§ 351. Adulterated drugs and devices

Footnotes

1. 1 So in original. Probably should be “subparagraph”.

Legislative history

Reconstructed from this section’s Code source credit and amendment notes, resolved against the local Statutes at Large. Editorial notes are evidence, not the law that made the change.

1. 1938

   Pub. L. 75–675 § 501 · 52 Stat. 1040

   Enacted · 21 U.S.C. § 351

   June 25, 1938, ch. 675, § 501, 52 Stat. 1049

   Source evidence

   Code source credit
   June 25, 1938, ch. 675, § 501, 52 Stat. 1049

   Enacted provision · exact public law section
   Sec. 501. adulterated drugs and devices A drug or device shall be deemed to be adulterated— Adulterated drugs and devices. Definition. (a) (1) If it consists in whole or in part of any filthy, putrid, or decomposed substance; or (2) if it has been prepared, packed, or held under insanitary conditions whereby it may have been contaminated with filth, or whereby it may have been rendered injurious to health; or (3) if it is a drug and its container is composed, in whole or in part, of any poisonous or deleterious substance which may render the contents injurious to health; or (4) if it is a drug and it bears or contains, for purposes of coloring only, a coal-tar color other than one from a batch that has been certified in accordance with regulations as provided by section 504. Post, p. 1052. (b) If it purports to be or is represented as a drug the name of which is recognized in an official compendium, and its strength differs from, or its quality or purity falls below, the standard set forth in such compendium. Such determination as to strength, quality, or purity shall be made in accordance with the tests or methods of assay set forth in such compendium, except that whenever tests or methods of assay have not been prescribed in such compendium, or such tests or methods of assay as are prescribed are, in the judgment of the Secretary, insufficient for the making of such determination, the Secretary shall bring such fact to the attention of the appropriate body charged with the revision of such compendium, and if such body fails within a reasonable time to prescribe tests or methods of assay which, in the judgment of the Secretary, are sufficient for purposes of this paragraph, then the Secretary shall promulgate regulations prescribing appropriate tests or methods of assay in accordance with which such determination as to strength, quality, or purity shall be made. No drug defined in an official compendium shall be deemed to be adulterated under this paragraph because it differs from the standard of strength, quality, or purity therefor set forth in such compendium, if its difference in strength, quality, or purity from such standard is plainly stated on its label. Whenever a drug is recognized in both the United States Pharmacopoeia and the Homoeopathic Pharmacopoeia of the United States it shall be subject to the requirements of the United States Pharmacopoeia unless it is labeled and offered for sale as a homoeopathic drug, in which case it shall be subject to the provisions of the Homoeopathic Pharmacopoeia of the United States and not to those of the United States Pharmacopoeia. (c) If it is not subject to the provisions of paragraph (b) of this section and its strength differs from, or its purity or quality falls below, that which it purports or is represented to possess. (d) If it is a drug and any substance has been (1) mixed or packed therewith so as to reduce its quality or strength or (2) substituted wholly or in part therefor.

2. 1960

   Color Additive Amendments of 1960

   Pub. L. 86–618 title I § 102(b)(1) · 74 Stat. 397

   Substituted · 21 U.S.C. § 351(a)

   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

   Source evidence

   Code amendment note
   Par. (a). 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.

   Enacted provision · exact public law section
   (1) Clause (4) of section 501 (a) of such Act (relating to drugs deemed adulterated by reason of uncertified coal tar color) is amended to read as follows: “(4) if (A) it is a drug which bears or contains, for purposes of coloring only, a color additive which is unsafe within 21 USC 376. the meaning of section 706(a), or (B) it is a color additive the intended use of which in or on drugs is for purposes of coloring only and is unsafe within the meaning of section 706 (a).”

3. 1962

   Drug Amendments of 1962

   Pub. L. 87–781 title I § 101 · 76 Stat. 780

   1. Amended · 21 U.S.C. § 351(a)

      Pub. L. 87–781 designated existing provisions of cl. (2) as (A)

   2. Added · 21 U.S.C. § 351(a)

      Pub. L. 87–781 added (B)

   Source evidence

   Code amendment note
   Par. (a). Pub. L. 87–781 designated existing provisions of cl. (2) as (A) and added (B).

   Enacted provision · exact public law section
   Sec. 101. requirement of adequate controls in manufacture Clause (2) of section 501(a) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 351(a)) is amended to read as follows: “(2)(A) if it has been prepared, packed, or held under insanitary conditions whereby it may have been contaminated with filth, or whereby it may have been rendered injurious to health; or (B) if it is a drug and the methods used in, or the facilities or controls used for, its manufacture, processing, packing, or holding do not conform to or are not operated or administered in conformity with current good manufacturing practice to assure that such drug meets the requirements of this Act as to safety and has the identity and strength, and meets the quality and purity characteristics, which it purports or is represented to possess;”.

4. 1968

   Animal Drug Amendments of 1968

   Pub. L. 90–399 § 101(a) · 82 Stat. 342

   Added · 21 U.S.C. § 351(a)

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

   Source evidence

   Code amendment note
   Par. (a). Pub. L. 90–399 added cls. (5) and (6).

   Enacted provision · exact public law section
   (a) Section 501(a) of the Federal Food, Drug, and Cosmetic Act, as amended, is amended by inserting before the period at 52 Stat. 1049 21 USC 351. the end thereof a semicolon and the following: “or (5) if it is a new animal drug which is unsafe within the meaning of section 512; or (6) Infra. if it is an animal feed bearing or containing a new animal drug, and such animal feed is unsafe within the meaning of section 512”.

5. 1976

   Medical Device Amendments of 1976

   Pub. L. 94–295 § 9(b)(1) · 90 Stat. 539

   1. Substituted · 21 U.S.C. § 351(a)

      Pub. L. 94–295, § 9(b)(1), substituted “(3) if its” for “(3) if it is a drug and its” in cl. (3)

   2. Substituted · 21 U.S.C. § 351(a)

      Pub. L. 94–295, § 9(b)(1), substituted “(4) if (A) it bears or contains” for “(4) if (A) it is a drug which bears or contains” in cl. (4)(A)

   3. Substituted · 21 U.S.C. § 351(a)

      Pub. L. 94–295, § 9(b)(1), substituted “drugs or devices” for “drugs” in cl. (4)(B)

   Source evidence

   Code amendment note
   Par. (a). 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).

   Enacted provision · exact public law section
   (1) Section 501(a) is amended (A) by inserting “(3) if its” in 21 USC 351. lieu of “(3) if it is a drug and its”: (2) by inserting “(4) if (A) it bears or contains” in lieu of “(4) if (A) it is a drug which bears or contains”: and (3) by inserting “or devices” after “drugs” in subclause (B) of clause (4).

6. 1976

   Medical Device Amendments of 1976

   Pub. L. 94–295 § 3(d) · 90 Stat. 539

   Added · 21 U.S.C. § 351(e)(i)

   Pub. L. 94–295, § 3(d), added pars. (e) to (i)

   Source evidence

   Code amendment note
   Pars. (e) to (i). Pub. L. 94–295, § 3(d), added pars. (e) to (i).

   Enacted provision · exact public law section
   (d) Section 501 is amended by adding at the end the following new paragraphs: “(e) If it is, or purports to be or is represented as, a device which is subject to a performance standard established under section 514, unless such device is in all respects in conformity with such standard. “(f) (1) If it is a class TIT device— “(A) (i) which is required by a regulation promulgated under Ante, p. 552. subsection (b) of section 515 to have an approval under such section of an application for premnrket approval and which is not exempt from section 515 under section 520(g), and “(ii) (I) for which an application for premarket approval or a notice of completion of a product development protocol was not filed with the Secretary within the ninety-day period beginning on the date of the promulgation of such regulation, or “(II) for which such an application was filed and approval of the application has been denied or withdrawn, or such a notice was filed and has been declared not completed or the approval of the device under the protocol has been withdrawn; “(B) (i) which was classified under section 513(f) into class Ante, p. 540. Ante, p. 552. III, which under section 515(a) is required to have in effect an approved application for premarket approval, and which is not exempt from section 515 under section 520(g), and Ante, p. 565. “(ii) which does not have such an application in effect; or “(C) which was classified under section 520(1) into class III, which under such section is required to have in effect an approved application under section 515, and which does not have such an application in effect. “(2) (A) In the case of a device classified under section 513(f) into class TIT and intended solely for investigational use, paragraph (1) (B) shall not apply with respect to such device during the period ending on the ninetieth day after the date of the promulgation of the regulations prescribing the procedures and conditions required by section 520(g) (2). “(B) In the case of a device subject to a regulation promulgated under subsection (b) of section 515, paragraph (1) shall not apply with respect to such device during the period ending— “(i) on the last day of the thirtieth calendar month beginning after the month in which the classification of the device in class III became effective under section 513, or “(ii) on the ninetieth day after the date of the promulgation of such regulation, whichever occurs later. “(g) If it is a banned device. “(h) If it is a device and the methods used in, or the facilities or controls used for, its manufacture, packing, storage, or installation are not in conformity with applicable requirements under section 520 (f) (1) or an applicable condition prescribed by an order under section 520(f)(2). “(i) If it is a device for which an exemption has been granted under section 520(g) for investigational use and the person who was granted such exemption or any investigator who uses such device, under such exemption fails to comply with a requirement prescribed by or under such section.”.

7. 1990

   Pub. L. 101–629 § 9(b) · 104 Stat. 4469

   1. Substituted · 21 U.S.C. § 351(f)(1)

      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” for “or withdrawn”; in cl. (B)(ii)

   2. Substituted · 21 U.S.C. § 351(f)(1)

      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 “which has an application which has been suspended or is otherwise not in effect” for “which does not have such an application in effect”; and in cl. (C)

   3. Substituted · 21 U.S.C. § 351(f)(1)

      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 “which has an application which has been suspended or is otherwise not in effect” for “which does not have such an application in effect”

   Source evidence

   Code amendment note
   Par. (f)(1). 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” for “or withdrawn”; in cl. (B)(ii), substituted “which has an application which has been suspended or is otherwise not in effect” for “which does not have such an application in effect”; and in cl. (C), substituted “which has an application which has been suspended or is otherwise not in effect” for “which does not have such an application in effect”.

   Enacted provision · exact public law section
   (b) Conforming Amendment.— Section 501(f) (21 U.S.C. 351(f) is amended— (1) in subparagraph (A)(ii)(II), by striking out “or withdrawn” and inserting in lieu thereof “, suspended, or withdrawn”, (2) in subparagraph (B)(ii), by striking out “which does not have such an application in effect” and inserting in lieu thereof “which has an application which has been suspended or is otherwise not in effect”, and (3) in subparagraph (C), by striking out “which does not have such an application in effect” and inserting in lieu thereof “which has an application which has been suspended or is otherwise not in effect”.

8. 1992

   Prescription Drug User Fee Act of 1992

   Pub. L. 102–571 title I § 107(8) · 106 Stat. 4491

   Substituted · 21 U.S.C. § 351(a)(4)

   Pub. L. 102–571 substituted “379e(a)” for “376(a)” in cls. (A) and (B)

   Source evidence

   Code amendment note
   Par. (a)(4). Pub. L. 102–571 substituted “379e(a)” for “376(a)” in cls. (A) and (B).

   Enacted provision · exact public law section
   (8) Section 501(a)(4) (21 U.S.C 351(a)(4)) is amended by striking out “706” each place it occurs and inserting in lieu thereof “721”.

9. 1997

   Food and Drug Administration Modernization Act of 1997

   Pub. L. 105–115 § 121(b)(1) · 111 Stat. 2296

   Inserted · 21 U.S.C. § 351(a)(2)(C)

   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 conformity with the positron emission tomography compounding standards and the official monographs of the United States Pharmacopoeia to assure that such drug meets the requirements of this chapter as to safety and has the identity and strength, and meets the quality and purity characteristics, that it purports or is represented to possess;” before “or (3)”

   Source evidence

   Code amendment note
   Par. (a)(2)(C). 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 conformity with the positron emission tomography compounding standards and the official monographs of the United States Pharmacopoeia to assure that such drug meets the requirements of this chapter as to safety and has the identity and strength, and meets the quality and purity characteristics, that it purports or is represented to possess;” before “or (3)”.

   Enacted provision · exact public law section
   (1) In general.— Section 501(a) (21 U.S.C. 351(a)) is amended by striking “; or (3)” and inserting the following: “; 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 conformity with the positron emission tomography compounding standards and the official monographs of the United States Pharmacopoeia to assure that such drug meets the requirements of this Act as to safety and has the identity and strength, and meets the quality and purity characteristics, that it purports or is represented to possess; or (3)”.

   Effective date note
   Pub. L. 105–115, title I, § 121(b)(2), Nov. 21, 1997, 111 Stat. 2320, provided that: “Section 501(a)(2)(C) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 351(a)(2)(C)) shall not apply 4 years after the date of enactment of this Act [Nov. 21, 1997] or 2 years after the date on which the Secretary of Health and Human Services establishes the requirements described in subsection (c)(1)(B) [section 121(c)(1)(B) of Pub. L. 105–115, set out as a note under section 355 of this title], whichever is later.” Amendment by Pub. L. 105–115 effective 90 days after Nov. 21, 1997, except as otherwise provided, see section 501 of Pub. L. 105–115, set out as an Effective Date of 1997 Amendment note under section 321 of this title.

10. 1997

    Food and Drug Administration Modernization Act of 1997

    Pub. L. 105–115 § 204(c) · 111 Stat. 2296

    1. Amended · 21 U.S.C. § 351(e)

       Pub. L. 105–115, § 204(c), designated existing provisions as subpar. (1)

    2. Added · 21 U.S.C. § 351(e)

       Pub. L. 105–115, § 204(c), added subpar. (2)

    Source evidence

    Code amendment note
    Par. (e). Pub. L. 105–115, § 204(c), designated existing provisions as subpar. (1) and added subpar. (2).

    Enacted provision · exact public law section
    (c) Section 501.— Section 501(e) (21 U.S.C. 351(e)) is amended— (1) by striking “(e)” and inserting “(e)(1)”; and (2) by inserting at the end the following: “(2) If it is declared to be, purports to be, or is represented as, a device that is in conformity with any standard recognized under section 514(c) unless such device is in all respects in conformity with such standard.”.

    Effective date note
    Pub. L. 105–115, title I, § 121(b)(2), Nov. 21, 1997, 111 Stat. 2320, provided that: “Section 501(a)(2)(C) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 351(a)(2)(C)) shall not apply 4 years after the date of enactment of this Act [Nov. 21, 1997] or 2 years after the date on which the Secretary of Health and Human Services establishes the requirements described in subsection (c)(1)(B) [section 121(c)(1)(B) of Pub. L. 105–115, set out as a note under section 355 of this title], whichever is later.” Amendment by Pub. L. 105–115 effective 90 days after Nov. 21, 1997, except as otherwise provided, see section 501 of Pub. L. 105–115, set out as an Effective Date of 1997 Amendment note under section 321 of this title.

11. 2012

    Food and Drug Administration Safety and Innovation Act

    Pub. L. 112–144 § 711 · 126 Stat. 993

    Inserted · 21 U.S.C. § 351

    Pub. L. 112–144, § 711, inserted concluding provisions

    Source evidence

    Code amendment note
    Pub. L. 112–144, § 711, inserted concluding provisions.

    Enacted provision · exact public law section
    SEC. 711. ENHANCING THE SAFETY AND QUALITY OF THE DRUG SUPPLY.   Section 501 (21 U.S.C. 351) is amended by adding at the end the following flush text: “For Definition. purposes of paragraph (a)(2)(B), the term ‘current good manufacturing practice’ includes the implementation of oversight and controls over the manufacture of drugs to ensure quality, including managing the risk of and establishing the safety of raw materials, materials used in the manufacturing of drugs, and finished drug products.” .

12. 2012

    Food and Drug Administration Safety and Innovation Act

    Pub. L. 112–144 § 608(b)(2)(A)(i) · 126 Stat. 993

    Substituted · 21 U.S.C. § 351(f)(1)(A)(i)

    Pub. L. 112–144, § 608(b)(2)(A)(i), substituted “an order issued” for “a regulation promulgated”

    Source evidence

    Code amendment note
    Par. (f)(1)(A)(i). Pub. L. 112–144, § 608(b)(2)(A)(i), substituted “an order issued” for “a regulation promulgated”.

    Enacted provision · exact public law section
    (i) in subclause (i), by striking “a regulation promulgated” and inserting “an order issued”; and

13. 2012

    Food and Drug Administration Safety and Innovation Act

    Pub. L. 112–144 § 608(b)(2)(A)(ii) · 126 Stat. 993

    Substituted · 21 U.S.C. § 351(f)(1)(A)(ii)(I)

    Pub. L. 112–144, § 608(b)(2)(A)(ii), substituted “issuance of such order” for “promulgation of such regulation”

    Source evidence

    Code amendment note
    Par. (f)(1)(A)(ii)(I). Pub. L. 112–144, § 608(b)(2)(A)(ii), substituted “issuance of such order” for “promulgation of such regulation”.

    Enacted provision · exact public law section
    (ii) in subclause (ii), by striking “promulgation of such regulation” and inserting “issuance of such order”;

14. 2012

    Food and Drug Administration Safety and Innovation Act

    Pub. L. 112–144 § 608(b)(2)(B) · 126 Stat. 993

    1. Substituted · 21 U.S.C. § 351(f)(2)(B)

       Pub. L. 112–144, § 608(b)(2)(B), substituted “an order issued” for “a regulation promulgated” in subcl. (ii)

    2. Substituted · 21 U.S.C. § 351(f)(2)(B)

       Pub. L. 112–144, § 608(b)(2)(B), substituted “issuance of such order” for “promulgation of such regulation” in subcl. (ii)

    Source evidence

    Code amendment note
    Par. (f)(2)(B). 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).

    Enacted provision · exact public law section
    (B) in subparagraph (2)(B)— (i) by striking “a regulation promulgated” and inserting “an order issued”; and (ii) by striking “promulgation of such regulation” and inserting “issuance of such order”; and

15. 2012

    Food and Drug Administration Safety and Innovation Act

    Pub. L. 112–144 § 608(b)(2)(C) · 126 Stat. 993

    Added · 21 U.S.C. § 351(f)(3)

    Pub. L. 112–144, § 608(b)(2)(C), added subpar. (3)

    Source evidence

    Code amendment note
    Par. (f)(3). Pub. L. 112–144, § 608(b)(2)(C), added subpar. (3).

    Enacted provision · exact public law section
    (C) by adding at the end the following: “(3) In the case of a device with respect to which a regulation was promulgated under section 515(b) prior to the date of enactment of the Food and Drug Administration Safety and Innovation Act, a reference in this subsection to an order issued under section 515(b) shall be deemed to include such regulation.” .

16. 2012

    Food and Drug Administration Safety and Innovation Act

    Pub. L. 112–144 § 707(a) · 126 Stat. 993

    Added · 21 U.S.C. § 351(j)

    Pub. L. 112–144, § 707(a), added par. (j)

    Source evidence

    Code amendment note
    Par. (j). Pub. L. 112–144, § 707(a), added par. (j).

    Enacted provision · exact public law section
    (a) In General.— Section 501 (21 U.S.C. 351) is amended by adding at the end the following: “(j) If it is a drug and it has been manufactured, processed, packed, or held in any factory, warehouse, or establishment and the owner, operator, or agent of such factory, warehouse, or establishment delays, denies, or limits an inspection, or refuses to permit entry or inspection.” .

17. 2017

    FDA Reauthorization Act of 2017

    Pub. L. 115–52 title VII § 702(c) · 131 Stat. 1005

    Inserted · 21 U.S.C. § 351(j)

    Pub. L. 115–52 inserted “or device” after “drug”

    Source evidence

    Code amendment note
    Par. (j). Pub. L. 115–52 inserted “or device” after “drug”.

    Enacted provision · exact public law section
    (c) Adulterated Devices.— Subsection (j) of section 501 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 351) is amended by inserting “or device” after “drug”.

24 of 24 references resolved to an enrolled provision