21 Usc 957

§ 957

TITLE 21—FOOD AND DRUGS

ters the United States through an international
land border with a controlled substance (except
a substance in schedule I) for which the individual does not possess a valid prescription issued
by a practitioner (as defined in section 802 of
this title) in accordance with applicable Federal
and State law (or documentation that verifies
the issuance of such a prescription to that individual) may not import the controlled substance
into the United States in an amount that exceeds 50 dosage units of the controlled substance.
(b) Compound, mixture, or preparation
The Attorney General may by regulation except any compound, mixture, or preparation
containing any depressant or stimulant substance listed in paragraph (a) or (b) of schedule
III or in schedule IV or V from the application
of all or any part of this subchapter if (1) the
compound, mixture, or preparation contains one
or more active medicinal ingredients not having
a depressant or stimulant effect on the central
nervous system, and (2) such ingredients are included therein in such combinations, quantity,
proportion, or concentration as to vitiate the
potential for abuse of the substances which do
have a depressant or stimulant effect on the
central nervous system.
(Pub. L. 91–513, title III, § 1006, Oct. 27, 1970, 84
Stat. 1288; Pub. L. 105–277, div. C, title VIII,
§ 872(a), Oct. 21, 1998, 112 Stat. 2681–707; Pub. L.
105–357, § 2(a), Nov. 10, 1998, 112 Stat. 3271.)
REFERENCES IN TEXT
Schedules I, III, IV, and V, referred to in text, are set
out in section 812(c) of this title.
AMENDMENTS
1998—Subsec. (a). Pub. L. 105–277 and Pub. L. 105–357
amended subsec. (a) identically, designating existing
provisions as par. (1), substituting ‘‘Subject to paragraph (2), the Attorney General’’ for ‘‘The Attorney
General’’, and adding par. (2).

Page 774

the United States from any place outside
thereof, any controlled substance or list I
chemical, or
(2) export from the United States any controlled substance or list I chemical,
unless there is in effect with respect to such person a registration issued by the Attorney General under section 958 of this title, or unless
such person is exempt from registration under
subsection (b).
(b) Exemptions
(1) The following persons shall not be required
to register under the provisions of this section
and may lawfully possess a controlled substance
or list I chemical:
(A) An agent or an employee of any importer
or exporter registered under section 958 of this
title if such agent or employee is acting in the
usual course of his business or employment.
(B) A common or contract carrier or warehouseman, or an employee thereof, whose possession of any controlled substance or list I
chemical is in the usual course of his business
or employment.
(C) An ultimate user who possesses such substance for a purpose specified in section
802(25) 1 of this title and in conformity with an
exemption granted under section 956(a) of this
title.
(2) The Attorney General may, by regulation,
waive the requirement for registration of certain importers and exporters if he finds it consistent with the public health and safety; and
may authorize any such importer or exporter to
possess controlled substances or list I chemicals
for purposes of importation and exportation.
(Pub. L. 91–513, title III, § 1007, Oct. 27, 1970, 84
Stat. 1288; Pub. L. 98–473, title II, § 523, Oct. 12,
1984, 98 Stat. 2076; Pub. L. 103–200, § 3(e), Dec. 17,
1993, 107 Stat. 2337.)
REFERENCES IN TEXT

FEDERAL MINIMUM REQUIREMENT
Pub. L. 105–357, § 2(b), Nov. 10, 1998, 112 Stat. 3271, provided that: ‘‘Section 1006(a)(2) of the Controlled Substances Import and Export Act [21 U.S.C. 956(a)(2)], as
added by this section, is a minimum Federal requirement and shall not be construed to limit a State from
imposing any additional requirement.’’
Pub. L. 105–277, div. C, title VIII, § 872(b), Oct. 21, 1998,
112 Stat. 2681–707, enacted a provision substantially
identical to that enacted by Pub. L. 105–357, § 2(b), set
out above.
JURISDICTION OF SECRETARY OF HEALTH AND HUMAN
SERVICES
Pub. L. 105–277, div. C, title VIII, § 872(c), Oct. 21, 1998,
112 Stat. 2681–707, and Pub. L. 105–357, § 2(c), Nov. 10,
1998, 112 Stat. 3271, provided that: ‘‘The amendment
made by subsection (a) [amending this section] shall
not be construed to affect the jurisdiction of the Secretary of Health and Human Services under the Federal
Food, Drug and Cosmetic Act (21 U.S.C. 301 et seq.).’’

Section 802(25) of this title, referred to in subsec.
(b)(1)(C), was redesignated section 802(26) of this title
by Pub. L. 98–473, title II, § 507(a), Oct. 12, 1984, 98 Stat.
2071, and was further redesignated section 802(27) of this
title by Pub. L. 99–570, title I, § 1003(b)(2), Oct. 27, 1986,
100 Stat. 3207–6.
AMENDMENTS
1993—Subsec. (a)(1). Pub. L. 103–200, § 3(e)(1)(A), inserted ‘‘or list I chemical’’ after ‘‘controlled substance’’.
Subsec. (a)(2). Pub. L. 103–200, § 3(e)(1)(B), substituted
‘‘or list I chemical,’’ for ‘‘in schedule I, II, III, IV, or
V,’’.
Subsec. (b)(1). Pub. L. 103–200, § 3(e)(2)(A), inserted ‘‘or
list I chemical’’ after ‘‘controlled substance’’ in introductory provisions and subpar. (B).
Subsec. (b)(2). Pub. L. 103–200, § 3(e)(2)(B), inserted ‘‘or
list I chemicals’’ after ‘‘controlled substances’’.
1984—Subsec. (a)(2). Pub. L. 98–473 inserted reference
to schedule V.

§ 957. Persons required to register
(a) Coverage
No person may—
(1) import into the customs territory of the
United States from any place outside thereof
(but within the United States), or import into

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.
1 See

References in Text note below.

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