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Regulations
& Codified CSA > USC > Subchapter
II > Section 958
Section 958. Registration Requirements
Applicants to import or export controlled substances in schedule I or II
(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.
Activity limited to specified substances
(b) Registration granted under this section shall not entitle a registrant to import or export
controlled substances other than specified in the registration.
Applicants to import controlled substances in schedule III, IV, or V or to export controlled
substances in schedule III or IV
(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(d) 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(h) of
this title.
Denial of application
(d)(1) The Attorney General may deny an application for registration under subsection (a) of this
section if he is unable to determine that such registration is consistent with the public interest (as
defined in subsection (a) of this section) 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) of this section, or revoke or suspend a registration under subsection (a) or (c) of
this section, if he determines that such registration is inconsistent with the public
interest (as defined in subsection (a) or (c) of this section) 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.
Registration period
(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, 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.
Rules and regulations
(f) The Attorney General is authorized to promulgate rules and regulations and to charge
reasonable fees relating to the registration of importers and exporters of controlled substances or
list I chemicals under this section.
Scope of authorized activity
(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 of this chapter.
Separate registrations for each principal place of business
(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.
Emergency situations
(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.
(Pub. L. 91-513, Title III, Section 1008, Oct. 27, 1970, 84 Stat. 1289; Pub. L. 98-473, Title II,
Sections 524, 525, Oct. 12, 1984, 98 Stat. 2076; Pub. L. 99-570, Title I, Section 1866(d), Oct. 27,
1986, 100 Stat. 3207-55.)
EDITORIAL NOTES
References in Text. Schedules I, II, III, IV, and V, referred to in subsecs. (a), (b), (c), and (h), are
set out in section 812(c) of this title.
This subchapter, referred to in subsec. (f), 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 U.S.C.A. Tables.
Code of Federal Regulations
Administrative functions, practices, and procedures, see 21 CFR 1316.01 et seq.
Controlled drugs, warnings, see 21 CFR 290.5 et seq.
Labeling and packaging requirements, see 21 CFR 1302.01 et seq.
Record keeping and reporting requirements, see 21 CFR 1304.01 et seq.
Registration requirements, see 21 CFR 1311.01 et seq.
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NOTICE: This is an
unofficial version. An official version of this publication may be obtained
directly from the Government Printing Office (GPO).
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