Magazine article Drug Topics

FDA Calls for Reclassification of Hydrocodone Products to Schedule II

Magazine article Drug Topics

FDA Calls for Reclassification of Hydrocodone Products to Schedule II

Article excerpt

WAR ON DRUGS

According to a recent FDA announcement, FDA is recommending to the U.S. Department of Health and Human Services (HHS) that hydrocodone combination products such as Vicodin be reclassified under Schedule H, placing tighter controls on the pain medications. Hydrocodone is currently a Schedule EH chug.

"This determination comes after a thorough analysis of extensive scientific literature, review of hundreds of public comments on the issue, and several public meetings," said Janet Woodcock, MD, director, FDA Center for Dmg Evaluation and Research.

This month, FDA will formally submit to HHS its recommendation for the product reclassifications. The agency expects agreement from the National Institute on Dmg Abuse. The Dmg Enforcement Agency will make the final decision.

Early in 2013, FDA's Dmg Safety and Risk Management Advisory Committee favored reclassification in a 19-10 vote. FDA had rejected a similar request for reclassification in 2008.

In March, a bipartisan bill was introduced to reclassify hydrocodone drugs, moving them from Schedule EH to Schedule H of the Controlled Substances Act.

Pharmacy associations respond

The National Association of Chain Dmg Stores (NACDS) continues to oppose the transfer of hydrocodone products to Schedule H, citing "the loss of pain control for millions of Americans."

In February 2013, NACDS, the National Community Pharmacists Association (NCPA), the Long Term Care Pharmacy Alliance, other professional healthcare groups, and patient advocacy groups sent a letter to FDA Commissioner Margaret A. …

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