On Thursday, September 15, 2016 the Drug Enforcement Administration (DEA) published a proposed rule (81 FR 63575-63631) which would "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, gamma-hydroxybutyric acid (GBL), and tableting and encapsulating machines."
Some of the proposed regulatory changes include, but are not limited to, the following:
- Mandate the electronic submission (DEA Office of Diversion Control secure network application) of all applications and other required filings and reports associated with the import and export of tableting and encapsulating machines, controlled substances, and listed chemicals (except for transshipment data)
- Proposing that import and export regulatory expiration periods, filing deadlines, and other timed action dates are to be generally calculated as "calendar days" unless otherwise noted
- Paper form import and export permits would be eliminated in favor of making them available via digital means
- Cease allowing exporters to amend foreign permit information on permit applications and issued permits
- Mandatory electronic reporting of return information for controlled substances imported or exported under permit procedures and for listed chemicals imported or exported under declaration procedures
- Cease allowing importers and exporters to amend information related to the authorization to import or export from the foreign competent national authority
- Amend the language relating to waivers of the 15-day advance reporting requirement for importations by "regular importers" and export transactions between regulated persons and "regular customers" - a waiver of the entire 15-day period will no longer be feasible
- Mandatory electronic filing of notifications of international transactions involving listed chemicals which meet or exceed the threshold amount identified in 1310.04
- Requiring that in maintaining records concerning imports and exports, the registrant needs to record the date on which the items are released by a customs officer at the port of entry or port of export
- Reports of unusual or excessive loss or disappearance of a listed chemical are to be filed through the DEA Office of Diversion Control secure network application
- Deliveries made by an importer directly to a customer without passing through the registered location of the importer (i.e. drop shipments), are explicitly prohibited under the proposed revisions to 1312.19 (controlled substances) and 1313.14 (listed chemicals)
- Requiring listed chemical importers and exporters to include both the date a customs officer releases an imported item or releases an item for export and the date that the shipment arrived at the location of the importer or exporter; the actual quantities of product both when released by a customs officer and at the time of shipment from the exporter's location or arrival at the importer's location, and the actual port of entry or export
If your company is subject to the DEA requirements for Controlled Substances, Listed Chemicals, or Tableting and Encapsulating Machines a thorough review of the proposed changes is necessary to ensure your business is prepared. GCSG has extensive experience with DEA compliance and can be a resource for your business to understand and prepare for the proposed changes.
Contact us here for more information.