Notes on 21 U.S.C. § 360 : US Code - Notes

Search Notes on 21 U.S.C. § 360 : US Code - Notes

(June 25, 1938, ch. 675, Sec. 510, as added Pub. L. 87-781, title
III, Sec. 302, Oct. 10, 1962, 76 Stat. 794; amended Pub. L. 89-74,
Sec. 4, July 15, 1965, 79 Stat. 231; Pub. L. 91-513, title II, Sec.
701(e), Oct. 27, 1970, 84 Stat. 1282; Pub. L. 92-387, Secs. 3, 4(a)-
(c), Aug. 16, 1972, 86 Stat. 560-562; Pub. L. 94-295, Sec. 4(a),
May 28, 1976, 90 Stat. 579; Pub. L. 105-115, title I, Sec.
125(a)(2)(C), title II, Secs. 206(a), 209(a), 213(b), title IV,
Sec. 417, Nov. 21, 1997, 111 Stat. 2325, 2338, 2341, 2347, 2379;
Pub. L. 107-188, title III, Sec. 321(a), June 12, 2002, 116 Stat.
675; Pub. L. 107-250, title II, Secs. 201(e), 207, 211, title III,
Sec. 302(b), Oct. 26, 2002, 116 Stat. 1609, 1613, 1614, 1616; Pub.
L. 108-214, Sec. 2(c)(2), Apr. 1, 2004, 118 Stat. 576.)
REFERENCES IN TEXT
The effective date of this subsection, referred to in subsec.
(o)(2)(C), probably means the date of the enactment of Pub. L. 107-
250, which enacted subsec. (o) of this section and was approved
Oct. 26, 2002.
AMENDMENTS
2004 - Subsec. (o)(1)(B), (2)(B). Pub. L. 108-214, Sec.
2(c)(2)(A), (B)(i), substituted "or adulterated" for ",
adulterated".
Subsec. (o)(2)(E). Pub. L. 108-214, Sec. 2(c)(2)(B)(ii),
substituted "semi-critical" for "semicritical".
2002 - Subsec. (h). Pub. L. 107-250, Sec. 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). Pub. L. 107-188, Sec. 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). Pub. L. 107-188, Sec. 321(a)(2), substituted
"subsection (b), (c), (d), or (i)" for "subsection (b), (c), or
(d)" in first sentence.
Subsec. (m)(1). Pub. L. 107-250, Sec. 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). Pub. L. 107-250, Sec. 302(b), added subsec. (o).
Subsec. (p). Pub. L. 107-250, Sec. 207, added subsec. (p).
1997 - Subsec. (g). Pub. L. 105-115, Sec. 213(b)(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). Pub. L. 105-115, Sec. 213(b)(1), (2), added
par. (4) and redesignated former par. (4) as (5).
Subsec. (i). Pub. L. 105-115, Sec. 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). Pub. L. 105-115, Sec. 125(a)(2)(C),
struck out ", 356, 357," before "or 360b of this title".
Subsec. (k). Pub. L. 105-115, Sec. 206(a)(1), inserted "or person
who is accredited under section 360m(a) of this title" after
"report to the Secretary".
Subsecs. (l), (m). Pub. L. 105-115, Sec. 206(a)(2), added
subsecs. (l) and (m).
Subsec. (n). Pub. L. 105-115, Sec. 209(a), added subsec. (n).
1976 - Subsec. (a)(1). Pub. L. 94-295, Sec. 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. (b) to (d). Pub. L. 94-295, Sec. 4(a)(3), inserted "or a
device or devices" after "drug or drugs".
Subsec. (e). Pub. L. 94-295, Sec. 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). Pub. L. 94-295, Sec. 4(a)(5), substituted
"drugs or devices" for "drugs".
Subsec. (h). Pub. L. 94-295, Sec. 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). Pub. L. 94-295, Sec. 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). Pub. L. 94-295, Sec. 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). Pub. L. 94-295, Sec. 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 "360b of this title,", and substituted "such
drug or device" for "such drug" wherever appearing.
Subsec. (j)(1)(B). Pub. L. 94-295, Sec. 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). Pub. L. 94-295, Sec. 4(a)(8)(D),
substituted "which drug is subject to section 353(b)(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(b)(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). Pub. L. 94-295, Sec. 4(a)(8)(E),
substituted "which drug is not subject to section 353(b)(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(b)(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). Pub. L. 94-295, Sec. 4(a)(8)(F), substituted
"an applicable list" for "such list".
Subsec. (j)(1)(D). Pub. L. 94-295, Sec. 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 360b of this
title,", and substituted "particular drug product or device" for
"particular drug product" wherever appearing.
Subsec. (j)(2). Pub. L. 94-295, Sec. 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). Pub. L. 94-295, Sec. 4(a)(9), added subsec. (k).
1972 - Subsec. (e). Pub. L. 92-387, Sec. 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). Pub. L. 92-387, Sec. 4(b), 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). Pub. L. 92-387, Sec. 4(c), inserted provision that
the regulations shall require such establishment to provide the
information required by subsec. (j).
Subsec. (j). Pub. L. 92-387, Sec. 3, added subsec. (j).
1970 - Subsec. (a). Pub. L. 91-513 struck out provisions defining
the wholesaling, jobbing, or distributing of depressant or
stimulant drugs.
Subsec. (b). Pub. 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). Pub. 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). Pub. 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 - Pub. L. 89-74, Sec. 4(e), included certain wholesalers in
section catchline.
Subsec. (a)(2), (3). Pub. L. 89-74, Sec. 4(a), added par. (2) and
redesignated former par. (2) as (3).
Subsecs. (b), (c). Pub. L. 89-74, Sec. 4(b), (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). Pub. L. 89-74 Sec. 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).
EFFECTIVE DATE OF 2002 AMENDMENT
Amendment by Pub. L. 107-188 effective upon the expiration of the
180-day period beginning June 12, 2002, see section 321(c) of Pub.
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(b), and 417 of 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 a note
under section 321 of this title.
EFFECTIVE DATE OF 1972 AMENDMENT
Section 5 of Pub. L. 92-387 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 Pub. L. 91-513 effective on first day of seventh
calendar month that begins after Oct. 26, 1970, see section 704 of
Pub. L. 91-513, set out as an Effective Date note under section 801
of this title.
EFFECTIVE DATE OF 1965 AMENDMENT
Amendment by Pub. L. 89-74 effective Feb. 1, 1966, subject to
registration with Secretary of names, places of business,
establishments, and other prescribed information prior to Feb. 1,
1966, see section 11 of Pub. L. 89-74, set out as a note under
section 321 of this title.
SAVINGS PROVISION
Amendment by Pub. 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 Pub. L. 91-513, set out as a note under section 321 of this
title.
CONGRESSIONAL DECLARATION OF NEED FOR REGISTRATION AND INSPECTION
OF DRUG ESTABLISHMENTS
Section 301 of Pub. L. 87-781 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."
DECLARATION OF POLICY OF DRUG LISTING ACT OF 1972
Section 2 of Pub. L. 92-387 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 [this chapter] 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 [section 355
or 357 of this title], or to other provisions of the Federal Food,
Drug, and Cosmetic Act."
REGISTRATION OF CERTAIN PERSONS OWNING OR OPERATING DRUG
ESTABLISHMENTS PRIOR TO OCT. 10, 1962
Section 303 of Pub. L. 87-781 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. (b) 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.