Regulatory Brief

 Schedules of Controlled Substances: Placement of Tramadol into Schedule IV


Formal Title: [Docket No. DEA-351] Schedules of Controlled Substances: Placement of Tramadol into Schedule IV - November 4, 2013

 Excerpts from the AVMA Response:

The Drug Enforcement Administration (DEA) proposes to place tramadol and related isomers into Schedule IV of the Controlled Substances Act (CSA). This proposed action is based on a recommendation from the Assistant Secretary for Health of the Department of Health and Human Services (HHS) and assessments by the DEA. If finalized, this action would impose the regulatory controls and administrative, civil, and criminal sanctions applicable to Schedule IV controlled substances on persons who handle (manufacture, distribute, dispense, import, export, engage in research, conduct instructional activities, or possess) or propose to handle tramadol.
The AVMA acknowledges that tramadol must be utilized with care and diligence in clinical medicine and research, to help avoid adverse events in veterinary patients as well as possible abuse situations. Fortunately, a 2009-2010 Working Group within FDA found that misuse and abuse of opioids within veterinary medicine was low1. Tramadol is typically used for pain relief, alone or in tandem with non-steroidal products in dogs.
Given that the AVMA’s mission is to improve animal and human health and advance the veterinary medical profession, we certainly understand the importance of controlling the use of any drug with high abuse potential. At the same time we would like to point out that due to the burdens associated with registration and record keeping of a Schedule IV controlled substance there is a potential for decreased use of tramadol to the detriment of some patients. The AVMA continues to be committed to educating our members to ensure they have current knowledge of DEA rules.

 Background Documents: