Rescheduling of hydrocodone combination products is set for Oct. 6

The widely prescribed products will have some supply chain hiccups

Tomorrow (Friday), the Federal Register will publish the Drug Enforcement Administration’s final rule on rescheduling hydrocodone combination products (HCPs) from Schedule III to Schedule II. (All the controlled substances DEA regulates are in a I-V schedule, which Schedule I being the most restrictive.) That publication will then make the official date for the entire industry’s conversion effective on October 6.

The action has been a long, long time coming; the DEA news release notes that the original request for rescheduling came in 1999. In 2013, FDA held an advisory panel that voted 19-0 for rescheduling. Still, there are bound to be hiccups in the drug distribution process: No HCP can be distributed with old labels (reading “Sched. III”) after Oct. 6; DEA expects that most product will have already been dispensed since its inventory turnover is relatively rapid; but product with old labels will have to be relabeled or discarded after that date. Product stored at manufacturer and wholesaler warehouses (but not in individual retail pharmacies, depending on regulations that vary by state) need to be in vaults—rooms with no windows that are penetration-resistant. Some prescribers (again, depending on the state) will no longer be able to prescribe the products, while all prescribers will need to fill out a DEA form (Form 222, or to use DEA’s electronic Controlled Substances Ordering System, CSOS.) Prescriptions will need to be filled for 30 days only in many cases (although DEA notes that DEA itself does not mandate this.)

“Our phone is ringing off the hook,” comments Rebecca Ciccarelli, marketing director at Custom Vault (Bethel, CT) a leading provider of modular vault systems for the pharma industry. "We have been working collaboratively with a number of our customers to get ahead of the curve regarding this regulatory change. Unfortunately, there are some industry players that are less prepared. But we are working fast and furious to ensure that all are in compliance quickly."

HCPs are one of the most widely prescribed products in the US. DEA cites data from IMS Health that there were 137 million prescriptions in 2013 for brands including Vicodin, Lortab, Hycodon, Mycodone, Tussionex, Pennkinetic, Tussigon and generics. (Pure hydrocodone, including the recently introduced Zohydro, has been Sched. II already.)

The schedule change is one more measure that federal and state governments, and at least part of the healthcare industry, support to address the ongoing crisis in prescription drug abuse, deaths and drug overdoses, many of which are attributable to HCPs. DEA’s comments in the Federal Register notice say that public comments were in favor of the change (including those from manufacturers adn distributors) by a 52%-41% margin (the remainder having no clear position); of the comments not favoring rescheduling, pharmacists and “ultimate users” (DEA’s term for patients) were a large portion.