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

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.

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).

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.

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.”