DEA Revises Fee Schedule

On August 29, 2006, DEA published in the Federal Register a Final Rule which establishes the schedule for DEA registration and reregistration application fees relating to the manufacture, distribution, and dispensing of controlled substances and listed chemicals to appropriately reflect all costs associated with its Diversion Control Program to conduct activities as mandated by 21 U.S.C. 822 and 958. A Notice of Proposed Rulemaking regarding this matter was published in the Federal Register on November 16, 2005.

The fee schedule is effective for all new and renewal applications postmarked on or after November 1, 2006.

Why is DEA Adjusting the Fees?

The Controlled Substances Act (CSA) requires that all manufacturers, distributors, dispensers, importers and exporters of controlled substances and List I chemicals obtain an annual registration with DEA (21 U.S.C. 822 and 958(f)). In addition, the CSA, as codified in 21 U.S.C. 821, authorizes the Attorney General, who in turn redelegates this authority to the Administrator of DEA, to "promulgate rules and regulations and to charge reasonable fees relating to the registration and control of the manufacture, distribution, and dispensing of controlled substances and listed chemicals" (21 U.S.C. 821 as amended by Pub. L. 108-447).

In October 1992, Congress passed the Departments of Commerce, Justice and State, the Judiciary, and Related Agencies Appropriations Act of 1993 which changed the source of funding for DEA's Diversion Control Program from being part of DEA's Congressional appropriation to full funding by registration and reregistration fees through the establishment of the Diversion Control Fee Account. The Appropriations Act of 1993 required that "[f]ees charged by the Drug Enforcement Administration under its diversion control program shall be set at a level that ensures the recovery of the full costs of operating the various aspects of that program." The legislation did not, however, provide clarification on what constituted the "Diversion Control Program," thus leaving open the issue as to what fee-setting criteria should be used to determine which costs could be reimbursed from the Diversion Control Fee Account.

On November 20, 2004, Congress passed the Departments of Commerce, Justice, and State, the Judiciary, and Related Agencies Appropriations Act of 2005 which provided clarification as to the activities constituting the Diversion Control Program. This Act was included in the Consolidated Appropriations Act of 2005, which was signed into law by the President on December 8, 2004 (Pub. L. 108-447). The Act amended 21 U.S.C. 886a to define the Diversion Control Program as "the controlled substance and chemical diversion control activities of the Drug Enforcement Administration," which are further defined as the "activities related to the registration and control of the manufacture, distribution and dispensing, importation and exportation of controlled substances and listed chemicals."

DEA is bound by all of the above-referenced statutory requirements in setting fees that recover the "full cost" of the Diversion Control Program and its activities, as defined in the most recent legislative action. Therefore, DEA has developed this rulemaking according to these legislative mandates.

Who is Affected by this Rulemaking and How?

All persons who manufacture, distribute, dispense, import, or export controlled substances and List I chemicals are affected by this rule. As mentioned previously, the new fees become effective November 1, 2006. The new fee schedule will be in effect for all new applications postmarked on or after November 1, 2006 and for all renewal applications postmarked on or after November 1, 2006.

The new and previous fee schedules are as follows:

*Practitioners, Mid-level Practitioners, Pharmacies, Hospitals/Clinics, and Teaching Institutions will pay a fee of $184 per annual registration period.

Summary

The new fee schedule will bring DEA’s Diversion Control Program’s budget in line with its operating costs as required by law. Importantly, it will allow DEA to continue to provide key diversion control services to detect and eliminate the diversion of controlled pharmaceuticals and listed chemicals from legitimate channels to illegal use, while at the same time ensuring their availability for legitimate medical and scientific purposes.

For more information on the Final Rule and DEA’s Diversion Control Program, contact Mark W. Caverly, Chief of the Liaison and Policy Section, at (202) 307-7297.