Regulatory update — DEA proposes registration fee increases for Diversion Control Program

On July 6, the U.S. Drug Enforcement Administration published a notice of proposed rulemaking in the Federal Register to adjust the fee schedule for registration and re-registration fees to cover the costs of the Diversion Control Program. The Diversion Control Program addresses the registration and control of the manufacture, distribution, dispensing, importation and exportation of controlled substances and List I chemicals as mandated by the Controlled Substances Act. DEA is considering four methodologies to calculate registration and re-registration fees: Past-Based Option, Future-Based Option, Flat Fee Option, and Weighted-Ratio Option. Although the increase in the fees may be passed down to the registrants' customers, the alternatives are analyzed on the worst-case scenario where the increase in the fee is absorbed fully by the registrants. For each of the alternatives considered, the calculated fees are analyzed for reasonableness by examining the absolute amount of the fee increase, the change in fee as a percentage of revenue from 2007 to 2012, and the relative fee increase across registrant groups. Comments in the proposed revisions are due to DEA by Sept. 6. For a copy of the proposed rule, go to www.gpo.gov/fdsys/pkg/FR-2011-07-06/pdf/2011-16847.pdf.