21 Usc 826

Page 397

§ 826

TITLE 21—FOOD AND DRUGS

91–513, Oct. 27, 1970, 84 Stat. 1242, as amended, and is
popularly known as the ‘‘Controlled Substances Act’’.
For complete classification of title II to the Code, see
second paragraph of Short Title note set out under section 801 of this title and Tables.
Subchapter II of this chapter, referred to in subsec.
(a)(1), (2), was in the original ‘‘title III’’, meaning title
III of Pub. L. 91–513, Oct. 27, 1970, 84 Stat. 1285. Part A
of title III comprises subchapter II of this chapter. For
classification of Part B, consisting of sections 1101 to
1105 of title III, see Tables.
AMENDMENTS
2000—Subsec. (a). Pub. L. 106–310, § 3502(b)(1), substituted ‘‘section 823(g)(1) of this title’’ for ‘‘section
823(g) of this title’’ in two places in concluding provisions.
Subsec. (d). Pub. L. 106–310, § 3502(b)(2), substituted
‘‘section 823(g)(1) of this title’’ for ‘‘section 823(g) of
this title’’.
1994—Subsec. (g). Pub. L. 103–322 inserted ‘‘or chemical’’ after ‘‘such substance’’ in last sentence.
1993—Subsec. (a). Pub. L. 103–200, § 3(d)(1), inserted
‘‘or a list I chemical’’ after ‘‘controlled substance’’ in
introductory provisions and par. (2) and inserted ‘‘or
list I chemicals’’ after ‘‘controlled substances’’ in par.
(3).
Subsec. (b). Pub. L. 103–200, § 3(d)(2), inserted ‘‘or list
I chemical’’ after ‘‘controlled substance’’.
Subsec. (f). Pub. L. 103–200, § 3(d)(3), inserted ‘‘or list
I chemicals’’ after ‘‘controlled substances’’ wherever
appearing.
Subsec. (g). Pub. L. 103–200, § 3(d)(4), inserted ‘‘or list
I chemicals’’ after ‘‘controlled substances’’ in two
places and ‘‘or list I chemical’’ after ‘‘controlled substance’’ wherever appearing.
1987—Subsec. (a)(5). Pub. L. 100–93 added par. (5).
1984—Subsec. (a)(3). Pub. L. 98–473, § 512(1), inserted
provisions relating to suspension, etc., recommended
by competent State authority.
Subsec. (a)(4). Pub. L. 98–473, § 512(2), added par. (4).
Subsec. (f). Pub. L. 98–473, § 304, inserted provisions
relating to vesting of right, title, and interest in the
United States.
Subsec. (g). Pub. L. 98–473, § 513, added subsec. (g).
1974—Subsec. (a). Pub. L. 93–281, § 4(a), provided for
revocation or suspension of a registration pursuant to
section 823(g) of this title for failure of a registrant to
comply with standards referred to in such section
823(g).
Subsec. (d). Pub. L. 93–281, § 4(b), substituted ‘‘A suspension under this subsection’’ for ‘‘Such suspension’’
in third sentence.
EFFECTIVE DATE OF 1994 AMENDMENT
Amendment by Pub. L. 103–322 effective 120 days after
Dec. 17, 1993, see section 330024(f) of Pub. L. 103–322, set
out as a note under section 802 of this title.
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 OF 1987 AMENDMENT
Amendment by Pub. L. 100–93 effective at end of fourteen-day period beginning Aug. 18, 1987, and inapplicable to administrative proceedings commenced before
end of such period, see section 15(a) of Pub. L. 100–93,
set out as a note under section 1320a–7 of Title 42, The
Public Health and Welfare.
PROVISIONAL REGISTRATION
Applicability of this section to provisional registrations, see section 703 of Pub. L. 91–513, set out as a note
under section 822 of this title.

§ 825. Labeling and packaging
(a) Symbol
It shall be unlawful to distribute a controlled
substance in a commercial container unless such

container, when and as required by regulations
of the Attorney General, bears a label (as defined in section 321(k) of this title) containing
an identifying symbol for such substance in accordance with such regulations. A different symbol shall be required for each schedule of controlled substances.
(b) Unlawful distribution without identifying
symbol
It shall be unlawful for the manufacturer of
any controlled substance to distribute such substance unless the labeling (as defined in section
321(m) of this title) of such substance contains,
when and as required by regulations of the Attorney General, the identifying symbol required
under subsection (a) of this section.
(c) Warning on label
The Secretary shall prescribe regulations
under section 353(b) of this title which shall provide that the label of a drug listed in schedule
II, III, or IV shall, when dispensed to or for a patient, contain a clear, concise warning that it is
a crime to transfer the drug to any person other
than the patient.
(d) Containers to be securely sealed
It shall be unlawful to distribute controlled
substances in schedule I or II, and narcotic
drugs in schedule III or IV, unless the bottle or
other container, stopper, covering, or wrapper
thereof is securely sealed as required by regulations of the Attorney General.
(Pub. L. 91–513, title II, § 305, Oct. 27, 1970, 84
Stat. 1256.)
REFERENCES IN TEXT
Schedules I, II, III, and IV, referred to in subsecs. (c)
and (d), are set out in section 812(c) of this title.
EFFECTIVE DATE
Section effective on first day of seventh calendar
month that begins after Oct. 26, 1970, but with Attorney
General authorized to postpone such effective date for
such period as he might determine to be necessary for
the efficient administration of this subchapter, see section 704(c) of Pub. L. 91–513, set out as a note under section 801 of this title.

§ 826. Production quotas for controlled substances
(a) Establishment of total annual needs
The Attorney General shall determine the
total quantity and establish production quotas
for each basic class of controlled substance in
schedules I and II and for ephedrine, pseudoephedrine, and phenylpropanolamine to be manufactured each calendar year to provide for the
estimated medical, scientific, research, and industrial needs of the United States, for lawful
export requirements, and for the establishment
and maintenance of reserve stocks. Production
quotas shall be established in terms of quantities of each basic class of controlled substance
and not in terms of individual pharmaceutical
dosage forms prepared from or containing such a
controlled substance.
(b) Individual production quotas; revised quotas
The Attorney General shall limit or reduce individual production quotas to the extent nec-

§ 826

TITLE 21—FOOD AND DRUGS

essary to prevent the aggregate of individual
quotas from exceeding the amount determined
necessary each year by the Attorney General
under subsection (a) of this section. The quota
of each registered manufacturer for each basic
class of controlled substance in schedule I or II
or for ephedrine, pseudoephedrine, or phenylpropanolamine shall be revised in the same proportion as the limitation or reduction of the aggregate of the quotas. However, if any registrant, before the issuance of a limitation or reduction in quota, has manufactured in excess of
his revised quota, the amount of the excess shall
be subtracted from his quota for the following
year.
(c) Manufacturing quotas for registered manufacturers
On or before October 1 of each year, upon application therefor by a registered manufacturer,
the Attorney General shall fix a manufacturing
quota for the basic classes of controlled substances in schedules I and II and for ephedrine,
pseudoephedrine, and phenylpropanolamine that
the manufacturer seeks to produce. The quota
shall be subject to the provisions of subsections
(a) and (b) of this section. In fixing such quotas,
the Attorney General shall determine the manufacturer’s estimated disposal, inventory, and
other requirements for the calendar year; and,
in making his determination, the Attorney General shall consider the manufacturer’s current
rate of disposal, the trend of the national disposal rate during the preceding calendar year,
the manufacturer’s production cycle and inventory position, the economic availability of raw
materials, yield and stability problems, emergencies such as strikes and fires, and other factors.
(d) Quotas for registrants who have not manufactured controlled substance during one or
more preceding years
The Attorney General shall, upon application
and subject to the provisions of subsections (a)
and (b) of this section, fix a quota for a basic
class of controlled substance in schedule I or II
for any registrant who has not manufactured
that basic class of controlled substance or
ephedrine, pseudoephedrine, or phenylpropanolamine during one or more preceding calendar
years. In fixing such quota, the Attorney General shall take into account the registrant’s reasonably anticipated requirements for the current year; and, in making his determination of
such requirements, he shall consider such factors specified in subsection (c) of this section as
may be relevant.
(e) Quota increases
At any time during the year any registrant
who has applied for or received a manufacturing
quota for a basic class of controlled substance in
schedule I or II or for ephedrine, pseudoephedrine, or phenylpropanolamine may apply
for an increase in that quota to meet his estimated disposal, inventory, and other requirements during the remainder of that year. In
passing upon the application the Attorney General shall take into consideration any occurrences since the filing of the registrant’s initial
quota application that may require an increased

Page 398

manufacturing rate by the registrant during the
balance of the year. In passing upon the application the Attorney General may also take into
account the amount, if any, by which the determination of the Attorney General under subsection (a) of this section exceeds the aggregate
of the quotas of all registrants under this section.
(f) Incidental production exception
Notwithstanding any other provisions of this
subchapter, no registration or quota may be required for the manufacture of such quantities of
controlled substances in schedules I and II or
ephedrine, pseudoephedrine, or phenylpropanolamine as incidentally and necessarily result from
the manufacturing process used for the manufacture of a controlled substance or of ephedrine, pseudoephedrine, or phenylpropanolamine
with respect to which its manufacturer is duly
registered under this subchapter. The Attorney
General may, by regulation, prescribe restrictions on the retention and disposal of such incidentally produced substances or chemicals.
(g) Reference to ephedrine, pseudoephedrine, or
phenylpropanolamine
Each reference in this section to ephedrine,
pseudoephedrine, or phenylpropanolamine includes each of the salts, optical isomers, and
salts of optical isomers of such chemical.
(Pub. L. 91–513, title II, § 306, Oct. 27, 1970, 84
Stat. 1257; Pub. L. 94–273, § 3(16), Apr. 21, 1976, 90
Stat. 377; Pub. L. 109–177, title VII, § 713, Mar. 9,
2006, 120 Stat. 264.)
REFERENCES IN TEXT
Schedules I and II, referred to in text, are set out in
section 812(c) of this title.
AMENDMENTS
2006—Subsec. (a). Pub. L. 109–177, § 713(1), inserted
‘‘and for ephedrine, pseudoephedrine, and phenylpropanolamine’’ after ‘‘for each basic class of controlled substance in schedules I and II’’.
Subsec. (b). Pub. L. 109–177, § 713(2), inserted ‘‘or for
ephedrine, pseudoephedrine, or phenylpropanolamine’’
after ‘‘for each basic class of controlled substance in
schedule I or II’’.
Subsec. (c). Pub. L. 109–177, § 713(3), inserted ‘‘and for
ephedrine, pseudoephedrine, and phenylpropanolamine’’
after ‘‘for the basic classes of controlled substances in
schedules I and II’’.
Subsec. (d). Pub. L. 109–177, § 713(4), inserted ‘‘or
ephedrine, pseudoephedrine, or phenylpropanolamine’’
after ‘‘that basic class of controlled substance’’.
Subsec. (e). Pub. L. 109–177, § 713(5), inserted ‘‘or for
ephedrine, pseudoephedrine, or phenylpropanolamine’’
after ‘‘for a basic class of controlled substance in schedule I or II’’.
Subsec. (f). Pub. L. 109–177, § 713(6), inserted ‘‘or
ephedrine, pseudoephedrine, or phenylpropanolamine’’
after ‘‘controlled substances in schedules I and II’’, ‘‘or
of ephedrine, pseudoephedrine, or phenylpropanolamine’’ after ‘‘the manufacture of a controlled substance’’, and ‘‘or chemicals’’ after ‘‘such incidentally
produced substances’’.
Subsec. (g). Pub. L. 109–177, § 713(7), added subsec. (g).
1976—Subsec. (c). Pub. L. 94–273 substituted ‘‘October’’ for ‘‘July’’.
EFFECTIVE DATE
Section effective on first day of seventh calendar
month that begins after Oct. 26, 1970, but with Attorney
General authorized to postpone such effective date for

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TITLE 21—FOOD AND DRUGS

such period as he might determine to be necessary for
the efficient administration of this subchapter, see section 704(c) of Pub. L. 91–513, set out as a note under section 801 of this title.
COORDINATION WITH UNITED STATES TRADE
REPRESENTATIVE
Pub. L. 109–177, title VII, § 718, Mar. 9, 2006, 120 Stat.
267, provided that: ‘‘In implementing sections 713
through 717 and section 721 of this title [amending this
section and sections 830, 842, 952, 960, and 971 of this
title], the Attorney General shall consult with the
United States Trade Representative to ensure implementation complies with all applicable international
treaties and obligations of the United States.’’

§ 827. Records and reports of registrants
(a) Inventory
Except as provided in subsection (c) of this
section—
(1) every registrant under this subchapter
shall, on May 1, 1971, or as soon thereafter as
such registrant first engages in the manufacture, distribution, or dispensing of controlled
substances, and every second year thereafter,
make a complete and accurate record of all
stocks thereof on hand, except that the regulations prescribed under this section shall permit each such biennial inventory (following
the initial inventory required by this paragraph) to be prepared on such registrant’s regular general physical inventory date (if any)
which is nearest to and does not vary by more
than six months from the biennial date that
would otherwise apply;
(2) on the effective date of each regulation of
the Attorney General controlling a substance
that immediately prior to such date was not a
controlled substance, each registrant under
this subchapter manufacturing, distributing,
or dispensing such substance shall make a
complete and accurate record of all stocks
thereof on hand; and
(3) on and after May 1, 1971, every registrant
under this subchapter manufacturing, distributing, or dispensing a controlled substance or
substances shall maintain, on a current basis,
a complete and accurate record of each such
substance manufactured, received, sold, delivered, or otherwise disposed of by him, except
that this paragraph shall not require the
maintenance of a perpetual inventory.
(b) Availability of records
Every inventory or other record required
under this section (1) shall be in accordance
with, and contain such relevant information as
may be required by, regulations of the Attorney
General, (2) shall (A) be maintained separately
from all other records of the registrant, or (B)
alternatively, in the case of nonnarcotic controlled substances, be in such form that information required by the Attorney General is
readily retrievable from the ordinary business
records of the registrant, and (3) shall be kept
and be available, for at least two years, for inspection and copying by officers or employees of
the United States authorized by the Attorney
General.
(c) Nonapplicability
The foregoing provisions of this section shall
not apply—

§ 827

(1)(A) to the prescribing of controlled substances in schedule II, III, IV, or V by practitioners acting in the lawful course of their
professional practice unless such substance is
prescribed in the course of maintenance or detoxification treatment of an individual; or
(B) to the administering of a controlled substance in schedule II, III, IV, or V unless the
practitioner regularly engages in the dispensing or administering of controlled substances
and charges his patients, either separately or
together with charges for other professional
services, for substances so dispensed or administered or unless such substance is administered in the course of maintenance treatment
or detoxification treatment of an individual;
(2)(A) to the use of controlled substances, at
establishments registered under this subchapter which keep records with respect to
such substances, in research conducted in conformity with an exemption granted under section 355(i) or 360b(j) of this title;
(B) to the use of controlled substances, at establishments registered under this subchapter
which keep records with respect to such substances, in preclinical research or in teaching;
or
(3) to the extent of any exemption granted to
any person, with respect to all or part of such
provisions, by the Attorney General by or pursuant to regulation on the basis of a finding
that the application of such provisions (or part
thereof) to such person is not necessary for
carrying out the purposes of this subchapter.
Nothing in the Convention on Psychotropic Substances shall be construed as superseding or
otherwise affecting the provisions of paragraph
(1)(B), (2), or (3) of this subsection.
(d) Periodic reports to Attorney General
Every manufacturer registered under section
823 of this title shall, at such time or times and
in such form as the Attorney General may require, make periodic reports to the Attorney
General of every sale, delivery or other disposal
by him of any controlled substance, and each
distributor shall make such reports with respect
to narcotic controlled substances, identifying by
the registration number assigned under this subchapter the person or establishment (unless exempt from registration under section 822(d) of
this title) to whom such sale, delivery, or other
disposal was made.
(e) Reporting and recordkeeping requirements of
drug conventions
In addition to the reporting and recordkeeping
requirements under any other provision of this
subchapter, each manufacturer registered under
section 823 of this title shall, with respect to
narcotic and nonnarcotic controlled substances
manufactured by it, make such reports to the
Attorney General, and maintain such records, as
the Attorney General may require to enable the
United States to meet its obligations under articles 19 and 20 of the Single Convention on Narcotic Drugs and article 16 of the Convention on
Psychotropic Substances. The Attorney General
shall administer the requirements of this subsection in such a manner as to avoid the unnecessary imposition of duplicative requirements