--- kind: "section" citation: "21 U.S.C. § 356h" title: "21" title_heading: "Food and Drugs" number: "356h" heading: "Competitive generic therapies" release: "119-102" date: "2026-07-12" url: "https://uscodex.org/usc/21/356h" units: - "Chapter 9 — Federal Food, Drug, and Cosmetic Act" - "Subchapter V — Drugs and Devices" - "Part A — Drugs and Devices" --- # §356h. Competitive generic therapies - (a) **In general—** The [Secretary](/usc/21/321.md?p=d) may, at the request of an applicant of a [drug](/usc/21/321.md?p=g-1) that is designated as a competitive generic therapy pursuant to [subsection (b)](#b), expedite the development and review of an abbreviated [new drug](/usc/21/321.md?p=p) application under [section 355(j) of this title](/usc/21/355.md?p=j) for such [drug](/usc/21/321.md?p=g-1). - (b) **Designation process—** - (1) **Request—** The applicant may request the [Secretary](/usc/21/321.md?p=d) to designate the [drug](/usc/21/321.md?p=g-1) as a competitive generic therapy. - (2) **Timing—** A request under [paragraph (1)](#b-1) may be made concurrently with, or at any time prior to, the submission of an abbreviated [new drug](/usc/21/321.md?p=p) application for the [drug](/usc/21/321.md?p=g-1) under [section 355(j) of this title](/usc/21/355.md?p=j). - (3) **Criteria—** A [drug](/usc/21/321.md?p=g-1) is eligible for designation as a competitive generic therapy under this section if the [Secretary](/usc/21/321.md?p=d) determines that there is inadequate generic competition. - (4) **Designation—** Not later than 60 calendar days after the receipt of a request under [paragraph (1)](#b-1), the [Secretary](/usc/21/321.md?p=d) may— - (A) determine whether the [drug](/usc/21/321.md?p=g-1) that is the subject of the request meets the criteria described in [paragraph (3)](#b-3); and - (B) if the [Secretary](/usc/21/321.md?p=d) finds that the [drug](/usc/21/321.md?p=g-1) meets such criteria, designate the [drug](/usc/21/321.md?p=g-1) as a competitive generic therapy. - (c) **Actions—** In expediting the development and review of an application under [subsection (a)](#a), the [Secretary](/usc/21/321.md?p=d) may, as requested by the applicant, take actions including the following: - (1) Hold meetings with the applicant and the review team throughout the development of the [drug](/usc/21/321.md?p=g-1) prior to submission of the application for such [drug](/usc/21/321.md?p=g-1) under [section 355(j) of this title](/usc/21/355.md?p=j). - (2) Provide timely advice to, and interactive communication with, the applicant regarding the development of the [drug](/usc/21/321.md?p=g-1) to ensure that the development program to gather the data necessary for approval is as efficient as practicable. - (3) Involve senior managers and experienced review staff, as appropriate, in a collaborative, coordinated review of such application, including with respect to [drug](/usc/21/321.md?p=g-1)-[device](/usc/21/321.md?p=h-1) combination [products](/usc/21/360eee.md?p=13) and other complex [products](/usc/21/360eee.md?p=13). - (4) Assign a cross-disciplinary project lead— - (A) to facilitate an efficient review of the development program and application, including manufacturing inspections; and - (B) to serve as a scientific liaison between the review team and the applicant. - (d) **Reporting requirement—** Not later than one year after the date of the approval of an application under [section 355(j) of this title](/usc/21/355.md?p=j) with respect to a [drug](/usc/21/321.md?p=g-1) for which the development and review is expedited under this section, the [sponsor](/usc/21/360fff.md?p=8) of such [drug](/usc/21/321.md?p=g-1) shall report to the [Secretary](/usc/21/321.md?p=d) on whether the [drug](/usc/21/321.md?p=g-1) has been marketed in [interstate commerce](/usc/21/321.md?p=b) since the date of such approval. - (e) **Definitions—** In this section: - (1) The term “generic [drug](/usc/21/321.md?p=g-1)” means a [drug](/usc/21/321.md?p=g-1) that is approved pursuant to [section 355(j) of this title](/usc/21/355.md?p=j). - (2) The term “inadequate generic competition” means, with respect to a [drug](/usc/21/321.md?p=g-1), there is not more than one approved [drugs](/usc/21/321.md?p=g-1)[^1] on the list of [drugs](/usc/21/321.md?p=g-1) described in [section 355(j)(7)(A) of this title](/usc/21/355.md?p=j-7-A) (not including [drugs](/usc/21/321.md?p=g-1) on the discontinued section of such list) that is— - (A) the reference listed [drug](/usc/21/321.md?p=g-1); or - (B) a generic [drug](/usc/21/321.md?p=g-1) with the same reference listed [drug](/usc/21/321.md?p=g-1) as the [drug](/usc/21/321.md?p=g-1) for which designation as a competitive generic therapy is sought. - (3) The term “reference listed [drug](/usc/21/321.md?p=g-1)” means the listed [drug](/usc/21/321.md?p=g-1) (as such term is used in [section 355(j) of this title](/usc/21/355.md?p=j)) for the [drug](/usc/21/321.md?p=g-1) involved. ## Footnotes [^1]: So in original. Probably should be “drug”. ## Source credit (June 25, 1938, ch. 675, § 506H, as added Pub. L. 115–52, title VIII, § 803(a), Aug. 18, 2017, 131 Stat. 1070.) ## Notes ### Statutory Notes and Related Subsidiaries ### Guidance; Amended Regulations Pub. L. 115–52, title VIII, § 803(b), Aug. 18, 2017, 131 Stat. 1071, provided that:In general.— Issuance.—The Secretary of Health and Human Services shall— not later than 18 months after the date of enactment of this Act [Aug. 18, 2017], issue draft guidance on section 506H of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 356h], as added by subsection (a); and not later than 1 year after the close of the comment period for the draft guidance, issue final guidance on such section 506H. Contents.—The guidance issued under this paragraph shall— specify the process and criteria by which the Secretary makes a designation under section 506H of the Federal Food, Drug, and Cosmetic Act, as added by subsection (a); specify the actions the Secretary may take to expedite the development and review of a competitive generic therapy pursuant to such a designation; and include good review management practices for competitive generic therapies. Amended regulations.—The Secretary of Health and Human Services shall issue or revise any regulations as may be necessary to carry out this section not later than 2 years after the date of enactment of this Act [Aug. 18, 2017].”