21 Cfr 1315.32

Drug Enforcement Administration, Justice
§ 1315.13, the Administrator may proportionately reduce the individual
manufacturing quotas and import
quotas of all other registrants to keep
the assessment of annual needs within
the limits originally established, or, alternatively, the Administrator may reduce the individual manufacturing
quota of any registrant whose quota is
suspended pursuant to § 1315.24(b) or
§§ 1301.36, 1309.43, 1309.44, or 1309.45 of
this chapter or is abandoned pursuant
to § 1315.27.
§ 1315.27

Abandonment of quota.

Any manufacturer assigned an individual manufacturing quota for a
chemical pursuant to § 1315.23 may at
any time abandon his right to manufacture all or any part of the quota by
filing with the Drug & Chemical Evaluation Section a written notice of the
abandonment, stating the name and
DEA Chemical Code Number, as set
forth in part 1310 of this chapter, of the
chemical and the amount which he has
chosen not to manufacture. The Administrator may, in his discretion, allocate the amount among the other
manufacturers in proportion to their
respective quotas.

Subpart D—Procurement and
Import Quotas

wwoods2 on DSKDVH8Z91PROD with CFR

§ 1315.30 Procurement
quotas.

and

import

(a) To determine the estimated needs
for, and to insure an adequate and uninterrupted
supply
of,
ephedrine,
pseudoephedrine, and phenylpropanolamine the Administrator shall issue procurement and import quotas.
(b) A procurement quota authorizes a
registered manufacturer to procure and
use quantities of each chemical for the
following purposes:
(1) Manufacturing the bulk chemical
into dosage forms.
(2) Manufacturing the bulk chemical
into other substances.
(3) Repackaging or relabeling the
chemical or dosage forms.
(c) An import quota authorizes a registered importer to import quantities
of the chemical for the following purposes:

§ 1315.32
(1) Distribution of the chemical to a
registered manufacturer that has a
procurement quota for the chemical.
(2) Other distribution of the chemical
consistent with the legitimate medical
and scientific needs of the United
States.
§ 1315.32 Obtaining a procurement
quota.
(a) Any person who is registered to
manufacture
ephedrine,
pseudoephedrine, or phenylpropanolamine, or whose requirement of registration is waived pursuant to § 1309.24
of this chapter, and who desires to use
during the next calendar year any
ephedrine, pseudoephedrine, or phenylpropanolamine for purposes of manufacturing (including repackaging or relabeling), must apply on DEA Form 250
for a procurement quota for the chemical. A separate application must be
made for each chemical desired to be
procured or used.
(b) The applicant must state separately all of the following:
(1) Each purpose for which the chemical is desired.
(2) The quantity desired for each purpose during the next calendar year.
(3) The quantities used and estimated
to be used, if any, for that purpose during the current and preceding 2 calendar years.
(c) If the purpose is to manufacture
the chemical into dosage form, the applicant must state the official name,
common or usual name, chemical
name, or brand name of that form. If
the dosage form produced is a controlled substance listed in any schedule, the applicant must also state the
schedule number and National Drug
Code Number, of the substance.
(d) If the purpose is to manufacture
another chemical, the applicant must
state the official name, common or
usual name, chemical name, or brand
name of the substance and the DEA
Chemical Code Number, as set forth in
part 1310 of this chapter.
(e) DEA Form 250 must 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
the Office of Diversion Control Web
site, and must be filed with the Drug &

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§ 1315.33

21 CFR Ch. II (4–1–10 Edition)

Chemical Evaluation Section, Drug Enforcement Administration. See the
Table of DEA Mailing Addresses in
§ 1321.01 of this chapter for the current
mailing address.
(f) 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 the chemical
necessary to manufacture products
that the applicant is authorized to
manufacture pursuant to § 1315.23; and
(2) Such other quantities of the
chemical as the applicant has applied
to procure and use and are consistent
with his past use, his estimated needs,
and the total quantity of the chemical
that will be produced.
(g) 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. The application must 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 the person if and to the
extent that he finds, after considering
the factors enumerated in paragraph (f)
of this section and any occurrences
since the issuance of the procurement
quota, that the need justifies an adjustment.
(h) Any person to whom a procurement quota has been issued, authorizing that person to procure and use a
quantity
of
ephedrine,
pseudoephedrine, or phenylpropanolamine during the current calendar year,
must, at or before the time of placing
an order with another manufacturer or
importer requiring the distribution of a
quantity of the chemical, certify in
writing to the other registrant that the
quantity
of
ephedrine,
pseudoephedrine, or phenylpropanolamine ordered does not exceed the person’s unused and available procurement quota of the chemical for the current calendar year. The written certification must be executed by a person

authorized to sign the registration application pursuant to § 1301.13 or
§ 1309.32(g) of this chapter or by a person granted power of attorney under
§ 1315.33 to sign the certifications. A
copy of such certification must be retained by the person procuring the
quantity
of
ephedrine,
pseudoephedrine, or phenylpropanolamine for two years from the date of the
certification. Registrants must 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.
(i) The certification required by paragraph (h) of this section must contain
all of the following:
(1) The date of the certification.
(2) The name and address of the registrant to whom the certification is directed.
(3) A reference to the purchase order
number to which the certification applies.
(4) The name of the person giving the
order to which the certification applies.
(5) The name of the chemical to
which the certification applies.
(6) A statement that the quantity
(expressed in grams) of the chemical to
which the certification applies does not
exceed the unused and available procurement quota of the chemical, issued
to the person giving the order, for the
current calendar year.
(7) The signature of the individual
authorized to sign a certification as
provided in paragraph (h) of this section.
[72 FR 37448, July 10, 2007, as amended at 73
FR 73555, Dec. 3, 2008; 75 FR 10684, Mar. 9,
2010]

§ 1315.33

Power of attorney.

(a) A registrant may authorize one or
more individuals, whether or not located at his registered location, to sign
certifications required under § 1315.32(h)
on the registrant’s behalf by executing
a power of attorney for each such individual. The registrant shall retain the
power of attorney in the files, with certifications required by § 1315.32(h), for
the same period as any certification
bearing the signature of the attorney.

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