2. Tablet Press & Capsule Filling Machine Transaction Regulations (March 2019)

3. Information provided today regarding the topics and regulations to be presented appears on the DEA Diversion website ( under icons for those subjects.

4. History and processing
Definitions
Report submission
Common transaction data elements
Specific data elements for domestic,
import and export transactions
Proof of identity and records Maintenance
Contacts

5. HISTORY
EXECUTIVE ORDER 13659
2/19/2014

6. Purpose: to streamline the export/import process for America’s businesses and to require the government-wide utilization of the International Trade Data System (ITDS).
This will be the single window through which businesses will electronically transmit data required by participating agencies for the importation or exportation of cargo.

7. Businesses will transmit their import and export data to the Customs Border Patrol’s (CBP) Automated Commercial Environment system (ACE)
but
The ITDS excludes applications for permits, licenses or certifications

8. This executive order resulted in electronic filing versus paper for the importation and exportation of cargo and hence there was a need to develop new regulations to implement the order.

9. Because advance notification of the importation or exportation of tablet presses and encapsulating machines is required by DEA, this information must first be provided to DEA before being submitted to CBP.

10. Thus, regulated persons will continue to use the filing process that must be completed in advance of importation or exportation; however, the processes will be electronic rather than paper.

11. Consequently, DEA has developed and amended its regulations
Consequently, DEA has developed and amended its regulations. Even end users of the machines will be affected by the regulations when they sell or give away their current machines. They will become a distributor or exporter.

12. AS A RESULT - 1 From To Report items, no form a Form 452
Report on imp/exp day days before
Domestic shipment oral field office notice
field office notice plus a Form 452 later
to DEA headquarters

13. AS A RESULT - 2
U.S. port of entry and U.S. port of export have new definitions.
One must list a reason for an import shipment.
Importer and exporters will need a DEA Transaction ID number before shipment which they can provide to their broker.

14. Notification to DEA is not new (Title 21 CFR Part 1310.03).
Each regulated person who engages in a regulated transaction involving … a tableting machine or an encapsulating machine shall keep a record of the transaction … and file reports …

15. The new DEA Form 452 will be accessed, completed and submitted by regulated persons through the DEA Diversion website (

16. One would currently place the cursor on the Reporting icon on the website. Then click on Regulated Machines to obtain information on establishing an account or entering the transaction data to be described later for the Form Reference guides for entering the information also appear.

17. After the submission of the form to DEA, the submitter will receive a Web Tracking number. Upon review, DEA will assign each completed report a Transaction ID. One can provide a copy of the form with the Transaction ID to their broker to indicate it was filed with DEA. This ID acknowledges receipt by DEA and not an approval or disapproval of the shipment.

18. Although the Form 452 data must be submitted at least 15 calendar days before the anticipated arrival at the U.S. port of import or the U.S. port of export, one may proceed with the transaction as soon as the Transaction ID has been issued for a completed report. Importers and exporters, not brokers, are responsible for completion of Form 452.

19. REGULATIONS FOR REMAINING TOPICS Title 21 Code of Federal Regulations (CFR)*
Definitions (CFR Part )
Submission of reports (CFR Part )
Report contents (CFR Part )
Proof of identity (CFR Part )
Maintenance of records (CFR Part )
*On DEA Diversion website under RESOURCES

20. DEFINITION - 1
Tableting machine means any manual, semi-automatic, or fully automatic equipment which may be used for the compaction or molding of powdered or granular solids, or semi-solid material, to produce coherent solid tablets.

21. DEFINITION - 2
Encapsulating machine means any manual, semi-automatic, or fully automatic equipment which may be used to fill shells or capsules with any powdered, granular, semi-solid, or liquid material.

22. DEFINITION - 3
Regulated person means any individual, corporation, partnership, or other legal entity who manufactures, distributes, imports or exports … a tableting or encapsulating machine …

23. DEFINITION - 4
Regulated transaction means a … distribution, importation, or exportation of a tableting machine or an encapsulating machine ...

24. DEFINITION - 5 Port of entry (see CFR 1300.02):
Essentially, in the U.S. where duties
are collected

25. DEFINITION - 6 Port of export (see CFR: 1300.02): use first port
where the machines were actually loaded
(when one conveyance stops at several ports
before leaving the U.S.) or use last U.S. port
for the last conveyance (when items are off
loaded from one conveyance to another) or
place of mailing (when mailing a machine)

26. SUBMISSION OF REPORTS - 1
Domestic transactions - 1
21 CFR (b)(2) and (f)
Orally reported to the Special Agent in Charge of the DEA for Divisional Office the area in which the person making the report is located when the order is placed with the seller

27. SUBMISSION OF REPORTS - 2
Domestic transactions - 2
File the Form 452 transaction data on the DEA Diversion website ( within 15 calendar days after the order has been shipped by the seller.

28. SUBMISSION OF REPORTS - 3
Import/Export transactions: 21 CFR
(c), 21 CFR (e)(1) and (e)(2)
File the Form 452 transaction data on the DEA Diversion website ( at least 15 calendar days before anticipated arrival at the U.S. ports of entry or export.

29. TRANSACTION DATA ENTRY
After logging into the system, one
Selects the 452 icon
Selects request type: import, export or
domestic transfer
Selects submission type: create a new form,
query for a past form, create an
amendment, cancel or delete

30. COMMON DATA FIELDS - 1
Contact information: Regulated person (U.S importer, U.S. exporter or domestic supplier) with associated consignor or consignee and broker
Name/business name
Address/business address
Point of contact
address
Telephone number

31. COMMON DATA FIELDS - 2 Past transaction party names and addresses
appear to eliminate entering similar data
from a previous transaction.

32. COMMON DATA FIELDS - 3 Quantity of machines For each machine, provide
Machine type: indicate encapsulating or
tableting
Make (manufacturer)
Model name and indicate manual or electric
Serial number (if none, indicate none)

33. COMMON DATA FIELDS - 4
One can report more than one machine on a transaction. After adding data for one machine, one can select the + icon to modify the last machine data (such as only a change in serial numbers) versus repeating similar data.

34. COMMON DATA FIELDS - 5 Transaction dates:
Proposed date at U.S. port of entry or
Proposed date at U.S. port of export or
Date of shipment to domestic customer.

35. COMMON DATA FIELDS - 6
After entering all the transaction data, a review page appears to allow one to check
a box on certification of data accuracy. Select submit icon and a web tracking # appears. Select print and the Form 452 is displayed with this #. Select log out icon or main page icon for next transaction.

36. COMMON DATA FIELDS - 7
After entering all the data, one can access the system several days later and query by various parameters to determine if a Transaction ID has been assigned. If yes, one can print the Form 452 which will have the original web tracking number plus the Transaction ID.

37. DOMESTIC REPORT CONTENTS
The previous common data fields plus
listing any changes made in
identifying information on the machine
(e.g. name, brand, model, serial number,
etc. )

38. IMPORT REPORT CONTENTS - 1
The previous common data fields plus
Proposed port of entry
Usage: for medical, commercial,
scientific, etc.

39. IMPORT REPORT CONTENTS - 2
List proposed changes in identifying information on a machine (e.g., name, brand, model, serial number, if any) that will take place after importation.

40. DENIAL OF RELEASE BY CBP
If a shipment has been denied release, importer must file the standard import data along with the reason for denial within five business days of the denial.

41. EXPORT REPORT CONTENTS - 1
The previous common data fields plus
Port of export
Foreign port and country of entry

42. EXPORT REPORT CONTENTS - 2
Provide intermediate consignee data, if any:
Name/business name
Address/business address
Point of contact
address
Telephone number

43. PROOF OF IDENTITY
Search or obtain documents to identify the other domestic party
Verify the existence and validity of
the foreign entity

44. MAINTENANCE OF RECORDS - 1
Records retained for two years
Readily retrievable and available for
inspection by DEA

45. MAINTENANCE OF RECORDS - 2
For each party of the transaction, provide name, address and contact information
Date of transaction
Machine information (make, model serial number and manual or electric status)
Method of transfer
Type of ID used by purchaser and unique ID#

46. CONTACT - 1 (Federal Register Notices)
Go to
Select RESOURCES near the top of the page
Select Federal Register Notices
Select a year under Rules
Select a topic

47. CONTACT - 2 Internet Submission Websites
Currently, use the below addresses:
For the Form 452 data:
For questions:

48. CONTACT - 3 John Kronebusch Drug Enforcement Administration
Diversion Control Division
Springfield, VA 22152
Telephone:
Fax: