21 USC 379 - Definitions

Termination of Section

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

Editorial Notes

Amendments

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

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

Statutory Notes and Related Subsidiaries

Effective Date of 2025 Amendment

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.

Termination Date

Puspan. 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

Puspan. 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

Puspan. 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.”

Puspan. 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 Puspan. 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.”