The U.S. Drug Enforcement Administration (DEA) has published the Final Rule moving hydrocodone combination products (HCPs) from Schedule III to Schedule II in the Federal Register. This Rule follows the recommendation by the Assistant Secretary for Health of the U.S. Department of Health and Human Services (HHS) and is supported by the DEA’s own evaluation of clinical data.
The DEA initially received a petition requesting that HCPs be reclassified as Schedule II of the Controlled Substances Act. In 2004, the DEA requested the HHS to provide scientific and medical evaluation of available data and a scheduling recommendation for HCPs. In 2008, the HHS recommended that HCPs remain controlled as a Schedule III drug. However, in 2009, the DEA requested that the data be reevaluated and another scientific and medical evaluation be provided. In December of 2013, the HHS submitted the reevaluation and their recommendation to place HCPs in Schedule II. The final conclusion to shift HCPs into Schedule II were based on the following findings: HCPs have a high potential for abuse (comparable to the Schedule II substance oxycodone), HCPs have a currently accepted medical use in treatment in the United States, and the abuse of HCPs may lead to severe psychological or physical dependence.
This issuance affects all persons who handle (eg, manufacture, distribute, dispense, import, export, engage in research, conduct instructional activities with, conduct chemical analysis with, or possess) or propose to handle HCPs. This Final Rule will go into effect in 45 days.
For more information visit FederalRegister.gov.