---
kind: "section"
citation: "21 U.S.C. § 355–2"
title: "21"
title_heading: "Food and Drugs"
number: "355–2"
heading: "Actions for delays of generic drugs and biosimilar biological products"
release: "119-102"
date: "2026-07-12"
url: "https://uscodex.org/usc/21/355-2"
units:
  - "Chapter 9 — Federal Food, Drug, and Cosmetic Act"
  - "Subchapter V — Drugs and Devices"
  - "Part A — Drugs and Devices"
---

# §355–2. Actions for delays of generic drugs and biosimilar biological products

- (a) **Definitions—** In this section—
  - (1) the term “commercially reasonable, market-based terms” means—
    - (A) a nondiscriminatory price for the sale of the covered [product](/usc/21/360eee.md?p=13) at or below, but not greater than, the most recent wholesale acquisition cost for the [drug](/usc/21/321.md?p=g-1), as defined in [section 1395w–3a(c)(6)(B) of title 42](/usc/42/1395w–3a.md?p=c-6-B);
    - (B) a schedule for delivery that results in the transfer of the covered [product](/usc/21/360eee.md?p=13) to the eligible [product](/usc/21/360eee.md?p=13) developer consistent with the timing under [subsection (b)(2)(A)(iv)](#b-2-A-iv); and
    - (C) no additional conditions are imposed on the sale of the covered [product](/usc/21/360eee.md?p=13);
  - (2) the term “covered [product](/usc/21/360eee.md?p=13)”—
    - (A) means—
      - (i) any [drug](/usc/21/321.md?p=g-1) approved under subsection (c) or (j) of [section 355 of this title](/usc/21/355.md) or biological [product](/usc/21/360eee.md?p=13) [licensed](/usc/21/360eee.md?p=9) under subsection (a) or (k) of [section 262 of title 42](/usc/42/262.md);
      - (ii) any combination of a [drug](/usc/21/321.md?p=g-1) or biological [product](/usc/21/360eee.md?p=13) described in [clause (i)](#a-2-A-i); or
      - (iii) when reasonably necessary to support approval of an application under [section 355 of this title](/usc/21/355.md), or [section 262 of title 42](/usc/42/262.md), as applicable, or otherwise meet the requirements for approval under either such section, any [product](/usc/21/360eee.md?p=13), including any [device](/usc/21/321.md?p=h-1), that is marketed or intended for use with such a [drug](/usc/21/321.md?p=g-1) or biological [product](/usc/21/360eee.md?p=13); and
    - (B) does not include any [drug](/usc/21/321.md?p=g-1) or biological [product](/usc/21/360eee.md?p=13) that appears on the [drug](/usc/21/321.md?p=g-1) shortage list in effect under [section 356e of this title](/usc/21/356e.md), unless—
      - (i) the [drug](/usc/21/321.md?p=g-1) or biological [product](/usc/21/360eee.md?p=13) has been on the [drug](/usc/21/321.md?p=g-1) shortage list in effect under such [section 356e of this title](/usc/21/356e.md) continuously for more than 6 months; or
      - (ii) the [Secretary](/usc/21/321.md?p=d) determines that inclusion of the [drug](/usc/21/321.md?p=g-1) or biological [product](/usc/21/360eee.md?p=13) as a covered [product](/usc/21/360eee.md?p=13) is likely to contribute to alleviating or preventing a shortage.
  - (3) the term “[device](/usc/21/321.md?p=h-1)” has the meaning given the term in [section 321 of this title](/usc/21/321.md);
  - (4) the term “eligible [product](/usc/21/360eee.md?p=13) developer” means a [person](/usc/21/321.md?p=e) that seeks to develop a [product](/usc/21/360eee.md?p=13) for approval pursuant to an application for approval under subsection (b)(2) or (j) of [section 355 of this title](/usc/21/355.md) or for licensing pursuant to an application under [section 262(k) of title 42](/usc/42/262.md?p=k);
  - (5) the term “license holder” means the holder of an application approved under subsection (c) or (j) of [section 355 of this title](/usc/21/355.md) or the holder of a license under subsection (a) or (k) of [section 262 of title 42](/usc/42/262.md) for a covered [product](/usc/21/360eee.md?p=13);
  - (6) the term “REMS” means a risk evaluation and mitigation strategy under [section 355–1 of this title](/usc/21/355–1.md);
  - (7) the term “REMS with ETASU” means a REMS that contains elements to assure [safe](/usc/21/321.md?p=u) use under [section 355–1(f) of this title](/usc/21/355–1.md?p=f);
  - (8) the term “[Secretary](/usc/21/321.md?p=d)” means the [Secretary](/usc/21/321.md?p=d) of Health and Human Services;
  - (9) the term “single, shared system of elements to assure [safe](/usc/21/321.md?p=u) use” means a single, shared system of elements to assure [safe](/usc/21/321.md?p=u) use under [section 355–1(f) of this title](/usc/21/355–1.md?p=f); and
  - (10) the term “sufficient quantities” means an amount of a covered [product](/usc/21/360eee.md?p=13) that the eligible [product](/usc/21/360eee.md?p=13) developer determines allows it to—
    - (A) conduct testing to support an application under—
      - (i) subsection (b)(2) or (j) of [section 355 of this title](/usc/21/355.md); or
      - (ii) [section 262(k) of title 42](/usc/42/262.md?p=k); and
    - (B) fulfill any regulatory requirements relating to approval of such an application.
- (b) **Civil action for failure to provide sufficient quantities of a covered product—**
  - (1) **In general—** An eligible [product](/usc/21/360eee.md?p=13) developer may bring a civil action against the license holder for a covered [product](/usc/21/360eee.md?p=13) seeking relief under this subsection in an appropriate district court of the United States alleging that the license holder has declined to provide sufficient quantities of the covered [product](/usc/21/360eee.md?p=13) to the eligible [product](/usc/21/360eee.md?p=13) developer on commercially reasonable, market-based terms.
  - (2) **Elements—**
    - (A) **In general—** To prevail in a civil action brought under [paragraph (1)](#b-1), an eligible [product](/usc/21/360eee.md?p=13) developer shall prove, by a preponderance of the evidence—
      - (i) that—
        - (I) the covered [product](/usc/21/360eee.md?p=13) is not subject to a REMS with ETASU; or
        - (II) if the covered [product](/usc/21/360eee.md?p=13) is subject to a REMS with ETASU—
          - (aa) the eligible [product](/usc/21/360eee.md?p=13) developer has obtained a covered [product](/usc/21/360eee.md?p=13) authorization from the [Secretary](/usc/21/321.md?p=d) in accordance with [subparagraph (B)](#b-2-B); and
          - (bb) the eligible [product](/usc/21/360eee.md?p=13) developer has provided a copy of the covered [product](/usc/21/360eee.md?p=13) authorization to the license holder;
      - (ii) that, as of the date on which the civil action is filed, the eligible [product](/usc/21/360eee.md?p=13) developer has not obtained sufficient quantities of the covered [product](/usc/21/360eee.md?p=13) on commercially reasonable, market-based terms;
      - (iii) that the eligible [product](/usc/21/360eee.md?p=13) developer has submitted a written request to purchase sufficient quantities of the covered [product](/usc/21/360eee.md?p=13) to the license holder, and such request—
        - (I) was sent to a named corporate officer of the license holder;
        - (II) was made by certified or registered mail with [return](/usc/21/360eee.md?p=17) receipt requested;
        - (III) specified an individual as the point of contact for the license holder to direct communications related to the sale of the covered [product](/usc/21/360eee.md?p=13) to the eligible [product](/usc/21/360eee.md?p=13) developer and a means for electronic and written communications with that individual; and
        - (IV) specified an address to which the covered [product](/usc/21/360eee.md?p=13) was to be shipped upon reaching an agreement to transfer the covered [product](/usc/21/360eee.md?p=13); and
      - (iv) that the license holder has not delivered to the eligible [product](/usc/21/360eee.md?p=13) developer sufficient quantities of the covered [product](/usc/21/360eee.md?p=13) on commercially reasonable, market-based terms—
        - (I) for a covered [product](/usc/21/360eee.md?p=13) that is not subject to a REMS with ETASU, by the date that is 31 days after the date on which the license holder received the request for the covered [product](/usc/21/360eee.md?p=13); and
        - (II) for a covered [product](/usc/21/360eee.md?p=13) that is subject to a REMS with ETASU, by 31 days after the later of—
          - (aa) the date on which the license holder received the request for the covered [product](/usc/21/360eee.md?p=13); or
          - (bb) the date on which the license holder received a copy of the covered [product](/usc/21/360eee.md?p=13) authorization issued by the [Secretary](/usc/21/321.md?p=d) in accordance with [subparagraph (B)](#b-2-B).
    - (B) **Authorization for covered product subject to a REMS with ETASU—**
      - (i) **Request—** An eligible [product](/usc/21/360eee.md?p=13) developer may submit to the [Secretary](/usc/21/321.md?p=d) a written request for the eligible [product](/usc/21/360eee.md?p=13) developer to be [authorized](/usc/21/360eee.md?p=2) to obtain sufficient quantities of an individual covered [product](/usc/21/360eee.md?p=13) subject to a REMS with ETASU.
      - (ii) **Authorization—** Not later than 120 days after the date on which a request under [clause (i)](#b-2-B-i) is received, the [Secretary](/usc/21/321.md?p=d) shall, by written notice, authorize the eligible [product](/usc/21/360eee.md?p=13) developer to obtain sufficient quantities of an individual covered [product](/usc/21/360eee.md?p=13) subject to a REMS with ETASU for purposes of—
        - (I) development and testing that does not involve human clinical trials, if the eligible [product](/usc/21/360eee.md?p=13) developer has agreed to comply with any conditions the [Secretary](/usc/21/321.md?p=d) determines necessary; or
        - (II) development and testing that involves human clinical trials, if the eligible [product](/usc/21/360eee.md?p=13) developer has—
          - (aa)
            - (AA) submitted protocols, informed consent documents, and informational materials for testing that include protections that provide safety protections comparable to those provided by the REMS for the covered [product](/usc/21/360eee.md?p=13); or
            - (BB) otherwise satisfied the [Secretary](/usc/21/321.md?p=d) that such protections will be provided; and
          - (bb) met any other requirements the [Secretary](/usc/21/321.md?p=d) may establish.
      - (iii) **Notice—** A covered [product](/usc/21/360eee.md?p=13) authorization issued under this subparagraph shall [state](/usc/21/321.md?p=a-1) that the provision of the covered [product](/usc/21/360eee.md?p=13) by the license holder under the terms of the authorization will not be a violation of the REMS for the covered [product](/usc/21/360eee.md?p=13).
  - (3) **Affirmative defense—** In a civil action brought under [paragraph (1)](#b-1), it shall be an affirmative defense, on which the defendant has the burden of persuasion by a preponderance of the evidence—
    - (A) that, on the date on which the eligible [product](/usc/21/360eee.md?p=13) developer requested to purchase sufficient quantities of the covered [product](/usc/21/360eee.md?p=13) from the license holder—
      - (i) neither the license holder nor any of its agents, wholesalers, or distributors was engaged in the manufacturing or commercial marketing of the covered [product](/usc/21/360eee.md?p=13); and
      - (ii) neither the license holder nor any of its agents, wholesalers, or distributors otherwise had access to inventory of the covered [product](/usc/21/360eee.md?p=13) to supply to the eligible [product](/usc/21/360eee.md?p=13) developer on commercially reasonable, market-based terms;
    - (B) that—
      - (i) the license holder sells the covered [product](/usc/21/360eee.md?p=13) through agents, distributors, or wholesalers;
      - (ii) the license holder has placed no restrictions, explicit or implicit, on its agents, distributors, or wholesalers to sell covered [products](/usc/21/360eee.md?p=13) to eligible [product](/usc/21/360eee.md?p=13) developers; and
      - (iii) the covered [product](/usc/21/360eee.md?p=13) can be purchased by the eligible [product](/usc/21/360eee.md?p=13) developer in sufficient quantities on commercially reasonable, market-based terms from the agents, distributors, or wholesalers of the license holder; or
    - (C) that the license holder made an offer to the individual specified pursuant to [paragraph (2)(A)(iii)(III)](#b-2-A-iii-III), by a means of communication (electronic, written, or both) specified pursuant to such paragraph, to sell sufficient quantities of the covered [product](/usc/21/360eee.md?p=13) to the eligible [product](/usc/21/360eee.md?p=13) developer at commercially reasonable market-based terms—
      - (i) for a covered [product](/usc/21/360eee.md?p=13) that is not subject to a REMS with ETASU, by the date that is 14 days after the date on which the license holder received the request for the covered [product](/usc/21/360eee.md?p=13), and the eligible [product](/usc/21/360eee.md?p=13) developer did not accept such offer by the date that is 7 days after the date on which the eligible [product](/usc/21/360eee.md?p=13) developer received such offer from the license holder; or
      - (ii) for a covered [product](/usc/21/360eee.md?p=13) that is subject to a REMS with ETASU, by the date that is 20 days after the date on which the license holder received the request for the covered [product](/usc/21/360eee.md?p=13), and the eligible [product](/usc/21/360eee.md?p=13) developer did not accept such offer by the date that is 10 days after the date on which the eligible [product](/usc/21/360eee.md?p=13) developer received such offer from the license holder.
  - (4) **Remedies—**
    - (A) **In general—** If an eligible [product](/usc/21/360eee.md?p=13) developer prevails in a civil action brought under [paragraph (1)](#b-1), the court shall—
      - (i) order the license holder to provide to the eligible [product](/usc/21/360eee.md?p=13) developer without delay sufficient quantities of the covered [product](/usc/21/360eee.md?p=13) on commercially reasonable, market-based terms;
      - (ii) award to the eligible [product](/usc/21/360eee.md?p=13) developer reasonable attorney’s fees and costs of the civil action; and
      - (iii) award to the eligible [product](/usc/21/360eee.md?p=13) developer a monetary amount sufficient to deter the license holder from failing to provide eligible [product](/usc/21/360eee.md?p=13) developers with sufficient quantities of a covered [product](/usc/21/360eee.md?p=13) on commercially reasonable, market-based terms, if the court finds, by a preponderance of the evidence—
        - (I) that the license holder delayed providing sufficient quantities of the covered [product](/usc/21/360eee.md?p=13) to the eligible [product](/usc/21/360eee.md?p=13) developer without a legitimate business justification; or
        - (II) that the license holder failed to comply with an order issued under [clause (i)](#b-4-A-i).
    - (B) **Maximum monetary amount—** A monetary amount awarded under [subparagraph (A)(iii)](#b-4-A-iii) shall not be greater than the revenue that the license holder earned on the covered [product](/usc/21/360eee.md?p=13) during the period—
      - (i) beginning on—
        - (I) for a covered [product](/usc/21/360eee.md?p=13) that is not subject to a REMS with ETASU, the date that is 31 days after the date on which the license holder received the request; or
        - (II) for a covered [product](/usc/21/360eee.md?p=13) that is subject to a REMS with ETASU, the date that is 31 days after the later of—
          - (aa) the date on which the license holder received the request; or
          - (bb) the date on which the license holder received a copy of the covered [product](/usc/21/360eee.md?p=13) authorization issued by the [Secretary](/usc/21/321.md?p=d) in accordance with [paragraph (2)(B)](#b-2-B); and
      - (ii) ending on the date on which the eligible [product](/usc/21/360eee.md?p=13) developer received sufficient quantities of the covered [product](/usc/21/360eee.md?p=13).
    - (C) **Avoidance of delay—** The court may issue an order under [subparagraph (A)(i)](#b-4-A-i) before conducting further proceedings that may be necessary to determine whether the eligible [product](/usc/21/360eee.md?p=13) developer is entitled to an award under clause [(ii)](#b-4-A-ii) or [(iii)](#b-4-A-iii) of subparagraph (A), or the amount of any such award.
- (c) **Limitation of liability—** A license holder for a covered [product](/usc/21/360eee.md?p=13) shall not be liable for any claim under Federal, [State](/usc/21/321.md?p=a-1), or local law arising out of the failure of an eligible [product](/usc/21/360eee.md?p=13) developer to follow adequate safeguards to assure [safe](/usc/21/321.md?p=u) use of the covered [product](/usc/21/360eee.md?p=13) during development or testing activities described in this section, including transportation, handling, use, or disposal of the covered [product](/usc/21/360eee.md?p=13) by the eligible [product](/usc/21/360eee.md?p=13) developer.
- (d) **Omitted—**
- (e) **Rule of construction—**
  - (1) **Definition—** In this subsection, the term “antitrust laws”—
    - (A) has the meaning given the term in subsection (a) of [section 12 of title 15](/usc/15/12.md); and
    - (B) includes [section 45 of title 15](/usc/15/45.md) to the extent that such section applies to unfair methods of competition.
  - (2) **Antitrust laws—** Nothing in this section shall be construed to limit the operation of any provision of the antitrust laws.
- (f) **Omitted—**
- (g) **Rule of construction—** Nothing in this section, the amendments made by this section, or in [section 355–1 of this title](/usc/21/355–1.md), shall be construed as—
  - (1) prohibiting a license holder from providing an eligible [product](/usc/21/360eee.md?p=13) developer access to a covered [product](/usc/21/360eee.md?p=13) in the absence of an authorization under this section; or
  - (2) in any way negating the applicability of a REMS with ETASU, as otherwise required under such [section 355–1 of this title](/usc/21/355–1.md), with respect to such covered [product](/usc/21/360eee.md?p=13).

## Source credit

(Pub. L. 116–94, div. N, title I, § 610, Dec. 20, 2019, 133 Stat. 3130.)

## Notes

### Editorial Notes

### Codification

Section was enacted as part of the Further Consolidated Appropriations Act, 2020, and not as part of the Federal Food, Drug, and Cosmetic Act which comprises this chapter.

Section is comprised of section 610 of Pub. L. 116–94. Subsecs. (d) and (f) of section 610 of Pub. L. 116–94 amended section 355–1 of this title.