The Drug Enforcement Administration has placed embutramide into schedule III of the Controlled Substances Act, effective Sept. 28. As a result, the regulatory controls and criminal sanctions of schedule III will be applicable to the manufacture, distribution, dispensing, importation, and exportation of embutramide and products containing embutramide.
In May 2005, the Food and Drug Administration approved a New Animal Drug Application for embutramide for marketing under the trade name Tributame Euthanasia Solution. The product is a combination of embutramide, chloroquine phosphate, and lidocaine for prescription use by intravenous injection for euthanasia of dogs.
According to the DEA, pharmacologic data suggest that the abuse potential of embutramide may be similar to that of other central nervous system depressants such as barbiturates and their products—schedule III through IV—that are controlled under the CSA.
After a review of available data, including a scheduling recommendation from the Department of Health and Human Services, the DEA filed a Notice of Proposed Rulemaking in the July 29, 2005, Federal Register that proposed placement of embutramide into schedule III of the CSA.
In August 2005, the AVMA submitted a comment to the DEA stating that the Association supported placement of embutramide into schedule III of the CSA to reduce the potential for drug diversion. However, the AVMA stated that it did not support the scheduling of Tributame because it believed the characteristics of the final formulation invalidated the potential for abuse. The Association believes the benefits of a prescription but unscheduled humane euthanasia solution are exceedingly valuable.
According to the DEA, available data suggest that the amounts of cardiotoxin present in the Tributame formulation are insufficient to eliminate the abuse potential of the product.
For further information on the DEA's final rule, contact Christine A. Sannerud, PhD, Chief, Drug and Chemical Evaluation Section, Office of Diversion Control, Drug Enforcement Administration, Washington, DC 20537, phone, (202) 307-7183. View the final rule online in the Aug. 29 issue of the Federal Register, available at www.gpoaccess.gov/fr.
To view the AVMA comment to the DEA in response to the July 2005 proposed rule, visit the Advocacy section of the AVMA Web site at www.avma.org/advocacy, click on Regulatory activities, and then click on Practice issue: Making a new embutramide-based euthanasia solution a controlled substance.