§ 382. — Exports of certain unapproved products.
[Laws in effect as of January 24, 2002]
[Document not affected by Public Laws enacted between
January 24, 2002 and December 19, 2002]
[CITE: 21USC382]
TITLE 21--FOOD AND DRUGS
CHAPTER 9--FEDERAL FOOD, DRUG, AND COSMETIC ACT
SUBCHAPTER VIII--IMPORTS AND EXPORTS
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.
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\1\ So in original. Probably should be subsection ``(b)(1)(A)''.
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(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 the eighth
paragraph under the heading ``Bureau of Animal Industry'' of act Mar. 4,
1913, ch. 145, 37 Stat. 832, 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.
