WHAT THE LAW DOINCongress, in plain words

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

21 U.S.C. 351: Adulterated drugs and devices

Created in 1960 by Public Law 86-618. Changed by 8 later laws. 1 bill in this Congress would change it.

12 other sections of the Code cite this one, including 21 U.S.C. 333, 21 U.S.C. 360, 21 U.S.C. 360a–1, 21 U.S.C. 360b, 21 U.S.C. 360c.

105 parts of federal rules cite it as their authority, written by Food and Drug Administration, Department of Health and Human Services (105).

This Congress

  • H.R. 9877 Health Equity and Accountability Act of 2026 · introduced · would change 505H

How it got here

2017

  • Pub. L. 115–52 inserted "or device" after "drug". (FDA Reauthorization Act of 2017) Law text · (j)

2012

  • Pub. L. 112–144, §711, inserted concluding provisions. (Food and Drug Administration Safety and Innovation Act) Law text
  • Pub. L. 112–144, §608(b)(2)(A)(i), substituted "an order issued" for "a regulation promulgated". (Food and Drug Administration Safety and Innovation Act) Law text · (f)
  • Pub. L. 112–144, §608(b)(2)(A)(ii), substituted "issuance of such order" for "promulgation of such regulation". (Food and Drug Administration Safety and Innovation Act) Law text · (f)
  • Pub. L. 112–144, §608(b)(2)(B), substituted "an order issued" for "a regulation promulgated" in introductory provisions and "issuance of such order" for "promulgation of such regulation" in subcl. (ii). (Food and Drug Administration Safety and Innovation Act) Law text · (f)
  • Pub. L. 112–144, §608(b)(2)(C), added subpar. (3). (Food and Drug Administration Safety and Innovation Act) Law text · (f)
  • Pub. L. 112–144, §707(a), added par. (j). (Food and Drug Administration Safety and Innovation Act) Law text · (j)

1997

  • Pub. L. 105–115, §121(b)(1), inserted "; or (C) if it is a compounded positron emission tomography drug and the methods used in, or the facilities and controls used for, its compounding, processing, packing, or holding do not conform to or are not operated or administered in conform… (Food and Drug Administration Modernization Act of 1997) Law text · (a)
  • Pub. L. 105–115, §204(c), designated existing provisions as subpar. (1) and added subpar. (2). (Food and Drug Administration Modernization Act of 1997) Law text · (e)

1992

  • Pub. L. 102–571 substituted "379e(a)" for "376(a)" in cls. (A) and (B). · (a)

1990

  • Pub. L. 101–629, §9(b), which directed the amendment of subpars. (A) to (C) of par. (f), was executed by making the amendments in cls. (A) to (C) of subpar. (1) of par. (f) as follows to reflect the probable intent of Congress: in cl. (A)(ii)(II), substituted ", suspended, or withdrawn… · (f)

1976

  • Pub. L. 94–295, §9(b)(1), substituted "(3) if its" for "(3) if it is a drug and its" in cl. (3), substituted "(4) if (A) it bears or contains" for "(4) if (A) it is a drug which bears or contains" in cl. (4)(A), and substituted "drugs or devices" for "drugs" in cl. (4)(B). · (a)
  • Pub. L. 94–295, §3(d), added pars. (e) to (i). · (e), (f), (g), (h), (i)

1968

  • Pub. L. 90–399 added cls. (5) and (6). · (a)

1962

  • Pub. L. 87–781 designated existing provisions of cl. (2) as (A) and added (B). · (a)

1960

  • Pub. L. 86–618 substituted provisions in cl. (4) relating to unsafe color additives for provisions which related to a coal-tar color other than one from a batch that has been certified in accordance with regulations as provided by section 354 of this title. · (a)

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.