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DEA rule imposes strictest controls on hydrocondone combination products

August 21, 2014

The Drug Enforcement Administration today issued a final rule imposing stricter regulatory controls and sanctions on people who handle or propose to handle hydrocodone combination products, drugs that contain hydrocodone and specified amounts of other substances. Effective in 45 days, the rule moves HCPs from Schedule III to Schedule II, as recommended by the Department of Health and Human Services and supported by its own evaluation, DEA said. The Controlled Substances Act places substances with accepted medical uses into one of four schedules; schedule II is for substances with the highest potential for harm and abuse. According to an analysis by HHS and the DEA, HCPs have a high potential for abuse, which may lead to severe psychological or physical dependence. A Food and Drug Administration advisory committee also recommended the schedule change last year.