Regulations &
Codified CSA > CFR > Section 1312 > Section 1312.22
Section 1312.22 Application for export permit.
(a) An application for a permit to export controlled substances shall be made on
DEA Form 161, and an
application for a permit to reexport controlled substances shall
be made on
DEA Form 161R. Forms may be obtained from, and shall be filed with, the Drug
Enforcement Administration, Import/Export
Unit, Washington, DC 20537. Each application shall show the exporter's
name, address, and registration number; a detailed description of each controlled substance
desired to be exported including the drug name, dosage form, National Drug Code
(NDC) number (in
accordance with Food and Drug Administration regulations), the Administration Controlled Substance Code Number as set forth in
part 1308 of this
chapter, the number and size of packages or containers, the name and quantity of the controlled
substance contained in any finished dosage units, and the quantity of any controlled substance
(expressed in anhydrous acid, base, or alkaloid) given in kilograms or parts thereof. The
application shall include the name, address, and business of the consignee, foreign port of entry,
the port of exportation, the approximate date of exportation, the name of the exporting carrier or
vessel (if known, or if unknown it should be stated whether shipment will be made by express,
freight, or otherwise, exports of controlled substances by mail being prohibited), the date and
number, if any, of the supporting foreign import license or permit accompanying the application,
and the authority by whom such foreign license or permit was issued. The application shall also
contain an affidavit that the packages are labeled in conformance with obligations of the United
States under international treaties, conventions, or protocols in effect on May 1,
1971. The
affidavit shall further state and that
to the best of affiant's knowledge and belief, the controlled substances therein are to be applied
exclusively to medical or scientific uses within the country to which exported, will not be
reexported therefrom and that there is an actual need for the controlled substance for medical or
scientific uses within such country, unless
the application is submitted for reexport in accordance with
paragraphs (c) and (d) of this section. In the case of exportation of crude cocaine, the affidavit may
state that to the best of knowledge and belief, the controlled substances will be processed within
the country to which exported, either for medical or scientific use within that country or for
reexportation in accordance with the laws of that country to another for medical or scientific use
within that country. The application shall be signed and dated by the exporter and shall contain
the address from which the substances will be shipped for exportation.
(b) There shall also be submitted with the application any import license or permit (and a
translation thereof if in a foreign language) or a certified copy of any such license or permit
issued by competent authorities in the country of destination, or other documentary evidence
deemed adequate by the Administrator, showing that the merchandise is consigned to an
authorized permittee, that it is to be applied exclusively to medical or scientific use within the
country of destination, that it will not be reexported from such country, and that there is an actual
need for the controlled substance for medical or scientific use within such country. (In the case of
exportation of bulk coca leaf alkaloid, the submitted evidence need only show the material
outlined in paragraph (a) of this section for such exportations.)
(c) Notwithstanding
paragraphs (a) and (b) of this section, the Administration may authorize any
controlled substance listed in Schedule I or II, or any narcotic drug listed
in Schedule III or IV, to be exported from the United States to a country for
subsequent export from that country to another country, if each of the
following conditions is met, in accordance with Sec. 1003(f) of the Act (21
U.S.C. 953(f)):
(1) Both the country
to which the controlled substance is exported from the United States
(referred to in this section as the "first country'') and the country to
which the controlled substance is exported from the first country (referred
to in this section as the "second country'') are parties to the Single
Convention on Narcotic Drugs, 1961, and the Convention on Psychotropic
Substances, 1971;
(2) The first country
and the second country have each instituted and maintain, in conformity with
such Conventions, a system of controls of imports of controlled substances
which the Administration deems adequate;
(3) With respect to
the first country, the controlled substance is consigned to a holder of such
permits or licenses as may be required under the laws of such country, and a
permit or license to import the controlled substance has been issued by the
country;
(4) With respect to
the second country, substantial evidence is furnished to the Administration
by the applicant for the export permit that--
(i) The controlled
substance is to be consigned to a holder of such permits or licenses as
may be required under the laws of such country, and a permit or license to
import the controlled substance is to be issued by the country; and
(ii) The controlled
substance is to be applied exclusively to medical, scientific, or other
legitimate uses within the country;
(5) The controlled
substance will not be exported from the second country;
(6) The person who
exported the controlled substance from the United States has complied with
paragraph (d) of this section and a permit to export the controlled
substance from the United States has been issued by the Administration; and
(7) Within 30 days
after the controlled substance is exported from the first country to the
second country, the person who exported the controlled substance from the
United States must deliver to the Administration documentation certifying
that such export from the first country has occurred. If the permit issued
by the Administration authorized the reexport of a controlled substance from
the first country to more than one second country, notification of each
individual reexport shall be provided. This documentation shall be submitted
on company letterhead, signed by a responsible company official, and shall
include all of the following information:
(i) Name of second
country;
(ii) Actual quantity
shipped;
(iii) Actual date
shipped; and
(iv) DEA export
permit number for the original export.
(d) Where a person is
seeking to export a controlled substance for reexport in accordance with
paragraph (c) of this section, the following requirements shall apply in
addition to (and not in lieu of) the requirements of paragraphs (a) and (b) of
this section:
(1) Bulk substances
will not be reexported in the same form as exported from the United States,
i.e., the material must undergo further manufacturing process. This further
manufactured material may only be reexported to a second country.
(2) Finished dosage
units, if reexported, must be in a commercial package, properly sealed and
labeled for legitimate medical use in the second country.
(3) Any proposed
reexportation must be made known to the Administration at the time the
initial DEA Form
161R is submitted. In addition, the following information must also be
provided where indicated on the form:
(i) Whether the drug
or preparation will be reexported in bulk or finished dosage units;
(ii) The product
name, dosage strength, commercial package size, and quantity;
(iii) The name of
consignee, complete address, and expected shipment date, as well as the
name and address of the ultimate consignee in the second country.
(4) The application (DEA
Form 161R) must also contain an affidavit that the consignee in the
second country is authorized under the laws and regulations of the second
country to receive the controlled substances. The affidavit must also
contain the following statement, in addition to the statements required
under paragraph (a) of this section:
(i) That the
packages are labeled in conformance with the obligations of the United
States under the Single Convention on Narcotic Drugs, 1961, the Convention
on Psychotropic Substances, 1971, and any amendments to such treaties;
(ii) That the
controlled substances are to be applied exclusively to medical or
scientific uses within the second country;
(iii) That the
controlled substances will not be further reexported from the second
country, and
(iv) That there is
an actual need for the controlled substances for medical or scientific
uses within the second country.
(5) If the applicant
proposes that the shipment of controlled substances will be separated into
parts after it arrives in the first country and then reexported to more than
one second country, the applicant shall so indicate on the DEA
Form 161R, providing all the information required in this section for
each second country.
(6) Within 30 days
after the controlled substance is exported from the United States, the
person who exported the controlled substance shall deliver to the
Administration documentation on the DEA
Form 161R initially completed for the transaction certifying that such
export occurred. This documentationshall be signed by a responsible company
official and shall include all of the following information:
(i) Actual quantity
shipped;
(ii) Actual date
shipped; and
(iii) DEA export
permit number.
(7) The controlled
substance will be reexported from the first country to the second country
(or second countries) no later than 180 days after the controlled substance
was exported from the United States.
(8) Shipments that
have been exported from the United States and are refused by the consignee
in either the first or second country, or are otherwise unacceptable or
undeliverable, may be returned to the registered exporter in the United
States upon authorization of the Administration. In these circumstances, the
exporter in the United States shall file a written request for the return of
the controlled substances to the United States with a brief summary of the
facts that warrant the return, along with a completed DEA Form 357,
Application for Import Permit, with the Drug Enforcement Administration,
Import/ Export Unit, Washington, DC 20537. The Administration will evaluate
the request after considering all the facts as well as the exporter's
registration status with the Administration. If the exporter provides
sufficient documentation, the Administration will issue an import permit for
the return of these drugs, and the exporter can then obtain an export permit
from the country of original importation. The substance may be returned to
the United States only after affirmative authorization is issued in writing
by the Administration.
(e) In considering
whether to grant an application for a permit under paragraphs (c) and (d) of
this section, the Administration shall consider whether the applicant has
previously obtained such a permit and, if so, whether the applicant complied
fully with the requirements of this section with respect to that previous
permit.
[36 FR 7815, Apr. 24, 1971. Redesignated at 38 FR 26609, Sept. 24, 1973, and amended at 52
FR 17290, May 7, 1987; 62 FR 13969, Mar. 24, 1997 ;
72 FR 72927, Dec. 26, 2007]
NOTICE: This is an
unofficial version. An official version of this publication may be obtained
directly from the Government Printing Office (GPO).
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