DEA Final Rule Reclassifies Hydrocodone Combination Products to Schedule II

The Drug Enforcement Administration (DEA) has 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 October 6, 2014, the rule moves hydrocodone combination products from Schedule III to Schedule II.

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, hydrocodone combination products 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.

The American Health Care Association submitted comments requesting delayed implementation to allow SNFs to accept orders for hydrocodone from physicians as done in hospitals. The final rule allows a form of delayed implementation of 45 days from the date of publication to the effective date, versus the usual 30 days. Pages 49672-49673 of the final rule address the impact on long term care facilities. Click here to read the final rule.