On September 15, 2016, the Drug Enforcement Administration (DEA) published in the Federal Register a notice of proposed rulemaking [Docket No. DEA–403] to update 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, gammahydroxybutyric 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 proposed 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/ACE).
The proposal additionally contains amendments that would 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 proposal includes additional substantive and technical amendments.
Electronic comments must be submitted, and written comments must be postmarked, on or before October 17, 2016. Commenters should be aware that the electronic Federal Docket Management System will not accept comments after 11:59 p.m. Eastern Time on the last day of the comment period.