Form DEA 488 DEA 488 Application for Import Quota for Ephedrine, Pseudoephedr

U.S. Department of Justice
Drug Enforcement Administration
SEE INSTRUCTIONS ON
SEPARATE PAGE

APPLICATION FOR IMPORT QUOTA FOR

EPHEDRINE, PSEUDOEPHEDRINE, AND PHENYLPROPANOLAMINE

No import quota may be issued unless a completed application form has been received.
21 CFR 1315.34

OMB Approval
No. 1117-0047

1. NAME OF LIST I CHEMICAL (Only one per DEA- 488)

2. DEA CHEMICAL CODE
NO:

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

4. YEAR FOR WHICH
QUOTA IS REQUESTED

5. DEA IMPORT REGISTRATION NO.

6. TYPE OF PRODUCT (only one per DEA 488)

7. NAME OF CONTACT PERSON

† Bulk API or Finished Dosage Forms in Bulk
† Finished product for distribution only
8. TELEPHONE No. (Include ext, if applicable)

9. FAX NO:

10. E-MAIL ADDRESS:

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

11. QUOTA HISTORY

2nd PRECEDING YEAR
(

1st PRECEDING YEAR

)

(

______________ Grams

)

(

______________ Grams

2ND PRECEDING YEAR

12. PRODUCTION DATA

QUOTA REQUESTED

CURRENT YEAR

1ST PRECEDING YEAR

(

)

)

______________ Grams

_________________ Grams

ESTIMATE
FOR CURRENT YEAR

ESTIMATE FOR YEAR
FOR WHICH
QUOTA IS REQUESTED

I. INVENTORY AS OF DEC. 31
a. Bulk List I Chemical . . . . . . . . . . . . . . . .
b. In-process material . . . . . . . . . . . . . . . .
c. Contained in FINISHED Dosage Forms

0

TOTAL (a + b + c) . . . . . . . . . . . . .

0

0

0
(Complete Worksheet A
for Quota Requested)

II. DISPOSITION (SALE ) / UTILIZATION
(Complete Worksheet A for Quota Requested)
a. Domestic . . . . . . . . . . . . . . . . . . . . . . . .
b. Exports . . . . . . . . . . . . . . . . . . . . . . . . .
TOTAL (a + b) . . . . . . . . . . . . . . . .

0

0

0

0

0

0

0

0

III. ACQUISITION / PRODUCTION
a. Domestic Sources . . . . . . . . . . . . . . . . .
b. Importation . . . . . . . . . . . . . . . . . . . . . . .
TOTAL (a + b) . . . . . . . . . . . . . . .

13. IF THE PURPOSE IS TO MANUFACTURE ANOTHER SUBSTANCES(S), FURNISH THE FOLLOWING INFORMATION:

NAME OF NEW SUBSTANCE

AMOUNT USED FOR THIS PURPOSE

DEA
CHEMICAL
CODE
NUMBER

2ND PRECEDING YEAR

1ST PRECEDING YEAR

% YIELD
(Historical)

CURRENT YEAR

14. IF THE PURPOSE IS TO MANUFACTURE THE LIST I CHEMCIALS INTO DOSAGE FORMS, FURNISH THE FOLOWING INFORMATION:
NAME OF DOSAGE FORM
(include product form, i.e. tablets, patches,
etc. and strengths)

SIGNATURE OF APPLICANT
DEA FORM 488

AUTHORITY
TO MARKET
THIS
PRODUCT

AMOUNT USED FOR THIS PURPOSE
ND

2

PRECEDING YEAR

1ST PRECEDING YEAR

PRINT or TYPE NAME and TITLE OF SIGNER

(3/31/2019)

RESET FORM

PRINT FORM

ESTIMATE FOR
CURRENT YEAR

ESTIMATE FOR
YEAR FOR WHICH
QUOTA IS REQUESTED

DATE