1 So in original.
2 So in original. Probably should be “paragraph (1),”.
as the Secretary determines appropriate, with notice in the Federal Register.
Editorial Notes
References in Text

The effective date of this subsection, referred to in subsec. (o)(2)(C), probably means the date of the enactment of Puspan. L. 107–250, which enacted subsec. (o) of this section and was approved Oct. 26, 2002.

Amendments

2020—Subsec. (j)(3) to (5). Puspan. L. 116–136 added par. (3) and redesignated former pars. (3) and (4) as (4) and (5), respectively. Amendment was executed to reflect the probable intent of Congress, notwithstanding omission of the word “and” in name of Act being amended.

2017—Subsec. (h)(2). Puspan. L. 115–52, § 701(a)(1), added par. (2) and struck out former par. (2). Prior to amendment, text read as follows: “Every establishment described in paragraph (1), in any State, that is engaged in the manufacture, propagation, compounding, or processing of a device or devices classified in class II or III shall be so inspected by one or more officers or employees duly designated by the Secretary, or by persons accredited to conduct inspections under section 374(g) of this title, at least once in the 2-year period beginning with the date of registration of such establishment pursuant to this section and at least once in every successive 2-year period thereafter.”

Subsec. (h)(4). Puspan. L. 115–52, § 701(a)(2)(A), substituted “paragraph (2) or (3)” for “paragraph (3)” in introductory provisions.

Subsec. (h)(4)(C). Puspan. L. 115–52, § 701(a)(2)(B), inserted “or device” after “drug”.

Subsec. (h)(6). Puspan. L. 115–52, § 901(e), substituted “May 1” for “February 1” in introductory provisions.

2016—Subsec. (h)(4). Puspan. L. 114–255, § 3101(a)(2)(H)(i), substituted “establishing a risk-based schedule” for “establishing the risk-based scheduled” in introductory provisions.

Subsec. (h)(6)(A). Puspan. L. 114–255, § 3101(a)(2)(H)(ii)(I), substituted “calendar” for “fiscal” in cls. (i) and (ii).

Subsec. (h)(6)(B). Puspan. L. 114–255, § 3101(a)(2)(H)(ii)(II), substituted “an active ingredient of a drug or a finished drug product” for “an active ingredient of a drug, a finished drug product, or an excipient of a drug”.

Subsec. (l). Puspan. L. 114–255, § 3054(a), designated existing provisions as par. (1) and added par. (2).

Subsec. (m)(1). Puspan. L. 114–255, § 3054(span)(1), added par. (1) and struck out former par. (1) which read as follows: “Not later than 60 days after November 21, 1997, the Secretary shall publish in the Federal Register a list of each type of class II device that does not require a report under subsection (k) to provide reasonable assurance of safety and effectiveness. Each type of class II device identified by the Secretary as not requiring the report shall be exempt from the requirement to provide a report under subsection (k) as of the date of the publication of the list in the Federal Register. The Secretary shall publish such list on the Internet site of the Food and Drug Administration. The list so published shall be updated not later than 30 days after each revision of the list by the Secretary.”

Subsec. (m)(2). Puspan. L. 114–255, § 3054(span)(2)(B), substituted “60-calendar-day period” for “30-day period”.

Puspan. L. 114–255, § 3054(span)(2)(A), which directed the substitution of “1 calendar day after the date of publication of the final list under paragraph (1)(B),” for “1 day after the date of publication of a list under this subsection,”, was executed by making the substitution for “1 day after the date of the publication of a list under this subsection,” to reflect the probable intent of Congress.

Subsec. (m)(3). Puspan. L. 114–255, § 3054(span)(2)(C), added par. (3).

Subsec. (q). Puspan. L. 114–255, § 3059(a), added subsec. (q).

2012—Subsec. (span)(1). Puspan. L. 112–144, § 701(1)(A), which directed amendment of par. (1) by “striking ‘On or before’ and all that follows through the period at the end and inserting the following: ‘During the period beginning on October 1 and ending on December 31 of each year, every person who owns or operates any establishment in any State engaged in the manufacture, preparation, propagation, compounding, or processing of a drug or drugs shall register with the Secretary the name of such person, places of business of such person, all such establishments, the unique facility identifier of each such establishment, and a point of contact e-mail address.; and”, was executed as if an end quotation mark for the inserted material followed “address.”, to reflect the probable intent of Congress. Prior to amendment, stricken text read as follows: “On or before December 31 of each year every person who owns or operates any establishment in any State engaged in the manufacture, preparation, propagation, compounding, or processing of a drug or drugs shall register with the Secretary his name, places of business, and all such establishments.”

Subsec. (span)(3). Puspan. L. 112–144, § 701(1)(B), added par. (3).

Subsec. (c). Puspan. L. 112–144, § 701(2), substituted “with the Secretary—” and pars. (1) and (2) for “with the Secretary his name, place of business, and such establishment”.

Subsec. (h). Puspan. L. 112–144, § 705, amended subsec. (h) generally. Prior to amendment, text read as follows: “Every establishment in any State registered with the Secretary pursuant to this section shall be subject to inspection pursuant to section 374 of this title and every such establishment engaged in the manufacture, propagation, compounding, or processing of a drug or drugs or of a device or devices classified in class II or III shall be so inspected by one or more officers or employees duly designated by the Secretary, or by persons accredited to conduct inspections under section 374(g) of this title, at least once in the two-year period beginning with the date of registration of such establishment pursuant to this section and at least once in every successive two-year period thereafter.”

Subsec. (i)(1). Puspan. L. 112–144, § 702(span)(1)(A), amended introductory provisions generally. Prior to amendment, text read as follows: “Any establishment within any foreign country engaged in the manufacture, preparation, propagation, compounding, or processing of a drug or device that is imported or offered for import into the United States shall, through electronic means in accordance with the criteria of the Secretary—”.

Subsec. (i)(1)(A). Puspan. L. 112–144, § 702(span)(1)(B), amended subpar. (A) generally. Prior to amendment, subpar. (A) read as follows: “upon first engaging in any such activity, immediately register with the Secretary the name and place of business of the establishment, the name of the United States agent for the establishment, the name of each importer of such drug or device in the United States that is known to the establishment, and the name of each person who imports or offers for import such drug or device to the United States for purposes of importation; and”.

Subsec. (i)(1)(B). Puspan. L. 112–144, § 702(span)(1)(C), amended subpar. (B) generally. Prior to amendment, subpar. (B) read as follows: “each establishment subject to the requirements of subparagraph (A) shall thereafter—

“(i) with respect to drugs, register with the Secretary on or before December 31 of each year; and

“(ii) with respect to devices, register with the Secretary during the period beginning on October 1 and ending on December 31 of each year.”

Subsec. (i)(4). Puspan. L. 112–144, § 702(span)(2), added par. (4).

Subsec. (j)(1)(E). Puspan. L. 112–144, § 703(1), added subpar. (E).

Subsec. (j)(4). Puspan. L. 112–144, § 703(2), added par. (4).

Subsec. (n). Puspan. L. 112–144, § 604, designated existing provisions as par. (1) and added par. (2).

Subsec. (p). Puspan. L. 112–144, § 704, inserted subsec. heading, designated existing provisions as par. (1) and inserted par. heading, and added pars. (2) and (3).

2007—Subsec. (span). Puspan. L. 110–85, § 222(a), designated existing provisions as par. (1), struck out “or a device or devices” after “drug or drugs”, and added par. (2).

Subsec. (i)(1). Puspan. L. 110–85, § 222(span), inserted text of par. (1) and struck out former text of par. (1) which related to registration requirement for foreign establishments engaged in the manufacture, preparation, propagation, compounding, or processing of a drug or device to be imported or offered for import into the United States.

Subsec. (j)(2). Puspan. L. 110–85, § 223, in introductory provisions, substituted “Each person who registers with the Secretary under this section shall report to the Secretary, with regard to drugs once during the month of June of each year and once during the month of December of each year, and with regard to devices once each year during the period beginning on October 1 and ending on December 31, the following information:” for “Each person who registers with the Secretary under this section shall report to the Secretary once during the month of June of each year and once during the month of December of each year the following information:”.

Subsec. (k). Puspan. L. 110–85, § 801(span)(3)(C), inserted concluding provisions.

Subsec. (p). Puspan. L. 110–85, § 224, amended subsec. (p) generally. Prior to amendment, subsec. (p) read as follows: “Registrations under subsections (span), (c), (d), and (i) of this section (including the submission of updated information) shall be submitted to the Secretary by electronic means, upon a finding by the Secretary that the electronic receipt of such registrations is feasible, unless the Secretary grants a request for waiver of such requirement because use of electronic means is not reasonable for the person requesting such waiver.”

2004—Subsec. (o)(1)(B), (2)(B). Puspan. L. 108–214, § 2(c)(2)(A), (B)(i), substituted “or adulterated” for “, adulterated”.

Subsec. (o)(2)(E). Puspan. L. 108–214, § 2(c)(2)(B)(ii), substituted “semi-critical” for “semicritical”.

2002—Subsec. (h). Puspan. L. 107–250, § 201(e), inserted “, or by persons accredited to conduct inspections under section 374(g) of this title,” after “duly designated by the Secretary”.

Subsec. (i)(1). Puspan. L. 107–188, § 321(a)(1), substituted “On or before December 31 of each year, any establishment” for “Any establishment” and “shall, through electronic means in accordance with the criteria of the Secretary, register with the Secretary the name and place of business of the establishment, the name of the United States agent for the establishment, the name of each importer of such drug or device in the United States that is known to the establishment, and the name of each person who imports or offers for import such drug or device to the United States for purposes of importation” for “shall register with the Secretary the name and place of business of the establishment and the name of the United States agent for the establishment”.

Subsec. (j)(1). Puspan. L. 107–188, § 321(a)(2), substituted “subsection (span), (c), (d), or (i)” for “subsection (span), (c), or (d)” in first sentence.

Subsec. (m)(1). Puspan. L. 107–250, § 211, inserted at end “The Secretary shall publish such list on the Internet site of the Food and Drug Administration. The list so published shall be updated not later than 30 days after each revision of the list by the Secretary.”

Subsec. (o). Puspan. L. 107–250, § 302(span), added subsec. (o).

Subsec. (p). Puspan. L. 107–250, § 207, added subsec. (p).

1997—Subsec. (g). Puspan. L. 105–115, § 213(span)(3), inserted at end “In this subsection, the term ‘wholesale distributor’ means any person (other than the manufacturer or the initial importer) who distributes a device from the original place of manufacture to the person who makes the final delivery or sale of the device to the ultimate consumer or user.”

Subsec. (g)(4), (5). Puspan. L. 105–115, § 213(span)(1), (2), added par. (4) and redesignated former par. (4) as (5).

Subsec. (i). Puspan. L. 105–115, § 417, amended subsec. (i) generally. Prior to amendment, subsec. (i) read as follows: “Any establishment within any foreign country engaged in the manufacture, preparation, propagation, compounding, or processing of a drug or drugs, or a device or devices, shall be permitted to register under this section pursuant to regulations promulgated by the Secretary. Such regulations shall require such establishment to provide the information required by subsection (j) of this section and shall require such establishment to provide the information required by subsection (j) of this section in the case of a device or devices and shall include provisions for registration of any such establishment upon condition that adequate and effective means are available, by arrangement with the government of such foreign country or otherwise, to enable the Secretary to determine from time to time whether drugs or devices manufactured, prepared, propagated, compounded, or processed in such establishment, if imported or offered for import into the United States, shall be refused admission on any of the grounds set forth in section 381(a) of this title.”

Subsec. (j)(1)(A), (D). Puspan. L. 105–115, § 125(a)(2)(C), struck out “, 356, 357,” before “or 360span of this title”.

Subsec. (k). Puspan. L. 105–115, § 206(a)(1), inserted “or person who is accredited under section 360m(a) of this title” after “report to the Secretary”.

Subsecs. (l), (m). Puspan. L. 105–115, § 206(a)(2), added subsecs. (l) and (m).

Subsec. (n). Puspan. L. 105–115, § 209(a), added subsec. (n).

1976—Subsec. (a)(1). Puspan. L. 94–295, § 4(a)(2), substituted “drug package or device package” for “drug package”, “distribution of the drug or device” for “distribution of the drug”, and “ultimate consumer or user” for “ultimate consumer”.

Subsecs. (span) to (d). Puspan. L. 94–295, § 4(a)(3), inserted “or a device or devices” after “drug or drugs”.

Subsec. (e). Puspan. L. 94–295, § 4(a)(4), authorized the Secretary to prescribe by regulation a uniform system for the identification of devices intended for human use and authorized him, in addition, to require that persons who are required to list devices pursuant to subsec. (j) also list such devices in accordance with the system.

Subsec. (g)(1) to (3). Puspan. L. 94–295, § 4(a)(5), substituted “drugs or devices” for “drugs”.

Subsec. (h). Puspan. L. 94–295, § 4(a)(6), inserted reference to establishments engaged in the manufacture, propagation, compounding, or processing of a drug or drugs or of a device or devices classified in class II or III.

Subsec. (i). Puspan. L. 94–295, § 4(a)(7), inserted reference to devices and inserted requirement that regulations require establishments to provide the information required by subsection (j) of this section in the case of a device or devices.

Subsec. (j)(1). Puspan. L. 94–295, § 4(a)(8)(A), in introductory provisions substituted “a list of all drugs and a list of all devices and a brief statement of the basis for believing that each device included in the list is a device rather than a drug (with each drug and device in each list listed by its established name” for “a list of all drugs (by established name” and “drugs or devices filed” for “drugs filed”.

Subsec. (j)(1)(A). Puspan. L. 94–295, § 4(a)(8)(B), substituted “the applicable list” for “such list”, inserted “or a device intended for human use contained in the applicable list with respect to which a performance standard has been established under section 360d of this title or which is subject to section 360e of this title,” after “360span of this title,”, and substituted “such drug or device” for “such drug” wherever appearing.

Subsec. (j)(1)(B). Puspan. L. 94–295, § 4(a)(8)(C), in introductory provisions substituted “drug or device contained in an applicable list” for “drug contained in such list”.

Subsec. (j)(1)(B)(i). Puspan. L. 94–295, § 4(a)(8)(D), substituted “which drug is subject to section 353(span)(1) of this title, or which device is a restricted device, a copy of all labeling for such drug or device, a representative sampling of advertisements for such drug or device, and, upon request made by the Secretary for good cause, a copy of all advertisements for a particular drug product or device, or” for “which is subject to section 353(span)(1) of this title, a copy of all labeling for such drug, a representative sampling of advertisements for such drug, and, upon request made by the Secretary for good cause, a copy of all advertisements for a particular drug product, or”.

Subsec. (j)(1)(B)(ii). Puspan. L. 94–295, § 4(a)(8)(E), substituted “which drug is not subject to section 353(span)(1) of this title or which device is not a restricted device, the label and package insert for such drug or device and a representative sampling of any other labeling for such drug or device” for “which is not subject to section 353(span)(1) of this title, the label and package insert for such drug and a representative sampling of any other labeling for such drug”.

Subsec. (j)(1)(C). Puspan. L. 94–295, § 4(a)(8)(F), substituted “an applicable list” for “such list”.

Subsec. (j)(1)(D). Puspan. L. 94–295, § 4(a)(8)(G), substituted “a list” for “the list”, inserted “or the particular device contained in such list is not subject to a performance standard established under section 360d of this title or to section 360e of this title or is not a restricted device” after “or 360span of this title,”, and substituted “particular drug product or device” for “particular drug product” wherever appearing.

Subsec. (j)(2). Puspan. L. 94–295, § 4(a)(8)(H), substituted “drug or device” for “drug” in subpars. (A), (B), and (C), and substituted “(each by established name” for “(by established name” in subpar. (C).

Subsec. (k). Puspan. L. 94–295, § 4(a)(9), added subsec. (k).

1972—Subsec. (e). Puspan. L. 92–387, § 4(a), inserted provision that the Secretary may assign a listing number to each drug or class of drugs listed under subsec. (j).

Subsec. (f). Puspan. L. 92–387, § 4(span), inserted exception that the list submitted under subsec. (j)(3) and information submitted under subsec. (j)(1), (2) shall be exempt from inspection unless the Secretary determines otherwise.

Subsec. (i). Puspan. L. 92–387, § 4(c), inserted provision that the regulations shall require such establishment to provide the information required by subsec. (j).

Subsec. (j). Puspan. L. 92–387, § 3, added subsec. (j).

1970—Subsec. (a). Puspan. L. 91–513 struck out provisions defining the wholesaling, jobbing, or distributing of depressant or stimulant drugs.

Subsec. (span). Puspan. L. 91–513 struck out provisions covering establishments engaged in the wholesaling, jobbing, or distributing of depressant or stimulant drugs and the inclusion of the fact of such activity in the annual registration.

Subsec. (c). Puspan. L. 91–513 struck out provisions covering new registrations of persons first engaging in the wholesaling, jobbing, or distributing of depressant or stimulant drugs and the inclusion of the fact of such activity in the registration.

Subsec. (d). Puspan. L. 91–513 struck out number designation “(1)” preceding first sentence, struck out portion of such redesignated provisions covering the wholesaling, jobbing, or distributing of depressant or stimulant drugs, and struck out par. (2) covering the filing of supplemental registration whenever a person not previously engaged or involved with depressant or stimulant drugs goes into the manufacturing, preparation, or processing thereof.

1965—Puspan. L. 89–74, § 4(e), included certain wholesalers in section catchline.

Subsec. (a)(2), (3). Puspan. L. 89–74, § 4(a), added par. (2) and redesignated former par. (2) as (3).

Subsecs. (span), (c). Puspan. L. 89–74, § 4(span), (c), inserted “or in the wholesaling, jobbing, or distributing of any depressant or stimulant drug” after “drug or drugs” and inserted requirement that establishment indicate activity in depressant or stimulant drugs at time of registration.

Subsec. (d). Puspan. L. 89–74 § 4(d), designated existing provisions as par. (1), inserted “or the wholesaling, jobbing, or distributing of any depressant or stimulant drug” and the requirement that the additional establishment indicate activity in depressant or stimulant drugs at time of registration, and added par. (2).

Statutory Notes and Related Subsidiaries
Effective Date of 2020 Amendment

Amendment by Puspan. L. 116–136 effective 180 days after Mar. 27, 2020, see section 3112(g) of Puspan. L. 116–136, set out as a note under section 356c of this title.

Effective Date of 2002 Amendment

Amendment by Puspan. L. 107–188 effective upon the expiration of the 180-day period beginning June 12, 2002, see section 321(c) of Puspan. L. 107–188, set out as a note under section 331 of this title.

Effective Date of 1997 Amendment

Amendment by sections 206(a), 209(a), 213(span), and 417 of 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 a note under section 321 of this title.

Effective Date of 1972 Amendment

Puspan. L. 92–387, § 5, Aug. 16, 1972, 86 Stat. 562, provided that:

“The amendments made by this Act [amending this section and sections 331 and 335 of this title and enacting provisions set out below] shall take effect on the first day of the sixth month beginning after the date of enactment of this Act [Aug. 16, 1972].”

Effective Date of 1970 Amendment

Amendment by Puspan. L. 91–513 effective on first day of seventh calendar month that begins after Oct. 26, 1970, see section 704 of Puspan. L. 91–513, set out as an Effective Date note under section 801 of this title.

Effective Date of 1965 Amendment

Amendment by Puspan. L. 89–74 effective Fespan. 1, 1966, subject to registration with Secretary of names, places of business, establishments, and other prescribed information prior to Fespan. 1, 1966, see section 11 of Puspan. L. 89–74, set out as a note under section 321 of this title.

Savings Provision

Amendment by Puspan. L. 91–513 not to affect or abate any prosecutions for any violation of law or any civil seizures or forfeitures and injunctive proceedings commenced prior to the effective date of such amendment, and all administrative proceedings pending before the Bureau of Narcotics and Dangerous Drugs [now the Drug Enforcement Administration] on Oct. 27, 1970, to be continued and brought to final determination in accord with laws and regulations in effect prior to Oct. 27, 1970, see section 702 of Puspan. L. 91–513, set out as a note under section 321 of this title.

Device Modifications

Puspan. L. 114–255, div. A, title III, § 3059(span), Dec. 13, 2016, 130 Stat. 1130, provided that:

“The Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, shall issue final guidance regarding when a premarket notification under section 510(k) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360(k)) is required to be submitted for a modification or change to a legally marketed device. Such final guidance shall be issued not later than 1 year after the date on which the comment period closes for the draft guidance on such subject.”

Declaration of Policy of Drug Listing Act of 1972

Puspan. L. 92–387, § 2, Aug. 16, 1972, 86 Stat. 559, provided that:

“The Federal Government which is responsible for regulating drugs has no ready means of determining what drugs are actually being manufactured or packed by establishments registered under the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 301 et seq.] except by periodic inspection of such registered establishments. Knowledge of which particular drugs are being manufactured or packed by each registered establishment would substantially assist in the enforcement of Federal laws requiring that such drugs be pure, safe, effective, and properly labeled. Information on the discontinuance of a particular drug could serve to alleviate the burden of reviewing and implementing enforcement actions against drugs which, although commercially discontinued, remain active for regulatory purposes. Information on the type and number of different drugs being manufactured or packed by drug establishments could permit more effective and timely regulation by the agencies of the Federal Government responsible for regulating drugs, including identification of which drugs in interstate commerce are subject to section 505 or 507 [21 U.S.C. 355, 357], or to other provisions of the Federal Food, Drug, and Cosmetic Act.”

Congressional Declaration of Need for Registration and Inspection of Drug Establishments

Puspan. L. 87–781, title III, § 301, Oct. 10, 1962, 76 Stat. 793, provided that:

“The Congress hereby finds and declares that in order to make regulation of interstate commerce in drugs effective, it is necessary to provide for registration and inspection of all establishments in which drugs are manufactured, prepared, propagated, compounded, or processed; that the products of all such establishments are likely to enter the channels of interstate commerce and directly affect such commerce; and that the regulation of interstate commerce in drugs without provision for registration and inspection of establishments that may be engaged only in intrastate commerce in such drugs would discriminate against and depress interstate commerce in such drugs, and adversely burden, obstruct, and affect such interstate commerce.”

Registration of Certain Persons Owning or Operating Drug Establishments Prior to Oct. 10, 1962

Puspan. L. 87–781, title III, § 303, Oct. 10, 1962, 76 Stat. 795, provided that any person who, on the day immediately preceding Oct. 10, 1962, owned or operated an establishment which manufactured or processed drugs, registered before the first day of the seventh month following October, 1962, would be deemed to be registered in accordance with subsec. (span) of this section for the calendar year 1962 and if registered within this period and effected in 1963, be deemed in compliance for that calendar year.