2016-28966: Revision of Import and Export Requirements for Controlled Substances, Listed Chemicals, and Tableting and Encapsulating Machines, Including Changes To Implement the International Trade Data System (ITDS); Revision of Reporting Requirements for Domestic Transactions in Listed Chemicals and Tableting and Encapsulating Machines; and Technical Amendments
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The Drug Enforcement Administration is 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, the Drug Enforcement Administration 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). 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.
The agency’s own summary, as published.
What this changes
Amends 14 parts of the Code of Federal Regulations — the standing rules this notice rewrites.
- 21 CFR 1300 Definitions
- 21 CFR 1301 Registration of Manufacturers, Distributors, and Dispensers of Controlled Substances
- 21 CFR 1302 Labeling and Packaging Requirements for Controlled Substances
- 21 CFR 1303 Quotas
- 21 CFR 1304 Records and Reports of Registrants
- 21 CFR 1308 Schedules of Controlled Substances
- 21 CFR 1309 Registration of Manufacturers, Distributors, Importers and Exporters of List I Chemicals
- 21 CFR 1310 Records and Reports of Listed Chemicals and Certain Machines; Importation and Exportation of Certain Machines
- 21 CFR 1312 Importation and Exportation of Controlled Substances
- 21 CFR 1313 Importation and Exportation of List I and List II Chemicals
- 21 CFR 1314 Retail Sale of Scheduled Listed Chemical Products
- 21 CFR 1315 Importation and Production Quotas for Ephedrine, Pseudoephedrine, and Phenylpropanolamine
- 21 CFR 1316 Administrative Functions, Practices, and Procedures
- 21 CFR 1321 DEA Mailing Addresses
Rulemaking docket
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