21 Cfr 1303.22

§ 1303.22

21 CFR Ch. II (4–1–18 Edition)

or II, and who applies for a manufacturing quota, an individual manufacturing quota authorizing that person to
manufacture during the next calendar
year a quantity of that basic class. Any
manufacturing quota fixed and issued
by the Administrator shall be subject
to his authority to reduce or limit it at
a later date pursuant to § 1303.26 and to
his authority to revoke or suspend it at
any time pursuant to §§ 1301.36 of this
chapter.
(b) No individual manufacturing
quota shall be required for registrants
listed in § 1303.12(e).

(1) The desired individual manufacturing quota; and
(2) Any additional factors which the
applicant finds relevant to the fixing of
his individual manufacturing quota, including the trend of (and recent
changes in) his and the national rates
of net disposal, his production cycle
and current inventory position, the
econolic and physical availability of
raw materials for use in manufacturing
and for inventory purposes, yield and
stability problems, potential disruptions to production (including possible
labor strikes) and recent unforeseen
emergencies such as floods and fires.

[36 FR 7786, Apr. 24, 1971. Redesignated at 38
FR 26609, Sept. 24, 1973, as amended at 62 FR
13958, Mar. 24, 1997]

[36 FR 7786, Apr. 24, 1971, as amended at 36
FR 13386, July 21, 1971; 37 FR 15920, Aug. 8,
1972. Redesignated at 38 FR 26609, Sept. 24,
1973, and amended at 46 FR 28841, May 29,
1981; 51 FR 5319, Feb. 13, 1986; 62 FR 13958,
Mar. 24, 1997; 75 FR 10677, Mar. 9, 2010; 81 FR
97020, Dec. 30, 2016]

nshattuck on DSK9F9SC42PROD with CFR

§ 1303.22 Procedure for applying for
individual manufacturing quotas.
Any person who is registered to manufacture any basic class of controlled
substance listed in Schedule I or II and
who desires to manufacture a quantity
of such class shall apply on DEA Form
189 for a manufacturing quota for such
quantity of such class. Copies of DEA
Form 189 may be obtained from, and
shall be filed (on or before May 1 of the
year preceding the calendar year for
which the manufacturing quota is
being applied) with, the UN Reporting
and Quota Section, Diversion Control
Division. See the Table of DEA Mailing
Addresses in § 1321.01 of this chapter for
the current mailing address. A separate
application must be made for each
basic class desired to be manufactured.
The applicant shall state:
(a) The name and Administration
Controlled Substances Code Number, as
set forth in part 1308 of this chapter, of
the basic class.
(b) For the basic class in each of the
current and preceding 2 calendar years,
(1) The authorized individual manufacturing quota, if any;
(2) The actual or estimated quantity
manufactured;
(3) The actual or estimated net disposal;
(4) The actual or estimated inventory
allowance pursuant to § 1303.24; and
(5) The actual or estimated inventory
as of December 31;
(c) For the basic class in the next calendar year,

§ 1303.23 Procedure for fixing
vidual manufacturing quotas.

(a) In fixing individual manufacturing quotas for a basic class of controlled substance listed in Schedule I
or II, the Administrator shall allocate
to each applicant who is currently
manufacturing such class a quota equal
to 100 percent of the estimated net disposal of that applicant for the next calendar year, adjusted—
(1) By the amount necessary to increase or reduce the estimated inventory of the applicant on December 31 of
the current year to his estimated inventory allowance for the next calendar year, pursuant to § 1303.24, and
(2) By any other factors which the
Administrator deems relevant to the
fixing of the individual manufacturing
quota of the applicant, including the
trend of (and recent changes in) his and
the national rates of net disposal, his
production cycle and current inventory
position, the economic and physical
availability of raw materials for use in
manufacturing and for inventory purposes, yield and stability problems, potential disruptions to production (including possible labor strikes), and recent unforeseen emergencies such as
floods and fires.
(b) In fixing individual manufacturing quotas for a basic class of controlled substance listed in Schedule I

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