The Controlled Substances Act (CSA) aims to ensure supply of controlled substances for US Drug Enforcement Administration (DEA) registered firms undertaking legitimate medical research and manufacturing while preventing the diversion of such products into the illicit market.
And a final rule – published at the end of last year – looks to streamline the process of importing and exporting controlled drugs, chemicals and production equipment to comply with the President’s Executive Order 13659 of February 19, 2014 and maintain a closed system of distribution.
Among the updates, regulated buyers and sellers of pill presses and capsule fillers intended to be used with controlled substances must fill out the new online Form 452 after which the DEA will issue a transaction identification number.
Regulated persons must now orally report domestic transactions as soon as an order is placed, with the written Form 452 to be filed within 15 calendar days after the order has been shipped by the seller.
For imports and exports, the Form must be submitted to the DEA 15 calendar days before the anticipated date of arrival at the port of entry, and the deal cannot be initiated until the transaction identification number is issued.
- The tightening up of reporting requirements for any excessive loss or disappearance of listed chemicals. Another new form – Form 107 – is to be filled in “whether or not the listed chemical is subsequently recovered or the responsible parties are identified and action taken against them.”
- Applications for import/export permits, declarations and other reports must be submitted electronically through the International Trade Data System (ITDS) – described by the US government as a “single window” for exports and imports
- Drop shipments - imported shipments sent directly to the final customer - are prohibited, and instead controlled products and machinery must first be sent to the DEA registered location
The full document as published in the Federal Register is presented below: