FDA Committee Recommends Schedule II Classification for Drugs Containing Hydrocodone

Topics: Controlled substances and Prescription drug abuse

The Food and Drug Administration (FDA) Drug Safety and Risk Management Advisory Committee recommended reclassifying hydrocodone combination products as Schedule II controlled substances after a two-day meeting, January 24-25, 2013. The committee voted 19 to 10 in favor of the recommendation after discussing the potential for abuse of drugs containing hydrocodone, either combined with other analgesics or as an antitussive, compared with current Schedule II drugs. The committee also discussed the potential impact of rescheduling the drug products on prescribing patterns, health care delivery, patients, and abuse and misuse of the drug. Drug Enforcement Administration requested FDA to undertake the review and make a recommendation regarding the rescheduling of the drug. FDA officials will now consider the vote and make a recommendation to the Department of Health and Human Services, reports NPR. The authority to schedule or reschedule a drug as a controlled substance resides with the United States Attorney General. The FDA meeting overview (PDF) and briefing document (PDF) are available on the FDA Web site.