---
kind: "section"
citation: "21 U.S.C. § 353d"
title: "21"
title_heading: "Food and Drugs"
number: "353d"
heading: "Process to update labeling for certain generic drugs"
release: "119-102"
date: "2026-07-12"
url: "https://uscodex.org/usc/21/353d"
units:
  - "Chapter 9 — Federal Food, Drug, and Cosmetic Act"
  - "Subchapter V — Drugs and Devices"
  - "Part A — Drugs and Devices"
---

# §353d. Process to update labeling for certain generic drugs

- (a) **Definitions—** For purposes of this section:
  - (1) The term “covered [drug](/usc/21/321.md?p=g-1)” means a [drug](/usc/21/321.md?p=g-1) approved under [section 355(c) of this title](/usc/21/355.md?p=c)—
    - (A) for which there are no unexpired patents included in the list under [section 355(j)(7) of this title](/usc/21/355.md?p=j-7) and no unexpired period of exclusivity;
    - (B) for which the approval of the application has been withdrawn for reasons other than safety or effectiveness; and
    - (C) for which—
      - (i)
        - (I) there is new scientific evidence available pertaining to new or existing conditions of use that is not reflected in the approved [labeling](/usc/21/321.md?p=m);
        - (II) the approved [labeling](/usc/21/321.md?p=m) does not reflect current legal and regulatory requirements for content or format; or
        - (III) there is a relevant accepted use in clinical practice that is not reflected in the approved [labeling](/usc/21/321.md?p=m); and
      - (ii) updating the approved [labeling](/usc/21/321.md?p=m) would benefit the public health.
  - (2) The term “period of exclusivity”, with respect to a [drug](/usc/21/321.md?p=g-1) approved under [section 355(c) of this title](/usc/21/355.md?p=c), means any period of exclusivity under clause (ii), (iii), or (iv) of [section 355(c)(3)(E) of this title](/usc/21/355.md?p=c-3-E), clause (ii), (iii), or (iv) of [section 355(j)(5)(F) of this title](/usc/21/355.md?p=j-5-F), or section [355a](/usc/21/355a.md), [355f](/usc/21/355f.md), or [360cc](/usc/21/360cc.md) of this title.
  - (3) The term “generic version” means a [drug](/usc/21/321.md?p=g-1) approved under [section 355(j) of this title](/usc/21/355.md?p=j) whose reference listed [drug](/usc/21/321.md?p=g-1) is a covered [drug](/usc/21/321.md?p=g-1).
  - (4) The term “relevant accepted use” means a use for a [drug](/usc/21/321.md?p=g-1) in clinical practice that is supported by scientific evidence that appears to the [Secretary](/usc/21/321.md?p=d) to meet the standards for approval under [section 355 of this title](/usc/21/355.md).
  - (5) The term “selected [drug](/usc/21/321.md?p=g-1)” means a covered [drug](/usc/21/321.md?p=g-1) for which the [Secretary](/usc/21/321.md?p=d) has determined through the process under [subsection (c)](#c) that the [labeling](/usc/21/321.md?p=m) should be changed.
- (b) **Identification of covered drugs—** The [Secretary](/usc/21/321.md?p=d) may identify covered [drugs](/usc/21/321.md?p=g-1) for which [labeling](/usc/21/321.md?p=m) updates would provide a public health benefit. To assist in identifying covered [drugs](/usc/21/321.md?p=g-1), the [Secretary](/usc/21/321.md?p=d) may do one or both of the following:
  - (1) Enter into cooperative agreements or contracts with public or private entities to review the available scientific evidence concerning such [drugs](/usc/21/321.md?p=g-1).
  - (2) Seek public input concerning such [drugs](/usc/21/321.md?p=g-1), including input on whether there is a relevant accepted use in clinical practice that is not reflected in the approved [labeling](/usc/21/321.md?p=m) of such [drugs](/usc/21/321.md?p=g-1) or whether new scientific evidence is available regarding the conditions of use for such [drug](/usc/21/321.md?p=g-1), by—
    - (A) holding one or more public meetings;
    - (B) opening a public docket for the submission of public comments; or
    - (C) other means, as the [Secretary](/usc/21/321.md?p=d) determines appropriate.
- (c) **Selection of drugs for updating—** If the [Secretary](/usc/21/321.md?p=d) determines, with respect to a covered [drug](/usc/21/321.md?p=g-1), that the available scientific evidence meets the standards under [section 355 of this title](/usc/21/355.md) for adding or modifying information to the [labeling](/usc/21/321.md?p=m) or providing supplemental information to the [labeling](/usc/21/321.md?p=m) regarding the use of the covered [drug](/usc/21/321.md?p=g-1), the [Secretary](/usc/21/321.md?p=d) may initiate the process under [subsection (d)](#d).
- (d) **Initiation of the process of updating—** If the [Secretary](/usc/21/321.md?p=d) determines that [labeling](/usc/21/321.md?p=m) changes are appropriate for a selected [drug](/usc/21/321.md?p=g-1) pursuant to [subsection (c)](#c), the [Secretary](/usc/21/321.md?p=d) shall provide notice to the holders of approved applications for a generic version of such [drug](/usc/21/321.md?p=g-1) that—
  - (1) summarizes the findings supporting the determination of the [Secretary](/usc/21/321.md?p=d) that the available scientific evidence meets the standards under [section 355 of this title](/usc/21/355.md) for adding or modifying information or providing supplemental information to the [labeling](/usc/21/321.md?p=m) of the covered [drug](/usc/21/321.md?p=g-1) pursuant to [subsection (c)](#c);
  - (2) provides a clear statement regarding the additional, modified, or supplemental information for such [labeling](/usc/21/321.md?p=m), according to the determination by the [Secretary](/usc/21/321.md?p=d) (including, as applicable, modifications to add the relevant accepted use to the [labeling](/usc/21/321.md?p=m) of the [drug](/usc/21/321.md?p=g-1) as an additional indication for the [drug](/usc/21/321.md?p=g-1)); and
  - (3) [states](/usc/21/321.md?p=a-1) whether the statement under [paragraph (2)](#d-2) applies to the selected [drug](/usc/21/321.md?p=g-1) as a class of covered [drugs](/usc/21/321.md?p=g-1) or only to a specific [drug product](/usc/21/321.md?p=dd).
- (e) **Response to notification—** Within 30 days of receipt of notification provided by the [Secretary](/usc/21/321.md?p=d) pursuant to [subsection (d)](#d), the holder of an approved application for a generic version of the selected [drug](/usc/21/321.md?p=g-1) shall—
  - (1) agree to change the approved [labeling](/usc/21/321.md?p=m) to reflect the additional, modified, or supplemental information the [Secretary](/usc/21/321.md?p=d) has determined to be appropriate; or
  - (2) notify the [Secretary](/usc/21/321.md?p=d) that the holder of the approved application does not believe that the requested [labeling](/usc/21/321.md?p=m) changes are warranted and submit a statement detailing the reasons why such changes are not warranted.
- (f) **Review of application holder’s response—**
  - (1) **In general—** Upon receipt of the application holder’s response, the [Secretary](/usc/21/321.md?p=d) shall promptly review each statement received under [subsection (e)(2)](#e-2) and determine which [labeling](/usc/21/321.md?p=m) changes pursuant to the [Secretary](/usc/21/321.md?p=d)’s notice under [subsection (d)](#d) are appropriate, if any. If the [Secretary](/usc/21/321.md?p=d) disagrees with the reasons why such [labeling](/usc/21/321.md?p=m) changes are not warranted, the [Secretary](/usc/21/321.md?p=d) shall provide opportunity for discussions with the application holders to reach agreement on whether the [labeling](/usc/21/321.md?p=m) for the covered [drug](/usc/21/321.md?p=g-1) should be updated to reflect available scientific evidence, and if so, the content of such [labeling](/usc/21/321.md?p=m) changes.
  - (2) **Changes to labeling—** After considering all responses from the holder of an approved application under paragraph [(1)](#e-1) or [(2)](#e-2) of subsection (e), and any discussion under [paragraph (1)](#f-1), the [Secretary](/usc/21/321.md?p=d) may order such holder to make the [labeling](/usc/21/321.md?p=m) changes the [Secretary](/usc/21/321.md?p=d) determines are appropriate. Such holder of an approved application shall—
    - (A) update its paper [labeling](/usc/21/321.md?p=m) for the [drug](/usc/21/321.md?p=g-1) at the next printing of that [labeling](/usc/21/321.md?p=m);
    - (B) update any electronic [labeling](/usc/21/321.md?p=m) for the [drug](/usc/21/321.md?p=g-1) within 30 days of such order; and
    - (C) submit the revised [labeling](/usc/21/321.md?p=m) through the form, “Supplement—Changes Being Effected”.
- (g) **Violation—** If the holder of an approved application for the generic version of the selected [drug](/usc/21/321.md?p=g-1) does not comply with the requirements of [subsection (f)(2)](#f-2), such generic version of the selected [drug](/usc/21/321.md?p=g-1) shall be deemed to be misbranded under [section 352 of this title](/usc/21/352.md).
- (h) **Limitations; generic drugs—**
  - (1) **In general—** With respect to any [labeling](/usc/21/321.md?p=m) change required under this section, the generic version shall be deemed to have the same conditions of use and the same [labeling](/usc/21/321.md?p=m) as its reference listed [drug](/usc/21/321.md?p=g-1) for purposes of clauses (i) and (v) of [section 355(j)(2)(A) of this title](/usc/21/355.md?p=j-2-A). Any [labeling](/usc/21/321.md?p=m) change so required shall not have any legal effect for the applicant that is different than the legal effect that would have resulted if a supplemental application had been submitted and approved to conform the [labeling](/usc/21/321.md?p=m) of the generic version to a change in the [labeling](/usc/21/321.md?p=m) of the reference [drug](/usc/21/321.md?p=g-1).
  - (2) **Supplemental applications—** Changes to [labeling](/usc/21/321.md?p=m) made in accordance with this section shall not be eligible for an exclusivity period under this chapter.
  - (3) **Selection of drugs—** The [Secretary](/usc/21/321.md?p=d) shall not identify a [drug](/usc/21/321.md?p=g-1) as a covered [drug](/usc/21/321.md?p=g-1) or select a [drug](/usc/21/321.md?p=g-1) [label](/usc/21/321.md?p=k) for updating under subsection [(b)](#b) or [(c)](#c) solely based on the availability of new safety information. Upon identification of a [drug](/usc/21/321.md?p=g-1) as a covered [drug](/usc/21/321.md?p=g-1) under [subsection (b)](#b), the [Secretary](/usc/21/321.md?p=d) may then consider the availability of new safety information (as defined in [section 355–1(b) of this title](/usc/21/355–1.md?p=b)) in determining whether the [drug](/usc/21/321.md?p=g-1) is a selected [drug](/usc/21/321.md?p=g-1) and in determining what [labeling](/usc/21/321.md?p=m) changes are appropriate.
- (i) **Rules of construction—**
  - (1) **Approval standards—** This section shall not be construed as altering the applicability of the standards for approval of an application under [section 355 of this title](/usc/21/355.md). No order shall be issued under this subsection unless the scientific evidence supporting the changed [labeling](/usc/21/321.md?p=m) meets the standards for approval applicable to any change to [labeling](/usc/21/321.md?p=m) under [section 355 of this title](/usc/21/355.md).
  - (2) **Removal of information—** Nothing in this section shall be construed to give the [Secretary](/usc/21/321.md?p=d) additional authority to remove approved indications for [drugs](/usc/21/321.md?p=g-1), other than the authority described in this section.
  - (3) **Secretary authority—** Nothing in this section shall be construed to limit the authority of the [Secretary](/usc/21/321.md?p=d) to require [labeling](/usc/21/321.md?p=m) changes under [section 355(o)](/usc/21/355.md?p=o) of this title.
  - (4) **Maintenance of labeling—** Nothing in this section shall be construed to affect the responsibility of the holder of an approved application under [section 355(j) of this title](/usc/21/355.md?p=j) to maintain its [labeling](/usc/21/321.md?p=m) in accordance with existing requirements, including subpart B of part 201 and sections 314.70 and 314.97 of title 21, Code of Federal Regulations (or any successor regulations).
- (j) **Reports—** Not later than 4 years after December 27, 2020, and every 4 years thereafter, the [Secretary](/usc/21/321.md?p=d) shall prepare and submit to the Committee on Energy and [Commerce](/usc/21/360hh.md?p=4) of the House of Representatives and the Committee on Health, Education, Labor, and Pensions of the Senate, a report that—
  - (1) describes the actions of the [Secretary](/usc/21/321.md?p=d) under this section, including—
    - (A) the number of covered [drugs](/usc/21/321.md?p=g-1) and description of the types of [drugs](/usc/21/321.md?p=g-1) the [Secretary](/usc/21/321.md?p=d) has selected for [labeling](/usc/21/321.md?p=m) changes and the rationale for such recommended changes; and
    - (B) the number of times the [Secretary](/usc/21/321.md?p=d) entered into discussions concerning a disagreement with an application holder or holders and a summary of the decision regarding a [labeling](/usc/21/321.md?p=m) change, if any; and
  - (2) includes any recommendations of the [Secretary](/usc/21/321.md?p=d) for modifying the program under this section.

## Source credit

(June 25, 1938, ch. 675, § 503D, as added Pub. L. 116–260, div. BB, title III, § 324, Dec. 27, 2020, 134 Stat. 2933.)