
From the U.S. Code Online via GPO Access
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[Laws in effect as of January 2, 2001]
[Document not affected by Public Laws enacted between
  January 2, 2001 and January 28, 2002]
[CITE: 21USC958]

 
                        TITLE 21--FOOD AND DRUGS
 
              CHAPTER 13--DRUG ABUSE PREVENTION AND CONTROL
 
                    SUBCHAPTER II--IMPORT AND EXPORT
 
Sec. 958. Registration requirements


(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(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.

(d) Denial of application

    (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.

(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 
of importers and exporters of controlled substances or list I chemicals 
under this section.

(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 
of this chapter.

(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.

(Pub. L. 91-513, title III, Sec. 1008, Oct. 27, 1970, 84 Stat. 1289; 
Pub. L. 98-473, title II, Secs. 524, 525, Oct. 12, 1984, 98 Stat. 2076; 
Pub. L. 99-570, title I, Sec. 1866(d), Oct. 27, 1986, 100 Stat. 3207-55; 
Pub. L. 103-200, Sec. 3(f), Dec. 17, 1993, 107 Stat. 2337.)

                       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, as amended. 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

    1993--Subsec. (c). Pub. L. 103-200, Sec. 3(f)(1), designated 
existing provisions as par. (1) and added par. (2).
    Subsec. (d)(3). Pub. L. 103-200, Sec. 3(f)(2)(A), inserted ``or list 
I chemical or chemicals,'' after ``substances,''.
    Subsec. (d)(6). Pub. L. 103-200, Sec. 3(f)(2)(B), inserted ``or list 
I chemicals'' after ``controlled substances'' wherever appearing.
    Subsec. (e). Pub. L. 103-200, Sec. 3(f)(3), inserted reference to 
section 830 of this title.
    Subsecs. (f) to (h). Pub. L. 103-200, Sec. 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, Sec. 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, Sec. 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.


                    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.

                  Section Referred to in Other Sections

    This section is referred to in sections 844, 957, 965 of this title.
