Form DEA-250 Application For Procurement Quota for Controlled Substan

Application for Procurement Quota for Controlled Substances and Ephedrine, Pseudoephedrine, and Phenylpropanolamine

DEA_Form_250

Application for Procurement Quota for Controlled Substances

OMB: 1117-0008

Document [pdf]
Download: pdf | pdf
APPLICATION FOR PROCUREMENT QUOTA
FOR CONTROLLED SUBSTANCE

U. S. Department of Justice
Drug Enforcement Administration

No procurement quota may be issued unless a completed application form
OMB APPROVAL
SEE INSTRUCTIONS
has been received, 21 CFR 1303.12(b).
ON REVERSE SIDE
No. 1117 - 0008
1. NAME OF BASIC CLASS DESIRED (Only one basic class per DEA-250)
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

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.
QUOTA HISTORY

11.

2nd PRECEDING YEAR

1st PRECEDING YEAR

Grams

Grams

2nd PRECEDING
YEAR

PRODUCTION DATA

1st PRECEDING
YEAR

CURRENT YEAR

QUOTA REQUESTED

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. IF THE PURPOSE IS TO MANUFACTURE THE BASIC CLASS INTO DOSAGE FORMS, FURNISH THE FOLLOWING INFORMATION:
AMOUNT USED FOR THIS PURPOSE
NAME OF DOSAGE FORM

SIGNATURE OF APPLICANT

DEA Form
(Feb. 1999)

- 250

SCHEDULE

2nd PRECEDING YEAR

1st PRECEDING YEAR

ESTIMATE FOR
CURRENT YEAR

PRINT or TYPE NAME and TITLE of SIGNER

All previous editions are Obsolete.

ESTIMATE FOR
YEAR FOR WHICH
QUOTA IS REQUESTED

DATE

INSTRUCTIONS FOR COMPLETING THE DEA FORM 250:
Application For Procurement Quota

The DEA-250 must be filed on or before April 1 of the year preceding the calendar year for
which the procurement 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 instruction is for that item which is 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).

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 1
hour 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. 1117-0008, Washington, D.C. 20503


File Typeapplication/pdf
File TitleDEA Form 250
SubjectApplication For Procurement Quota For Controlled Substance
AuthorITS Services, Inc.
File Modified2000-11-29
File Created2000-11-20

© 2024 OMB.report | Privacy Policy