Federal food, drug, and cosmetic act

19/03/2009 12:11:05
Federal food, drug, and cosmetic act

Federal food, drug, and cosmetic act

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) 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.

(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.

(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.)

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.

Amendments

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 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.

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.

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.

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, 360, 371,
382, 384 of this title; title 15 section 1456; title 42 section 262.

Sec. 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 country to which such drug will be
exported of such disapproval.

(b) List of eligible countries for export; criteria for addition to
list; direct export; petition for exemption

(1)(A) A drug or device described in subsection (a) of this section
may be exported to any country, if the drug or device complies with the
laws of that country and has valid marketing authorization by the
appropriate authority--
(i) in Australia, Canada, Israel, Japan, New Zealand,
Switzerland, or South Africa; or
(ii) in the European Union or a country in the European Economic
Area (the countries in the European Union and the European Free
Trade Association) if the drug or device is marketed in that country
or the drug or device is authorized for general marketing in the
European Economic Area.

(B) The Secretary may designate an additional country to be included
in the list of countries described in clauses (i) and (ii) of
subparagraph (A) if all of the following requirements are met in such
country:
(i) Statutory or regulatory requirements which require the
review of drugs and devices for safety and effectiveness by an
entity of the government of such country and which authorize the
approval of only those drugs and devices which have been determined
to be safe and effective by experts employed by or acting on behalf
of such entity and qualified by scientific training and experience
to evaluate the safety and effectiveness of drugs and devices on the
basis of adequate and well-controlled investigations, including
clinical investigations, conducted by experts qualified by
scientific training and experience to evaluate the safety and
effectiveness of drugs and devices.
(ii) Statutory or regulatory requirements that the methods used
in, and the facilities and controls used for--
(I) the manufacture, processing, and packing of drugs in the
country are adequate to preserve their identity, quality,
purity, and strength; and
(II) the manufacture, preproduction design validation,
packing, storage, and installation of a device are adequate to
assure that the device will be safe and effective.

(iii) Statutory or regulatory requirements for the reporting of
adverse reactions to drugs and devices and procedures to withdraw
approval and remove drugs and devices found not to be safe or
effective.
(iv) Statutory or regulatory requirements that the labeling and
promotion of drugs and devices must be in accordance with the
approval of the drug or device.
(v) The valid marketing authorization system in such country or
countries is equivalent to the systems in the countries described in
clauses (i) and (ii) of subparagraph (A).

The Secretary shall not delegate the authority granted under this
subparagraph.
(C) An appropriate country official, manufacturer, or exporter may
request the Secretary to take action under subparagraph (B) to designate
an additional country or countries to be added to the list of countries
described in clauses (i) and (ii) of subparagraph (A) by submitting
documentation to the Secretary in support of such designation. Any
person other than a country requesting such designation shall include,
along with the request, a letter from the country indicating the desire
of such country to be designated.
(2) A drug described in subsection (a) of this section may be
directly exported to a country which is not listed in clause (i) or (ii)
of paragraph (1)(A) if--
(A) the drug complies with the laws of that country and has
valid marketing authorization by the responsible authority in that
country; and
(B) the Secretary determines that all of the following
requirements are met in that country:
(i) Statutory or regulatory requirements which require the
review of drugs for safety and effectiveness by an entity of the
government of such country and which authorize the approval of
only those drugs which have been determined to be safe and
effective by experts employed by or acting on behalf of such
entity and qualified by scientific training and experience to
evaluate the safety and effectiveness of drugs on the basis of
adequate and well-controlled investigations, including clinical
investigations, conducted by experts qualified by scientific
training and experience to evaluate the safety and effectiveness
of drugs.
(ii) Statutory or regulatory requirements that the methods
used in, and the facilities and controls used for the
manufacture, processing, and packing of drugs in the country are
adequate to preserve their identity, quality, purity, and
strength.
(iii) Statutory or regulatory requirements for the reporting
of adverse reactions to drugs and procedures to withdraw
approval and remove drugs found not to be safe or effective.
(iv) Statutory or regulatory requirements that the labeling
and promotion of drugs must be in accordance with the approval
of the drug.

(3) The exporter of a drug described in subsection (a) of this
section which would not meet the conditions for approval under this
chapter or conditions for approval of a country described in clause (i)
or (ii) of paragraph (1)(A) may petition the Secretary for authorization
to export such drug to a country which is not described in clause (i) or
(ii) of paragraph (1)(A) or which is not described in paragraph (2). The
Secretary shall permit such export if--
(A) the person exporting the drug--
(i) certifies that the drug would not meet the conditions
for approval under this chapter or the conditions for approval
of a country described in clause (i) or (ii) of paragraph
(1)(A); and
(ii) provides the Secretary with credible scientific
evidence, acceptable to the Secretary, that the drug would be
safe and effective under the conditions of use in the country to
which it is being exported; and

(B) the appropriate health authority in the country to which the
drug is being exported--
(i) requests approval of the export of the drug to such
country;
(ii) certifies that the health authority understands that
the drug is not approved under this chapter or in a country
described in clause (i) or (ii) of paragraph (1)(A); and
(iii) concurs that the scientific evidence provided pursuant
to subparagraph (A) is credible scientific evidence that the
drug would be reasonably safe and effective in such country.

The Secretary shall take action on a request for export of a drug under
this paragraph within 60 days of receiving such request.

(c) Investigational use exemption

A drug or device intended for investigational use in any country
described in clause (i) or (ii) of subsection (b)(1)(A) of this section
may be exported in accordance with the laws of that country and shall be
exempt from regulation under section 355(i) or 360j(g) of this title.

(d) Anticipation of market authorization

A drug or device intended for formulation, filling, packaging,
labeling, or further processing in anticipation of market authorization
in any country described in clause (i) or (ii) of subsection (b)(1)(A)
of this section may be exported for use in accordance with the laws of
that country.

(e) Diagnosis, prevention, or treatment of tropical disease

(1) A drug or device which is used in the diagnosis, prevention, or
treatment of a tropical disease or another disease not of significant
prevalence in the United States and which does not otherwise qualify for
export under this section shall, upon approval of an application, be
permitted to be exported if the Secretary finds that the drug or device
will not expose patients in such country to an unreasonable risk of
illness or injury and the probable benefit to health from the use of the
drug or device (under conditions of use prescribed, recommended, or
suggested in the labeling or proposed labeling of the drug or device)
outweighs the risk of injury or illness from its use, taking into
account the probable risks and benefits of currently available drug or
device treatment.
(2) The holder of an approved application for the export of a drug
or device under this subsection shall report to the Secretary--
(A) the receipt of any credible information indicating that the
drug or device is being or may have been exported from a country for
which the Secretary made a finding under paragraph (1)(A) to a
country for which the Secretary cannot make such a finding; and
(B) the receipt of any information indicating adverse reactions
to such drug.

(3)(A) If the Secretary determines that--
(i) a drug or device for which an application is approved under
paragraph (1) does not continue to meet the requirements of such
paragraph; or
(ii) the holder of an approved application under paragraph (1)
has not made the report required by paragraph (2),

the Secretary may, after providing the holder of the application an
opportunity for an informal hearing, withdraw the approved application.
(B) If the Secretary determines that the holder of an approved
application under paragraph (1) or an importer is exporting a drug or
device from the United States to an importer and such importer is
exporting the drug or device to a country for which the Secretary cannot
make a finding under paragraph (1) and such export presents an imminent
hazard, the Secretary shall immediately prohibit the export of the drug
or device to such importer, provide the person exporting the drug or
device from the United States prompt notice of the prohibition, and
afford such person an opportunity for an expedited hearing.

(f) Prohibition of export of drug or device

A drug or device may not be exported under this section--
(1) if the drug or device is not manufactured, processed,
packaged, and held in substantial conformity with current good
manufacturing practice requirements or does not meet international
standards as certified by an international standards organization
recognized by the Secretary;
(2) if the drug or device is adulterated under clause (1),
(2)(A), or (3) of section 351(a) or subsection (c) or (d) of section
351 of this title;
(3) if the requirements of subparagraphs (A) through (D) of
section 381(e)(1) of this title have not been met;
(4)(A) if the drug or device is the subject of a notice by the
Secretary or the Secretary of Agriculture of a determination that
the probability of reimportation of the exported drug or device
would present an imminent hazard to the public health and safety of
the United States and the only means of limiting the hazard is to
prohibit the export of the drug or device; or
(B) if the drug or device presents an imminent hazard to the
public health of the country to which the drug or device would be
exported;
(5) if the labeling of the drug or device is not--
(A) in accordance with the requirements and conditions for
use in--
(i) the country in which the drug or device received
valid marketing authorization under subsection (b) of this
section; and
(ii) the country to which the drug or device would be
exported; and

(B) in the language and units of measurement of the country
to which the drug or device would be exported or in the language
designated by such country; or

(6) if the drug or device is not promoted in accordance with the
labeling requirements set forth in paragraph (5).

In making a finding under paragraph (4)(B), (5), or (6) the Secretary
shall consult with the appropriate public health official in the
affected country.

(g) Notification of Secretary

The exporter of a drug or device exported under subsection (b)(1) of
this section shall provide a simple notification to the Secretary
identifying the drug or device when the exporter first begins to export
such drug or device to any country listed in clause (i) or (ii) of
subsection (b)(1)(A) of this section. When an exporter of a drug or
device first begins to export a drug or device to a country which is not
listed in clause (i) or (ii) of subsection (b)(1)A) \1\ of this section,
the exporter shall provide a simple notification to the Secretary
identifying the drug or device and the country to which such drug or
device is being exported. Any exporter of a drug or device shall
maintain records of all drugs or devices exported and the countries to
which they were exported.
---------------------------------------------------------------------------
\1\ So in original. Probably should be subsection ``(b)(1)(A)''.
---------------------------------------------------------------------------

(h) References to Secretary and term ``drug''

For purposes of this section--
(1) a reference to the Secretary shall in the case of a
biological product which is required to be licensed under the Act of
March 4, 1913 [21 U.S.C. 151 et seq.] (37 Stat. 832-833) (commonly
known as the Virus-Serum Toxin Act) be considered to be a reference
to the Secretary of Agriculture, and
(2) the term ``drug'' includes drugs for human use as well as
biologicals under section 262 of title 42 or the Act of March 4,
1913 (37 Stat. 832-833) (commonly known as the Virus-Serum Toxin
Act).

(i) Exportation

Insulin and antibiotic drugs may be exported without regard to the
requirements in this section if the insulin and antibiotic drugs meet
the requirements of section 381(e)(1) of this title.

(June 25, 1938, ch. 675, Sec. 802, as added Pub. L. 99-660, title I,
Sec. 102(2), Nov. 14, 1986, 100 Stat. 3743; amended Pub. L. 104-134,
title III, Sec. 2102(d)(1), Apr. 26, 1996, 110 Stat. 1321-315; Pub. L.
104-180, title VI, Sec. 603(c), Aug. 6, 1996, 110 Stat. 1595; Pub. L.
105-115, title I, Sec. 125(c), Nov. 21, 1997, 111 Stat. 2326.)

References in Text

Act of March 4, 1913 (known as the Virus-Serum Toxin Act), referred
to in subsecs. (a)(1)(A)(ii), (C), (2)(C) and (h), is act Mar. 4, 1913,
ch. 145, 37 Stat. 828, as amended, which is classified generally to
chapter 5 (Sec. 151 et seq.) of this title. For complete classification
of this Act to the Code, see Short Title note set out under section 151
of this title and Tables.

Amendments

1997--Subsec. (i). Pub. L. 105-115 added subsec. (i).
1996--Pub. L. 104-134 reenacted section catchline without change and
amended text generally. Prior to amendment, text related to exports of
certain unapproved products, including provisions relating to drugs
intended for human or animal use which required approval or licensing,
conditions for export, active pursuit of drug approval or licensing,
application for export, contents, approval or disapproval, list of
eligible countries for export, and criteria for list change, report to
Secretary by holder of approved application, events requiring report,
and annual report to Secretary on pursuit of approval of drug, export of
drug under approved application prohibited under certain conditions,
determination by Secretary of noncompliance, failure of active pursuit
of drug approval, imminent hazard of drug to public health, or
exportation of drug to noneligible country, notices, hearings, and
prohibition on exportation of drug under certain circumstances, drugs
used in prevention or treatment of tropical disease, and reference to
Secretary and holder of application.
Subsec. (f)(5). Pub. L. 104-180 substituted ``if the labeling of the
drug or device is not'' for ``if the drug or device is not labeled''.

Section Referred to in Other Sections

This section is referred to in sections 321, 331, 381, 384 of this
title.

Sec. 383. Office of International Relations

(a) Establishment

There is established in the Department of Health and Human Services
an Office of International Relations.

(b) Agreements with foreign countries

In carrying out the functions of the office under subsection (a) of
this section, the Secretary may enter into agreements with foreign
countries to facilitate commerce in devices between the United States
and such countries consistent with the requirements of this chapter. In
such agreements, the Secretary shall encourage the mutual recognition
of--
(1) good manufacturing practice regulations promulgated under
section 360j(f) of this title, and
(2) other regulations and testing protocols as the Secretary
determines to be appropriate.

(c) Harmonizing regulatory requirements

(1) The Secretary shall support the Office of the United States
Trade Representative, in consultation with the Secretary of Commerce, in
meetings with representatives of other countries to discuss methods and
approaches to reduce the burden of regulation and harmonize regulatory
requirements if the Secretary determines that such harmonization
continues consumer protections consistent with the purposes of this
chapter.
(2) The Secretary shall support the Office of the United States
Trade Representative, in consultation with the Secretary of Commerce, in
efforts to move toward the acceptance of mutual recognition agreements
relating to the regulation of drugs, biological products, devices,
foods, food additives, and color additives, and the regulation of good
manufacturing practices, between the European Union and the United
States.
(3) The Secretary shall regularly participate in meetings with
representatives of other foreign governments to discuss and reach
agreement on methods and approaches to harmonize regulatory
requirements.
(4) The Secretary shall, not later than 180 days after November 21,
1997, make public a plan that establishes a framework for achieving
mutual recognition of good manufacturing practices inspections.
(5) Paragraphs (1) through (4) shall not apply with respect to
products defined in section 321(ff) of this title.

(June 25, 1938, ch. 675, Sec. 803, as added Pub. L. 101-629, Sec. 15(a),
Nov. 28, 1990, 104 Stat. 4525; amended Pub. L. 105-115, title IV,
Sec. 410(b), Nov. 21, 1997, 111 Stat. 2373.)

Amendments

1997--Subsec. (c). Pub. L. 105-115 added subsec. (c).

Effective Date of 1997 Amendment

Amendment by Pub. L. 105-115 effective 90 days after Nov. 21, 1997,
except as otherwise provided, see section 501 of Pub. L. 105-115, set
out as a note under section 321 of this title.

Report on Activities of Office of International Relations

Section 15(b) of Pub. L. 101-629 directed Secretary of Health and
Human Services, not later than 2 years after Nov. 28, 1990, to prepare
and submit to the appropriate committees of Congress a report on the
activities of the Office of International Relations under 21 U.S.C. 383.

Sec. 384. Importation of covered products

(a) Regulations

The Secretary, after consultation with the United States Trade
Representative and the Commissioner of Customs, shall promulgate
regulations permitting pharmacists and wholesalers to import into the
United States covered products.

(b) Limitation

Regulations under subsection (a) of this section shall--
(1) require that safeguards be in place to ensure that each
covered product imported pursuant to such subsection complies with
section 355 of this title (including with respect to being safe and
effective for its intended use), with sections 351 and 352 of this
title, and with other applicable requirements of this chapter;
(2) require that an importer of a covered product pursuant to
subsection (a) of this section comply with the applicable provisions
of this section, including subsection (d) of this section; and
(3) contain any additional provisions determined by the
Secretary to be appropriate as a safeguard to protect the public
health or as a means to facilitate the importation of such products.

(c) Records

Regulations under subsection (a) of this section shall require that
records regarding the importation of covered products pursuant to such
subsection be provided to and maintained by the Secretary for a period
of time determined to be necessary by the Secretary.

(d) Importation

Regulations under subsection (a) of this section shall require an
importer of a covered product pursuant to such subsection to provide to
the Secretary the following information and records:
(1) The name and amount of the active ingredient of such product
and description of the dosage form.
(2) The date that the product is shipped and the quantity of the
product that is shipped, points of origin and destination for the
product, the price paid for the product by the importer, and (once
the product is distributed) the price for which such product is sold
by the importer.
(3) Documentation from the foreign seller specifying the
original source of the product and the amount of each lot of the
product originally received.
(4) The manufacturer's lot or control number of the product
imported.
(5) The name, address, and telephone number of the importer,
including the professional license number of the importer, if any.
(6) For a product that is coming directly from the first foreign
recipient of the product from the manufacturer:
(A) Documentation demonstrating that such product came from
such recipient and was received by the recipient from such
manufacturer.
(B) Documentation of the amount of each lot of the product
received by such recipient to demonstrate that the amount being
imported into the United States is not more than the amount that
was received by the recipient.
(C) In the case of the initial imported shipment,
documentation demonstrating that each batch of such shipment was
statistically sampled and tested for authenticity and
degradation.
(D) In the case of all subsequent shipments from such
recipient, documentation demonstrating that a statistically
valid sample of such shipments was tested for authenticity and
degradation.
(E) Certification from the importer or manufacturer of such
product that the product is approved for marketing in the United
States and meets all labeling requirements under this chapter.

(7) For a product that is not coming directly from the first
foreign recipient of the product from the manufacturer:
(A) Documentation demonstrating that each batch in all
shipments offered for importation into the United States was
statistically sampled and tested for authenticity and
degradation.
(B) Certification from the importer or manufacturer of such
product that the product is approved for marketing in the United
States and meets all labeling requirements under this chapter.

(8) Laboratory records, including complete data derived from all
tests necessary to assure that the product is in compliance with
established specifications and standards.
(9) Documentation demonstrating that the testing required by
paragraphs (6) through (8) was performed at a qualifying laboratory
(as defined in subsection (k) of this section).
(10) Any other information that the Secretary determines is
necessary to ensure the protection of the public health.

(e) Testing

Regulations under subsection (a) of this section--
(1) shall require that testing referred to in paragraphs (6)
through (8) of subsection (d) of this section be conducted by the
importer of the covered product pursuant to subsection (a) of this
section, or the manufacturer of the product;
(2) shall require that if such tests are conducted by the
importer, information needed to authenticate the product being
tested, and to confirm that the labeling of such product complies
with labeling requirements under this chapter, be supplied by the
manufacturer of such product to the pharmacist or wholesaler, and
shall require that such information be kept in strict confidence and
used only for purposes of testing under this chapter; and
(3) may include such additional provisions as the Secretary
determines to be appropriate to provide for the protection of trade
secrets and commercial or financial information that is privileged
or confidential.

(f) Country limitation

Regulations under subsection (a) of this section shall provide that
covered products may be imported pursuant to such subsection only from a
country, union, or economic area that is listed in subparagraph (A) of
section 382(b)(1) of this title or designated by the Secretary, subject
to such limitations as the Secretary determines to be appropriate to
protect the public health.

(g) Suspension of importations

The Secretary shall require that importations of specific covered
products or importations by specific importers pursuant to subsection
(a) of this section be immediately suspended upon discovery of a pattern
of importation of such products or by such importers that is counterfeit
or in violation of any requirement pursuant to this section, until an
investigation is completed and the Secretary determines that the public
is adequately protected from counterfeit and violative covered products
being imported pursuant to subsection (a) of this section.

(h) Prohibited agreements

No manufacturer of a covered product may enter into a contract or
agreement that includes a provision to prevent the sale or distribution
of covered products imported pursuant to subsection (a) of this section.

(i) Studies; reports

(1) Study by Secretary

(A) In general

The Secretary shall conduct, or contract with an entity to
conduct, a study on the imports permitted pursuant to subsection
(a) of this section, including consideration of the information
received under subsection (d) of this section. In conducting
such study, the Secretary or entity shall--
(i) evaluate the compliance of importers with
regulations under subsection (a) of this section, and the
number of shipments pursuant to such subsection, if any,
that have been determined to be counterfeit, misbranded, or
adulterated, and determine how such compliance contrasts
with the number of shipments of prescription drugs
transported within the United States that have been
determined to be counterfeit, misbranded, or adulterated;
and
(ii) consult with the United States Trade Representative
and the Commissioner of Patents and Trademarks to evaluate
the effect of importations pursuant to subsection (a) of
this section on trade and patent rights under Federal law.

(B) Report

Not later than 2 years after the effective date of final
regulations under subsection (a) of this section, the Secretary
shall prepare and submit to the Congress a report describing the
findings of the study under subparagraph (A).

(2) Study by General Accounting Office

The Comptroller General of the United States shall conduct a
study to determine the effect of this section on the price of
covered products sold to consumers at retail. Not later than 18
months after the effective date of final regulations under
subsection (a) of this section, the Comptroller General shall
prepare and submit to the Congress a report describing the findings
of such study.

(j) Construction

Nothing in this section shall be construed to limit the statutory,
regulatory, or enforcement authority of the Secretary relating to the
importation of covered products, other than with respect to section
381(d)(1) of this title as provided in this section.

(k) Definitions

(1) Covered product

(A) In general

For purposes of this section, the term ``covered product''
means a prescription drug, except that such term does not
include a controlled substance in schedule I, II, or III under
section 812(c) of this title or a biological product as defined
in section 262 of title 42.

(B) Charitable contributions; parenteral drugs

Notwithstanding any other provision of this section, section
381(d)(1) of this title--
(i) continues to apply to a covered product donated or
otherwise supplied for free by the manufacturer of the drug
to a charitable or humanitarian organization, including the
United Nations and affiliates, or to a government of a
foreign country; and
(ii) continues to apply to a covered product that is a
parenteral drug the importation of which pursuant to
subsection (a) of this section is determined by the
Secretary to pose a threat to the public health.

(2) Other terms

For purposes of this section:
(A) The term ``importer'' means a pharmacist or wholesaler.
(B) The term ``pharmacist'' means a person licensed by a
State to practice pharmacy, including the dispensing and selling
of prescription drugs.
(C) The term ``prescription drug'' means a drug subject to
section 353(b) of this title.
(D) The term ``qualifying laboratory'' means a laboratory in
the United States that has been approved by the Secretary for
purposes of this section.
(E) The term ``wholesaler'' means a person licensed as a
wholesaler or distributor of prescription drugs in the United
States pursuant to section 353(e)(2)(A) of this title. Such term
does not include a person authorized to import drugs under
section 381(d)(1) of this title.

(l) Conditions

This section shall become effective only if the Secretary
demonstrates to the Congress that the implementation of this section
will--
(1) pose no additional risk to the public's health and safety;
and
(2) result in a significant reduction in the cost of covered
products to the American consumer.

(m) Sunset

Effective upon the expiration of the 5-year period beginning on the
effective date of final regulations under subsection (a) of this
section, this section ceases to have any legal effect.

(June 25, 1938, ch. 675, Sec. 804, as added Pub. L. 106-387, Sec. 1(a)
[title VII, Sec. 745(c)(2)], Oct. 28, 2000, 114 Stat. 1549, 1549A-36.)

Findings

Pub. L. 106-387, Sec. 1(a) [title VII, Sec. 745(b)], Oct. 28, 2000,
114 Stat. 1549, 1549A-35, provided that: ``The Congress makes the
following findings:
``(1) The cost of prescription drugs for Americans continues to
rise at an alarming rate.
``(2) Millions of Americans, including Medicare beneficiaries on
fixed incomes, face a daily choice between purchasing life-
sustaining prescription drugs, or paying for other necessities, such
as food and housing.
``(3) Many life-saving prescription drugs are available in
countries other than the United States at substantially lower
prices, even though such drugs were developed and are approved for
use by patients in the United States.
``(4) Many Americans travel to other countries to purchase
prescription drugs because the medicines that they need are
unaffordable in the United States.
``(5) Americans should be able to purchase medicines at prices
that are comparable to prices for such medicines in other countries,
but efforts to enable such purchases should not endanger the gold
standard for safety and effectiveness that has been established and
maintained in the United States.''

Section Referred to in Other Sections

This section is referred to in sections 331, 333, 381 of this title.

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