Collapse to view only § 379j-73. Reauthorization; reporting requirements
- § 379j-71. Definitions
- § 379j-72. Authority to assess and use OTC monograph fees
- § 379j-73. Reauthorization; reporting requirements
§ 379j–71. DefinitionsIn 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.
(C) Monitoring of clinical and other research conducted in connection with 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 span 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.)
§ 379j–72. Authority to assess and use OTC monograph fees
(a) Types of feesBeginning 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 periodFor 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 activitiesA 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 2026For 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 2027For 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 yearsFor 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 generalEach 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 changesA 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 generalFor 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 revenueFor 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 generalFor 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 feesFor 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 percentageThe 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
(B) Decrease
(C) Rationale for adjustment
(3) Additional direct cost adjustmentThe 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 adjustmentAn 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 adjustmentAn 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 percentageThe 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 settingThe 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 facilitiesEach 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 generalFailure 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.)
§ 379j–73. Reauthorization; reporting requirements
(a) Performance report
(1) In general
(2) Additional informationBeginning 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
(b) Fiscal report
(c) Public availability
(d) Reauthorization
(1) ConsultationIn 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;
(C) scientific and academic experts;
(D) health care professionals;
(E) representatives of patient and consumer advocacy groups; and
(F) the regulated industry.
(2) Public review of recommendationsAfter 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;
(C) provide for a period of 30 calendar days for the public to provide written comments on such recommendations;
(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
(4) Minutes of negotiation meetings
(A) Public availability
(B) Content
(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.)