PART 1315--IMPORTATION AND PRODUCTION QUOTAS FOR EPHEDRINE, PSEUDOEPHEDRINE,
AND PHENYLPROPANOLAMINE - Subpart D--Procurement and Import Quotas
Sec. 1315.30 Procurement and import quotas.
(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:
(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.
Sec. 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 Sec. 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 & Chemical Evaluation Section, Drug
Enforcement Administration, Department of Justice, Washington, DC 20537.
(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 Sec.
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, Department of Justice, Washington, DC 20537. 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 Sec. 1301.13 or
Sec. 1309.32(g) of this chapter.
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.
Sec. 1315.34 Obtaining an import quota.
(a) Any person who is registered to import ephedrine,
pseudoephedrine, or phenylpropanolamine, or whose requirement of registration is waived pursuant
to Sec. 1309.24(c) of this chapter, and who desires to import during the next
calendar year any ephedrine, pseudoephedrine, or phenylpropanolamine or drug
products containing these chemicals, must apply on DEA Form 488 for an import
quota for the chemical. A separate application must be made for each chemical
desired to be imported.
(b) The applicant must provide the following information in the
application:
(1) The applicant's name and DEA registration number.
(2) The name and address of a contact person and contact information
(telephone number, fax number, e-mail address).
(3) Name of the chemical and DEA Chemical Code number.
(4) Type of product (bulk or finished dosage forms).
(5) For finished dosage forms, the official name, common or usual name,
chemical name, or brand name, NDC number, and the authority to market the drug
product under the Federal Food, Drug and Cosmetic Act of each form to be
imported.
(6) The amount requested expressed in terms of base.
(7) For the current and preceding two calendar years, expressed in terms of
base:
(i) Distribution/Sales--name, address, and registration number (if
applicable) of each customer and the amount sold.
(ii) Inventory as of December 31 (each form--bulk, in-process, finished
dosage form).
(iii) Acquisition--imports.
(c) For each form of the chemical (bulk or dosage unit), the applicant must
state the quantity desired for import during the next calendar year.
(d) DEA Form 488 must be filed on or before April 1 of the year preceding
the calendar year for which the import quota is being applied. Copies of DEA
Form 488 may be obtained from the Office of Diversion Control Web site, and
must be filed with the Drug & Chemical Evaluation Section, Drug
Enforcement Administration, Department of Justice, Washington, DC 20537.
(e) The Administrator may at his discretion request additional information
from an applicant.
(f) On or before July 1 of the year preceding the calendar year during
which the quota shall be effective, the Administrator shall issue to each
qualified applicant an import quota authorizing him to import:
(1) All quantities of the chemical necessary to manufacture products that
registered manufacturers are authorized to manufacture pursuant to Sec.
1315.23; and
(2) Such other quantities of the chemical that the applicant has applied to
import and that are consistent with his past imports, the estimated medical,
scientific, and industrial needs of the United States, the establishment and
maintenance of reserve stocks, and the total quantity of the chemical that
will be produced.
Sec. 1315.36 Amending an import quota.
(a) An import quota authorizes the registered importer to import up to the
set quantity of ephedrine, pseudoephedrine, or phenylpropanolamine and
distribute the chemical or drug products on the DEA Form 488. An importer must
apply to change the quantity to be imported.
(b) Any person to whom an import quota has been issued may at any time
request an increase in the quota quantity 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, Department of Justice, Washington, DC 20537. The Administrator
may increase the import quota of the person if and to the extent that he
determines that the approval is necessary to provide for medical, scientific,
or other legitimate purposes regarding the chemical. The Administrator shall
specify a period of time for which the approval is in effect or shall provide
that the approval is in effect until the Administrator notifies the applicant
in writing that the approval is terminated.
(c) With respect to the application under paragraph (b) of this section,
the Administrator shall approve or deny the application within 60 days of
receiving the application. If the Administrator does not approve or deny the
application within 60 days of receiving it, the application is deemed to be
approved and the approval remains in effect until the Administrator notifies
the applicant in writing that the approval is terminated.
NOTICE: This is an
unofficial version. An official version of this publication may be obtained
directly from the Government Printing Office (GPO).
