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Import Restrictions on Controlled Substance Proposed for Removal

Friday, July 14, 2017
Sandler, Travis & Rosenberg Trade Report

The Drug Enforcement Administration is accepting comments through Aug. 11 on a proposed rule that would remove naldemedine and its salts from the schedules of the Controlled Substances Act. This would remove the regulatory controls and administrative, civil, and criminal sanctions applicable to controlled substances on persons who import, export, manufacture, distribute, reverse distribute, dispense, or conduct research or chemical analysis on this substance. Naldemedine is currently a schedule II controlled substance as a derivative of opium alkaloids and opiates but was recently approved by the Food and Drug Administration for treating opioid-induced constipation in adults with chronic non-cancer pain.

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