Title 21 — Food and DrugsRelease 119-73not60
§958 Registration Requirements
Title 21 › Chapter 13— DRUG ABUSE PREVENTION AND CONTROL › Subchapter II— IMPORT AND EXPORT › § 958
Summary
The Attorney General must register people who apply to import or export controlled drugs or list I chemicals when the application meets public-interest tests and U.S. treaty duties that were in effect on May 1, 1971. For drugs in schedules I and II the Attorney General must find the registration fits the public interest (using the factors in 21 U.S.C. 823(a)(1)–(6)). For imports of schedules III–V and exports of III–IV, registration must be given unless it conflicts with the public interest (using 823(e)(1)–(6)). List I chemicals must be registered unless that would be against the public interest; a specified exempt drug product under 21 U.S.C. 802(39)(A)(iv) does not need registration. The Attorney General may make rules and charge fees for these registrations. If the Attorney General cannot find the registration is in the public interest or consistent with the listed treaties, he may deny, suspend, or revoke a registration. Actions can be limited to particular drugs or chemicals. Before denying, suspending, or revoking, the Attorney General must give the applicant or registrant a written notice explaining the reasons and offer a hearing at least 30 days after the notice. In urgent cases he may suspend a registration immediately if public health or safety is in danger. When a registration is suspended or revoked, covered drugs or chemicals can be seized or sealed; perishable items may be sold by court order with proceeds held by the court. Final revocation leads to forfeiture to the United States and disposal under 21 U.S.C. 881(e). Registrations last no more than one year, require a separate registration for each main business location, and registered persons may only import, export, or possess what their registration allows. Before allowing bulk manufacturers to import schedule I or II drugs (or issuing rules to allow importation), the Attorney General must give existing bulk manufacturers a chance for a hearing, except in emergencies described in 21 U.S.C. 952(a)(2)(A).
Full Legal Text
Title 21, §958
Food and Drugs — Source: USLM XML via OLRC
(a)The Attorney General shall register an applicant to import or export a controlled substance in schedule I or II if he determines that such registration is consistent with the public interest and with United States obligations under international treaties, conventions, or protocols in effect on May 1, 1971. In determining the public interest, the factors enumerated in paragraph (1) through (6) of section 823(a) of this title shall be considered.
(b)Registration granted under this section shall not entitle a registrant to import or export controlled substances other than specified in the registration.
(c)(1)The Attorney General shall register an applicant to import a controlled substance in schedule III, IV, or V or to export a controlled substance in schedule III or IV, unless he determines that the issuance of such registration is inconsistent with the public interest. In determining the public interest, the factors enumerated 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 General shall consider the factors specified in section 823(i) of this title.
(d)(1)The Attorney General may deny an application 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 obligations under international treaties, conventions, or protocols in effect on May 1, 1971.
(2)The Attorney General may deny an application for registration under subsection (c), or revoke or suspend a registration under subsection (a) or (c), if he determines that such registration 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 revocation 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 subsection, 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 General, 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. Proceedings to deny, revoke, or suspend shall be conducted pursuant to this subsection in accordance 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 discretion, 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, including judicial review thereof, unless sooner withdrawn by the Attorney General or dissolved by a court of competent jurisdiction.
(6)In the event that the Attorney General suspends 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 suspension 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 proceeds of the sale with the court. Upon a revocation 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 accordance with section 881(e) of this title.
(e)No registration shall be issued under this subchapter for a period in excess of one year. Unless the regulations of the Attorney General otherwise provide, section 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)The Attorney General is authorized to promulgate rules and regulations and to charge reasonable fees relating to the registration and control of importers and exporters of controlled substances or listed chemicals.
(g)Persons registered by the Attorney General under this section to import or export controlled substances or list I chemicals may import or export (and for the purpose of so importing 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)A separate registration shall be required at each principal place of business where the applicant imports or exports controlled substances or list I chemicals.
(i)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 manufacturer of a controlled substance in schedule I or II, and prior to issuing a regulation under section 952(a) of this title authorizing the importation of such a substance, the Attorney General shall give manufacturers holding registrations for the bulk manufacture of the substance an opportunity for a hearing.
Legislative History
Notes & Related Subsidiaries
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 Tables. 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), substituted “823(e)” for “823(d)”. Subsec. (c)(2)(B). Pub. L. 117–215, § 103(b)(2)(B), substituted “823(i)” for “823(h)”. 2004—Subsec. (f). Pub. L. 108–447, which directed amendment of subsec. (f) of section 1088 of the Controlled Substances Import and Export Act by inserting “and control” after “the registration” and substituting “listed chemicals” for “list I chemicals under this section”, 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” wherever 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 “sections” for first reference to “section”. 1984—Subsec. (b). Pub. L. 98–473, § 524, substituted “Registration granted under this section shall not entitle a registrant to import or export controlled substances other than specified in the registration” for “Registration granted under subsection (a) of this section 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 redesignated former subsecs. (e) to (h) as (f) to (i), respectively.
Statutory Notes and Related Subsidiaries
Effective Date
of 1993 AmendmentAmendment 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.
Reference
Citations & Metadata
Citation
21 U.S.C. § 958
Title 21 — Food and Drugs
Last Updated
Apr 5, 2026
Release point: 119-73not60