office of diversion control, regulatory section drug enforcement … · 2016-07-28 · drug...
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Drug Enforcement Administration Office of Diversion Control, Regulatory Section
Drug Enforcement Administration Way Overdue Pharmaceutical Training Seminar
April 2016
IMPORT/EXPORT UNIT
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Drug Enforcement Administration Office of Diversion Control, Regulatory Section
Drug Enforcement Administration
Per 21 CFR § 1312, DEA regulates the import, export, and transshipment
of controlled substances.
Per 21 CFR § 1313, DEA regulates the import, export, and transshipment
of listed chemicals.
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Drug Enforcement Administration Office of Diversion Control, Regulatory Section
Controlled Substances & List Chemicals
DEA-357 DEA-161 DEA Form-236 DEA Form-486
Imports Exports Imports Exports
Schedule I & II
Schedule III Narcotic
Schedule III Non-Narcotic (7369 requires a PERMIT)
Schedule IV Narcotic
Schedule IV Non-Narcotic
Schedule V Narcotic
Schedule V Non-Narcotic
List I & II Chemicals
Ephedrine, Pseudoephedrine, & Phenylpropanolamine
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Drug Enforcement Administration Office of Diversion Control, Regulatory Section
DEA-357 Form
Purpose: To import controlled substances in schedules I, II, III narcotic, IV narcotic, or V narcotic into the United States. To DEA: A completed DEA-357 From DEA: Import Permit Note: Imports of controlled substances in schedules I, II, and III narcotic are usually (a) Narcotic Raw Material; (2) controlled substances in schedules II and III narcotic not readily available in the U.S.; (c) for clinical trials or scientific purposes.
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Drug Enforcement Administration Office of Diversion Control, Regulatory Section
DEA-161 Form
Purpose: To export controlled substances in schedules I, II, III narcotic, or IV narcotic from the United States. To DEA: A completed DEA-161; A “readable” photocopy of import permit or letter of no objection From DEA: Export Permit Note: The affidavit is in lieu of the letter of “No Re-Exportation” and “medical, scientific, or other legitimate use” statement.
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Drug Enforcement Administration Office of Diversion Control, Regulatory Section
DEA-161R Form
Purpose: To export controlled substances in schedules I, II, III narcotic, or IV narcotic from the United States to a (1st) foreign country for subsequent re-export to other (2nd) foreign countries. To DEA: A completed DEA-161R; A “readable” photocopy of import permit or letter of no objection from 1st country From DEA: Export Permit Note: The affidavit is in lieu of additional documentation; This form is for re-exports only … do NOT use this form for re-exports that are not going to happen!
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Drug Enforcement Administration Office of Diversion Control, Regulatory Section
DEA-236 Form (Imports)
Purpose: To import non-narcotic controlled substances in schedules III, IV, or V into the United States from a foreign country. To DEA: A DEA-236 at least 15 days prior to the import entering a U.S. port From DEA: The Transaction ID
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Drug Enforcement Administration Office of Diversion Control, Regulatory Section
DEA-236 Form (Exports)
Purpose: To export non-narcotic controlled substances in schedules III or IV, or any controlled substances in schedule V from the United States to a foreign country. To DEA: A DEA-236 at least 15 days prior to the export departing a U.S. port; A “readable” photocopy of import permit or letter of no objection; The letter of no re-exportation & statement of medical, scientific, or other legitimate use From DEA: The Transaction ID
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Drug Enforcement Administration Office of Diversion Control, Regulatory Section
DEA-486 Form (Imports)
Purpose: To import listed chemicals into the United States from a foreign country. To DEA: A DEA-486 with your Transferees at least 15 days prior to the import entering a U.S. port From DEA: The Transaction ID Note: Do not use the DEA-486 form to import Ephedrine, Pseudoephedrine, or Phenylpropanolamine into the United States; The 15 days can be waived if you are a regular importer of the listed chemical.
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Drug Enforcement Administration Office of Diversion Control, Regulatory Section
DEA-486 Form (Exports)
Purpose: To export listed chemicals from the United States to a foreign country. To DEA: A DEA-486 at least 15 days prior to the export departing a U.S. port From DEA: The Transaction ID Note: The 15 days can be waived if you have regular customer status with your customer provided that you have shipped to your customer’s address at least 1 time during the prior 6 months or 2 or more times during the prior 12 months.
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Drug Enforcement Administration Office of Diversion Control, Regulatory Section
DEA-486A Form (Imports)
Purpose: To import Ephedrine, Pseudoephedrine, or Phenylpropanolamine into the United States from a foreign country. To DEA: A DEA-486A with your Transferees at least 15 days prior to the import entering a U.S. port From DEA: The Transaction ID Note: The 15 days is not waived even if you are a regular importer of these listed chemicals.
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Drug Enforcement Administration Office of Diversion Control, Regulatory Section
PITA Issues
• Foreign Entities (name & address) • Substance (trade name vs. controlled substance) • Base Weight (do the math!, include the C.F.) • Ports (first port into/last port from a country) • Return Information (missing in action) • Name & Contact # (signature + print your name)
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Drug Enforcement Administration Office of Diversion Control, Regulatory Section
PITA Issues
• Reference Number (DEA-236 & DEA-486) • Cancel vs. Delete (there is a difference) • National Drug Code (Go Blue!) • Air Waybills (PDFs only) • Estimates & Assessments (check INBC website) • Derivatives and weird substances (ODE not ODG)
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Drug Enforcement Administration Office of Diversion Control, Regulatory Section
INCB Estimates
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Drug Enforcement Administration Office of Diversion Control, Regulatory Section
INCB Assessments
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Drug Enforcement Administration Office of Diversion Control, Regulatory Section
Derivatives and Weird Substances
ODGI will no longer obtain a Controlled Substance Status Determination on behalf of registrants.
Registrants must obtain these from the Drug & Chemical Evaluation Section (ODE)
To DEA: Letter and chemical structure to [email protected] requesting DEA drug code and conversion factor
From DEA: Controlled Substance Status Determination
Submit this status with your DEA-357, DEA-161, or DEA-236.
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Drug Enforcement Administration Office of Diversion Control, Regulatory Section
Alphabet Bouillabaisse … What?!?!
DEA . . . CATAIR . . . AESTIR . . . CBP
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Drug Enforcement Administration Office of Diversion Control, Regulatory Section
ACE Message Set For Imports
1 2 3 4 5 6 7 8 9
10 1 2 3 4 5 6 7 8 9
20 1 2 3 4 5 6 7 8 9
30 1 2 3 4 5 6 7 8 9
40 1 2 3 4 5 6 7 8 9
50 1 2 3 4 5 6 7 8 9
60 1 2 3 4 5 6 7 8 9
70 1 2 3 4 5 6 7 8 9
80
O IP G 0 1 0 0 1 D E A D E A Y YP G 0 2 PP G 0 2 C C S A 8 1 1 2P G 0 4 0 0 0 0 0 0 9 7 8 0 9 6 GP G 0 2 C C S A 8 1 1 2P G 0 4 0 0 0 0 0 0 3 9 1 1 4 0 GP G 0 6 C S H I NP G 1 4 1 Y 2 7 T F G 7P G 1 9 L A P 1 6 4 R D 0 4 4 5 3 5 5P G 2 2 D E A 0 4P G 3 0 A 1 0 1 7 2 0 1 5
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Drug Enforcement Administration Office of Diversion Control, Regulatory Section
AESTIR (Appendix Q) for Exports
DEA form information necessary for Customs & Border Protection (CBP) for U.S. exports
of controlled substances and listed chemicals:
DEA Permit or Transaction Number Transaction Type (E)
DEA Registration or Company ID Number DEA Drug Code*
Quantity* (Base Weight) Unit of Measure* (KG,G,MG,MCG)
* Multiple occurring
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Drug Enforcement Administration Office of Diversion Control, Regulatory Section
Drug Enforcement Administration
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Drug Enforcement Administration Office of Diversion Control, Regulatory Section
Drug Enforcement Administration
Questions?
concerning this material and material not covered