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Reports for Regulated Machines - DEA Form 452
Home
Reporting
Reports for Regulated Machines - DEA Form 452
Regulated Machines (Tableting and Encapsulating)
The Import/Export Section administers and monitors DEA's Import and
Export program for controlled substances, chemicals, and transactions of
regulated machines. Regulated transactions include domestic distribution,
importation, or exportation of a tableting machine or encapsulating
machine. Regulated machines include tableting and encapsulating machines
ranging from manual, semi-automatic, and fully automatic equipment.
Letter from DEA Administrator Anne Milgram: E-Comerce Platforms Selling
Pill Press Machines
Transactions of Regulated Machines Online
Regulated Machines Online
DEA Form 452 - Import, Export, or Domestic Transactions of Tableting and
Encapsulating Machines
Statutes and Regulations
Please see Title 21, Chapter 13, of the United States Code and Title 21,
Parts 1300 to 1321, of the Code of Federal Regulations for the applicable
statutes and regulations, some of which have been excerpted below:
Regulated person: Regulated person means any individual, corporation,
partnership, association, or other legal entity who manufactures,
distributes, imports, or exports a listed chemical, a tableting machine, or
an encapsulating machine, or who acts as a broker or trader for an
international transaction involving a listed chemical, tableting machine,
or encapsulating machine. (21 U.S.C. § 802(38); 21 C.F.R. § 1300.02)
Regulated transaction: Regulated transaction means a distribution,
importation, or exportation of a tableting machine or encapsulating machine
except that such term does not include a domestic lawful distribution in
the usual course of business between agents and employees of a single
regulated person; in this context, agents or employees means individuals
under the direct management and control of the regulated person. (21 U.S.C.
§ 802(39)(B); 21 C.F.R. § 1300.02)
Tableting machine: 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 C.F.R. § 1300.02)
Encapsulating machine: 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. (21 C.F.R. § 1300.02)
Reporting Requirements:
Each regulated person who engages in a regulated transaction involving a
listed chemical, a tableting machine, or an encapsulating machine shall
keep a record of the transaction as specified by § 1310.04 and file
reports as specified by § 1310.05. (21 C.F.R. § 1310.03(a))
Record of regulated transactions (21 U.S.C. § 830(a)):
Each regulated person who engages in a regulated transaction involving a
listed chemical, a tableting machine, or an encapsulating machine shall
keep a record of the transaction for two years after the date of the
transaction. (21 U.S.C. § 830(a); 21 C.F.R. § 1310.04(a))
A record under this subsection shall be retrievable and shall include the
date of the regulated transaction, the identity of each party to the
regulated transaction, a statement of the quantity and form of the listed
chemical, a description of the tableting machine or encapsulating machine,
and a description of the method of transfer. Such record shall be available
for inspection and copying by the Attorney General. (21 U.S.C. § 830(a))
It is the duty of each regulated person who engages in a regulated
transaction to identify each other party to the transaction. It is the duty
of such other party to present proof of identity to the regulated person.
The Attorney General shall specify by regulation the types of documents and
other evidence that constitute proof of identity for purposes of this
paragraph. (21 U.S.C. § 830(a))
A record under this section shall be kept at the regulated person's place
of business where the transaction occurred, except that records may be kept
at a single, central location of the regulated person if the regulated
person has notified the Administration of the intention to do so. Written
notification must be submitted by registered or certified mail, return
receipt requested, to the Special Agent in Charge of the DEA Divisional
Office for the area in which the records are required to be kept. (21
C.F.R. § 1310.04(c))
The records required to be kept under this section shall be readily
retrievable and available for inspection and copying by authorized
employees of the Administration under the provisions of 21 U.S.C. 880. (21
C.F.R. § 1310.04(d))
Reports:
Each regulated person shall report to the Attorney General, in such form
and manner as the Attorney General shall prescribe by regulation-any
regulated transaction in a tableting machine or an encapsulating machine.
(21 U.S.C. § 830(b))
Domestic regulated transaction: Each regulated person must orally report
any domestic regulated transaction in a tableting machine or an
encapsulating machine to the Special Agent in Charge of the DEA Divisional
Office for the area in which the regulated person making the report is
located when the order is placed with the seller. The regulated person also
must file a report of the transaction (on DEA Form 452) with the
Administration through the DEA Diversion Control Division secure network
application within 15 calendar days after the order has been shipped by the
seller. A report (DEA Form 452) may list more than one machine for a single
transaction. Upon receipt and review, the Administration will assign a
completed report a transaction identification number. The report will not
be deemed filed until a transaction identification number has been issued
by the Administration. (21 C.F.R. § 1310.05(b)(2))
Imports and exports of tableting machines and encapsulating machines: Each
regulated person who imports or exports a tableting machine, or
encapsulating machine, must file a report of such importation or
exportation on DEA Form 452 with the Administration through the DEA
Diversion Control Division secure network application, at least 15 calendar
days before the anticipated arrival at the port of entry or port of export.
In order to facilitate the importation or exportation of any tableting
machine or encapsulating machine and implement the purpose of the Act,
regulated persons may report to the Administration as far in advance as
possible. A separate report (DEA Form 452) must be filed for each shipment,
in accordance with § 1310.06(e). Upon receipt and review, the
Administration will assign a completed report a transaction identification
number. The report will not be deemed filed until a transaction
identification number has been issued by the Administration. The importer
or exporter may only proceed with the transaction once the transaction
identification number has been issued. Any tableting machine or
encapsulating machine may be imported or exported if that machine is needed
for medical, commercial, scientific, or other legitimate uses. However, an
importation or exportation of a tableting machine or encapsulating machine
may not be completed with a person whose description or identifying
characteristic has previously been furnished to the regulated person by the
Administration unless the transaction is approved by the Administration.
(21 C.F.R. § 1310.05(c)(1))
Denied release at the port of entry: In the event that a shipment of
tableting or encapsulating machine(s) has been denied release by a customs
officer at the port of entry for any reason, the importer who attempted to
import the shipment must, within 5 business days of the denial, report to
the Administration that the shipment was denied, the basis for denial, and
such other information as is required by § 1310.06(g). Such report must be
transmitted to the Administration through the DEA Diversion Control
Division secure network application. Upon the importer's report of a denied
entry, DEA will assign the report a transaction identification number and
the original import notification will be void and of no effect. No shipment
of tableting machines or encapsulating machines denied entry for any reason
will be allowed entry without a subsequent refiling of an amended DEA Form
452 by the regulated person. In such circumstances, the regulated person
may proceed with the release of the tableting machines or encapsulating
machines upon receipt of a transaction identification number for the
refiled and amended DEA Form 452 without regard to the 15-day advance
filing requirement in paragraph (c)(1) of this section, so long as the
article is otherwise cleared for entry under U.S. customs laws. (21 C.F.R.
§ 1310.05(c)(2))
Content of records and reports: 21 C.F.R. § 1310.06.
Proof of identity: 21 C.F.R. § 1310.07.
Submit a report using the DEA Form 452 Online
In order to submit a report for an import, export, or domestic transaction
of a regulated machine using the DEA Form 452, you must first set up an
account through DEA's secure network system. Once an account has been set
up, you may begin electronically submitting transactions through the secure
network application. Reference guides are provided below:
Registering/Creating a Company User Account (PDF)
Completing a DEA Form 452 for Import (PDF)
Completing a DEA Form 452 for Export (PDF)
Completing a DEA Form 452 for Domestic Transfer (PDF)
Contact:
For assistance, please contact the Import/Export Section via email at:
Tablet-EncapsuleMachine@dea.gov
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