As reported in the Federal Register on July 2, 2014, the DEA is rescheduling tramadol as a Schedule IV controlled substance. Manufacturing labeling “CIV” and pharmacy inventory requirements will be effective August 18, 2014. Efforts to place the pain medication in this category came after the Assistant Secretary of the HHS and the DEA performed evaluations and analyses of abuse potential, medical use and dependence liability. Anyone who handles tramadol must abide by registration, disposal, security, labeling, inventory, recording, reporting, prescription, importation/exportation and liability requirements for Controlled Substance Act (CSA) schedule IV regulatory controls following the effective date of August 18, 2014. The agency also pointed out that every “DEA registrant who possesses any quantity of tramadol on the effective date of this final rule must take an inventory of all stocks of tramadol on hand as of August 18, 2014, pursuant to 21 U.S.C. 827 and 958, and in accordance with 21 CFR 1304.03,1304.04, and 1304.11 (a) and (d).”
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