21 USC 351 - Adulterated drugs and devices

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

(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

Editorial Notes

Amendments

2017—Par. (j). Puspan. L. 115–52 inserted “or device” after “drug”.

2012—Puspan. L. 112–144, § 711, inserted concluding provisions.

Par. (f)(1)(A)(i). Puspan. L. 112–144, § 608(span)(2)(A)(i), substituted “an order issued” for “a regulation promulgated”.

Par. (f)(1)(A)(ii)(I). Puspan. L. 112–144, § 608(span)(2)(A)(ii), substituted “issuance of such order” for “promulgation of such regulation”.

Par. (f)(2)(B). Puspan. L. 112–144, § 608(span)(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).

Par. (f)(3). Puspan. L. 112–144, § 608(span)(2)(C), added subpar. (3).

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

1997—Par. (a)(2)(C). Puspan. L. 105–115, § 121(span)(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)”.

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

1992—Par. (a)(4). Puspan. L. 102–571 substituted “379e(a)” for “376(a)” in cls. (A) and (B).

1990—Par. (f)(1). Puspan. L. 101–629, § 9(span), 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 (A)(ii)(II), substituted “, suspended, or withdrawn” for “or withdrawn”; in cl.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”.

1976—Par. (a). Puspan. L. 94–295, § 9(span)(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).

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

1968—Par. (a). Puspan. L. 90–399 added cls. (5) and (6).

1962—Par. (a). Puspan. L. 87–781 designated existing provisions of cl. (2) as (A) and added (B).

1960—Par. (a). Puspan. 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.

Statutory Notes and Related Subsidiaries

Effective and Termination Dates of 1997 Amendment

Puspan. L. 105–115, title I, § 121(span)(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 Puspan. L. 105–115, set out as a note under section 355 of this title], whichever is later.”

Amendment by Puspan. L. 105–115 effective 90 days after Nov. 21, 1997, except as otherwise provided, see section 501 of Puspan. L. 105–115, set out as an Effective Date of 1997 Amendment note under section 321 of this title.

Effective Date of 1968 Amendment

Amendment by Puspan. L. 90–399 effective on first day of thirteenth calendar month after July 13, 1968, see section 108(a) of Puspan. L. 90–399, set out as an Effective Date and Transitional Provisions note under section 360span of this title.

Effective Date of 1962 Amendment; Exceptions

Amendment by Puspan. L. 87–781 effective on first day of seventh calendar month following October 1962, see section 107 of Puspan. L. 87–781, set out as a note under section 321 of this title.

Effective Date of 1960 Amendment

Amendment by Puspan. L. 86–618 effective July 12, 1960, subject to the provisions of section 203 of Puspan. L. 86–618, see section 202 of Puspan. L. 86–618, set out as a note under section 379e of this title.

Effective Date; Postponement

Par. (a)(4) effective Jan. 1, 1940, see act June 23, 1939, ch. 242, 53 Stat. 853, set out as an Effective Date; Postponement in Certain Cases note under section 301 of this title.

Approval by Regulation Prior to July 9, 2012

Puspan. L. 112–144, title VI, § 608(span)(3), July 9, 2012, 126 Stat. 1059, provided that:

“The amendments made by this subsection [amending this section and section 360e of this title] shall have no effect on a regulation that was promulgated prior to the date of enactment of this Act [July 9, 2012] requiring that a device have an approval under section 515 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360e) of an application for premarket approval.”

Guidance

Puspan. L. 112–144, title VII, § 707(span), July 9, 2012, 126 Stat. 1068, provided that:

“Not later than 1 year after the date of enactment of this section [July 9, 2012], the Secretary of Health and Human Services shall issue guidance that defines the circumstances that would constitute delaying, denying, or limiting inspection, or refusing to permit entry or inspection, for purposes of section 501(j) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 351(j)] (as added by subsection (a)).”

Executive Documents

Transfer of Functions

For transfer of functions of Federal Security Administrator to Secretary of Health, Education, and Welfare [now Health and Human Services], and of Food and Drug Administration in the Department of Agriculture to Federal Security Agency, see notes set out under section 321 of this title.