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Title 21, Food and DrugsRelease 119-110

§335c Authority to Withdraw Approval of Abbreviated Drug Applications

Title 21 › CHAPTER 9 — FEDERAL FOOD, DRUG, AND COSMETIC ACT › SUBCHAPTER III — PROHIBITED ACTS AND PENALTIES › § 335c

Last updated Sep 22, 2026|Official source

Summary

The Secretary must cancel approval of a generic drug application if the approval was gained through bribery, illegal gifts, or fraud or false statements. The Secretary may also cancel approval if the applicant keeps failing to make the drug as promised and has put, or tried to put, adulterated or misbranded product into the market. The Secretary cannot act without a written order after a hearing where the company can challenge the facts. During investigations the Secretary can take testimony, evidence, and issue subpoenas. The company can ask a U.S. Court of Appeals (D.C. or its home circuit) to review the decision within 60 days of notice.

Full Legal Text

Title 21, §335c

Food and Drugs, Source: USLM XML via OLRC

(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.

Legislative History

Notes & Related Subsidiaries

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.

Reference

Citations & Metadata

Citation

21 U.S.C. § 335c

Title 21, Food and Drugs

Last Updated

Sep 22, 2026

Release point: 119-110