Hydrocodone Combination Products Reclassified as Schedule II

September 5, 2014 | Strategic Insights for Ambulatory Care


​The U.S. Drug Enforcement Administration (DEA) and the U.S. Department of Justice have published a final rule, available in the August 22, 2014, Federal Register, that reschedules hydrocodone combination products from schedule III to the more restrictive schedule II of the Controlled Substances Act. A list of brand name combination products is available from the National Library of Medicine. In January 2013, the U.S. Food and Drug Administration held a public Drug Safety and Risk Management Advisory Committee meeting, which included members with scientific and medical expertise in the subject of opioid abuse and a patient representative, and public comments were invited. In December 2013, the U.S. Department of Health and Human Services (HHS) submitted its report to DEA recommending that hydrocodone combination products be rescheduled.

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