21 U.S.C. § 957 — Persons required to register

Page 897 TITLE 21—FOOD AND DRUGS § 957 territory of the United States, a controlled sub- stance in schedule I or II or a narcotic drug in schedule III or IV, unless such substance or drug is a part of the cargo entered in the manifest or part of the official supplies of the vessel, air- craft, or vehicle. (Pub. L. 91–513, title III, § 1005, 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. §§ 955a to 955d. Transferred Editorial Notes CODIFICATION Sections, Pub. L. 96–350, §§ 1–4, Sept. 15, 1980, 94 Stat. 1159, 1160, relating to maritime drug law enforcement, were transferred to sections 1901 to 1904 of the former Appendix to Title 46, Shipping. Sections 1901 to 1904 of the former Appendix to Title 46 were repealed and re- stated in chapter 705 of Title 46, Shipping, by Pub. L. 109–304, §§ 10(2), 19, Oct. 6, 2006, 120 Stat. 1683, 1710. For disposition of sections of the former Appendix to Title 46, see Disposition Table preceding section 101 of Title 46. § 956. Exemption authority (a) Individual possessing controlled substance (1) Subject to paragraph (2), the Attorney Gen- eral may by regulation exempt from sections 952(a) and (b), 953, 954, and 955 of this title any individual who has a controlled substance (ex- cept a substance in schedule I) in his possession for his personal medical use, or for administra- tion to an animal accompanying him, if he law- fully obtained such substance and he makes such declaration (or gives such other notifica- tion) as the Attorney General may by regulation require. (2) Notwithstanding any exemption under paragraph (1), a United States resident who en- ters the United States through an international land border with a controlled substance (except a substance in schedule I) for which the indi- vidual does not possess a valid prescription issued by a practitioner (as defined in section 802 of this title) in accordance with applicable Federal and State law (or documentation that verifies the issuance of such a prescription to that individual) may not import the controlled substance into the United States in an amount that exceeds 50 dosage units of the controlled substance. (b) Compound, mixture, or preparation The Attorney General may by regulation ex- cept any compound, mixture, or preparation containing any depressant or stimulant sub- stance listed in paragraph (a) or (b) of schedule III or in schedule IV or V from the application of all or any part of this subchapter if (1) the compound, mixture, or preparation contains one or more active medicinal ingredients not having a depressant or stimulant effect on the central nervous system, and (2) such ingredients are in- cluded therein in such combinations, quantity, proportion, or concentration as to vitiate the potential for abuse of the substances which do have a depressant or stimulant effect on the central nervous system. (Pub. L. 91–513, title III, § 1006, Oct. 27, 1970, 84 Stat. 1288; Pub. L. 105–277, div. C, title VIII, § 872(a), Oct. 21, 1998, 112 Stat. 2681–707; Pub. L. 105–357, § 2(a), Nov. 10, 1998, 112 Stat. 3271.) Editorial Notes REFERENCES IN TEXT Schedules I, III, IV, and V, referred to in text, are set out in section 812(c) of this title. AMENDMENTS 1998—Subsec. (a). Pub. L. 105–277 and Pub. L. 105–357 amended subsec. (a) identically, designating existing provisions as par. (1), substituting ‘‘Subject to para- graph (2), the Attorney General’’ for ‘‘The Attorney General’’, and adding par. (2). Statutory Notes and Related Subsidiaries FEDERAL MINIMUM REQUIREMENT Pub. L. 105–357, § 2(b), Nov. 10, 1998, 112 Stat. 3271, pro- vided that: ‘‘Section 1006(a)(2) of the Controlled Sub- stances Import and Export Act [21 U.S.C. 956(a)(2)], as added by this section, is a minimum Federal require- ment and shall not be construed to limit a State from imposing any additional requirement.’’ Pub. L. 105–277, div. C, title VIII, § 872(b), Oct. 21, 1998, 112 Stat. 2681–707, enacted a provision substantially identical to that enacted by Pub. L. 105–357, § 2(b), set out above. JURISDICTION OF SECRETARY OF HEALTH AND HUMAN SERVICES Pub. L. 105–277, div. C, title VIII, § 872(c), Oct. 21, 1998, 112 Stat. 2681–707, and Pub. L. 105–357, § 2(c), Nov. 10, 1998, 112 Stat. 3271, provided that: ‘‘The amendment made by subsection (a) [amending this section] shall not be construed to affect the jurisdiction of the Sec- retary of Health and Human Services under the Federal Food, Drug and Cosmetic Act (21 U.S.C. 301 et seq.).’’ § 957. Persons required to register (a) Coverage No person may— (1) import into the customs territory of the United States from any place outside thereof (but within the United States), or import into the United States from any place outside thereof, any controlled substance or list I chemical, or (2) export from the United States any con- trolled substance or list I chemical, unless there is in effect with respect to such per- son a registration issued by the Attorney Gen- eral under section 958 of this title, or unless such person is exempt from registration under subsection (b). (b) Exemptions (1) The following persons shall not be required to register under the provisions of this section and may lawfully possess a controlled substance or list I chemical: Page 898 TITLE 21—FOOD AND DRUGS § 958 1 See References in Text note below. (A) An agent or an employee of any importer or exporter registered under section 958 of this title if such agent or employee is acting in the usual course of his business or employment. (B) A common or contract carrier or ware- houseman, or an employee thereof, whose pos- session of any controlled substance or list I chemical is in the usual course of his business or employment. (C) An ultimate user who possesses such sub- stance for a purpose specified in section 802(25) 1 of this title and in conformity with an exemption granted under section 956(a) of this title. (2) The Attorney General may, by regulation, waive the requirement for registration of cer- tain importers and exporters if he finds it con- sistent with the public health and safety; and may authorize any such importer or exporter to possess controlled substances or list I chemicals for purposes of importation and exportation. (Pub. L. 91–513, title III, § 1007, Oct. 27, 1970, 84 Stat. 1288; Pub. L. 98–473, title II, § 523, Oct. 12, 1984, 98 Stat. 2076; Pub. L. 103–200, § 3(e), Dec. 17, 1993, 107 Stat. 2337.) Editorial Notes REFERENCES IN TEXT Section 802(25) of this title, referred to in subsec. (b)(1)(C), was redesignated section 802(26) of this title by Pub. L. 98–473, title II, § 507(a), Oct. 12, 1984, 98 Stat. 2071, and was further redesignated section 802(27) of this title by Pub. L. 99–570, title I, § 1003(b)(2), Oct. 27, 1986, 100 Stat. 3207–6. AMENDMENTS 1993—Subsec. (a)(1). Pub. L. 103–200, § 3(e)(1)(A), in- serted ‘‘or list I chemical’’ after ‘‘controlled sub- stance’’. Subsec. (a)(2). Pub. L. 103–200, § 3(e)(1)(B), substituted ‘‘or list I chemical,’’ for ‘‘in schedule I, II, III, IV, or V,’’. Subsec. (b)(1). Pub. L. 103–200, § 3(e)(2)(A), inserted ‘‘or list I chemical’’ after ‘‘controlled substance’’ in intro- ductory provisions and subpar. (B). Subsec. (b)(2). Pub. L. 103–200, § 3(e)(2)(B), inserted ‘‘or list I chemicals’’ after ‘‘controlled substances’’. 1984—Subsec. (a)(2). Pub. L. 98–473 inserted reference to schedule V. Statutory Notes and Related Subsidiaries EFFECTIVE DATE OF 1993 AMENDMENT Amendment by Pub. L. 103–200 effective on date that is 120 days after Dec. 17, 1993, see section 11 of Pub. L. 103–200, set out as a note under section 802 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. PROVISIONAL REGISTRATION Pub. L. 91–513, title III, § 1104, Oct. 27, 1970, 84 Stat. 1294, as amended by Pub. L. 99–514, § 2, Oct. 22, 1986, 100 Stat. 2095, provided that: ‘‘(a)(1) Any person— ‘‘(A) who is engaged in importing or exporting any controlled substance on the day before the effective date of section 1007 [May 1, 1971], ‘‘(B) who notifies the Attorney General that he is so engaged, and ‘‘(C) who is registered on such day under section 510 of the Federal Food, Drug, and Cosmetic Act [section 360 of this title] or under section 4722 of the Internal Revenue Code of 1986 [formerly I.R.C. 1954, section 4722 of title 26], shall, with respect to each establishment for which such registration is in effect under any such section, be deemed to have a provisional registration under section 1008 [section 958 of this title] for the import or export (as the case may be) of controlled substances. ‘‘(2) During the period his provisional registration is in effect under this section, the registration number as- signed such person under such section 510 or under such section 4722 (as the case may be) shall be his registra- tion number for purposes of part A of this title [this subchapter]. ‘‘(b) The provisions of section 304 [section 824 of this title], relating to suspension and revocation of reg- istration, shall apply to a provisional registration under this section. ‘‘(c) Unless sooner suspended or revoked under sub- section (b), a provisional registration of a person under subsection (a)(1) of this section shall be in effect until— ‘‘(1) the date on which such person has registered with the Attorney General under section 1008 [section 958 of this title] or has had his registration denied under such section, or ‘‘(2) such date as may be prescribed by the Attorney General for registration of importers or exporters, as the case may be, whichever occurs first.’’ § 958. Registration requirements (a) Applicants to import or export controlled substances in schedule I or II The Attorney General shall register an appli- cant to import or export a controlled substance in schedule I or II if he determines that such registration is consistent with the public inter- est and with United States obligations under international treaties, conventions, or protocols in effect on May 1, 1971. In determining the pub- lic interest, the factors enumerated in para- graph (1) through (6) of section 823(a) of this title shall be considered. (b) Activity limited to specified substances Registration granted under this section shall not entitle a registrant to import or export con- trolled substances other than specified in the registration. (c) Applicants to import controlled substances in schedule III, IV, or V or to export controlled substances in schedule III or IV; applicants to import or export list I chemicals (1) The Attorney General shall register an ap- plicant to import a controlled substance in schedule III, IV, or V or to export a controlled substance in schedule III or IV, unless he deter- mines that the issuance of such registration is inconsistent with the public interest. In deter- mining the public interest, the factors enumer- ated in paragraphs (1) through (6) of section 823(e) of this title shall be considered. (2)(A) The Attorney General shall register an applicant to import or export a list I chemical unless the Attorney General determines that registration of the applicant is inconsistent with the public interest. Registration under this subsection shall not be required for the import or export of a drug product that is exempted under section 802(39)(A)(iv) of this title. (B) In determining the public interest for the purposes of subparagraph (A), the Attorney Gen-