21 Usc 826

§ 826

TITLE 21—FOOD AND DRUGS

abolic steroid, unless the steroid or product
bears a label clearly identifying an anabolic
steroid or product containing an anabolic steroid by the nomenclature used by the International Union of Pure and Applied Chemistry
(IUPAC).
(2)(A) A product described in subparagraph (B)
is exempt from the International Union of Pure
and Applied Chemistry nomenclature requirement of this subsection if such product is labeled in the manner required under the Federal
Food, Drug, and Cosmetic Act [21 U.S.C. 301 et
seq.].
(B) A product is described in this subparagraph if the product—
(i) is the subject of an approved application
as described in section 505(b) or (j) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C.
355(b), (j)]; or
(ii) is exempt from the provisions of section
505 of such Act relating to new drugs because—
(I) it is intended solely for investigational
use as described in section 505(i) of such Act;
and
(II) such product is being used exclusively
for purposes of a clinical trial that is the
subject of an effective investigational new
drug application.
(Pub. L. 91–513, title II, § 305, Oct. 27, 1970, 84
Stat. 1256; Pub. L. 113–260, § 3(a), Dec. 18, 2014, 128
Stat. 2931.)
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.
The Federal Food, Drug, and Cosmetic Act, referred
to in subsec. (e)(2)(A), is act June 25, 1938, ch. 675, 52
Stat. 1040, which is classified generally to chapter 9
(§ 301 et seq.) of this title. For complete classification of
this Act to the Code, see section 301 of this title and
Tables.
AMENDMENTS
2014—Subsec. (e). Pub. L. 113–260 added subsec. (e).
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.
IDENTIFICATION AND PUBLICATION OF LIST OF PRODUCTS
CONTAINING ANABOLIC STEROIDS
Pub. L. 113–260, § 4, Dec. 18, 2014, 128 Stat. 2932, provided that:
‘‘(a) IN GENERAL.—The Attorney General may, in the
Attorney General’s discretion, collect data and analyze
products to determine whether they contain anabolic
steroids and are properly labeled in accordance with
this Act [see section 1 of Pub. L. 113–260, set out as a
Short Title of 2014 Amendment note under section 801
of this title] and the amendments made by this Act.
The Attorney General may publish in the Federal Register or on the website of the Drug Enforcement Administration a list of products which the Attorney General has determined, based on substantial evidence,
contain an anabolic steroid and are not labeled in accordance with this Act and the amendments made by
this Act.
‘‘(b) ABSENCE FROM LIST.—The absence of a product
from the list referred to in subsection (a) shall not con-

Page 706

stitute evidence that the product does not contain an
anabolic steroid.’’

§ 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 necessary to prevent the aggregate of individual
quotas from exceeding the amount determined
necessary each year by the Attorney General
under subsection (a). 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

Page 707

§ 826a

TITLE 21—FOOD AND DRUGS

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
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.
(h) Quotas applicable to drugs in shortage
(1) Not later than 30 days after the receipt of
a request described in paragraph (2), the Attorney General shall—
(A) complete review of such request; and
(B)(i) as necessary to address a shortage of a
controlled substance, increase the aggregate
and individual production quotas under this
section applicable to such controlled substance and any ingredient therein to the level
requested; or
(ii) if the Attorney General determines that
the level requested is not necessary to address
a shortage of a controlled substance, the Attorney General shall provide a written response detailing the basis for the Attorney
General’s determination.

The Secretary shall make the written response
provided under subparagraph (B)(ii) available to
the public on the Internet Web site of the Food
and Drug Administration.
(2) A request is described in this paragraph if—
(A) the request pertains to a controlled substance on the list of drugs in shortage maintained under section 356e of this title;
(B) the request is submitted by the manufacturer of the controlled substance; and
(C) the controlled substance is in schedule
II.
(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; Pub. L. 112–144, title X, § 1005,
July 9, 2012, 126 Stat. 1105.)
REFERENCES IN TEXT
Schedules I and II, referred to in text, are set out in
section 812(c) of this title.
AMENDMENTS
2012—Subsec. (h). Pub. L. 112–144 added subsec. (h).
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
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.’’

§ 826a. Attorney General report on drug shortages
Not later than 6 months after July 9, 2012, and
annually thereafter, the Attorney General shall