The U.S. Drug Enforcement Administration (DEA) announced it will publish the Final Rule moving hydrocodone combination products (HCPs) from Schedule III to Schedule II on August 22 in the Federal Register. This Rule follows the recommendation by the Assistant Secretary for Health of the U.S. Department of Health and Human Services (HHS) and is supported by the DEA's own evaluation of clinical data.
The new rules include these requirements:
HCP prescriptions issued on or after Oct. 6 must comply with requirements for Schedule II prescriptions. Refills are prohibited.
HCP prescriptions issued before Oct. 6 with authorized refills may be dispensed in accordance with DEA rules for refilling, partial filling, transferring and central filling Schedule III-V controlled substances until April 8, 2015.
Compliance with the Schedule II requirements for HCP prescriptions means that effective Oct. 6, HCP prescriptions must be written on paper or electronically transmitted. Fax transmission is not allowed. Except for emergency situations that are governed by specific requirements, HCP prescriptions also cannot be called into a pharmacy.
The DEA initially received a petition requesting that HCPs be reclassified as Schedule II of the Controlled Substances Act. In 2004, the DEA requested the HHS to provide scientific and medical evaluation of available data and a scheduling recommendation for HCPs. In 2008, the HHS recommended that HCPs remain controlled as a Schedule III drug. However, in 2009, the DEA requested that the data be reevaluated and another scientific and medical evaluation be provided. In December of 2013, the HHS submitted the reevaluation and their recommendation to place HCPs in Schedule II. The final conclusion to shift HCPs into Schedule II were based on the following findings: HCPs have a high potential for abuse (comparable to the Schedule II substance oxycodone), HCPs have a currently accepted medical use in treatment in the United States, and the abuse of HCPs may lead to severe psychological or physical dependence.