Form DEA-189 Application for Individual manufacturing Quota for a Bas

APPLICATION FOR INDIVIDUAL MANUFACTURING QUOTA
FOR A BASIC CLASS OF CONTROLLED SUBSTANCE

U. S. Department of Justice
Drug Enforcement Administration

No individual manufacturing quota may be issued unless a completed
SEE INSTRUCTIONS
application form has been received, 21 CFR 1303.22.
ON REVERSE SIDE
1. NAME OF BASIC CLASS DESIRED (Only one basic class per DEA-189)
2. SCHEDULE NUMBER

3. DEA DRUG CODE NUMBER

4. NAME AND ADDRESS OF REGISTRANT (Include No., Street, City, State and ZIP Code)

5. YEAR FOR WHICH QUOTA IS REQUESTED

OMB APPROVAL
No. 1117 - 0006

6. DEA REGISTRATION NUMBER

7. NAME OF CONTACT PERSON

8. TELEPHONE NO. (Include ext., if applicable)

9. FAX NUMBER

NOTE: All quantities are to be expressed in grams of anhydrous acid, base or alkaloid (not as salts).
QUOTAS PREVIOUSLY ISSUED BY DEA

10.

2nd PRECEDING YEAR

1st PRECEDING YEAR

Grams

Grams

QUOTA REQUESTED

CURRENT YEAR

QUOTA HISTORY

11.

2nd PRECEDING
YEAR

PRODUCTION DATA

1st PRECEDING
YEAR

Grams

ESTIMATE
FOR CURRENT
YEAR

Grams

ESTIMATE FOR
YEAR FOR WHICH
QUOTA IS REQUESTED

I. INVENTORY AS OF DEC. 31
a. Bulk controlled substance .........................
b. In-process material
..........................
c. Contained in FINISHED Dosage Forms ......
TOTAL (a + b + c)

..........................

II. DISPOSITION / UTILIZATION
a. Domestic
..................................................
b. Exports
...................................................
TOTAL (a + b) ........................................
III. ACQUISITION / PRODUCTION
a. Domestic Sources ........................................
b. Importation
.........................................
TOTAL (a + b)
.......................................
12. IF THE PURPOSE IS TO MANUFACTURE ANOTHER SUBSTANCE (S), FURNISH THE FOLLOWING INFORMATION:
NAME OF
NEW
SUBSTANCE

DEA
DRUG CODE
NUMBER

AMOUNT USED FOR THIS PURPOSE
2nd PRECEDING YEAR

1st PRECEDING YEAR

% YIELD
(Historical)

CURRENT YEAR

13. REMARKS

SIGNATURE OF APPLICANT

DEA Form
(Feb. 1999)

- 189

PRINT or TYPE NAME and TITLE of SIGNER

All previous editions are Obsolete.

DATE

INSTRUCTIONS FOR COMPLETING THE DEA FORM 189:
Application For Individual Manufacturing Quota

The DEA-189 must be filed on or before May 1 of the year preceding the calendar year for
which the manufacturing quota is being applied. Regulations governing quotas are
included in Title 21, Code of Federal Regulations, Part 1300 to end. Copies of these
regulations may be ordered from: The Government Printing Office, Superintendent of
Documents, Attn: New Orders, P.O. Box 371954, Pittsburgh, PA 15250-7954. Submit the
completed form to:
Drug Enforcement Administration
Office of Diversion Control
Drug & Chemical Evaluation Section (ODE)
Washington, D.C. 20537

The following instructions are for those items which are not completely self-explanatory.
Item 11(I). This is to include all factory and branch stocks which have reached that point in
manufacturing as to be identifiable, whether in bulk form, in the process of
manufacture, in finished form, or otherwise (e.g., damaged, defective, or impure
substances awaiting disposal, substances held in quarantine, or substances
maintained for extemporaneous compounding), as a basic class of controlled
substance manufactured or otherwise acquired by a registrant, whether in bulk,
commercial containers, or contained in pharmaceutical preparations in the
possession of the registrant (including stocks held by the registrant under
separate registration as a manufacturer, importer, exporter or distributor).
Item 13.

Enter any additional factors which may be relevant to the establishment of a
manufacturing quota including the trend of and recent changes in the individual
companies and the national rates of net disposal, production cycles and current
inventory position, 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 or fires.

Under the Paperwork Reduction Act, a person is not required to respond to a collection of information unless it displays
a currently valid OMB control number. Public reporting burden for this collection of information is estimated to average
30 minutes per response, including the time for reviewing instructions, searching existing data sources, gathering and
maintaining the data needed, and completing and reviewing the collection of information. Send comments regarding
this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden,
to the FOI and Records Management Section, Drug Enforcement Administration, Washington, D.C. 20537; and to the
Office of Management and Budget, Paperwork Reduction Project No. 1117-0006, Washington, D.C. 20503