WHAT THE LAW DOINCongress, in plain words

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

21 U.S.C. 356c: Discontinuance or interruption in the production of life-saving drugs

Created in 1997 by the Food and Drug Administration Modernization Act of 1997 (Public Law 105-115). Changed by 4 later laws. 1 bill in this Congress would change it.

4 other sections of the Code cite this one, including 21 U.S.C. 356c–1, 21 U.S.C. 356d, 21 U.S.C. 356e, 21 U.S.C. 374.

3 parts of federal rules cite it as their authority, written by Food and Drug Administration, Department of Health and Human Services (3).

This Congress

  • S. 2665 Drug Shortage Prevention Act of 2025 · introduced · would change (g), (h), (j)

How it got here

2022

  • Pub. L. 117–328, §2515(b)(1), substituted "in the United States," for "in the United States,," in concluding provisions. (Consolidated Appropriations Act, 2023) Law text · (a)
  • Pub. L. 117–328, §2515(a)(1), made technical amendment to directory language of Pub. L. 116–136, §3111(1). See 2020 Amendment note below. (Consolidated Appropriations Act, 2023) Law text · (g)

2020

  • Pub. L. 116–136, §3112(a)(2), in concluding provisions, inserted ", or a permanent discontinuance in the manufacture of an active pharmaceutical ingredient or an interruption in the manufacture of the active pharmaceutical ingredient of such drug that is likely to lead to a meaningful … (Coronavirus Aid, Relief, and Economic Security Act" or the "CARES Act) Law text · (a)
  • Pub. L. 116–136, §3112(a)(1), inserted "or any such drug that is critical to the public health during a public health emergency declared by the Secretary under section 247d of title 42" after "during surgery". (Coronavirus Aid, Relief, and Economic Security Act" or the "CARES Act) Law text · (a)
  • Pub. L. 116–136, §3111(1), as amended by Pub. L. 117–328, §2515(a)(1), substituted "the Secretary shall, as appropriate" for "the Secretary may" in introductory provisions. (Coronavirus Aid, Relief, and Economic Security Act" or the "CARES Act) Law text · (g)
  • Pub. L. 116–136, §3111(2), inserted "prioritize and" before "expedite the review". (Coronavirus Aid, Relief, and Economic Security Act" or the "CARES Act) Law text · (g)
  • Pub. L. 116–136, §3111(3), inserted "prioritize and" before "expedite an inspection". (Coronavirus Aid, Relief, and Economic Security Act" or the "CARES Act) Law text · (g)
  • Pub. L. 116–136, §3112(b), added subsec. (j). (Coronavirus Aid, Relief, and Economic Security Act" or the "CARES Act) Law text · (j)

2016

  • Pub. L. 114–255, §3101(a)(2)(E)(i), substituted "discontinuance" for "discontinuation". (21st Century Cures Act) Law text · (c)
  • Pub. L. 114–255, §3101(a)(2)(E)(ii), substituted "section 355(j) of this title, that could help" for "section 355(j) of this title that could help". (21st Century Cures Act) Law text · (g)

2012

  • Pub. L. 112–144 amended section generally. Prior to amendment, section related to discontinuance of life saving products. (Food and Drug Administration Safety and Innovation Act) Law text

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.