21 U.S.C. § 958 — Registration requirements

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- Page 899 TITLE 21—FOOD AND DRUGS § 958 eral shall consider the factors specified in sec- tion 823(i) of this title. (d) Denial of application (1) The Attorney General may deny an appli- cation for registration under subsection (a) if he is unable to determine that such registration is consistent with the public interest (as defined in subsection (a)) and with the United States obli- gations under international treaties, conven- tions, or protocols in effect on May 1, 1971. (2) The Attorney General may deny an appli- cation for registration under subsection (c), or revoke or suspend a registration under sub- section (a) or (c), if he determines that such reg- istration is inconsistent with the public interest (as defined in subsection (a) or (c)) or with the United States obligations under international treaties, conventions, or protocols in effect on May 1, 1971. (3) The Attorney General may limit the rev- ocation or suspension of a registration to the particular controlled substance, or substances, or list I chemical or chemicals, with respect to which grounds for revocation or suspension exist. (4) Before taking action pursuant to this sub- section, the Attorney General shall serve upon the applicant or registrant an order to show cause as to why the registration should not be denied, revoked, or suspended. The order to show cause shall contain a statement of the basis thereof and shall call upon the applicant or registrant to appear before the Attorney Gen- eral, or his designee, at a time and place stated in the order, but in no event less than thirty days after the date of receipt of the order. Pro- ceedings to deny, revoke, or suspend shall be conducted pursuant to this subsection in accord- ance with subchapter II of chapter 5 of title 5. Such proceedings shall be independent of, and not in lieu of, criminal prosecutions or other proceedings under this subchapter or any other law of the United States. (5) The Attorney General may, in his discre- tion, suspend any registration simultaneously with the institution of proceedings under this subsection, in cases where he finds that there is an imminent danger to the public health and safety. Such suspension shall continue in effect until the conclusion of such proceedings, includ- ing judicial review thereof, unless sooner with- drawn by the Attorney General or dissolved by a court of competent jurisdiction. (6) In the event that the Attorney General sus- pends or revokes a registration granted under this section, all controlled substances or list I chemicals owned or possessed by the registrant pursuant to such registration at the time of sus- pension or the effective date of the revocation order, as the case may be, may, in the discretion of the Attorney General, be seized or placed under seal. No disposition may be made of any controlled substances or list I chemicals under seal until the time for taking an appeal has elapsed or until all appeals have been concluded, except that a court, upon application therefor, may at any time order the sale of perishable controlled substances or list I chemicals. Any such order shall require the deposit of the pro- ceeds of the sale with the court. Upon a revoca- tion order becoming final, all such controlled substances or list I chemicals (or proceeds of the sale thereof which have been deposited with the court) shall be forfeited to the United States; and the Attorney General shall dispose of such controlled substances or list I chemicals in ac- cordance with section 881(e) of this title. (e) Registration period No registration shall be issued under this sub- chapter for a period in excess of one year. Unless the regulations of the Attorney General other- wise provide, sections 822(f), 825, 827, and 830 of this title shall apply to persons registered under this section to the same extent such sections apply to persons registered under section 823 of this title. (f) Rules and regulations The Attorney General is authorized to promul- gate rules and regulations and to charge reason- able fees relating to the registration and control of importers and exporters of controlled sub- stances or listed chemicals. (g) Scope of authorized activity Persons registered by the Attorney General under this section to import or export con- trolled substances or list I chemicals may im- port or export (and for the purpose of so import- ing or exporting, may possess) such substances to the extent authorized by their registration and in conformity with the other provisions of this subchapter and subchapter I. (h) Separate registrations for each principal place of business A separate registration shall be required at each principal place of business where the appli- cant imports or exports controlled substances or list I chemicals. (i) Emergency situations Except in emergency situations as described in section 952(a)(2)(A) of this title, prior to issuing a registration under this section to a bulk man- ufacturer of a controlled substance in schedule I or II, and prior to issuing a regulation under sec- tion 952(a) of this title authorizing the importa- tion of such a substance, the Attorney General shall give manufacturers holding registrations for the bulk manufacture of the substance an opportunity for a hearing. (Pub. L. 91–513, title III, § 1008, Oct. 27, 1970, 84 Stat. 1289; Pub. L. 98–473, title II, §§ 524, 525, Oct. 12, 1984, 98 Stat. 2076; Pub. L. 99–570, title I, § 1866(d), Oct. 27, 1986, 100 Stat. 3207–55; Pub. L. 103–200, § 3(f), Dec. 17, 1993, 107 Stat. 2337; Pub. L. 108–447, div. B, title VI, § 633(c), Dec. 8, 2004, 118 Stat. 2922; Pub. L. 117–215, title I, § 103(b)(2), Dec. 2, 2022, 136 Stat. 2263.) Editorial Notes REFERENCES IN TEXT Schedules I, II, III, IV, and V, referred to in subsecs. (a), (c), and (i), are set out in section 812(c) of this title. This subchapter, referred to in subsecs. (d)(4) and (g), was in the original ‘‘this title’’, meaning title III of Pub. L. 91–513, Oct. 27, 1970, 84 Stat. 1285. Part A of title III comprises this subchapter. For classification of Part B, consisting of sections 1101 to 1105 of title III, see Ta- bles. Page 900 TITLE 21—FOOD AND DRUGS § 959 CODIFICATION In subsecs. (a) and (d), ‘‘May 1, 1971’’ substituted for ‘‘the effective date of this section’’ and ‘‘the effective date of this part’’, respectively. AMENDMENTS 2022—Subsec. (c)(1). Pub. L. 117–215, § 103(b)(2)(A), sub- stituted ‘‘823(e)’’ for ‘‘823(d)’’. Subsec. (c)(2)(B). Pub. L. 117–215, § 103(b)(2)(B), sub- stituted ‘‘823(i)’’ for ‘‘823(h)’’. 2004—Subsec. (f). Pub. L. 108–447, which directed amendment of subsec. (f) of section 1088 of the Con- trolled Substances Import and Export Act by inserting ‘‘and control’’ after ‘‘the registration’’ and substituting ‘‘listed chemicals’’ for ‘‘list I chemicals under this sec- tion’’, was executed to subsec. (f) of this section, which is section 1008 of the Controlled Substances Import and Export Act, to reflect the probable intent of Congress. 1993—Subsec. (c). Pub. L. 103–200, § 3(f)(1), designated existing provisions as par. (1) and added par. (2). Subsec. (d)(3). Pub. L. 103–200, § 3(f)(2)(A), inserted ‘‘or list I chemical or chemicals,’’ after ‘‘substances,’’. Subsec. (d)(6). Pub. L. 103–200, § 3(f)(2)(B), inserted ‘‘or list I chemicals’’ after ‘‘controlled substances’’ wher- ever appearing. Subsec. (e). Pub. L. 103–200, § 3(f)(3), inserted reference to section 830 of this title. Subsecs. (f) to (h). Pub. L. 103–200, § 3(f)(4), inserted ‘‘or list I chemicals’’ after ‘‘controlled substances’’. 1986—Subsec. (e). Pub. L. 99–570 substituted ‘‘sec- tions’’ for first reference to ‘‘section’’. 1984—Subsec. (b). Pub. L. 98–473, § 524, substituted ‘‘Registration granted under this section shall not enti- tle a registrant to import or export controlled sub- stances other than specified in the registration’’ for ‘‘Registration granted under subsection (a) of this sec- tion shall not entitle a registrant to import or export controlled substances in schedule I or II other than those specified in the registration’’. Subsecs. (d) to (i). Pub. L. 98–473, § 525, added subsec. (d), redesignated former subsec. (d) as (e) and struck out reference to section 824 of this title, and redesig- nated former subsecs. (e) to (h) as (f) to (i), respec- tively. 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. § 959. Possession, manufacture, or distribution of controlled substance (a) Manufacture or distribution for purpose of unlawful importation It shall be unlawful for any person to manu- facture or distribute a controlled substance in schedule I or II or flunitrazepam or a listed chemical intending, knowing, or having reason- able cause to believe that such substance or chemical will be unlawfully imported into the United States or into waters within a distance of 12 miles of the coast of the United States. (b) Manufacture or distribution of listed chem- ical for purpose of manufacture or unlawful importation of controlled substance It shall be unlawful for any person to manu- facture or distribute a listed chemical— (1) intending or knowing that the listed chemical will be used to manufacture a con- trolled substance; and (2) intending, knowing, or having reasonable cause to believe that the controlled substance will be unlawfully imported into the United States. (c) Possession, manufacture, or distribution by person on board aircraft It shall be unlawful for any United States cit- izen on board any aircraft, or any person on board an aircraft owned by a United States cit- izen or registered in the United States, to— (1) manufacture or distribute a controlled substance or listed chemical; or (2) possess a controlled substance or listed chemical with intent to distribute. (d) Acts committed outside territorial jurisdic- tion of United States This section is intended to reach acts of manu- facture or distribution committed outside the territorial jurisdiction of the United States. (Pub. L. 91–513, title III, § 1009, Oct. 27, 1970, 84 Stat. 1289; Pub. L. 99–570, title III, § 3161(a), Oct. 27, 1986, 100 Stat. 3207–94; Pub. L. 104–237, title I, § 102(a), (b), Oct. 3, 1996, 110 Stat. 3100; Pub. L. 104–305, § 2(b)(2)(A), Oct. 13, 1996, 110 Stat. 3807; Pub. L. 114–154, § 2, May 16, 2016, 130 Stat. 387; Pub. L. 115–91, div. A, title X, § 1012(b), Dec. 12, 2017, 131 Stat. 1546.) Editorial Notes REFERENCES IN TEXT Schedules I and II, referred to in subsec. (a), are set out in section 812(c) of this title. AMENDMENTS 2017—Subsec. (d). Pub. L. 115–91 struck out ‘‘; venue’’ after ‘‘United States’’ in heading and ‘‘Any person who violates this section shall be tried in the United States district court at the point of entry where such person enters the United States, or in the United States Dis- trict Court for the District of Columbia.’’ after ‘‘United States.’’ in text. 2016—Subsec. (a). Pub. L. 114–154, § 2(2), substituted ‘‘It shall be unlawful for any person to manufacture or distribute a controlled substance in schedule I or II or flunitrazepam or a listed chemical intending, knowing, or having reasonable cause to believe that such sub- stance or chemical will be unlawfully imported into the United States or into waters within a distance of 12 miles of the coast of the United States.’’ for ‘‘It shall be unlawful for any person to manufacture or dis- tribute a controlled substance in schedule I or II or flunitrazepam or listed chemical— ‘‘(1) intending that such substance or chemical will be unlawfully imported into the United States or into waters within a distance of 12 miles of the coast of the United States; or ‘‘(2) knowing that such substance or chemical will be unlawfully imported into the United States or into waters within a distance of 12 miles of the coast of the United States.’’ Subsecs. (b) to (d). Pub. L. 114–154 added subsec. (b) and redesignated former subsecs. (b) and (c) as (c) and (d), respectively. 1996—Subsec. (a). Pub. L. 104–305 inserted ‘‘or flunitrazepam’’ after ‘‘schedule I or II’’ in introductory provisions. Pub. L. 104–237, § 102(a), inserted ‘‘or listed chemical’’ after ‘‘schedule I or II’’ in introductory provisions and ‘‘or chemical’’ after ‘‘substance’’ in pars. (1) and (2). Subsec. (b). Pub. L. 104–237, § 102(b), inserted ‘‘or list- ed chemical’’ after ‘‘controlled substance’’ in pars. (1) and (2). 1986—Pub. L. 99–570 designated first sentence as sub- sec. (a) and inserted ‘‘or into waters within a distance