TITLE 21 - FOOD AND DRUGS
CHAPTER 13 - DRUG ABUSE PREVENTION AND CONTROL
SUBCHAPTER I - CONTROL AND ENFORCEMENT
Part D - Offenses and Penalties
HEAD
Sec. 842. Prohibited acts B
STATUTE
(a) Unlawful acts
It shall be unlawful for any person -
(1) who is subject to the requirements of part C to distribute
or dispense a controlled substance in violation of section 829 of
this title;
(2) who is a registrant to distribute or dispense a controlled
substance not authorized by his registration to another
registrant or other authorized person or to manufacture a
controlled substance not authorized by his registration;
(3) who is a registrant to distribute a controlled substance in
violation of section 825 of this title;
(4) to remove, alter, or obliterate a symbol or label required
by section 825 of this title;
(5) to refuse or negligently fail to make, keep, or furnish any
record, report, notification, declaration, order or order form,
statement, invoice, or information required under this subchapter
or subchapter II of this chapter;
(6) to refuse any entry into any premises or inspection
authorized by this subchapter or subchapter II of this chapter;
(7) to remove, break, injure, or deface a seal placed upon
controlled substances pursuant to section 824(f) or 881 of this
title or to remove or dispose of substances so placed under seal;
(8) to use, to his own advantage, or to reveal, other than to
duly authorized officers or employees of the United States, or to
the courts when relevant in any judicial proceeding under this
subchapter or subchapter II of this chapter, any information
acquired in the course of an inspection authorized by this
subchapter concerning any method or process which as a trade
secret is entitled to protection, or to use to his own advantage
or reveal (other than as authorized by section 830 of this title)
any information that is confidential under such section;
(9) who is a regulated person to engage in a regulated
transaction without obtaining the identification required by
830(a)(3) of this title.(!1)
(10) negligently to fail to keep a record or make a report
under section 830 of this title;
(11) to distribute a laboratory supply to a person who uses, or
attempts to use, that laboratory supply to manufacture a
controlled substance or a listed chemical, in violation of this
subchapter or subchapter II of this chapter, with reckless
disregard for the illegal uses to which such a laboratory supply
will be put;
(12) who is a regulated seller, or a distributor required to
submit reports under subsection (b)(3) of section 830 of this
title -
(A) to sell at retail a scheduled listed chemical product in
violation of paragraph (1) of subsection (d) of such section,
knowing at the time of the transaction involved (independent of
consulting the logbook under subsection (e)(1)(A)(iii) of such
section) that the transaction is a violation; or
(B) to knowingly or recklessly sell at retail such a product
in violation of paragraph (2) of such subsection (d);
(13) who is a regulated seller to knowingly or recklessly sell
at retail a scheduled listed chemical product in violation of
subsection (e) of such section; or
(14) who is a regulated seller or an employee or agent of such
seller to disclose, in violation of regulations under
subparagraph (C) of section 830(e)(1) of this title, information
in logbooks under subparagraph (A)(iii) of such section, or to
refuse to provide such a logbook to Federal, State, or local law
enforcement authorities.
As used in paragraph (11), the term "laboratory supply" means a
listed chemical or any chemical, substance, or item on a special
surveillance list published by the Attorney General, which contains
chemicals, products, materials, or equipment used in the
manufacture of controlled substances and listed chemicals. For
purposes of paragraph (11), there is a rebuttable presumption of
reckless disregard at trial if the Attorney General notifies a firm
in writing that a laboratory supply sold by the firm, or any other
person or firm, has been used by a customer of the notified firm,
or distributed further by that customer, for the unlawful
production of controlled substances or listed chemicals a firm
distributes and 2 weeks or more after the notification the notified
firm distributes a laboratory supply to the customer.
(b) Manufacture
It shall be unlawful for any person who is a registrant to
manufacture a controlled substance in schedule I or II, or
ephedrine, pseudoephedrine, or phenylpropanolamine or any of the
salts, optical isomers, or salts of optical isomers of such
chemical, which is -
(1) not expressly authorized by his registration and by a quota
assigned to him pursuant to section 826 of this title; or
(2) in excess of a quota assigned to him pursuant to section
826 of this title.
(c) Penalties
(1)(A) Except as provided in subparagraph (B) of this paragraph
and paragraph (2), any person who violates this section shall, with
respect to any such violation, be subject to a civil penalty of not
more than $25,000. The district courts of the United States (or,
where there is no such court in the case of any territory or
possession of the United States, then the court in such territory
or possession having the jurisdiction of a district court of the
United States in cases arising under the Constitution and laws of
the United States) shall have jurisdiction in accordance with
section 1355 of title 28 to enforce this paragraph.
(B) In the case of a violation of paragraph (5) or (10) of
subsection (a) of this section, the civil penalty shall not exceed
$10,000.
(2)(A) If a violation of this section is prosecuted by an
information or indictment which alleges that the violation was
committed knowingly and the trier of fact specifically finds that
the violation was so committed, such person shall, except as
otherwise provided in subparagraph (B) of this paragraph, be
sentenced to imprisonment of not more than one year or a fine under
title 18, or both.
(B) If a violation referred to in subparagraph (A) was committed
after one or more prior convictions of the offender for an offense
punishable under this paragraph (2), or for a crime under any other
provision of this subchapter or subchapter II of this chapter or
other law of the United States relating to narcotic drugs,
marihuana, or depressant or stimulant substances, have become
final, such person shall be sentenced to a term of imprisonment of
not more than 2 years, a fine under title 18, or both.
(C) In addition to the penalties set forth elsewhere in this
subchapter or subchapter II of this chapter, any business that
violates paragraph (11) of subsection (a) of this section shall,
with respect to the first such violation, be subject to a civil
penalty of not more than $250,000, but shall not be subject to
criminal penalties under this section, and shall, for any
succeeding violation, be subject to a civil fine of not more than
$250,000 or double the last previously imposed penalty, whichever
is greater.
(3) Except under the conditions specified in paragraph (2) of
this subsection, a violation of this section does not constitute a
crime, and a judgment for the United States and imposition of a
civil penalty pursuant to paragraph (1) shall not give rise to any
disability or legal disadvantage based on conviction for a criminal
offense.
(4)(A) If a regulated seller, or a distributor required to submit
reports under section 830(b)(3) of this title, violates paragraph
(12) of subsection (a) of this section, or if a regulated seller
violates paragraph (13) of such subsection, the Attorney General
may by order prohibit such seller or distributor (as the case may
be) from selling any scheduled listed chemical product. Any sale of
such a product in violation of such an order is subject to the same
penalties as apply under paragraph (2).
(B) An order under subparagraph (A) may be imposed only through
the same procedures as apply under section 824(c) of this title for
an order to show cause.
SOURCE
(Pub. L. 91-513, title II, Sec. 402, Oct. 27, 1970, 84 Stat. 1262;
Pub. L. 95-633, title II, Sec. 202(b)(1), (2), Nov. 10, 1978, 92
Stat. 3776; Pub. L. 100-690, title VI, Sec. 6056, Nov. 18, 1988,
102 Stat. 4318; Pub. L. 104-237, title II, Sec. 205, Oct. 3, 1996,
110 Stat. 3103; Pub. L. 105-277, div. A, Sec. 101(b) [title I, Sec.
117], Oct. 21, 1998, 112 Stat. 2681-50, 2681-68; Pub. L. 107-273,
div. B, title IV, Sec. 4002(b)(16), (d)(2)(B), Nov. 2, 2002, 116
Stat. 1808, 1809; Pub. L. 109-177, title VII, Secs. 711(f)(1)(A),
(2), 714, Mar. 9, 2006, 120 Stat. 262-264.)
REFERENCES IN TEXT
Schedules I and II, referred to in subsec. (b), are set out in
section 812(c) of this title.
AMENDMENTS
2006 - Subsec. (a)(12) to (14). Pub. L. 109-177, Sec.
711(f)(1)(A), added pars. (12) to (14).
Subsec. (b). Pub. L. 109-177, Sec. 714, inserted ", or ephedrine,
pseudoephedrine, or phenylpropanolamine or any of the salts,
optical isomers, or salts of optical isomers of such chemical,"
after "manufacture a controlled substance in schedule I or II" in
introductory provisions.
Subsec. (c)(4). Pub. L. 109-177, Sec. 711(f)(2), added par. (4).
2002 - Subsec. (c)(2)(A). Pub. L. 107-273, Sec. 4002(d)(2)(B)(i),
substituted "under title 18" for "of not more than $25,000".
Subsec. (c)(2)(B). Pub. L. 107-273, Sec. 4002(d)(2)(B)(ii),
substituted "under title 18" for "of $50,000".
Subsec. (c)(2)(C). Pub. L. 107-273, Sec. 4002(b)(16), realigned
margins.
1998 - Subsec. (a)(5). Pub. L. 105-277, Sec. 101(b) [title I,
Sec. 117(1)], inserted "negligently" before "fail".
Subsec. (a)(10). Pub. L. 105-277, Sec. 101(b) [title I, Sec.
117(2)], inserted "negligently" before "to fail".
Subsec. (c)(1). Pub. L. 105-277, Sec. 101(b) [title I, Sec.
117(3)], designated existing provisions as subpar. (A), inserted
"subparagraph (B) of this paragraph and" before "paragraph (2)",
and added subpar. (B).
1996 - Subsec. (a). Pub. L. 104-237, Sec. 205(a), added par. (11)
and closing provisions.
Subsec. (c)(2)(C). Pub. L. 104-237, Sec. 205(b), added subpar.
(C).
1988 - Subsec. (a)(8). Pub. L. 100-690, Sec. 6056(a), inserted ",
or to use to his own advantage or reveal (other than as authorized
by section 830 of this title) any information that is confidential
under such section" after "protection".
Subsec. (a)(9). Pub. L. 100-690, Sec. 6056(b), amended par. (9)
generally. Prior to amendment, par. (9) read as follows: "to
distribute or sell piperidine in violation of regulations
established under section 830(a)(2) of this title, respecting
presentation of identification."
Subsec. (a)(10). Pub. L. 100-690, Sec. 6056(d), added par. (10).
Subsec. (c)(2)(C). Pub. L. 100-690, Sec. 6056(c), struck out
subpar. (C) which read as follows: "Subparagraphs (A) and (B) shall
not apply to a violation of subsection (a)(5) of this section with
respect to a refusal or failure to make a report required under
section 830(a) of this title (relating to piperidine reporting)."
1978 - Subsec. (a)(9). Pub. L. 95-633, Sec. 202(b)(1), added par.
(9).
Subsec. (c)(2)(C). Pub. L. 95-633, Sec. 202(b)(2), added subpar.
(C).
EFFECTIVE DATE OF 1988 AMENDMENT
Amendment by Pub. L. 100-690 effective 120 days after Nov. 18,
1988, see section 6061 of Pub. L. 100-690, set out as a note under
section 802 of this title.
EFFECTIVE DATE OF 1978 AMENDMENT
Amendment by Pub. L. 95-633 effective Nov. 10, 1978, see section
203(a) of Pub. L. 95-633 set out as an Effective Date note under
section 830 of this title.
REPEALS
Pub. L. 96-359, Sec. 8(b), Sept. 26, 1980, 94 Stat. 1194,
repealed section 203(d) of Pub. L. 95-633, which had provided for
the repeal of subsecs. (a)(9) and (c)(2)(C) of this section
effective Jan. 1, 1981.
FOOTNOTE
(!1) So in original. Probably should be "section 830(a)(3) of
this title;".
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