DEA: Placement of Tramadol Into Schedule IV

July 11, 2014 -- The U.S. Drug Enforcement Administration (DEA) has announced tramadol has been placed into schedule IV of the Controlled Substances Act (CSA) effective August 18, 2014. The new scheduling applies to all tramadol salts, isomers, and salts of isomers.

This action imposes the regulatory controls applicable to schedule IV controlled substances on persons who handle or propose to handle tramadol.

The Controlled Substances Act (CSA) is the federal U.S. drug policy under which the manufacture, importation, possession, use and distribution of certain narcotics, stimulants, depressants, hallucinogens, anabolic steroids and other chemicals is regulated. Under the CSA, every controlled substance is classified in one of five schedules based upon its potential for abuse, currently accepted medical use, and the degree of dependence the drug or other substance may cause.

Schedule IV drugs have a low potential for abuse relative to the drugs in schedule III. These drugs have a currently accepted medical use in treatment in the United States. Abuse of the drug may lead to limited physical dependence or psychological dependence relative to the drugs in schedule III.

Tramadol is a centrally acting opioid analgesic that has been widely used in Europe since the mid-1970s. It was first approved for use in the United States by the U.S. Food and Drug Administration (FDA) in 1995 under the trade name Ultram, but was not scheduled under the CSA at that time. Subsequently, the FDA approved for marketing generic, combination, and extended release tramadol products including Ultracet, Ultram ER, ConZip, Ryzolt and Rybix ODT. The rescheduling of tramadol comes at a time of growing concern relating to abuse and misuse of opioid analgesics.

The Drug Enforcement Administration's decision follows the September 2010 scheduling recommendation by the Assistant Secretary of the HHS. After assessment of tramadol's abuse potential, legitimate medical use, and dependence liability, it was recommended that tramadol be scheduled as a Class IV substance. After a review of the available data, including the scientific and medical evaluation, the DEA concluded that tramadol has an abuse potential and meets the requirements for schedule IV controls under the CSA.

Posted: July 2014


View comments

Hide
(web3)