FDA to Recommend Reclassification of Hydrocodone Combination Products as Schedule II Controlled Substances

Food and Drug Administration (FDA) plans to submit a formal recommendation to reclassify hydrocodone combination products as Schedule II controlled substances (CS) to the Department of Health and Human Services by early December 2013. FDA expects the National Institute on Drug Abuse (NIDA) to concur with the recommendation, indicates a statement on the FDA Web site. FDA also indicates that while “the value of and access to these drugs has been a consistent source of public debate,” the agency has “been challenged with determining how to balance the need to ensure continued access to those patients who rely on continuous pain relief while addressing the ongoing concerns about abuse and misuse.” Drug Enforcement Administration (DEA) makes the final decision about the appropriate scheduling of these drugs. In January 2013, FDA’s Drug Safety and Risk Management Advisory Committee made a recommendation that hydrocodone combination products be classified as Schedule II drugs following a 19-to-10 vote that concluded a two-day meeting during which members discussed the potential for abuse and misuse of the medications and the potential impact of rescheduling the drug products.