Instructions for Completing 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
Diversion Control Division (DRE)
8701 Morrissette Drive
Springfield, VA 22152

The following instructions are for items which are not completely self-explanatory on the form.

Item 12(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 substances 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 14. Please provide the authority by which you may legally market the product under the Food, Drug and Cosmetic Act.

Privacy Act Information for DEA Form 250

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.