Avalere Health
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Oct 28, 2013

FDA’s Statement on Proposed Hydrocodone Reclassification

Published

Oct 28, 2013

On October 24, Janet Woodcock, Director of the Center for Drug Evaluation and Research (CDER) at FDA, issued a statement indicating the Agency’s intent to recommend reclassifying hydrocodone combination products from Schedule III to Schedule II products.

Her recommendation is in response to the DEA’s 2009 request to HHS to change the classification of hydrocodone combination products, hoping to address widespread abuse of opioid drug products in the U.S.  Such changes will likely enforce much stricter security controls for patients and prescribers of hydrocodone, as well as causing manufacturers and distributors to comply with much stricter DEA-mandated Schedule II storage and security requirements.

Assuming the DEA follows FDA’s recommendations, stricter scheduling requirements will put the cost burden on manufacturers and some distributors, as many will need to devote additional resources to meeting DEA requirements.

FDA says they will submit a National Institute on Drug Abuse-approved formal recommendation package to HHS by December 2013.

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