[Code of Federal Regulations]
[Title 21, Volume 9]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR1312.31]

[Page 135-136]
 
                         TITLE 21-FOOD AND DRUGS
 
   CHAPTER II--DRUG ENFORCEMENT ADMINISTRATION, DEPARTMENT OF JUSTICE
 
PART 1312--IMPORTATION AND EXPORTATION OF CONTROLLED SUBSTANCES--Table of Contents
 
Sec. 1312.31  Schedule I: Application for prior written approval.

    (a) A controlled substance listed in schedule I may be imported into 
the United States for transshipment, or may be transferred or 
transshipped within the United States for immediate exportation, 
provided that:
    (1) The controlled substance is necessary for scientific, medical, 
or other legitimate purposes in the country of destination, and

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    (2) A transshipment permit has been issued by the Administrator.
    (b) An application for a transshipment permit must be submitted to 
the Drug Enforcement Administration, Drug Operations Section, 
Washington, DC 20537, at least 30 days, or in the case of an emergency 
as soon as practicable, prior to the expected date of importation, 
transfer or transshipment. Each application shall contain the following:
    (1) The date of execution;
    (2) The identification and description of the controlled substance;
    (3) The net quantity thereof;
    (4) The number and size of the controlled substance containers;
    (5) The name, address, and business of the foreign exporter;
    (6) The foreign port of exportation;
    (7) The approximate date of exportation;
    (8) The identification of the exporting carrier;
    (9) The name, address and business of the importer, transferor, or 
transshipper;
    (10) The registration number, if any, of the importer, transferor or 
transshipper;
    (11) The U.S. port of entry;
    (12) The approximate date of entry;
    (13) The name, address and business of the consignee at the foreign 
port of entry;
    (14) The shipping route from the U.S. port of exportation to the 
foreign port of entry;
    (15) The approximate date of receipt by the consignee at the foreign 
port of entry; and
    (16) The signature of the importer, transferor or transshipper, or 
his agent accompanied by the agent's title.
    (c) An application shall be accompanied by an export license, 
permit, or a certified copy of the export license, permit, or other 
authorization, issued by a competent authority of the country of origin 
(or other documentary evidence deemed adequate by the Administrator).
    (d) An application shall be accompanied by an import license or 
permit or a certified copy of such license or permit issued by a 
competent authority of the country of destination (or other documentary 
evidence deemed adequate by the Administrator), indicating that the 
controlled substance:
    (1) Is to be applied exclusively to scientific, medical or other 
legitimate uses within the country of destination;
    (2) Will not be exported from such country; and
    (3) Is needed therein because there is an actual shortage thereof 
and a demand therefor for scientific, medical or other legitimate uses 
within such country.
    (e) Verification by an American consular officer of the signatures 
on a foreign import license or permit shall be required, if such license 
or permit does not bear the seal of the authority signing them.
    (f) The Administrator may require an applicant to submit such 
documents or written statements of fact relevant to the application as 
he deems necessary to determine whether the application should be 
granted. The failure of the applicant to provide such documents or 
statements within a reasonable time after being requested to do so shall 
be deemed to be a waiver by the applicant of an opportunity to present 
such documents or facts for consideration by the Administrator in 
granting or denying the application.
    (g) The Administrator shall, within 21 days from the date of receipt 
of the application, either grant or deny the application. The applicant 
shall be accorded an opportunity to amend the application, with the 
Administrator either granting or denying the amended application within 
7 days of its receipt. If the Administrator does not grant or deny the 
application within 21 days of its receipt, or in the case of an amended 
application, within 7 days of its receipt, the application shall be 
deemed approved and the applicant may proceed.

[36 FR 7815, Apr. 24, 1971, as amended at 37 FR 15923, Aug. 8, 1972. 
Redesignated at 38 FR 26609, Sept. 24, 1973, and further amended at 45 
FR 74715, Nov. 12, 1980; 51 FR 5319, Feb. 13, 1986; 53 FR 48244, Nov. 
30, 1988; 62 FR 13969, Mar. 24, 1997]

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