[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: 21CFR1312.22]

[Page 131-132]
 
                         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. 1312.22  Application for export permit.

    (a) An application for a permit to export controlled substances 
shall be made on DEA Form 161 which may be obtained from, and shall be 
filed with, the Drug Enforcement Administration, Drug Operations 
Section, 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, 
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

[[Page 132]]

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, 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. 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.)

[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]