DEA Reschedules Hydrocodone Combination Products

On August 22nd, the US Drug Enforcement Agency (DEA) formally rescheduled hydrocodone combination products (HCPs), moving them from Schedule III to Schedule II of the Controlled Substances Act. This move of HCPs to a more restrictive class was supported by a DEA evaluation of relevant data and recommended by the U.S. Department of Health and Human Services’ (HHS) Assistant Secretary for Health.

Starting on October 6th, HCP prescriptions must comply with Schedule II protocols, which mean prescription refills will be prohibited. According to the American Medical Association (AMA), this reclassification won’t prevent the authorized refill of HCP prescriptions issued prior to October 6th, but “state law, insurance limitations, and some pharmacy quality and safety operations and processes” may. Due to the tenuous refill eligibility of HCP prescriptions issued prior to October 6th, the AMA recommends that prescribers issue new prescriptions to patients starting on October 6th, rather than relying on preexisting refills. According to this new law, “prescriptions for HCPs must be written on a hard copy, original prescription or electronically transmitted where e-prescribing of C-IIs is allowed by state law.” Accordingly, prescriptions for HCPs can’t be called or faxed into pharmacies and refills are prohibited—though multiple, consecutive prescriptions, that allow up to 90 days of medication, may be issued at once, when it has been deemed medically appropriate.