Quotas
> Quota Applications
> DEA Form 488 Instructions
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
Office of Diversion Control (ODE)
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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