The Drug Enforcement Administration has issued a final rule requiring the electronic submission through the Automated Commercial Environment of required data for the import and export of tableting and encapsulating machines, controlled substances, and listed chemicals. This rule is effective as of Jan. 30 but compliance is not required until 180 days after Dec. 30 (approximately June 30, 2017).
Previous DEA regulations required applications for permits, declarations, and other required notices and reports for these products to be filed in paper form (or by electronic means in some circumstances). The DEA is now authorizing electronic submission, and making this procedure mandatory over paper in most circumstances, as follows.
- DEA registrants or regulated persons applying for permits (DEA forms 161, 161R, 161R-EEA, and 357) or filing notifications or reports will apply or file directly with the DEA through the Diversion Control Division secure network application.
- DEA import/export declarations (forms 236, 486, and 486A) will be replaced with an electronic process. Upon receipt of a complete declaration through the DCD secure network application, the DEA will provide the importer or exporter with the notice of receipt that must then be filed as part of the U.S. Customs and Border Protection import or export filing through ACE. The DEA will also transmit the declaration information electronically to CBP so that customs officers can validate importations and exportations subject to DEA regulations.
- Regulated persons must submit reports of domestic regulated transactions in tableting machines and encapsulating machines through the DCD secure network application in addition to import and export regulated transactions.
Other changes made by this rule include the following.
- allowing for the expanded reexportation of controlled substances among members of the European Economic Area
- clearly specifying how and under what conditions controlled substance import and export permits and declarations may be amended or cancelled and when a new permit or declaration is required instead of an amendment
- specifying that import and export declarations for controlled substances expire 180 calendar days after the date they are deemed filed with the DEA
- allowing registrants and regulated persons to proceed with controlled substance import or export transactions as soon as the transaction identification number has been issued, regardless of whether 15 calendar days have elapsed since its issuance
- requiring each regulated person who seeks to import or export a listed chemical that meets or exceeds a threshold quantity to provide a declaration (by filing form 486/486A) no later than 15 calendar days before the date of release by a customs officer at the port of entry (or three business days for entities with regular customs and importer status)
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