Registration requirements

21 U.S.C. § 958

• Title: 21 — Food and Drugs
• Chapter: SUBCHAPTER II—IMPORT AND EXPORT

Text

(a) Applicants to import or export controlled substances in schedule I or II
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) Activity limited to specified substances
Registration granted under this section shall not entitle a registrant to import or export controlled 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 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) Denial of application
(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) Registration period
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, 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 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) Scope of authorized activity
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) Separate registrations for each principal place of business
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) 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 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.

History

(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

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 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.