21 C.F.R. § 1312.13 Issuance of import permit.
Title 21 - Food and Drugs
(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 §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 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]
Title 21: Food and Drugs
PART 1312—IMPORTATION AND EXPORTATION OF CONTROLLED SUBSTANCES
Importation of Controlled Substances
§ 1312.13 Issuance of import permit.
