§ 381. — Imports and exports.
[Laws in effect as of January 7, 2003]
[Document affected by Public Law 3]
[CITE: 21USC381]
TITLE 21--FOOD AND DRUGS
CHAPTER 9--FEDERAL FOOD, DRUG, AND COSMETIC ACT
SUBCHAPTER VIII--IMPORTS AND EXPORTS
Sec. 381. Imports and exports
(a) Imports; list of registered foreign establishments; samples from
unregistered foreign establishments; examination and refusal of
admission
The Secretary of the Treasury shall deliver to the Secretary of
Health and Human Services, upon his request, samples of food, drugs,
devices, and cosmetics which are being imported or offered for import
into the United States, giving notice thereof to the owner or consignee,
who may appear before the Secretary of Health and Human Services and
have the right to introduce testimony. The Secretary of Health and Human
Services shall furnish to the Secretary of the Treasury a list of
establishments registered pursuant to subsection (i) of section 360 of
this title and shall request that if any drugs and devices manufactured,
prepared, propagated, compounded, or processed in an establishment not
so registered are imported or offered for import into the United States,
samples of such drugs and devices be delivered to the Secretary of
Health and Human Services, with notice of such delivery to the owner or
consignee, who may appear before the Secretary of Health and Human
Services and have the right to introduce testimony. If it appears from
the examination of such samples or otherwise that (1) such article has
been manufactured, processed, or packed under insanitary conditions or,
in the case of a device, the methods used in, or the facilities or
controls used for, the manufacture, packing, storage, or installation of
the device do not conform to the requirements of section 360j(f) of this
title, or (2) such article is forbidden or restricted in sale in the
country in which it was produced or from which it was exported, or (3)
such article is adulterated, misbranded, or in violation of section 355
of this title, then such article shall be refused admission, except as
provided in subsection (b) of this section. The Secretary of the
Treasury shall cause the destruction of any such article refused
admission unless such article is exported, under regulations prescribed
by the Secretary of the Treasury, within ninety days of the date of
notice of such refusal or within such additional time as may be
permitted pursuant to such regulations. Clause (2) of the third sentence
of this paragraph \1\ shall not be construed to prohibit the admission
of narcotic drugs the importation of which is permitted under the
Controlled Substances Import and Export Act [21 U.S.C. 951 et seq.].
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\1\ So in original. Probably should be ``subsection''.
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(b) Disposition of refused articles
Pending decision as to the admission of an article being imported or
offered for import, the Secretary of the Treasury may authorize delivery
of such article to the owner or consignee upon the execution by him of a
good and sufficient bond providing for the payment of such liquidated
damages in the event of default as may be required pursuant to
regulations of the Secretary of the Treasury. If it appears to the
Secretary of Health and Human Services that an article included within
the provisions of clause (3) of subsection (a) of this section can, by
relabeling or other action, be brought into compliance with this chapter
or rendered other than a food, drug, device, or cosmetic, final
determination as to admission of such article may be deferred and, upon
filing of timely written application by the owner or consignee and the
execution by him of a bond as provided in the preceding provisions of
this subsection, the Secretary may, in accordance with regulations,
authorize the applicant to perform such relabeling or other action
specified in such authorization (including destruction or export of
rejected articles or portions thereof, as may be specified in the
Secretary's authorization). All such relabeling or other action pursuant
to such authorization shall in accordance with regulations be under the
supervision of an officer or employee of the Department of Health and
Human Services designated by the Secretary, or an officer or employee of
the Department of the Treasury designated by the Secretary of the
Treasury.
(c) Charges concerning refused articles
All expenses (including travel, per diem or subsistence, and
salaries of officers or employees of the United States) in connection
with the destruction provided for in subsection (a) of this section and
the supervision of the relabeling or other action authorized under the
provisions of subsection (b) of this section, the amount of such
expenses to be determined in accordance with regulations, and all
expenses in connection with the storage, cartage, or labor with respect
to any article refused admission under subsection (a) of this section,
shall be paid by the owner or consignee and, in default of such payment,
shall constitute a lien against any future importations made by such
owner or consignee.
(d) Reimportation
(1) Except as provided in paragraph (2) and section 384 of this
title, no drug subject to section 353(b) of this title or composed
wholly or partly of insulin which is manufactured in a State and
exported may be imported into the United States unless the drug is
imported by the manufacturer of the drug.
(2) The Secretary may authorize the importation of a drug the
importation of which is prohibited by paragraph (1) if the drug is
required for emergency medical care.
(3)(A) Subject to subparagraph (B), no component of a drug, no
component part or accessory of a device, or other article of device
requiring further processing, which is ready or suitable for use for
health-related purposes, and no article of a food additive, color
additive, or dietary supplement, including a product in bulk form, shall
be excluded from importation into the United States under subsection (a)
of this section if each of the following conditions is met:
(i) The importer of such article of a drug or device or importer
of such article of a food additive, color additive, or dietary
supplement submits to the Secretary, at the time of initial
importation, a statement in accordance with the following:
(I) Such statement provides that such article is intended to
be further processed by the initial owner or consignee, or
incorporated by the initial owner or consignee, into a drug,
biological product, device, food, food additive, color additive,
or dietary supplement that will be exported by the initial owner
or consignee from the United States in accordance with
subsection (e) of this section or section 382 of this title, or
with section 262(h) of title 42.
(II) The statement identifies the manufacturer of such
article and each processor, packer, distributor, or other entity
that had possession of the article in the chain of possession of
the article from the manufacturer to such importer of the
article.
(III) The statement is accompanied by such certificates of
analysis as are necessary to identify such article, unless the
article is a device or is an article described in paragraph (4).
(ii) At the time of initial importation and before the delivery
of such article to the importer or the initial owner or consignee,
such owner or consignee executes a good and sufficient bond
providing for the payment of such liquidated damages in the event of
default as may be required pursuant to regulations of the Secretary
of the Treasury.
(iii) Such article is used and exported by the initial owner or
consignee in accordance with the intent described under clause
(i)(I), except for any portions of the article that are destroyed.
(iv) The initial owner or consignee maintains records on the use
or destruction of such article or portions thereof, as the case may
be, and submits to the Secretary any such records requested by the
Secretary.
(v) Upon request of the Secretary, the initial owner or
consignee submits a report that provides an accounting of the
exportation or destruction of such article or portions thereof, and
the manner in which such owner or consignee complied with the
requirements of this subparagraph.
(B) Notwithstanding subparagraph (A), the Secretary may refuse
admission to an article that otherwise would be imported into the United
States under such subparagraph if the Secretary determines that there is
credible evidence or information indicating that such article is not
intended to be further processed by the initial owner or consignee, or
incorporated by the initial owner or consignee, into a drug, biological
product, device, food, food additive, color additive, or dietary
supplement that will be exported by the initial owner or consignee from
the United States in accordance with subsection (e) of this section or
section 382 of this title, or with section 262(h) of title 42.
(C) This section may not be construed as affecting the
responsibility of the Secretary to ensure that articles imported into
the United States under authority of subparagraph (A) meet each of the
conditions established in such subparagraph for importation.
(4) The importation into the United States of blood, blood
components, source plasma, or source leukocytes or of a component,
accessory, or part thereof is not permitted pursuant to paragraph (3)
unless the importation complies with section 262(a) of title 42 or the
Secretary permits the importation under appropriate circumstances and
conditions, as determined by the Secretary. The importation of tissue or
a component or part of tissue is not permitted pursuant to paragraph (3)
unless the importation complies with section 264 of title 42.
(e) Exports
(1) A food, drug, device, or cosmetic intended for export shall not
be deemed to be adulterated or misbranded under this chapter if it--
(A) accords to the specifications of the foreign purchaser,
(B) is not in conflict with the laws of the country to which it
is intended for export,
(C) is labeled on the outside of the shipping package that it is
intended for export, and
(D) is not sold or offered for sale in domestic commerce.
(2) Paragraph (1) does not apply to any device--
(A) which does not comply with an applicable requirement of
section 360d or 360e of this title,
(B) which under section 360j(g) of this title is exempt from
either such section, or
(C) which is a banned device under section 360f of this title,
unless, in addition to the requirements of paragraph (1), either (i) the
Secretary has determined that the exportation of the device is not
contrary to public health and safety and has the approval of the country
to which it is intended for export or (ii) the device is eligible for
export under section 382 of this title.
(3) A new animal drug that requires approval under section 360b of
this title shall not be exported pursuant to paragraph (1) if such drug
has been banned in the United States.
(4)(A) Any person who exports a drug, animal drug, or device may
request that the Secretary--
(i) certify in writing that the exported drug, animal drug, or
device meets the requirements of paragraph (1) or section 382 of
this title; or
(ii) certify in writing that the drug, animal drug, or device
being exported meets the applicable requirements of this chapter
upon a showing that the drug or device meets the applicable
requirements of this chapter.
The Secretary shall issue such a certification within 20 days of the
receipt of a request for such certification.
(B) If the Secretary issues a written export certification within
the 20 days prescribed by subparagraph (A), a fee for such certification
may be charged but shall not exceed $175 for each certification. Fees
collected for a fiscal year pursuant to this subparagraph shall be
credited to the appropriation account for salaries and expenses of the
Food and Drug Administration and shall be available in accordance with
appropriations Acts until expended without fiscal year limitation. Such
fees shall be collected in each fiscal year in an amount equal to the
amount specified in appropriations Acts for such fiscal year and shall
only be collected and available for the costs of the Food and Drug
Administration.
(f) Labeling of exported drugs
(1) If a drug (other than insulin, an antibiotic drug, an animal
drug, or a drug exported under section 382 of this title) being exported
in accordance with subsection (e) of this section is being exported to a
country that has different or additional labeling requirements or
conditions for use and such country requires the drug to be labeled in
accordance with those requirements or uses, such drug may be labeled in
accordance with such requirements and conditions for use in the country
to which such drug is being exported if it also is labeled in accordance
with the requirements of this chapter.
(2) If, pursuant to paragraph (1), the labeling of an exported drug
includes conditions for use that have not been approved under this
chapter, the labeling must state that such conditions for use have not
been approved under this chapter. A drug exported under section 382 of
this title is exempt from this section.
(g) Warning notice of importation in violation of chapter
(1) With respect to a prescription drug being imported or offered
for import into the United States, the Secretary, in the case of an
individual who is not in the business of such importations, may not send
a warning notice to the individual unless the following conditions are
met:
(A) The notice specifies, as applicable to the importation of
the drug, that the Secretary has made a determination that--
(i) importation is in violation of subsection (a) of this
section because the drug is or appears to be adulterated,
misbranded, or in violation of section 355 of this title;
(ii) importation is in violation of subsection (a) of this
section because the drug is or appears to be forbidden or
restricted in sale in the country in which it was produced or
from which it was exported;
(iii) importation is or appears to be in violation of
subsection (d)(1) of this section; or
(iv) importation otherwise is or appears to be in violation
of Federal law.
(B) The notice does not specify any provision described in
subparagraph (A) that is not applicable to the importation of the
drug.
(C) The notice states the reasons underlying such determination
by the Secretary, including a brief application to the principal
facts involved of the provision of law described in subparagraph (A)
that is the basis of the determination by the Secretary.
(2) For purposes of this section, the term ``warning notice'', with
respect to the importation of a drug, means a communication from the
Secretary (written or otherwise) notifying a person, or clearly
suggesting to the person, that importing the drug for personal use is,
or appears to be, a violation of this chapter.
(h) Protection against adulteration of food
(1) The Secretary shall give high priority to increasing the number
of inspections under this section for the purpose of enabling the
Secretary to inspect food offered for import at ports of entry into the
United States, with the greatest priority given to inspections to detect
the intentional adulteration of food.
(2) The Secretary shall give high priority to making necessary
improvements to the information management systems of the Food and Drug
Administration that contain information related to foods imported or
offered for import into the United States for purposes of improving the
ability of the Secretary to allocate resources, detect the intentional
adulteration of food, and facilitate the importation of food that is in
compliance with this chapter.
(3) The Secretary shall improve linkages with other regulatory
agencies of the Federal Government that share responsibility for food
safety, and shall with respect to such safety improve linkages with the
States and Indian tribes (as defined in section 450b(e) of title 25).
(i) Testing for rapid detection of adulteration of food
(1) For use in inspections of food under this section, the Secretary
shall provide for research on the development of tests and sampling
methodologies--
(A) whose purpose is to test food in order to rapidly detect the
adulteration of the food, with the greatest priority given to detect
the intentional adulteration of food; and
(B) whose results offer significant improvements over the
available technology in terms of accuracy, timing, or costs.
(2) In providing for research under paragraph (1), the Secretary
shall give priority to conducting research on the development of tests
that are suitable for inspections of food at ports of entry into the
United States.
(3) In providing for research under paragraph (1), the Secretary
shall as appropriate coordinate with the Director of the Centers for
Disease Control and Prevention, the Director of the National Institutes
of Health, the Administrator of the Environmental Protection Agency, and
the Secretary of Agriculture.
(4) The Secretary shall annually submit to the Committee on Energy
and Commerce of the House of Representatives, and the Committee on
Health, Education, Labor, and Pensions of the Senate, a report
describing the progress made in research under paragraph (1), including
progress regarding paragraph (2).
(j) Temporary holds at ports of entry
(1) If an officer or qualified employee of the Food and Drug
Administration has credible evidence or information indicating that an
article of food presents a threat of serious adverse health consequences
or death to humans or animals, and such officer or qualified employee is
unable to inspect, examine, or investigate such article upon the article
being offered for import at a port of entry into the United States, the
officer or qualified employee shall request the Secretary of Treasury to
hold the food at the port of entry for a reasonable period of time, not
to exceed 24 hours, for the purpose of enabling the Secretary to
inspect, examine, or investigate the article as appropriate.
(2) The Secretary shall request the Secretary of Treasury to remove
an article held pursuant to paragraph (1) to a secure facility, as
appropriate. During the period of time that such article is so held, the
article shall not be transferred by any person from the port of entry
into the United States for the article, or from the secure facility to
which the article has been removed, as the case may be. Subsection (b)
of this section does not authorize the delivery of the article pursuant
to the execution of a bond while the article is so held.
(3) An officer or qualified employee of the Food and Drug
Administration may make a request under paragraph (1) only if the
Secretary or an official designated by the Secretary approves the
request. An official may not be so designated unless the official is the
director of the district under this chapter in which the article
involved is located, or is an official senior to such director.
(4) With respect to an article of food for which a request under
paragraph (1) is made, the Secretary, promptly after the request is
made, shall notify the State in which the port of entry involved is
located that the request has been made, and as applicable, that such
article is being held under this subsection.
(k) Importation by debarred persons
(1) If an article of food is being imported or offered for import
into the United States, and the importer, owner, or consignee of the
article is a person who has been debarred under section 335a(b)(3) of
this title, such article shall be held at the port of entry for the
article, and may not be delivered to such person. Subsection (b) of this
section does not authorize the delivery of the article pursuant to the
execution of a bond while the article is so held. The article shall be
removed to a secure facility, as appropriate. During the period of time
that such article is so held, the article shall not be transferred by
any person from the port of entry into the United States for the
article, or from the secure facility to which the article has been
removed, as the case may be.
(2) An article of food held under paragraph (1) may be delivered to
a person who is not a debarred person under section 335a(b)(3) of this
title if such person affirmatively establishes, at the expense of the
person, that the article complies with the requirements of this chapter,
as determined by the Secretary.
(l) Failure to register
(1) \2\ If an article of food is being imported or offered for
import into the United States, and such article is from a foreign
facility for which a registration has not been submitted to the
Secretary under section 350d of this title, such article shall be held
at the port of entry for the article, and may not be delivered to the
importer, owner, or consignee of the article, until the foreign facility
is so registered. Subsection (b) of this section does not authorize the
delivery of the article pursuant to the execution of a bond while the
article is so held. The article shall be removed to a secure facility,
as appropriate. During the period of time that such article is so held,
the article shall not be transferred by any person from the port of
entry into the United States for the article, or from the secure
facility to which the article has been removed, as the case may be.
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\2\ So in original. No par. (2) has been enacted.
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(m) Prior notice of imported food shipments
(1) In the case of an article of food that is being imported or
offered for import into the United States, the Secretary, after
consultation with the Secretary of the Treasury, shall by regulation
require, for the purpose of enabling such article to be inspected at
ports of entry into the United States, the submission to the Secretary
of a notice providing the identity of each of the following: The
article; the manufacturer and shipper of the article; if known within
the specified period of time that notice is required to be provided, the
grower of the article; the country from which the article originates;
the country from which the article is shipped; and the anticipated port
of entry for the article. An article of food imported or offered for
import without submission of such notice in accordance with the
requirements under this paragraph shall be refused admission into the
United States. Nothing in this section may be construed as a limitation
on the port of entry for an article of food.
(2)(A) Regulations under paragraph (1) shall require that a notice
under such paragraph be provided by a specified period of time in
advance of the time of the importation of the article of food involved
or the offering of the food for import, which period shall be no less
than the minimum amount of time necessary for the Secretary to receive,
review, and appropriately respond to such notification, but may not
exceed five days. In determining the specified period of time required
under this subparagraph, the Secretary may consider, but is not limited
to consideration of, the effect on commerce of such period of time, the
locations of the various ports of entry into the United States, the
various modes of transportation, the types of food imported into the
United States, and any other such consideration. Nothing in the
preceding sentence may be construed as a limitation on the obligation of
the Secretary to receive, review, and appropriately respond to any
notice under paragraph (1).
(B)(i) If an article of food is being imported or offered for import
into the United States and a notice under paragraph (1) is not provided
in advance in accordance with the requirements under paragraph (1), such
article shall be held at the port of entry for the article, and may not
be delivered to the importer, owner, or consignee of the article, until
such notice is submitted to the Secretary, and the Secretary examines
the notice and determines that the notice is in accordance with the
requirements under paragraph (1). Subsection (b) of this section does
not authorize the delivery of the article pursuant to the execution of a
bond while the article is so held. The article shall be removed to a
secure facility, as appropriate. During the period of time that such
article is so held, the article shall not be transferred by any person
from the port of entry into the United States for the article, or from
the secure facility to which the article has been removed, as the case
may be.
(ii) In carrying out clause (i) with respect to an article of food,
the Secretary shall determine whether there is in the possession of the
Secretary any credible evidence or information indicating that such
article presents a threat of serious adverse health consequences or
death to humans or animals.
(3)(A) This subsection may not be construed as limiting the
authority of the Secretary to obtain information under any other
provision of this chapter.
(B) This subsection may not be construed as authorizing the
Secretary to impose any requirements with respect to a food to the
extent that it is within the exclusive jurisdiction of the Secretary of
Agriculture pursuant to the Federal Meat Inspection Act (21 U.S.C. 601
et seq.), the Poultry Products Inspection Act (21 U.S.C. 451 et seq.),
or the Egg Products Inspection Act (21 U.S.C. 1031 et seq.).
(n) Labeling of food refused admission
(1) If a food has been refused admission under subsection (a) of
this section, other than such a food that is required to be destroyed,
the Secretary may require the owner or consignee of the food to affix to
the container of the food a label that clearly and conspicuously bears
the statement: ``UNITED STATES: REFUSED ENTRY''.
(2) All expenses in connection with affixing a label under paragraph
(1) shall be paid by the owner or consignee of the food involved, and in
default of such payment, shall constitute a lien against future
importations made by such owner or consignee.
(3) A requirement under paragraph (1) remains in effect until the
Secretary determines that the food involved has been brought into
compliance with this chapter.
(o) Registration statement
If an article that is a drug or device is being imported or offered
for import into the United States, and the importer, owner, or consignee
of such article does not, at the time of offering the article for
import, submit to the Secretary a statement that identifies the
registration under section 360(i) of this title of each establishment
that with respect to such article is required under such section to
register with the Secretary, the article may be refused admission. If
the article is refused admission for failure to submit such a statement,
the article shall be held at the port of entry for the article, and may
not be delivered to the importer, owner, or consignee of the article,
until such a statement is submitted to the Secretary. Subsection (b) of
this section does not authorize the delivery of the article pursuant to
the execution of a bond while the article is so held. The article shall
be removed to a secure facility, as appropriate. During the period of
time that such article is so held, the article shall not be transferred
by any person from the port of entry into the United States for the
article, or from the secure facility to which the article has been
removed, as the case may be.
(June 25, 1938, ch. 675, Sec. 801, 52 Stat. 1058; Oct. 18, 1949, ch.
696, Secs. 1-3, 63 Stat. 882; Pub. L. 87-781, title III, Sec. 306, Oct.
10, 1962, 76 Stat. 796; Pub. L. 90-399, Sec. 106, July 13, 1968, 82
Stat. 353; Pub. L. 91-513, title II, Sec. 701(h), Oct. 27, 1970, 84
Stat. 1282; Pub. L. 94-295, Secs. 3(f), 4(b)(3), May 28, 1976, 90 Stat.
578, 580; Pub. L. 100-293, Sec. 3, Apr. 22, 1988, 102 Stat. 96; Pub. L.
102-300, Sec. 6(b)(1), June 16, 1992, 106 Stat. 240; Pub. L. 102-353,
Sec. 5, Aug. 26, 1992, 106 Stat. 943; Pub. L. 103-80, Sec. 3(cc),
(dd)(1), Aug. 13, 1993, 107 Stat. 778, 779; Pub. L. 104-134, title II,
Sec. 2102(a)-(c), Apr. 26, 1996, 110 Stat. 1321-313, 1321-314; Pub. L.
104-180, title VI, Sec. 603(a), (b), Aug. 6, 1996, 110 Stat. 1594, 1595;
Pub. L. 105-115, title I, Sec. 125(a)(2)(D), Nov. 21, 1997, 111 Stat.
2325; Pub. L. 106-387, Sec. 1(a) [title VII, Secs. 745(c)(1), 746(c)],
Oct. 28, 2000, 114 Stat. 1549, 1549A-36, 1549A-40; Pub. L. 107-188,
title III, Secs. 302(a)-(d), 303(c), 304(e), 305(c), 307(a), 308(a),
321(b)(1), 322(a), June 12, 2002, 116 Stat. 662, 663, 665, 667, 668,
670, 672, 676.)
References in Text
The Controlled Substances Import and Export Act, referred to in
subsec. (a), is title III of Pub. L. 91-513, Oct. 27, 1970, 84 Stat.
1285, as amended, which is classified principally to subchapter II
(Sec. 951 et seq.) of chapter 13 of this title. For complete
classification of this Act to the Code, see Short Title note set out
under section 951 of this title and Tables.
The Federal Meat Inspection Act, referred to in subsec. (m)(3)(B),
is titles I to IV of act Mar. 4, 1907, ch. 2907, as added Pub. L. 90-
201, Dec. 15, 1967, 81 Stat. 584, and amended, which are classified
generally to subchapters I to IV (Sec. 601 et seq.) of chapter 12 of
this title. For complete classification of this Act to the Code, see
Short Title note set out under section 601 of this title and Tables.
The Poultry Products Inspection Act, referred to in subsec.
(m)(3)(B), is Pub. L. 85-172, Aug. 28, 1957, 71 Stat. 441, as amended,
which is classified generally to chapter 10 (Sec. 451 et seq.) of this
title. For complete classification of this Act to the Code, see Short
Title note set out under section 451 of this title and Tables.
The Egg Products Inspection Act, referred to in subsec. (m)(3)(B),
is Pub. L. 91-597, Dec. 29, 1970, 84 Stat. 1620, as amended, which is
classified generally to chapter 15 (Sec. 1031 et seq.) of this title.
For complete classification of this Act to the Code, see Short Title
note set out under section 1031 of this title and Tables.
Amendments
2002--Subsec. (d)(3). Pub. L. 107-188, Sec. 322(a), amended par. (3)
generally. Prior to amendment, par. (3) read as follows: ``No component
of a drug, no component part or accessory of a device, or other article
of device requiring further processing, which is ready or suitable for
use for health-related purposes, and no food additive, color additive,
or dietary supplement, including a product in bulk form, shall be
excluded from importation into the United States under subsection (a) of
this section if--
``(A) the importer of such article of a drug or device or
importer of the food additive, color additive, or dietary supplement
submits a statement to the Secretary, at the time of initial
importation, that such article of a drug or device, food additive,
color additive, or dietary supplement is intended to be further
processed by the initial owner or consignee, or incorporated by the
initial owner or consignee into a drug, biological product, device,
food, food additive, color additive, or dietary supplement that will
be exported by such owner or consignee from the United States in
accordance with subsection (e) of this section or section 382 of
this title or section 262(h) of title 42;
``(B) the initial owner or consignee responsible for such
imported article maintains records that identify the use of such
imported article and upon request of the Secretary submits a report
that provides an accounting of the exportation or the disposition of
the imported article, including portions that have been destroyed,
and the manner in which such person complied with the requirements
of this paragraph; and
``(C) any imported component, part, article, or accessory of a
drug or device and any food additive, color additive, or dietary
supplement not incorporated or further processed as described in
subparagraph (A) is destroyed or exported by the owner or
consignee.''
Subsec. (h). Pub. L. 107-188, Sec. 302(a)-(c), added subsec. (h).
Subsec. (i). Pub. L. 107-188, Sec. 302(d), added subsec. (i).
Subsec. (j). Pub. L. 107-188, Sec. 303(c), added subsec. (j).
Subsec. (k). Pub. L. 107-188, Sec. 304(e), added subsec. (k).
Subsec. (l). Pub. L. 107-188, Sec. 305(c), added subsec. (l).
Subsec. (m). Pub. L. 107-188, Sec. 307(a), added subsec. (m).
Subsec. (n). Pub. L. 107-188, Sec. 308(a), added subsec. (n).
Subsec. (o). Pub. L. 107-188, Sec. 321(b)(1), added subsec. (o).
2000--Subsec. (d)(1). Pub. L. 106-387, Sec. 1(a) [title VII,
Sec. 745(c)(1)], inserted ``and section 384 of this title'' after
``paragraph (2)''.
Subsec. (g). Pub. L. 106-387, Sec. 1(a) [title VII, Sec. 746(c)],
added subsec. (g).
1997--Subsec. (d)(1). Pub. L. 105-115 inserted ``or composed wholly
or partly of insulin'' after ``353(b) of this title''.
1996--Subsec. (d)(3). Pub. L. 104-180, Sec. 603(a), substituted
``accessory of a device, or other article of device requiring further
processing, which is ready'' for ``accessory of a device which is
ready'' in introductory provisions, inserted ``further processed by the
initial owner or consignee, or'' after ``is intended to be'' in subpar.
(A), and inserted ``article,'' after ``part,'' and ``or further
processed'' after ``incorporated'' in subpar. (C).
Pub. L. 104-134, Sec. 2102(a)(1), added par. (3)
Subsec. (d)(4). Pub. L. 104-134, Sec. 2102(a)(1), added par. (4).
Subsec. (e)(1). Pub. L. 104-134, Sec. 2102(b)(1), struck out
concluding provisions which read as follows: ``This paragraph does not
authorize the exportation of any new animal drug, or an animal feed
bearing or containing a new animal drug, which is unsafe within the
meaning of section 360b of this title.''
Subsec. (e)(2). Pub. L. 104-134, Sec. 2102(b)(2), in concluding
provisions, substituted ``either (i) the Secretary'' for ``the
Secretary'' and added cl. (ii).
Subsec. (e)(3), (4). Pub. L. 104-134, Sec. 2102(b)(3), added pars.
(3) and (4).
Subsec. (f). Pub. L. 104-180, Sec. 603(b), inserted ``(other than
insulin, an antibiotic drug, an animal drug, or a drug exported under
section 382 of this title)'' after ``If a drug'' in par. (1) and ``A
drug exported under section 382 of this title is exempt from this
section.'' at end of par. (2).
Pub. L. 104-134, Sec. 2102(c), added subsec. (f).
1993--Subsec. (a). Pub. L. 103-80, Sec. 3(dd)(1), substituted
``Health and Human Services'' for ``Agriculture'' after ``Secretary of''
in two places in first sentence.
Subsec. (b). Pub. L. 103-80, Sec. 3(cc), substituted ``Secretary of
Health and Human Services'' for ``Administrator'' after ``If it appears
to the'', ``Secretary'' for ``Administrator'' after ``provisions of this
subsection, the'', ``Secretary's'' for ``Administrator's'' after ``as
may be specified in the'', ``Department of Health and Human Services''
for ``Federal Security Agency'', and ``Secretary'' for ``Administrator''
after ``designated by the''.
1992--Subsecs. (a), (b). Pub. L. 102-300, which directed the
substitution of ``Health and Human Services'' for ``Health, Education,
and Welfare'' wherever appearing, was executed in second sentence of
subsec. (a), but could not be executed in first sentence of subsec. (a)
or in subsec. (b) because such words did not appear. See 1993 Amendment
note above and Transfer of Functions note below.
Subsec. (d)(1). Pub. L. 102-353 substituted ``manufacturer of'' for
``person who manufactured''.
1988--Subsecs. (d), (e). Pub. L. 100-293 added subsec. (d) and
redesignated former subsec. (d) as (e).
1976--Subsec. (a). Pub. L. 94-295, Secs. 3(f)(2), 4(b)(3), expanded
provisions requiring the Secretary of Health, Education, and Welfare to
request that the Secretary of the Treasury deliver to the Secretary of
Health, Education, and Welfare items imported or offered for import into
the United States that were manufactured, prepared, propagated,
compounded, or processed in non-registered establishments by extending
the provisions to include devices imported or offered for import, and,
in cl. (1), inserted reference to devices which were manufactured,
packed, stored, or installed using methods, facilities, or controls not
conforming to the requirements of section 360j(f) of this title.
Subsec. (d). Pub. L. 94-295, Sec. 3(f)(1), designated existing
provisions as par. (1) and added par. (2).
1970--Subsec. (a). Pub. L. 91-513 substituted ``Clause (2) of the
third sentence of this paragraph'' for ``This paragraph'' and ``the
Controlled Substances Import and Export Act'' for ``section 173 of this
title'' in last sentence.
1968--Subsec. (d). Pub. L. 90-399 provided that nothing in subsec.
(d) shall authorize the exportation of any new animal drug, or an animal
feed bearing or containing a new animal drug, which is unsafe within the
meaning of section 360b of this title.
1962--Subsec. (a). Pub. L. 87-781 inserted provisions requiring the
Secretary of Health, Education, and Welfare to furnish the Secretary of
the Treasury a list of establishments registered under section 360(i) of
this title, and to request that samples of any drugs from any
establishments not so registered be delivered to the Secretary of
Health, Education, and Welfare, with notice of delivery to the consignee
who may appear before the Secretary to testify.
1949--Subsec. (a). Act Oct. 18, 1949, Sec. 1, inserted before period
at end of second sentence ``, except as provided in subsection (b) of
this section. The Secretary of the Treasury shall cause the destruction
of any such article refused admission unless such article is exported,
under regulations prescribed by the Secretary of the Treasury within
ninety days of the notice of such refusal or within such additional time
as may be permitted pursuant to such regulations''.
Subsec. (b). Act Oct. 18, 1949, Sec. 2, provided for express
statutory authority for the long-standing administrative practice of
releasing imported articles that do not comply with the requirements of
the law so that they may be relabeled or given appropriate treatment to
bring them into compliance.
Subsec. (c). Act Oct. 18, 1949, Sec. 3, charged all costs, including
salaries and travel and subsistence expenses of officers and employees,
against importers.
Effective Date of 2002 Amendment
Amendment by section 321(b)(1) of 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.
Amendment by section 322(a) of Pub. L. 107-188 effective upon the
expiration of the 90-day period beginning June 12, 2002, see section
322(c) of Pub. L. 107-188, set out as a note under section 331 of this
title.
Effective Date of 1988 Amendment
Amendment by Pub. L. 100-293 effective upon expiration of 90 days
after Apr. 22, 1988, see section 8(a) of Pub. L. 100-293, set out as a
note under section 353 of this title.
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 1968 Amendment
Amendment of subsec. (d) by Pub. L. 90-399 effective on first day of
thirteenth calendar month after July 13, 1968, see section 108(a) of
Pub. L. 90-399, set out as an Effective Date and Transitional Provisions
note under section 360b of this title.
Regulations
Pub. L. 107-188, title III, Sec. 307(c), June 12, 2002, 116 Stat.
672, provided that:
``(1) In general.--Not later than 18 months after the date of the
enactment of this Act [June 12, 2002], the Secretary of Health and Human
Services shall promulgate proposed and final regulations for the
requirement of providing notice in accordance with section 801(m) of the
Federal Food, Drug, and Cosmetic Act [21 U.S.C. 381(m)] (as added by
subsection (a) of this section). Such requirement of notification takes
effect--
``(A) upon the effective date of such final regulations; or
``(B) upon the expiration of such 18-month period if the final
regulations have not been made effective as of the expiration of
such period, subject to compliance with the final regulations when
the final regulations are made effective.
``(2) Default; minimum period of advance notice.--If under paragraph
(1) the requirement for providing notice in accordance with section
801(m) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 381(m)]
takes effect without final regulations having been made effective, then
for purposes of such requirement, the specified period of time that the
notice is required to be made in advance of the time of the importation
of the article of food involved or the offering of the food for import
shall be not fewer than eight hours and not more than five days, which
shall remain in effect until the final regulations are made effective.''
Savings Provision
Amendment by Pub. L. 91-513 not to affect or abate any prosecutions
for violation of law or any civil seizure or forfeitures and injunctive
proceedings commenced prior to the effective date of such amendment, and
all administrative proceedings pending before the Bureau of Narcotic and
Dangerous Drugs [now 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.
Construction of Amendments by Pub. L. 107-188
Pub. L. 107-188, title III, Sec. 308(c), June 12, 2002, 116 Stat.
673, provided that: ``With respect to articles of food that are imported
or offered for import into the United States, nothing in this section
[amending this section and section 343 of this title] shall be construed
to limit the authority of the Secretary of Health and Human Services or
the Secretary of the Treasury to require the marking of refused articles
of food under any other provision of law.''
Transfer of Functions
Secretary and Department of Health, Education, and Welfare
redesignated Secretary and Department of Health and Human Services by
Pub. L. 96-88, title V, Sec. 509(b), Oct. 17, 1979, 93 Stat. 695, which
is classified to section 3508(b) of Title 20, Education.
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 note set out under section
41 of this title.
Study and Report on Trade in Pharmaceuticals
Pub. L. 108-173, title XI, Sec. 1123, Dec. 8, 2003, 117 Stat. 2469,
provided that: ``The President's designees shall conduct a study and
report on issues related to trade and pharmaceuticals.''
Findings
Pub. L. 106-387, Sec. 1(a) [title VII, Sec. 746(b)], Oct. 28, 2000,
114 Stat. 1549, 1549A-40, provided that: ``The Congress finds as
follows:
``(1) Patients and their families sometimes have reason to
import into the United States drugs that have been approved by the
Food and Drug Administration (`FDA').
``(2) There have been circumstances in which--
``(A) an individual seeking to import such a drug has
received a notice from FDA that importing the drug violates or
may violate the Federal Food, Drug, and Cosmetic Act [21 U.S.C.
301 et seq.]; and
``(B) the notice failed to inform the individual of the
reasons underlying the decision to send the notice.
``(3) FDA should not send a warning notice regarding the
importation of a drug without providing to the individual involved a
statement of the underlying reasons for the notice.''
Section Referred to in Other Sections
This section is referred to in sections 331, 333, 334, 342, 343,
360, 371, 382, 384 of this title; title 15 section 1456; title 42
section 262.
