---
kind: "section"
citation: "21 U.S.C. § 335a"
title: "21"
title_heading: "Food and Drugs"
number: "335a"
heading: "Debarment, temporary denial of approval, and suspension"
release: "119-102"
date: "2026-07-12"
url: "https://uscodex.org/usc/21/335a"
units:
  - "Chapter 9 — Federal Food, Drug, and Cosmetic Act"
  - "Subchapter III — Prohibited Acts and Penalties"
---

# §335a. Debarment, temporary denial of approval, and suspension

- (a) **Mandatory debarment; certain drug applications—**
  - (1) **Corporations, partnerships, and associations—** If the [Secretary](/usc/21/321.md?p=d) finds that a [person](/usc/21/321.md?p=e) other than an individual has been convicted, after May 13, 1992, of a felony under Federal law for conduct relating to the development or approval, including the process for development or approval, of any [abbreviated drug application](/usc/21/321.md?p=aa), the [Secretary](/usc/21/321.md?p=d) shall debar such [person](/usc/21/321.md?p=e) from submitting, or assisting in the submission of, any such application.
  - (2) **Individuals—** If the [Secretary](/usc/21/321.md?p=d) finds that an individual has been convicted of a felony under Federal law for conduct—
    - (A) relating to the development or approval, including the process for development or approval, of any [drug product](/usc/21/321.md?p=dd), or
    - (B) otherwise relating to the regulation of any [drug product](/usc/21/321.md?p=dd) under this chapter,

    the [Secretary](/usc/21/321.md?p=d) shall debar such individual from providing services in any capacity to a [person](/usc/21/321.md?p=e) that has an approved or pending [drug product](/usc/21/321.md?p=dd) application.

- (b) **Permissive debarment; certain drug applications; food imports—**
  - (1) **In general—** The [Secretary](/usc/21/321.md?p=d), on the [Secretary](/usc/21/321.md?p=d)’s own initiative or in response to a petition, may, in accordance with paragraph [(2)](#b-2) or [(3)](#b-3), debar—
    - (A) a [person](/usc/21/321.md?p=e) other than an individual from submitting or assisting in the submission of any [abbreviated drug application](/usc/21/321.md?p=aa);
    - (B) an individual from providing services in any capacity to a [person](/usc/21/321.md?p=e) that has an approved or pending [drug product](/usc/21/321.md?p=dd) application;
    - (C) a [person](/usc/21/321.md?p=e) from importing an article of [food](/usc/21/321.md?p=f) or offering such an article for import into the United States; or
    - (D) a [person](/usc/21/321.md?p=e) from importing or offering for import into the United States a [drug](/usc/21/321.md?p=g-1).
  - (2) **Persons subject to permissive debarment; certain drug applications—** The following [persons](/usc/21/321.md?p=e) are subject to debarment under subparagraph [(A)](#b-1-A) or [(B)](#b-1-B) of paragraph (1):
    - (A) **Corporations, partnerships, and associations—** Any [person](/usc/21/321.md?p=e) other than an individual that the [Secretary](/usc/21/321.md?p=d) finds has been convicted—
      - (i) for conduct that—
        - (I) relates to the development or approval, including the process for the development or approval, of any [abbreviated drug application](/usc/21/321.md?p=aa); and
        - (II) is a felony under Federal law (if the [person](/usc/21/321.md?p=e) was convicted before May 13, 1992), a misdemeanor under Federal law, or a felony under [State](/usc/21/321.md?p=a-1) law, or
      - (ii) of a conspiracy to commit, or aiding or abetting, a criminal offense described in [clause (i)](#b-2-A-i) or a felony described in [subsection (a)(1)](#a-1),

      if the [Secretary](/usc/21/321.md?p=d) finds that the type of conduct which served as the basis for such conviction undermines the process for the regulation of [drugs](/usc/21/321.md?p=g-1).

    - (B) **Individuals—**
      - (i) Any individual whom the [Secretary](/usc/21/321.md?p=d) finds has been convicted of—
        - (I) a misdemeanor under Federal law or a felony under [State](/usc/21/321.md?p=a-1) law for conduct relating to the development or approval, including the process for development or approval, of any [drug product](/usc/21/321.md?p=dd) or otherwise relating to the regulation of [drug products](/usc/21/321.md?p=dd) under this chapter, or
        - (II) a conspiracy to commit, or aiding or abetting, such criminal offense or a felony described in [subsection (a)(2)](#a-2),

        if the [Secretary](/usc/21/321.md?p=d) finds that the type of conduct which served as the basis for such conviction undermines the process for the regulation of [drugs](/usc/21/321.md?p=g-1).

      - (ii) Any individual whom the [Secretary](/usc/21/321.md?p=d) finds has been convicted of—
        - (I) a felony which is not described in [subsection (a)(2)](#a-2) or clause (i) of this subparagraph and which involves bribery, payment of illegal gratuities, fraud, perjury, false statement, racketeering, blackmail, extortion, falsification or destruction of records, or interference with, obstruction of an investigation into, or prosecution of, any criminal offense, or
        - (II) a conspiracy to commit, or aiding or abetting, such felony,

        if the [Secretary](/usc/21/321.md?p=d) finds, on the basis of the conviction of such individual and other information, that such individual has demonstrated a pattern of conduct sufficient to find that there is reason to believe that such individual may violate requirements under this chapter relating to [drug products](/usc/21/321.md?p=dd).

      - (iii) Any individual whom the [Secretary](/usc/21/321.md?p=d) finds materially participated in acts that were the basis for a conviction for an offense described in [subsection (a)](#a) or in clause [(i)](#b-2-B-i) or [(ii)](#b-2-B-ii) for which a conviction was obtained, if the [Secretary](/usc/21/321.md?p=d) finds, on the basis of such participation and other information, that such individual has demonstrated a pattern of conduct sufficient to find that there is reason to believe that such individual may violate requirements under this chapter relating to [drug products](/usc/21/321.md?p=dd).
      - (iv) Any [high managerial agent](/usc/21/321.md?p=cc) whom the [Secretary](/usc/21/321.md?p=d) finds—
        - (I) worked for, or worked as a consultant for, the same [person](/usc/21/321.md?p=e) as another individual during the period in which such other individual took actions for which a felony conviction was obtained and which resulted in the debarment under [subsection (a)(2)](#a-2), or [clause (i)](#b-2-B-i), of such other individual,
        - (II) had actual knowledge of the actions described in [subclause (I)](#b-2-B-iv-I) of such other individual, or took action to avoid such actual knowledge, or failed to take action for the purpose of avoiding such actual knowledge,
        - (III) [knew](/usc/21/321.md?p=bb) that the actions described in [subclause (I)](#b-2-B-iv-I) were violative of law, and
        - (IV) did not report such actions, or did not cause such actions to be reported, to an officer, employee, or agent of the [Department](/usc/21/321.md?p=c) or to an appropriate law enforcement officer, or failed to take other appropriate action that would have ensured that the process for the regulation of [drugs](/usc/21/321.md?p=g-1) was not undermined, within a reasonable time after such agent first [knew](/usc/21/321.md?p=bb) of such actions,

        if the [Secretary](/usc/21/321.md?p=d) finds that the type of conduct which served as the basis for such other individual’s conviction undermines the process for the regulation of [drugs](/usc/21/321.md?p=g-1).

  - (3) **Persons subject to permissive debarment; food or drug importation—** A [person](/usc/21/321.md?p=e) is subject to debarment under [paragraph (1)(C)](#b-1-C) if—
    - (A) the [person](/usc/21/321.md?p=e) has been convicted of a felony for conduct relating to the importation into the United States of any [food](/usc/21/321.md?p=f);
    - (B) the [person](/usc/21/321.md?p=e) has engaged in a pattern of importing or offering for import adulterated [food](/usc/21/321.md?p=f) that presents a threat of serious adverse health consequences or death to humans or animals;
    - (C) the [person](/usc/21/321.md?p=e) has been convicted of a felony for conduct relating to the importation into the United States of any [drug](/usc/21/321.md?p=g-1) or controlled substance (as defined in [section 802 of this title](/usc/21/802.md));
    - (D) the [person](/usc/21/321.md?p=e) has engaged in a pattern of importing or offering for import—
      - (i) controlled substances that are prohibited from importation under [section 1401(m) of title 19](/usc/19/1401.md?p=m); or
      - (ii) adulterated or misbranded [drugs](/usc/21/321.md?p=g-1) that are—
        - (I) not designated in an [authorized](/usc/21/360eee.md?p=2) electronic data interchange system as a [product](/usc/21/360eee.md?p=13) that is regulated by the [Secretary](/usc/21/321.md?p=d); or
        - (II) [knowingly](/usc/21/321.md?p=bb) or intentionally falsely designated in an [authorized](/usc/21/360eee.md?p=2) electronic data interchange system as a [product](/usc/21/360eee.md?p=13) that is regulated by the [Secretary](/usc/21/321.md?p=d).
  - (4) **Stay of certain orders—** An order of the [Secretary](/usc/21/321.md?p=d) under clause [(iii)](#b-2-B-iii) or [(iv)](#b-2-B-iv) of paragraph (2)(B) shall not take effect until 30 days after the order has been issued.
  - (5) **Definition—** For purposes of [paragraph (3)(D)](#b-3-D), the term “pattern of importing or offering for import” means importing or offering for import a [drug](/usc/21/321.md?p=g-1) described in clause [(i)](#b-3-D-i) or [(ii)](#b-3-D-ii) of paragraph (3)(D) in an amount, frequency, or dosage that is inconsistent with personal or household use by the importer.
- (c) **Debarment period and considerations—**
  - (1) **Effect of debarment—** The [Secretary](/usc/21/321.md?p=d)—
    - (A) shall not accept or review (other than in connection with an audit under this section) any [abbreviated drug application](/usc/21/321.md?p=aa) submitted by or with the assistance of a [person](/usc/21/321.md?p=e) debarred under subsection [(a)(1)](#a-1) or [(b)(2)(A)](#b-2-A) during the period such [person](/usc/21/321.md?p=e) is debarred,
    - (B) shall, during the period of a debarment under subsection [(a)(2)](#a-2) or [(b)(2)(B)](#b-2-B), debar an individual from providing services in any capacity to a [person](/usc/21/321.md?p=e) that has an approved or pending [drug product](/usc/21/321.md?p=dd) application and shall not accept or review (other than in connection with an audit under this section) an [abbreviated drug application](/usc/21/321.md?p=aa) from such individual, and
    - (C) shall, if the [Secretary](/usc/21/321.md?p=d) makes the finding described in paragraph (6) or (7) of [section 335b(a) of this title](/usc/21/335b.md?p=a), assess a civil penalty in accordance with [section 335b of this title](/usc/21/335b.md).
  - (2) **Debarment periods—**
    - (A) **In general—** The [Secretary](/usc/21/321.md?p=d) shall debar a [person](/usc/21/321.md?p=e) under subsection [(a)](#a) or [(b)](#b) for the following periods:
      - (i) The period of debarment of a [person](/usc/21/321.md?p=e) (other than an individual) under [subsection (a)(1)](#a-1) shall not be less than 1 year or more than 10 years, but if an act leading to a subsequent debarment under [subsection (a)](#a) occurs within 10 years after such [person](/usc/21/321.md?p=e) has been debarred under [subsection (a)(1)](#a-1), the period of debarment shall be permanent.
      - (ii) The debarment of an individual under [subsection (a)(2)](#a-2) shall be permanent.
      - (iii) The period of debarment of any [person](/usc/21/321.md?p=e) under paragraph [(2)](#b-2) or [(3)](#b-3) of subsection (b) shall not be more than 5 years.

      The [Secretary](/usc/21/321.md?p=d) may determine whether debarment periods shall run concurrently or consecutively in the case of a [person](/usc/21/321.md?p=e) debarred for multiple offenses.

    - (B) **Notification—** Upon a conviction for an offense described in subsection [(a)](#a) or [(b)](#b) or upon execution of an agreement with the United States to plead guilty to such an offense, the [person](/usc/21/321.md?p=e) involved may notify the [Secretary](/usc/21/321.md?p=d) that the [person](/usc/21/321.md?p=e) acquiesces to debarment and such [person](/usc/21/321.md?p=e)’s debarment shall commence upon such notification.
  - (3) **Considerations—** In determining the appropriateness and the period of a debarment of a [person](/usc/21/321.md?p=e) under [subsection (b)](#b) and any period of debarment beyond the minimum specified in [subparagraph (A)(i)](#c-2-A-i) of paragraph (2), the [Secretary](/usc/21/321.md?p=d) shall consider where applicable—
    - (A) the nature and seriousness of any offense involved,
    - (B) the nature and extent of management participation in any offense involved, whether corporate policies and practices encouraged the offense, including whether inadequate institutional controls contributed to the offense,
    - (C) the nature and extent of voluntary steps to mitigate the impact on the public of any offense involved, including the recall or the discontinuation of the [distribution](/usc/21/360eee.md?p=5) of suspect [drugs](/usc/21/321.md?p=g-1), full cooperation with any investigations (including the extent of disclosure to appropriate authorities of all wrongdoing), the relinquishing of profits on [drug](/usc/21/321.md?p=g-1) approvals fraudulently obtained, and any other actions taken to substantially limit potential or actual adverse effects on the public health,
    - (D) whether the extent to which changes in ownership, management, or operations have corrected the causes of any offense involved and provide reasonable assurances that the offense will not occur in the future,
    - (E) whether the [person](/usc/21/321.md?p=e) to be debarred is able to present adequate evidence that current production of [drugs](/usc/21/321.md?p=g-1) subject to [abbreviated drug applications](/usc/21/321.md?p=aa) and all pending [abbreviated drug applications](/usc/21/321.md?p=aa) are free of fraud or material false statements, and
    - (F) prior convictions under this chapter or under other Acts involving matters within the jurisdiction of the [Food](/usc/21/321.md?p=f) and [Drug](/usc/21/321.md?p=g-1) Administration.
- (d) **Termination of debarment—**
  - (1) **Application—** Any [person](/usc/21/321.md?p=e) that is debarred under [subsection (a)](#a) (other than a [person](/usc/21/321.md?p=e) permanently debarred) or any [person](/usc/21/321.md?p=e) that is debarred under [subsection (b)](#b) may apply to the [Secretary](/usc/21/321.md?p=d) for termination of the debarment under this subsection. Any information submitted to the [Secretary](/usc/21/321.md?p=d) under this paragraph does not constitute an amendment or supplement to pending or approved [abbreviated drug applications](/usc/21/321.md?p=aa).
  - (2) **Deadline—** The [Secretary](/usc/21/321.md?p=d) shall grant or deny any application respecting a debarment which is submitted under [paragraph (1)](#d-1) within 180 days of the date the application is submitted.
  - (3) **Action by the Secretary—**
    - (A) **Corporations—**
      - (i) **Conviction reversal—** If the conviction which served as the basis for the debarment of a [person](/usc/21/321.md?p=e) under [subsection (a)(1)](#a-1) or paragraph [(2)(A)](#b-2-A) or [(3)](#b-3) of subsection (b) is reversed, the [Secretary](/usc/21/321.md?p=d) shall withdraw the order of debarment.
      - (ii) **Application—** Upon application submitted under [paragraph (1)](#d-1), the [Secretary](/usc/21/321.md?p=d) shall terminate the debarment of a [person](/usc/21/321.md?p=e) if the [Secretary](/usc/21/321.md?p=d) finds that—
        - (I) changes in ownership, management, or operations have fully corrected the causes of the offense involved and provide reasonable assurances that the offense will not occur in the future, and
        - (II) in applicable cases, sufficient audits, conducted by the [Food](/usc/21/321.md?p=f) and [Drug](/usc/21/321.md?p=g-1) Administration or by independent experts acceptable to the [Food](/usc/21/321.md?p=f) and [Drug](/usc/21/321.md?p=g-1) Administration, demonstrate that pending applications and the development of [drugs](/usc/21/321.md?p=g-1) being tested before the submission of an application are free of fraud or material false statements.

      In the case of [persons](/usc/21/321.md?p=e) debarred under [subsection (a)(1)](#a-1), such termination shall take effect no earlier than the expiration of one year from the date of the debarment.

    - (B) **Individuals—**
      - (i) **Conviction reversal—** If the conviction which served as the basis for the debarment of an individual under [subsection (a)(2)](#a-2) or clause [(i)](#b-2-B-i), [(ii)](#b-2-B-ii), [(iii)](#b-2-B-iii), or [(iv)](#b-2-B-iv) of subsection (b)(2)(B) or [subsection (b)(3)](#b-3) is reversed, the [Secretary](/usc/21/321.md?p=d) shall withdraw the order of debarment.
      - (ii) **Application—** Upon application submitted under [paragraph (1)](#d-1), the [Secretary](/usc/21/321.md?p=d) shall terminate the debarment of an individual who has been debarred under [subsection (b)(2)(B)](#b-2-B) or [subsection (b)(3)](#b-3) if such termination serves the interests of justice and adequately protects the integrity of the [drug](/usc/21/321.md?p=g-1) approval process or the [food](/usc/21/321.md?p=f) importation process, as the case may be.
  - (4) **Special termination—**
    - (A) **Application—** Any [person](/usc/21/321.md?p=e) that is debarred under [subsection (a)(1)](#a-1) (other than a [person](/usc/21/321.md?p=e) permanently debarred under [subsection (c)(2)(A)(i)](#c-2-A-i)) or any individual who is debarred under [subsection (a)(2)](#a-2) may apply to the [Secretary](/usc/21/321.md?p=d) for special termination of debarment under this subsection. Any information submitted to the [Secretary](/usc/21/321.md?p=d) under this subparagraph does not constitute an amendment or supplement to pending or approved [abbreviated drug applications](/usc/21/321.md?p=aa).
    - (B) **Corporations—** Upon an application submitted under [subparagraph (A)](#d-4-A), the [Secretary](/usc/21/321.md?p=d) may take the action described in [subparagraph (D)](#d-4-D) if the [Secretary](/usc/21/321.md?p=d), after an [informal hearing](/usc/21/321.md?p=x), finds that—
      - (i) the [person](/usc/21/321.md?p=e) making the application under [subparagraph (A)](#d-4-A) has demonstrated that the felony conviction which was the basis for such [person](/usc/21/321.md?p=e)’s debarment involved the commission of an offense which was not [authorized](/usc/21/360eee.md?p=2), requested, commanded, performed, or recklessly tolerated by the board of directors or by a [high managerial agent](/usc/21/321.md?p=cc) acting on behalf of the [person](/usc/21/321.md?p=e) within the scope of the board’s or agent’s office or employment,
      - (ii) all individuals who were involved in the commission of the offense or who [knew](/usc/21/321.md?p=bb) or should have known of the offense have been removed from employment involving the development or approval of any [drug](/usc/21/321.md?p=g-1) subject to sections[^1] [355](/usc/21/355.md) of this title,
      - (iii) the [person](/usc/21/321.md?p=e) fully cooperated with all investigations and promptly disclosed all wrongdoing to the appropriate authorities, and
      - (iv) the [person](/usc/21/321.md?p=e) acted to mitigate any impact on the public of any offense involved, including the recall, or the discontinuation of the [distribution](/usc/21/360eee.md?p=5), of any [drug](/usc/21/321.md?p=g-1) with respect to which the [Secretary](/usc/21/321.md?p=d) requested a recall or discontinuation of [distribution](/usc/21/360eee.md?p=5) due to concerns about the safety or efficacy of the [drug](/usc/21/321.md?p=g-1).
    - (C) **Individuals—** Upon an application submitted under [subparagraph (A)](#d-4-A), the [Secretary](/usc/21/321.md?p=d) may take the action described in [subparagraph (D)](#d-4-D) if the [Secretary](/usc/21/321.md?p=d), after an [informal hearing](/usc/21/321.md?p=x), finds that such individual has provided substantial assistance in the investigations or prosecutions of offenses which are described in subsection [(a)](#a) or [(b)](#b) or which relate to any matter under the jurisdiction of the [Food](/usc/21/321.md?p=f) and [Drug](/usc/21/321.md?p=g-1) Administration.
    - (D) **Secretarial action—** The action referred to in subparagraphs [(B)](#d-4-B) and [(C)](#d-4-C) is—
      - (i) in the case of a [person](/usc/21/321.md?p=e) other than an individual—
        - (I) terminating the debarment immediately, or
        - (II) limiting the period of debarment to less than one year, and
      - (ii) in the case of an individual, limiting the period of debarment to less than permanent but to no less than 1 year,

      whichever best serves the interest of justice and protects the integrity of the [drug](/usc/21/321.md?p=g-1) approval process.

- (e) **Publication and list of debarred persons—** The [Secretary](/usc/21/321.md?p=d) shall publish in the Federal Register the name of any [person](/usc/21/321.md?p=e) debarred under subsection [(a)](#a) or [(b)](#b), the effective date of the debarment, and the period of the debarment. The [Secretary](/usc/21/321.md?p=d) shall also maintain and make available to the public a list, updated no less often than quarterly, of such [persons](/usc/21/321.md?p=e), of the effective dates and minimum periods of such debarments, and of the termination of debarments.
- (f) **Temporary denial of approval—**
  - (1) **In general—** The [Secretary](/usc/21/321.md?p=d), on the [Secretary](/usc/21/321.md?p=d)’s own initiative or in response to a petition, may, in accordance with [paragraph (3)](#f-3), refuse by order, for the period prescribed by [paragraph (2)](#f-2), to approve any [abbreviated drug application](/usc/21/321.md?p=aa) submitted by any [person](/usc/21/321.md?p=e)—
    - (A) if such [person](/usc/21/321.md?p=e) is under an active Federal criminal investigation in connection with an action described in [subparagraph (B)](#f-1-B),
    - (B) if the [Secretary](/usc/21/321.md?p=d) finds that such [person](/usc/21/321.md?p=e)—
      - (i) has bribed or attempted to bribe, has paid or attempted to pay an illegal gratuity, or has induced or attempted to induce another [person](/usc/21/321.md?p=e) to bribe or pay an illegal gratuity to any officer, employee, or agent of the [Department](/usc/21/321.md?p=c) of Health and Human Services or to any other Federal, [State](/usc/21/321.md?p=a-1), or local official in connection with any [abbreviated drug application](/usc/21/321.md?p=aa), or has conspired to commit, or aided or abetted, such actions, or
      - (ii) has [knowingly](/usc/21/321.md?p=bb) made or caused to be made a pattern or practice of false statements or misrepresentations with respect to material facts relating to any [abbreviated drug application](/usc/21/321.md?p=aa), or the production of any [drug](/usc/21/321.md?p=g-1) subject to an [abbreviated drug application](/usc/21/321.md?p=aa), to any officer, employee, or agent of the [Department](/usc/21/321.md?p=c) of Health and Human Services, or has conspired to commit, or aided or abetted, such actions, and
    - (C) if a significant question has been raised regarding—
      - (i) the integrity of the approval process with respect to such [abbreviated drug application](/usc/21/321.md?p=aa), or
      - (ii) the reliability of data in or concerning such [person](/usc/21/321.md?p=e)’s [abbreviated drug application](/usc/21/321.md?p=aa).

    Such an order may be modified or terminated at any time.

  - (2) **Applicable period—**
    - (A) **In general—** Except as provided in [subparagraph (B)](#f-2-B), a denial of approval of an application of a [person](/usc/21/321.md?p=e) under [paragraph (1)](#f-1) shall be in effect for a period determined by the [Secretary](/usc/21/321.md?p=d) but not to exceed 18 months beginning on the date the [Secretary](/usc/21/321.md?p=d) finds that the conditions described in subparagraphs [(A)](#f-1-A), [(B)](#f-1-B), and [(C)](#f-1-C) of paragraph (1) exist. The [Secretary](/usc/21/321.md?p=d) shall terminate such denial—
      - (i) if the investigation with respect to which the finding was made does not result in a criminal charge against such [person](/usc/21/321.md?p=e), if criminal charges have been brought and the charges have been dismissed, or if a judgment of acquittal has been entered, or
      - (ii) if the [Secretary](/usc/21/321.md?p=d) determines that such finding was in error.
    - (B) **Extension—** If, at the end of the period described in [subparagraph (A)](#f-2-A), the [Secretary](/usc/21/321.md?p=d) determines that a [person](/usc/21/321.md?p=e) has been criminally charged for an action described in [subparagraph (B)](#f-1-B) of paragraph (1), the [Secretary](/usc/21/321.md?p=d) may extend the period of denial of approval of an application for a period not to exceed 18 months. The [Secretary](/usc/21/321.md?p=d) shall terminate such extension if the charges have been dismissed, if a judgment of acquittal has been entered, or if the [Secretary](/usc/21/321.md?p=d) determines that the finding described in [subparagraph (A)](#f-2-A) was in error.
  - (3) **Informal hearing—** Within 10 days of the date an order is issued under [paragraph (1)](#f-1), the [Secretary](/usc/21/321.md?p=d) shall provide such [person](/usc/21/321.md?p=e) with an opportunity for an [informal hearing](/usc/21/321.md?p=x), to be held within such 10 days, on the decision of the [Secretary](/usc/21/321.md?p=d) to refuse approval of an [abbreviated drug application](/usc/21/321.md?p=aa). Within 60 days of the date on which such hearing is held, the [Secretary](/usc/21/321.md?p=d) shall notify the [person](/usc/21/321.md?p=e) given such hearing whether the [Secretary](/usc/21/321.md?p=d)’s refusal of approval will be continued, terminated, or otherwise modified. Such notification shall be final agency action.
- (g) **Suspension authority—**
  - (1) **In general—** If—
    - (A) the [Secretary](/usc/21/321.md?p=d) finds—
      - (i) that a [person](/usc/21/321.md?p=e) has engaged in conduct described in [subparagraph (B)](#f-1-B) of subsection (f)(1) in connection with 2 or more [drugs](/usc/21/321.md?p=g-1) under [abbreviated drug applications](/usc/21/321.md?p=aa), or
      - (ii) that a [person](/usc/21/321.md?p=e) has engaged in flagrant and repeated, material violations of good manufacturing practice or good laboratory practice in connection with the development, manufacturing, or [distribution](/usc/21/360eee.md?p=5) of one or more [drugs](/usc/21/321.md?p=g-1) approved under an [abbreviated drug application](/usc/21/321.md?p=aa) during a 2-year period, and—
        - (I) such violations may undermine the safety and efficacy of such [drugs](/usc/21/321.md?p=g-1), and
        - (II) the causes of such violations have not been corrected within a reasonable period of time following notice of such violations by the [Secretary](/usc/21/321.md?p=d), and
    - (B) such [person](/usc/21/321.md?p=e) is under an active investigation by a Federal authority in connection with a civil or criminal action involving conduct described in [subparagraph (A)](#g-1-A),

    the [Secretary](/usc/21/321.md?p=d) shall issue an order suspending the [distribution](/usc/21/360eee.md?p=5) of all [drugs](/usc/21/321.md?p=g-1) the development or approval of which was related to such conduct described in [subparagraph (A)](#g-1-A) or suspending the [distribution](/usc/21/360eee.md?p=5) of all [drugs](/usc/21/321.md?p=g-1) approved under [abbreviated drug applications](/usc/21/321.md?p=aa) of such [person](/usc/21/321.md?p=e) if the [Secretary](/usc/21/321.md?p=d) finds that such conduct may have affected the development or approval of a significant number of [drugs](/usc/21/321.md?p=g-1) which the [Secretary](/usc/21/321.md?p=d) is unable to identify. The [Secretary](/usc/21/321.md?p=d) shall exclude a [drug](/usc/21/321.md?p=g-1) from such order if the [Secretary](/usc/21/321.md?p=d) determines that such conduct was not likely to have influenced the safety or efficacy of such [drug](/usc/21/321.md?p=g-1).

  - (2) **Public health waiver—** The [Secretary](/usc/21/321.md?p=d) shall, on the [Secretary](/usc/21/321.md?p=d)’s own initiative or in response to a petition, waive the suspension under [paragraph (1)](#g-1) (involving an action described in [paragraph (1)(A)(i)](#g-1-A-i)) with respect to any [drug](/usc/21/321.md?p=g-1) if the [Secretary](/usc/21/321.md?p=d) finds that such waiver is necessary to protect the public health because sufficient quantities of the [drug](/usc/21/321.md?p=g-1) would not otherwise be available. The [Secretary](/usc/21/321.md?p=d) shall act on any petition seeking action under this paragraph within 180 days of the date the petition is submitted to the [Secretary](/usc/21/321.md?p=d).
- (h) **Termination of suspension—** The [Secretary](/usc/21/321.md?p=d) shall withdraw an order of suspension of the [distribution](/usc/21/360eee.md?p=5) of a [drug](/usc/21/321.md?p=g-1) under [subsection (g)](#g) if the [person](/usc/21/321.md?p=e) with respect to whom the order was issued demonstrates in a petition to the [Secretary](/usc/21/321.md?p=d)—
  - (1)
    - (A) on the basis of an audit by the [Food](/usc/21/321.md?p=f) and [Drug](/usc/21/321.md?p=g-1) Administration or by experts acceptable to the [Food](/usc/21/321.md?p=f) and [Drug](/usc/21/321.md?p=g-1) Administration, or on the basis of other information, that the development, approval, manufacturing, and [distribution](/usc/21/360eee.md?p=5) of such [drug](/usc/21/321.md?p=g-1) is in substantial compliance with the applicable requirements of this chapter, and
    - (B) changes in ownership, management, or operations—
      - (i) fully remedy the patterns or practices with respect to which the order was issued, and
      - (ii) provide reasonable assurances that such actions will not occur in the future, or
  - (2) the initial determination was in error.

  The [Secretary](/usc/21/321.md?p=d) shall act on a submission of a petition under this subsection within 180 days of the date of its submission and the [Secretary](/usc/21/321.md?p=d) may consider the petition concurrently with the suspension proceeding. Any information submitted to the [Secretary](/usc/21/321.md?p=d) under this subsection does not constitute an amendment or supplement to a pending or approved [abbreviated drug application](/usc/21/321.md?p=aa).

- (i) **Procedure—** The [Secretary](/usc/21/321.md?p=d) may not take any action under subsection [(a)](#a), [(b)](#b), [(c)](#c), [(d)(3)](#d-3), [(g)](#g), or [(h)](#h) with respect to any [person](/usc/21/321.md?p=e) unless the [Secretary](/usc/21/321.md?p=d) has issued an order for such action made on the record after opportunity for an agency hearing on disputed issues of material fact. In the course of any investigation or hearing under this subsection, the [Secretary](/usc/21/321.md?p=d) may administer oaths and affirmations, examine witnesses, receive evidence, and issue subpoenas requiring the attendance and testimony of witnesses and the production of evidence that relates to the matter under investigation.
- (j) **Judicial review—**
  - (1) **In general—** Except as provided in [paragraph (2)](#j-2), any [person](/usc/21/321.md?p=e) that is the subject of an adverse decision under subsection [(a)](#a), [(b)](#b), [(c)](#c), [(d)](#d), [(f)](#f), [(g)](#g), or [(h)](#h) may obtain a review of such decision by the United States Court of Appeals for the District of Columbia or for the circuit in which the [person](/usc/21/321.md?p=e) resides, by filing in such court (within 60 days following the date the [person](/usc/21/321.md?p=e) is notified of the [Secretary](/usc/21/321.md?p=d)’s decision) a petition requesting that the decision be modified or set aside.
  - (2) **Exception—** Any [person](/usc/21/321.md?p=e) that is the subject of an adverse decision under clause [(iii)](#b-2-B-iii) or [(iv)](#b-2-B-iv) of subsection (b)(2)(B) may obtain a review of such decision by the United States District Court for the District of Columbia or a district court of the United States for the district in which the [person](/usc/21/321.md?p=e) resides, by filing in such court (within 30 days following the date the [person](/usc/21/321.md?p=e) is notified of the [Secretary](/usc/21/321.md?p=d)’s decision) a complaint requesting that the decision be modified or set aside. In such an action, the court shall determine the matter de novo.
- (k) **Certification—** Any application for approval of a [drug product](/usc/21/321.md?p=dd) shall include—
  - (1) a certification that the applicant did not and will not use in any capacity the services of any [person](/usc/21/321.md?p=e) debarred under subsection [(a)](#a) or [(b)](#b), in connection with such application, and
  - (2) if such application is an [abbreviated drug application](/usc/21/321.md?p=aa), a list of all convictions, described in subsections [(a)](#a) and [(b)](#b) which occurred within the previous 5 years, of the applicant and affiliated [persons](/usc/21/321.md?p=e) responsible for the development or submission of such application.
- (l) **Applicability—**
  - (1) **Conviction—** For purposes of this section, a [person](/usc/21/321.md?p=e) is considered to have been convicted of a criminal offense—
    - (A) when a judgment of conviction has been entered against the [person](/usc/21/321.md?p=e) by a Federal or [State](/usc/21/321.md?p=a-1) court, regardless of whether there is an appeal pending,
    - (B) when a plea of guilty or nolo contendere by the [person](/usc/21/321.md?p=e) has been accepted by a Federal or [State](/usc/21/321.md?p=a-1) court, or
    - (C) when the [person](/usc/21/321.md?p=e) has entered into participation in a first offender, deferred adjudication, or other similar arrangement or program where judgment of conviction has been withheld.
  - (2) **Effective dates—** [Subsection (a)](#a), [subparagraph (A)](#b-2-A) of subsection (b)(2), clauses [(i)](#b-2-B-i) and [(ii)](#b-2-B-ii) of subsection (b)(2)(B), and [subsection (b)(3)(A)](#b-3-A) shall not apply to a conviction which occurred more than 5 years before the initiation of an agency action proposed to be taken under subsection [(a)](#a) or [(b)](#b). Clauses [(iii)](#b-2-B-iii) and [(iv)](#b-2-B-iv) of subsection (b)(2)(B), [subsection (b)(3)(B)](#b-3-B), and subsections [(f)](#f) and [(g)](#g) shall not apply to an act or action which occurred more than 5 years before the initiation of an agency action proposed to be taken under subsection [(b)](#b), [(f)](#f), or [(g)](#g). [Clause (iv)](#b-2-B-iv) of subsection (b)(2)(B) shall not apply to an action which occurred before June 1, 1992. [Subsection (k)](#k) shall not apply to applications submitted to the [Secretary](/usc/21/321.md?p=d) before June 1, 1992.
- (m) **Devices; mandatory debarment regarding third-party inspections and reviews—**
  - (1) **In general—** If the [Secretary](/usc/21/321.md?p=d) finds that a [person](/usc/21/321.md?p=e) has been convicted of a felony under [section 331(gg) of this title](/usc/21/331.md?p=gg), the [Secretary](/usc/21/321.md?p=d) shall debar such [person](/usc/21/321.md?p=e) from being accredited under section [360m(b)](/usc/21/360m.md?p=b) or [374(g)(2)](/usc/21/374.md?p=g-2) of this title and from carrying out activities under an agreement described in [section 383(b) of this title](/usc/21/383.md?p=b).
  - (2) **Debarment period—** The [Secretary](/usc/21/321.md?p=d) shall debar a [person](/usc/21/321.md?p=e) under [paragraph (1)](#m-1) for the following periods:
    - (A) The period of debarment of a [person](/usc/21/321.md?p=e) (other than an individual) shall not be less than 1 year or more than 10 years, but if an act leading to a subsequent debarment under such paragraph occurs within 10 years after such [person](/usc/21/321.md?p=e) has been debarred under such paragraph, the period of debarment shall be permanent.
    - (B) The debarment of an individual shall be permanent.
  - (3) **Termination of debarment; judicial review; other matters—** Subsections [(c)(3)](#c-3), [(d)](#d), [(e)](#e), [(i)](#i), [(j)](#j), and [(l)(1)](#l-1) apply with respect to a [person](/usc/21/321.md?p=e) (other than an individual) or an individual who is debarred under [paragraph (1)](#m-1) to the same extent and in the same manner as such subsections apply with respect to a [person](/usc/21/321.md?p=e) who is debarred under [subsection (a)(1)](#a-1), or an individual who is debarred under [subsection (a)(2)](#a-2), respectively.

## Footnotes

[^1]: So in original. Probably should be “section”.

## Source credit

(June 25, 1938, ch. 675, § 306, as added Pub. L. 102–282, § 2, May 13, 1992, 106 Stat. 150; amended Pub. L. 105–115, title I, § 125(b)(2)(C), Nov. 21, 1997, 111 Stat. 2325; Pub. L. 107–188, title III, § 304(a)–(c), June 12, 2002, 116 Stat. 665, 666; Pub. L. 107–250, title II, § 203, Oct. 26, 2002, 116 Stat. 1610; Pub. L. 115–271, title III, § 3022(b)(2), Oct. 24, 2018, 132 Stat. 3938.)

## Notes

### Editorial Notes

### Prior Provisions

A prior section 306 of act June 25, 1938, was renumbered section 309 and is classified to section 336 of this title.

### Amendments

2018—Subsec. (b)(1). Pub. L. 115–271, § 3022(b)(2)(A)(i), inserted “or (3)” after “paragraph (2)” in introductory provisions.

Subsec. (b)(1)(D). Pub. L. 115–271, § 3022(b)(2)(A)(ii)–(v), added subpar. (D).

Subsec. (b)(3). Pub. L. 115–271, § 3022(b)(2)(B)(i), inserted “or drug” after “food” in heading.

Subsec. (b)(3)(C), (D). Pub. L. 115–271, § 3022(b)(2)(B)(ii)–(iv), added subpars. (C) and (D).

Subsec. (b)(5). Pub. L. 115–271, § 3022(b)(2)(C), added par. (5).

2002—Subsec. (a). Pub. L. 107–188, § 304(b)(1), substituted “Mandatory debarment; certain drug applications” for “Mandatory debarment” in heading.

Subsec. (b). Pub. L. 107–188, § 304(b)(2)(A), substituted “Permissive debarment; certain drug applications; food imports” for “Permissive debarment” in heading.

Subsec. (b)(1)(C). Pub. L. 107–188, § 304(a)(1), added subpar. (C).

Subsec. (b)(2). Pub. L. 107–188, § 304(b)(2)(B), substituted “permissive debarment; certain drug applications” for “permissive debarment” in heading.

Pub. L. 107–188, § 304(a)(2)(A), inserted “subparagraph (A) or (B) of” before “paragraph (1)” in introductory provisions.

Subsec. (b)(3), (4). Pub. L. 107–188, § 304(a)(2)(B), (C), added par. (3) and redesignated former par. (3) as (4).

Subsec. (c)(2)(A)(iii). Pub. L. 107–188, § 304(b)(3), substituted “paragraph (2) or (3) of subsection (b)” for “subsection (b)(2)”.

Subsec. (d)(3)(A)(i). Pub. L. 107–188, § 304(b)(4)(A), substituted “subsection (a)(1) or paragraph (2)(A) or (3) of subsection (b)” for “subsection (a)(1) or (b)(2)(A)”.

Subsec. (d)(3)(A)(ii)(II). Pub. L. 107–188, § 304(b)(4)(B), inserted “in applicable cases,” before “sufficient audits”.

Subsec. (d)(3)(B)(i). Pub. L. 107–188, § 304(b)(4)(C), inserted “or subsection (b)(3)” after “subsection (b)(2)(B)”.

Subsec. (d)(3)(B)(ii). Pub. L. 107–188, § 304(b)(4)(C), (D), inserted “or subsection (b)(3)” after “subsection (b)(2)(B)” and “or the food importation process, as the case may be” before period.

Subsec. (l)(2). Pub. L. 107–188, § 304(c), in first sentence struck out “and” after “subsection (b)(2),” and inserted “, and subsection (b)(3)(A)” after “subsection (b)(2)(B)” and in second sentence inserted “, subsection (b)(3)(B),” after “subsection (b)(2)(B)”.

Subsec. (m). Pub. L. 107–250 added subsec. (m).

1997—Subsec. (d)(4)(B)(ii). Pub. L. 105–115 struck out “or 357” after “355”.

### Statutory Notes and Related Subsidiaries

### Construction

Pub. L. 102–282, § 7, May 13, 1992, 106 Stat. 162, provided that: “No amendment made by this Act [enacting this section and sections 335b and 335c of this title and amending sections 321, 336, 337, and 355 of this title] shall preclude any other civil, criminal, or administrative remedy provided under Federal or State law, including any private right of action against any person for the same action subject to any action or civil penalty under an amendment made by this Act.”

### Congressional Findings

Pub. L. 102–282, § 1(c), May 13, 1992, 106 Stat. 149, provided that: “The Congress finds that— there is substantial evidence that significant corruption occurred in the Food and Drug Administration’s process of approving drugs under abbreviated drug applications, there is a need to establish procedures designed to restore and to ensure the integrity of the abbreviated drug application approval process and to protect the public health, and there is a need to establish procedures to bar individuals who have been convicted of crimes pertaining to the regulation of drug products from working for companies that manufacture or distribute such products.”