The Drug Enforcement Administration's increased fee schedule for controlled substances registration becomes effective Dec. 1, 2003.
The fees are being increased despite opposition from the AVMA and other medical organizations. According to the DEA, it is authorized to make the fee increases to cover its operating costs, on the basis of the following three authorities:
- 21 U.S.C.821 authorizes the DEA to collect "reasonable fees relating to the registration and control of the manufacture, distribution, and dispensing of controlled substances and to the registration and control of regulated persons and of regulated transactions"
- 21 U.S.C. 958(f) permits the DEA to collect "reasonable fees relating to the registration of importers and exporters of controlled substances or List 1 chemicals"
- the departments of Commerce, Justice, and State, the Judiciary, and Related Agencies Appropriation Act of 1993 (Pub. L. 102-395) requires the DEA to collect fees to ensure the recovery of the full costs of operating the Diversion Control Program
The new fee schedule will affect all new applications or renewal applications postmarked on or after Dec. 1, 2003. The final rule on controlled substances registration and reregistration application fees was published in the Federal Register, Vol. 68, No. 197 (Oct. 10, 2003).
On the basis of the new fee schedule, the annual costs are as follows for the indicated registrant classes; $1,625 for manufacturers, $813 for distributors and importers/exporters, $130 for dispensers/practitioners, and $130 for researchers and narcotic treatment programs.
The fee increases will be used to cover the DEA's increased cost of "doing business" and the implementation of new programs and initiatives since the last fee increase in 1993. The new initiatives and programs include responding to Internet-based diversion, developing a system to permit electronic transmission of controlled substances prescriptions, developing electronic forms for controlled substances, and increasing the number of diversion investigations.
For more information, write to Patricia M. Good, Chief, Liaison and Policy Section, Office of Diversion Control, Drug Enforcement Administration, Washington, D.C. 20537; phone, (202) 307-7297.