21 USC CHAPTER 9, SUBCHAPTER VII, Part C, subpart 10: fees relating to over-the-counter drugs

From Title 21—FOOD AND DRUGSCHAPTER 9—FEDERAL FOOD, DRUG, AND COSMETIC ACTSUBCHAPTER VII—GENERAL AUTHORITYPart C—Fees

subpart 10—fees relating to over-the-counter drugs

§379j–71. Definitions

In this subpart:

(1) The term "affiliate" means a business entity that has a relationship with a second business entity if, directly or indirectly—

(A) one business entity controls, or has the power to control, the other business entity; or

(B) a third party controls, or has power to control, both of the business entities.

(2) The term "contract manufacturing organization facility" means an OTC monograph drug facility where neither the owner of such manufacturing facility nor any affiliate of such owner or facility sells the OTC monograph drug produced at such facility directly to wholesalers, retailers, or consumers in the United States.

(3) The term "costs of resources allocated for OTC monograph drug activities" means the expenses in connection with OTC monograph drug activities for—

(A) officers and employees of the Food and Drug Administration, contractors of the Food and Drug Administration, advisory committees, and costs related to such officers, employees, and committees and costs related to contracts with such contractors;

(B) management of information, and the acquisition, maintenance, and repair of computer resources;

(C) leasing, maintenance, renovation, and repair of facilities and acquisition, maintenance, and repair of fixtures, furniture, scientific equipment, and other necessary materials and supplies; and

(D) collecting fees under section 379j–72 of this title and accounting for resources allocated for OTC monograph drug activities.

(4) The term "FDA establishment identifier" is the unique number automatically generated by Food and Drug Administration's Field Accomplishments and Compliance Tracking System (FACTS) (or any successor system).

(5) The term "OTC monograph drug" means a nonprescription drug without an approved new drug application which is governed by the provisions of section 355h of this title.

(6) The term "OTC monograph drug activities" means activities of the Secretary associated with OTC monograph drugs and inspection of facilities associated with such products, including the following activities:

(A) The activities necessary for review and evaluation of OTC monographs and OTC monograph order requests, including—

(i) orders proposing or finalizing applicable conditions of use for OTC monograph drugs;

(ii) orders affecting status regarding general recognition of safety and effectiveness of an OTC monograph ingredient or combination of ingredients under specified conditions of use;

(iii) all OTC monograph drug development and review activities, including intra-agency collaboration;

(iv) regulation and policy development activities related to OTC monograph drugs;

(v) development of product standards for products subject to review and evaluation;

(vi) meetings referred to in section 355h(i) of this title;

(vii) review of labeling prior to issuance of orders related to OTC monograph drugs or conditions of use; and

(viii) regulatory science activities related to OTC monograph drugs.

(B) Inspections related to OTC monograph drugs.

(D) Safety activities with respect to OTC monograph drugs, including—

(i) collecting, developing, and reviewing safety information on OTC monograph drugs, including adverse event reports;

(ii) developing and using improved adverse event data-collection systems, including information technology systems; and

(iii) developing and using improved analytical tools to assess potential safety risks, including access to external databases.

(E) Other activities necessary for implementation of section 355h of this title.

(7) The term "OTC monograph order request" means a request for an order submitted under section 355h(b)(5) of this title.

(8) The term "Tier 1 OTC monograph order request" means any OTC monograph order request not determined to be a Tier 2 OTC monograph order request.

(9)(A) The term "Tier 2 OTC monograph order request" means, subject to subparagraph (B), an OTC monograph order request for—

(i) the reordering of existing information in the drug facts label of an OTC monograph drug;

(ii) the addition of information to the other information section of the drug facts label of an OTC monograph drug, as limited by section 201.66(c)(7) of title 21, Code of Federal Regulations (or any successor regulations);

(iii) modification to the directions for use section of the drug facts label of an OTC monograph drug, if such changes conform to changes made pursuant to section 355h(c)(3)(A) of this title;

(iv) the standardization of the concentration or dose of a specific finalized ingredient within a particular finalized monograph;

(v) a change to ingredient nomenclature to align with nomenclature of a standards-setting organization;

(vi) the addition of an interchangeable term in accordance with section 330.1 of title 21, Code of Federal Regulations (or any successor regulations); or

(vii) the addition or modification of a testing procedure applicable to one or more OTC monograph drugs, provided that such additional or modified testing procedure reflects a voluntary consensus standard with respect to pharmaceutical quality that is—

(I) established by a national or international standards development organization; and

(II) recognized by the Secretary through a process described in guidance for industry, initially published in July 2023, or any successor guidance, publicly available on the website of the Food and Drug Administration, which addresses voluntary consensus standards for pharmaceutical quality.

(B) The Secretary may, based on program implementation experience or other factors found appropriate by the Secretary, characterize any OTC monograph order request as a Tier 2 OTC monograph order request (including recharacterizing a request from Tier 1 to Tier 2) and publish such determination in a proposed order issued pursuant to section 355h of this title.

(10)(A) The term "OTC monograph drug facility" means a foreign or domestic business or other entity that—

(i) is—

(I) under one management, either direct or indirect; and

(II) at one geographic location or address engaged in manufacturing or processing the finished dosage form of an OTC monograph drug;

(ii) includes a finished dosage form manufacturer facility in a contractual relationship with the sponsor of one or more OTC monograph drugs to manufacture or process such drugs; and

(iii) does not include a business or other entity whose only manufacturing or processing activities are one or more of the following: production of clinical research supplies, testing, or placement of outer packaging on packages containing multiple products, for such purposes as creating multipacks, when each monograph drug product contained within the overpackaging is already in a final packaged form prior to placement in the outer overpackaging.

(B) For purposes of subparagraph (A)(i)(II), separate buildings or locations within close proximity are considered to be at one geographic location or address if the activities conducted in such buildings or locations are—

(i) closely related to the same business enterprise;

(ii) under the supervision of the same local management; and

(iii) under a single FDA establishment identifier and capable of being inspected by the Food and Drug Administration during a single inspection.

(C) If a business or other entity would meet criteria specified in subparagraph (A), but for being under multiple management, the business or other entity is deemed to constitute multiple facilities, one per management entity, for purposes of this paragraph.

(11) The term "OTC monograph drug meeting" means any meeting regarding the content of a proposed OTC monograph order request.

(12) The term "person" includes an affiliate of a person.

(13) The terms "requestor" and "sponsor" have the meanings given such terms in section 355h of this title.

(June 25, 1938, ch. 675, §744L, as added Pub. L. 116–136, div. A, title III, §3862, Mar. 27, 2020, 134 Stat. 459; amended Pub. L. 119–37, div. F, title V, §6503, Nov. 12, 2025, 139 Stat. 637.)

Termination of Section

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

Editorial Notes

Amendments

2025—Par. (9)(A)(vi). Pub. L. 119–37, §6503(2)(A), substituted "the addition" for "addition".

Par. (9)(A)(vii). Pub. L. 119–37, §6503(1), (2)(B), (3), added cl. (vii)

Statutory Notes and Related Subsidiaries

Effective Date of 2025 Amendment

Amendment 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

Pub. L. 119–37, div. F, title V, §6509(a), Nov. 12, 2025, 139 Stat. 648, provided that: "Sections 744L and 744M of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–71; 379j–72) shall cease to be effective October 1, 2030."

Savings Clause

Pub. L. 119–37, div. F, title V, §6511, Nov. 12, 2025, 139 Stat. 648, provided that: "Notwithstanding the amendments made by this title [amending this section and sections 355, 355h, 379j–72, and 379j–73 of this title], part 10 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–71 et seq.), as in effect on the day before the date of enactment of this Act [Nov. 12, 2025], shall continue to be in effect with respect to assessing and collecting any fee required by such part for a fiscal year prior to fiscal year 2026."

Finding

Pub. L. 119–37, div. F, title V, §6502, Nov. 12, 2025, 139 Stat. 637, provided that: "Congress finds that the fees authorized by the amendments made in this title [amending this section and sections 355, 355h, 379j–72, and 379j–73 of this title] will be dedicated to over-the-counter (OTC) monograph drug activities, as set forth in the goals identified for purposes of part 10 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–71 et seq.), in the letters from the Secretary of Health and Human Services to the Chairman of the Committee on Energy and Commerce of the House of Representatives and the Chairman of the Committee on Health, Education, Labor, and Pensions of the Senate, as set forth in the Congressional Record."

Pub. L. 116–136, div. A, title III, §3861, Mar. 27, 2020, 134 Stat. 458, provided that: "The Congress finds that the fees authorized by the amendments made in this part [part II of subtitle F of title III of div. A of Pub. L. 116–136, enacting this subpart] will be dedicated to OTC monograph drug activities, as set forth in the goals identified for purposes of part 10 of subchapter C of chapter VII of the Federal Food, Drug, and Cosmetic Act [this subpart], in the letters from the Secretary of Health and Human Services to the Chairman of the Committee on Health, Education, Labor, and Pensions of the Senate and the Chairman of the Committee on Energy and Commerce of the House of Representatives, as set forth in the Congressional Record."

§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

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) 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

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) Amount

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

(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

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) 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

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

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

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) Refund of fee if order request withdrawn

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) Refunds

(A) In general

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) Disputes concerning fees

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) Notice

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) 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 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) Operating reserve adjustment

(A) In general

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) Decrease

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) Rationale for adjustment

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) 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;

(D) $30,000 for fiscal year 2029; and

(E) $0 for fiscal year 2030.

(4) One-time facility fee workload adjustment

(A) In general

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) 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

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

(2) Order requests

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) Meetings

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) Crediting and availability of fees

(1) In general

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) Collections and appropriation Acts

(A) In general

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) Use of fees and limitation

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) Compliance

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) Provision for early payments

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) Authorization of appropriations

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) Collection of unpaid fees

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) Construction

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.

(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.)

Termination of Section

For 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 Amendment

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–73. Reauthorization; reporting requirements

(a) Performance report

(1) In general

Not later than 120 calendar days after the end of each fiscal year for which fees are collected under this subpart, the Secretary shall prepare and submit to the Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor, and Pensions of the Senate a report concerning the progress of the Food and Drug Administration in achieving the goals identified in the letters described in section 6502 of the Over-the-Counter Monograph Drug User Fee Amendments during such fiscal year and the future plans of the Food and Drug Administration for meeting such goals.

(2) Additional information

Beginning with fiscal year 2026, the annual report under this subsection shall include—

(A) the progress of the Food and Drug Administration in achieving the goals, and future plans for meeting the goals, including—

(i) the number of Tier 1 OTC monograph order requests for which a proposed order was issued, and the number of such requests for which a final order was issued, in the previous fiscal year;

(ii) the number of Tier 2 OTC monograph order requests for which a proposed order was issued, and the number of such requests for which a final order was issued, in the previous fiscal year;

(iii) the number of specified safety OTC monograph order requests for which a proposed order was issued, and the number of such requests for which a final order was issued, in the previous fiscal year;

(iv) the number of generally recognized as safe and effective finalization OTC monograph order requests for which a proposed order was issued, and the number of such requests for which a final order was issued, in the previous fiscal year;

(v) the average timeline for processing OTC monograph order requests, in the aggregate and by submission type, in the previous fiscal year; and

(vi) postmarket safety activities with respect to OTC monograph drugs, including—

(I) collecting, developing, and reviewing safety information on OTC monograph drugs, including adverse event reports;

(II) developing and using improved analytical tools, adverse event data-collection systems, including information technology systems, to assess potential safety problems, including access to external databases; and

(III) activities under section 379aa of this title;

(B) information regarding registration of OTC monograph drug facilities and contract manufacturing organization facilities and payment of registration fees by such facilities, including—

(i) the OTC monograph drug facilities and contract manufacturing organization facilities that were first registered under section 360(c) or 360(i) of this title in the fiscal year; and

(ii) for each OTC monograph drug facility and contract manufacturing organization facility that was assessed a facility fee under section 379j–72(a) of this title in the fiscal year, whether the facility paid such fee;

(C) the status of implementation of evidence and testing standards under section 355h(r) of this title for nonprescription drugs intended for topical administration, including—

(i) the application of evidence or testing standards; and

(ii) the number of active ingredient requests for nonprescription drugs intended for topical administration reviewed using the standards under section 355h(b) of this title; and

(D) the progress of the Food and Drug Administration in allowing nonclinical testing alternatives to animal testing for the consideration of sunscreen active ingredients.

(3) Confidentiality

Nothing in paragraph (2) shall be construed to authorize the disclosure of information that is prohibited from disclosure under section 331(j) of this title or section 1905 of title 18 or that is subject to withholding under section 552(b)(4) of title 5.

(b) Fiscal report

Not later than 120 calendar days after the end of each fiscal year for which fees are collected under this subpart, the Secretary shall prepare and submit to the Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor, and Pensions of the Senate a report on the implementation of the authority for such fees during such fiscal year and the use, by the Food and Drug Administration, of the fees collected for such fiscal year.

(c) Public availability

The Secretary shall make the reports required under subsections (a) and (b) available to the public on the internet website of the Food and Drug Administration.

(d) Reauthorization

(1) Consultation

In developing recommendations to present to the Congress with respect to the goals described in subsection (a), and plans for meeting the goals, for OTC monograph drug activities for the first 5 fiscal years after fiscal year 2030, and for the reauthorization of this subpart for such fiscal years, the Secretary shall consult with—

(A) the Committee on Energy and Commerce of the House of Representatives;

(B) the Committee on Health, Education, Labor, and Pensions of the Senate;

(D) health care professionals;

(E) representatives of patient and consumer advocacy groups; and

(F) the regulated industry.

(2) Public review of recommendations

After negotiations with the regulated industry, the Secretary shall—

(A) present the recommendations developed under paragraph (1) to the congressional committees specified in such paragraph;

(B) publish such recommendations in the Federal Register;

(D) hold a meeting at which the public may present its views on such recommendations; and

(E) after consideration of such public views and comments, revise such recommendations as necessary.

(3) Transmittal of recommendations

Not later than January 15, 2030, the Secretary shall transmit to the Congress the revised recommendations under paragraph (2), a summary of the views and comments received under such paragraph, and any changes made to the recommendations in response to such views and comments.

(4) Minutes of negotiation meetings

(A) Public availability

The Secretary shall make publicly available, on the public website of the Food and Drug Administration, robust written minutes of all negotiation meetings conducted under this subsection between the Food and Drug Administration and the regulated industry, not later than 30 days after each such negotiation meeting.

(B) Content

The robust written minutes described under subparagraph (A) shall contain, in detail, any substantive proposal made by any party to the negotiations as well as significant controversies or differences of opinion during the negotiations and their resolution.

(June 25, 1938, ch. 675, §744N, as added Pub. L. 116–136, div. A, title III, §3862, Mar. 27, 2020, 134 Stat. 468; amended Pub. L. 119–37, div. F, title V, §6505(a), Nov. 12, 2025, 139 Stat. 642.)

Termination of Section

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

Editorial Notes

References in Text

Section 6502 of the Over-the-Counter Monograph Drug User Fee Amendments, referred to in subsec. (a)(1), is section 6502 of title V of div. F of Pub. L. 119–37, which is set out as a note under section 379j–71 of this title.

Amendments

2025—Subsec. (a). Pub. L. 119–37, §6505(a)(1), designated existing provisions as par. (1), inserted heading, substituted "Not later than 120 calendar days after the end of each fiscal year" for "Beginning with fiscal year 2021, and not later than 120 calendar days after the end of each fiscal year thereafter" and "section 6502 of the Over-the-Counter Monograph Drug User Fee Amendments" for "section 3861(b) of the CARES Act", and added pars. (2) and (3).

Subsec. (b). Pub. L. 119–37, §6505(a)(2), substituted "each fiscal year" for "fiscal year 2021 and each subsequent fiscal year".

Subsec. (d)(1), (3). Pub. L. 119–37, §6505(a)(3)(A), substituted "2030" for "2025".

Subsec. (d)(4). Pub. L. 119–37, §6505(a)(3)(B), added par. (4).

Statutory Notes and Related Subsidiaries

Effective Date of 2025 Amendment

Termination Date

Pub. L. 119–37, div. F, title V, §6509(b), Nov. 12, 2025, 139 Stat. 648, provided that: "Section 744N of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j–73) shall cease to be effective January 31, 2031."