Hydrocodone Combination Products Re-classified as Schedule II Substance

On Friday, August 21, 2014, the U.S. Drug Enforcement Administration published the Final Rule changing hydrocodone combination products from Schedule III to Schedule II in the Federal Register. In 45 days, this change will go into effect and the more restrictive regulatory controls and sanctions of Schedule II substances will apply to the handling of any and all hydrocodone combination products.

Hydrocodone itself has always been in Schedule II, but hydrocodone combination products have been in Schedule III since Congress passed the Controlled Substances Act in 1970. In 1999, a physician petitioned to have hydrocodone combination products rescheduled. Subsequent analyses by both the Assistant Secretary for Health of the U.S. Department of Health and Human Services and the U.S. Drug Enforcement Administration concluded that hydrocodone combination products have a high potential for abuse that could result in dangerous psychological and/or physical dependence.

In 2013, the matter was brought forward in a public Advisory Committee meeting of the U.S. Food and Drug Administration. In a vote of 19 to 10, the committee voted to recommend the reclassification of hydrocodone combination products in Schedule II. By December 2013, this recommendation was forwarded to the U.S. Drug Enforcement Administration, ultimately leading to the Finale Rule published earlier this month.

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