The Drug Enforcement Administration (DEA) has officially changed tramadol from a non-classified drug to a Schedule IV substance under the Controlled Substances Act, effective Aug. 18, 2014. This change was published in the Federal Register (2014;79:37624).
Ever since the FDA approved tramadol for the management of chronic pain in 1995, there has been an ongoing debate over its safety, potential for abuse and regulation.
In 2010, the assistant secretary of the Department of Health and Human Services (HHS) provided the DEA with evidence in favor of a scheduling change. After a review of the available data and the recommendation from HHS, the DEA published a notice of proposed rulemaking to classify tramadol as a Schedule IV controlled substance in November 2013.
The notice allowed anyone interested to submit written comments on the proposal: 16 supported the change, nine opposed it and two did not take a position. The opponents argued that controlling tramadol would limit its access to elderly patients and called for a solution to ensure timely access for patients in long-term care facilities.
The DEA maintained, however, that the change should not hinder valid access to the drug for those with an appropriate medical condition and legal prescription in any setting.