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From Health Law Daily, September 15, 2016

DEA to clarify and streamline import/export requirements

By Harold Bishop, J.D.

The Drug Enforcement Administration (DEA) is proposing to update its regulations for the import and export of tableting and encapsulating machines, controlled substances, and listed chemicals, and reports required for domestic transactions in listed chemicals, gamma-hydroxybutyric acid (a drug used in the medical setting as a general anesthetic, but also used illegally to enhance athletic performance and as a date rape drug), and tableting and encapsulating machines. The amendments would codify current practices and incorporate current procedures and technological advancements and allow for implementation of the President’s Executive Order 13659, on streamlining the export/import process and requiring government-wide utilization of the International Trade Data System (ITDS) (Proposed rule, 81 FR 63575, September 15, 2016).

Streamlining export/import process. Section 3 of Executive Order 13659, "Streamlining the Export/Import Process for America’s Businesses," directs participating agencies to have capabilities, agreements, and other requirements in place to allow electronic filing through ITDS and supporting systems of data and other relevant documents (exclusive of applications for permits, licenses, or certifications) required for imported and exported goods.

Current regulations inconsistent with ITDS use. Existing DEA regulations specifically require applications for permits, and declarations and other required notices and reports to be filed in paper form, or by electronic means in some circumstances. As a result, the DEA is proposing to amend its regulations in order to integrate DEA procedures related to the importation and exportation of tableting and encapsulating machines, controlled substances, and listed chemicals with the ITDS.

Application and filing changes. Because the ITDS excludes applications for permits, licenses, or certifications, the ITDS single window will not be used by DEA registrants, regulated persons, or brokers or traders applying for permits or filing import/export declarations, notifications or reports with the DEA. Under the proposal, the DEA import/export application and filing processes will continue to remain separate from (and in advance of) the ITDS single window. Entities will continue to use the DEA application and filing processes; however, the processes will be electronic rather than paper. After the DEA’s approval or notification of receipt as appropriate, the DEA will transmit the necessary information electronically to the ITDS and the registrant or regulated person so that customs officers can validate importations and exportations subject to DEA regulations.

Reporting changes. Because of the requirement that regulated persons submit reports of regulated transactions in tableting machines and encapsulating machines to the DEA, the DEA also proposes to require such domestic regulated transaction reports to be submitted through the DEA Office of Diversion Control secure network application, in addition to import and export regulated transactions. Mandatory reporting requirements for domestic regulated transactions are included as part of the proposal because it allows for the DEA to create an efficient, streamlined reporting structure of regulated activities applicable to tableting and encapsulating machines.

Reexportation of controlled substances in European Economic Area. The proposal contains amendments that would implement section 4, Re-exportation Among Members of the European Economic Area, of the Improving Regulatory Transparency for New Medical Therapies Act (P.L. 114–89), signed into law on November 25, 2015. Section 4 amended section 1003 of the Controlled Substances Import and Export Act (21 U.S.C. § 953) by making changes that allow for reexportation of controlled substances among members of the European Economic Area.

Additional changes. The proposal also includes technical and stylistic changes to several regulations to clarify and simplify the language and to further the goals of the President’s memorandum on Transparency and Open Government (74 FR 4685, January 26, 2009).

Comments on the Proposed rule should be submitted by October 17, 2016.

MainStory: TopStory ControlledNews DrugBiologicNews EnforcementNews ImportNews PrescriptionDrugNews

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