21 U.S.C. § 953 — Exportation of controlled substances

Page 894 TITLE 21—FOOD AND DRUGS § 953 apply for an increase in the amount of such chemical that the registrant is authorized to import, and the Attorney General may approve the application if the Attorney General deter- mines that the approval is necessary to provide for medical, scientific, or other legitimate pur- poses regarding the chemical. (2) With respect to the application under para- graph (1): (A) Not later than 60 days after receiving the application, the Attorney General shall ap- prove or deny the application. (B) In approving the application, the Attor- ney General shall specify the period of time for which the approval is in effect, or shall provide that the approval is effective until the registrant involved is notified in writing by the Attorney General that the approval is ter- minated. (C) If the Attorney General does not approve or deny the application before the expiration of the 60-day period under subparagraph (A), the application is deemed to be approved, and such approval remains in effect until the At- torney General notifies the registrant in writ- ing that the approval is terminated. (e) Reference to ephedrine, pseudoephedrine, or phenylpropanolamine Each reference in this section to ephedrine, pseudoephedrine, or phenylpropanolamine in- cludes each of the salts, optical isomers, and salts of optical isomers of such chemical. (Pub. L. 91–513, title III, § 1002, Oct. 27, 1970, 84 Stat. 1285; Pub. L. 95–633, title I, § 105, Nov. 10, 1978, 92 Stat. 3772; Pub. L. 98–473, title II, §§ 519–521, Oct. 12, 1984, 98 Stat. 2075; Pub. L. 109–177, title VII, § 715, Mar. 9, 2006, 120 Stat. 264.) Editorial Notes REFERENCES IN TEXT Schedules I, II, III, IV, and V, referred to in subsecs. (a) and (b), are set out in section 812(c) of this title. AMENDMENTS 2006—Subsec. (a). Pub. L. 109–177, § 715(1)(A), inserted ‘‘or ephedrine, pseudoephedrine, or phenylpropanola- mine,’’ after ‘‘schedule III, IV, or V of subchapter I,’’ in introductory provisions. Subsec. (a)(1). Pub. L. 109–177, § 715(1)(B), inserted ‘‘, and of ephedrine, pseudoephedrine, and phenyl- propanolamine,’’ after ‘‘coca leaves’’. Subsecs. (d), (e). Pub. L. 109–177, § 715(2), added sub- secs. (d) and (e). 1984—Subsec. (a)(1). Pub. L. 98–473, § 519, amended par. (1) generally, inserting references to poppy straw and concentrate of poppy straw. Subsec. (a)(2)(C). Pub. L. 98–473, § 520, added subpar. (C). Subsec. (b)(2). Pub. L. 98–473, § 521, substituted ‘‘is im- ported pursuant to such notification, or declaration, or in the case of any nonnarcotic controlled substance in schedule III, such import permit, notification, or dec- laration, as the Attorney General may by regulation prescribe, except that if a nonnarcotic controlled sub- stance in schedule IV or V is also listed in schedule I or II of the Convention on Psychotropic Substances it shall be imported pursuant to such import permit re- quirements, prescribed by regulation of the Attorney General, as are required by the Convention’’ for ‘‘is im- ported pursuant to such notification or declaration re- quirements as the Attorney General may by regulation prescribe, except that if a nonnarcotic controlled sub- stance in schedule III, IV, or V is also listed in schedule I or II of the Convention on Psychotropic Substances it shall be imported pursuant to such import permit re- quirements, prescribed by regulation of the Attorney General, as are required by the Convention’’. 1978—Subsec. (b)(2). Pub. L. 95–633 inserted provision relating to exception for nonnarcotic controlled sub- stances listed in schedule I or II of the Convention on Psychotropic Substances. Statutory Notes and Related Subsidiaries EFFECTIVE DATE OF 1978 AMENDMENT Amendment by Pub. L. 95–633 effective on date the Convention on Psychotropic Substances enters into force in the United States [July 15, 1980], see section 112 of Pub. L. 95–633, set out as an Effective Date note under section 801a of this title. EFFECTIVE DATE Section effective on first day of seventh calendar month that begins after Oct. 26, 1970, see 1105(a) of Pub. L. 91–513, set out as a under section 951 of this title. § 953. Exportation of controlled substances (a) Narcotic drugs in schedule I, II, III, or IV It shall be unlawful to export from the United States any narcotic drug in schedule I, II, III, or IV unless— (1) it is exported to a country which is a party to— (A) the International Opium Convention of 1912 for the Suppression of the Abuses of Opium, Morphine, Cocaine, and Derivative Drugs, or to the International Opium Con- vention signed at Geneva on February 19, 1925; or (B) the Convention for Limiting the Manu- facture and Regulating the Distribution of Narcotic Drugs concluded at Geneva, July 13, 1931, as amended by the protocol signed at Lake Success on December 11, 1946, and the protocol bringing under international control drugs outside the scope of the con- vention of July 13, 1931, for limiting the manufacture and regulating the distribution of narcotic drugs (as amended by the pro- tocol signed at Lake Success on December 11, 1946), signed at Paris, November 19, 1948; or (C) the Single Convention on Narcotic Drugs, 1961, signed at New York, March 30, 1961; (2) such country has instituted and main- tains, in conformity with the conventions to which it is a party, a system for the control of imports of narcotic drugs which the Attorney General deems adequate; (3) the narcotic drug is consigned to a holder of such permits or licenses as may be required under the laws of the country of import, and a permit or license to import such drug has been issued by the country of import; (4) substantial evidence is furnished to the Attorney General by the exporter that (A) the narcotic drug is to be applied exclusively to medical or scientific uses within the country of import, and (B) there is an actual need for the narcotic drug for medical or scientific uses within such country; and (5) a permit to export the narcotic drug in each instance has been issued by the Attorney General. Page 895 TITLE 21—FOOD AND DRUGS § 953 (b) Exception for exportation for special sci- entific purposes Notwithstanding subsection (a), the Attorney General may authorize any narcotic drug (in- cluding crude opium and coca leaves) in sched- ule I, II, III, or IV to be exported from the United States to a country which is a party to any of the international instruments mentioned in subsection (a) if the particular drug is to be applied to a special scientific purpose in the country of destination and the authorities of such country will permit the importation of the particular drug for such purpose. (c) Nonnarcotic controlled substances in sched- ule I or II It shall be unlawful to export from the United States any nonnarcotic controlled substance in schedule I or II unless— (1) it is exported to a country which has in- stituted and maintains a system which the At- torney General deems adequate for the control of imports of such substances; (2) the controlled substance is consigned to a holder of such permits or licenses as may be required under the laws of the country of im- port; (3) substantial evidence is furnished to the Attorney General that (A) the controlled sub- stance is to be applied exclusively to medical, scientific, or other legitimate uses within the country to which exported, (B) it will not be exported from such country, and (C) there is an actual need for the controlled substance for medical, scientific, or other legitimate uses within the country; and (4) a permit to export the controlled sub- stance in each instance has been issued by the Attorney General. (d) Exception for exportation for special sci- entific purposes Notwithstanding subsection (c), the Attorney General may authorize any nonnarcotic con- trolled substance in schedule I or II to be ex- ported from the United States if the particular substance is to be applied to a special scientific purpose in the country of destination and the authorities of such country will permit the im- portation of the particular drug for such pur- pose. (e) Nonnarcotic controlled substances in sched- ule III or IV; controlled substances in sched- ule V It shall be unlawful to export from the United States to any other country any nonnarcotic controlled substance in schedule III or IV or any controlled substances in schedule V unless— (1) there is furnished (before export) to the Attorney General documentary proof that im- portation is not contrary to the laws or regu- lations of the country of destination for con- sumption for medical, scientific, or other le- gitimate purposes; (2) it is exported pursuant to such notifica- tion or declaration, or in the case of any non- narcotic controlled substance in schedule III, such export permit, notification, or declara- tion as the Attorney General may by regula- tion prescribe; and (3) in the case of a nonnarcotic controlled substance in schedule IV or V which is also listed in schedule I or II of the Convention on Psychotropic Substances, it is exported pursu- ant to such export permit requirements, pre- scribed by regulation of the Attorney General, as are required by the Convention. (f) Exception for exportation for subsequent ex- port Notwithstanding subsections (a)(4) and (c)(3), the Attorney General may authorize any con- trolled substance that is in schedule I or II, or is a narcotic drug in schedule III or IV, to be ex- ported from the United States to a country for subsequent export from that country to another country, if each of the following conditions is met: (1) Both the country to which the controlled substance is exported from the United States (referred to in this subsection as the ‘‘first country’’) and the country to which the con- trolled substance is exported from the first country (referred to in this subsection as the ‘‘second country’’) are parties to the Single Convention on Narcotic Drugs, 1961, and the Convention on Psychotropic Substances, 1971. (2) The first country and the second country have each instituted and maintain, in con- formity with such Conventions, a system of controls of imports of controlled substances which the Attorney General deems adequate. (3) With respect to the first country, the controlled substance is consigned to a holder of such permits or licenses as may be required under the laws of such country, and a permit or license to import the controlled substance has been issued by the country. (4) With respect to the second country, sub- stantial evidence is furnished to the Attorney General by the person who will export the con- trolled substance from the United States that— (A) the controlled substance is to be con- signed to a holder of such permits or licenses as may be required under the laws of such country, and a permit or license to import the controlled substance is to be issued by the country; and (B) the controlled substance is to be ap- plied exclusively to medical, scientific, or other legitimate uses within the country. (5)(A) The controlled substance will not be exported from the second country, except that the controlled substance may be exported from a second country that is a member of the European Economic Area to another country that is a member of the European Economic Area, provided that the first country is also a member of the European Economic Area. (B) Subsequent to any re-exportation de- scribed in subparagraph (A), a controlled sub- stance may continue to be exported from any country that is a member of the European Economic Area to any other such country, if— (i) the conditions applicable with respect to the first country under paragraphs (1), (2), (3), (4), (6), and (7) are met by each subse- quent country from which the controlled substance is exported pursuant to this para- graph; and (ii) the conditions applicable with respect to the second country under paragraphs (1), Page 896 TITLE 21—FOOD AND DRUGS § 954 (2), (3), (4), (6), and (7) are met by each subse- quent country to which the controlled sub- stance is exported pursuant to this para- graph. (6)(A) Within 30 days after the controlled substance is exported from the first country to the second country, the person who exported the controlled substance from the United States delivers to the Attorney General docu- mentation certifying that such export from the first country has occurred. (B) In the case of re-exportation among members of the European Economic Area, within 30 days after each re-exportation, the person who exported the controlled substance from the United States delivers to the Attor- ney General— (i) documentation certifying that such re- exportation has occurred; and (ii) information concerning the consignee, country, and product. (7) A permit to export the controlled sub- stance from the United States has been issued by the Attorney General. (g) Limitation Subject to paragraphs (5) and (6) of subsection (f) in the case of any controlled substance in schedule I or II or any narcotic drug in schedule III or IV, the Attorney General shall not pro- mulgate nor enforce any regulation, subregu- latory guidance, or enforcement policy which impedes re-exportation of any controlled sub- stance among European Economic Area coun- tries, including by promulgating or enforcing any requirement that— (1) re-exportation from the first country to the second country or re-exportation from the second country to another country occur with- in a specified period of time; or (2) information concerning the consignee, country, and product be provided prior to ex- portation of the controlled substance from the United States or prior to each re-exportation among members of the European Economic Area. (Pub. L. 91–513, title III, § 1003, Oct. 27, 1970, 84 Stat. 1286; Pub. L. 95–633, title I, § 106, Nov. 10, 1978, 92 Stat. 3772; Pub. L. 98–473, title II, § 522, Oct. 12, 1984, 98 Stat. 2076; Pub. L. 109–57, § 1(b), Aug. 2, 2005, 119 Stat. 592; Pub. L. 114–89, § 4, Nov. 25, 2015, 129 Stat. 701.) Editorial Notes REFERENCES IN TEXT Schedules I, II, III, IV and V, referred to in text, are set out in section 812(c) of this title. AMENDMENTS 2015—Subsec. (f)(5). Pub. L. 114–89, § 4(1)(A), des- ignated existing provisions as subpar. (A), inserted ‘‘, except that the controlled substance may be ex- ported from a second country that is a member of the European Economic Area to another country that is a member of the European Economic Area, provided that the first country is also a member of the European Eco- nomic Area’’ before period at end, and added subpar. (B). Subsec. (f)(6). Pub. L. 114–89, § 4(1)(B), designated ex- isting provisions as subpar. (A) and added subpar. (B). Subsec. (g). Pub. L. 114–89, § 4(2), added subsec. (g). 2005—Subsec. (f). Pub. L. 109–57 added subsec. (f). 1984—Subsec. (e). Pub. L. 98–473 in cl. (1) inserted pro- visions for consumption for medical, etc., purposes, added cls. (2) and (3), and struck out former cls. (2) to (4), respectively, relating to a special controlled sub- stance invoice, two additional copies of the invoice, and exportation of a nonnarcotic controlled substance in schedule III, IV, or V, also listed in schedule I or II of the Convention. 1978—Subsec. (e)(4). Pub. L. 95–633 added par. (4). Statutory Notes and Related Subsidiaries EFFECTIVE DATE OF 1978 AMENDMENT Amendment by Pub. L. 95–633 effective on date the Convention on Psychotropic Substances enters into force in the United States [July 15, 1980], see section 112 of Pub. L. 95–633, set out as an Effective Date note under section 801a of this title. EFFECTIVE DATE Section effective on first day of seventh calendar month that begins after Oct. 26, 1970, see 1105(a) of Pub. L. 91–513, set out as a under section 951 of this title. § 954. Transshipment and in-transit shipment of controlled substances Notwithstanding sections 952, 953, and 957 of this title— (1) A controlled substance in schedule I may— (A) be imported into the United States for transshipment to another country, or (B) be transferred or transshipped from one vessel, vehicle, or aircraft to another vessel, vehicle, or aircraft within the United States for immediate exportation, if and only if it is so imported, transferred, or transshipped (i) for scientific, medical, or other legitimate purposes in the country of destination, and (ii) with the prior written ap- proval of the Attorney General (which shall be granted or denied within 21 days of the re- quest). (2) A controlled substance in schedule II, III, or IV may be so imported, transferred, or transshipped if and only if advance notice is given to the Attorney General in accordance with regulations of the Attorney General. (Pub. L. 91–513, title III, § 1004, Oct. 27, 1970, 84 Stat. 1287.) Editorial Notes REFERENCES IN TEXT Schedules I, II, III, and IV, referred to in text, are set out in section 812(c) of this title. Statutory Notes and Related Subsidiaries EFFECTIVE DATE Section effective on first day of seventh calendar month that begins after Oct. 26, 1970, see 1105(a) of Pub. L. 91–513, set out as a under section 951 of this title. § 955. Possession on board vessels, etc., arriving in or departing from United States It shall be unlawful for any person to bring or possess on board any vessel or aircraft, or on board any vehicle of a carrier, arriving in or de- parting from the United States or the customs