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Ingested titles 12–51 and 54 from OLRC USLM XML @119-100 (the whole Code now, uniform edition; Title 53 is reserved/empty). LegalText 11,221 -> 59,740; repo total 105,704 records. Deterministic (byte-identical rerun, verified on Title 42's 8,356 sections); make check green. make legal-us-code default now covers every title. Co-Authored-By: Claude Opus 4.8 <noreply@anthropic.com>
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| LegalText | 21 U.S.C. § 335c | Authority to withdraw approval of abbreviated drug applications | us | united_states_code | code_section | 21 | FOOD AND DRUGS | 9 | FEDERAL FOOD, DRUG, AND COSMETIC ACT | 335c | 21 U.S.C. § 335c | current | 119-100 | 2026-06-26 | official | https://uscode.house.gov/download/releasepoints/us/pl/119/100/xml_usc21@119-100.zip | /us/usc/t21/s335c | data/legal/raw/us/code/title-21/usc21.xml | cc75bed73f9cefdf4aee5e5f8386ffb341b6d3404b5f8768fd9d86ca4b6661e1 | 3dbd7a61c8616baefb8459bd8dac3b93242106deb416308c8d4dd5a9143176d1 | 180b58dea767cf4a1b8c567536ae426a1ad51ec9be7cff8b2075610b8434f95a | 2026-07-04 | official |
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21 U.S.C. § 335c - Authority to withdraw approval of abbreviated drug applications
Text
(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.
(June 25, 1938, ch. 675, § 308, as added Pub. L. 102–282, § 4, May 13, 1992, 106 Stat. 160.)
Notes
Statutory Notes and Related Subsidiaries
ConstructionThis 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.