Application for Procurement Quota for Ephedrine, Pseudoephedrine, and Phenylpropanolamine

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

250_instruct

Application for Procurement Quota for Ephedrine, Pseudoephedrine, and Phenylpropanolamine

OMB: 1117-0008

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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 (ODE)
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.

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 TitleInstructions for Form 250 - Application for Procurement Quota
SubjectInstructions for Form 250 - Application for Procurement Quota
AuthorDEA Office of Diversion Control
File Modified2007-12-13
File Created2007-12-13

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