On December 30, 2016, the Drug Enforcement Administration (DEA) published in the Federal Register a final rule [Docket No. DEA–403] updating its regulations for the import and export of tableting and encapsulating machines, controlled substances, and listed chemicals, and its regulations relating to reports required for domestic transactions in listed chemicals, gamma-hydroxybutyric acid, and tableting and encapsulating machines. In accordance with Executive Order 13563, DEA has reviewed its import and export regulations and reporting requirements for domestic transactions in listed chemicals (and gamma-hydroxybutyric acid) and tableting and encapsulating machines, and evaluated them for clarity, consistency, continued accuracy, and effectiveness. The amendments clarify certain policies and reflect current procedures and technological advancements.
The amendments also allow for the implementation, as applicable to tableting and encapsulating machines, controlled substances, and listed chemicals, of the President’s Executive Order 13659 on streamlining the export/import process and requiring the government-wide utilization of the International Trade Data System (ITDS). Within the ITDS, businesses are able to transmit their import and export data using through an Electronic Data Interchange (EDI), an electronic communication framework providing standards for exchanging data via any electronic means. U.S. Customs and Border Protection (CBP) has identified the Automated Commercial Environment (ACE), and any successor system to ACE, to serve as an authorized EDI for purposes of import and export data required by CBP and participating agencies. This rule additionally contains amendments that implement recent changes to the Controlled Substances Import and Export Act (CSIEA) for reexportation of controlled substances among members of the European Economic Area made by the Improving Regulatory Transparency for New Medical Therapies Act. The rule also includes additional substantive and technical and stylistic amendments.
A pilot program that commenced on August 1, 2016 to test the use of electronic transmission through CBP’s ACE system, of data, forms and documents required by the DEA using the Partner Government Agency (PGA) Message Set and the Document Image System (DIS) was successful and, as a result, will be ended when the final rule becomes effective. At that time, all importers, exporters, and brokers will be able to use ACE to electronically file required data and documentation associated with the importation and exportation of controlled substances and listed chemicals.
The final rule is effective January 30, 2017. However, compliance with the revisions to DEA regulations made by this rule is not required until June 28, 2017.