21 USC 381 - Imports

Page 383

TITLE 21—FOOD AND DRUGS

and procedural standards applicable to the employees of the agency from which such employee is detailed and those of the Foundation.
(2) Voluntary service; acceptance of Federal
employees
(A) Foundation
The Executive Director of the Foundation
may accept the services of employees detailed from Federal agencies with or without
reimbursement to those agencies.
(B) Food and Drug Administration
The Commissioner may accept the uncompensated services of Foundation fellows or
trainees. Such services shall be considered
to be undertaking an activity under contract
with the Secretary as described in section
379 of this title.
(l) Annual reports
(1) Reports to Foundation
Any recipient of a grant, contract, fellowship, memorandum of understanding, or cooperative agreement from the Foundation under
this section shall submit to the Foundation a
report on an annual basis for the duration of
such grant, contract, fellowship, memorandum
of understanding, or cooperative agreement,
that describes the activities carried out under
such grant, contract, fellowship, memorandum
of understanding, or cooperative agreement.
(2) Report to Congress and the FDA
Beginning with fiscal year 2009, the Executive Director shall submit to Congress and the
Commissioner an annual report that—
(A) describes the activities of the Foundation and the progress of the Foundation in
furthering the goals and priorities established under subsection (c)(2), including the
practical impact of the Foundation on regulated product development;
(B) provides a specific accounting of the
source and use of all funds used by the Foundation to carry out such activities; and
(C) provides information on how the results of Foundation activities could be incorporated into the regulatory and product
review activities of the Food and Drug Administration.
(m) Separation of funds
The Executive Director shall ensure that the
funds received from the Treasury are held in
separate accounts from funds received from entities under subsection (i).
(n) Funding
From amounts appropriated to the Food and
Drug Administration for each fiscal year, the
Commissioner shall transfer not less than
$500,000 and not more than $1,250,000, to the
Foundation to carry out subsections (a), (b), and
(d) through (m).
(June 25, 1938, ch. 675, § 770, as added Pub. L.
110–85, title VI, § 601(a), Sept. 27, 2007, 121 Stat.
890.)
§ 379dd–1. Location of Foundation
The Foundation shall, if practicable, be located not more than 20 miles from the District
of Columbia.

§ 381

(June 25, 1938, ch. 675, § 771, as added Pub. L.
110–85, title VI, § 601(b), Sept. 27, 2007, 121 Stat.
897.)
§ 379dd–2. Activities of the Food and Drug Administration
(a) In general
The Commissioner shall receive and assess the
report submitted to the Commissioner by the
Executive Director of the Foundation under section 379dd(l)(2) of this title.
(b) Report to Congress
Beginning with fiscal year 2009, the Commissioner shall submit to Congress an annual report
summarizing the incorporation of the information provided by the Foundation in the report
described under section 379dd(l)(2) of this title
and by other recipients of grants, contracts,
memoranda of understanding, or cooperative
agreements into regulatory and product review
activities of the Food and Drug Administration.
(c) Extramural grants
The provisions of this part and section
360bbb–5 of this title shall have no effect on any
grant, contract, memorandum of understanding,
or cooperative agreement between the Food and
Drug Administration and any other entity entered into before, on, or after September 27, 2007.
(June 25, 1938, ch. 675, § 772, as added Pub. L.
110–85, title VI, § 601(b), Sept. 27, 2007, 121 Stat.
897.)
SUBCHAPTER VIII—IMPORTS AND
EXPORTS
§ 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,
tobacco products, 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 or section 387e(h) of this title and
shall request that if any drugs, devices, or tobacco products 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, devices, or tobacco products 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 meth-

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ods 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, or prohibited from introduction or
delivery for introduction into interstate commerce under section 331(ll) of this title, or (4) the
recordkeeping requirements under section 2223
of this title (other than the requirements under
subsection (f) of such section) have not been
complied with regarding such article, then such
article shall be refused admission, except as provided in subsection (b) of this section. With respect to an article of food, if importation of such
food is subject to, but not compliant with, the
requirement under subsection (q) that such food
be accompanied by a certification or other assurance that the food meets applicable requirements of this chapter, then such article shall be
refused admission. If such article is subject to a
requirement under section 379aa or 379aa–1 of
this title and if the Secretary has credible evidence or information indicating that the responsible person (as defined in such section 379aa or
379aa–1 of this title) has not complied with a requirement of such section 379aa or 379aa–1 of
this title with respect to any such article, or has
not allowed access to records described in such
section 379aa or 379aa–1 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.].
(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 (1)
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, or (2)
with respect to an article described in subsection (a) relating to the requirements of sections 2 379aa or 379aa–1 of this title,,3 the responsible person (as defined in section 379aa or
1 So

in original. Probably should be ‘‘subsection’’.
in original. Probably should be ‘‘section’’.
3 So in original.
2 So

Page 384

379aa–1 of this title) can take action that would
assure that the responsible person is in compliance with section 379aa or 379aa–1 of this title,
as the case may be, 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,
or, with respect to clause (2), the responsible
person, 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

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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

§ 381

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, tobacco product or
cosmetic intended for export shall not be
deemed to be adulterated or misbranded under
this chapter, and a tobacco product intended for
export shall not be deemed to be in violation of
section 387f(e), 387g, 387k, or 387t(a) of this title,
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 food, drug,
animal drug, or device may request that the
Secretary—
(i) certify in writing that the exported food,
drug, animal drug, or device meets the requirements of paragraph (1) or section 382 of
this title; or
(ii) certify in writing that the food, drug,
animal drug, or device being exported meets
the applicable requirements of this chapter
upon a showing that the food, 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

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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.
(C) For purposes of this paragraph, a certification by the Secretary shall be made on such
basis, and in such form (including a publicly
available listing) as the Secretary determines
appropriate.
(D) With regard to fees pursuant to subparagraph (B) in connection with written export certifications for food:
(i) Such fees shall be collected and available
solely for the costs of the Food and Drug Administration associated with issuing such certifications.
(ii) Such fees may not be retained in an
amount that exceeds such costs for the respective fiscal year.
(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.

Page 386

(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).

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(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.

§ 381

(l) Failure to register
(1) 4 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 (or for
which a registration has been suspended under
such section), 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.
(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; any country
to which the article has been refused entry; 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
4 So

in original. No par. (2) has been enacted.

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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

Page 388

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.
(p) Report
(1) Not later than 36 months after June 22,
2009, and annually thereafter, the Secretary
shall submit to the Committee on Health, Education, Labor, and Pensions of the Senate and
the Committee on Energy and Commerce of the
House of Representatives, a report regarding—
(A) the nature, extent, and destination of
United States tobacco product exports that do
not conform to tobacco product standards established pursuant to this chapter;
(B) the public health implications of such
exports, including any evidence of a negative
public health impact; and
(C) recommendations or assessments of policy alternatives available to Congress and the
executive branch to reduce any negative public health impact caused by such exports.
(2) The Secretary is authorized to establish appropriate information disclosure requirements
to carry out this subsection.
(q) Certifications concerning imported foods
(1) In general
The Secretary may require, as a condition of
granting admission to an article of food imported or offered for import into the United
States, that an entity described in paragraph
(3) provide a certification, or such other assurances as the Secretary determines appropriate, that the article of food complies with
applicable requirements of this chapter. Such
certification or assurances may be provided in
the form of shipment-specific certificates, a
listing of certified facilities that manufacture,
process, pack, or hold such food, or in such
other form as the Secretary may specify.
(2) Factors to be considered in requiring certification
The Secretary shall base the determination
that an article of food is required to have a
certification described in paragraph (1) on the
risk of the food, including—
(A) known safety risks associated with the
food;
(B) known food safety risks associated
with the country, territory, or region of origin of the food;
(C) a finding by the Secretary, supported
by scientific, risk-based evidence, that—
(i) the food safety programs, systems,
and standards in the country, territory, or
region of origin of the food are inadequate
to ensure that the article of food is as safe

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as a similar article of food that is manufactured, processed, packed, or held in the
United States in accordance with the requirements of this chapter; and
(ii) the certification would assist the
Secretary in determining whether to
refuse or admit the article of food under
subsection (a); and
(D) information submitted to the Secretary in accordance with the process established in paragraph (7).
(3) Certifying entities
For purposes of paragraph (1), entities that
shall provide the certification or assurances
described in such paragraph are—
(A) an agency or a representative of the
government of the country from which the
article of food at issue originated, as designated by the Secretary; or
(B) such other persons or entities accredited pursuant to section 384d of this title to
provide such certification or assurance.
(4) Renewal and refusal of certifications
The Secretary may—
(A) require that any certification or other
assurance provided by an entity specified in
paragraph (2) be renewed by such entity at
such times as the Secretary determines appropriate; and
(B) refuse to accept any certification or assurance if the Secretary determines that
such certification or assurance is not valid
or reliable.
(5) Electronic submission
The Secretary shall provide for the electronic submission of certifications under this
subsection.
(6) False statements
Any statement or representation made by an
entity described in paragraph (2) to the Secretary shall be subject to section 1001 of title
18.
(7) Assessment of food safety programs, systems, and standards
If the Secretary determines that the food
safety programs, systems, and standards in a
foreign region, country, or territory are inadequate to ensure that an article of food is as
safe as a similar article of food that is manufactured, processed, packed, or held in the
United States in accordance with the requirements of this chapter, the Secretary shall, to
the extent practicable, identify such inadequacies and establish a process by which the foreign region, country, or territory may inform
the Secretary of improvements made to such
food safety program, system, or standard and
demonstrate that those controls are adequate
to ensure that an article of food is as safe as
a similar article of food that is manufactured,
processed, packed, or held in the United States
in accordance with the requirements of this
chapter.
(June 25, 1938, ch. 675, § 801, 52 Stat. 1058; Oct. 18,
1949, ch. 696, §§ 1–3, 63 Stat. 882; Pub. L. 87–781,
title III, § 306, Oct. 10, 1962, 76 Stat. 796; Pub. L.
90–399, § 106, July 13, 1968, 82 Stat. 353; Pub. L.

91–513, title II, § 701(h), Oct. 27, 1970, 84 Stat. 1282;
Pub. L. 94–295, §§ 3(f), 4(b)(3), May 28, 1976, 90
Stat. 578, 580; Pub. L. 100–293, § 3, Apr. 22, 1988, 102
Stat. 96; Pub. L. 102–300, § 6(b)(1), June 16, 1992,
106 Stat. 240; Pub. L. 102–353, § 5, Aug. 26, 1992, 106
Stat. 943; Pub. L. 103–80, § 3(cc), (dd)(1), Aug. 13,
1993, 107 Stat. 778, 779; Pub. L. 104–134, title II,
§ 2102(a)–(c), Apr. 26, 1996, 110 Stat. 1321–313,
1321–314; Pub. L. 104–180, title VI, § 603(a), (b),
Aug. 6, 1996, 110 Stat. 1594, 1595; Pub. L. 105–115,
title I, § 125(a)(2)(D), Nov. 21, 1997, 111 Stat. 2325;
Pub. L. 106–387, § 1(a) [title VII, §§ 745(c)(1),
746(c)], Oct. 28, 2000, 114 Stat. 1549, 1549A–36,
1549A–40; Pub. L. 107–188, title III, §§ 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; Pub. L. 109–462, § 5(a), Dec. 22, 2006, 120
Stat. 3475; Pub. L. 110–85, title IX, § 912(b)(2),
Sept. 27, 2007, 121 Stat. 952; Pub. L. 111–31, div. A,
title I, § 103(l), June 22, 2009, 123 Stat. 1837; Pub.
L. 111–353, title I, §§ 102(b)(3), 107(b), title II,
§ 204(j)(2), title III, §§ 301(c), 303(a)–(c), 304(a), Jan.
4, 2011, 124 Stat. 3889, 3910, 3937, 3955–3957.)
AMENDMENT OF SUBSECTION (a)
Pub. L. 111–353, title III, § 301(c), (d), Jan. 4,
2011, 124 Stat. 3955, provided that, effective 2
years after Jan. 4, 2011, subsection (a) of this
section is amended by inserting ‘‘or the importer
(as defined in section 384a of this title) is in violation of such section 384a of this title’’ after
‘‘or in violation of section 355 of this title’’.
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, which is classified principally to subchapter II (§ 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,
which are classified generally to subchapters I to IV
(§ 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, which is classified generally to chapter 10 (§ 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, which is classified principally to chapter 15 (§ 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
2011—Subsec. (a). Pub. L. 111–353, §§ 204(j)(2), 303(a), inserted ‘‘or (4) the recordkeeping requirements under
section 2223 of this title (other than the requirements
under subsection (f) of such section) have not been complied with regarding such article,’’ in the third sentence before ‘‘then such article shall be refused admission’’ and inserted after the third sentence ‘‘With respect to an article of food, if importation of such food
is subject to, but not compliant with, the requirement
under subsection (q) that such food be accompanied by
a certification or other assurance that the food meets
applicable requirements of this chapter, then such article shall be refused admission.’’

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Subsec. (b). Pub. L. 111–353, § 303(c), substituted ‘‘with
respect to an article described in subsection (a) relating to the requirements of sections 379aa or 379aa–1 of
this title,’’ for ‘‘with respect to an article included
within the provision of the fourth sentence of subsection (a)’’ in second sentence.
Subsec. (e)(4)(A). Pub. L. 111–353, § 107(b)(1)(A), substituted ‘‘a food, drug’’ for ‘‘a drug’’ in introductory
provisions.
Subsec. (e)(4)(A)(i). Pub. L. 111–353, § 107(b)(1)(B), substituted ‘‘exported food, drug’’ for ‘‘exported drug’’.
Subsec. (e)(4)(A)(ii). Pub. L. 111–353, § 107(b)(1)(C), substituted ‘‘the food, drug’’ for ‘‘the drug’’ in two places.
Subsec. (e)(4)(C). Pub. L. 111–353, § 107(b)(2), added subpar. (C).
Subsec. (e)(4)(D). Pub. L. 111–353, § 107(b)(3), added subpar. (D).
Subsec. (l). Pub. L. 111–353, § 102(b)(3), inserted ‘‘(or for
which a registration has been suspended under such
section)’’ after ‘‘section 350d of this title’’.
Subsec. (m)(1). Pub. L. 111–353, § 304(a), inserted ‘‘any
country to which the article has been refused entry;’’
after ‘‘the country from which the article is shipped;’’.
Subsec. (q). Pub. L. 111–353, § 303(b), added subsec. (q).
2009—Subsec. (a). Pub. L. 111–31, § 103(l)(1)(C), which
directed substitution of ‘‘drugs, devices, or tobacco
products’’ for ‘‘drugs or devices’’ wherever appearing,
was executed by making the substitution for ‘‘drugs
and devices’’ in two places in second sentence, to reflect the probable intent of Congress.
Pub. L. 111–31, § 103(l)(1)(A), (B), inserted ‘‘tobacco
products,’’ after ‘‘devices,’’ in first sentence and ‘‘or
section 387e(h)’’ after ‘‘section 360’’ in second sentence.
Subsec. (e)(1). Pub. L. 111–31, § 103(l)(2), in introductory provisions, inserted ‘‘tobacco product’’ after
‘‘drug, device,’’ and ‘‘, and a tobacco product intended
for export shall not be deemed to be in violation of section 387f(e), 387g, 387k, or 387t(a) of this title,’’ after
‘‘chapter’’.
Subsec. (p). Pub. L. 111–31, § 103(l)(3), added subsec. (p).
2007—Subsec. (a). Pub. L. 110–85 substituted ‘‘is adulterated, misbranded, or in violation of section 355 of
this title, or prohibited from introduction or delivery
for introduction into interstate commerce under section 331(ll) of this title,’’ for ‘‘is adulterated, misbranded, or in violation of section 355 of this title,’’.
2006—Subsec. (a). Pub. L. 109–462, § 5(a)(1), inserted
after third sentence ‘‘If such article is subject to a requirement under section 379aa or 379aa–1 of this title
and if the Secretary has credible evidence or information indicating that the responsible person (as defined
in such section 379aa or 379aa–1 of this title) has not
complied with a requirement of such section 379aa or
379aa–1 of this title with respect to any such article, or
has not allowed access to records described in such section 379aa or 379aa–1 of this title, then such article
shall be refused admission, except as provided in subsection (b) of this section.’’
Subsec. (b). Pub. L. 109–462, § 5(a)(2), in second sentence, inserted ‘‘(1)’’ before ‘‘an article included’’, ‘‘or
(2) with respect to an article included within the provision of the fourth sentence of subsection (a), the responsible person (as defined in section 379aa or 379aa–1
of this title) can take action that would assure that the
responsible person is in compliance with section 379aa
or 379aa–1 of this title, as the case may be,’’ before
‘‘final determination’’, and ‘‘, or, with respect to clause
(2), the responsible person,’’ before ‘‘to perform’’.
2002—Subsec. (d)(3). Pub. L. 107–188, § 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 di-

Page 390

etary 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, § 302(a)–(c), added subsec.
(h).
Subsec. (i). Pub. L. 107–188, § 302(d), added subsec. (i).
Subsec. (j). Pub. L. 107–188, § 303(c), added subsec. (j).
Subsec. (k). Pub. L. 107–188, § 304(e), added subsec. (k).
Subsec. (l). Pub. L. 107–188, § 305(c), added subsec. (l).
Subsec. (m). Pub. L. 107–188, § 307(a), added subsec.
(m).
Subsec. (n). Pub. L. 107–188, § 308(a), added subsec. (n).
Subsec. (o). Pub. L. 107–188, § 321(b)(1), added subsec.
(o).
2000—Subsec. (d)(1). Pub. L. 106–387, § 1(a) [title VII,
§ 745(c)(1)], inserted ‘‘and section 384 of this title’’ after
‘‘paragraph (2)’’.
Subsec. (g). Pub. L. 106–387, § 1(a) [title VII, § 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, § 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, § 2102(a)(1), added par. (3)
Subsec. (d)(4). Pub. L. 104–134, § 2102(a)(1), added par.
(4).
Subsec. (e)(1). Pub. L. 104–134, § 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, § 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, § 2102(b)(3), added
pars. (3) and (4).
Subsec. (f). Pub. L. 104–180, § 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, § 2102(c), added subsec. (f).
1993—Subsec. (a). Pub. L. 103–80, § 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, § 3(cc), substituted ‘‘Secretary of Health and Human Services’’ for ‘‘Administrator’’ after ‘‘If it appears to the’’, ‘‘Secretary’’ for

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‘‘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, §§ 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 nonregistered 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, § 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, § 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, § 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, § 3, charged all costs, including salaries and travel and subsistence expenses of
officers and employees, against importers.
EFFECTIVE DATE OF 2011 AMENDMENT
Amendment by section 301(c) of Pub. L. 111–353 effective 2 years after Jan. 4, 2011, see section 301(d) of Pub.
L. 111–353, set out as a note under section 331 of this
title.
Pub. L. 111–353, title III, § 304(c), Jan. 4, 2011, 124 Stat.
3958, provided that: ‘‘The amendment made by this section [amending this section] shall take effect 180 days
after the date of enactment of this Act [Jan. 4, 2011].’’

EFFECTIVE DATE OF 2006 AMENDMENT
Pub. L. 109–462, § 5(b), Dec. 22, 2006, 120 Stat. 3476, provided that: ‘‘The amendments made by this section
[amending this section] shall take effect 1 year after
the date of enactment of this Act [Dec. 22, 2006].’’
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. 111–353, title III, § 304(b), Jan. 4, 2011, 124 Stat.
3958, provided that: ‘‘Not later than 120 days after the
date of enactment of this Act [Jan. 4, 2011], the Secretary shall issue an interim final rule amending subpart I of part 1 of title 21, Code of Federal Regulations,
to implement the amendment made by this section
[amending this section].’’
Pub. L. 107–188, title III, § 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,

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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 2011 AMENDMENT
Pub. L. 111–353, title III, § 303(d), Jan. 4, 2011, 124 Stat.
3957, provided that: ‘‘Nothing in the amendments made
by this section [amending this section] shall limit the
authority of the Secretary to conduct inspections of
imported food or to take such other steps as the Secretary deems appropriate to determine the admissibility of imported food.’’
Nothing in amendments by sections 107(b), 204(j)(2),
301(c), and 303(a)–(c) of Pub. L. 111–353 to be construed
to apply to certain alcohol-related facilities, see section 2206 of this title.
Nothing in amendments by Pub. L. 111–353 to be construed to alter jurisdiction and authorities established
under certain other Acts or in a manner inconsistent
with international agreements to which the United
States is a party, see sections 2251 and 2252 of this title.
CONSTRUCTION OF AMENDMENTS BY PUB. L. 107–188
Pub. L. 107–188, title III, § 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,
§ 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 notes set out under
section 321 of this title.
PORT SHOPPING
Pub. L. 111–353, title I, § 115, Jan. 4, 2011, 124 Stat. 3922,
provided that: ‘‘Until the date on which the Secretary
promulgates a final rule that implements the amendments made by section 308 of the Public Health Security and Bioterrorism Preparedness and Response Act
of 2002, (Public Law 107–188) [amending this section and
section 343 of this title], the Secretary shall notify the
Secretary of Homeland Security of all instances in
which the Secretary refuses to admit a food into the
United States under section 801(a) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 381(a)) so that the
Secretary of Homeland Security, acting through the
Commissioner of Customs and Border Protection, may
prevent food refused admittance into the United States
by a United States port of entry from being admitted
by another United States port of entry, through the notification of other such United States ports of entry.’’
MODIFICATION OF DEADLINES FOR SECRETARIAL ACTION
With respect to any time periods specified in an
amendment by div. A of Pub. L. 111–31 that begin on
June 22, 2009, within which the Secretary of Health and
Human Services is required to carry out and complete
specified activities, with certain limitations, the calculation of such time periods shall commence on the
first day of the first fiscal quarter following the initial
2 consecutive fiscal quarters of fiscal year 2010 for
which the Secretary has collected fees under section

Page 392

387s of this title, and the Secretary may extend or reduce the duration of one or more such time periods, except that no such period shall be extended for more
than 90 days, see section 6 of Pub. L. 111–31, set out as
a note under section 387 of this title.
STUDY AND REPORT ON TRADE IN PHARMACEUTICALS
Pub. L. 108–173, title XI, § 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, § 1(a) [title VII, § 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.’’

§ 382. Exports of certain unapproved products
(a) Drugs or devices intended for human or animal use which require approval or licensing
A drug or device—
(1) which, in the case of a drug—
(A)(i) requires approval by the Secretary
under section 355 of this title before such
drug may be introduced or delivered for introduction into interstate commerce; or
(ii) requires licensing by the Secretary
under section 262 of title 42 or by the Secretary of Agriculture under the Act of March
4, 1913 [21 U.S.C. 151 et seq.] (known as the
Virus-Serum Toxin Act) before it may be introduced or delivered for introduction into
interstate commerce;
(B) does not have such approval or license;
and
(C) is not exempt from such sections or
Act; and
(2) which, in the case of a device—
(A) does not comply with an applicable requirement under section 360d or 360e of this
title;
(B) under section 360j(g) of this title is exempt from either such section; or
(C) is a banned device under section 360f of
this title, is adulterated, misbranded, and in
violation of such sections or Act unless the
export of the drug or device is, except as provided in subsection (f) of this section, authorized under subsection (b), (c), (d), or (e)
of this section or section 381(e)(2) of this
title. If a drug or device described in paragraphs (1) and (2) may be exported under subsection (b) of this section and if an application for such drug or device under section 355
or 360e of this title or section 262 of title 42
was disapproved, the Secretary shall notify
the appropriate public health official of the