[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2005]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR1312.13]

[Page 149-150]
 
                         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. 1312.13  Issuance of import permit.

    (a) The Administrator may authorize importation of any controlled 
substance listed in Schedule I or II or any narcotic drug listed in 
Schedule III, IV, or V if he finds:
    (1) That the substance is crude opium, poppy straw, concentrate of 
poppy straw, or coca leaves, in such quantity as the Administrator finds 
necessary to provide for medical, scientific, or other legitimate 
purposes;
    (2) That the substance is necessary to provide for medical and 
scientific needs or other legitimate needs of the United States during 
an emergency where domestic supplies of such substance or drug are found 
to be inadequate, or in any case in which the Administrator finds that 
competition among domestic manufacturers of the controlled substance is 
inadequate and will not be rendered adequate by the registration of 
additional manufacturers under section 303 of the Controlled Substances 
Act (21 U.S.C. 823); or
    (3) That the domestic supply of any controlled substance is 
inadequate for scientific studies, and that the importation of that 
substance for scientific purposes is only for delivery to officials of 
the United Nations, of the United States, or of any State, or to any 
person registered or exempted from registration under sections 1007 and 
1008 of the Act (21 U.S.C. 957 and 958).
    (4) That the importation of the controlled substance is for 
ballistics or other analytical or scientific purposes, and that the 
importation of that substance is only for delivery to officials of the 
United Nations, of the United States, or of any State, or to any person 
registered or exempted from registration under sections 1007 and 1008 of 
the Act (21 U.S.C. 957 and 958).
    (b) The Administrator may require that such non-narcotic controlled 
substances in Schedule III as he shall designate by regulation in Sec. 
1312.30 of this part be imported only pursuant to the issuance of an 
import permit. The Administrator may authorize the importation of such 
substances if he finds that the substance is being imported for medical, 
scientific or other legitimate uses.
    (c) If a non-narcotic substance listed in Schedule IV or V is also 
listed in Schedule I or II of the Convention on Psychotropic Substances, 
1971, it shall be imported only pursuant to the issuance of an import 
permit. The Administrator may authorize the importation of such 
substances if it is found that the substance is being imported for 
medical, scientific or other legitimate uses.
    (d) 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.
    (e) Each import permit shall be issued in sextuplet and serially 
numbered, with all six copies bearing the same serial number and being 
designated ``original'' (Copy 1), ``duplicate'' (Copy 2), etc., 
respectively. All

[[Page 150]]

copies of import permits shall bear the signature of the Director or his 
delegate, and facsimiles of signatures shall not be used. No permit 
shall be altered or changed by any person after being signed by the 
Administrator or his delegate and any change or alteration upon the face 
of any permit after it shall have been signed by the Administrator or 
his delegate shall render it void and of no effect. Permits are not 
transferable. Each copy of the permit shall have printed or stamped 
thereon the disposition to be made thereof. Each permit shall be dated 
and shall certify that the importer named therein is thereby permitted 
as a registrant under the Act, to import, through the port named, one 
shipment of not to exceed the specified quantity of the named controlled 
substances, shipment to be made before a specified date. Not more than 
one shipment shall be made on a single import permit. The permit shall 
state that the Administrator is satisfied that the consignment proposed 
to be imported is required for legitimate purposes.
    (f) Notwithstanding paragraphs (a)(1) and (a)(2) of this section, 
the Administrator shall permit, pursuant to 21 U.S.C. 952(a)(1) or 
(a)(2)(A), the importation of approved narcotic raw material (opium, 
poppy straw and concentrate of poppy straw) having as its source:
    (1) Turkey,
    (2) India,
    (3) Yugoslavia,
    (4) France,
    (5) Poland,
    (6) Hungary, and
    (7) Australia.
    (g) At least eighty (80) percent of the narcotic raw material 
imported into the United States shall have as its original source Turkey 
and India. Except under conditions of insufficient supplies of narcotic 
raw materials, not more than twenty (20) percent of the narcotic raw 
material imported into the United States annually shall have as its 
source Yugoslavia, France, Poland, Hungary and Australia.

[36 FR 23624, Dec. 11, 1971, as amended at 37 FR 15923, Aug. 8, 1972. 
Redesignated at 38 FR 26609, Sept. 24, 1973, and amended at 46 FR 41776, 
Aug. 18, 1981; 52 FR 17289, May 7, 1987]