21 Usc 958

Page 775

TITLE 21—FOOD AND DRUGS
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.
PROVISIONAL REGISTRATION
Pub. L. 91–513, title III, § 1104, Oct. 27, 1970, 84 Stat.
1294, as amended by Pub. L. 99–514, § 2, Oct. 22, 1986, 100
Stat. 2095, provided that:
‘‘(a)(1) Any person—
‘‘(A) who is engaged in importing or exporting any
controlled substance on the day before the effective
date of section 1007 [May 1, 1971],
‘‘(B) who notifies the Attorney General that he is so
engaged, and
‘‘(C) who is registered on such day under section 510
of the Federal Food, Drug, and Cosmetic Act [section
360 of this title] or under section 4722 of the Internal
Revenue Code of 1986 [formerly I.R.C. 1954, section
4722 of title 26],
shall, with respect to each establishment for which
such registration is in effect under any such section, be
deemed to have a provisional registration under section
1008 [section 958 of this title] for the import or export
(as the case may be) of controlled substances.
‘‘(2) During the period his provisional registration is
in effect under this section, the registration number assigned such person under such section 510 or under such
section 4722 (as the case may be) shall be his registration number for purposes of part A of this title [this
subchapter].
‘‘(b) The provisions of section 304 [section 824 of this
title], relating to suspension and revocation of registration, shall apply to a provisional registration
under this section.
‘‘(c) Unless sooner suspended or revoked under subsection (b), a provisional registration of a person under
subsection (a)(1) of this section shall be in effect until—
‘‘(1) the date on which such person has registered
with the Attorney General under section 1008 [section
958 of this title] or has had his registration denied
under such section, or
‘‘(2) such date as may be prescribed by the Attorney
General for registration of importers or exporters, as
the case may be,
whichever occurs first.’’

§ 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 deter-

§ 958

mines 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) 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

§ 959

TITLE 21—FOOD AND DRUGS

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.
(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.

Page 776

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.)
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
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.
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.

§ 959. Possession, manufacture, or distribution of
controlled substance
(a) Manufacture or distribution for purpose of
unlawful importation
It shall be unlawful for any person to manufacture or distribute a controlled substance in
schedule I or II or flunitrazepam or a listed
chemical intending, knowing, or having reasonable cause to believe that such substance or
chemical will be unlawfully imported into the
United States or into waters within a distance
of 12 miles of the coast of the United States.