Hydrocodone Combination Products Moved to Schedule 2

On Aug. 22, the Drug Enforcement Administration (DEA) issued a final rule that moved hydrocodone combinations products (HCPs) from Schedule 3 to Schedule 2 of the Controlled Substances Act (CSA), effective Oct. 6, 2014. The DEA received more than 600 comments on the rule, a small majority of which supported the change, according to a DEA press release online.

Upon the effective date of this final rule, any person who handles HCPs will be subject to the CSA’s Schedule 2 regulatory controls. In addition, they will be subject to administrative, civil and criminal sanctions applicable to Schedule 2 controlled substances, including registration, security, labeling and packaging, quotas, inventory, records and reports, orders for HCPs, prescriptions, importation and exportation, and liability.

The complete DEA final rule is available in the Federal Register online. In addition, the American Pharmacists Association has provided information online about concerns with the rescheduling, including the short turnaround time to implement the new requirements, as well as the history of the rescheduling of HCPs and a past joint letter submitted by national organizations representing more than 100,000 pharmacists. MPA will keep members updated on the effects of this rescheduling and provide additional details as they become available.