WHAT THE LAW DOINCongress, in plain words

The law › Title 21, Food and Drugs › Chapter 9

21 U.S.C. 335a: Debarment, temporary denial of approval, and suspension

Created in 1992 by Public Law 102-282. Changed by 4 later laws. No bill we track in this Congress changes it.

4 other sections of the Code cite this one, including 21 U.S.C. 321, 21 U.S.C. 331, 21 U.S.C. 335b, 21 U.S.C. 381.

1 part of federal rules cite it as their authority, written by Food and Drug Administration, Department of Health and Human Services (1).

This Congress

No bill we track in the 119th Congress changes this section.

    How it got here

    2018

    • Pub. L. 115–271, §3022(b)(2)(A)(i), inserted "or (3)" after "paragraph (2)" in introductory provisions. (Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act" or the "SUPPORT for Patients and Communities Act) Law text · (b)
    • Pub. L. 115–271, §3022(b)(2)(A)(ii)–(v), added subpar. (D). (Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act" or the "SUPPORT for Patients and Communities Act) Law text · (b)
    • Pub. L. 115–271, §3022(b)(2)(B)(i), inserted "or drug" after "food" in heading. (Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act" or the "SUPPORT for Patients and Communities Act) Law text · (b)
    • Pub. L. 115–271, §3022(b)(2)(B)(ii)–(iv), added subpars. (C) and (D). (Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act" or the "SUPPORT for Patients and Communities Act) Law text · (b), (D)
    • Pub. L. 115–271, §3022(b)(2)(C), added par. (5). (Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act" or the "SUPPORT for Patients and Communities Act) Law text · (b)

    2002

    • Pub. L. 107–188, §304(b)(1), substituted "Mandatory debarment; certain drug applications" for "Mandatory debarment" in heading. (Public Health Security and Bioterrorism Preparedness and Response Act of 2002) Law text · (a)
    • Pub. L. 107–188, §304(b)(2)(A), substituted "Permissive debarment; certain drug applications; food imports" for "Permissive debarment" in heading. (Public Health Security and Bioterrorism Preparedness and Response Act of 2002) Law text · (b)
    • Pub. L. 107–188, §304(a)(1), added subpar. (C). (Public Health Security and Bioterrorism Preparedness and Response Act of 2002) Law text · (b)
    • Pub. L. 107–188, §304(b)(2)(B), substituted "permissive debarment; certain drug applications" for "permissive debarment" in heading. (Public Health Security and Bioterrorism Preparedness and Response Act of 2002) Law text · (b)
    • Pub. L. 107–188, §304(a)(2)(A), inserted "subparagraph (A) or (B) of" before "paragraph (1)" in introductory provisions. (Public Health Security and Bioterrorism Preparedness and Response Act of 2002) Law text · (b)
    • Pub. L. 107–188, §304(a)(2)(B), (C), added par. (3) and redesignated former par. (3) as (4). (Public Health Security and Bioterrorism Preparedness and Response Act of 2002) Law text · (b), (4)
    • Pub. L. 107–188, §304(b)(3), substituted "paragraph (2) or (3) of subsection (b)" for "subsection (b)(2)". (Public Health Security and Bioterrorism Preparedness and Response Act of 2002) Law text · (c)
    • 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)". (Public Health Security and Bioterrorism Preparedness and Response Act of 2002) Law text · (d)
    • Pub. L. 107–188, §304(b)(4)(B), inserted "in applicable cases," before "sufficient audits". (Public Health Security and Bioterrorism Preparedness and Response Act of 2002) Law text · (d)
    • Pub. L. 107–188, §304(b)(4)(C), inserted "or subsection (b)(3)" after "subsection (b)(2)(B)". (Public Health Security and Bioterrorism Preparedness and Response Act of 2002) Law text · (d)
    • 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. (Public Health Security and Bioterrorism Preparedness and Response Act of 2002) Law text · (d)
    • 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)". (Public Health Security and Bioterrorism Preparedness and Response Act of 2002) Law text · (l)
    • Pub. L. 107–250 added subsec. (m). (Medical Device User Fee and Modernization Act of 2002) Law text · (m)

    1997

    • Pub. L. 105–115 struck out "or 357" after "355". (Food and Drug Administration Modernization Act of 1997) Law text · (d)

    Text, outline and history from the official U.S. Code (2024 edition) on GovInfo, published by the Office of the Law Revision Counsel. Changes made after that edition appear under This Congress.