PART 1315--IMPORTATION AND PRODUCTION QUOTAS FOR EPHEDRINE, PSEUDOEPHEDRINE,
AND PHENYLPROPANOLAMINE - Subpart C--Individual Manufacturing Quotas
Sec. 1315.21 Individual manufacturing quotas.
The Administrator shall, on or before July 1 of each year, fix for and
issue to each person registered to manufacture in bulk ephedrine,
pseudoephedrine, or phenylpropanolamine who applies for a manufacturing quota
an individual manufacturing quota authorizing that person to manufacture
during the next calendar year a quantity of that chemical. Any manufacturing
quota fixed and issued by the Administrator is subject to his authority to
reduce or limit it at a later date pursuant to Sec. 1315.26 and to his
authority to revoke or suspend it at any time pursuant to Sec. Sec.
1301.36, 1309.43, 1309.44, or
1309.45 of this chapter.
Sec. 1315.22 Procedure for applying for individual manufacturing quotas.
Any person who is registered to manufacture ephedrine,
pseudoephedrine, or
phenylpropanolamine and who desires to manufacture a quantity of the chemical
must apply on DEA Form 189 for a manufacturing quota for the quantity of the
chemical. Copies of DEA Form 189 may be obtained from the Office of Diversion
Control Web site, and must be filed (on or before April 1 of the year
preceding the calendar year for which the manufacturing quota is being
applied) with the Drug & Chemical Evaluation Section, Drug Enforcement
Administration, Department of Justice, Washington, DC 20537. A separate
application must be made for each chemical desired to be manufactured. The
applicant must state the following:
(a) The name and DEA Chemical Code Number, as set forth in part 1310 of
this chapter, of the chemical.
(b) For the chemical 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 Sec. 1315.24;
and
(5) The actual or estimated inventory as of December 31.
(c) For the chemical in the next calendar year,
(1) The desired individual manufacturing quota; and
(2) Any additional factors that the applicant finds relevant to the fixing
of the individual manufacturing quota, including any of the following:
(i) The trend of (and recent changes in) the applicant's and the national
rates of net disposal.
(ii) The applicant's production cycle and current inventory position.
(iii) The economic and physical availability of raw materials for use in
manufacturing and for inventory purposes.
(iv) Yield and stability problems.
(v) Potential disruptions to production (including possible labor strikes).
(vi) Recent unforeseen emergencies such as floods and fires.
Sec. 1315.23 Procedure for fixing individual manufacturing quotas.
(a) In fixing individual manufacturing quotas for ephedrine,
pseudoephedrine, and phenylpropanolamine, the Administrator shall allocate to
each applicant who is currently manufacturing the chemical 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 Sec. 1315.24, and
(2) By any other factors which the Administrator deems relevant to the
fixing of the individual manufacturing quota of the applicant, including:
(i) The trend of (and recent changes in) the applicant's and the national
rates of net disposal,
(ii) The applicant's production cycle and current inventory position,
(iii) The economic and physical availability of raw materials for use in
manufacturing and for inventory purposes,
(iv) Yield and stability problems,
(v) Potential disruptions to production (including possible labor strikes),
and
(vi) Recent unforeseen emergencies such as floods and fires.
(b) In fixing individual manufacturing quotas for a chemical, the
Administrator shall allocate to each applicant who is not currently
manufacturing the chemical a quota equal to 100 percent of the reasonably
estimated net disposal of that applicant for the next calendar year, as
determined by the Administrator, adjusted--
(1) By the amount necessary to provide the applicant his estimated
inventory allowance for the next calendar year, pursuant to Sec. 1315.24; and
(2) By any other factors which the Administrator deems relevant to the
fixing of the individual manufacturing quota of the applicant, including any
of the following:
(i) The trend of (and recent changes in) the national rate of net disposal.
(ii) The applicant's production cycle and current inventory position.
(iii) The economic and physical availability of raw materials for use in
manufacturing and for inventory purposes.
(iv) Yield and stability problems.
(v) Potential disruptions to production (including possible labor strikes).
(vi) Recent unforeseen emergencies such as floods and fires.
(c) On or before March 1 of each year the Administrator shall adjust the
individual manufacturing quota allocated for that year to each applicant in
paragraph (a) of this section by the amount necessary to increase or reduce
the actual inventory of the applicant to December 31 of the preceding year to
his estimated inventory allowance for the current calendar year, pursuant to
Sec. 1315.24.
Sec. 1315.24 Inventory allowance.
(a) For the purpose of determining individual manufacturing quotas pursuant
to Sec. 1315.23, each registered manufacturer shall be allowed as a part of
the quota an amount sufficient to maintain an inventory equal to either of the
following:
(1) For current manufacturers, 50 percent of his average estimated net
disposal for the current calendar year and the last preceding calendar year;
or
(2) For new manufacturers, 50 percent of his reasonably estimated net
disposal for the next calendar year as determined by the Administrator.
(b) During each calendar year each registered manufacturer shall be allowed
to maintain an inventory of a chemical not exceeding 65 percent of his
estimated net disposal of that chemical for that year, as determined at the
time his quota for that year was determined. At any time the inventory of a
chemical held by a manufacturer exceeds 65 percent of his estimated net
disposal, his quota for that chemical is automatically suspended and shall
remain suspended until his inventory is less than 60 percent of his estimated
net disposal. The Administrator may, upon application and for good cause
shown, permit a manufacturer whose quota is, or is likely to be, suspended under this paragraph to continue
manufacturing and to accumulate an inventory in excess of 65 percent of his
estimated net disposal, upon such conditions and within such limitations as
the Administrator may find necessary or desirable.
(c) If, during a calendar year, a registrant has manufactured the entire
quantity of a chemical allocated to him under an individual manufacturing
quota, and his inventory of that chemical is less than 40 percent of his
estimated net disposal of that chemical for that year, the Administrator may,
upon application pursuant to Sec. 1315.25, increase the quota of such
registrant sufficiently to allow restoration of the inventory to 50 percent of
the estimated net disposal for that year.
Sec. 1315.25 Increase in individual manufacturing quotas.
(a) Any registrant who holds an individual manufacturing quota for a
chemical may file with the Administrator an application on DEA Form 189 for an
increase in the registrant's quota to meet the registrant's estimated net
disposal, inventory, and other requirements during the remainder of that
calendar year.
(b) The Administrator, in passing upon a registrant's application for an
increase in the individual manufacturing quota, shall take into consideration
any occurrences since the filing of the registrant's initial quota application
that may require an increased manufacturing rate by the registrant during the
balance of the calendar year. In passing upon the application the
Administrator may also take into consideration the amount, if any, by which
his determination of the total quantity for the chemical to be manufactured
under Sec. 1315.11 exceeds the aggregate of all the individual manufacturing
quotas for the chemical, and the equitable distribution of such excess among
other registrants.
Sec. 1315.26 Reduction in individual manufacturing quotas.
The Administrator may at any time reduce an individual manufacturing quota
for a chemical that he has previously fixed to prevent the aggregate of the
individual manufacturing quotas and import quotas outstanding or to be granted
from exceeding the assessment of annual needs that has been established for
that chemical pursuant to Sec. 1315.11, as adjusted pursuant to Sec.
1315.13.
If a quota assigned to a new manufacturer pursuant to Sec. 1315.23(b), or if a
quota assigned to any manufacturer is increased pursuant to Sec. 1315.24(c),
or if an import quota issued to an importer pursuant to Sec.
1315.34, causes
the total quantity of a chemical to be manufactured and imported during the
year to exceed the assessment of annual needs that has been established for
that chemical pursuant to Sec. 1315.11, as adjusted pursuant to Sec. 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 Sec. 1315.24(b) or Sec. Sec.
1301.36, 1309.43, 1309.44, or
1309.45 of this chapter or is abandoned pursuant to Sec.
1315.27.
Sec. 1315.27 Abandonment of quota.
Any manufacturer assigned an individual manufacturing quota for a chemical
pursuant to Sec. 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.
NOTICE: This is an
unofficial version. An official version of this publication may be obtained
directly from the Government Printing Office (GPO).