On August 22, 2014, the United States Drug Enforcement Administration (DEA) published a notice in the Federal Register announcing the reclassification of Hydrocodone Combination Products (HCPs) as Schedule II narcotics under the Controlled Substances Act, 21 U.S.C. §§ 801, et. seq (the CSA). Under the new rule, any combination painkiller containing hydrocodone or oxycodone constitutes a Schedule II narcotic. The rule applies to widely used, name brand HCPs, such as Vicodin and Lortab, as well as to individualized specialty compounds. The regulatory change is effective October 1, 2014 and has far reaching implications for both pharmacies and prescribers.
The reclassification from Schedule III to Schedule II is the culmination of lobbying efforts by the DEA dating back to 2009. While pure hydrocodone and oxycodone have been classified as Schedule II drugs since 1971, the DEA long has argued that HCPs are equally dangerous due to their addictive qualities and over-prescription.
As a result of the reclassification, seemingly non-addictive drugs, such as ibuprofen and acetaminophen, will be considered Schedule II narcotics if they are ingredients in HCPs. Pharmacies and prescribers will be forced to carefully scrutinize outgoing drugs to determine whether they qualify as an HCP. The DEA imposes increased record keeping, tracking, and security requirements for Schedule II narcotics. Pharmacies and prescribers must be aware of these distinctions as they now apply to HCPs.
There are other practical ramifications that impinge on both patients and prescribers. For example, prescribers will be restricted in the amount of pills they can prescribe for any given time. Schedule II narcotics cannot be prescribed in excess of a three (3) month supply. Refills are prohibited and therefore require a new prescription after three (3) months. It is unclear how the DEA will address outstanding prescriptions with automatic refills in October 2014.
Finally, pharmacies and prescribers should be aware that the reclassification has a direct impact on state regulatory boards, which frequently defer to the CSA in drafting state rules. Pharmacy Benefit Managers (PBMs) may use the reclassification as an opportunity to put additional pressure on pharmacies responding to the change. Frier Levitt can assist pharmacies in responding to the reclassification and in meeting various legal standards. Frier Levitt can advise clients on compliance with State and Federal laws and regulations. Contact Frier Levitt for help navigating your pharmacy through the evolving regulatory requirements and avoiding potential liability.
