By Karla L. Palmer –
On Monday, November 4, 2013, the Drug Enforcement Administration (“DEA”) published a notice of proposed rulemaking (“NPR” ), proposing to place the substance 2 –((diemthylamino)methyl)-1-(3-methyloxyphenyl) cyclohexanol), and its salts, isomers, salts of isomers, and all isometric configurations of possible forms, including tramadol, in Schedule IV of the Controlled Substances Act (“CSA”). Although not entirely unexpected given DEA’s published concerns about the abuse potential, it comes at time almost eighteen years after the drug was first marketed in the Untied States.
Trade names of the substance include Ultram® and Ultracet®. Schedule IV controlled substances are those substances that have a low potential for abuse relative to drugs in Schedule III, have a currently accepted medical use in the United States, and the abuse of the drug could lead to limited physical dependence relative to the drugs in Schedule III. Tramadol was approved for marketing in 1995 as a non-controlled analgesic. The drug was not scheduled based on information related to its low potential for abuse and very weak narcotic effect. DEA now reports that data demonstrates, because of inadequate product labeling (which has undergone several revisions) and lack of established abuse potential, it has become known to narcotics abusers. As a result, DEA received numerous reports of its abuse and dependence (see here). At least 10 states have already scheduled tramadol as a controlled substance, and at least four citizen petitions to reschedule tramadol have been pending at DEA since approximately 2005.
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