III to II – And So the Schedule Goes for Hydrocodone Combo Products

On October 24, 2013 the FDA announced its intent to recommend to the Drug Enforcement Administration (DEA) that Hydrocodone-containing combination products be rescheduled into the more restrictive Schedule II.  Such a move will make it more difficult for patients to obtain the products, as well as for healthcare practitioners to prescribe these products.  In most states, Schedule II drugs cannot be refilled and must have an original written prescription each time a prescription is dispensed. 

The FDA announcement may be found here. The DEA has long been a vocal proponent of the rescheduling. FDA’s recommendation is expected to be formally submitted through the Department of Health and Human Services and the National Institute on Drug Abuse, who will undoubtedly concur with the recommendation, to the DEA, after which the process for the change will begin in earnest.

This move is understandable since Hydrocodone combination products are among the most abused drugs in this country.  The discussion has been going on for a long time and all stakeholders have been involved in the process.  How long the rescheduling will take is not known, but what is clear is that this is going to happen.  Thus, manufacturers and distributors must begin now to make appropriate arrangements to assure proper storage of the products when they become Schedule II drugs and should begin getting ready for label changes for the new designation.  There will need to be some transition period; thus, firms must understand their burn rates of the Schedule III labeled products so they are not caught with a significant amount of product to recall.  All interested parties, therefore, need to keep a close eye on this process to assure a smooth transition.

Questions on this issue as well as other regulatory matters should directed to Joan Janulis (j.janulis@lachmanconsultants.com).