21 CFR 1303.12(b)

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Drug Enforcement Administration, Justice
(b) In making his determinations, the
Administrator shall consider the following factors:
(1) Total net disposal of the class by
all manufacturers during the current
and 2 preceding years;
(2) Trends in the national rate of net
disposal of the class;
(3) Total actual (or estimated) inventories of the class and of all substances
manufactured from the class, and
trends in inventory accumulation;
(4) Projected demand for such class
as indicated by procurement quotas requested pursuant to § 1303.12; and
(5) Other factors affecting medical,
scientific, research, and industrial
needs in the United States and lawful
export requirements, as the Administrator
finds
relevant,
including
changes in the currently accepted medical use in treatment with the class or
the substances which are manufactured
from it, 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.
(c) The Administrator shall, on or before May 1 of each year, publish in the
FEDERAL REGISTER, general notice of
an aggregate production quota for any
basic class determined by him under
this section. A copy of said notice shall
be mailed simultaneously to each person registered as a bulk manufacturer
of the basic class. The Administrator
shall permit any interested person to
file written comments on or objections
to the proposal and shall designate in
the notice the time during which such
filings may be made. The Administrator may, but shall not be required
to, hold a public hearing on one or
more issues raised by the comments
and objections filed with him. In the
event the Administrator decides to
hold such a hearing, he shall publish
notice of the hearing in the FEDERAL
REGISTER, which notice shall summarize the issues to be heard and shall set
the time for the hearing which shall
nnt be less than 30 days after the date
of publication of the notice. After consideration of any comments or objections, or after a hearing if one is or-

§ 1303.12
dered by the Administrator, the Administrator shall issue and publish in
the FEDERAL REGISTER his final order
determining the aggregate production
quota for the basic class of controlled
substance. The order shall include the
findings of fact and conclusions of law
upon which the order is based. The
order shall specify the date on which it
shall take effect. A copy of said order
shall be mailed simultaneously to each
person registered as a bulk manufacturer of the basic class.
[36 FR 7786, Apr. 24, 1971, as amended at 37
FR 15919, Aug. 8, 1972. Redesignated at 38 FR
26609, Sept. 24, 1973]

§ 1303.12 Procurement quotas.
(a) In order to determine the estimated needs for, and to insure an adequate and uninterrupted supply of,
basic classes of controlled substances
listed in Schedules I and II (except raw
opium being imported by the registrant
pursuant to an import permit) the Administrator shall issue procurement
quotas authorizing persons to procure
and use quantities of each basic class
of such substances for the purpose of
manufacturing such class into dosage
forms or into other substances.
(b) Any person who is registered to
manufacture
controlled
substances
listed in any schedule and who desires
to use during the next calendar year
any basic class of controlled substances
listed in Schedule I or II (except raw
opium being imported by the registrant
pursuant to an import permit) for purposes of manufacturing, shall apply on
DEA Form 250 for a procurement quota
for such basic class. A separate application must be made for each basic class
desired to be procured or used. The applicant shall state whether he intends
to manufacture the basic class himself
or purchase it from another manufacturer. The applicant shall state separately each purpose for which the basic
class is desired, the quantity desired
for that purpose during the next calendar year, and the quantities used and
estimated to be used, if any, for that
purpose during the current and preceding 2 calendar years. If the purpose
is to manufacture the basic class into
dosage form, the applicant shall state
the official name, common or usual
name, chemical name, or brand name

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wwoods2 on DSKDVH8Z91PROD with CFR

§ 1303.12

21 CFR Ch. II (4–1–10 Edition)

of that form. If the purpose is to manufacture another substance, the applicant shall state the official name, common or usual name, chemical name, or
brand name of the substance, and, if a
controlled substance listed in any
schedule, the schedule number and Administration Controlled Substances
Code Number, as set forth in part 1308
of this chapter, of the substance. If the
purpose is to manufacture another
basic class of controlled substance listed in Schedule I or II, the applicant
shall also state the quantity of the
other basic class which the applicant
has applied to manufacture pursuant to
§ 1303.22 and the quantity of the first
basic class necessary to manufacture a
specified unit of the second basic class.
DEA Form 250 shall be filed on or before April 1 of the year preceding the
calendar year for which the procurement quota is being applied. Copies of
DEA Form 250 may be obtained from,
and shall be filed with, the Drug and
Chemical Evaluation Section, Drug Enforcement Administration. See the
Table of DEA Mailing Addresses in
§ 1321.01 of this chapter for the current
mailing address.
(c) The Administrator shall, on or before July 1 of the year preceding the
calendar year during which the quota
shall be effective, issue to each qualified applicant a procurement quota authorizing him to procure and use:
(1) All quantities of such class necessary to manufacture all quantities of
other basic classes of controlled substances listed in Schedules I and II
which the applicant is authorized to
manufacture pursuant to § 1303.23; and
(2) Such other quantities of such
class as the applicant has applied to
procure and use and are consistent
with his past use, his estimated needs,
and the total quantity of such class
that will be produced.
(d) Any person to whom a procurement quota has been issued may at any
time request an adjustment in the
quota by applying to the Administrator with a statement showing the
need for the adjustment. Such application shall be filed with the Drug &
Chemical Evaluation Section, Drug Enforcement Administration. See the
Table of DEA Mailing Addresses in
§ 1321.01 of this chapter for the current

mailing address. The Administrator
shall increase or decrease the procurement quota of such person if and to the
extent that he finds, after considering
the factors enumerated in paragraph
(c) of this section and any occurrences
since the issuance of the procurement
quota, that the need justifies an adjustment.
(e) The following persons need not
obtain a procurement quota:
(1) Any person who is registered to
manufacture a basic class of controlled
substance listed in Schedule I or II and
who uses all of the quantity he manufactures in the manufacture of a substance not controlled under the Act;
(2) Any person who is registered or
authorized to conduct chemical analysis with controlled substances (for
controlled substances to be used in
such analysis only); and
(3) Any person who is registered to
conduct research with a basic class of
controlled substance listed in Schedule
I or II and who is authorized to manufacture a quantity of such class pursuant to § 1301.13 of this chapter.
(f) Any person to whom a procurement quota has been issued, authorizing that person to procure and use a
quantity of a basic class of controlled
substances listed in Schedules I or II
during the current calendar year, shall,
at or before the time of giving an order
to another manufacturer requiring the
distribution of a quantity of such basic
class, certify in writing to such other
manufacturer that the quantity of such
basic class ordered does not exceed the
person’s unused and available procurement quota of such basic class for the
current calendar year. The written certification shall be executed by the
same individual who signed the DEA
Form 222 transmitting the order. Manufacturers shall not fill an order from
persons required to apply for a procurement quota under paragraph (b) of this
section unless the order is accompanied
by a certification as required under
this section. The certification required
by this section shall contain the following: The date of the certification;
the name and address of the bulk manufacturer to whom the certification is
directed; a reference to the number of
the DEA Form 222 to which the certification applies; the name of the person

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Drug Enforcement Administration, Justice

(4) Whether any decreased demand
for that class will result in excessive
inventory accumulation by all persons
registered to handle that class (including manufacturers, distributors, practitioners, importers, and exporters), notwithstanding the possibility that individual manufacturing quotas may be
suspended pursuant to § 1303.24(b) or
abandoned pursuant to § 1303.27;
(5) Other factors affecting medical,
scientific, research, and industrial
needs in the United States and lawful
export requirements, as the Administrator
finds
relevant,
including
changes in the currently accepted medical use in treatment with the class or
the substances which are manufactured
from it, 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.
(c) The Administrator in the event he
determines to increase or reduce the
aggregate production quota for a basic
class of controlled substance, shall
publish in the FEDERAL REGISTER general notice of an adjustment in the aggregate production quota for that class
determined by him under this section.
A copy of said notice shall be mailed
simultaneously to each person registered as a bulk manufacturer of the
basic class. The Administrator shall
permit any interested person to file
written comments on or objections to
the proposal and shall designate in the
notice the time during which such filings may be made. The Administrator
may, but shall not be required to, hold
a public hearing on one or more issues
raised by the comments and objections
filed with him. In the event the Administrator decides to hold such a hearing,
he shall publish notice of the hearing
in the FEDERAL REGISTER, which notice
shall summarize the issues to be heard
and shall set the time for the hearing,
which shall not be less than 10 days
after the date of publication of the notice. After consideration of any comments or objections, or after a hearing
if one is ordered by the Administrator,
the Administrator shall issue and publish in the FEDERAL REGISTER his final

giving the order to which the certification applies; the name of the basic
class specified in the DEA Form 222 to
which the certification applies; the appropriate schedule within which is listed the basic class specified in the DEA
Form 222 to which the certification applies; a statement that the quantity
(expressed in grams) of the basic class
specified in the DEA Form 222 to which
the certification applies does not exceed the unused and available procurement quota of such basic class, issued
to the person giving the order, for the
current calendar year; and the signature of the individual who signed the
DEA Form 222 to which the certification applies.
[36 FR 7786, Apr. 24, 1971. Redesignated at 38
FR 26609, Sept. 24, 1973]
EDITORIAL NOTE: For FEDERAL REGISTER citations affecting § 1303.12, see the List of CFR
Sections Affected, which appears in the
Finding Aids section of the printed volume
and on GPO Access.

wwoods2 on DSKDVH8Z91PROD with CFR

§ 1303.13

§ 1303.13 Adjustments of aggregate
production quotas.
(a) The Administrator may at any
time increase or reduce the aggregate
production quota for a basic class of
controlled substance listed in Schedule
I or II which he has previously fixed
pursuant to § 1303.11.
(b) In determining to adjust the aggregate production quota, the Administrator shall consider the following factors:
(1) Changes in the demand for that
class, changes in the national rate of
net disposal of the class, and changes
in the rate of net disposal of the class
by registrants holding individual manufacturing quotas for that class;
(2) Whether any increased demand for
that class, the national and/or individual rates of net disposal of that
class are temporary, short term, or
long term;
(3) Whether any increased demand for
that class can be met through existing
inventories, increased individual manufacturing quotas, or increased importation, without increasing the aggregate production quota, taking into account production delays and the probability that other individual manufacturing quotas may be suspended pursuant to § 1303.24(b);

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