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.

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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