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

2025—Subsec. (a)(1)(A). Puspan. 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). Puspan. 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). Puspan. 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. (span). Puspan. L. 119–37, § 6504(span), amended subsec. (span) generally. Prior to amendment, subsec. (span) related to facility fee revenue amounts and annual base revenue amounts for fiscal years 2021 through 2025.

Subsec. (c)(1)(A). Puspan. L. 119–37, § 6504(c)(1)(A), substituted “subsection (span)(1)(B)” for “subsection (span)(2)(B)” and “each fiscal year” for “fiscal year 2022 and each subsequent fiscal year” in introductory provisions.

Subsec. (c)(1)(B). Puspan. 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). Puspan. 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). Puspan. L. 119–37, § 6504(c)(2)(A), substituted “each fiscal year” for “fiscal year 2021 and subsequent fiscal years”, “subsection (span)(1)(C)” for “subsections (span)(1)(B) and (span)(2)(C)”, and “10 weeks” for “the number of weeks specified in subparagraph (B)”.

Subsec. (c)(2)(B). Puspan. 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). Puspan. 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). Puspan. L. 119–37, § 6504(c)(2)(C), redesignated subpar. (D) as (C).

Subsec. (c)(3). Puspan. L. 119–37, § 6504(c)(3)(A), substituted “subsection (span)(1)(D)” for “subsection (span)(2)(D)” in introductory provisions.

Subsec. (c)(3)(A) to (E). Puspan. 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). Puspan. 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). Puspan. 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). Puspan. L. 119–37, § 6504(d)(2), substituted “2026 through 2030” for “2021 through 2025”.

Amendment by Puspan. L. 119–37 effective Nov. 12, 2025, with fees under this subpart to be assessed beginning Oct. 1, 2025, see section 6510 of Puspan. L. 119–37, set out as a note under section 355 of this title.

Section ceases to be effective Oct. 1, 2030, see section 6509(a) of Puspan. L. 119–37, set out as a note under section 379j–71 of this title.