21 Cfr 1315.32

§ 1315.32

21 CFR Ch. II (4–1–18 Edition)

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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:
(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 UN Reporting & Quota Section, Diversion
Control Division, 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 UN Reporting & Quota Section, Diversion Control
Division, 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,

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Drug Enforcement Administration, Justice
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
§ 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.
The power of attorney must be available for inspection together with other
certification records.
(b) A registrant may revoke any
power of attorney at any time by executing a notice of revocation.
(c) The power of attorney and notice
of revocation must be similar to the
following format:
Power of Attorney for certifications
of quota for procurement of ephedrine,
pseudoephedrine, and phenylpropanolamine
llllll (Name of registrant)
llllll (Address of registrant)
llllll (DEA registration number)
I, llllll (name of person granting
power), the undersigned, who am authorized
to sign the current application for registration of the above-named registrant under the
Controlled Substances Act or Controlled
Substances Import and Export Act, have
made, constituted, and appointed, and by
these presents, do make, constitute, and appoint llllll (name of attorney-in-fact),
my true and lawful attorney for me in my
name, place, and stead, to sign certifications
of quota for procurement of ephedrine,
pseudoephedrine, and phenylpropanolamine
in accordance with Part 1315 of Title 21 of
the Code of Federal Regulations. I hereby
ratify and confirm all that said attorney
must lawfully do or cause to be done by virtue hereof.
llllllllllllllllllllllll
(Signature of person granting power)
I, llllll (name of attorney-in-fact),
hereby affirm that I am the person named
herein as attorney-in-fact and that the signature affixed hereto is my signature.
(Signature of attorney-in-fact)
Witnesses:
1. llllll
2. llllll
Signed and dated on the ll day of l,
(year), at llllll.

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