Posted 21 August 2014
By Alexander Gaffney, RAC
In a long-anticipated move, the Drug Enforcement Administration (DEA) has announced it will now regulate all hydrocodone combination products as Schedule II drugs under federal law.
The move follows an October 2013 recommendation by the US Food and Drug Administration (FDA), which also recommended that the drugs be regulated as Schedule II products under the Controlled Substances Act (CSA), a 1970 law which places controls on substances known to be dangerous, prone to abuse or lacking medically-accepted uses.
Combination hydrocodone products were previously regulated as Class III products under the CSA, meaning DEA considered them to have a moderate potential for abuse and the potential for dependency issues, but still recognized their accepted medical use.
As a Class II substance, the hydrocodone combination products will be considered to have a recognized medical benefit, but also a high potential for abuse and dependency, and will be subject to more stringent prescribing controls, such as bans on refills.
Non-combination hydrocodone drugs are already Schedule II drugs under the CSA, but the new policy will affect some of the country's most popular painkillers, including Vicodin. FDA last year cited figures indicating that hydrocodone combination products were prescribed more than 130 million times in the US in 2011 alone—a figure that has likely risen since then.
The new scheduling decision, announced 21 August 2014 in a Federal Register notice issued by DEA, brings to a close a five-year process that began in 2009, when DEA petitioned FDA to determine if hydrocodone-containing products should be regulated more stringently under the CSA.
DEA's decision had been anticipated since February 2014, when it released a draft version of the final rule. DEA said in its rule that it received more than 500 comments on its proposed rule, of which roughly half supported the measure, while another half opposed it, citing factors that included the difficulty of obtaining refills for painkillers and the added cost of needing to see a physician on a monthly basis.
The rule comes into effect in 45 days.
Regulatory Focus Article on FDA Recommendation