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Title 21, Food and DrugsRelease 119-110

§356h Competitive Generic Therapies

Title 21 › CHAPTER 9 — FEDERAL FOOD, DRUG, AND COSMETIC ACT › SUBCHAPTER V — DRUGS AND DEVICES › Part A — Drugs and Devices › § 356h

Last updated Sep 23, 2026|Official source

Summary

The Secretary can speed up the review of an abbreviated new drug application when the drug’s maker asks to have the drug named a competitive generic therapy. The maker can ask anytime before or when they file the application. The Secretary must decide within 60 calendar days whether the drug meets the rule that there is inadequate generic competition and, if so, give it the designation. If the review is sped up, the Secretary can hold meetings, give timely advice, involve senior review staff, and assign a cross-disciplinary lead to help with review and inspections and to be a scientific contact. Within one year after the drug is approved, the sponsor must report to the Secretary whether the drug has been sold across state lines since approval. Definitions: "generic drug" — approved under section 355(j); "inadequate generic competition" — no more than one approved drug on the list at 355(j)(7)(A) (excluding discontinued entries) that is the reference listed drug or a generic with the same reference listed drug; "reference listed drug" — the listed drug used as the comparison.

Full Legal Text

Title 21, §356h

Food and Drugs, Source: USLM XML via OLRC

(a)In general
The Secretary may, at the request of an applicant of a drug that is designated as a competitive generic therapy pursuant to subsection (b), expedite the development and review of an abbreviated new drug application under section 355(j) of this title for such drug.
(b)Designation process
(1)Request
The applicant may request the Secretary to designate the drug as a competitive generic therapy.
(2)Timing
A request under paragraph (1) may be made concurrently with, or at any time prior to, the submission of an abbreviated new drug application for the drug under section 355(j) of this title.
(3)Criteria
A drug is eligible for designation as a competitive generic therapy under this section if the Secretary determines that there is inadequate generic competition.
(4)Designation
Not later than 60 calendar days after the receipt of a request under paragraph (1), the Secretary may—
(A)determine whether the drug that is the subject of the request meets the criteria described in paragraph (3); and
(B)if the Secretary finds that the drug meets such criteria, designate the drug as a competitive generic therapy.
(c)Actions
In expediting the development and review of an application under subsection (a), the Secretary 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 prior to submission of the application for such drug under section 355(j) of this title.
(2)Provide timely advice to, and interactive communication with, the applicant regarding the development of the drug 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-device combination products and other complex products.
(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 with respect to a drug for which the development and review is expedited under this section, the sponsor of such drug shall report to the Secretary on whether the drug has been marketed in interstate commerce since the date of such approval.
(e)Definitions
In this section: (1)
(2)The term “inadequate generic competition” means, with respect to a drug, there is not more than one approved drugs on the list of drugs described in section 355(j)(7)(A) of this title (not including drugs on the discontinued section of such list) that is—
(A)the reference listed drug; or
(B)a generic drug with the same reference listed drug as the drug for which designation as a competitive generic therapy is sought.
(3)The term “reference listed drug” means the listed drug (as such term is used in section 355(j) of this title) for the drug involved.

Legislative History

Notes & Related Subsidiaries

Statutory Notes and Related Subsidiaries

Guidance; Amended

Regulations

Pub. L. 115–52, title VIII, § 803(b), Aug. 18, 2017, 131 Stat. 1071, provided that: “(1) In general.—“(A) Issuance.—The Secretary of Health and Human Services shall—“(i) 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 “(ii) not later than 1 year after the close of the comment period for the draft guidance, issue final guidance on such section 506H. “(B) Contents.—The guidance issued under this paragraph shall—“(i) 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); “(ii) specify the actions the Secretary may take to expedite the development and review of a competitive generic therapy pursuant to such a designation; and “(iii) include good review management practices for competitive generic therapies. “(2) 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].”

Reference

Citations & Metadata

Citation

21 U.S.C. § 356h

Title 21, Food and Drugs

Last Updated

Sep 23, 2026

Release point: 119-110