Code of Federal Regulations Title 21. Food and Drugs § 21.1312.23 Issuance of export permit

(a) The Administrator may authorize exportation of any controlled substance listed in Schedule I or II or any narcotic controlled substance listed in Schedule III or IV if he finds that such exportation is permitted by subsections 1003(a), (b), (c), (d), or (f) of the Act (21 U.S.C. 953(a), (b), (c), (d), or (f).

(b) The Administrator may require that such non-narcotic controlled substances in Schedule III as shall be designated by regulation in § 1312.30 of this part be exported only pursuant to the issuance of an export permit. The Administrator may authorize the exportation of such substances if he finds that such exportation is permitted by section 1003(e) of the Act (21 U.S.C. 953(e)).

(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, it shall be exported only pursuant to the issuance of an export permit. The Administrator may authorize the exportation of such substances if he finds that such exportation is permitted by section 1003(e) of the Act (21 U.S.C. 953(e)).

(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)If an exportation is approved, the Administrator shall issue an export permit bearing his or her signature or that of his or her delegate. Each permit will be assigned a permit number that is a unique, randomly generated identifier. A permit shall not be altered or changed by any person after being signed. Any change or alteration upon the face of any permit after it has been signed renders it void and of no effect. Permits are not transferable. The Administrator or his/her delegate shall date and certify on each permit that the exporter named therein is thereby permitted as a registrant under the Act, to export, through the port of export named, one shipment of not to exceed the specified quantity of the named controlled substances, shipment to be made before a specified date. Only one shipment may be made on a single export permit. A single export permit shall authorize a quantity of goods to be exported at one place, at one time, for delivery to one consignee, on a single conveyance, at one place, on one bill of lading, air waybill, or commercial loading document;  a single permit shall not authorize a quantity of goods to be exported if the goods are divided onto two or more conveyances. Each export permit shall be predicated upon, inter alia, an import certificate or other documentary evidence issued by a foreign competent national authority.

(f) No export permit shall be issued for the exportation, or reexportation, of any controlled substance to any country when the Administration has information to show that the estimates or assessments submitted with respect to that country for the current period, under the Single Convention on Narcotic Drugs, 1961, or the Convention on Psychotropic Substances, 1971, have been, or, considering the quantity proposed to be imported, will be exceeded. If it shall appear through subsequent advice received from the International Narcotics Control Board of the United Nations that the estimates or assessments of the country of destination have been adjusted to permit further importation of the controlled substance, an export permit may then be issued if otherwise permissible.