, the Secretary may refund the fee or a portion of the fee if no substantial work was performed on the order request after the application was filed. The Secretary shall have the sole discretion to refund a fee or a portion of the fee under this subparagraph. A determination by the Secretary concerning a refund under this subparagraph shall not be reviewable.

(3)(A)Other than refunds provided pursuant to any of subparagraphs (D) through (G) of paragraph (2), the Secretary shall not refund any fee paid under paragraph (1) except as provided in subparagraph (B).

(B)To qualify for the return of a fee claimed to have been paid in error under paragraph (1) or (2), a person shall submit to the Secretary a written request justifying such return within 180 calendar days after such fee was paid.

(4)Within the timeframe specified in subsection (c), the Secretary shall publish in the Federal Register the amount of the fees under paragraph (1) for such fiscal year.

(b)(1)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)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)(1)(A)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)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)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 benefits 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)(A)For each fiscal year, for purposes of subsection (b)(1)(C), the Secretary may, in addition to adjustments under paragraph (1), further increase the fee revenue and fees if such an adjustment is necessary to provide operating reserves of carryover user fees for OTC monograph drug activities for not more than 10 weeks.

(B)If the Secretary has carryover balances for such process in excess of 10 weeks of the operating reserves referred to in subparagraph (A), the Secretary shall decrease the fee revenue and fees referred to in such subparagraph to provide for not more than 10 weeks of such operating reserves.

(C)If an adjustment under this paragraph is made, the rationale for the amount of the increase or decrease (as applicable) in fee revenue and fees shall be contained in the annual Federal Register notice under paragraph (5) publishing fee revenue and fees for the fiscal year involved.

(3)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)(A)In addition to the adjustments under paragraphs (1), (2), and (3), the Secretary may further increase the fee revenues and fees through a one-time adjustment made for fiscal year 2028, 2029, or 2030, in accordance with this paragraph.

(B)(i)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)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)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)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)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)(1)(A)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)The penalties under this paragraph shall apply until the fee established by subsection (a)(1) is paid.

(2)An OTC monograph order request submitted by a person subject to fees under subsection (a) shall be considered incomplete and shall not be accepted for filing by the Secretary until all fees owed by such person under this section have been paid.

(3)A person subject to fees under this section shall be considered ineligible for OTC monograph drug meetings until all such fees owed by such person have been paid.

(f)(1)Fees authorized under subsection (a) shall be collected and available for obligation only to the extent and in the amount provided in advance in appropriations Acts. Such fees are authorized to remain available until expended. Such sums as may be necessary may be transferred from the Food and Drug Administration salaries and expenses appropriation account without fiscal year limitation to such appropriation account for salaries and expenses with such fiscal year limitation. The sums transferred shall be available solely for OTC monograph drug activities.

(2)(A)Subject to subparagraph (C), the fees authorized by this section shall be collected and available in each fiscal year in an amount not to exceed the amount specified in appropriation Acts, or otherwise made available for obligation, for such fiscal year.

(B)The fees authorized by this section shall be available to defray increases in the costs of the resources allocated for OTC monograph drug activities (including increases in such costs for an additional number of full-time equivalent positions in the Department of Health and Human Services to be engaged in such activities), only if the Secretary allocates for such purpose an amount for such fiscal year (excluding amounts from fees collected under this section) no less than $12,000,000, multiplied by the adjustment factor applicable to the fiscal year involved under subsection (c)(1).

(C)The Secretary shall be considered to have met the requirements of subparagraph (B) in any fiscal year if the costs funded by appropriations and allocated for OTC monograph drug activities are not more than 15 percent below the level specified in such subparagraph.

(D)Payment of fees authorized under this section for a fiscal year, prior to the due date for such fees, may be accepted by the Secretary in accordance with authority provided in advance in a prior year appropriations Act.

(3)For each of the fiscal years 2026 through 2030, there is authorized to be appropriated for fees under this section an amount equal to the total amount of fees assessed for such fiscal year under this section.

(g)In any case where the Secretary does not receive payment of a fee assessed under subsection (a) within 30 calendar days after it is due, such fee shall be treated as a claim of the United States Government subject to subchapter II of chapter 37 of title 31.

(h)This section may not be construed to require that the number of full-time equivalent positions in the Department of Health and Human Services, for officers, employers, and advisory committees not engaged in OTC monograph drug activities, be reduced to offset the number of officers, employees, and advisory committees so engaged.

Notes & Related Subsidiaries

Termination of SectionFor termination of section by section 6509(a) of Pub. L. 119–37, see Termination Date note below.

Editorial Notes

Amendments

2025—Subsec. (a)(1)(A). Pub. L. 119–37, § 6504(a)(1), designated existing provisions as cl. (i) and inserted heading, substituted “at any time during the applicable period specified in clause (ii) for a fiscal year” for “on December 31 of the fiscal year or at any time during the preceding 12-month period”, and added cl. (ii). Subsec. (a)(1)(B)(i)(I). Pub. L. 119–37, § 6504(a)(2), amended subcl. (I) generally. Prior to amendment, subcl. (I) read as follows: “has ceased all activities related to OTC monograph drugs prior to December 31 of the year immediately preceding the applicable fiscal year; and”. Subsec. (a)(1)(D). Pub. L. 119–37, § 6504(a)(3), amended subpar. (D) generally. Prior to amendment, subpar. (D) related to due date in fiscal year 2021 and in each subsequent fiscal year for required facility fees. Subsec. (b). Pub. L. 119–37, § 6504(b), amended subsec. (b) generally. Prior to amendment, subsec. (b) related to facility fee revenue amounts and annual base revenue amounts for fiscal years 2021 through 2025. Subsec. (c)(1)(A). Pub. L. 119–37, § 6504(c)(1)(A), substituted “subsection (b)(1)(B)” for “subsection (b)(2)(B)” and “each fiscal year” for “fiscal year 2022 and each subsequent fiscal year” in introductory provisions. Subsec. (c)(1)(B). Pub. L. 119–37, § 6504(c)(1)(B), substituted “a fiscal year shall be equal to the product of—” for “fiscal year 2022 and each subsequent fiscal year shall be equal to the product of—” in introductory provisions, added cls. (i) and (ii), and struck out former cls. (i) and (ii) which read as follows: “(i) the applicable fee under subsection (a)(2) for the preceding fiscal year; and “(ii) the inflation adjustment percentage under subparagraph (C).” Subsec. (c)(1)(C). Pub. L. 119–37, § 6504(c)(1)(C), inserted “the sum of” after “is equal to” in introductory provisions, redesignated subcls. (I) and (II) of cl. (ii) as cls. (i) and (ii), respectively, and adjusted margins, substituted “Washington–Arlington–Alexandria–DC–VA–MD–WV” for “Washington-Baltimore, DC–MD–VA–WV” in cl. (ii), as redesignated, and struck out former cl. (i) and introductory provisions of former cl. (ii), which read as follows: “(i) for each of fiscal years 2022 and 2023, the average annual percent change that occurred in the Consumer Price Index for urban consumers (Washington-Baltimore, DC–MD–VA–WV; Not Seasonally Adjusted; All items; Annual Index) for the first 3 years of the preceding 4 years of available data; and “(ii) for each of fiscal years 2024 and 2025, the sum of—”. Subsec. (c)(2)(A). Pub. L. 119–37, § 6504(c)(2)(A), substituted “each fiscal year” for “fiscal year 2021 and subsequent fiscal years”, “subsection (b)(1)(C)” for “subsections (b)(1)(B) and (b)(2)(C)”, and “10 weeks” for “the number of weeks specified in subparagraph (B)”. Subsec. (c)(2)(B). Pub. L. 119–37, § 6504(c)(2)(B), (C), struck out subpar. (B) and redesignated former subpar. (C) as (B). Prior to amendment, text of subpar. (B) read as follows: “The number of weeks specified in this subparagraph is— “(i) 3 weeks for fiscal year 2021; “(ii) 7 weeks for fiscal year 2022; “(iii) 10 weeks for fiscal year 2023; “(iv) 10 weeks for fiscal year 2024; and “(v) 10 weeks for fiscal year 2025.” Subsec. (c)(2)(C). Pub. L. 119–37, § 6504(c)(2)(C), (D), redesignated subpar. (D) as (C) and substituted “paragraph (5) publishing” for “paragraph (4) establishing”. Former subpar. (C) redesignated (B). Subsec. (c)(2)(D). Pub. L. 119–37, § 6504(c)(2)(C), redesignated subpar. (D) as (C). Subsec. (c)(3). Pub. L. 119–37, § 6504(c)(3)(A), substituted “subsection (b)(1)(D)” for “subsection (b)(2)(D)” in introductory provisions. Subsec. (c)(3)(A) to (E). Pub. L. 119–37, § 6504(c)(3)(B), added subpars. (A) to (E) and struck out former subpars. (A) to (E) which provided additional direct cost adjustment amounts for fiscal years 2021 to 2025, respectively. Subsec. (c)(4), (5). Pub. L. 119–37, § 6504(c)(4), added pars. (4) and (5) and struck out former par. (4) which related to annual fee setting for fiscal year 2021 and subsequent fiscal years. Subsec. (f)(2)(D). Pub. L. 119–37, § 6504(d)(1), struck out “in subsequent years” after “payments” in heading and “(after fiscal year 2021)” after “a fiscal year” in text. Subsec. (f)(3). Pub. L. 119–37, § 6504(d)(2), substituted “2026 through 2030” for “2021 through 2025”.

Statutory Notes and Related Subsidiaries

Effective Date

of 2025 AmendmentAmendment by Pub. L. 119–37 effective Nov. 12, 2025, with fees under this subpart to be assessed beginning Oct. 1, 2025, see section 6510 of Pub. L. 119–37, set out as a note under section 355 of this title. Termination Date Section ceases to be effective Oct. 1, 2030, see section 6509(a) of Pub. L. 119–37, set out as a note under section 379j–71 of this title.

§379j–72 Authority to Assess and Use Otc Monograph Fees