DEA Regulations for Tablet Press and Capsule Filler Sales

New DEA Regulations Released

New DEA regulations governing the sale of tablet presses and capsule fillers will take effect March 31, 2017 (updated from January 30, 2017).

In accordance with Executive Order 13563, the Drug Enforcement Administration reviewed its import and export regulations as well as reporting requirements for domestic transactions in, among other things, tableting machines (commonly referred to as “tablet presses” or “pill presses”) and encapsulating machines (commonly referred to as “encapsulators” or “capsule fillers”).

The regulation changes clarify certain policies and reflect current procedures and technological advancements including the government-wide use of the International Trade Data Systems (ITDS).

Reporting and a New Form

The DEA regulations now mandate electronic reporting requirements for all regulated transactions involving tablet presses and capsule fillers including domestic, import and export transactions (CFR 1310.05(b)(2)).  The regulation requires mandatory, oral reporting of domestic transactions when the order is placed with the seller.  The regulations also now require electronic reporting using a new form, DEA Form 452, “Reports for Regulated Machines.”  This new form covers imports, exports, and domestic regulated transactions.

The new form will be accessed, completed, and submitted by regulated persons entirely through the DEA Diversion Control Division secure network application.  Upon receipt and review, the DEA will assign each completed report a transaction identification number.  The DEA Form 452 will not be deemed filed until the DEA issues a transaction identification number.  This allows the DEA to appropriately track and monitor the process, streamline the report filing process and eliminate duplicate filings with a local office and the import/export office.

Domestic Transactions

In the past, the DEA regulations indicated oral reporting, “whenever possible,” in advance of the transaction followed by a written report.  The new rule (CFR 1310.05(b)(2)) requires a mandatory oral report and electronic filing of the written report.  The oral report is now required when the order is placed and the electronic Form 452 is required to be filed within 15 calendar days after the order has been shipped by the seller.

Import/Export Transactions

For imports/exports, the same DEA Form 452 is required to be electronically submitted to the DEA through the DEA Diversion Control Division secure network application.  This can be submitted as far in advance as possible, but no less than 15 calendar days prior to the anticipated date of arrival at the port of entry or port of export.  The importer/exporter may not initiate an import or export transaction until the DEA issues a transaction identification number.  The form now includes a reason for importation, for example, commercial, medical, scientific, or other legitimate use of the machine.

Required Information

DEA regulations require the following information for regulated transactions regarding the sale of a tablet press or a capsule filler:

  1. The name/business name of the regulated person;
  2. The date of the regulated transaction;
  3. The name/business name, address and contact information (e.g. telephone numbers, email addresses, etc.) of the purchaser;
  4. A description of each machine – including make, model serial number (if any) and whether the machine is manual or electric, as well as the number of machines being received; and
  5. Any changes made by the regulated person in identifying information of the machines (e.g. name, brand, serial number, etc.).
  6. The method of transfer; and
  7. Identification of the purchaser and any unique number on that identification

Key Dates

The rules were scheduled to be effective January 30, 2017, but as stated above, the effective date has been delayed until March 31, 2017. Compliance with these new DEA regulations was originally June 28, 2017 and has been revised to July 31, 2017.

Code Citations

21 CFR 1310.03(a) – persons required to keep records and file reports
21 CFR 1310.05(b)(2) – domestic reporting
21 CFR 1310.05(c)(1) – import/export reporting
21 CFR 1310.06(a) – Content of records and reports
21 CFR 1310.06(e)(1) – import report requirements
21 CFR 1310.06(e)(2) – export report requirements
21 CFR 1310.06(f) – domestic report requirements

Additional Reading and Information

Federal Register Dec. 30, 2016 notice.

January 25th, 2017 Update to Federal Register Dec. notice.

United States Department of Justice, Drug Enforcement Administration, Diversion Control Division

FDAlawblog.com

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