Hydrocodone Combo Products May Shift to Schedule II

The Drug Enforcement Administration (DEA) published a proposal to reschedule hydrocodone combination products (HCPs) from Schedule III to Schedule II. This is a proposal recommended by the Assistant Secretary for Health and supported by the DEA's data evaluation.

The Controlled Substances Act deems the most potentially harmful and abusable medications under Schedule II. Hydrocodone by itself is already classified as Schedule II, but HCPs were placed in Schedule III when Congress passed the Act in 1970. The initial petition to reschedule of HCPs came from a physician in 1999. Following scientific and medical evaluation, the FDA held a public Advisory Committee meeting in January 2013 regarding this matter. The Committee voted 19-10 to recommend rescheduling HCPs from Schedule III to II.

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Study analysis by the Health and Human Services department and the DEA shows high abuse potential with HCPs, which may lead to severe psychological or physical dependence. An increasing trend in emergency department visits, addiction treatment center admissions, and deaths have resulted from HCP abuse. Also, the total prescriptions of HCPs exceed that of any other opioid analgesic, which further compounds their abuse potential and risk.  Several epidemiological surveys and retrospective review of medical records of addiction treatment populations show that HCPs are among the most abused opioids in prescription opioid-dependent patients in the country.

Members of the public are invited to submit comments or request a hearing through Regulations.gov through April 27, 2014.

For more information visit the DEA website.

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