Last month, the DEA published in the Federal Register the final rule to transfer hydrocodone combination products (HCPs) from schedule III to schedule II. This rule takes effect Oct. 6, 2014. HCPs have been controlled in schedule III since enactment of the Controlled Substances Act in 1971. HCPs are the most frequently prescribed opioid in the United States: Nearly 137 million prescriptions for HCPs were dispensed in 2013.
Click here to view the final rule for details on the regulatory requirements and various compliance dates.
The DEA has attempted to alleviate any burdens upon registrants caused by a 45-day effective date. For example, the DEA modified quota requirements to allow repackaging/relabeling of HCPs without a quota until Dec. 8, 2014. The department is also permitting legitimate HCP prescriptions issued before Oct. 6, 2014 to be refilled until April 8, 2015, if the prescription authorizes refills.
However, the AMA reports that due to state laws, insurance limitations, and some pharmacy processes, some health insurers and pharmacies may not honor refills on or after Oct. 6, 2014. Therefore, prescribers should be prepared to provide new hard copy or electronic prescriptions for patients beginning on Oct. 6, 2014, rather than have patients use what would have been existing refills. Click here for an AMA information sheet.
The Notice of Proposed Rulemaking (NPRM), Final Rule, and its supporting documents (i.e., medical and scientific evaluations, and economic impact analysis) may be viewed online at www.regulations.gov, Docket No. DEA-389. Or, obtain the documents on the DEA website at www.deadiversion.usdoj.gov.