-CITE-
21 USC Sec. 958. 01/22/02
-EXPCITE-
TITLE 21 - FOOD AND DRUGS
CHAPTER 13 - DRUG ABUSE PREVENTION
AND CONTROL
SUBCHAPTER II - IMPORT AND
EXPORT
-HEAD-
Sec. 958. Registration requirements
-STATUTE-
(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.
-SOURCE-
(Pub. L. 91-513, title III, Sec.
1008, Oct. 27, 1970, 84 Stat. 1289;
Pub. L. 98-473, title II, Sec. 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.)
-REFTEXT-
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.
-COD-
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.
-MISC3-
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.
-SECREF-
SECTION REFERRED
TO IN OTHER SECTIONS
This section is referred to in
sections 957, 965
of this title.
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