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21 U.S.C. § 335c — Authority to withdraw approval of abbreviated drug applications
Federal law — U.S. Code and appendices · legal_authorities
**(a) In general** The Secretary—
(1) shall withdraw approval of an abbreviated drug application if the Secretary finds that the approval was obtained, expedited, or otherwise facilitated through bribery, payment of an illegal gratuity, or fraud or material false statement, and
(2) may withdraw approval of an abbreviated drug application if the Secretary finds that the applicant has repeatedly demonstrated a lack of ability to produce the drug for which the application was submitted in accordance with the formulations or manufacturing practice set forth in the abbreviated drug application and has introduced, or attempted to introduce, such adulterated or misbranded drug into commerce.
**(b) Procedure** The Secretary may not take any action under subsection (a) with respect to any person unless the Secretary 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 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.
**(c) Applicability** Subsection (a) shall apply with respect to offenses or acts regardless of when such offenses or acts occurred.
**(d) Judicial review** Any person that is the subject of an adverse decision under subsection (a) 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 resides, by filing in such court (within 60 days following the date the person is notified of the Secretary’s decision) a petition requesting that the decision
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Source file: Laws/federal/codes/united-states-code/title-21/section-335c-authority-to-withdraw-approval-of-abbreviated-drug-applications--044bfe6995.md
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Source location: Title 21, Chapter 9, § 335c; chapter-009-federal-food-drug-and-cosmetic-act.md
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**(a) In general** The Secretary—
(1) shall withdraw approval of an abbreviated drug application if the Secretary finds that the approval was obtained, expedited, or otherwise facilitated through bribery, payment of an illegal gratuity, or fraud or material false statement, and
(2) may withdraw approval of an abbreviated drug application if the Secretary finds that the applicant has repeatedly demonstrated a lack of ability to produce the drug for which the application was submitted in accordance with the formulations or manufacturing practice set forth in the abbreviated drug application and has introduced, or attempted to introduce, such adulterated or misbranded drug into commerce.
**(b) Procedure** The Secretary may not take any action under subsection (a) with respect to any person unless the Secretary 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 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.
**(c) Applicability** Subsection (a) shall apply with respect to offenses or acts regardless of when such offenses or acts occurred.
**(d) Judicial review** Any person that is the subject of an adverse decision under subsection (a) 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 resides, by filing in such court (within 60 days following the date the person is notified of the Secretary’s decision) a petition requesting that the decision be modified or set aside.
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Federal law — U.S. Code and appendices · legal_authorities
**(a) Mandatory debarment; certain drug applications**
(1) **Corporations, partnerships, and associations** — If the Secretary finds that a person 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, the Secretary shall debar such person from submitting, or assisting in the submission of, any such application.
(2) **Individuals** — If the Secretary 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, or
(B) otherwise relating to the regulation of any drug product under this chapter,
the Secretary shall debar such individual from providing services in any capacity to a person that has an approved or pending drug product application.
**(b) Permissive debarment; certain drug applications; food imports**
(1) **In general** — The Secretary, on the Secretary’s own initiative or in response to a petition, may, in accordance with paragraph (2) or (3), debar—
(A) a person other than an individual from submitting or assisting in the submission of any abbreviated drug application;
(B) an individual from providing services in any capacity to a person that has an approved or pending drug product application;
(C) a person from importing an article of food or offering such an article for import into the United States; or
(D) a person from importing or offering for import into the United States a drug.
(2) **Persons subject to permissive debarment; certain drug applications** — The following persons are subject to debarment under sub
Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 335a
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Federal law — U.S. Code and appendices · legal_authorities
Page 76
TITLE 21—FOOD AND DRUGS
§ 335c
(1) $250,000, or
(2) one-half of the penalty so imposed and
collected,
whichever is less. The decision of the Secretary
on such award shall not be reviewable.
(June 25, 1938, ch. 675, § 307, as added Pub. L.
102–282, § 3, May 13, 1992, 106 Stat. 159; amended
Pub. L. 103–80, § 3(g), Aug. 13, 1993, 107 Stat. 776.)
Editorial Notes
PRIOR PROVISIONS
A prior section 307 of act June 25, 1938, was renum-
bered section 310 and is classified to section 337 of this
title.
AMENDMENTS
1993—Subsec. (b)(3)(A). Pub. L. 103–80 made technical
amendment to reference to May 13, 1992, to reflect cor-
rection of corresponding provision of original act.
Statutory Notes and Related Subsidiaries
CONSTRUCTION
This section not to 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 Pub. L.
102–282, see section 7 of Pub. L. 102–282, set out as a note
under section 335a of this title.
§ 335c. Authority to withdraw approval of abbre-
viated drug applications
(a) In general
The Secretary—
(1) shall withdraw approval of an abbre-
viated drug application if the Secretary finds
that the approval was obtained, expedited, or
otherwise facilitated through bribery, pay-
ment of an illegal gratuity, or fraud or mate-
rial false statement, and
(2) may withdraw approval of an abbreviated
drug application if the Secretary finds that
the applicant has repeatedly demonstrated a
lack of ability to produce the drug for which
the application was submitted in accordance
with the formulations or manufacturing prac-
tice set forth in the abbreviated drug applica-
t
Source: Supplied 2024 U.S. Code historical extraction · 21 U.S.C. § 335c
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