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Title: | Diversion Control Division | DEA Form 488 |
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Keywords: | Diversion Control Division |
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Body: | DEA.Registration.Help@dea.gov
1.800.882.9539
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DEA Form 488
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Reporting
DEA Form 488
Instructions for Completing DEA Form 488: Application for Import Quota for
Ephedrine, Pseudoephedrine, Phenylpropanolamine
The DEA-488 must be filed on or before April 1 of the year preceding the
calendar year for which the import quota is being applied. Regulations
governing quotas are included in Title 21, Code of Federal Regulations,
Part 1315. 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
Diversion Control Division (DRE)
8701 Morrissette Drive
Springfield, VA 22152
The following instructions are for those items which are not completely
self-explanatory:
Item 11. Under the "current year" heading, write the year in which the
application is being submitted, and write the 1st and 2nd preceding year to
the "current year" under the corresponding headings. Under the "quota
requested" heading write the year for which the quota is being requested,
the year entered in item 4.
Item 12(I). For each of the corresponding years enter the known or
estimated inventory in grams of anhydrous acid, base, or alkaloid as of
December 31 of that year. The inventory should be separated into the
following subcategories: bulk material, in-process material, and contained
in finished dosage forms.
Item 12(II). Worksheet A should only be completed for domestic sales and/or
utilization for the year for which the import quota is being requested. For
the domestic and export disposition (sales)/utilization, subcategories (a)
and (b), respectively, the information should be entered for the 1st and
2nd preceding years, current year and year quota requested categories.
Item 13. Enter any new substances, controlled substances or List I
chemicals, which would be manufactured from the List I chemical for which
the quota application is being submitted. Also include the yield of the
reaction or synthesis of the new substance.
Item 14. List each dosage form in which the requested List I chemical will
be manufactured, packaged, or labeled. Include the strengths of the
manufactured dosage forms. Enter the amount of the List I chemical used or
estimated to be used for the manufacture of each dosage form for each year.
Provide the authority by which you may legally market the product under the
Federal, Food, Drug & Cosmetic Act.
Privacy Act Information
Authority: Section 1002 of the Controlled Substances Import and Export Act.
Purpose: Control importation of ephedrine, pseudoephedrine,
phenylpropanolamine, into the United States.
Routine Uses: The Import/Export Declaration produces information required
for law enforcement purposes. Disclosures of information from this system
are made to the following categories of users for the purposes stated.
A. Other Federal law enforcement and regulatory agencies for law
enforcement and regulatory purposes.
B. State and local law enforcement and regulatory agencies for law
enforcement and regulatory purposes.
C. Persons registered under the Controlled Substances Act (P.L. 91-513) for
the purpose of verifying the registration of customers.
Effect: Failure to complete this form will preclude the import of the
chemicals mentioned.
Under the Paperwork Reduction Act, a person is not required to respond to a
collection of information unless it displays a current valid OMB control
number. Public reporting burden for this collection of information is
estimated to average 1 hour, 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 the Office of Management and Budget, Paperwork Reduction
Project No. 1117-0047, Washington, D.C.
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FOIA
DIVERSION CONTROL DIVISION
U.S. Department of Justice
Drug Enforcement Administration
DIVERSION CONTROL DIVISION
8701 Morrissette Drive
Springfield, VA 22152
1.800.882.9539
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